AntiTeta – II (Tetanus Antitoxin serum – purified) is prepared from the serum of horses that have been immunized tetanus toxin
 

DESCRIPTION:

Antiteta – II is almost colourless or very faintly yellow liquid

 

COMPOSITION:
One ampoule of AntiTeta – II contains:

 

                                                                                               
 

PHARMACEUTICAL FORM:

Injectable solution – Intramuscular or subcutaneous route.

PACKAGE:

Each box of 20 ampoules, each ampoule contains 1,5000 IU
 

PRECAUTIONS:

Read the enclosed leaflet carefully before use

Keep out of reach of children

Do not use the ampoules of AntiTeta – II that were cracked; had waste matte; precipitated; frozen; unclear
label or exceed the expiry date.

INDICATIONS:
*Prevention:

Patient who has wound especially those liable to be exposed to tetanus.

Patient, who is wounded, but has been vaccinated with tetanus toxoid vaccine for the last 10 years.

Patient, who is wounded, but didn’t properly follow vaccination schedule.

*Treatment: used for patient with tetanus disease.

CONTRAINDICATIONS:

The patient who had hypersensitivity with equine immunoglobulin

Pregnant women.

WARNINGS:
-No contra-indication for lactating women but should be very careful while using.

-It must be very careful for patients who have been vaccinated with any kind of serum is obtained from horses or any animals.

-Patient need to be checked sensitivity before injection: prepare a 1% solution of AntiTeta-II, inject a dose of 0.1 ml intradermally. If diameter of the redness at the injection site is less than 1cm after 15 minutes, the result is negative; if the other result is positive. If a positive result is obtained when testing the subject’s sensitivity, but the treatment of AntiTeta – II really need for the patient, desensitizing should be done using Besredka method: inject a dose of 0.5ml of 1% AntiteTa

– Iisubcutaneously, patient should be under medical supervision for 30 minutes. If there is no reaction, inject 0.1ml of AntiTete – II. If there is no reaction after 30 minuter, inject the rest of AntiTeta – II

-Should always be readily available in case of rare anaphylactic reactions following the administration.

- In case of prevention: should be weighed and careful with the patient who had hypersensitivity with equire  immunoglobulin or patient who is allergic due to any reason.

-In case of treatment: due to the seriousness of tetanus disease, there are no contra-indications, but medicine to prevent shock should be available before injection.

DOSAGE & ADMINISTRATION:
*Dosage:

-Prevention dose: Children and Adults: inject a dose of 1,500 IU in the shortest possible time after wounded. A double dose is used in cases: risk injury; late in the day to inject; over weight men.

-Treatment dose: Optimal dose to becom effective is not defined
 

+Newborn babies: 5.000 IU – 10.000 IU

+Childern & Adults: 50.000 IU – 1000.000 UI - a half of intramuscular in injection and a half of subcutaneous injection
 

*Administration::

Intramuscular or subcutaneous injection. It is imperative to do Besredka method: inject 0.1 ml of Antiteta – II, after 30 minutes if there is no reaction, inject 0.25 ml of AntiTeta-II. If there is no reaction after 30 minutes, inject the rest of AntiTeta-II.

SIDE EFFECTS:

- Side effects are generally mild and confined to the injection site, these can be erythema, itchiness… In serious cases patient can go into shock or into a daze.

- A few hours or 7 – 10 days after the injection of a heterologous serum an immune complex reaction may occur.

STORAGE: Store between +20C and +80C (in a refrigerator), do not freeze. Protect from light.

SHELF-LIFE: 30 months from the manufacturing date

SPECIFICATION: Manufacture’s