Description
80 mg/ml, solution for injection for horses, cattle, pigs, sheep, goats, dogs and cats, used in arrhythmia and cardiovascular failure
Active substance and excipient content
Each 1 ml dose contains:
Active substance:
Caffeine 80 mg
Excipient:
Sodium benzoate (E211) 120 mg
Therapeutic indications
Arrhythmia and cardiovascular failure during infectious, non life-threatening diseases.
Contraindications
Do not use in case of acute heart failure, myocardial ischemia.
Adverse reactions
In case of subcutaneous administration of caffeine, topical reactions due to irritation caused by the product may appear.
Intravenous administration may produce anxiety, motor agitation and increased heart rate and arrhythmia. Tachypnea is also observed.
In piglets susceptible to stress for genetic reasons, intravenous injection of caffeine produces typical clinical signs of the impact of stressors, which is manifested in anxiety, motor agitation, emitting noises, increased heart rate and tachypnea, as well as raised creatine phosphokinase activity (after 45 minutes from administration of caffeine). Possible reactions also include gastrointestinal disorders due to increased secretion by gastric glands.
In animals diagnosed with epilepsy, intravenous administration of caffeine may produce convulsions.
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
Product for subcutaneous, intramuscular or intravenous use in the following doses:
| horses, cattle | 5 – 20 ml |
| pigs, sheep, goats | 1.5 – 7.5 ml |
| dogs | 0.25 – 0.75 ml |
| cats | 0.05 – 0.5 ml |
While determining the amount to be administered, consider the current clinical condition of an animal, its weight, route of administration and animal-specific susceptibility to caffeine.
In case of subcutaneous or intramuscular administration, the effect is observed after 15-30 minutes, whereas in case of intravenous administration, it is observed immediately. Under justified circumstances, administer another dose after 6-8 hours.
Indications for use
None.
Withdrawal period
Edible tissues:
Horses, cattle, pigs, sheep, goats: zero days
Milk:
Cattle, sheep, goats: zero days
Dogs, cats: not applicable
Special precautions for storage
Keep out of the sight and reach of children.
Store below 25°C. Protect from light. Do not freeze.
Do not use this veterinary medicinal product after the use-by date given on the label.
Shelf life after first opening the immediate packaging: 28 days.
Special warnings
Special precautions for use in animals:
In animals diagnosed with epilepsy, use the product accordingly to the benefit/risk assessment. In case of adverse reactions from the central nervous system, stop administering the drug immediately and start anticonvulsant therapy.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Avoid direct exposure to the product. In case of accidental self-injection, immediately seek doctor’s assistance and present the doctor with the information leaflet or package.
Caffeine may be dangerous to human life, if consumed in a dose 5–10 g. Severe poisoning has been reported after taking 1.0 g of caffeine (15 mg/kg of b.w.).
Pregnancy:
The safety of the veterinary medicinal product has not been established during pregnancy.
Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Lactation:
The safety of the veterinary medicinal product has not been established during lactation.
Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction:
Caffeine enhances the effect of digitalis-based products and beta-adrenomimetics.
If used with methylxanthines and beta adrenomimietics (adrenaline, isoprenaline, orciprenaline), potentiation of both drug groups on heart is observed, which is manifested in arrhythmia. Positive inotropic effect of caffeine and cardiac glycosides was observed as well.
Overdose (symptoms, emergency procedures, antidotes):
Caffeine overdose may lead to tachycardia or tachycardia with arrhytmia, blood pressure drop, anxiety. Administration of toxic doses may produce seizures. Moreover, product overdose may lead to stiffness and tremor, increased production of urine. Carnivorous species may respond by vomiting. In case of caffeine overdose, use pentobarbital sodium.
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.
Shelf life
2 years
For animal treatment only
Subject to medical prescription – prescription drug
Tobe administered under veterinary supervision.
Other information
For more information about this veterinary medicinal product, contact the Marketing Authorization Holder.
Biowet Puławy Sp z o. o.
Arciucha 2, 24-100 Puławy
Tel./Fax: +48 (81) 886 33 53, Tel: +48 (81) 888 91 00
e-mail: sekretariat@biowet.pl
Available pack: amber glass bottles containing 50 ml of the product.
2016-03-31 SPC
CPLW-31.03.2016 r.
27.07.2017
