Protet-IG

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.

May reduce the efficacy of live vaccines.

Adverse reaction following administration of human tetanus immunoglobulin 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, human tetanus immunoglobulin should be given only if the expected benefits out way the risks.

While administering human tetanus immunoglobulin 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.

Human tetanus immunoglobulin 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.

Vaccines, Anti-sera & Immunoglobulin

Not applicable.

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