Powder and solvent for injection, suspension. Mycobacterium Bovis BCG (Bacillus Calmette-Guerin), Danish strain 1331, live attenuated. 

Read this leaflet carefully before you or your child are vaccinated. It contains information that is important to you.

  • Save this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you or your child only. Do not give it to others.
  • If you or your child experience side effects, talk to a doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. WHAT BCG-VACCINE AJVACCINES IS AND WHAT IT IS USED FOR 
2. WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD IS VACCINATED WITH BCG-VACCINE AJVACCINES 
3. HOW TO BECOME VACCINES AJVACCINES 
4. POSSIBLE SIDE EFFECTS 
5. HOW TO STORE BCG-VACCINE AJVACCINES 
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

1. WHAT BCG VACCINE AJVACCINES IS AND WHAT IT IS USED FOR

BCG vaccine AJVaccines contains bacteria of the type Mycobacterium Bovis BCG and is used for protection against tuberculosis.

2. WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD IS VACCINATED WITH BCG-VACCINE AJVACCINES

You or your child should not be vaccinated with the BCG vaccine AJVaccines


  if you are allergic (hypersensitive) to any of the excipients in the vaccine (listed in section 6).if you suffer from an acute, severe fever or extensive skin infection. In these cases, the vaccination should be postponed. if you have decreased resistance to infection is due to a disease of the immune system. if you are receiving medical treatment that affects the immune response, e.g. corticosteroid is or radiation therapy. if you have been exposed to immunosuppressive therapy in utero or through breastfeeding (eg treatment with TNF -α inhibitors).if you suffer from any malignant condition (eg lymphoma, leukemia or Hodgkin’s disease ).if your immune status is unclear.if you are infected with HIV .if you are receiving medical treatment for tuberculosis.

Warnings and cautions

Talk to your doctor, pharmacist or nurse before you or your child are vaccinated with the BCG vaccine AJVaccines. The doctor or nurse is extra careful when it comes to vaccination with BCG vaccine AJVaccines

  if you have eczema . The vaccination can be given in an eczema-free area.If you have skin test for tuberculosis – infection and the test was positive no need for vaccination. Vaccination can then cause a serious local reaction.

Other medicines and BCG vaccine AJVaccines

  Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.Other vaccines can be given at the same time as the BCG vaccine AJVaccines at different injection sites.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before getting vaccinated with the BCG vaccine AJVaccines.

Vaccination is not recommended during pregnancy or lactation, although no adverse effects on the unborn or breast-fed infant have been associated with the BCG vaccine AJVaccines.

Driving and using machines

BCG vaccine AJVaccines have no effect on the ability to drive and use machines.

BCG vaccine AJVaccines contain potassium and sodium

BCG vaccine AJVaccines contains less than 1 mmol potassium (39 mg) per dose, ie are essential ‘potassium-free’.

BCG vaccine AJVaccines contains less than 1 mmol sodium (23 mg) per dose, ie are essential ‘sodium-free’.

3. HOW TO VACCINATE YOUR CHILD WITH BCG-VACCINE AJVACCINES

The doctor or nurse gives the vaccine by injection into the upper layer of the skin.

The recommended dose is 0.05 ml for children under 12 months of age and 0.1 ml for adults and children 12 months or older.

The injection site should not be covered to facilitate healing.

Expected reactions to the vaccination are:

  Slight swelling, redness and tenderness at the injection site followed by a local lesion .A few weeks later, this lesion develops into a small wound.After a few months, the wound heals, leaving a small, flat scar.Slight swelling of the lymph nodes in the armpit can be experienced.

These are common reactions to vaccination.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, BCG vaccine AJVaccines can cause side effects, although not everybody gets them.

Severe allergic reactions (such as redness of the face and neck, swelling of the face, throat, or throat, rash, difficulty breathing, and collapse) may occur in rare cases (less than 1 in 1,000).

Contact a doctor immediately if you experience any of the above reactions.

Other side effects include:

Uncommon side effects (may affect up to 1 in 100 people)

  FeverSwelling of the lymph nodes in the armpit that is larger than 1 cm acrossInflammation of the lymph nodes, sometimes with oozing sores and varAn exuding wound at the injection siteHeadache
Rare side effects (may affect up to 1 in 1,000 people)
  Accumulation of goods at the injection siteInfection with the bacteria from the vaccine may occur. Infection one can spread in the body, even to the skeleton

Fainting, seizures, and seizures have been observed in patients receiving injections.

In very premature infants (at or before the 28th week of pregnancy), the interval between breaths may be longer than normal for 2-3 days after vaccination.

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly via

The Medical Products Agency

Box 26

751 03 Uppsala

Website: www.lakemedelsverket.se.

By reporting side effects, you can help increase drug safety information.

5. HOW TO STORE BCG-VACCINE AJVACCINES

  Keep this vaccine out of the reach and sight of children.Store in a refrigerator (2 ° C – 8 ° C).Store in the original package in a light-sensitive manner.Do not freeze.Do not use this medicine after the expiry date which is stated on the carton after “EXP”.The expiration date is the last day of the specified month
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. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

Content declaration

The active substance is:

The freeze-dried powder containing live attenuated bacteria of the type Mycobacteriumbovis BCG (Bacillus Calmette-Guerin), Danish strain 1331. 1 ml vaccine contains between 2-8 million bacteria.

The excipients are:

Sodium glutamate, magnesium sulfate heptahydrate, dipotassium phosphate, L-asparagine monohydrate, iron ammonium citrate, glycerol 85%, citric acid monohydrate, and water for injections.

What the medicine looks like and the contents of the pack

AJVaccines BCG vaccine consists of a powder and solvent for injection , suspension (2-8 X 10 5 cells / 0.1 ml dose or 1-4 × 10 5 cells / 0.05 mL dose ). Pack sizes of 1, 5, or 10 vials and pack sizes of 1 vial with a syringe and two injection needles (one long for the addition of fluid and one short for intradermal injection ).

The powder in the light yellow vial is white and crystalline. The powder may be difficult to see due to the small amount of powder in the vial.

The liquid in the clear vial is a colorless solution with no visible particles.

The mixed vaccine should look like a homogeneous, slightly opaque, colorless suspension.

Pack sizes: Packs of 1, 5, 10 vials and 1 vial in a 1- dose injection kit.

Not all pack sizes may be available for sale.

Marketing Authorization Holder and Manufacturer

AJ Vaccines A / S

Artillerivej 5

DK-2300 Copenhagen S

Denmark

tel: +45 7229 7000

fax: +45 7229 7999

Email:  ajvaccines@ajvaccines.com

Further information on this medicine can be obtained from

the representative of the marketing authorization holder:

Agent

Scandinavian Biopharma Distribution AB

Industrivägen 1 
171 48 Solna

tel: 08-4705600

e-mail: info@sbdistribution.se

This medicinal product is authorized under the European Economic Area under the names:

DK, BCG Vaccine “AJ Vaccines” 
EL, FI, SK, UK: BCG Vaccine AJVaccines 
FR: VACCINE BCG AJVaccines 
NO: BCG Vaccine AJVaccines 
PL: BCG Szczepionka AJVaccines 
SE: BCG Vaccine AJVaccines 
UK: BCG Vaccines

Muhammad Nadeem

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