Description
Solution for injection for horses, cattle, swine and dogs with analgesic, spasmolytic, antipyretic and anti-inflammatory effects.
500 mg/ml, solution for injections for horses, cattle, swine and dogs
Active substance and excipient content
1 ml contains:
Active substance:
Metamizole sodium 500 mg
Excipient:
Sodium pyrosulphate 0.9 mg
Therapeutic indications
Metamizole sodium displays analgesic, spasmolytic, antipyretic and anti-inflammatory effects.
Indications for the use of the drug:
- Pain relief in colic of various aetiology or in other spastic diseases of the gastrointestinal tract in horses and cattle.
- Equine paralytic myoglobinuria.
- Obstruction of the oesophagus with a foreign body.
- Conditions with fever such as mastitis, MMA (Mastitis Metritis Agalactia) syndrome in swine, swine influenza.
- Acute arthritis, rheumatic conditions of the musculoskeletal system, neuritis, neuralgia, tendinitis and inflammation of tendon sheaths.
Contraindications
Do not use in cats.
Do not use in animals with disorders of the haematopoietic system.
Do not use in animals with renal insufficiency and asthma.
Do not use in the case of hypersensitivity to the active substance or the excipient.
Adverse reactions
Fast intravenous administration may cause shock.
Any adverse reactions emerged after administration of the product or any observed symptoms not listed in the leaflet (including symptoms reported in humans following exposure to the product) should be reported to the competent veterinarian, Marketing Authorization Holder or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The report form should be downloaded from https://www.urpl.gov.pl (Department of Veterinary Medicinal Products).
Amount to be administered per species, method and route of administration
The drug should be administered intramuscularly or in a slow intravenous infusion.
In horses whose tissues are intended for human consumption, the drug should only be administered intravenously.
The drug can be administered again after 8 hours.
Posology:
| Species | Metamizole sodium dose | Product dose |
| Horses | 20–50 mg/kg b.w. | 0.4-1.0 ml/10 kg b.w. |
| Cattle | 20-40 mg/kg b.w. | 0.4-0.8 ml/10 kg b.w. |
| Swine | 15-50 mg/kg b.w. | 0.3-1.0 ml/10 kg b.w. |
| Dogs | 20-50 mg/kg b.w. | 0.4-1.0 ml/10 kg b.w. |
Indications for proper administration
In order to properly administer the product, instructions in this leaflet should be followed.
Withdrawal period
Horses:
Edible tissues: 12 days after the intravenous administration.
In horses whose tissues are intended for human consumption, the drug should only be administered intravenously.
Cattle:
Edible tissues: 12 days after the intravenous administration
20 days after the intramuscular administration
Milk: 4 days
Swine:
Edible tissues: 12 days after the intravenous administration
20 days after the intramuscular administration
Dogs: not applicable.
Special precautions for storage
Store in the original container in order to protect from light.
Store at a temperature below 25°C.
Do not use this veterinary medicinal product after its expiry date given on the label.
Shelf life after first opening of the immediate container – 28 days.
Special warnings
Special precautions for use in animals:
Do not use subcutaneously – metamizole may irritate the subcutaneous tissue.
Special precautions for people administering veterinary medicinal product to animals:
Caution should be taken to avoid accidental self-injection. In rare cases, metamizole can cause reversible but potentially life-threatening agranulocytosis or other reactions such as skin allergies. Persons with diagnosed hypersensitivity to pyrazolones or aspirin should avoid contact with the product.
In the case of accidental self-injection, immediately seek medical advice and show the package leaflet or the label to the physician.
Pregnancy:
The product can be used in pregnancy.
Lactation:
The product can be used during lactation.
Interactions with other medicinal products or other forms of interaction:
Phenobarbital, other barbiturates and glutethimide can accelerate metamizole elimination. Simultaneous administration of chlorpromazine may lead to the occurrence of severe hypothermia.
Overdose (symptoms, emergency procedures, antidotes):
No specific symptoms of overdosage are known.
Pharmaceutical incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Other information
For more information about this veterinary medicinal product, contact the Marketing Authorization Holder.
Available containers: 50 ml, 100 ml.
Some container sizes may not be available in the market.
Shelf life
2 years
For animal treatment only.
Subject to medical prescription – prescription drug.
To be administered only by a veterinary surgeon.
Name and address of the manufacturer responsible for batch release:
Biowet Puławy Sp. z o.o.
Arciucha 2, 24-100 Puławy
phone/fax: (81) 886 33 53
2016-01-20 SPC
CPLW 2016.03.18
27.-07.2017 r.
