Stamaril

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Update Date 14/08/2020 . 6 mins read
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Uses

What is Stamaril® (Yellow Fever vaccine) used for?

Stamaril® is a live-attenuated (weakened) vaccine that provides immunization against Yellow Fever in patients who are:

  • Traveling to or living in an endemic area.
  • Traveling to any country that requires an International Certificate of Vaccination for entry (which may or may not depend on the previous itinerary).
  • Handling potentially infectious materials (e.g. laboratory personnel).

How should I take Stamaril® (Yellow Fever vaccine)?

It is preferable that the vaccine is injected by the subcutaneous route.

Intramuscular injection may be performed if this is in accordance with applicable official recommendations.

For intramuscular use, the recommended injection sites are the anterolateral aspect of the thigh in children less than 12 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 12 months through 35 months of age or the deltoid muscle in children from 36 months of age onwards and adults.

How do I store Stamaril® (Yellow Fever vaccine)?

This drug should be stored in a refrigerator (2-8°C) and be protected from light and moisture. Do not freeze this product. Always check the label before using this product. For safety, keep out of the reach of children and pets.

Do not use if the printed expiration date has passed, the product seal has been broken, or the product has changed in color, odor, or consistency.

The Vaccine Vial Monitors (VVMs) are on the cap of Stamaril® supplied through Sanofi Pasteur. The colored dot which appears on the cap of the vial is a VVM. This is a time-temperature sensitive dot that provides an indication of the cumulative heat to which the vial has been exposed. It warns the end-user when exposure to heat is likely to have degraded the vaccine beyond an acceptable level.

Do not dispose of this product by pouring it down the drain, toilet, or into the environment. Ask your pharmacist regarding the proper way and location of disposal.

Precautions & warnings

What should I know before using Stamaril® (Yellow Fever vaccine)?

Before injected, there are some important that you may notice:

  • As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of anaphylaxis or other severe hypersensitivity reaction following the administration of the vaccine.
  • Syncope can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent injury from faints and manage syncopal reactions.
  • Because intramuscular injection can cause injection site hematoma, Stamaril® should not be given by the intramuscular route to persons with any bleeding disorder, such as hemophilia or thrombocytopenia, or to persons on anticoagulant therapy. The subcutaneous route of administration should be used instead.
  • Stamaril® should be administered only to persons who are/will be at risk of infection with yellow fever virus or who must be vaccinated to comply with international health regulations. Before considering the administration of the Yellow Fever vaccine, care should be taken to identify those who might be at increased risk of adverse reactions following vaccination

Also, Stamaril® is contraindicated in some case of:

  • Hypersensitivity to the active substance or to any of the excipients or to eggs or chicken proteins
  • Severe hypersensitivity reactions (g., anaphylaxis) after a previous dose of any yellow fever vaccine
  • Children aged less than 6 months
  • Immunosuppression, whether congenital, idiopathic or as a result of treatment with systemic steroids (greater than the standard dose of topical or inhaled steroids), radiotherapy or cytotoxic drugs
  • History of thymus dysfunction (including myasthenia gravis, thymoma, thymectomy)
  • Symptomatic HIV infection
  • Asymptomatic HIV infection when accompanied by evidence of impaired immune function
  • Moderate or severe febrile illness or acute illness

Is it safe during pregnancy or breastfeeding?

This medication is pregnancy risk category D, according to the US Food and Drug Administration (FDA). Do not administer this vaccine or any live vaccine to pregnant women as there is an increased risk of fetal harm. Only administer this vaccine if the potential benefits outweigh the potential risks, as determined by your physician.

FDA pregnancy risk category reference below:

  • A=No risk
  • B=No risk in some studies
  • C=There may be some risk
  • D=Positive evidence of risk
  • X=Contraindicated
  • N=Unknown

Side effects

What side effects can occur when using Stamaril® (Yellow Fever vaccine)?

All drugs have the potential to elicit side effects even with normal use. Side effects, if any occur, usually subside within a few hours.

Potential side effects while using this drug include:

  • Injection site reactions
    • Pain
    • Bruising
    • Swelling
    • Inflammation
  • Headache
  • Malaise
  • Diarrhea
  • Muscle pain
  • Weakness

Rare, serious adverse reactions:

  • Anaphylaxis
    • Rash or hives
    • Swelling of the lips, tongue, throat
    • Difficulty breathing or swallowing
    • Dizziness or loss of consciousness
  • CNS disturbances (within 1 month after injection)
    • High fever with a headache
    • Confusion
    • Lethargy
    • Stiff neck
    • Meningitis
    • Fits
    • Loss or difficulty of movement or feeling
  • Yellow Fever-like symptoms (within 10 days after injection)
    • Fatigue
    • Fever
    • Headache
    • Muscle pain
    • Low blood pressure

You may experience some, none, or other side effects not mentioned above. If you experience serious adverse reactions, you must stop taking the drug immediately. If you have any concerns about a side effect or it becomes bothersome, consult your doctor or pharmacist.

Interactions

What drugs may interact with Stamaril® (Yellow Fever vaccine)?

This drug may interact with other medications. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist.

Products may interact with this drug, including:

  • Other live vaccines (e.g. flu vaccine, MMR)

Does food or alcohol interact with Stamaril® (Yellow Fever vaccine)?

Stamaril® is not likely to interact with food or alcohol. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Stamaril® (Yellow Fever vaccine)?

Stamaril® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

It must not be administered to persons who are receiving immunosuppressant therapy (e.g., cytotoxic agents, systemic steroids, greater than the standard dose of topical or inhaled steroids or other agents).

It can induce false-positive results with laboratory and/or diagnostic tests for other flavivirus related diseases such as dengue or Japanese encephalitis.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Stamaril® (yellow fever virus).

What is the dose of Stamaril® (Yellow Fever vaccine) for an adult?

Primary vaccination

The vaccine should be given at least 10 days before entering an endemic area since protective immunity may not be achieved until at least this time has elapsed.

For adults, the recommended dose is a single dose of 0.5 ml of the reconstituted vaccine.

For older people, the dose is the same as for adults. However due to a potentially higher risk of yellow fever vaccine-associated severe and potentially fatal disease in persons from 60 years of age, the vaccine should only be given when it is considered that there is a significant and unavoidable risk of acquiring yellow fever infection.

Re-vaccination

The duration of protection following administration of one single 0.5 ml dose of Stamaril® is expected to be at least 10 years and may be life-long.

Re-vaccination with one dose of 0.5 ml may be needed in some individuals who had an insufficient immune response after their primary vaccination. Re-vaccination may also be required, depending on official recommendations of local Health Authorities, as a condition of entry in some countries.

What is the dose of Stamaril® (Yellow Fever vaccine) for a child?

Primary vaccination

The vaccine should be given at least 10 days before entering an endemic area since protective immunity may not be achieved until at least this time has elapsed.

For children aged 9 months and older, the recommended dose is a single dose of 0.5 ml of the reconstituted vaccine.

For children from 6 to 9 months of age, vaccination is not recommended, except in specific circumstances and in accordance with available official recommendations, in which case the dose is the same as in children aged 9 months and older.

For children under 6 months of age, vaccination is contraindicated in this case.

Re-vaccination

Re-vaccination with one dose of 0.5 ml may be needed in some individuals who had an insufficient immune response after their primary vaccination. Re-vaccination may also be required, depending on official recommendations of local Health Authorities, as a condition of entry in some countries.

How is Stamaril® (Yellow Fever vaccine) available?

Stamaril® is available in the following dosage forms and strengths:

  • 10 vials 10 doses + 10 vials 5 ml (diluent)
  • 1 dose (0.5 ml) contains: Yellow fever virus1 17D-204 strain (live, attenuated), not less than 1000 IU

What should I do in case of an emergency or overdose?

Overdose is not likely to occur with vaccinations. In case of a severe reaction or emergency, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

Stamaril® is a single-dose injection that offers lifelong protection, therefore multiple doses are not necessary.

Hello Health Group does not provide medical advice, diagnosis or treatment.

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