Tetana

Tetana

Manufacturer:

IBSS Biomed

Distributor:

Biogenetech
Full Prescribing Info
Contents
Adsorbed tetanus vaccine.
Description
1 dose (0.5 ml) contains: Tetanus toxoid not less than 40 IU adsorbed on aluminium hydroxide, hydrated not more than 0.7 mg of Al3+.
Excipients/Inactive Ingredients: Sodium chloride, Water for injections, Adjuvant.
Action
Pharmacotherapeutic Group: Tetanus toxoid. ATC Code: J07AM01.
Pharmacology: Pharmacodynamics: The active substance of the vaccine is purified tetanus toxoid (T) adsorbed on aluminium hydroxide. Toxoid is obtained by formaldehyde inactivation of tetanus toxin derived from Clostridium tetani culture.
Tetanus toxoid retains antigenic properties of the native toxin. Devoid of pathogenicity, it has strong antigenic properties and induces immune response which consists of production of specific antibodies, and triggers mechanisms which provide formation of immune memory. Immunizing properties of the vaccine are enhanced by aluminium hydroxide (adjuvant).
One dose of Tetana vaccine does not protect against infection with tetanus. After two to four weeks from the administration of the second dose of Tetana, or vaccines containing DT, Td antigens, and after the third dose of DTP (primary vaccination), 90% of patients develop the immunity. However, the immunity is short-lasting. The supplementary dose (the last dose of basic vaccination) provides immunity for 5 to 10 years.
Booster doses provide long-lasting protection against the disease.
Tetana complies with the requirements of the European Pharmacopoeia and WHO.
Pharmacokinetics: Not applicable.
Toxicology: Preclinical safety data: Prior to release, each production lot is a subject to specific toxicity analysis performed according to the European Pharmacopoeia requirements.
Indications/Uses
The vaccine is indicated for active immunisation of children, adolescents and adults against tetanus: Within the National Immunisation Programme: In case of contraindications for using: DTP, DT or Td vaccines; as a booster dose.
In unvaccinated pregnant women.
In active-passive prevention of tetanus in the case of contaminated wounds and at high risk of Clostridium tetani infection.
Subjects suffering from AIDS or HIV positive, should receive the vaccination according to a standard schedule, and in the case of injury they should always receive human tetanus immunoglobulin (immunoglobulin with a high titre of tetanus antibodies), regardless of their history of immunisation against tetanus.
This vaccine is recommended for basic and booster vaccination.
Dosage/Direction for Use
Basic vaccination: The basic vaccination schedule consists of three doses of the vaccine: Two doses of the vaccine with an interval of 4-6 weeks (primary vaccination).
The third dose of the vaccine in 6-12 months after the second dose (supplementary vaccination). This dose ensures immunity lasting from 5 to 10 years.
Booster vaccination: One dose of the vaccine every 10 years after the completion of the basic vaccination. (See table.)

Click on icon to see table/diagram/image

Posology during pregnancy: Unvaccinated women or those with incomplete basic vaccination should be vaccinated. Women who received one or two doses of the vaccine before the pregnancy should complete the vaccination scheme during pregnancy.
Pregnant women who were vaccinated more than 10 years ago should receive a booster dose.
Method of administration: A dose of 0.5 ml should be administered intramuscularly into the deltoid muscle or anterolateral part of the thigh.
Overdosage
Overdose is very unlikely because the packaging contains a single dose only.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in Description.
Acute febrile illnesses. Mild infections are not contraindications to the vaccine administration.
Exacerbation of chronic diseases. In such cases, the vaccination should be postponed until the exacerbation subsides.
Suspicion of infection (other than tetanus) during the incubation period.
Thrombocytopenia or neurological disorders after previous dose of the vaccine.
Because of the importance of vaccination against tetanus, contraindications should be limited, especially in the case of injury.
If there are any contraindications for vaccination with Tetana, it is necessary to assess the risk associated with vaccine administration in relation to the risk of infection.
In case of injury and existing contraindications for using Tetana vaccine, tetanus immunoglobulin should be administered immediately.
Special Precautions
Vaccination should be preceded by accurate review of the medical history (especially with regard to previous vaccinations and possible occurrence of undesirable effects) and a clinical examination.
As with other injectable vaccines, appropriate immediate treatment should be readily available in case of an anaphylactic shock following the administration of the vaccine.
In patients undergoing immunosuppressive therapy or with immune deficiency, immunological response may be reduced. In such cases vaccination should be postponed until the end of therapy and anti-tetanus antibodies level should be assessed after vaccination.
Thiomersal (an organomercuric compound) has been used in the manufacturing process of this medicinal product, and residues of it are present in the final product. Therefore, sensitisation reactions may occur.
Precautions should be taken during the use of the vaccine in individuals who have experienced or have known allergic reactions and have experienced health disorders following previous vaccine administration.
Do not administer intravenously.
Make sure that the needle is not introduced into a blood vessel.
Following injection, the vaccinated person should remain under medical supervision for 30 minutes.
Effects on ability to drive and use machines: Tetana vaccine has no or negligible influence on the ability to drive and use machines.
Fertility: Tetana vaccine has not been evaluated in fertility studies.
Use In Pregnancy & Lactation
Pregnancy: The vaccine may be administered during pregnancy, if recommended (see Dosage & Administration).
Breast-feeding: No data available.
Adverse Reactions
Frequencies of adverse reactions are defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Adverse reactions from post-marketing spontaneous monitoring (frequency not known): Blood and lymphatic system disorders: Thrombocytopenia; lymph nodes enlarged and (or) pain.
Immune system disorders: Rhinitis; hypersensitivity reactions, including anaphylactic shock.
Nervous system disorders: Headache; dizziness; hypotonic-hyporesponsive episode; syncope; loss of consciousness; tremor.
Eye disorders: Lacrimation.
Ear and labyrinth disorders: Hearing impaired.
Vascular disorders: Hypotension; pallor.
Gastrointestinal disorders: Nausea, vomiting, dry mouth.
Skin and subcutaneous tissue disorders: Rash (including papular rash), urticaria, angioedema (Quincke's oedema), erythema nodosum, petechia.
Musculoskeletal and connective tissue disorders: Pain in the injected extremity; pain in the injected arm; arthralgia.
Renal and urinary disorders: Renal failure.
General disorders and administration site conditions: General adverse drug reactions: Subfebrile state, fever, chills, cold sensation, hyperhidrosis, weakness, malaise. These symptoms usually subside within 24-48 hours.
Adverse drug reactions at the administration site: Redness, erythema, pain, swelling, swelling of the limb, injected limb mobility decreased, rash, itching, burning sensation, inflammation, cyanosis, hematoma (most probably caused by incorrect administration of the vaccine), induration, injection site warmth. Itchy lymphatic infiltration may also develop. Such adverse reactions most often develop in individuals who receive multiple vaccinations. Subcutaneous nodules (granulomas) may occur, which sometimes develop into aseptic abscesses (1:100 000). Granulomas which do not subside within 6 weeks may be the result of developing hypersensitivity to aluminium.
Investigations: Body temperature decrease.
Drug Interactions
Tetana may be administered simultaneously with other vaccines, according to the National Immunisation Programme, and with immunoglobulins, if necessary.
Different vaccines and immunoglobulins used at the same time should be administered into different injection sites and with separate syringes and needles.
Caution For Usage
Special precautions for disposal and other handling: After shaking, Tetana is a milky, homogenous cream shade suspension.
Upon storage, a white sediment with a clear supernatant above can be observed.
Before use, the ampoule should be well shaken in order to obtain a homogenous suspension. The vaccine should be visually inspected for any foreign particulate matter and/or abnormal change in physical appearance. In case of any change, the vaccine should not be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Storage
Store in an upright position in a refrigerator (+2°C to +8°C).
Do not freeze. In case of freezing, discard the vaccine.
Shelf-Life: 36 months.
ATC Classification
J07AM01 - tetanus toxoid ; Belongs to the class of tetanus bacterial vaccines.
Presentation/Packing
Susp for inj (amp) 0.5 mL (milky, homogenous cream shade) x 10's.
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