Prescribing Information
For the use of a Registered Medical Practitioner or Hospital or Laboratory only
Inactivated Influenza Vaccine (Whole Virion) IP
(Pandemic Influenza (H1N1) 2009 Monovalent Vaccine)
VaxiFlu-S
COMPOSITION:
A single 0.5 mL dose contains:
Purified 15 mcg Haemagglutinin Antigen of A/California/7/2009 H1N1
Influenza NIBRG-121xp virus in Phosphate Buffered Isotonic
Sodium Chloride Solution. 50 mcg thiomersal added as preservative.
The H1N1 virus strain is propagated in allantoic fluid of hen’s egg and inactivated by β-propiolactone.
DESCRIPTION:
VaxiFlu-S™for intramuscular injection is a sterile, aqueous and slightly opalescent liquid. VaxiFlu-S™ contains highly concentrated,
inactivated influenza virus that has been grown in the allantoic fluid of embryonated chicken eggs, purified in a Sucrose Density Gradient using a continuous flow Zonal centrifuge, inactivated by β -propiolactone, purified virus is further diluted in a phosphate buffered isotonic solution.
The vaccine induces neutralizing antibodies.
The Haemagglutinin antigen content of the single dose (0.5 mL) is not less than 15 µg of A/California/7/2009 H1N1 Influenza NIBRG-121xp, corresponding to the recommendations for influenza vaccine (inactivated) (Indian Pharmacopoeia, 2007 and WHO Technical Report Series,
No. 927, 2005 Annex 3). The Haemagglutinin antigen content is determined after inactivation of the virus with β- propiolactone, using single radial immunodiffusion test as recommended by the World Health Organization (WHO).
MECHANISM OF ACTION:
Influenza illness and its complications follow infection with influenza viruses. Global surveillance of influenza identifies yearly antigenic variants.
In some human studies, vaccine induced antibody titer of ≥1:40 have been associated with protection from influenza illness in up to 50% of subjects. Antibody against one influenza virus type or subtype confers limited or no protection against another. Furthermore, antibody to one antigenic
variant of influenza virus might not protect against a new antigenic variant of the same type or subtype.
INDICATIONS:
VaxiFlu-S™ is indicated for active immunization against influenza disease caused by pandemic (H1N1) 2009 virus for the age of 18 years and above.
CONTRA-INDICATIONS:
VaxiFlu-S™ should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), or to any component of the vaccine, or who has had a life-threatening reaction to previous influenza vaccinations.
PRECAUTIONS AND WARNINGS:
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give VaxiFlu-S™ should be
based on careful consideration of the potential benefits and risks.
If VaxiFlu-S™ is administered to immunocompromised persons, including individuals receiving immunosuppressive therapy, the expected
immune response may not be obtained.
Prior to administration of any dose of VaxiFlu-S™, the healthcare provider should review the patient’s prior immunization history for possible adverse events, to determine the existence of any contraindication to immunization with VaxiFlu-S™ and to allow an assessment of benefits and risks.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
USE IN PREGNANCY AND LACTATION:
It is not known whether Influenza Vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VaxiFlu-S™ should be given to a pregnant woman only if clearly needed.
It is not known whether Influenza Vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VaxiFlu-S™ is administered to a nursing woman.
DRUG INTERACTIONS:
There are no data to assess the concomitant administration of VaxiFlu-S™ with other vaccines. If VaxiFlu-S™ is to be given at the same time as another injectable vaccine(s), the vaccines should always be administered at different injection sites.
VaxiFlu-S™ should not be mixed with any other vaccine in the same syringe or vial.
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to VaxiFlu-S™.
ADVERSE REACTIONS:
VaxiFlu-S™ and seasonal trivalent Inactivated Influenza Vaccines are manufactured by the same process and can lead to similar type of adverse events. The following adverse events are commonly reported with seasonal trivalent Influenza Virus Vaccines:
Local Adverse Events: pain, mass, inflammation, ecchymosis, edema, allergic reaction, hemorrhage, erythema, swelling, induration, pruritus, etc.
Systemic Adverse Events: headache, fatigue, malaise, myalgia, fever, arthralgia, sweating, shivering, sore throat, chills, nausea, cough, wheezing, chest tightness, other difficulties in breathing and facial edema, etc.
DOSAGE & ADMINISTRATION:
VaxiFlu-S™ vials contain an aqueous and slightly opalescent liquid. Shake the vial before withdrawing the dose of vaccine. A separate syringe and needle or a sterile disposable unit should be used for each injection to prevent transmission of infectious agents from one person to another. Needles should be disposed of properly and not recapped. It is recommended that small syringes (0.5-mL or 1-mL) should be used to minimize any product loss.
VaxiFlu-S™ should be administered as follows:
Adults (18 years of age and older):
VaxiFlu-S™ should be administered as a single 0.5-mL intramuscular injection preferably in the region of the deltoid muscle of the upper arm.
STORAGE CONDITIONS:
STORE AT 2˚ TO 8˚ C, DO NOT FREEZE.
Discard if the vaccine has been frozen.
PROTECT FROM LIGHT
Every packing shows an expiry date of Vaccine; the product should not be used after expiry date.
PRESENTATION:
Multiple dose (5.0 mL) vial of liquid vaccine for 10 doses.
™ Trademark of Cadila Healthcare Limited
MANUFACTURED BY:
Cadila Healthcare Ltd., Ahmedabad
Marketed by:
Zydus Vaxxicare
(A division of Cadila Healthcare Ltd)
Influenza illness and its complications follow infection with influenza viruses. Global surveillance of influenza identifies yearly antigenic variants.
In some human studies, vaccine induced antibody titer of ≥1:40 have been associated with protection from influenza illness in up to 50% of subjects. Antibody against one influenza virus type or subtype confers limited or no protection against another. Furthermore, antibody to one antigenic
variant of influenza virus might not protect against a new antigenic variant of the same type or subtype.
INDICATIONS:
VaxiFlu-S™ is indicated for active immunization against influenza disease caused by pandemic (H1N1) 2009 virus for the age of 18 years and above.
CONTRA-INDICATIONS:
VaxiFlu-S™ should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), or to any component of the vaccine, or who has had a life-threatening reaction to previous influenza vaccinations.
PRECAUTIONS AND WARNINGS:
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give VaxiFlu-S™ should be
based on careful consideration of the potential benefits and risks.
If VaxiFlu-S™ is administered to immunocompromised persons, including individuals receiving immunosuppressive therapy, the expected
immune response may not be obtained.
Prior to administration of any dose of VaxiFlu-S™, the healthcare provider should review the patient’s prior immunization history for possible adverse events, to determine the existence of any contraindication to immunization with VaxiFlu-S™ and to allow an assessment of benefits and risks.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
USE IN PREGNANCY AND LACTATION:
It is not known whether Influenza Vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VaxiFlu-S™ should be given to a pregnant woman only if clearly needed.
It is not known whether Influenza Vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VaxiFlu-S™ is administered to a nursing woman.
DRUG INTERACTIONS:
There are no data to assess the concomitant administration of VaxiFlu-S™ with other vaccines. If VaxiFlu-S™ is to be given at the same time as another injectable vaccine(s), the vaccines should always be administered at different injection sites.
VaxiFlu-S™ should not be mixed with any other vaccine in the same syringe or vial.
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to VaxiFlu-S™.
ADVERSE REACTIONS:
VaxiFlu-S™ and seasonal trivalent Inactivated Influenza Vaccines are manufactured by the same process and can lead to similar type of adverse events. The following adverse events are commonly reported with seasonal trivalent Influenza Virus Vaccines:
Local Adverse Events: pain, mass, inflammation, ecchymosis, edema, allergic reaction, hemorrhage, erythema, swelling, induration, pruritus, etc.
Systemic Adverse Events: headache, fatigue, malaise, myalgia, fever, arthralgia, sweating, shivering, sore throat, chills, nausea, cough, wheezing, chest tightness, other difficulties in breathing and facial edema, etc.
DOSAGE & ADMINISTRATION:
VaxiFlu-S™ vials contain an aqueous and slightly opalescent liquid. Shake the vial before withdrawing the dose of vaccine. A separate syringe and needle or a sterile disposable unit should be used for each injection to prevent transmission of infectious agents from one person to another. Needles should be disposed of properly and not recapped. It is recommended that small syringes (0.5-mL or 1-mL) should be used to minimize any product loss.
VaxiFlu-S™ should be administered as follows:
Adults (18 years of age and older):
VaxiFlu-S™ should be administered as a single 0.5-mL intramuscular injection preferably in the region of the deltoid muscle of the upper arm.
STORAGE CONDITIONS:
STORE AT 2˚ TO 8˚ C, DO NOT FREEZE.
Discard if the vaccine has been frozen.
PROTECT FROM LIGHT
Every packing shows an expiry date of Vaccine; the product should not be used after expiry date.
PRESENTATION:
Multiple dose (5.0 mL) vial of liquid vaccine for 10 doses.
™ Trademark of Cadila Healthcare Limited
MANUFACTURED BY:
Cadila Healthcare Ltd., Ahmedabad
Marketed by:
Zydus Vaxxicare
(A division of Cadila Healthcare Ltd)
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