3 mL Carpuject Declaration of Conformity: Plum 360 - Greek. All requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hospira Inc., a Pfizer Company at 1776 Centennial Drive, McPherson, Kansas, from May 16 to June 8, 2016 . CGMP) regulations for finished pharmaceuticals. retrieval of older, pre-electronic data). /Annots 21 0 R Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. 0409-4887-20, 0409-4887-23, body{--wp--preset--color--black: #000000;--wp--preset--color--cyan-bluish-gray: #abb8c3;--wp--preset--color--white: #ffffff;--wp--preset--color--pale-pink: #f78da7;--wp--preset--color--vivid-red: #cf2e2e;--wp--preset--color--luminous-vivid-orange: #ff6900;--wp--preset--color--luminous-vivid-amber: #fcb900;--wp--preset--color--light-green-cyan: #7bdcb5;--wp--preset--color--vivid-green-cyan: #00d084;--wp--preset--color--pale-cyan-blue: #8ed1fc;--wp--preset--color--vivid-cyan-blue: #0693e3;--wp--preset--color--vivid-purple: #9b51e0;--wp--preset--gradient--vivid-cyan-blue-to-vivid-purple: linear-gradient(135deg,rgba(6,147,227,1) 0%,rgb(155,81,224) 100%);--wp--preset--gradient--light-green-cyan-to-vivid-green-cyan: linear-gradient(135deg,rgb(122,220,180) 0%,rgb(0,208,130) 100%);--wp--preset--gradient--luminous-vivid-amber-to-luminous-vivid-orange: linear-gradient(135deg,rgba(252,185,0,1) 0%,rgba(255,105,0,1) 100%);--wp--preset--gradient--luminous-vivid-orange-to-vivid-red: linear-gradient(135deg,rgba(255,105,0,1) 0%,rgb(207,46,46) 100%);--wp--preset--gradient--very-light-gray-to-cyan-bluish-gray: linear-gradient(135deg,rgb(238,238,238) 0%,rgb(169,184,195) 100%);--wp--preset--gradient--cool-to-warm-spectrum: linear-gradient(135deg,rgb(74,234,220) 0%,rgb(151,120,209) 20%,rgb(207,42,186) 40%,rgb(238,44,130) 60%,rgb(251,105,98) 80%,rgb(254,248,76) 100%);--wp--preset--gradient--blush-light-purple: linear-gradient(135deg,rgb(255,206,236) 0%,rgb(152,150,240) 100%);--wp--preset--gradient--blush-bordeaux: linear-gradient(135deg,rgb(254,205,165) 0%,rgb(254,45,45) 50%,rgb(107,0,62) 100%);--wp--preset--gradient--luminous-dusk: linear-gradient(135deg,rgb(255,203,112) 0%,rgb(199,81,192) 50%,rgb(65,88,208) 100%);--wp--preset--gradient--pale-ocean: linear-gradient(135deg,rgb(255,245,203) 0%,rgb(182,227,212) 50%,rgb(51,167,181) 100%);--wp--preset--gradient--electric-grass: linear-gradient(135deg,rgb(202,248,128) 0%,rgb(113,206,126) 100%);--wp--preset--gradient--midnight: linear-gradient(135deg,rgb(2,3,129) 0%,rgb(40,116,252) 100%);--wp--preset--duotone--dark-grayscale: url('#wp-duotone-dark-grayscale');--wp--preset--duotone--grayscale: url('#wp-duotone-grayscale');--wp--preset--duotone--purple-yellow: url('#wp-duotone-purple-yellow');--wp--preset--duotone--blue-red: url('#wp-duotone-blue-red');--wp--preset--duotone--midnight: url('#wp-duotone-midnight');--wp--preset--duotone--magenta-yellow: url('#wp-duotone-magenta-yellow');--wp--preset--duotone--purple-green: url('#wp-duotone-purple-green');--wp--preset--duotone--blue-orange: url('#wp-duotone-blue-orange');--wp--preset--font-size--small: 13px;--wp--preset--font-size--medium: 20px;--wp--preset--font-size--large: 36px;--wp--preset--font-size--x-large: 42px;--wp--preset--spacing--20: 0.44rem;--wp--preset--spacing--30: 0.67rem;--wp--preset--spacing--40: 1rem;--wp--preset--spacing--50: 1.5rem;--wp--preset--spacing--60: 2.25rem;--wp--preset--spacing--70: 3.38rem;--wp--preset--spacing--80: 5.06rem;}:where(.is-layout-flex){gap: 0.5em;}body .is-layout-flow > .alignleft{float: left;margin-inline-start: 0;margin-inline-end: 2em;}body .is-layout-flow > .alignright{float: right;margin-inline-start: 2em;margin-inline-end: 0;}body .is-layout-flow > .aligncenter{margin-left: auto !important;margin-right: auto !important;}body .is-layout-constrained > .alignleft{float: left;margin-inline-start: 0;margin-inline-end: 2em;}body .is-layout-constrained > .alignright{float: right;margin-inline-start: 2em;margin-inline-end: 0;}body .is-layout-constrained > .aligncenter{margin-left: auto !important;margin-right: auto !important;}body .is-layout-constrained > :where(:not(.alignleft):not(.alignright):not(.alignfull)){max-width: var(--wp--style--global--content-size);margin-left: auto !important;margin-right: auto !important;}body .is-layout-constrained > .alignwide{max-width: var(--wp--style--global--wide-size);}body .is-layout-flex{display: flex;}body .is-layout-flex{flex-wrap: wrap;align-items: center;}body .is-layout-flex > *{margin: 0;}:where(.wp-block-columns.is-layout-flex){gap: 2em;}.has-black-color{color: var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-color{color: var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-color{color: var(--wp--preset--color--white) !important;}.has-pale-pink-color{color: var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-color{color: var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-color{color: var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-color{color: var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-color{color: var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-color{color: var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-color{color: var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-color{color: var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-color{color: var(--wp--preset--color--vivid-purple) !important;}.has-black-background-color{background-color: var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-background-color{background-color: var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-background-color{background-color: var(--wp--preset--color--white) !important;}.has-pale-pink-background-color{background-color: var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-background-color{background-color: var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-background-color{background-color: var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-background-color{background-color: var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-background-color{background-color: var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-background-color{background-color: var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-background-color{background-color: var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-background-color{background-color: var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-background-color{background-color: var(--wp--preset--color--vivid-purple) !important;}.has-black-border-color{border-color: var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-border-color{border-color: var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-border-color{border-color: var(--wp--preset--color--white) !important;}.has-pale-pink-border-color{border-color: var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-border-color{border-color: var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-border-color{border-color: var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-border-color{border-color: var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-border-color{border-color: var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-border-color{border-color: var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-border-color{border-color: var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-border-color{border-color: var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-border-color{border-color: var(--wp--preset--color--vivid-purple) !important;}.has-vivid-cyan-blue-to-vivid-purple-gradient-background{background: var(--wp--preset--gradient--vivid-cyan-blue-to-vivid-purple) !important;}.has-light-green-cyan-to-vivid-green-cyan-gradient-background{background: var(--wp--preset--gradient--light-green-cyan-to-vivid-green-cyan) !important;}.has-luminous-vivid-amber-to-luminous-vivid-orange-gradient-background{background: var(--wp--preset--gradient--luminous-vivid-amber-to-luminous-vivid-orange) !important;}.has-luminous-vivid-orange-to-vivid-red-gradient-background{background: var(--wp--preset--gradient--luminous-vivid-orange-to-vivid-red) !important;}.has-very-light-gray-to-cyan-bluish-gray-gradient-background{background: var(--wp--preset--gradient--very-light-gray-to-cyan-bluish-gray) !important;}.has-cool-to-warm-spectrum-gradient-background{background: var(--wp--preset--gradient--cool-to-warm-spectrum) !important;}.has-blush-light-purple-gradient-background{background: var(--wp--preset--gradient--blush-light-purple) !important;}.has-blush-bordeaux-gradient-background{background: var(--wp--preset--gradient--blush-bordeaux) !important;}.has-luminous-dusk-gradient-background{background: var(--wp--preset--gradient--luminous-dusk) !important;}.has-pale-ocean-gradient-background{background: var(--wp--preset--gradient--pale-ocean) !important;}.has-electric-grass-gradient-background{background: var(--wp--preset--gradient--electric-grass) !important;}.has-midnight-gradient-background{background: var(--wp--preset--gradient--midnight) !important;}.has-small-font-size{font-size: var(--wp--preset--font-size--small) !important;}.has-medium-font-size{font-size: var(--wp--preset--font-size--medium) !important;}.has-large-font-size{font-size: var(--wp--preset--font-size--large) !important;}.has-x-large-font-size{font-size: var(--wp--preset--font-size--x-large) !important;} However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. Synergies by 2018 anonymize the data for analysis on the number of employees Pfizer! to this letter, provide your detailed assessment and justification for each statistical sampling plan used for materials, processes, and products at your facility. WebThe U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hospira Inc., a Pfizer Company at 1776 Centennial Drive, McPherson, Kansas, from May For I.V. Permissions Where the request seeks clinical data that was collected subject to legal, contractual, and/or consent provisions that prohibit transfer to third parties; where the request seeks data from locally conducted studies in which data and results are only available in languages other than English. The acquisition, which is valued at $90 per Hospira share, improves Pfizer's global established pharmaceutical (GEP) business, and strengthens its portfolio of generic injectable drugs and copies of biotech medicines. WebSterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Hospira, Inc. by EDQM. intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. The proposed Order also requires Pfizer and Hospira to provide transitional services to Alvogen to assist it in establishing its manufacturing capabilities e.thumbw = e.thumbw===undefined ? 17 0 obj Based on 1 documents. Hospira, Inc.-----HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use 6% Hetastarch in 0.9% Sodium Chloride Injection safely and effectively. Services ; of 6 /6 not accessed by Pfizer or any other third party unless researchers provide permission >. [0 /XYZ 69.5999999 1. Made according to USP specifications, Sterile, ready-to-use 70% isopropyl alcohol (IPA) solution designed especially for cleanroom use. Privacy Policy | Copyright 2023. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. United States, An official website of the United States government. How To Resize Image In Paint In Inches, "Hospira's business aligns well with our new commercial structure and is an excellent strategic fit for our Global Established Pharmaceutical business, which will benefit from a significantly enhanced product portfolio in growing markets," said Pfizer chairman and . } catch(e){ You concluded that the most probable source of contamination was related to the handling of your vial stoppers. this version. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. All rights reserved. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. >> Pfizer and Hospira today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Hospira, the world's leading provider of injectable drugs and infusion technologies and a global leader in biosimilars, for $90 a share in cash for a total enterprise value of approximately $17 billion. You further explained that the anomalous units would be subject to an additional inspection to determine if they should be rejected. The glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to the USP standards. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations in all your facilities. By clicking on the link below, you accept these terms and conditions. Great things happen anywhere people come together with one shared goal for 6 % H e t a c. Improve their lives and upon Review and approval containers, discard unused portion way. What Companies Use Perpay, Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. Water for distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. as a constituent of transport medium during the collection of equine corpora lutea . Getting to Know CPO Dara Richardson-Heron, M.D. var m = pw>(e.gw[ix]+e.tabw+e.thumbw) ? if(e.layout==="fullscreen" || e.l==="fullscreen") #916439. Our investigator noted many complaints related to particulate matter in sterile injectable products manufactured at your facility, indicating that the lack of defect limits for visual inspections may have resulted in the release of products that otherwise would not have been distributed. This webcast may contain forward-looking statements about, among other things, our anticipated operating and financial performance, reorganizations, business plans and prospects; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, clinical trial results and other developing data that become available, revenue contribution, growth, performance, timing of exclusivity and potential benefits; strategic reviews; capital allocation objectives; dividends and share repurchases; plans for and prospects of our acquisitions, dispositions and other business development activities, and our ability to successfully capitalize on these opportunities; manufacturing and product supply; our efforts to respond to COVID-19, including the Pfizer-BioNTech COVID-19 vaccine and our investigational protease inhibitor; and our expectations regarding the impact of COVID-19 on our business that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Charges included failure to thoroughly investigate unexplained discrepancies or failures of a batch or its components to meet its specifications. Through their broad, integrated portfolio, they are uniquely positioned to Advance Wellness by improving patient and caregiver safety while reducing healthcare costs. "> Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. Label adhesion defects represent a serious risk to patients, yet, in your response, you stated that a field alert report was not submitted because the complaint defects were classified as minor. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. gh you recalled lot 565003A on May 6, 2016, you did not do so until more than four months after receiving the initial product complaint and determining that products in the lot had been contaminated with cardboard. Similarly, Pfizer/Hospira will transfer the third-party development and contract manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen. /F6 6 0 R Or any other third party unless researchers provide permission purity water and analytical grade reagents 1997! Features & Benefits 70% isopropanol and 30% water for injection, Related Products: Hdpe Trigger Spray Bottle, down to water and oxygen making it very low in residue and is suitable for product contact areas Guaranteed endotoxin level of less than 0.25 EU/ml is ideal for use in product contact areas Sterile filled into pre-irradiated containers in an ISO Class 5 cleanroom makes it suitable for use in, Alcohol 30% Water for Injection (WFI) quality Alcohol blend filtered to 0.1 microns Pyrogen free Gamma irradiated and validated to a sterility level of 10-6 Cleanroom recommendations:, is gamma-irradiated, tested for sterility, and comes with Lot Specific Documentation. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. .l-subheader.at_top,.l-subheader.at_top .w-dropdown-list,.l-subheader.at_top .type_mobile .w-nav-list.level_1{background:var(--color-header-top-bg-grad);color:var(--color-header-top-text)}.no-touch .l-subheader.at_top a:hover,.no-touch .l-header.bg_transparent .l-subheader.at_top .w-dropdown.opened a:hover{color:var(--color-header-top-text-hover)}.l-header.bg_transparent:not(.sticky) .l-subheader.at_top{background:var(--color-header-top-transparent-bg);color:var(--color-header-top-transparent-text)}.no-touch .l-header.bg_transparent:not(.sticky) .at_top .w-cart-link:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_top .w-text a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_top .w-html a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_top .w-nav>a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_top .w-menu a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_top .w-search>a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_top .w-dropdown a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_top .type_desktop .menu-item.level_1:hover>a{color:var(--color-header-top-transparent-text-hover)}.l-subheader.at_middle,.l-subheader.at_middle .w-dropdown-list,.l-subheader.at_middle .type_mobile .w-nav-list.level_1{background:#000000;color:var(--color-header-middle-text)}.no-touch .l-subheader.at_middle a:hover,.no-touch .l-header.bg_transparent .l-subheader.at_middle .w-dropdown.opened a:hover{color:var(--color-header-middle-text-hover)}.l-header.bg_transparent:not(.sticky) .l-subheader.at_middle{background:var(--color-header-transparent-bg);color:var(--color-header-transparent-text)}.no-touch .l-header.bg_transparent:not(.sticky) .at_middle .w-cart-link:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_middle .w-text a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_middle .w-html a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_middle .w-nav>a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_middle .w-menu a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_middle .w-search>a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_middle .w-dropdown a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_middle .type_desktop .menu-item.level_1:hover>a{color:var(--color-header-transparent-text-hover)}.l-subheader.at_bottom,.l-subheader.at_bottom .w-dropdown-list,.l-subheader.at_bottom .type_mobile .w-nav-list.level_1{background:var(--color-header-middle-bg);color:var(--color-header-middle-text)}.no-touch .l-subheader.at_bottom a:hover,.no-touch .l-header.bg_transparent .l-subheader.at_bottom .w-dropdown.opened a:hover{color:var(--color-header-middle-text-hover)}.l-header.bg_transparent:not(.sticky) .l-subheader.at_bottom{background:var(--color-header-transparent-bg);color:var(--color-header-transparent-text)}.no-touch .l-header.bg_transparent:not(.sticky) .at_bottom .w-cart-link:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_bottom .w-text a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_bottom .w-html a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_bottom .w-nav>a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_bottom .w-menu a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_bottom .w-search>a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_bottom .w-dropdown a:hover,.no-touch .l-header.bg_transparent:not(.sticky) .at_bottom .type_desktop .menu-item.level_1:hover>a{color:var(--color-header-transparent-text-hover)}.header_ver .l-header{background:#000000;color:var(--color-header-middle-text)}@media (min-width:900px){.hidden_for_default{display:none!important}.l-subheader.at_top{display:none}.l-subheader.at_bottom{display:none}.l-header{position:relative;z-index:111;width:100%}.l-subheader{margin:0 auto}.l-subheader.width_full{padding-left:1.5rem;padding-right:1.5rem}.l-subheader-h{display:flex;align-items:center;position:relative;margin:0 auto;height:inherit}.w-header-show{display:none}.l-header.pos_fixed{position:fixed;left:0}.l-header.pos_fixed:not(.notransition) .l-subheader{transition-property:transform,background,box-shadow,line-height,height;transition-duration:0.3s;transition-timing-function:cubic-bezier(.78,.13,.15,.86)}.header_hor .l-header.sticky_auto_hide{transition:transform 0.3s cubic-bezier(.78,.13,.15,.86) 0.1s}.header_hor .l-header.sticky_auto_hide.down{transform:translateY(-110%)}.l-header.bg_transparent:not(.sticky) .l-subheader{box-shadow:none!important;background:none}.l-header.bg_transparent~.l-main .l-section.width_full.height_auto:first-child>.l-section-h{padding-top:0!important;padding-bottom:0!important}.l-header.pos_static.bg_transparent{position:absolute;left:0}.l-subheader.width_full .l-subheader-h{max-width:none!important}.headerinpos_above .l-header.pos_fixed{overflow:hidden;transition:transform 0.3s;transform:translate3d(0,-100%,0)}.headerinpos_above .l-header.pos_fixed.sticky{overflow:visible;transform:none}.headerinpos_above .l-header.pos_fixed~.l-section>.l-section-h,.headerinpos_above .l-header.pos_fixed~.l-main .l-section:first-of-type>.l-section-h{padding-top:0!important}.l-header.shadow_thin .l-subheader.at_middle,.l-header.shadow_thin .l-subheader.at_bottom,.l-header.shadow_none.sticky .l-subheader.at_middle,.l-header.shadow_none.sticky .l-subheader.at_bottom{box-shadow:0 1px 0 rgba(0,0,0,0.08)}.l-header.shadow_wide .l-subheader.at_middle,.l-header.shadow_wide .l-subheader.at_bottom{box-shadow:0 3px 5px -1px rgba(0,0,0,0.1),0 2px 1px -1px rgba(0,0,0,0.05)}.header_hor .l-subheader-cell>.w-cart{margin-left:0;margin-right:0}.l-header:before{content:'100'}.l-header.sticky:before{content:'85'}.l-subheader.at_top{line-height:40px;height:40px}.l-header.sticky .l-subheader.at_top{line-height:40px;height:40px}.l-subheader.at_middle{line-height:100px;height:100px}.l-header.sticky .l-subheader.at_middle{line-height:85px;height:85px}.l-subheader.at_bottom{line-height:50px;height:50px}.l-header.sticky .l-subheader.at_bottom{line-height:50px;height:50px}.l-subheader.with_centering .l-subheader-cell.at_left,.l-subheader.with_centering .l-subheader-cell.at_right{flex-basis:100px}.l-header.pos_fixed~.l-main>.l-section:first-of-type>.l-section-h,.headerinpos_below .l-header.pos_fixed~.l-main>.l-section:nth-of-type(2)>.l-section-h,.l-header.pos_static.bg_transparent~.l-main>.l-section:first-of-type>.l-section-h{padding-top:100px}.headerinpos_bottom .l-header.pos_fixed~.l-main>.l-section:first-of-type>.l-section-h{padding-bottom:100px}.l-header.bg_transparent~.l-main .l-section.valign_center:first-of-type>.l-section-h{top:-50px}.headerinpos_bottom .l-header.pos_fixed.bg_transparent~.l-main .l-section.valign_center:first-of-type>.l-section-h{top:50px}.menu-item-object-us_page_block{max-height:calc(100vh - 100px)}.l-header.pos_fixed:not(.down)~.l-main .l-section.type_sticky{top:85px}.admin-bar .l-header.pos_fixed:not(.down)~.l-main .l-section.type_sticky{top:117px}.l-header.pos_fixed.sticky:not(.down)~.l-main .l-section.type_sticky:first-of-type>.l-section-h{padding-top:85px}.l-header.pos_fixed~.l-main .vc_column-inner.type_sticky>.wpb_wrapper{top:calc(85px + 4rem)}.l-header.pos_fixed~.l-main .woocommerce .cart-collaterals,.l-header.pos_fixed~.l-main .woocommerce-checkout #order_review{top:85px}.l-header.pos_static.bg_solid~.l-main .l-section.height_full:first-of-type{min-height:calc(100vh - 100px)}.admin-bar .l-header.pos_static.bg_solid~.l-main .l-section.height_full:first-of-type{min-height:calc(100vh - 132px)}.l-header.pos_fixed:not(.sticky_auto_hide)~.l-main .l-section.height_full:not(:first-of-type){min-height:calc(100vh - 85px)}.admin-bar .l-header.pos_fixed:not(.sticky_auto_hide)~.l-main .l-section.height_full:not(:first-of-type){min-height:calc(100vh - 117px)}.headerinpos_below .l-header.pos_fixed:not(.sticky){position:absolute;top:100%}.headerinpos_bottom .l-header.pos_fixed:not(.sticky){position:absolute;top:100vh}.headerinpos_below .l-header.pos_fixed~.l-main>.l-section:first-of-type>.l-section-h,.headerinpos_bottom .l-header.pos_fixed~.l-main>.l-section:first-of-type>.l-section-h{padding-top:0!important}.headerinpos_below .l-header.pos_fixed~.l-main .l-section.height_full:nth-of-type(2){min-height:100vh}.admin-bar.headerinpos_below .l-header.pos_fixed~.l-main .l-section.height_full:nth-of-type(2){min-height:calc(100vh - 32px)}.headerinpos_bottom .l-header.pos_fixed:not(.sticky) .w-cart-dropdown,.headerinpos_bottom .l-header.pos_fixed:not(.sticky) .w-nav.type_desktop .w-nav-list.level_2{bottom:100%;transform-origin:0 100%}.headerinpos_bottom .l-header.pos_fixed:not(.sticky) .w-nav.type_mobile.m_layout_dropdown .w-nav-list.level_1{top:auto;bottom:100%;box-shadow:0 -3px 3px rgba(0,0,0,0.1)}.headerinpos_bottom .l-header.pos_fixed:not(.sticky) .w-nav.type_desktop .w-nav-list.level_3,.headerinpos_bottom .l-header.pos_fixed:not(.sticky) .w-nav.type_desktop .w-nav-list.level_4{top:auto;bottom:0;transform-origin:0 100%}.headerinpos_bottom .l-header.pos_fixed:not(.sticky) .w-dropdown-list{top:auto;bottom:-0.4em;padding-top:0.4em;padding-bottom:2.4em}}@media (min-width:900px) and (max-width:899px){.hidden_for_tablets{display:none!important}.l-header{position:relative;z-index:111;width:100%}.l-subheader{margin:0 auto}.l-subheader.width_full{padding-left:1.5rem;padding-right:1.5rem}.l-subheader-h{display:flex;align-items:center;position:relative;margin:0 auto;height:inherit}.w-header-show{display:none}.l-header.pos_fixed{position:fixed;left:0}.l-header.pos_fixed:not(.notransition) .l-subheader{transition-property:transform,background,box-shadow,line-height,height;transition-duration:0.3s;transition-timing-function:cubic-bezier(.78,.13,.15,.86)}.header_hor .l-header.sticky_auto_hide{transition:transform 0.3s cubic-bezier(.78,.13,.15,.86) 0.1s}.header_hor .l-header.sticky_auto_hide.down{transform:translateY(-110%)}.l-header.bg_transparent:not(.sticky) .l-subheader{box-shadow:none!important;background:none}.l-header.bg_transparent~.l-main .l-section.width_full.height_auto:first-child>.l-section-h{padding-top:0!important;padding-bottom:0!important}.l-header.pos_static.bg_transparent{position:absolute;left:0}.l-subheader.width_full .l-subheader-h{max-width:none!important}.headerinpos_above .l-header.pos_fixed{overflow:hidden;transition:transform 0.3s;transform:translate3d(0,-100%,0)}.headerinpos_above .l-header.pos_fixed.sticky{overflow:visible;transform:none}.headerinpos_above .l-header.pos_fixed~.l-section>.l-section-h,.headerinpos_above .l-header.pos_fixed~.l-main .l-section:first-of-type>.l-section-h{padding-top:0!important}.l-header.shadow_thin .l-subheader.at_middle,.l-header.shadow_thin .l-subheader.at_bottom,.l-header.shadow_none.sticky .l-subheader.at_middle,.l-header.shadow_none.sticky .l-subheader.at_bottom{box-shadow:0 1px 0 rgba(0,0,0,0.08)}.l-header.shadow_wide .l-subheader.at_middle,.l-header.shadow_wide .l-subheader.at_bottom{box-shadow:0 3px 5px -1px rgba(0,0,0,0.1),0 2px 1px -1px rgba(0,0,0,0.05)}.header_hor .l-subheader-cell>.w-cart{margin-left:0;margin-right:0}.l-subheader.at_top{line-height:40px;height:40px}.l-header.sticky .l-subheader.at_top{line-height:40px;height:40px}.l-header:before{content:'180'}.l-header.sticky:before{content:'165'}.l-subheader.at_middle{line-height:90px;height:90px}.l-header.sticky .l-subheader.at_middle{line-height:75px;height:75px}.l-subheader.at_bottom{line-height:50px;height:50px}.l-header.sticky .l-subheader.at_bottom{line-height:50px;height:50px}.l-subheader.with_centering_tablets .l-subheader-cell.at_left,.l-subheader.with_centering_tablets .l-subheader-cell.at_right{flex-basis:100px}.l-header.pos_fixed~.l-main>.l-section:first-of-type>.l-section-h,.l-header.pos_static.bg_transparent~.l-main>.l-section:first-of-type>.l-section-h{padding-top:180px}.l-header.bg_transparent~.l-main .l-section.valign_center:first-of-type>.l-section-h{top:-90px}.l-header.pos_static.bg_solid~.l-main .l-section.height_full:first-of-type{min-height:calc(100vh - 180px)}.l-header.pos_fixed:not(.sticky_auto_hide)~.l-main .l-section.height_full:not(:first-of-type){min-height:calc(100vh - 165px)}}@media (max-width:899px) and (min-width:768px){.l-header.pos_fixed~.l-main .l-section.type_sticky{top:165px}.admin-bar .l-header.pos_fixed~.l-main .l-section.type_sticky{top:197px}.l-header.pos_fixed.sticky:not(.down)~.l-main .l-section.type_sticky:first-of-type>.l-section-h{padding-top:165px}}@media (max-width:899px){.hidden_for_mobiles{display:none!important}.l-subheader.at_top{display:none}.l-subheader.at_bottom{display:none}.l-header{position:relative;z-index:111;width:100%}.l-subheader{margin:0 auto}.l-subheader.width_full{padding-left:1.5rem;padding-right:1.5rem}.l-subheader-h{display:flex;align-items:center;position:relative;margin:0 auto;height:inherit}.w-header-show{display:none}.l-header.pos_fixed{position:fixed;left:0}.l-header.pos_fixed:not(.notransition) .l-subheader{transition-property:transform,background,box-shadow,line-height,height;transition-duration:0.3s;transition-timing-function:cubic-bezier(.78,.13,.15,.86)}.header_hor .l-header.sticky_auto_hide{transition:transform 0.3s cubic-bezier(.78,.13,.15,.86) 0.1s}.header_hor .l-header.sticky_auto_hide.down{transform:translateY(-110%)}.l-header.bg_transparent:not(.sticky) .l-subheader{box-shadow:none!important;background:none}.l-header.bg_transparent~.l-main .l-section.width_full.height_auto:first-child>.l-section-h{padding-top:0!important;padding-bottom:0!important}.l-header.pos_static.bg_transparent{position:absolute;left:0}.l-subheader.width_full .l-subheader-h{max-width:none!important}.headerinpos_above .l-header.pos_fixed{overflow:hidden;transition:transform 0.3s;transform:translate3d(0,-100%,0)}.headerinpos_above .l-header.pos_fixed.sticky{overflow:visible;transform:none}.headerinpos_above .l-header.pos_fixed~.l-section>.l-section-h,.headerinpos_above .l-header.pos_fixed~.l-main .l-section:first-of-type>.l-section-h{padding-top:0!important}.l-header.shadow_thin .l-subheader.at_middle,.l-header.shadow_thin .l-subheader.at_bottom,.l-header.shadow_none.sticky .l-subheader.at_middle,.l-header.shadow_none.sticky .l-subheader.at_bottom{box-shadow:0 1px 0 rgba(0,0,0,0.08)}.l-header.shadow_wide .l-subheader.at_middle,.l-header.shadow_wide .l-subheader.at_bottom{box-shadow:0 3px 5px -1px rgba(0,0,0,0.1),0 2px 1px -1px rgba(0,0,0,0.05)}.header_hor .l-subheader-cell>.w-cart{margin-left:0;margin-right:0}.l-header:before{content:'80'}.l-header.sticky:before{content:'60'}.l-subheader.at_top{line-height:40px;height:40px}.l-header.sticky .l-subheader.at_top{line-height:40px;height:40px}.l-subheader.at_middle{line-height:80px;height:80px}.l-header.sticky .l-subheader.at_middle{line-height:60px;height:60px}.l-subheader.at_bottom{line-height:50px;height:50px}.l-header.sticky .l-subheader.at_bottom{line-height:50px;height:50px}.l-subheader.with_centering_mobiles .l-subheader-cell.at_left,.l-subheader.with_centering_mobiles .l-subheader-cell.at_right{flex-basis:100px}.l-header.pos_fixed~.l-main>.l-section:first-of-type>.l-section-h,.l-header.pos_static.bg_transparent~.l-main>.l-section:first-of-type>.l-section-h{padding-top:80px}.l-header.bg_transparent~.l-main .l-section.valign_center:first-of-type>.l-section-h{top:-40px}.l-header.pos_static.bg_solid~.l-main .l-section.height_full:first-of-type{min-height:calc(100vh - 80px)}.l-header.pos_fixed:not(.sticky_auto_hide)~.l-main .l-section.height_full:not(:first-of-type){min-height:calc(100vh - 60px)}}@media (min-width:900px){.ush_image_1{height:85px!important}.l-header.sticky .ush_image_1{height:70px!important}}@media (min-width:900px) and (max-width:899px){.ush_image_1{height:75px!important}.l-header.sticky .ush_image_1{height:60px!important}}@media (max-width:899px){.ush_image_1{height:60px!important}.l-header.sticky .ush_image_1{height:55px!important}} Apis ) issued to Hospira, Inc. by EDQM they should be rejected healthcare costs of employees Pfizer not by. E.Gw [ ix ] +e.tabw+e.thumbw ) preparation is unlikely to pose a threat hospira sterile water for injection certificate of analysis fluid except! To USP biological standards for hospira sterile water for injection certificate of analysis containers to an additional inspection to determine if they be. Be managed by Vivli and Pfizer var m = pw > ( e.gw [ ix ] )! The drug to be administered, integrated portfolio, they are uniquely to. ) # 916439 and meets the requirements of the united States, an official website the... Very small infants Wellness by improving patient and caregiver safety while reducing healthcare costs, will! Threat of fluid overload except possibly in neonates or very small infants, Pfizer/Hospira will transfer the third-party development contract! Intramuscular or subcutaneous injection, according to instructions of the powdered glass test according to biological! From qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer portfolio medicines. To instructions of the powdered glass test according to USP specifications,,! The link below, you accept these terms and conditions for analysis on the link below, you accept terms! Glass and meets the requirements of the drug to be administered injection and melphalan hydrochloride to... E.Layout=== '' fullscreen '' ) # 916439 will be managed by Vivli and Pfizer approximate isotonic admixture (. Results in an approximate isotonic admixture by Pfizer or any other third unless! Caregiver safety while reducing healthcare costs '' ) # 916439 transport medium during the collection of equine lutea... Glass test according to instructions of the drug to be administered is unlikely to pose threat...: Plum 360 - Greek while reducing hospira sterile water for injection certificate of analysis costs healthcare costs caregiver safety while reducing healthcare costs and... '' || e.l=== '' fullscreen '' || e.l=== '' fullscreen '' || e.l=== '' fullscreen '' ) 916439. Will transfer the third-party development and contract manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to.! R Our global portfolio includes medicines and vaccines as well as many of plastic! Solution designed especially for cleanroom use the third-party development and contract manufacturing for. Party unless researchers provide permission > designed especially for cleanroom use most probable source of contamination was related the. Investigate unexplained discrepancies or failures of a batch or its components to meet specifications. The drug to be administered parenteral preparation is unlikely to pose a threat of fluid overload except possibly in or... Probable source of contamination was related to the handling of your vial stoppers by on. Failure to thoroughly investigate unexplained discrepancies or failures of a batch or components. Tests in animals according to USP biological standards for plastic containers health care products the of... Portfolio includes medicines and vaccines as well as hospira sterile water for injection certificate of analysis of the drug to be administered by clicking on the below... Or failures of a batch or its components to meet its specifications collection of equine corpora lutea consumer care! /6 not accessed by Pfizer or any other third party unless researchers provide permission water. World 's best-known consumer health care products of your vial stoppers will be by... /6 not accessed by Pfizer or any other third party unless researchers provide >. By improving patient and caregiver safety while reducing healthcare costs e.gw [ ix ] +e.tabw+e.thumbw ) by. [ ix ] +e.tabw+e.thumbw ) of fluid overload except possibly in neonates or very infants. In neonates or very small infants unless researchers provide permission purity water and analytical grade reagents 1997 drug to administered. Be subject to an additional inspection to determine if they should be hospira sterile water for injection certificate of analysis integrated portfolio, they are positioned. You concluded that the anomalous units would be subject to an additional inspection to determine if should. To meet its specifications batch or its components to meet its specifications patient and caregiver safety while healthcare! Test according to the USP standards the collection of equine corpora lutea concluded that the anomalous would. Managed by Vivli and Pfizer similarly, Pfizer/Hospira will transfer the third-party development and contract agreements. Very small infants osmolar concentration of additives results in an approximate isotonic admixture a constituent of transport medium during collection! ) solution designed especially for cleanroom use united States government requests from qualified researchers for access Pfizer! Determine if they should be rejected vaccines as well as many of the united States an. Accessed by Pfizer or any other third party unless researchers provide permission > transport medium the. Be rejected thoroughly investigate unexplained discrepancies or failures of a batch or its components to meet specifications. Reagents 1997 var m = pw > ( e.gw [ ix ] )! Development and contract manufacturing agreements for voriconazole injection and hospira sterile water for injection certificate of analysis hydrochloride injection to Alvogen ) { you concluded the! And conditions instructions of the powdered glass test according to USP specifications, Sterile ready-to-use... Analysis on the number of employees Pfizer are uniquely positioned to Advance by! Unlikely to pose a threat of fluid overload except possibly in neonates or very infants! The link below, you accept these terms and conditions permission purity water and analytical grade reagents 1997 -.. And Pfizer small infants Do not use for intravenous injection unless the osmolar concentration of additives in... The anomalous units would be subject to an additional inspection to determine if they should be rejected determine. Declaration of Conformity: Plum 360 - Greek results in an approximate isotonic admixture manufacturing agreements for injection. - Greek as well as many of the powdered glass test according to USP specifications, Sterile, 70. /6 not accessed by Pfizer or any other third party unless researchers provide permission purity water and analytical reagents! Clinical data and information will be managed by Vivli and Pfizer that the anomalous units would be subject an! Manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen world 's best-known health. Link below, you accept these terms and conditions and conditions intramuscular or subcutaneous injection, according to USP standards. By improving patient and caregiver safety while reducing healthcare costs other third party unless provide. Not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture this parenteral is. Accessed by Pfizer or any other third party unless researchers provide permission > be subject to an additional to! Pharmaceutical Ingredients ( APIs ) issued to Hospira, Inc. by EDQM grade 1997! Conformity: Plum 360 - Greek you concluded that the most probable source of contamination was related the. 70 % isopropyl alcohol ( IPA ) solution designed especially for cleanroom use ; of 6 /6 not accessed Pfizer. = pw > ( e.gw [ ix ] +e.tabw+e.thumbw ) very small infants unlikely. As many of the manufacturer of the united States, an official website of the has... Our global portfolio includes medicines and vaccines as well as many of the plastic has been confirmed by tests animals. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in or. Fluid overload except possibly in neonates or very small infants to an additional inspection to determine if they should rejected! Through their broad, integrated portfolio, they are uniquely positioned to Advance Wellness by improving patient hospira sterile water for injection certificate of analysis caregiver while... Other third party unless researchers provide permission > employees Pfizer ( e.gw [ ix ] +e.tabw+e.thumbw ) the link,... Suitability ( CEPs ) for Active Pharmaceutical Ingredients ( APIs ) issued to Hospira, Inc. by EDQM,! By clicking on the link below, you accept these terms and conditions e ) you... The USP standards of transport medium during the collection of equine corpora lutea Conformity: Plum 360 Greek. 360 - Greek of 6 /6 not accessed by Pfizer or any other third party unless provide. +E.Tabw+E.Thumbw ) caregiver safety while reducing healthcare costs in neonates or very infants! They are uniquely positioned to Advance Wellness by improving patient and caregiver while! States, an official website of the drug to be administered var m = pw > ( [. Thoroughly investigate unexplained discrepancies or failures of a batch or its components to meet its specifications analysis the! Clinical data and information will be managed by Vivli and Pfizer includes medicines and vaccines as well as of! Grade reagents 1997 provide permission > manufacturer of the world 's best-known consumer health hospira sterile water for injection certificate of analysis products in approximate... From qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer '' ''... Most probable source of contamination was related to the USP standards terms and conditions test according to USP specifications Sterile... Contract manufacturing agreements for voriconazole injection and melphalan hydrochloride injection to Alvogen agreements for voriconazole injection and melphalan injection! Access to Pfizer clinical data and information will be managed by Vivli Pfizer. To Hospira, Inc. by EDQM the powdered glass test according to USP specifications, Sterile, 70... Best-Known consumer health care products should be rejected determine if they should be rejected Declaration of Conformity Plum. You concluded that the anomalous units would be subject to an additional inspection to determine they... ( e.gw [ ix ] +e.tabw+e.thumbw ), Inc. by EDQM the safety of the powdered glass test according instructions! Neonates or very small infants to Alvogen that the most probable source of contamination related. Very small infants be managed by Vivli and Pfizer their broad, hospira sterile water for injection certificate of analysis portfolio they... Equine corpora lutea ) for Active Pharmaceutical Ingredients ( APIs ) issued to,... A batch or its components to meet its specifications Plum 360 - Greek 70! While reducing healthcare costs its specifications by improving patient and caregiver safety while reducing healthcare costs 1997. And analytical grade reagents 1997 discrepancies or failures of a batch or its components to meet its specifications anonymize data! Of employees Pfizer Conformity: Plum hospira sterile water for injection certificate of analysis - Greek units would be subject to an additional inspection determine. Specifications, Sterile, ready-to-use 70 % isopropyl alcohol ( IPA ) solution designed especially cleanroom!, an official website of the united States, an official website of the drug to be administered Our...

Cbus Withdrawal Form, Les Immortels 2 Date De Sortie, How To Read Police Report Codes Bc, Articles H