Protet-IG IM Injection

Indications and uses Protet-IG is indicated for -

• Prophylaxis of tetanus following injury in patients whose immunization is incomplete or uncertain.
• Therapeutically in the treatment of tetanus.

Tetanus immunoglobulin should always be administered in conjunction with an active tetanus vaccination unless there are contraindications or confirmations of adequate vaccination.

Protet-IG is a sterile solution containing Protet-IG which is prepared by Cohn fractionation of plasma of individuals with high titers of antibody to the tetanus antigen and heat inactivation step in manufacturing process (60°C, 10 hrs) is used to inactivate infectious agents such as Hepatitis B virus, Hepatitis C virus, Protet-IG immunodeficiency virus and so on.

Human clostridium tetani toxoid immune globulin prevents tetanus toxoid from damaging tissue and producing the symptoms associated with tetanus. The immune globulin binds to tetanus toxiod, interfering with the normal interaction of the toxoid with human tissue. This prevents the toxoid from invading the nervous system and producing painful muscle spasms as well as autonomic dysfunction. The Clostridium tetani bacterium is killed either via antibiotic treatment of the host's immune system and immune globulin-bound toxoid is likely broken down by phagocytic immune cells.

Post-exposure prophylaxis of tetanus:

• For adults and children single dose of 250 IU should be given. The dose may be increased to 500 IU in case of:
• Infected wounds where surgically appropriate treatment cannot be achieved within 24 hours
• Deep or contaminated wounds with tissue damage and reduced oxygen supply, as well as foreign body injury (e.g., bites, stings or shots)
• Burns, congelations
• Tissue necrosis
• Septicaemic abortion
• Adults weighing more than the average

In case of extensive bums, it is advisable to administer a second injection of 250 IU human tetanus immunoglobulin after the exsudative phase of the burn has subsided (about 36 hours after onset of the bum).

At the same time, 0.5 ml of tetanus vaccine in a different extremity with a separate syringe and complete immunization schedule is required to be administered.

Therapy of clinically manifest tetanus: For adults and children single doses of 3,000 to 6,000 IU (in combination with other appropriate clinical procedures).

Administrations: Human Tetanus Immunoglobulin should only be administered by intramuscular injection. Human tetanus immunoglobulin should not be administered by intravenously.

Do not use solutions which are cloudy or contain residues (deposits/particles)

Human tetanus immunoglobulin is a ready for use solution and should be administered at body temperature. If comparatively large total volumes are required, it is advisable to administer them in divided doses at different sites

In the presence of a severe coagulation disorder where intramuscular injections are contraindicated, human tetanus immunoglobulin may be given subcutaneously (under the skin) for prophylaxis. Afterwards the injection site should be compressed with a swab. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route

Co-administration: Immunoglobulin administration may impair the efficacy of live, attenuated virus vaccines such as measles, rubella, mumps and varicella vaccines for a period of up to three months.

After administration of human tetanus immunoglobulin an interval of at least three months should elapse before vaccination with live, attenuated virus vaccines. In the case of measles, this impairment may persist for up to five months. Therefore, patients receiving measles vaccine should have their antibody status checked.

May reduce the efficacy of live vaccines.

• Known hypersensitivity to any of the components of the product
• Known hypersensitivity to human immunoglobulins
• Like any other intramuscular injections, human tetanus immunoglobulin is not advocated for patients with bleeding disorders
• In patients with a history of immunoglobulin A (IgA) deficiency or severe anaphylactic reactions to plasma products, the risk-benefit ratio must be considered

Adverse reaction following administration of Protet-IG is infrequent and mild, but severe local and systemic reactions have occurred rarely.

• Local reactions at the injection site: Local pain, tenderness or swelling.

In rare cases the following adverse reactions may occur:

• Immune system disorders: Allergic reactions including fall in blood pressure, dyspnoea, cutaneous reactions, in isolated cases reaching as far as anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration of immunoglobulins.
• Generalized reactions: Chills, fever, headache, malaise, nausea, vomiting, arthralgia and moderate back pain.
• Heart and vascular disorders: Cardiovascular reactions particularly if the product is inadvertently injected intravascularly.

The safety for use of human tetanus immunoglobulin in human pregnancy has not been established in controlled clinical trials. Long lasting clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the fetus and the neonate are to be expected.

Should not be administered intravenously

A separate sterile syringe must be used for each patient to prevent the possible transmission of hepatitis B and other infectious diseases.

Should be administered with caution to individuals who have exhibited systemic allergic reactions to immunoglobulin. Epinephrine (0.1~0.5ml, 1:1000) should be available for immediate treatment.

In patients who have severe thrombocytopenia or any coagulation disorder that would contra-indicated intramuscular injection, Protet-IG should be given only if the expected benefits out way the risks.

While administering Protet-IG care should be taken to drawback the plunger of the syringe before injection in order to be certain that the needle is not in blood vessel.

Protet-IG is prepared from human plasma is pasteurized in its bulk condition to reduce the risk of viruses infections but freedom from the risk of unknown viruses (Parvovirus B-19, etc) cannot be assumed. The infused patient is continuously checked for long time after injection.

Not applicable.

Vaccines, Anti-sera & Immunoglobulin

Keep out of the reach and sight of children. Store at +2 °C to +8 °C. Transportation should also be in designed packs to maintain the product temperature +2 °C to +8 °C. Do not freeze. Discard vaccine if frozen. Protect from light