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VACCINE BCG, 1 dose, multidose vial

https://medicalguidelines.msf.org/en/node/983
https://unicat.msf.org/cat/product/12362
STD DVACVBCG3VD

Valid Article

Former Code(s): DVACZBE0015 DVACMISC105 DVACZFR0105 DVACMISC108 DVACZFR0108
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
19.3 - Vaccines
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
J07AN01
Anatomical Therapeutic Chemical Classification according to WHOCC
0208
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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VACCINE BCG

CAUTION

This multidose vaccine is worded and codified by unit (= 1 dose) to make the order easier.

Therapeutic Action

Freeze-dried vaccine from live-attenuated strain of Mycobacterium tuberculosis

Indications

Prevention of tuberculosis

There are 2 main groups of 2 strains:

  • French and Danish
  • British and Japanese

Before ordering, check with the Ministry of Health (identify the strain and the vaccine used in the country). If necessary, specify the strain when ordering.

Vaccine usually supplied by the Ministry of Health of the country concerned.

Instructions for use

Reconstitute the powder vial with the diluent supplied by the manufacturer.

Must be given by intradermal route with an auto-disable syringe, with needle, s.u., BCG imm., 0.05 ml.

Follow the national immunisation schedule, or failing that, the WHO schedule.

Check the recommended doses according the age groups:

  • children < 1 year: 1 dose = 0.05 ml
  • children from 1 year and adults: 1 dose = 0.1 ml

Caution! Depending on the dose to be administered (0.05 ml or 0.1 ml), the number of vaccine vials and diluents to be ordered should be adapted:

  • 1 multidose vial + 1 diluent vial = 20 doses x 0.05 ml/dose
  • 1 multidose vial + 1 diluent vial = 10 doses x 0.1 ml/dose

Do not forget to order the diluent together with the vaccine!

Orders are always done in number of doses and not in number of vials! (See Preliminary remarks on Vaccines)

Precautions for Use

Contraindicated in pregnancy.

As with all injectable vaccines and or immunoglobulins, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the product.

Storage

  • Protect from sunlight
  • Powder: between 2°C and 8°C. Freezing is possible but unnecessary
  • Diluent: a cold chain is not required for storage. However, at least 12 hrs before reconstitution of the vaccine, the diluent must be refrigerated between 2°C and 8°C so that the diluent and lyophilised powder are at the same temperature (a thermic shock during reconstitution would reduce the vaccine efficacy). Do not freeze.
  • Reconstituted vaccine: between 2°C and 8°C for 6 hrs maximum
  • The vaccine vial monitor (VVM) is mandatory on each vaccine.

(Cf Introduction: Thermosensitive products)