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פרוקוואד PROQUAD (MEASLES VIRUS ENDERS EDMONSTON STRAIN (LIVE, ATTENUATED), MUMPS VIRUS JERYL LYNN™ (LEVEL B) STRAIN (LIVE, ATTENUATED), RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED), VARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED))

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

תת-עורי, תוך-שרירי : S.C, I.M

צורת מינון:

אבקה וממס להכנת תרחיף להזרקה : POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Posology : מינונים

4.2   Posology and method of administration

Posology
ProQuad should be used in accordance to official recommendations.


•     Individuals 12 months of age to 12 years of age
Individuals from 12 months of age should receive two doses of ProQuad or a single dose of ProQuad followed by a second dose of a monovalent varicella vaccine to ensure optimal protection against varicella (see section 5.1). At least one month must elapse between the first and second dose of any live viral attenuated vaccine. It is preferred that the second dose be administered within three months following the first dose.


•     Individuals between 9 and 12 months of age
Immunogenicity and safety data show that ProQuad can be administered to individuals between 9 and 12 months of age, under special circumstances (e.g., in accordance with official recommendations or when early protection is considered necessary). In such cases, individuals should receive a second dose of ProQuad, given a minimum of 3 months apart, to ensure optimal protection against measles and varicella (see sections 4.4 and 5.1).


•     Individuals less than 9 months of age
ProQuad is not indicated in this subset of the paediatric population. The safety and efficacy of ProQuad in children under 9 months of age have not been established.

ProQuad may be used as the second dose in individuals who have previously received measles, mumps, and rubella vaccine and varicella vaccine.

Method of administration

The vaccine is to be injected intramuscularly (IM) or subcutaneously (SC).
The preferred injection sites are the anterolateral area of the thigh in younger children and the deltoid area in older children, adolescents, and adults.

The vaccine should be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder.

Precautions to be taken before handling or administering the medicinal product: see section 6.6.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.
The vaccine should under no circumstances be injected intravascularly.

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154 72 34392 00

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