DESCRIPTION
Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) (Sii Triple Antigen) as supplied by Serum Institute of India Ltd. is a sterile, whitish turibid, uniform suspension of diphtheria, tetanus toxoids and pertussis vaccine adsorbed on aluminium phosphate and suspended in isotonic sodium chloride solution.Each dose of 0.5 ml contains:

Diphtheria Toxoid	25 Lf.
Tetanus Toxoid	5 Lf.
B. Pertussis	4 IU
Adsorbed on Aluminium Phosphate (AlPO4)	1.5 mg.
Thiomersal	0.01% as preservative.

INDICATIONS
DPT Vaccine (Adsorbed) is indicated for the primary immunization of infants, at or above the age of 6 weeks, and of children through six years of age against diphtheria, tetanus and whooping cough.

DOSAGE
For the purpose of primary immunization it is recommended that 3 doses each of 0.5 ml should be inoculated on 3 separate occasions at 4 weeks interval.
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.
Although it is recommended that immunization be started at 6 weeks, if for any reason it is delayed, the same schedule may be used up to the sixth birthday.
A reinforcing injection of 0.5 ml. intramuscularly should be administered between four and six years of age (i.e. at the time of school entry).
This booster dose is not necessary if the fourth primary immunizing dose has been administered after the fourth birthday.

ADMINISTRATION
DPT vaccine should be administered by deep intramuscular injection. The preferred site for injection is the anterolateral aspect of the upper thigh.
Only sterile needles and syringes should be used for each injection. The vaccine should be well shaken before use.
Each injection of the primary immunization series should be made into a different site with a sterile disposable syringe and needle.

ADVERSE REACTIONS
Mild local reactions consisting of erytherna, pain and tenderness, swelling and induration at the injection site are common, usually self-limited and subside without treatment. Persistent nodules at the site of injection have occurred following the use of an adsorbed vaccine, but this complication is unusual. Abscess at the site of injection has been reported (6-10 per million doses).
Mild to moderate systemic reactions occur frequently following injections of this vaccine. These usually consist of one or more of the following symptoms and signs: temperature elevation 38°C, drowsiness, fretfulness, anorexia, vomiting, irritability, persistent or unusual crying. These symptoms are most frequent during the first 24 hours following vaccine injection and may persist for one to two days. The following adverse reactions -high fever (40.5°C), collapse, screaming episodes, convulsions, signs of encephalopathy which can be serious and, occasionally fatal have been reported following administration of preparations containing pertussis vaccine. The incidence of these reactions is unknown, but they seem to be exceedingly rare, if any of these reactions occur, further immunization against pertussis is contraindicated. See also Contraindications and Precautions.
Sudden-infant-death-syndrome (SIDS) has been reported following administration of vaccine containing diphtheria, tetanus toxoids and pertussis vaccine. The significance of these reports is not clear. It should be borne in mind that the three primary immunizing doses of these vaccine are usually administered to infants between the age of 6 weeks and 6 months and that approximately 85% of SIDS cases occur in the period from one through six months of age with the peak incidence at age two to four months.

CONTRAINDICATIONS
DPT Vaccine (Adsorbed) should not be administered to infants or children with high fever, or other evidence of acute illness or infection. The presence of an evolving or changing neurological disorder is a contraindication to receipt of this vaccine. While data to support exclusion of pertussis immunization because of a family history of convulsive or other neurological disorders are scarce, a personal or family history of central nervous system disease or convulsions is considered a contraindication to use of this vaccine. Occurence of any of the following signs, symptoms or conditions following administration is a contraindication to further use of this product and or pertussis vaccine as the single antigen: fever over 40°C (104°F); convulsion(s) with or without accompanying fever; alterations of consciousness; focal neurologic signs; screaming episodes; shock; collapse; thrombocytopenia purpura.
DPT Vaccine (Adsorbed) should not be administered to children over six years of age or to adults because of the danger of reactions to diphtheria toxoid or to pertussis vaccine and because pertussis is less severe in these age groups than in infants and young children.
The specific contraindications adopted by individual national health authorities should reflect a balance between the risk from the vaccine and the risk from the disease. Because the risk from the vaccine remains extremely low in comparison to the risk from the disease in many developing countries, authorities there may choose to offer immunization to children who are mildly to moderately ill or malnourished.

PRECAUTIONS AND WARNING
Individuals receiving corticosteroids or other immunosuppressive drugs may not develop an optimum immunologic response. This product should be used only for infants and children from 6 weeks through six years of age. The possibility of allergic reactions in individuals sensitive to the components of the vaccine should be borne in mind. Adrenaline injection (1:1000) should be kept ready for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs. Frequent booster doses of tetanus toxoid in the presence of adequate or excessive serum levels of tetanus antitoxin have been associated with increased incidence and severity of reactions and should be avoided. If hypersensitivity to the diphtheria component is suspected, tetanus toxoid should be used for reinforcing doses.
A separate sterile syringe and needle should be used for each individual patient to prevent the transmission of hepatitis or other infectious agents.
DPT VACCINE (ADSORBED) SHOULD BE USED ONLY FOR INFANTS AND CHILDREN THROUGH SIX YEARS OF AGE.

WITHDRAWING THE VACCINE FROM A SEALED GLASS AMPOULE
Shake the ampoule to disperse the contents thoroughly immediately before withdrawing the dose.Tap the ampoule to ensure that the solution is in the lower portion rather than in the neck of the ampoule Wipe the neck of the ampoule with a suitable antiseptic using a sterile piece of cotton break off the top of the ampoule at the constriction by thumb pressure.

WITHDRAWING THE VACCINE FROM A RUBBER-STOPPERED VIAL
DO NOT REMOVE THE RUBBER STOPPER FROM THE VIAL
Shake the vial to disperse the contents thoroughly immediately before each withdrawal of vaccine. Apply a sterile piece of cotton moistened with a suitable antiseptic to the surface of the rubber stopper and allow to dry. Draw into the sterile syringe a volume of air equal to the amount of vaccine to be withdrawn from the vial. Pierce the centre of the rubber stopper with the sterile needle of the syringe. invert the vial, slowly inject into it the air contained in the syringe, and keeping the point of the needle immersed. withdraw into the syringe the required amount of vaccine. Then hold the syringe plunger steady and withdraw the needle from the vial.
Carefully insert the needle intramuscularly at the prepared injection site. In order to avoid intravenous injection, pull back the plunger of the syringe to make certain that no blood is withdrawn before injecting the desired dose.

STORAGE
Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) should be stored at a temperature between 2°C and 8°C (35° to 46°F).
NOT TO BE FROZEN.
Product which has been exposed to freezing should not be used.

PRESENTATION
Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) is supplied, ready for use, in rubber-stoppered multi-dose vials, and in single-dose glass ampoules.
i) 0.5 ml X 10 ampoules box
ii) 0.5 ml X 50 ampoules box
iii) 5 ml - 10 dose single vial carton
iv) 5 ml - 10 dose X 50 vials box

Gene Vac-B™   Recombinant Hepatitis-B Vaccine I.P. DESCRIPTION Gene Vac-B™ (Recombinant Hepatitis - B Vaccine, I.P.) is a non infectious recombinant DNA Hepatitis B Vaccine. It contains purified surface antigen of the virus obtained by culturing genetically-engineered Hansenula polymorpha yeast cells having the surface antigen gene of the Hepatitis B virus. The Hepatitis-B surface antigen (HBsAg) expressed in the cells of Hansenula polymorpha is purified through several chemical steps and formulated as a suspension of the antigen adsorbed on aluminium hydroxide and thiomersal is added as preservative. The vaccine does not contain any material of human or animal origin.   COMPOSITION Each ml contains : 20 mcg of purified Hepatitis B surface antigen Adsorbed on Aluminium hydroxide (Al+++) 1.25 mg Preservative: Thiomersal 0.01% Produced in Hansenula Polymorpha (yeast)       Dose : 1 Paediatric dose - 0.5 ml     1 Adult dose - 1 ml   By intramuscular injection INDICATIONS Gene Vac-B™ is indicated for active immunisation against Hepatitis-B infection in subjects considered at risk of exposure to HBV-positive material. Immunisation against hepatitis B is expected in the long term to reduce not only the incidence of this disease, but also its chronic complications such as chronic active hepatitis B and hepatitis B associated cirrhosis and primary hepatocellular carcinoma. In areas of low prevalence of hepatitis B, immunisation with Gene Vac-B™ is recommended for neonates/infants and adolescents as well as for subjects who are, or will be, at increased risk of infection such as.   Health Care Personnel.   Patients receiving frequent blood products.   Personnel and residents of institution.   Persons at increased risk due to their sexual behaviour.   Illicit users of addictive injectable drugs.   Travellers to areas with a high endemicity of HBV.   Infants born of mothers who are HBV carries.   Persons originating from areas with a high endemicity of HBV.   Others: Police personnel, fire brigade personnel, armed forces personnel and anybody who through their work or personal lifestyle may be exposed to HBV.   Household contacts of any of the above groups and of patients with acute or chronic HBV infection.   In areas of intermediate or high prevalence of hepatitis B, with most of the population at risk of acquiring the disease, immunisation should be offered to all neonates and young children. Immunisation should also be considered for adolescents and young adults. The vaccine can be safely and effectively given simultaneously but at different injection site with DTP, DT, TT, BCG, Polio vaccine (OPV and IPV) and yellow fever vaccine. CONTRAINDICATIONS Gene Vac-B™ should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous Hepatitis B Vaccine administration. PRECAUTIONS AND WARNINGS Because of the period of latency of hepatitis-B infection it is possible for unrecognised infection to be present at the time of immunisation. The vaccine may not prevent hepatitis B infection in such cases. The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E and other pathogens known to infect the liver. The immune response to Hepatitis B vaccines is related to age. In general, people over 40 years of age respond less well. In haemodiaysis patients and persons with an impaired immune system, adequate anti-HBs antibody titres may not be obtained after the primary immunisation course and such patients may therefore require administration of additional doses of vaccine (see Dosage recommendation for Immunocompromised persons) As with all injectable vaccines, appropriate medication (eg adrenaline) should always be readily available for treatment in case of rare anaphylactic reactions following the administration of the vaccine. Gene Vac-B™ should not be administered in the gluteal muscle or intradermally since this may result in a lower immune response. Gene Vac-B™ may be used to complete a primary immunisation course started either with plasma-derived or with other genetically-engineered hepatitis B vaccines, or as a booster dose in subjects who have previously received a primary immunisation course with plasma-derived or with other genetically-engineered hepatitis B vaccines. ADVERSE REACTIONS The undersirable events are temporally related to the administration of Hepatitis B Vaccine. They are usually mild and confined to the first few days of the vaccination. The most common reactions are mild soreness, erythema, induration, fatigue, fever, malaise, influenza-like symptoms Less common systemic reactions include nausea, vomiting, diarrhoea, abdominal pain, abnormal liverfunction tests, arthralgia, mystalgia, rash, pruritus, urticaria, liver function. DOSAGE AND ADMINISTRATION Paediatric dose vaccines 10 mcg dose (in 0.5 ml suspension) is recommended for neonates, infants and children upto 10 years of age. Adult dose vaccine 20 mcg dose (1.0 ml suspension) is recommended for adults and children above 10 years of age. IMMUNISATION SCHEDULE Primary Immunisation A series of three intramuscular injections is required to achieve optimal protection. Two primary immunisation schedules can be recommended:   A rapid schedule, with immunisation at 0,1 and 2 months, will confer protection more quickly and is expected to provide better patient compliance.   Schedules which have more time between the second and third doses. such as  immunisation at 0,1 and 6 months, may take longer to confer protection, but will produce   higher anti-HBs antibody titres.   The immunisation schedule may be adapted to meet local immunisation recommendations. The following timing of injections gives general guidance :   1st dose at elected date 2nd dose 4 to 10 weeks after the 1st dose 3rd dose 1 to 5 months after the 2nd dose BOOSTER DOSE. It would seem advisable to recommend a booster dose when the anti-HBs antibody titre falls below 10 IU/L, particularly for all people at risk.   After the 0, 1, 2 month primary immunisation schedule a booster dose is recommended 12 months after the first dose. The next booster may be required after 8 years.   After the 0, 1, 6 month primary immunisation schedule a booster dose may be required  after 5 years after the primary course.   SPECIAL DOSAGE RECOMMENDATIONSDOSAGE RECOMMENDATION FOR NEONATES BORN OF MOTHERS WHO ARE HBV CARRIERS. The 0, 1, 2 month immunisation schedule is recommended, and should start at birth. Concommitant administration of Hepatitis B immunoglobulin not necessary, but when Hepatitis B immunoglobulin is given simultaneously with Gene Vac-B™ a separate injection site must be chosen. DOSAGE RECOMMENDATION FOR KNOWN OR PRESUMED EXPOSURE OF HBV In circumstances where exposure to HBV has recently occurred (eg needlesstick with contaminated needle) the first dose of Gene Vac-B™ can be administered simultaneously with Hepatitis B immunoglobulin which however must be given at a separate injection site. The rapid immunisation schedule should be advised. DOSAGE RECOMMENDATION FOR IMMUNOCOMPROMISED PERSONS. The primary immunisation schedule for chronic haemodialysis patients or persons who have an impaired immune system is four doses of 40 mcg at 0, 1, 2 and 6 months from the date of first dose. The immunisation schedule should be adapted in order to ensure that the anti-HBs antibody titre remains above the accepted protective level of 10 IU/L METHOD OF ADMINISTRATION Gene Vac-B™ should be injected intramusculary in the deltoid region in adults and children or in the anterolateral thigh in neonates, infants and young children. The vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders. The vaccine should be well shaken before use. Only sterile needle and syringes should be used for each injection. STORAGE Gene Vac-B™ should be stored between 2° and 8°C. Not to be frozen. Discard if vaccine has been frozen.   PRESENTATIONS 0.5 ml Single dose (Paediatric) vial 5 ml 10 doses (Paediatric) vial 1 ml Single dose (Adult) vial 10 ml 10 doses (Adult) vial