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Influenza Whoinsert Generic Name As on 080710 capacity. Healthcare providers need to assess the benefit and potential risks of administering the vaccine to pregnant women. It is not known whether Influenza Vaccine(Human,Live Attenuated) is excreted in human milk. Therefore, as some viruses are Influenza Vaccine excreted in human milk and additionally, because of the possibility of shedding of vaccine virus and the close proximity of a nursing infant and mother, caution should be exercised if Influenza Vaccine(Human,Live Attenuated) is administered to nursing Sii mothers. (Human, Live Attenuated) Effects on ability to drive and use machines The vaccine is unlikely to produce an effect on the ability to drive and use machines. Pandemic (H1N1) (Freeze-Dried) ADVERSE REACTIONS In clinical trials a few local and systemic reaction were observed. They were mild to moderate in severity and resolved without DESCRIPTION any sequelae. Influenza Vaccine(Human,Live Attenuated) Pandemic (H1N1), freeze dried is a live monovalent vaccine for administration by Local : Nasal discomfort, stuffy nose, sneezing, runny nose, loss of smell red eyes, lacrimation, facial swelling. intranasal spray. The influenza vaccine contains Influenza virus cultivated on embryonated eggs. Systemic : Headache, fatigue, myalgia, arthralgia, irritability, loss of appetite, sore throat, cough, diarrhoea. The incidence was similar in both the study groups. COMPOSITION There were a few unsolicited event reported in both the groups and none of them were causally related to study vaccines. [Propagated in Embryonated hen eggs (SPF)] Each single dose of 0.5 ml contains: 7 OVERDOSE A/17/California/2009/38 > 10 EID50 No case of overdose has been reported. Gelatin (Partially hydrolyzed) 2.5%, Sorbitol 5%, L-Alanine 0.1% L-Histidine 0.21%, Tricine 0.3%, L-Arginine hydrochloride 1.6% Lactalbumin hydrolysate 0.35%, Phosphate buffer saline Base PHARMACOLOGICAL PROPERTIES Reconstitute with Sterile Water for Inhalation USP. The vaccine contains no preservatives. Pharmacodynamic properties Dose: 0.5 ml intranasal (spray 0.25 ml per nostril). The tip attached to the sprayer is equipped with a nozzle that produces a fine Influenza Vaccine(Human,Live Attenuated) is a live monovalent vaccine for administration by intranasal spray. The influenza mist that is primarily deposited in the nose and nasopharynx. virus strain in Influenza Vaccine(Human,Live Attenuated) is (a) cold-adapted (ca) (i.e., it replicates efficiently at 25ºC, a Influenza Vaccine(Human,Live Attenuated) is supplied as a vial containing freeze-dried cake in USP type 1 glass vials. A temperature that is restrictive for replication of many wild-type influenza viruses); (b) temperature-sensitive (ts) (i.e., it is ampoule/vial containing sterile water for inhalation as diluent, syringe (for reconstitution of multi dose vaccine vial), syringe restricted in replication at 39ºC, a temperature at which many wild-type influenza viruses grow efficiently); and (c) attenuated (for administration) , needle free device and intranasal spray device are also supplied along with the vaccine. (att) (it does not produce classic influenza-like illness in the ferret model of human influenza infection). The cumulative effect The vaccine complies with the WHO recommendation and EU decision for the pandemic. of the antigenic properties and the ca, ts, and att phenotypes is that the attenuated vaccine virus replicates in the nasopharynx to induce protective immunity. INDICATIONS Immune mechanisms conferring protection against influenza following receipt of Intranasal Live attenuated influenza vaccines Influenza Vaccine(Human,Live Attenuated), Intranasal is indicated for the active immunization of individuals above 3 years of are not fully understood, though it is well-established that these vaccines provide clinical protection to the majority of the age against influenza disease caused by pandemic (H1N1) 2009 virus. vaccinees. Likewise, naturally acquired immunity to wild-type influenza has not been completely elucidated. Serum antibodies Prophylaxis of influenza in an officially declared pandemic situation (see sections Posology and method of administration and and mucosal antibodies may play a role in prevention and recovery from infection. However, it is well known that there are no Pharmacodynamic properties). correlates of protection for live attenuated influenza vaccines. Pandemic influenza vaccine should be used in accordance with official guidance. Pharmacokinetic properties POSOLOGY AND METHOD OF ADMINISTRATION Not applicable. Each freeze-dried vaccine vial is reconstituted using the entire contents of sterile water for inhalation that is supplied along Preclinical safety data with the vaccine, using the supplied syringe and vial adapter. Influenza Vaccine(Human,Live Attenuated) has undergone Single-dose and Repeated-dose toxicity studies in mice and rats when A dose of 0.5 ml is administered as 0.25 ml per nostril using a 0.5/1.0 ml syringe and a spray device. The sprayer device creates a administered intranasally. In single-dose studies, higher than normal doses of the vaccine were given to animals and they were fine spray that primarily deposits the vaccine in the nose and nasopharynx. A single intranasal dose is recommended for people observed for 14 days for toxic effects. No vaccine-related untoward effects were found in animals receiving Influenza above 3 years of age. Vaccine(Human,Live Attenuated). Adults (18-49 years), elderly (≥ 50 years) and children and adolescents (3-17 years) of age: A single dose of 0. 5 ml by intranasal In repeated-dose toxicity studies, three doses of higher than normal doses of the vaccine were given intranasally to animals on route. A second dose of vaccine could be given after an interval of at least 21 days. day 0, 7 and 14 and were subsequently sacrificed. Necropsy was done to assess adverse effects on any organs. No vaccine-related There is no clinical experience in children below 3 years of age. adverse effects were found in the study animals receiving Influenza Vaccine(Human,Live Attenuated). For further information, see (Pharmacodynamic properties). If the vaccine is not used immediately then it should be stored at 2-8ºC for no longer than 6 hours. While storing the reconstituted INCOMPATIBILITIES vaccine, ensure that the administration syringe is locked on to the needle free transfer device and the combined unit is stored at In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 2 to 8ºC to ensure that the opening created by the device is blocked and the syringe is also stored in a manner which prevents the proliferation of bio-burden. Any opened container remaining at the end of a session (within six hours of reconstitution) should be INSTRUCTIONS FOR USE AND HANDLING AND DISPOSAL discarded. The vaccine vial monitor (see figure), if present would have been removed on reconstitution. The vaccine should be allowed to reach room temperature before use. Shake before use. The diluent supplied is specially designed for use with the vaccine. Only this diluent must be used to reconstitute the vaccine. Do Once Influenza Vaccine(Human,Live Attenuated), Intranasal has been administered, the sprayer should be disposed of according not use diluents from other types of vaccine or from other manufacturers. Using an incorrect diluent may result in damage to the to the standard procedures for medical waste (e.g., sharps container or biohazard container). vaccine and/or serious reactions to those receiving the vaccine. Diluent must not be frozen, but should be kept cool. The diluent and reconstituted vaccine should be inspected visually for any foreign particulate matter and / or variation of SHELF-LIFE physical aspects prior to administration. In the event of either being observed, discard the diluent or reconstituted vaccine. Do not exceed the expiry date printed on the outer box. CONTRAINDICATIONS STORAGE Hypersensitivity Influenza Vaccine(Human,Live Attenuated) Intranasal SHOULD BE STORED IN A REFRIGERATOR AT 2-8ºC (35-46ºF) UPON RECEIPT Influenza Vaccine(Human,Live Attenuated) is contraindicated in individuals with a history of hypersensitivity, especially AND UNTIL USE. THE PRODUCT MUST BE USED BEFORE THE EXPIRATION DATE ON THE LABEL. anaphylactic reactions, to eggs, egg proteins, gentamicin, gelatin, or arginine or with life-threatening reactions to previous The cold chain (2 to 8ºC) must be maintained when transporting Influenza Vaccine(Human,Live Attenuated) Intranasal influenza vaccinations. Concomitant Pediatric and Adolescent Aspirin Therapy and Reye's syndrome PRESENTATION Influenza Vaccine(Human,Live Attenuated) is contraindicated in children and adolescents (3-17 years of age) receiving aspirin Influenza Vaccine(Human, Live Attenuated) Pandemic (H1N1) is available as: therapy or aspirin-containing therapy, because of the association of Reye's syndrome with aspirin and wild-type influenza 1 dose vial plus diluent ( 0.5 ml) infection. 5 dose vial plus diluent (2.5 ml) WARNINGS AND PRECAUTIONS THE VACCINE VIAL MONITOR (Optional) Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) Inner square lighter than outer circle. If the expiry date has not passed, to the active substance(s), to any of the excipients, and to residues e.g. eggs, chicken proteins, etc. USE the vaccine. As with all vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event
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