September 1, 2014
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BCG Vaccine (Freeze-Dried) by Sanofi Pasteur Limited

(bacillus Calmette-Guerin)

DIN (Drug Identification Number)

00075124 BCG VACCINE (FREEZE-DRIED) 0.1MG/0.1ML

What side effects are possible with BCG Vaccine (Freeze-Dried) by Sanofi Pasteur Limited?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • burning upon urination after first treatment

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • blood in urine
  • cough or shortness of breath
  • eye trouble
  • fatigue, fever, and chills that last more than 48 hours or are severe
  • joint pain
  • nausea and vomiting or lack of appetite
  • rash
  • severe and continuing painful urination
  • unexpected frequent urge to urinate
  • unexpected increased frequency of urination
  • yellow eyes or yellowing of skin (sign of liver disease)

It is important to contact your doctor if you develop a cough or fever up to 6 months after treatment with BCG, to rule out the possibility of active tuberculosis.

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for BCG Vaccine (Freeze-Dried) by Sanofi Pasteur Limited?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Handling of urine: Because BCG contains live mycobacteria urine may also contain the live bacteria. You should use appropriate infection control procedures to protect others from infection. This is especially true if you are living with someone who has reduced immunity (e.g. on chemotherapy).

For up to 6 hours after therapy, you should urinate while sitting to minimize the risk of splashing urine. Also, you should disinfect with equal volume of household bleach for 15 minutes before flushing.

Systemic BCG reaction: Although rare, a systemic granulomatous illness have been reported subsequent to exposure to BCG. Based on past reports, "systemic BCG reaction" may have any of the following signs: fever ≥39.5°C for 12 hours; fever ≥38.5°C for 48 hours; cough/pneumonitis; liver dysfunction; or the classical signs of severe infection such as low blood pressure, difficulty breathing.  Although rare, the reaction is much more likely to occur if BCG  is administered within 14 days of biopsy, TUR, or traumatic bladder catheterization (associated with hematuria).

Pregnancy: BCG has not been studied for use by pregnant women. It is best to use birth control while being treated with this medication. Tell your doctor immediately if you become pregnant during treatment. BCG should be used by pregnant women only if the benefits outweigh the risks.

Breast-feeding: It is not known whether BCG passes into breast milk. Women should not breast-feed while receiving BCG treatment due to risk of potential harm to the infant.

What other drugs could interact with BCG Vaccine (Freeze-Dried) by Sanofi Pasteur Limited?

There may be an interaction between bacillus Calmette-Guérin and any of the following:

  • azathioprine, 6-mercaptopurine
  • corticosteroids and other immunosuppressants
  • cyclosporine
  • flucytosine
  • ganciclovir
  • interferon
  • plicamycin
  • other cancer medications
  • PPD skin test

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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