Analgin 30% Injectable solution (metamizole sodium) 100 ml

Analgin 30% Injectable solution (metamizole sodium)

1. NAME  OF THE MARKETING AUTHORISATION HOLDER

Name: Biovet

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Analgin 30%

 COMPOSITION

 PHARMACOLOGICAL ACTION

 Metamizole is an antipyretic from the antipyrine (pyrazolone) group. It possesses pronounced analgesic, antifebrile, anti-inflammatory, antineuralgic, antirheumatic, spasmolytic and sedative properties. It eliminates the spasms of the forestomachs and regulates their motor function. It does not suppress the intestinal peristalsis. Metamizole restricts the inflammatory edema. It is well tolerated by animals.

In pharmacokinetic terms metamizole is a typical precursor. After oral administration it is quickly hydrolyzed in the gastrointestinal tract to the active compound 4-methylaminoantipyrin. Intravenously and intramuscularly injected metamizole has comparable bioavailability parameters and tmax as those recorded after oral administration. The primary metabolite 4-methylaminoantipyrin undergoes further metabolization in liver to the final metabolites 4-formyl-aminoantipyrin, aminoantipyrin and 4-acetylaminoantipyrin. 4-methylaminoantipyrin and its 3 major secondary metabolites account for approximately 77% of the total residue in human serum 2 to 8 hours after administration of 14C-metamizole.

INDICATIONS

 As spasmolytic in large ruminants, horses, pigs, dogs and cats: in catarrhal-spasmatic colic, meteorism and intestinal constipation; in spasms of the uterine cervix during birth; for pains of urinary and biliary origin; nevritis; acute gastric dilatation accompanied by severe colic attacks; for allaying the irritability of the animals and preparing them for stomach lavage; in esophageal obstruction; in joint and muscular rheumatism.

CONTRAINDICATIONS

 Do not use simultaneously with chlorpromazine, barbiturates or phenylbutazone.

As no withdrawal period for milk is recommended the product must not be administered to dairy animals during lactation or in the dry period as well as in animals the milk of which is intended for human consumption or to pregnant animals which are expected to give milk for consumption by man 2 months prior to parturition.

MODE OF ADMINISTRATION

Intramuscularly and intravenously (deeply injected).

In case of intramuscular administration the prescribed total dose is recommended to be divided and injected into multiple injection sites. Injection of solution may possibly irritate subcutaneous tissues without causing necrosis or suppuration. All this imposes the muscular injection of the product to be made under strict observation of sterility conditions.

TARGET SPECIES

Large ruminants, horses, pigs, dogs and cats.

DOSAGE

Horses, pigs: 8.3 ml to 16.7 ml per 100 kg b.w. (2.5 g to 5 g metamizole per 100 kg b.w.).

Large ruminants: 8.3 ml per 100 kg b.w. (2.5 g metamizole per 100 kg b.w.).

Dogs, cats: 1.7 ml per 2.5 kg to 5 kg b.w. (100 to 200 mg metamizole per 1 kg b.w.).

The effect of the administration of Analgin is manifested 5 to 10 minutes after the administration and is retained for about 1 hour.

If pains and unease of the animal reoccur, the injection may be repeated.

SIDE EFFECTS

The continuous administration of high doses may cause leukopenia, agranulocytosis. Intramuscular injection of solution may possibly irritate subcutaneous tissues without causing necrosis or suppuration.

WITHDRAWAL PERIOD

Meat:

Large ruminants: 18 days before slaughter

Horses, pigs: 15 days before slaughter

STORAGE

In the original container in warehouse facilities protected from direct sunlight.

Keep out of the reach and sight of children.

PACKING

Cardboard box with 1 amber glass vial of 100 ml with a rubber stopper and aluminum cap.

WARNING

Special precautions to be taken by the person administering the product to animals.

Do not eat, drink or smoke while handling the product.

After use, wash hands with water and soap.

The continuous administration of high doses may cause leukopenia, agranulocytosis.

Do not administer to dairy animals during lactation or in the dry period as well as in animals the milk of which is intended for human consumption or to pregnant animals which are expected to give milk for consumption by man 2 months prior to parturition.

Metamizole is incompatible with chlorpromazine, barbiturates or phenylbutazone.