DESCRIPTION
SII Td-Vac (Diphtheria And Tetanus Vaccine (Adsorbed) for Adults And Adolescents I.P.) is prepared by combining purified diphtheria toxoid and purified tetanus toxoid. 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 I.P. and WHO when tested by the methods outlined in I.P. and WHO; TRS. (1990), 800.

POTENCY
Each single 0.5 ml human dose contains

Diphtheria Toxoid	5 Lf (2IU)
Tetanus Toxoid	5Lf (40IU)
Adsorbed on Aluminium Phosphate, AL+++	1.25 mg
Preservative: Thiomersal	0.01 %

INDICATIONS
For primary vaccination and revaccination of adults and adolescents, who are having contraindications of DTP.
Primary vaccination and revaccination of children older than 7 years. In order to prevent allergic reactions to the protein of Diphtheria toxoid, the quantity of the toxoid has been markedly reduced.

After a primary immunisation course of either DTP or Td, adsorbed Td for adults may be used as a booster at intervals of approximately 10 years, but with a minimum of at least one year between doses. It can safely replace monovalent tetanus toxoid (TT) vaccine, including during pregnancy.

The vaccine can be safely and effectively given simultaneously with BCG, Measles, Polio Vaccine (IPV and OPV), Hepatitis B and Yellow Fever Vaccine.
 

APPLICATION & DOSAGE
Two injections of 0.5 ml. at least four weeks apart followed by a third injection 6 to 12 months after the second dose. The vaccine should also be given as a booster immunisation every 5 to 10 years.


METHOD OF INNOCULATION
The vaccine should be injected intramuscularly. The preferred site for injection is deltoid muscles. Care should be taken not to inject into the blood vessel or the skin. Only sterile syringes and needles should be used for each injection. The vaccine should be well shaken before use.
Once opened, multi-dose vials should be kept between +2°C and +8°C. Multi-dose vials of SII Td-Vac from which one or more doses of vaccine have been removed during an immunisation session may be used in subsequent immunisation sessions for upto a maximum of 4 weeks, provided that all of the following conditions are met

The vaccine should be visually inspected for any foreign particulate matter and /or variation of physical aspect prior to administration. In event of either being observed discard the vaccine.

REACTIONS
Reactions, are generally mild and confined to the site of injection. Some inflammation may occur together with transient fever, malaise and irritability. Occasionally a nodule may develop at the site of injection but this is rare.

PRECAUTIONS
ADRENALINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCUR DUE TO ANY COMPONENT OF THE VACCINE. For treatment of severe anaphylaxis the initial dose of adrenaline is 0.1-0.5 mg (0.1-0.5ml of 1:1000 injection) given s/c or i/m. Single dose should not exceed 1 mg (1ml). For infants and children the recommended dose of adrenaline is 0.01mg/kg (0.01ml/kg of 1:1000 injection). Single paediatric dose should not exceed 0.5mg (0.5ml). The mainstay in the treatment of severe anaphylaxis is the prompt use of adrenaline, which can be lifesaving. It should be used at the first suspicion of anaphylaxis.

As with the use of all vaccines, the vaccinees should remain under observation for not less than 30 minutes for possibility of occurrence of immediate or early allergic reactions. Efcorlin hydrochloride and antihistaminics should also be available in addition to supportive measures such as oxygen inhalation.

Special care should be taken to ensure that the injection does not enter a blood vessel.

IT IS EXTREMELY IMPORTANT WHEN THE PARENT, GUARDIAN, OR ADULT PATIENT RETURNS FOR THE NEXT DOSE IN THE SERIES, THE PARENT, GUARDIAN, OR ADULT PATIENT SHOULD BE QUESTIONED CONCERNING OCCURRENCE OF ANY SYMPTOMS AND/OR SIGNS OF AN ADVERSE REACTION AFTER THE PREVIOUS DOSE.


DRUG INTERACTIONS
If Td and TIG or Diphtheria Antitoxin are administered concurrently, separate syringes and separate sites should be used.
As with other intramuscular injections, use with caution in patients on anticoagulant therapy.
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids used in greater than physiologic doses), may reduce the immune response to vaccines.
 

CONTRAINDICATIONS & WARNINGS
The vaccine should not be given to persons who showed a severe reaction to a previous dose of Diphtheria and Tetanus vaccine.
A history of systemic allergic or neurologic reactions following a previous dose of SII Td-Vac is an absolute contraindication for further use.

Immunization should be deferred during the course of an acute illness. Vaccination of persons with severe, febrile illness should generally be deferred until these persons have recovered. However, the presence of minor illnesses such as mild upper respiratory infections with or without fever should not preclude vaccination.

HIV INFECTION
Diphtheria and tetanus vaccine (Adsorbed) for adults and adolescents may be used in adults and adolescents with known or suspected HIV infection. Although the data are limited and further studies are being encouraged, there is no evidence to date of any increased rate of adverse reactions using this vaccine in symptomatic or asymptomatic HIV infected adults and adolescents.

STORAGE OF THE VACCINE
The vaccine should be stored between +2°C and +8°C. NOT TO BE FROZEN. Transportation should be between +2°C and +8°C.

PRESENTATION
1 dose ampoule of 0.5 ml
10 dose vial of 5 ml