Description
Morbital, 133.3 mg/ml + 26.7 mg/ml, solution for injection for dogs and cats
Statement of the active substance(s) and other ingredient(s)
Each ml contains:
Active substances:
Pentobarbital sodium 133.3 mg
Pentobarbital 26.7 mg
Clear, colourless solution.
Target species
Dogs, cats
Indications for use
Product intended for use in euthanasia of dogs and cats.
Contraindications
Not for intrapulmonary, intrapleural and intramuscular administration.
Do not use for anaesthesia.
Do not use in animals from which meat and offal are intended for human consumption.
Special warnings
Special precautions for safe use in the target species:
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 should avoid contact with the veterinary medicinal product.
When handling the product, use caution to avoid direct contact. If inhaled, go to fresh air immediately. In case of contact with skin, wash the affected area with soap and water and change clothes, if contaminated with the product. In case of contact with eyes, wash immediately with plenty of water and consult a physician. After ingestion, subcutaneous or intramuscular injection, the product begins to be rapidly absorbed. In case of ingestion or parenteral administration, always seek medical advice immediately and show the package leaflet to the physician. Due to possible sedation, difficulty breathing and blood pressure fluctuations, the person exposed to the product should not drive motor vehicles and always stay under care of others.
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 injection or ingestion of 2.5 ml of the product. One gram of pentobarbital (which corresponds to less than 7 ml of the product) may be lethal for humans. In case of exposure to the veterinary medicinal product, symptomatic treatment should be applied in order to sustain the basic vital signs.
Other precautions:
Consumption of meat from animals euthanised using this product is dangerous. It may result in deep anaesthesia or death. This also applies to heat treated meat, as barbiturates are resistant to high temperatures. For this reason, carcass of euthanised animals must not be destined for ingestion by other animals, but they should be disposed of in accordance with applicable regulations.
Pregnancy:
If used in pregnant bitches and queens, the death of the mother causes the death of the foetus.
Interaction with other medicinal products and other forms of interaction:
Barbiturates enhance the inhibitory action of d-tubocurarine and hexamethonium on neurotransmission in the motor end plate. What is more, pentobarbital and streptomycin interact to induce significant vasodilation, mainly of kidney vessels. Intravenous injection of calcium solution cancels vasodilating effect, allowing the use of sodium pentobarbital in animals treated with streptomycin. Interactions with some aminoglycosides have also been confirmed.
Overdose:
Not applicable.
Special restrictions for use and special conditions for use:
For administration only by a veterinarian.
Major incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Adverse events
| Frequency unknown (cannot be determined on the basis of available data) :
| Agitation. 1 Dyspnoea. |
1 Transient reaction.
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 Warszawa, Tel.: +48 22 49-21-687, Fax: +48 22 49-21-605, https://smz.ezdrowie.gov.pl.
Dosage for each target species, route(s) and method(s) of administration
Intravenous injection is the recommended route of administration.
Intraperitoneal administration is allowed when intravenous injection is impossible or dangerous.
Intracardiac administration is allowed only upon prior elimination of pain or loss of consciousness.
In case of rapid administration (preferably intravenous), the animal falls asleep without any adverse effects. Respiratory and cardiac arrest occur within a dozen or so seconds. Corneal reflex may persist for up to 90 seconds.
Dosage:
| Morbital | Pentobarbital sodium | Pentobarbital | |
| Intravenous administration | 0.3-0.6 ml/kg b.w. | 39.99–79.98 mg/kg b.w. | 8.01-16.02 mg/kg b.w. |
| Intraperitoneal administration | 1.0-2.0 ml/kg b.w. | 133.3-266.6 mg/kg b.w. | 26.7-53.4 mg/kg b.w. |
| Intracardiac administration | 0.3-0.6 ml/kg b.w. | 39.99–79.98 mg/kg b.w. | 8.01-16.02 mg/kg b.w. |
Advice on correct administration
The preferred route of administration, involving the smallest and shortest possible pain, is intravenous injection.
In case when intravenous administration is impossible or dangerous, intraperitoneal administration is allowed. This route of administration allows for slow induction of sedation and anaesthesia in animals, therefore they should be provided with peace and quiet.
In fearful, aggressive or wild animals, premedication is recommended. Intracardiac administration is allowed only in exceptional cases, that is in fully sedated, unconscious and deeply anaesthetised animals.
The product should be injected at a fixed pace, with optimum doses administered rapidly. Administration of a deficient dose may induce signs of prolonged sleep with potential awakening.
Before the procedure, animal body weight should be determined as accurately as possible. Smaller doses per 1 kg of body weight are more effective in adult, ill and starving dogs.
In any case, make sure that death of an animal has been obtained indeed, as deep anaesthesia may give the appearances of death.
Withdrawal period(s)
Not applicable.
Special storage precautions
Keep out of the sight and reach of children.
Store below 25℃.
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 package: 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 prescription.
Marketing authorisation numbers and pack sizes
651/99
Pack size: 100ml
Date on which the package leaflet was last revised
26/11/2024
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 2024-11-26
2025-03-21
