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medicalmeds.eu Medicines Vaccines, serums, phage and anatoxins. Serum the antitetanic horse cleared concentrated

Serum the antitetanic horse cleared concentrated

Препарат Сыворотка противостолбнячная лошадиная очищенная концентрированная. ФГУП НПО «Микроген» Россия


Producer: Federal state unitary enterprise NPO Mikrogen Russia

Code of automatic telephone exchange: J06

Pharm group: Immune serums and immunoglobulins

Release form: Liquid dosage forms. Solution for injections.

Indications to use: Tetanus.


General characteristics. Structure:

Active ingredients: not less than 1200 international anti-toxic activity units (ME) of immunoglobin fraction of blood serum of horses, immunizirovanny tetanic anatoxin or toxin, containing specific antibodies in 1 ml of solution.




Pharmacological properties:

Pharmacodynamics. Neutralizes a tetanin


Indications to use:

Emergency specific prevention and treatment of tetanus.


Route of administration and doses:

Emergency prevention of tetanus:
The emergency prevention of tetanus provides primary surgical treatment of a wound and creation, if necessary, of specific immunity against tetanus.

The emergency specific prevention of tetanus is carried out at:
• injuries with disturbance of integrity of integuments and mucous;
• frostbites and burns of the second, third and fourth degrees;
• extra hospital abortions;
• childbirth out of medical institutions;
• gangrene or necrosis of fabrics of any type, abscesses;
• the getting injuries of digestive tract;
• stings animals.

Apply to the emergency specific prevention of tetanus:
• EXPERT anatoxin;
• immunoglobulin of the person antitetanic (IChPS);
• in the absence of IChPS – serum antitetanic.
The EXPERT anatoxin and IChPS enter according to application instructions of these drugs.

The scheme of the choice of prophylactics for the emergency specific prevention of tetanus is presented in table 1.

For the purpose of the emergency prevention of tetanus serum antitetanic is entered subcutaneously in a dose 3000 ME.

Before administration of serum antitetanic put an intracutaneous test with serum horse cleared divorced 1:100. For statement of test use syringes with scale interval of 0,1 ml and fine needles. Divorced serum is entered vnutrikozhno into the flexion surface of a forearm of 0,1 ml. The accounting of reaction is carried out in 20 min.

Test is considered negative if diameter of the hypostasis or reddening appearing on site introductions, less than 1 cm. Test is considered positive if hypostasis or reddening has a diameter of 1 cm and more.

At a negative intracutaneous test serum antitetanic is entered subcutaneously in number of 0,1 ml (use the sterile syringe, the opened ampoule is closed a sterile napkin). In the absence of reaction in 30 min. enter, using the sterile syringe, all appointed serum dose subcutaneously (with the preventive purpose), intravenously or to the spinal canal (with the medical purpose).

At a positive intracutaneous test or emergence of anaphylactic reaction to a subcutaneous injection of 0,1 ml of serum antitetanic its further introduction is contraindicated. In this case introduction of IChPS is shown.

Administration of drug is registered in the established registration form with the indication of date of an inoculation, dose, manufacturer of drug, number of a series, reaction to administration of drug.

Treatment of tetanus:
Serum antitetanic is entered the patient into the earliest terms from the beginning of a disease in a dose of 100 000-200 000 ME.

Serum is entered intravenously or into the spinal canal after check of sensitivity to a foreign protein (test with serum horse cleared divorced 1:100). Depending on disease severity administration of serum is repeated before disappearance of reflex spasms.

The table 1 Scheme of the Choice of Prophylactics when performing the emergency specific prevention of tetanus

The previous tetanus inoculations the drug containing tetanic anatoxin

 

Age group The terms which passed after the last inoculation The used drugs
AS-anatoksin1 ICHPS2 PSS *

There is a documentary confirmation on inoculations

Full course of planned inoculations according to age

 

children and teenagers independently
from term
not vvodyat3 do not enter

Full course of planned inoculations without the last age revaccination

 

children and teenagers independently
from term
0,5 do not enter
Full course immunizatsii4 adults no more than 5 years          do not enter
more than 5 years 0,5 ml do not enter
Two privivki5 in total age no more than 5 years 0,5 ml do not enter
more than 5 years 1,0 ml 250 ME 3000 ME7
One inoculation in total age no more than 2 years 0,5 ml not vvodyat6
more than 2 years 1,0 ml 250 ME 3000 ME7
Not vaccinated children up to 5 months - not vvodyat9 250 ME  
the others of age - 0,5 ml7,8 250 ME 3000 ME7

There is no documentary confirmation on inoculations

 

In the anamnesis there were no contraindications to inoculations children up to 5 months - do not enter 250 ME  
children since 5 months, teenagers, the military personnel, being the military personnel - 0,5 ml not vvodyat6
Other contingents in total age - 1,0 ml 250 ME 3000 ME

• PSS – serum antitetanic 

• IChPS – immunoglobulin of the person antitetanic 

Notes: 

1. Instead of 0,5 ml the EXPERT anatoxin it is possible to use ADS-m-anatoxin if vaccination against diphtheria this drug is necessary. If localization of a wound allows, the EXPERT anatoxin it is preferable to enter into the area of its arrangement by a hypodermic obkalyvaniye. 

2. To apply one of the specified drugs: IPSCh or PSS (it is preferable to enter IPSCh). 

3. At the "infected" wounds enter 0,5 ml the EXPERT anatoxin if after the last revaccination there passed 5 and more years. 

4. The full course of immunization the EXPERT anatoxin for adults consists of two inoculations on 0,5 ml everyone with an interval of 30-40 days and revaccinations in 6-12 months the same dose. According to the reduced scheme a full course of immunization the EXPERT anatoxin in the doubled dose (1 ml) and a revaccination in 6 months - 2 years a dose of 0,5 ml the EXPERT anatoxin includes single vaccination. 

5. Two inoculations according to the usual scheme of immunization (for adults and children) or one inoculation according to the reduced scheme of immunization for adults. 

6. At the "infected" wounds enter IPSCh or PSS. 

7. All persons who received active and passive prevention for end of a course of immunization in 6 months – 2 years have to be revaktsinirovana of 0,5 ml the EXPERT anatoxin. 

8. If necessary to appoint the EXPERT anatoxin to children up to 6 years, the drug should be administered intramusculary. 

9. After normalization of a posttraumatic state children to 3-year age – according to terms of the National calendar of preventive inoculations. 

 

Precautionary measures at use

Drug with the broken integrity or the absent marking, expired is not suitable for use, at change of physical properties and disturbances of the mode of storage storage. 

Before administration of antitetanic serum surely put an intracutaneous test with serum horse cleared divorced 1:100 for detection of sensitivity to a foreign protein. 

Considering possibility of shock at administration of serum antitetanic, behind everyone vaccinated it is necessary to provide medical observation within 1 hour after administration of drug. Venues of inoculations have to be provided with means of antishock therapy. 

The persons who received antitetanic serum have to be warned about need of the immediate request for medical care in case of the signs characteristic of a serum disease. 


Features of use:

Drug with the broken integrity or the absent marking, expired is not suitable for use, at change of physical properties and disturbances of the mode of storage storage.

Before administration of antitetanic serum surely put an intracutaneous test with serum horse cleared divorced 1:100 for detection of sensitivity to a foreign protein.

Considering possibility of shock at administration of serum antitetanic, behind everyone vaccinated it is necessary to provide medical observation within 1 hour after administration of drug. Venues of inoculations have to be provided with means of antishock therapy.

The persons who received antitetanic serum have to be warned about need of the immediate request for medical care in case of the signs characteristic of a serum disease.

Use at pregnancy and during breastfeeding. Use of drug is allowed according to vital indications taking into account possible advantage for mother and risk for a fruit or the child.


Side effects:

Administration of serum can be followed by various allergic reactions: immediate (right after administration of serum or in several hours), early (for 2-6 days) and remote (on the 2nd week and later). These reactions are shown by a symptom complex of a serum disease (temperature increase, emergence of an itch of a small tortoiseshell, skin rash, a dermahemia, joint pains, etc.) and in rare instances an acute anaphylaxis.


Interaction with other medicines:

At joint administration of antitetanic serum and tetanic anatoxin oppression of an immune response is noted.


Contraindications:

1. Contraindications to use of specific means of the emergency prevention of tetanus:
2. Existence in the anamnesis system allergic reactions and complications on the previous administration of serum horse divorced 1:100, serums antitetanic or hypersensitivity to drugs.
3. Pregnancy:
 - in the first half introduction the EXPERT anatoxin and serums antitetanic is contraindicated;
 - in the second half administration of serum antitetanic is contraindicated.



Storage conditions:

Period of validity - 3 years.


Issue conditions:

According to the recipe


Packaging:

Solution for injections. Serum antitetanic – on 3000, 10000, 20000, 50000 ME in ampoules. Serum volume in an ampoule for each dosage is estimated depending on specific activity of drug. Serum horse cleared divorced 1:100-on 1 ml in ampoules. On 5 ampoules with serum of antitetanic and 5 ampoules with serum horse cleared divorced 1:100 (5 sets) in a pack from a cardboard together with a knife ampoule or the scarificator ampoule and the application instruction. When using ampoules with a notch, a ring or a point for opening a knife ampoule or the scarificator ampoule does not invest.



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