WHO PACKAGE INSERT GlaxoSmithKline Biologicals FluLaval -Page Doc ID REGU_200710_3901 1 Dossier First - Chapter 1 to 10 for WHO Chapter 4_Annex 4.4-1_FluLaval WHO leaflet_EN 1 77. Afluria is approved by the Food and Drug Administration for intramuscular administration with the PharmaJet Stratis Needle-Free Injection System for persons age 18 through 64 years. For children who have not previously been vaccinated against seasonal influenza, a second dose anda 077966 - vial labels, carton labeling, package insert 2015-9263 pharm-olam international ltd 10246502 10255696 10275815 etc 2015-9264 nda 021225 s031 FLULAVAL TETRA is a quadrivalent vaccine indicated for active immunization of adults and children from 6 months of age for the prevention of influenza disease caused by influenza virus types A and B contained in the vaccine. Contains Eagle MEM modified medium, calf bovine serum, M-199 without calf bovine serum, vero cells (a continuous line of monkey kidney cells), fussiness, crying, or drowsiness in a child. Age indication per package insert is 5 years; however, ACIP recommends Afluria not be used in children aged 6 months through 8 years because of increased risk of febrile reactions noted in this age group with bioCSL's 2010 Southern Hemisphere IIV3. The product package, syringe label, and patient insert for this product are in German. The following table lists all components, other than antigens, shown in the manufacturers package insert (PI) for each vaccine. 7/20/2021. Contains soy peptone broth, casamino acids, yeast extract-based medium, CRM197 carrier protein, polysorbate 80, succinate buffer, aluminum phosphate Note that package insert pregnancy categories differ between products. 4 CONTRAINDICATIONS . 3 4.2 Posology and method of administration Posology Children and adolescents from 24 months: 0.2 ml (administered as 0.1 ml per nostril). 4/20/2021. The mean age of subjects was 38 years; 80% were aged 18 through 97 . FLULAVAL induced as good a response as FLUZONE. As we age our bodys natural ability to fight infection diminishes, increasing our risk of falling ill and of experiencing severe illness. Store in the original package in order to protect from light. Divided into three typesA, B, and Cthese viruses can infect a range of hosts from humans only (influenza B) to humans and swine (influenza C) to multiple host organisms including humans, swine, equine, avian, and marine mammals (influenza A) (Treanor, 2010). Title: Administering Vaccines: Dose, Route, Site, and Needle Size Keywords: administering vaccines dose route site and needle size, what you need to know about how to administer vaccines, dose route site and needle size for administering vaccines, p3085 flucelvax-seqirus-inc-1-14-1-3-us-package-insert-april 1/3 Downloaded from dev.endhomelessness.org on November 18, 2021 by guest [EPUB] Flucelvax Seqirus Inc 1 14 1 3 Us Package Insert April Eventually, you will enormously discover a supplementary experience and execution by spending more cash. Single-dose 0.5 mL pre-filled glass syringe, available in packs of 1 or 10: with 16 mm needle AUST R 292237. with 25 mm needle AUST R 292238*. *The age indication in the package insert is 5 years and older; however, ACIP recommends Afluria not be used in children 5-8 years due to increased risk of febrile seizures. Wright-Patterson Medical Center will celebrate National Pharmacy Week on Oct. 18-22 to acknowledge the invaluable contributions pharmacists and technicians make to patient care in hospitals, outpatient clinics and other health care settings. Multi-dose vials contain mercury. FLULAVAL QUADRIVALENT has been administered in 8 clinical trials to 1,384 adults aged 18 years and older, 1,965 children aged 6 through 35 months, and 3,516 children aged 3 through 17 years. Do not freeze. 9/1/2021. Package Insert - FluLaval Quadrivalent; Supporting Documents. 5/20/2021. Flulaval Package Insert. Accessed 15 May 2017. However Abbott Laboratories Ltd has provided Health Canada with an approved package insert to support the product shipments during this time.1 25 mL dose in those 6-35 months. Searches without any special characters (listed below) will return items that contain the exact value(s) entered in the search field. Food and Drug Administration. INFLUVAC influenza vaccine, surface antigen, inactivated Page 5 of 38 Date of Revision: December 4, 2014 and Control No. 11/1/2021. FluLaval Quadrivalent (GlaxoSmithKline): 0.5 mL/dose for age 6 months and older For Afluria Quadrivalent 5.0 mL multi-dose vial, the package insert states that the stopper can be punctured up to 20 times, allowing up to 20 doses of 0.25 mL dose for children age 635 months old. Influenza Vaccine Products for the 20212022 Influenza Season FluLaval Quadrivalent (FDA package insert) 6 months or older: Intramuscular: Egg protein, polysorbate 80: FluMist Quadrivalent (FDA package insert) 2-49 years: Nasal spray: Egg protein, gentamicin, pork gelatin: Fluzone High-Dose Quadrivalent (FDA package insert) 65 years or older: Intramuscular: Egg protein: To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov. 94 FLULAVAL (N = 721) or a US-licensed trivalent, inactivated influenza vaccine (N = 279). From the Flulaval package insert: This indication is based on immune response elicited by FLULAVAL, and there have been no controlled trials adequately demonstrating a decrease in influenza disease after vaccination with FLULAVAL. Labeled contraindications in package insert: History of severe allergic reaction to any vaccine component* or to a previous dose of influenza vaccine (like other flu vaccines) Note though that ACIP recommends vaccination of persons with egg allergy FluLaval Quadrivalent: 0.5 mL Do not freeze. Licensed biological products with supporting documents is arranged alphabetically by the proper name of the product(s). Amino Acid Medium Nutrient Gardasil 9 HPV Amount not specified in Package Insert Amino Acid Medium Nutrient Havrix HepA Amino acid supplement - 0.3% w/v Formaldehyde Inactivating Agent Flulaval Quad Influenza 25 mcg Formaldehyde Inactivating Agent FluZone High-Dose Influenza 100 mcg Formaldehyde Inactivating Agent FluZone 2. 6.5 Nature and Contents of Container. Consult package information for age indications. The product package, syringe label, and patient insert for this product are in German. Refrigerate. Package leaflet: Information for the user Influvac sub-unit Tetra, suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated) 2021/2022 season This medicine is subject to additional monitoring. If in doubt, check the package insert accompanying the vaccine you are using. a double dose for babies 6-35 months. Fluarix and Flulaval are indicated for persons three years or older, and Fluzone is indicated for persons six months or older. This will allow quick identification of new safety information. Information is provided for original product approvals, new indications, and the current package insert. Among recipients of FLULAVAL, 57% were female; 91% of subjects were white and 9% were . Influenza (Flulaval) Quadrivalent ovalbumin, formaldehyde, sodium deoxycholate, Finally, a trivalent cell culturebased Package inserts for New Aspects of the 2014-2015 Recommendations. July 2, 2021 Approval Letter - FluLaval ; July 2, 2020 Approval Letter - FluLaval ; February 6, 2020 Approval Letter - FluLaval; The package insert for LAIV4 notes that antiviral agents might reduce the effectiveness of the vaccine if given within the interval from 48 hours before to 14 days after vaccination . These data indicate that LAIV4 may be administered safely to persons with a history of egg allergy. It is now recommended that intranasal LAIV be administered in children 2 to 8 years of age, as studies demonstrate its increased protection against influenza. 1/20/2021. FluLaval is approved as a 0.5 mL dose, including in this younger age group. All eight egg-allergic children tolerated LAIV doses without any allergic symptoms. FluLaval 0.5 mL Fluzone 0.25 mL or 0.5 mL 4. Each of these circulate as different strains and subtypes, which change over time. Store in the original package in order to protect from light. FluLaval Quad 0.50mL prefilled syringe Fluzone Quad 0.50mL prefilled syringe 6mo-18yrs 0.50mL regardless of age (includes 6-35mo) 1000 maximum orders Vaccine Presentations Maine Department of Health and Human Services 6 Older adults. However Abbott Laboratories Ltd has provided Health Canada with an approved package insert to support the product shipments during this time.1 A Dear Health Care Provider letter detailing FLULAVAL QUADRIVALENT is approved for use in persons aged 6 months and older. VACCINES AND INGREDIENTS. Find out what health conditions may be a health risk when taken with Flulaval 2006-2007 intramuscular To access package inserts for all currently available GSK has one of the broadest portfolios of travel vaccines in the industry, covering diseases such as hepatitis A and B, rabies, typhoid and cholera. Flucelvax Tetra is a vaccine used to protect adults and children from 2 years of age against influenza (flu). FLUCELVAX QUADRIVALENT - Seqirus Inc. 1.14.1.3 US Package Insert 07/2018 (Revision 2) Page 4 of 17 a 0.5 mL single-dose pre-filled Luer Lock syringe a 5 mL multi-dose vial containing 10 doses (each dose is 0.5 mL). Update December 2016 - FluLaval: On 11-18-16, the FDA lowered the minimum age for use of FluLaval from 3 years to 6 months. 6.5 Nature and Contents of Container. FluLaval Quadrivalent Influenza Virus Vaccine: 11/18/2016: Package Insert Clinical Review Statistical Review and Evaluation Statistical Review Assay: 8/15/2013: Package Insert Statistical Review and Evaluation Final Clinical Review : FluMist Quadrivalent Package Insert Clinical Review However Abbott Laboratories Ltd has provided Health Canada with an approved package insert to support the product shipments during this time.1 A Dear Health Care Provider letter detailing FLULAVAL QUADRIVALENT is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Each vaccine entry links to the manufacturers package insert that contains information about dosage, ingredient quantity, and how the vaccine is made. USE IN SPECIFIC POPULATIONS 10/20/2020. Vaccination for these individuals Fluzone High-Dose Quadrivalent package insert 2021-2022 . Vaccine Ingredients: (in addition to the virus strain(s) being vaccinated against) Effect of package insert language on health-care providers perceptions of influenza vaccination safety during pregnancy. without needle AUST R 281035*. The product package, syringe label, and patient insert for this product are in German. season include the following: Afluria, Fluarix, FluLaval, Fluzone, Flucelvax, Fluzone High-Dose, Fluad, Flublok, and FluMist.1 The Alaska Immunization Program will supply 10 presentations of quadrivalent influenza vaccine this season (Table). 6/20/2021. Some products are pregnancy category B (animal studies conducted with those products In the United States, quadrivalent IIV (IIV4) vaccines include Fluarix Quadrivalent, FluLaval Quadrivalent, and Fluzone Quadrivalent; trivalent IIV (IIV3) include Afluria, Fluvirin, and Fluzone. FluLaval is approved as a 0.5 mL dose, including in this younger. **Influ Inact 48+ mos pres free and Influ Inact 48+ mos w/Thimerosal are other CHIRP codes which may in package inserts regarding vaccine safety in pregnancy could contribute to hesitancy.5 We sought to evaluate the effect of the package insert (FluLaval, GlaxoSmithKline, Sainte-Foy, QC, Canada), and even more positively framed statement B: use only from the second pregnancy trimester FLULAVAL TETRA is a quadrivalent vaccine indicated for active immunization of adults and children from 6 months of age for the prevention of influenza disease caused by influenza virus types A and B contained in the vaccine. Fluarix Package Insert (injectable) GlaxoSmithKline Fluvirin Package Insert (injectable) Novartis (Seqirus) Vaccines Fluarix Quadrivalent Package Insert (injectable) GlaxoSmithKline Fluzone Package Insert (injectable) Sanofi Pasteur Flublok Package Insert (injectable) Protein Sciences Corporation Fluzone High-Dose Package Insert (injectable) 202021 Influenza Vaccine Composition1 Madin FluLaval Vaccine Many providers requested FluLaval for this flu season. This is different from Fluzone, which is approved as a 0.25 mL dose in those 6-35 months. The impact of temperature and divalent-cation-containing buffer on the stability of N1 and N2. I. season include the following: Afluria, Fluarix, FluLaval, Fluzone, Flucelvax, Fluzone HighDose, Fluad, - Flublok, and FluMist. 3. without needle AUST R 281035*. Update December 2016 - FluLaval: On 11-18-16, the FDA lowered the minimum age for use of FluLaval from 3 years. Some vaccines, like influenza vaccines, are modified frequently and you may wish to consult the package inserts online and your doctor for the most current information. Licensed biological products with supporting documents is arranged alphabetically by the proper name of the product(s). Sanofi Pasteur Product Monograph 372 - FLUZONE High-Dose Page 6 of 23 Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions, adverse reaction rates Providers using FluLaval are reminded that the dose (0.5-mL) is the same for all children in the indicated age range of 6 months and older. NAME OF THE MEDICINAL PRODUCT FluLaval, suspension for injection Influenza vaccine (split virion, inactivated) Publication 7/2/2021 Prescribing information for FluLaval influenza vaccine 2021-2022 formulation. Package Insert (Recommended Storage Conditions) Stability Information for Exposure to ABOVE Recommended Temperature Range Stability Information for Exposure to BELOW Recommended Temperature Range FluLaval 5 mL (multi-dose vial*) 2 to 8C (36 to 46F); Do NOT freeze; Discard if vaccine has been frozen; 12/20/2020. They are more Flulaval ; thimerosal (multi-dose vial only), formaldehyde, sodium deoxycholate, ovalbumin, phosphate buffer, -tocopheryl hydrogen succinate, polysorbate 80 Flulaval Quad 2020-2021 (PF) 60 Mcg (15 X 4)/0.5 Ml IM Syringe Influenza Vaccine - Uses, Side Effects, and More Generic Name(S): flu vacc qs2020-21 6mos up(PF) View Free Coupon . 3/20/2021. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA Table 1 Comparison of Composition for FluLaval Tetra and Influsplit Tetra Drug Product Ingredients FluLaval Tetra Influsplit Tetra FluLaval (IIV4) 0.5 mL (single-dose syringe) 0 6 months & older3 150 90686 Sanofi Pasteur Flublok (RIV4) 0.5 mL (single-dose syringe) 0 18 years & older 185 90682 Fluzone (IIV4)) 0.5 mL (single-dose syringe) 0 6 months & older3 150 90686 0.5 mL (single-dose vial) 0 6 months & older3 150 90686 Refrigerate. In contrast, the dose for FluLaval and Fluarix is 0.5 mL the same for people of all ages. *The age indication in the package insert is 5 years and older; however, ACIP recommends Afluria not be used in children 5-8 years due to increased risk of febrile seizures. Publication 7/2/2021 Prescribing information for Fluzone High-Dose Quadrivalent influenza vaccine 2021-2022 formulation. 5 96 of other racial/ethnic groups. Safety and effectiveness of FLULAVAL have not been established in pregnant women, nursing mothers, or children. The licensed 0.5mL of Fluarix, FluLaval, or Fluzone is . People who provide essential community services 1. **Influ Inact 48+ mos pres free and Influ Inact 48+ mos w/Thimerosal are other CHIRP codes which may be used for the trivalent Fluvirin The following table lists substances, other than active ingredients (i.e., antigens), shown in the manufacturers package insert (PI) as being contained in the final formulation of each vaccine. Influenza Vaccine Package Insert Language Concerning Previous Allergic Reactions to Influenza Vaccines Egg-based IIV4s and LAIV4: History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or to a previous dose of any influenza vaccine.
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