ANTI TETANUS Sera 1,500 UI (Equine)

DESCRIPTION

Anti Tetanus Sera is a purified antisera produced from equine’s plasma having immunity against tetanus and contains phenol as preservatives. It is a yellowish clear liquid.

COMPOSITION

ANTI TETANUS Sera 1,500 IU:
Each mL contains:
Active Ingredient:
• Tetanus antitoxin 1,500 IU
Excipient:
• Phenol 2.5 mg

ANTI TETANUS Sera 20,000 IU:
Each mL contains: Active ingredient:
• Tetanus antitoxin 5,000 IU
Excipient:
• Phenol 2.5 mg

INDICATION

  • ANTI TETANUS Sera 15,000 IU
    For prevention of tetanus infection, in patients with wounds contaminated with dirt, dust or other materials that may cause infection due to Clostridium tetani in unsure or has not obtain complete tetanus immunization.
  • ANTI TETANUS Sera 20,000 IU:
    For treatment against tetanus

MECHANISM OF ACTION
Passive immunization, anti tetanus components are injected to neutralize the tetanus toxin in the patient’s blood circulation.

ADMINISTRATION
A. Intramuscularly

  • The result of sensitivity test must be negative
  • Administration must be done slowly
  • The patient must be observed for at least 30 minutes

B. Intravenously

  • Prior to administration injection intramuscularly
  • If there is no symptom of allergic, then continue with injection intravenously
  • Administration must be done slowly
  • The patient must be observed for at least 1 (one) hour

POSOLOGY

  • Tetanus Prevention:
    Prophylactic dose (1,500 IU) or more are administered intramuscularly.
  • Tetanus Treatment:
    10,000 IU or more, intramuscularly or intravenously depends on patient conditions. Perform sensitivity test prior to administration; if proven sensitive, do desensitization.

SIDE EFFECTS

  • Anaphylactiv shock; rarely occurs. If it does, it will occur immediately or in a few hours after injection
  • Serum sicknessl It may occur between 7 to 10 days after injection. The symptoms include febrile, itching, dyspnea and other allergic symptoms.
  • Fever with shivering; normally occours after intravenous injection.

Soreness at injection site; usually occurs 24 hours after injection of a large volume

DRUG INTERACTION
Not reported.

CONTRAINDICATION
Person who is allergic to equine antisera.

WARNING & PRECAUTIONS

  1. Precautions on Antisera Administration
    • Adrenaline (1:1,000) should always be drawn up in readiness before antisera is administered. Corticosteroid and H1 antihistamine may need to be available as well.
    • Do not inject antisera which has just been taken out from the refrigerator, particularly when administering large volumes. The temperature should be raised first to match with the body temperature (Do not heat under flame).
    • The patient should be in a relax condition when antisera is injected.
  2. Sensitivity Test

    • Diluted 0.02 mL antisera 1:1,000 in physiological saline solution; inject intradermally. If result is negative, repeat test using 1:100 dilution.

    • In patient with no allergic record, the sensitivity test may be done directly as from dilution 1 : 100. Perform negative control using physiological saline solution, and positive control using histamine.

    • Positive test: the result of sensitivity test is positive if there is an induration and erythema of not less than 3 mm after 15-20 minutes; compare with negative control. If the result is positive, continue with desensitization.

  3. Treatment to the Side Effects

    1. Anaphylactic shock

      • At the earliest sign of a reaction, antisera administration must be temporarily suspended.

      • Inject 0.3 - 0.5 mL adrenaline (1 : 1,000) intramuscularly. For children administer 0.01 mL/kg of body weight, or maximum 0.3 mL.

      • Check blood pressure regularly, if low pressure persists, re inject 0.5 mL adrenaline 1 : 1,000. If necessary inject corticosteroid intramuscularly.

      • If shock still persists, immediately send the patient to the hospital.

    2. Serum Sickness
      Treat patient with antihistamine for a few days; patient is advised to rest. Corticosteroid may be administered if necessary.
    3. Fever with shivering
      No treatment needed, will normally disappear within 24 hours. Provide the patient with blanket and hot water bottle.
    4. No treatment is needed and will disappear.
  4. Inform the patient that he/ she has been injected with animal derived antisera, and the information has to be conveyed to the doctor, who will inject further dose of antisera.

PRESENTATION
Box : 10 Ampoules @ 1 mL (1,500 IU)
Box : 10 Vials @ 4 mL (20,000 IU)

BIOSAT 1.5
Box : 10 ampoules @ 1 mL (1,500 IU)

BIOSAT 20
Box : 1 vial @ 4 mL