MEASLES AND RUBELLA VACCINE

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

유효 성분:

MEASLES VIRUS VACCINE LIVE ATTENUATED; RUBELLA VIRUS VACCINE LIVE ATTENUATED

제공처:

BIO FARMA - Indonesia

INN (International Name):

MEASLES VIRUS VACCINE LIVE ATTENUATED; RUBELLA VIRUS VACCINE LIVE ATTENUATED

복용량:

5 DOSIS

약제 형태:

CAIRAN INJEKSI

패키지 단위:

DUS, 50 VIAL @ 5 DOSIS + DUS, 50 AMPUL PELARUT @ 2,5 ML

Manufactured by:

SERUM Institute - India

승인 날짜:

2019-06-24

제품 특성 요약

DESCRIPTION
The vaccine is prepared from the live, attenuated strains of
Edmonston-Zagreb measles virus and
Wistar RA 27/3 rubella virus. Both measles and rubella viruses are
propagated on human diploid cells
(HDC). The vaccine is lyophilized and is provided with diluent. The
product has the appearance of a
yellowish-white dry cake. The vaccine meets the requirements of W.H.O.
when tested by the methods
outlined in W.H.O., TRS 840 (1994).
POTENCY
Each single human dose when reconstituted in a volume of 0.5 ml
contains not less than 1000 CCID
50
of measles virus and 1000 CCID
of rubella virus.
50
INDICATIONS
For active immunization against measles and rubella in children age 9
months – 16 years old.
The vaccine can be given simultaneously with IPV, Yellow fever vaccine
and Rotavirus vaccine.
APPLICATION AND DOSAGE
The vaccine should be reconstituted only with the entire diluent
supplied (Sterile water for injections)
using a sterile syringe and needle. With gentle shaking the dried cake
is easily dissolved. After
reconstitution the vaccine should be used immediately. A single dose
of 0.5 ml should be administered
by deep subcutaneous injection into the anterolateral aspect of upper
thigh in toddlers and upper arm
in older children. If the vaccine is not used immediately then it
should be stored in the dark at 2-8ºC
for no longer than 6 hours.
Any opened container remaining at the end of a session (within six
hours of reconstitution) should be
discarded. The vaccine vial monitor (see figure), for this type of
vaccine is attached to the vial cap and
should be discarded when the vaccine is being reconstituted.
The diluent supplied is specially designed for use with the vaccine.
Only this diluent must be used to
reconstitute the vaccine. Do not use diluents from other types of
vaccine or for MR vaccine from other
manufacturers. Water for injections must NOT be used for this purpose.
Using an incorrect diluent may
result in damage to the vaccine and/or serious reactions to those
receiving the vaccine. Diluent must
n