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VACCINE PNEUMOC.CONJ. PCV10, monodose, 0.5ml vial(Pneumosil)

https://medicalguidelines.msf.org/en/node/971
https://unicat.msf.org/cat/product/88288
STD DVACVPCV3V-

Valid Article

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.
J07AL02
Anatomical Therapeutic Chemical Classification according to WHOCC
P
The order of this product needs to be justified and is only acceptable under certain conditions.
0208
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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VACCINE PNEUMOCOCCAL CONJUGATE PCV10

CAUTION

The multldose vaccines are worded and codified by unit (= 1 dose) to make the order easier.

Therapeutic Action

10-valent polysaccharide conjugate vaccine

Streptococcus pneumoniae serotypes 1, 5, 6B, 7F, 19F are contained in Pneumosil® and Synflorix® vaccines

Streptococcus pneumoniae serotypes 6A and 19A are only contained in Pneumosil®

Streptococcus pneumoniae serotypes 4 and 18C are only contained in Synflorix®

Indications

Active immunisation against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae, in children from 6 weeks of age

Most countries have introduced PCV vaccine in their routine immunisation activities.

Beyond routine immunisation, MSF recommends PCV in particular for children with severe acute malnutrition, children born from HIV-positive mothers and people with functional or surgical asplenia.

The choice between Pneumosil® (PCV-10 SII), Synflorix® (PCV-10-GSKI) and Prevenar® (PCV-13-Pfizer) vaccine will depend on which vaccine is introduced and registered in the country where it will be used.

Remark: Pneumosil® will probably replace Synflorix® in some countries where MSF works, or at least will be registered in some of these countries.

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Instructions for use

Suspension in a liquid form. Shake well before use to homogenise the suspension.

Must be given as IM injection into the anterolateral part of the thigh in children < 2 years and into the deltoid muscle in children ≥ 2 years.

The serological profile of Pneumosil® offers better protection against invasive pneumococcal disease in African children than Synflorix®.

Different codes have been created depending on the country of destination and the prevalence of invasive pneumococcal disease. Before ordering, check which vaccine is introduced and registered in the country (Synflorix® or Pneumosil®).

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

Precautions for Use

Do not administer into the gluteal muscle.

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

  • Keep refrigerated between 2ºC and 8ºC - Protect from sunlight
  • Do not freeze.
  • Synflorix® vaccines:
    • opened 2-dose vials should be discarded at the end of each immunisation session or after 6 hrs from first opening, whichever comes first.
    • opened 4-dose vials, kept between 2ºC and 8ºC, may be used in subsequent immunisation sessions for up to 28 days.
    • Check the vial presentation!
  • Pneumosil® vaccines: opened vials may be used in subsequent immunisation sessions (for up to 28 days), provided the conditions outlined in the WHO Policy Statement: Handling of multi-dose vaccine vials after opening, WHO/IVB/14.07
  • The vaccine vial monitor (VVM) is mandatory on each vaccine.

(Cf Introduction: Thermosensitive products)