Tetanus Immunoglobulin

Registered South African indications:

• Post-exposure prophylaxis
• Therapy of tetanus infection

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients 
• Hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA 

Cautions

• Pregnancy
• Breastfeeding
• IgA deficiency

Forms avail. in SA and covered in this monograph: inj

Post-exposure prophylaxis
- Less than 24hrs since exposure
- Low risk of contamination

• IM: 250 IU, as a single dose

Post-exposure prophylaxis
- More than 24hrs since exposure
- High risk of contamination
- Deep wounds with reduced oxygen supply
- Injury secondary to foreign body penetration

• IM: 500 IU, as a single dose

Therapy of clinically manifest tetanus

• IM: 3000-6000 IU, as a single dose; It is recommended that part of the dose is infiltrated locally at the wound site

For therapy of clinically manifest tetanus, the dosage can also be given by locally infiltrating the wound site

Immunoglobulins supplement but do not replace antibiotic therapy

See additional prescribing points for administration directions

Paed. forms avail. in SA and covered in this monograph: inj

Therapy of clinically manifest tetanus

• Younger than 1 month: IM: 500 IU, as a single dose
• Older than 1 month: See adult dosage

Post-exposure prophylaxis- not immunised/ incomplete immunisation
- Major wounds
- Unhygienic care of the umbilical cord

• Younger than 7 years: IM: 4 IU/kg, as a single dose
• Older than 7 years: See adult dosage

For therapy of clinically manifest tetanus, the dosage can also be given by locally infiltrating the wound site

Immunoglobulins supplement but do not replace antibiotic therapy

See additional prescribing points for administration directions

Pregnancy

• Caution
• The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials
• Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected

Breastfeeding

• Caution
• There are no data on the excretion of tetanus immunoglobulin in human milk

Renal impairment

• No dose adjustment recommended

Hepatic impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP) 

Drugs in Sport

• Permitted - No warning

Central Nervous System Disorders

• Tremor  
• Dizziness  

Cardiovascular Disorders

• Chest pain  

Respiratory Disorders

• Dyspnoea  

Gastrointestinal Disorders

• Glossitis
• Buccal ulceration

Musculoskeletal Disorders

• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Discomfort at injection site
• Local induration
• Facial oedema  

Immune, Blood and Lymphatic System Disorders

• Anaphylactic reactions

Live attenuated virus vaccines  

None routine

Administration directions: IM

• DO NOT administer into blood vessels
• IM Adults: Deltoid preferred
• IM Infants: Lateral aspect of thigh preferred
• If large volumes required (> 2ml infants, > 5ml adults) divide dosage and administer at different anatomical sites
• When simultaneous vaccination is necessary, the immunoglobulin and the vaccine should be administered at two different anatomical sites
• If intramuscular administration is contraindicated (bleeding disorders), the injection can be administered subcutaneously. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route
• It is strongly recommended that every time that Human Tetanus Immunoglobulin is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product

Tetanus immunoglobulins provide passive immunity against tetanus toxin, by  supplying antibodies to neutralize the free form of toxins produced by C. tetani.

Injection (per 1ml) 250iu

• Tetagam (National Bioproducts)

Injection (per 1ml) 500iu

• Tetagam (National Bioproducts)