Indications & Uses
Tetagam-P is indicated for the prophylaxis of tetanus following injury in patients whose immunization is incomplete or uncertain, as well as for the therapeutic treatment of tetanus. Tetanus immunoglobulin should always be given together with an active tetanus vaccination, unless contraindications exist or adequate vaccination has already been confirmed.
Pharmacology
Human tetanus immunoglobulin works by neutralizing tetanus toxin before it can harm the body's tissues. It binds directly to the toxin produced by *Clostridium tetani*, blocking its normal interaction with human tissue. In doing so, it stops the toxin from reaching the nervous system, where it would otherwise trigger painful muscle spasms and disrupt the body's automatic (autonomic) functions. The bacteria themselves are cleared either by antibiotic treatment or by the host's own immune defenses, while the toxin-antibody complexes formed by the immune globulin are thought to be broken down by the body's phagocytic immune cells.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Post-exposure prophylaxis of tetanus: For adults and children, a single dose of 250 IU should be given. The dose may be increased to 500 IU in the following cases: 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; frostbite; tissue necrosis; septicaemic abortion; and adults weighing more than the average. In case of extensive burns, it is advisable to administer a second injection of 250 IU human tetanus immunoglobulin after the exudative phase of the burn has subsided (about 36 hours after onset of the burn). At the same time, 0.5 ml of tetanus vaccine should be administered in a different extremity with a separate syringe, and the complete immunization schedule should be followed. Therapy of clinically manifest tetanus: For adults and children, single doses of 3,000 to 6,000 IU are given, in combination with other appropriate clinical procedures.
Side Effects
Tetagam-P is usually well tolerated, and side effects are mild and infrequent. Severe local and general reactions have happened, but rarely. At the injection site, you may notice pain, tenderness or swelling. In rare cases, the following may happen. Allergic reactions (immune system disorders) can include a fall in blood pressure, shortness of breath (dyspnoea), skin reactions, and in a few isolated cases, anaphylactic shock. This can happen even when a person has shown no sign of hypersensitivity after earlier immunoglobulin doses. General reactions can include chills, fever, headache, malaise, nausea, vomiting, joint pain (arthralgia) and moderate back pain. Heart and blood vessel reactions can also occur, particularly if the product is accidentally injected into a blood vessel.
Cautions & Contraindications
Warnings & Precautions
Should not be given by intravenous injection. A separate sterile syringe must be used for each patient, to prevent the possible transmission of hepatitis B and other infectious diseases. It should be given with caution to individuals who have shown systemic allergic reactions to immunoglobulin, and epinephrine (0.1 to 0.5 ml, 1:1000) should be kept available for immediate treatment. In patients with severe thrombocytopenia or any coagulation disorder that would otherwise rule out an intramuscular injection, Tetagam-P should be given only if the expected benefits outweigh the risks. While administering Tetagam-P, care should be taken to draw back the plunger of the syringe before injecting, to make sure the needle has not entered a blood vessel. Tetagam-P is prepared from human plasma and is pasteurized in bulk to reduce the risk of viral infection, but freedom from the risk of unknown viruses, such as Parvovirus B-19, cannot be assumed. The patient should be watched closely for a long period after the injection is given.
Contraindications
Known hypersensitivity to any component of the product or to human immunoglobulins in general is a contraindication. Like any other intramuscular injection, human tetanus immunoglobulin is not recommended for patients with bleeding disorders. In those with a history of immunoglobulin A (IgA) deficiency or severe anaphylactic reactions to plasma products, the risk-benefit ratio must be carefully weighed before use.
Pregnancy & Breastfeeding
Safety in human pregnancy has not been confirmed through controlled clinical trials. That said, long-standing clinical experience with immunoglobulins as a class suggests they are not expected to harm the course of pregnancy or affect the developing baby, whether before or after birth.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Keep Human Tetanus Immunoglobulin out of the sight and reach of children. Store it at +2 °C to +8 °C. When it is transported, use packs made for the purpose so the temperature stays between +2 °C and +8 °C. Don't let it freeze, and discard the vaccine if it has been frozen. Protect it from light.
Common questions about Protet-IG 250 IU/ml
What is Protet-IG 250 IU/ml IM Injection?
Protet-IG 250 IU/ml IM Injection is a medicine that contains Human Tetanus Immunoglobulin. It is made by Incepta Pharmaceuticals Ltd. It belongs to the Vaccines group of medicines.
What is Protet-IG used for?
Tetagam-P is indicated for the prophylaxis of tetanus following injury in patients whose immunization is incomplete or uncertain, as well as for the therapeutic treatment of tetanus. Tetanus immunoglobulin should always be given together with an active tetanus vaccination, unless contraindications exist or adequate vaccination has already been confirmed.
What are the side effects of Protet-IG?
Tetagam-P is usually well tolerated, and side effects are mild and infrequent. Severe local and general reactions have happened, but rarely.
Can I take Protet-IG during pregnancy or while breastfeeding?
Safety in human pregnancy has not been confirmed through controlled clinical trials. That said, long-standing clinical experience with immunoglobulins as a class suggests they are not expected to harm the course of pregnancy or affect the developing baby, whether before or after birth. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Protet-IG?
Keep Human Tetanus Immunoglobulin out of the sight and reach of children. Store it at +2 °C to +8 °C.
Do I need a prescription for Protet-IG?
Protet-IG is a prescription (Rx) medicine. Take it as your doctor advises.