SII DiphtheriaTetanus-Pertussis Vaccine Adsorbed -10 doses

국가: 말레이시아

언어: 영어

출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

유효 성분:

Diphtheria Toxoid; Tetanus Toxoid; KILLED B. PERTUSSIS

제공처:

SM PHARMACEUTICALS SDN. BHD.

INN (국제 이름):

Diphtheria Toxoid; Tetanus Toxoid; KILLED B. PERTUSSIS

패키지 단위:

5ml mL

Manufactured by:

SERUM INSTITUTE OF INDIA PRIVATE LIMITED

제품 특성 요약

SII
DESCRIPTION
Diphtheria,Tetanus and Pertussis Vaccine Adsorbed is prepared by
combining purified Diphtheria
toxoid, purified tetanus toxoid and killed Bordetella pertussis
bacilli. The antigens are adsorbed onto
aluminium phosphate as adjuvant. Thiomersal is added as preservative.
The vaccine has the
appearance of a greyish - white suspension and does not contain any
horse serum protein. Therefore it
does not induce sensitization to sera of equine origin. The vaccine
meets the requirements of W.H.O.,
EP and IP when tested by the methods outlined in W.H.O., TRS. 980
(2014), EP and IP.
POTENCY
Each single 0.5 ml human dose contains
Diphtheria Toxoid
25 Lf (
30 IU)
Tetanus Toxoid
5 Lf ( 40 IU)
B. pertussis
16 OU ( 4 IU)
+++
Adsorbed on Aluminium Phosphate, Al
1.25 mg
Preservative : 0.005% Thiomersal
INDICATIONS
For the primary immunization of infants, above the age of six weeks,
and of pre-school children
against diphtheria, tetanus and whooping cough. The vaccine can be
safely and effectively given
simultaneously with BCG, Measles, Polio vaccines (IPV and OPV),
Hepatitis B, Yellow fever Vaccine,
, Varicella vaccine and vitamin A supplementation.
APPLICATION AND DOSAGE
For the purpose of primary immunization it is recommended that 3 doses
of 0.5 ml should be
inoculated on 3 separate occasions at 4 to 6 week intervals. The first
dose should be given at
approximately 6 weeks of age. Reinforcing injections of 0.5 ml should
be given 12 months after the
primary immunization and also between the ages of 4 to 6 years.
METHOD OF INOCULATION
DTP vaccine should be injected intramuscularly. The anterolateral
aspect of the upper thigh is the
preferred site of injection. (An injection into a child's buttocks may
cause injury to the sciatic nerve
and is not recommended). It must not be injected into the skin as this
may give rise to local reaction.
Only sterile needles and syringes should be used for each injection.
The vaccine should be well shaken
before use.
Once opened, multi-dose vials should be kept between +2ºC and +8�