Coffenal

Caffeine 80mg/ml
Solution for injections

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Description

Coffenal 80 mg/ml solution for injection for horses, cattle, pigs, sheep, goats, dogs and cats

Statement of the active substance(s) and other ingredient(s)
Each ml contains:
Active substance:
Caffeine       80 mg
Excipient:
Sodium benzoate (E211)    120 mg

Clear, yellow solution.

Target species
Horse, cattle, pig, sheep, goat, dog, cat

Indications for use
Arrhythmias and circulatory failure during infectious diseases in non-life-threatening conditions.

Contraindications
Do not use in case of acute heart failure and/or myocardial hypoxia.

Special warnings

Special precautions for safe use in the target species:
In animals diagnosed with epilepsy, caffeine should be administered only according to the benefit-risk assessment. In case of symptoms from the central nervous system, immediately discontinue product use and administer antiepileptic drug therapy.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Avoid direct contact with the veterinary medicinal product. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Caffeine may endanger the life of humans if consumed in a dose of 5 to 10 g. Acute poisoning has been observed after consumption of caffeine in a dose of 1.0 g (15 mg/kg b.w.)

Pregnancy and lactation:
No information is available on the safety of this veterinary medicinal product when used during pregnancy and lactation in the target species.
Use only according 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-derived products and beta-adrenergic agonists.
If used with methylxanthines and beta-adrenergic agonists (adrenaline, isoprenaline, orciprenaline), enhanced effect of both drug groups on the heart is observed, which is manifested in arrhythmia. Also, the synergy of positive inotropic effect of caffeine and cardiac glycosides has been reported.

Overdose:
Caffeine overdose may lead to tachycardia or tachyarrhythmia, decreased arterial blood pressure, anxiety. Seizures may occur in case of administration of toxic doses. Moreover, overdose of the veterinary medicinal product may lead to muscle stiffness and tremor, increased urine production. In carnivores, vomiting may occur. In case of caffeine overdose, it is recommended to administer pentobarbital sodium.

Major incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Adverse events
Horse, cattle, pig, sheep, goat, dog, cat:

Frequency unknown
(cannot be determined based on the available data):
Reaction at the administration site1
Anxiety2,4, hyperactivity2,4, vocalizing 2,4
Convulsions3
Increased heart rate2,4, arrhythmia2
Increased respiratory rate2,4
Gastrointestinal tract disorders5
Increased creatine phosphokinase activity4, 6

 1 may occur after subcutaneous injection and is related to the irritating drug effect
2 may occur after intravenous injection of the product
3 may occur after intravenous injection of the product in animals diagnosed with epilepsy
4 may occur in piglets with porcine stress syndrome
5 may occur as a result of increased gastric glands secretion
6 may occur within 45 minutes after caffeine administration

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. If you notice any side effects, even those not already listed in this package leaflet, or you think that the medicine has not worked, please contact, in the first instance, your veterinarian. You can also report any adverse events to the marketing authorization holder using the contact details found at the end of this leaflet, or via your national reporting system:
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Tel.: +48 22 49 21 687
Fax: +48 22 49 21 605
E-mail: pw@urpl.gov.pl
Website: https://smz.ezdrowie.gov.pl

Dosage for each target species, route(s) and method(s) of administration
Subcutaneous, intramuscular or intravenous use.

This veterinary medicinal product is administered in the following doses:

horses, cattle5 – 20 ml
pigs, sheep, goats1.5 – 7.5 ml
dogs0.25 – 0.75 ml
cats0.05 – 0.5 ml

While determining the dose size, clinical condition, body weight, route of administration and specific sensitivity of the animal to caffeine should be taken into account.
The product takes effect within 15 to 30 minutes after subcutaneous or intramuscular administration, or immediately after intravenous administration. In justified cases, another dose may be administered after 6 to 8 hours.

Advice on correct administration
None.

Withdrawal period(s)
Meat and offal:
Horse, cattle, pig, sheep, goat: zero days
Milk:
Cattle, sheep, goat: zero days

Special precautions for storage
Keep out of the sight and reach of children.
Store below 25℃. Protect from light. Do not freeze.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after “Exp”. The expiry date refers to the last day of that month.
Shelf-life after first opening the immediate packaging: 28 days.

Special precautions for disposal
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any applicable national collection systems. These measures should help to protect the environment.
Ask your veterinary surgeon how to dispose of medicines no longer required.

Classification of veterinary medicinal products
Veterinary medicinal product subject to a veterinary prescription.

Marketing authorisation numbers and pack sizes
MA number: 23/94
Pack sizes: 50 ml

Date on which the package leaflet was last revised
07/05/2025

Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).

Contact details

Marketing authorisation holder and manufacturer responsible for batch release:
Biowet Puławy Sp. z o.o.
Henryka Arciucha 2
24-100 Puławy
Poland
Tel./Fax: + 48 (81) 886 33 53, Tel: + 48 (81) 888 91 00
e-mail: sekretariat@biowet.pl

Contact details to report suspected adverse events:
Biowet Puławy Sp. z o.o.
Henryka Arciucha 2
24-100 Puławy
Poland
Tel.: + 48 (81) 888 91 33, Tel: +48 509 750 444
e-mail: biowet@biowet.pl

SPC: 2025-05-07

 

2025-07-17

 

Additional information

animal type

dogs, cats, horses, cattle, pigs, other