Description
Morbital Plus, 400 mg/ml, solution for injection for cattle, horses, pigs, dogs and cats
Statement of the active substance(s) and other ingredient(s)
Each ml contains:
Active substance
Pentobarbital sodium 400 mg
(which corresponds to 364.6 mg of pentobarbital)
Excipients:
| Qualitative composition of excipient(s) and other constituent(s) | Quantitative composition |
| Benzyl alcohol (E 1519) | 20 mg |
| Patent Blue V (E 131) | 0.01 mg |
| Ethanol 96% | |
| Propylene glycol | |
| Water for injection |
Clear, blue solution.
Target species
Cattle, horses (ponies), pigs, dogs, cats.
Indications for use
Product intended for use in euthanasia of cattle, horses (ponies), pigs, dogs and cats.
Contraindications
Do not use for anaesthesia.
Special warnings
None
Special precautions for safe use in the target species:
Pentobarbital injected intravenously may cause drug induced agitation. To prevent it, administer a proper sedatives before administration of pentobarbital.
Intraperitoneal injection may produce prolonged drug induced agitation; this route of administration may only be used after the animal has been properly sedated.
In order to reduce the risk of agitation, animals should be euthanised in a peaceful environment.
Do not administer the product per os.
Avoid intrasplenic drug administration or injections to organs/tissues with reduced absorption capabilities; this route of administration is only permitted in case of small animals.
Intracardial administration is only possible when the animal has been fully sedated, unconscious or anaesthetized.
Once cardiac and respiratory arrest have been confirmed, monitor the animal for another 10 minutes. In case of finding any signs of life, such as respiration, heartbeat or corneal reflex, it is recommended to re-administer the full or half the recommended product dose.
In case of accidental administration of the product to animals not intended for euthanasia, begin ventilation, administer oxygen and analeptics immediately.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Persons with known hypersensitivity to barbiturates and pregnant women should avoid direct contact with the veterinary medicinal product.
Pentobarbital is a potent hypnotic and sedative, therefore it may be toxic for humans once ingested or absorbed through the skin.
Particular caution should be taken to avoid accidental ingestion or self-injection.
In case of accidental self-injection, swallowing, spilling on skin, contact with eyes, seek medical advice immediately and show the package leaflet or the label to the physician.
Immediate medical advice is particularly important in case of self-injection.
In case of spilling on skin, immediately flush the affected area with plenty of water.
In case of contact with eyes, immediately rinse with plenty of water and seek medical advice.
In case of swallowing, rinse mouth and seek medical advice.
In case of contact with the product, do not drive, as sedation is likely to occur.
While administering the product, use impermeable protective gloves.
To the physician:
Pentobarbital concentration in the product is high enough to produce a serious effect on the central nervous system in an adult after accidental self-injection or swallowing of as much as 1 ml. It was found that a dose of 1 g of pentobarbital sodium (which corresponds to 2.5 ml of the product) may be lethal for humans. In case of poisoning on pentobarbital, extend intensive care in order to sustain blood circulation and respiration.
Other precautions:
Consumption of remains of a euthanised animal by other animals may lead to poisoning, sedation or even death. Barbiturates show high stability even at high temperatures. Due to the risk of secondary poisoning, remains of euthanised animals, even after being heat treated, must not be used for feeding to other animals. They should be disposed of in accordance with the local regulations and in a manner preventing access by other animals.
Pregnancy and lactation:
The product can be used in pregnant and lactating animals.
Interaction with other medicinal products and other forms of interaction:
While euthanizing an aggressive animal when intravenous administration is difficult, it is recommended to use premedication with a sedative that is easier to administer (per os, subcutaneously or intramuscularly).
Premedication with sedatives, due to impaired circulation, may delay the expected effect of pentobarbital. This may not be reflected in clinical signs, as agents used for premedication (opioids, agonists of alpha-2 adrenergic receptors, phenothiazines, etc.) by depressing the central nervous system may enhance the pentobarbital performance.
Overdose:
Not applicable.
Special restrictions for use and special conditions for use:
None
Major incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Adverse events
Minor muscle contractions may be observed in the animal after administration of the veterinary medicinal product. When an intravenous injection is not properly administered into a vein or the product is injected to organs with reduced absorption capabilities, death may be delayed. Barbiturates may produce an irritating effect in case of perivascular administration.
Pentobarbital sodium may cause animal agitation. Premedication/sedation significantly reduces the risk of agitation.
At times, after cardiac arrest, agonal respiration may be observed in the animal. At this stage, the animal is dead in clinical terms.
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: Department for Documentation Assessment and Pharmacovigilance of Veterinary Medicinal Products, 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, https://smz.ezdrowie.gov.pl
Dosage for each target species, routes and method of administration
Dogs, cats, pigs, piglets – administration of Morbital Plus in ml per 1 kg body weight
| Pentobarbital sodium mg/kg b.w. | Morbital plus in ml/kg b.w. | Route(s) and method of administration | |
| Dogs, cats | 100-200 mg | 0.25-0.5 ml/kg b.w. | rapid intravenous or intracardial injection |
| Pigs | 100-200 mg | 0.25-0.5 ml/kg b.w. | rapid intravenous injection |
| Piglets | 100-200 mg | 0.25-0.5 ml/kg b.w. | rapid intravenous or intracardial injection |
Cattle, horses, ponies – administration of Morbital Plus in ml/100 kg b.w.
| Cattle | 50 mg | 12.5 ml/100 kg b.w. | rapid intravenous (injection) |
| Horses, ponies | 50 mg | 12.5 ml/100 kg b.w. | rapid intravenous (injection) |
Intravenous injection should be the preferred method of administration. In necessary, before administration of the veterinary medicinal product, a proper sedative should be used. In case of cattle and horses, premedication is compulsory.
In case intravenous administration is problematic, intracardiac injection may be applied only after prior use of deep sedation or anaesthesia.
In small animals, intraperitoneal administration is allowed, but must be preceded by proper sedation.In pets, pentobarbital should be administered at a fixed pace until loss of consciousness is acknowledged.
In horses and cattle, pentobarbital must be administered as a rapid injection.
Advice on correct administration
Do not administer the product with visible signs of deterioration.
Withdrawal period(s)
Not applicable.
Appropriate actions must be taken to ensure that remains of animals this veterinary medicinal product was administered to, as well as animal-by products from these animals will not enter the food chain and will not be destined for consumption by humans or other animals.
Special storage precautions
Store in the original package.
Store below 25°C.
Special precautions for disposal of unused medicinal products or waste materials derived from such medicinal products, if applicable
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.
Classification of veterinary medicinal products
Veterinary medicinal product subject to prescription
For administration only by a veterinarian.
Marketing authorisation numbers and pack sizes
MA number:
Date on which the package leaflet was last revised
08.12.2022
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, + 48 509 750 444
e-mail: biowet@biowet.pl
SPC 2022-12-08
2025-03-21
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