Label: STAMARIL- yellow fever virus strain 17d-204 live antigen kit

  • NDC Code(s): 49281-911-58, 49281-913-01
  • Packager: Sanofi Pasteur Inc.
  • Category: VACCINE LABEL
  • DEA Schedule: None
  • Marketing Status: Unapproved drug for use in drug shortage

Drug Label Information

Updated December 7, 2018

If you are a consumer or patient please visit this version.

  • PATIENT PACKAGE INSERT

    Powder and solvent for suspension for injection in prefilled syringe

    YELLOW FEVER VACCINE (LIVE)

    Read all of this leaflet carefully before you or your child are vaccinated.
    • Keep this leaflet. You may need to read it again.
    • If you have any further questions, ask your doctor or pharmacist.
    • This vaccine has been prescribed for you. Do not pass it on to others.
    • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist, see section 4.

    In this leaflet:

    1. What STAMARIL is and what it is used for
    2. Before you use STAMARIL
    3. How to use STAMARIL
    4. Possible side effects
    5. How to store STAMARIL
    6. Further information

    1. WHAT STAMARIL IS AND WHAT IT IS USED FOR

    STAMARIL is a vaccine that provides protection against a serious infectious disease called yellow fever. Yellow fever occurs in certain areas of the world and is spread to man through the bites of infected mosquitoes.

    STAMARIL is given to people who:

    • are travelling to, passing through or living in an area where yellow fever occurs,
    • are travelling to any country that requires an International Certificate of Vaccination for entry, this may depend on the countries previously visited during the same trip,
    • may handle infectious materials such as laboratory workers.

    To obtain a vaccination certificate against yellow fever it is necessary to be vaccinated in an approved vaccination centre so that an International Certificate of Vaccination can be issued. This certificate is valid from the 10th day and until 10 years after the first dose of vaccine. Certificates issued after a booster vaccination (see section 3 below) are valid immediately after the injection.

    2. BEFORE YOU USE STAMARIL

    It is important to tell your doctor or nurse if any of the points below apply to the person receiving the vaccine. If there is anything you do not understand, ask your doctor or nurse to explain.

    STAMARIL should not be given if you or your child:

    • are allergic to eggs, chicken proteins or any other ingredient of STAMARIL,
    • have experienced a serious reaction after an injection of a yellow fever vaccine,
    • have a poor or weakened immune system for any reason, such as illness or medical treatments (for example corticoids or chemotherapy),
    • have a weakened immune system due to HIV infection. Your doctor will tell you if you can still receive STAMARIL based on your blood tests,
    • are infected with HIV and have active symptoms due to the infection,
    • have a history of problems with your thymus gland or have had your thymus gland removed for any reason,
    • have an illness with a fever or acute infection. The vaccination will be postponed until you have recovered,
    • are less than 6 months old.

    Take special care with STAMARIL if:

    • you are over 60 years old as you have an increased risk of certain types of severe but rare reactions to vaccines (including serious reactions that affect the brain and nerves, as well as vital organs, see section 4). You will only be given the vaccine if the risk of infection with the virus is well established in countries where you are going to stay,
    • your child is aged 6 to 9 months. STAMARIL may be given to children aged between 6 and 9 months only in special situations and on the basis of current official recommendations,
    • you are infected with the HIV but do not present with any HIV infection related symptoms, your doctor will specify whether STAMARIL can be given based on your blood tests,
    • your child is infected with the HIV (AIDS). The doctor may need to perform specific exams and seek advice from a specialist before telling you whether your child may receive STAMARIL,
    • you have bleeding disorders (such as haemophilia or a low level of platelets) or are taking medicines that reduce blood circulation. You can still receive STAMARIL provided that it is injected under the skin and not into a muscle (see section 3).

    Taking other medicines

    Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

    If you have recently been receiving any treatment which may have weakened your immune system, vaccination against yellow fever should be postponed until your laboratory results show that your immune system has recovered. Your doctor will advise you when it is safe for you to be vaccinated.

    STAMARIL can be given at the same time as a measles vaccine or vaccines against typhoid (those containing the Vi capsular polysaccharide) and/or hepatitis A vaccines.

    Pregnancy and breastfeeding

    Tell your doctor or nurse if you are pregnant, think you might be pregnant or are breastfeeding. You should not receive STAMARIL unless this cannot be avoided. Your doctor or nurse can advise you on whether it is essential that you are vaccinated while pregnant or breastfeeding.

    Important information about some of the ingredients of STAMARIL:

    STAMARIL contains a small amount of sorbitol. The vaccine should not be given to people who have fructose intolerance.

    3. HOW TO USE STAMARIL

    STAMARIL is given as an injection by a doctor or nurse. It is usually injected just underneath the skin but it can be given into a muscle if that is in the applicable official recommendation for the country in which you live.

    It must not be injected into a blood vessel.

    Posology

    STAMARIL is given as a single, 0.5 millilitre dose to adults and children from 6 months of age. The first dose should be given at least 10 days before being at risk of infection with yellow fever, because it takes 10 days for the first dose of vaccine to work and provide good protection against the yellow fever virus. The protection provided by this dose will last 10 years.

    A booster dose (0.5 millilitre) is recommended every 10 years if you are still thought to be at risk of infection with yellow fever (e.g. you still travel to or are living in areas where yellow fever can be caught or could be infected through your work).

    If you have any further questions on the use of this vaccine, ask your doctor.

    4. POSSIBLE SIDE EFFECTS

    Like all medicines, STAMARIL can cause side effects, although not everybody gets them.

    Serious side effects

    The following serious side effects have sometimes been reported:

    Allergic reactions

    • Rash, itching or hives on the skin.
    • Swelling of the face, lips, tongue or other parts of the body.
    • Difficulty swallowing or breathing.
    • Loss of consciousness.

    Reactions affecting the brain and nerves

    These may occur within one month of the vaccination and have sometimes been fatal.

    Symptoms include:

    • High fever with headache and confusion.
    • Extreme tiredness.
    • Stiff neck.
    • Inflammation of brain and nerve tissues.
    • Fits.
    • Loss of movement or feeling affecting certain parts or all of the body.

    Serious reaction affecting vital organs

    This may occur within 10 days of the vaccination and may have a fatal outcome. The reaction can resemble an infection with the yellow fever virus. It generally begins with feeling tired, fever, headache, muscle pain and sometimes low blood pressure. It may then go on to a severe muscle and liver disorders, drops in number of some types of blood cells resulting in unusual bruising or bleeding and increased risk of infections, and loss of normal functioning of the kidneys and lungs.

    If you experience ANY of the above symptoms contact your doctor IMMEDIATELY.

    Other side effects

    Very common side effects (reported by more than 1 in 10 people)

    Problems around the injection site (such as rednesss, bruising, pain or discomfort, swelling or appearance of a hard lump) and headache.

    Common side effects (reported by less than 1 in 10 people)

    Feeling or being sick, diarrhoea, muscle pains, fever and weakness.

    Uncommon side effects (reported by less than 1 in 100 people)

    Painful joints and stomach pains.

    Other possible side effects include:

    Swollen glands.

    Reporting of side effects

    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.

    5. HOW TO STORE STAMARIL

    Keep out of the reach and sight of children.

    Do not use STAMARIL after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

    Store in a refrigerator between 2°C and 8°C. Do not freeze.

    Keep the vial and syringe in the outer carton in order to protect from light.

    Use immediately after reconstitution.

    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

    6. FURTHER INFORMATION

    What STAMARIL contains

    Active substance:

    *
    produced in specified pathogen-free chick embryos
    Yellow fever virus*, 17D-204 strain (live, attenuated) not less than 1000 IU

    The other ingredients are:

    Lactose, sorbitol, L-histidine hydrochloride, L-alanine, sodium chloride, potassium chloride, disodium phosphate, monopotassium phosphate, calcium chloride, magnesium sulphate and water for injections.

    What STAMARIL looks like and contents of the pack

    STAMARIL is presented as a powder and solvent for suspension for injection (powder in a vial (0.5 ml dose) + solvent in a prefilled syringe (0.5 ml dose) with or without needle). Pack size of 1, 10 or 20.

    After reconstitution the suspension is beige to pink beige.

    Not all pack sizes or presentations may be marketed.

    Marketing Authorisation Holder

    SANOFI PASTEUR SA
    2, AVENUE PONT PASTEUR
    69007 LYON
    FRANCE

    This leaflet was last approved in 01/2014.

    The following information is intended for medical or healthcare professionals only:

    Instruction for reconstitution:

    Before use, the beige to orange beige powder is mixed with the clear colourless sodium chloride solvent provided in a syringe to make a beige to pink beige suspension.

    For syringe without attached needle only: after removing the syringe tip cap, the needle should be firmly placed on the tip of the syringe and secured by rotating a quarter of a turn (90°).

    The powder is reconstituted by adding the solvent provided in the pre-filled syringe to the vial. The vial is shaken and, after complete dissolution, the suspension obtained is withdrawn into this same syringe for injection.

    Contact with disinfectants is to be avoided so as not to inactivate the virus.

    Use immediately after reconstitution.

    Any unused product or waste material should be disposed of, preferably by heat inactivation or incineration, in accordance with local requirements.

    See also section 3. HOW TO USE STAMARIL.

  • HEALTH CARE PROVIDER LETTER

    April 2017

    Dear Health Care Professional:

    This letter is to provide an update on the status of YF-VAX® (Yellow Fever Vaccine) supply. Sanofi Pasteur is experiencing delays in the production process of YF-VAX vaccine and it is anticipated that the product will be unavailable from mid-2017 to mid-2018 as we transition production to a new state-of-the-art facility. Ordering restrictions have been implemented to responsibly manage the limited remaining supply of YF-VAX vaccine. YF-VAX vaccine will continue to be available while current supplies last.

    As the sole manufacturer of yellow fever vaccine in the United States, we take our responsibility seriously and are making every effort to maintain access to yellow fever vaccine. We have worked with the Food and Drug Administration (FDA) to make another yellow fever vaccine available in the US. This vaccine, STAMARIL® (Yellow Fever Vaccine [Live]), manufactured by Sanofi Pasteur in France, is a live, attenuated yellow fever vaccine that is investigational/unlicensed in the US, but it is registered and currently distributed in over 70 countries. The mechanism by which we can make this vaccine available is called an Expanded Access Investigational New Drug Application (IND), made possible under US regulations.

    An Expanded Access IND program is similar to a clinical trial and requires training of clinical site staff and monitoring of vaccine recipients. There are additional rigorous documentation and informed consent procedures. Further, only health care providers who are certified by state health departments to administer yellow fever vaccine will be eligible. Given all of these restrictions, a limited number of clinical sites can participate in this program. These locations have been selected to include sites that immunize the most patients with YF-VAX vaccine, and geographic location. The objective is to provide the broadest access possible to yellow fever vaccine, given the regulatory requirements of the Expanded Access IND program.

    Once YF-VAX vaccine is no longer available, health care providers and patients will be able to find locations that will administer STAMARIL vaccine by visiting the CDC web page at http://wwwnc.cdc.gov/travel/yellow-fever-vaccination-clinics/search. They may also visit http://wwwnc.cdc.gov/travel/ for information about which countries require yellow fever vaccination for entry and for which countries the CDC recommends yellow fever vaccination.

    Supply of YF-VAX vaccine from our new US facility is planned for mid-2018. A significant number of doses had been planned to bridge the gap between the former manufacturing facility and the new facility. However, there was an unavoidable equipment issue that resulted in halting production. This did not affect any doses of YF-VAX vaccine that are being shipped to customers. All doses shipped to customers received release clearance for safety and potency from the FDA Center for Biologics Evaluation and Research.

    Sanofi Pasteur recognizes the challenge this supply disruption will cause for your practice and for patients in need of yellow fever vaccine. We are making every effort to see that yellow fever vaccination continues in the US during this YF-VAX vaccine supply disruption and we appreciate your understanding.

    For more information on YF-VAX vaccine availability and our vaccine supply situation, you can contact Sanofi Pasteur by calling 1-800-VACCINE (1-800-822-2463).

    IMPORTANT SAFETY INFORMATION FOR YF-VAX VACCINE

    Indication

    YF-VAX vaccine is indicated for active immunization for the prevention of yellow fever in persons 9 months of age and older in the following categories: persons living in or traveling to yellow fever endemic areas, persons traveling internationally through countries with yellow fever, and laboratory personnel who handle virulent yellow fever virus or concentrated preparations of the yellow fever vaccine virus strains.

    Safety Information

    The most common local and systemic adverse reactions to YF-VAX vaccine include edema and pain at the injection site; mild headache, myalgia, and fever. Other adverse reactions may occur. YF-VAX vaccine should not be administered to an individual with a history of acute hypersensitivity to eggs, egg products, or to any component of the vaccine. Anaphylaxis may occur following the use of YF-VAX vaccine, even in individuals with no prior history of hypersensitivity to the vaccine components. Infants younger than 9 months of age should not be vaccinated with YF-VAX vaccine. Vaccination with YF-VAX vaccine is also contraindicated in lactating women who are providing breast milk to infants younger than 9 months of age due to the potential for transmission of vaccine virus in breast milk. In addition, YF-VAX vaccine is contraindicated in immunosuppressed individuals. Yellow fever vaccine-associated viscerotropic and neurotropic diseases are known rare serious adverse events. Vaccination with YF-VAX vaccine may not protect all individuals.

    Before administering YF-VAX vaccine, please click here accompanying full Prescribing Information.

    Sincerely,

    Matthew Wilcox
    Vice President Marketing, US

  • PRINCIPAL DISPLAY PANEL - 0.5 ml Vial Label

    STAMARIL

    YELLOW FEVER VACCINE (LIVE)

    Powder

    1 dose

    SC or IM after reconstitution

    Sanofi Pasteur

    PRINCIPAL DISPLAY PANEL - 0.5 ml Vial Label
  • PRINCIPAL DISPLAY PANEL - 0.5 ml Syringe Label

    SOLVENT

    0,5 ml

    SOLUTION OF 0.4%
    SODIUM CHLORIDE

    Sanofi Pasteur

    PRINCIPAL DISPLAY PANEL  - 0.5 ml Syringe Label
  • PRINCIPAL DISPLAY PANEL - Kit Carton

    STAMARIL

    YELLOW FEVER VACCINE (LIVE)

    Powder and solvent for suspension for injection (powder in vial and 0.5 ml of solvent in prefilled syringe)

    Box of 1

    Subcutaneous or intramuscular use

    SANOFI PASTEUR

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    STAMARIL 
    yellow fever virus strain 17d-204 live antigen kit
    Product Information
    Product TypeVACCINEItem Code (Source)NDC:49281-913
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49281-913-011 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL, SINGLE-USE 0.5 mL
    Part 21 SYRINGE 0.5 mL
    Part 1 of 2
    STAMARIL 
    yellow fever virus strain 17d-204 live antigen injection, powder, lyophilized, for suspension
    Product Information
    Route of AdministrationSUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN (UNII: PY4EET359T) (YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN - UNII:PY4EET359T) YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN1000 [iU]  in 0.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    SORBITOL (UNII: 506T60A25R)  
    HISTIDINE MONOHYDROCHLORIDE (UNII: 1D5Q932XM6)  
    ALANINE (UNII: OF5P57N2ZX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.5 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage09/27/2016
    Part 2 of 2
    SALINE DILUENT 
    sodium chloride diluent injection
    Product Information
    Item Code (Source)NDC:49281-911
    Route of AdministrationSUBCUTANEOUS
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49281-911-580.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage09/27/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage09/27/2016
    Labeler - Sanofi Pasteur Inc. (086723285)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sanofi Pasteur SA578763542MANUFACTURE(49281-913)