DESCRIPTION & INDICATION:
A clear to slightly turbid solution containing purified Vi capsular polysaccharide of Salmonella typhi (Strain Ty2) conjugated with Tetanus toxoid protein for prevention of typhoid fever. The manufacturing facilities meets the requirements as per cGMP guidelines of revised schedule ‘M’ from the Drugs & Cosmetic Act, Government of India.
COMPOSITION :
One dose (0.5 ml) contains: 5 µg of Vi polysaccharide of Salmonella typhi (Strain Ty2) conjugated to 5 µg Tetanus toxoid protein in isotonic saline 0.5 ml.
INDICATIONS :
Peda TyphTM is indicated for active immunization against Salmonella typhi in infants of age ? 3 months, children and adults.
CONTRA – INDICATIONS:
Hypersensitivity to any constituent of the vaccine.
Pregnant & lactating women.
In the event of fever or severe infection, persistent diarrhoea and vomiting.
PRECAUTIONS :
The vaccine should be shaken gently and visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either of the above, being observed, discard the vaccine.
As with other vaccines, in rare cases anaphylactic shock may occur in susceptible individual. The mainstay in the treatment of severe anaphylaxis is the prompt use of adrenaline, which can be life saving. It should be used at the first suspicion of anaphylaxis. The vaccinee should remain under observation for not less than 30 minutes for possibility of occurrence of rapid allergic reactions. Hydrocortisone & antihistaminic should also be available in addition to supportive measures such as oxygen inhalation.
ADMINISTRATION :
Inject 0.5ml intramuscularly. Do not inject intravenously or intradermally. Prevention becomes effective 4 weeks after immunization.
DOSAGE :
One dose followed by booster after 2½-3 years of primary vaccination. Vaccination can be done from 3 months age onwards .
POSSIBLE SIDE EFFECTS :
As for any product, there may be more or less moderate and temporary side effects like: – Pain, induration, erythema, purities at the injection site. – Rare, transient febrile reactions. – Paracetamol or Ibuprofen cover for 36 hours after vaccination shall decrease the intensity of side effects.
STORAGE :
Store between +2° to +8°C in the refrigerator. Do not freeze, discard if the vaccine has been frozen.
PACK SIZE :
One dose in glass vial with disposable syringe and aslo in prefilled syringe pack.
SHELF LIFE :
The shelf life of the product is 36 months from the date of manufacture if stored at recommended storage conditions.