Fluvirin label

Fluvirin

Fluvirin Recall

Get an alert when a recall is issued.

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

There is currently no usage information available for this product. We apologize for any inconvenience.

History

There is currently no drug history available for this drug.

Other Information

There are no additional details available for this product.

Fluvirin Manufacturers

  • Catalent Belgium Sa
    Fluvirin | Catalent Belgium Sa
    No Recall

    Fluvirin | Catalent Belgium Sa

    Fluvirin | Catalent Belgium Sa

    There is currently no dosage information available for this product. We apologize for any inconvenience.

  • Novartis Vaccines And Diagnostics Ltd
    Fluvirin | Novartis Vaccines And Diagnostics Ltd
    No Recall

    Fluvirin | Novartis Vaccines And Diagnostics Ltd

    Fluvirin | Novartis Vaccines And Diagnostics Ltd
    2.1 Preparation for Administration

    Inspect FLUVIRIN® syringes and multidose vials visually for particulate matter and/or discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered.

    Shake the syringe vigorously before administering the vaccine and shake the multidose vial preparation each time before withdrawing a dose of vaccine.

    Between uses, return the multidose vial to the recommended storage conditions between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen.

    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.

    2.2 Recommended Dose and Schedule

    Children (4 to 17 years of age):

    Children aged 4 to 8 years should receive 2 doses of vaccine if they have not been vaccinated previously at any time with any influenza virus vaccine. Children aged 4 to 8 years who received only 1 dose in their first year of vaccination in the previous season should receive 2 doses. FLUVIRIN® should be given as a 0.5-mL intramuscular injection on day 1 followed by another 0.5-mL intramuscular injection at least 4 weeks later. 2 doses are required for protection in these children. (15.3)

    Children aged 4 to 8 years who have been vaccinated with two doses of any influenza virus vaccine in the previous season, or with one dose in the year prior to the previous season, should receive only one dose. (15.3)

    Children aged 9 years and older should receive a single 0.5-mL intramuscular injection.

    The needle size may range from 7/8 to 1¼ inches, depending on the size of the child's deltoid muscle, and should be of sufficient length to penetrate the muscle tissue. The anterolateral thigh can be used, but the needle should be longer, usually 1 inch.

    Adults (18 years and older):

    FLUVIRIN® should be administered as a single 0.5-mL intramuscular injection preferably in the region of the deltoid muscle of the upper arm.

    The vaccine should not be injected in the gluteal region or areas where there may be a major nerve trunk. A needle of ≥1 inch is preferred because needles <1 inch might be of insufficient length to penetrate muscle tissue in certain adults.

  • Novartis Vaccines And Diagnostics Limited
    Fluvirin | Novartis Vaccines And Diagnostics Limited
    No Recall

    Fluvirin | Novartis Vaccines And Diagnostics Limited

    Fluvirin | Novartis Vaccines And Diagnostics Limited
    2.1 Preparation for Administration

    Inspect FLUVIRIN® syringes and multidose vials visually for particulate matter and/or discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered.

    Shake the syringe vigorously before administering the vaccine and shake the multidose vial preparation each time before withdrawing a dose of vaccine.

    Between uses, return the multidose vial to the recommended storage conditions between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen.

    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.

    2.2 Recommended Dose and Schedule

    Children (4 to 17 years of age):

    Children aged 4 to 8 years should receive 2 doses of vaccine if they have not been vaccinated previously at any time with any influenza virus vaccine. Children aged 4 to 8 years who received only 1 dose in their first year of vaccination in the previous season should receive 2 doses. FLUVIRIN® should be given as a 0.5-mL intramuscular injection on day 1 followed by another 0.5-mL intramuscular injection at least 4 weeks later. 2 doses are required for protection in these children. (15.3)

    Children aged 4 to 8 years who have been vaccinated with two doses of any influenza virus vaccine in the previous season, or with one dose in the year prior to the previous season, should receive only one dose. (15.3)

    Children aged 9 years and older should receive a single 0.5-mL intramuscular injection.

    The needle size may range from 7/8 to 1¼ inches, depending on the size of the child's deltoid muscle, and should be of sufficient length to penetrate the muscle tissue. The anterolateral thigh can be used, but the needle should be longer, usually 1 inch.

    Adults (18 years and older):

    FLUVIRIN® should be administered as a single 0.5-mL intramuscular injection preferably in the region of the deltoid muscle of the upper arm.

    The vaccine should not be injected in the gluteal region or areas where there may be a major nerve trunk. A needle of ≥1 inch is preferred because needles <1 inch might be of insufficient length to penetrate muscle tissue in certain adults.

  • Novartis Vaccines And Diagnostics Limited
    Fluvirin | Novartis Vaccines And Diagnostics Limited
    No Recall

    Fluvirin | Novartis Vaccines And Diagnostics Limited

    Fluvirin | Novartis Vaccines And Diagnostics Limited
    2.1 Preparation for Administration

    Inspect FLUVIRIN® syringes and multidose vials visually for particulate matter and/or discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered.

    Shake the syringe vigorously before administering the vaccine and shake the multidose vial preparation each time before withdrawing a dose of vaccine.

    Between uses, return the multidose vial to the recommended storage conditions between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen.

    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.

    2.2 Recommended Dose and Schedule

    Children (4 to 17 years of age):

    Children aged 4 to 8 years should receive 2 doses of vaccine if they have not been vaccinated previously at any time with any influenza virus vaccine. Children aged 4 to 8 years who received only 1 dose in their first year of vaccination in the previous season should receive 2 doses. FLUVIRIN® should be given as a 0.5-mL intramuscular injection on day 1 followed by another 0.5-mL intramuscular injection at least 4 weeks later. 2 doses are required for protection in these children. (15.3)

    Children aged 4 to 8 years who have been vaccinated with two doses of any influenza virus vaccine in the previous season, or with one dose in the year prior to the previous season, should receive only one dose. (15.3)

    Children aged 9 years and older should receive a single 0.5-mL intramuscular injection.

    The needle size may range from 7/8 to 1¼ inches, depending on the size of the child's deltoid muscle, and should be of sufficient length to penetrate the muscle tissue. The anterolateral thigh can be used, but the needle should be longer, usually 1 inch.

    Adults (18 years and older):

    FLUVIRIN® should be administered as a single 0.5-mL intramuscular injection preferably in the region of the deltoid muscle of the upper arm.

    The vaccine should not be injected in the gluteal region or areas where there may be a major nerve trunk. A needle of ≥1 inch is preferred because needles <1 inch might be of insufficient length to penetrate muscle tissue in certain adults.

  • Novartis Vaccines And Diagnostics Limited
    Fluvirin | Novartis Vaccines And Diagnostics Limited
    No Recall

    Fluvirin | Novartis Vaccines And Diagnostics Limited

    Fluvirin | Novartis Vaccines And Diagnostics Limited
    2.1 Preparation for Administration

    Shake the syringe vigorously before administering the vaccine and shake the multidose vial preparation each time before withdrawing a dose of vaccine.

    Inspect FLUVIRIN® syringes and multidose vials visually for particulate matter and/or discoloration prior to administration [see DESCRIPTION (11)]. If either of these conditions exists, the vaccine should not be administered.

    Between uses, return the multidose vial to the recommended storage conditions between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen.

    A separate sterile syringe and needle must 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.

    For intramuscular use only.

    2.2 Recommended Dose and Schedule

    The dose and schedule for Fluvirin is presented in Table 1.

    TABLE 1 Fluvirin Dose and Schedule

    a 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines.
    "-" indicates information is not applicable

    Age Dose Schedule 4 years through 8 years One or two doses a, 0.5 mL each If 2 doses, administer at least 1 month apart 9 years and older One dose, 0.5 mL -

    In children, the needle size may range from 7/8 to 1¼ inches, depending on the size of the child's deltoid muscle, and should be of sufficient length to penetrate the muscle tissue. The anterolateral thigh can be used, but the needle should be longer, usually 1 inch.

    In adults, a needle of ≥1 inch is preferred because needles <1 inch might be of insufficient length to penetrate muscle tissue in certain adults. The preferred site for intramuscular injection is the deltoid muscle of the upper arm. The vaccine should not be injected in the gluteal region or areas where there may be a major nerve trunk.

  • Novartis Vaccines And Diagnostics Limited
    Fluvirin | Novartis Vaccines And Diagnostics Limited
    No Recall

    Fluvirin | Novartis Vaccines And Diagnostics Limited

    Fluvirin | Novartis Vaccines And Diagnostics Limited
    2.1 Preparation for Administration

    Shake the syringe vigorously before administering the vaccine and shake the multidose vial preparation each time before withdrawing a dose of vaccine.

    Inspect FLUVIRIN® syringes and multidose vials visually for particulate matter and/or discoloration prior to administration [see DESCRIPTION (11)]. If either of these conditions exists, the vaccine should not be administered.

    Between uses, return the multidose vial to the recommended storage conditions between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen.

    A separate sterile syringe and needle must 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.

    For intramuscular use only.

    2.2 Recommended Dose and Schedule

    The dose and schedule for Fluvirin is presented in Table 1.

    TABLE 1 Fluvirin Dose and Schedule

    a 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines.

    "-" indicates information is not applicable

    Age Dose Schedule 4 years through 8 years One or two doses a, 0.5 mL each If 2 doses, administer at least 1 month apart 9 years and older One dose, 0.5 mL -

    In children, the needle size may range from 7/8 to 1¼ inches, depending on the size of the child's deltoid muscle, and should be of sufficient length to penetrate the muscle tissue. The anterolateral thigh can be used, but the needle should be longer, usually 1 inch.

    In adults, a needle of ≥1 inch is preferred because needles <1 inch might be of insufficient length to penetrate muscle tissue in certain adults. The preferred site for intramuscular injection is the deltoid muscle of the upper arm. The vaccine should not be injected in the gluteal region or areas where there may be a major nerve trunk.