133.3 mg/ml + 26.7 mg/ml, solution for injection for dogs and cats
Active substance and excipient content
1 ml of the product contains :
Sodium pentobarbitone -133.3 mg/ml
Pentobarbitone – 26.7 mg/ml
Euthanasia of dogs and cats.
Do not administer intrapulmonarily, intrapleurally and intramuscularly.
Do not use for anaesthesiology.
Do not use in animals whose tissues are intended for human consumption.
During the use of the preparation, temporary excitement and breathlessness symptoms may occur.
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 http://www.urpl.gov.pl (Department of Veterinary Medicinal Products).
Posology per each species, routes and methods of administration
The recommended route of administration is the intravenous administration.
Intraperitoneal administration is acceptable if intravenous administration is impossible or dangerous.
Intracardial administration is permissible only in animals in full sedation which are unconscious or anaesthetised.
In rapid administration of Morbital (preferably intravenously), the animal falls asleep with no adverse effects. Within slightly over ten seconds, respiration ceases and cardiac arrest occurs. Corneal reaction may remain up to 1.5 minutes.
|Intravenous||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||1.0-2.0 ml/kg b.w.||133.3-266.6 mg/kg b.w.||26.7-53.4 mg/kg b.w.|
|Intracardial||0.3-0.6 ml/kg b.w.||39.99–79.98 mg/kg b.w.||8.01-16.02 mg/kg b.w.|
Recommendations for proper administration
The recommended route of administration with the smallest and shortest pain is the intravenous administration.
Intraperitoneal administration is acceptable if intravenous administration is impossible or dangerous. Using this route, animals may slowly become sedated and anaesthetised. Therefore, peace and quiet should be provided for them.
In timid, aggressive or wild animals, premedication is recommended. Intracardial administration may only be used in exceptional cases in animals in full sedation which are unconscious or anaesthetised.
The preparation should be injected evenly, quickly administering optimal doses. Administration of an incomplete dose may induce symptoms of prolonged sleep with possible awakening.
The bodyweight of an animal has to be determined as accurately as possible before the procedure. Lower doses per 1 kg are effective in adult dogs as well as sick and starving dogs.
In each case, make sure whether the death of the animal has taken place since deep anaesthesia may simulate symptoms of death.
Special precautions for storage
Keep out of the sight and reach of children.
Store at a temperature below 25°C.
Do not use this veterinary medical product after the expiry date given on the label.
The durability period after the first opening of the immediate container: 28 days.
Special precautions for use in animals:
After accidental administration of the product to animals not intended for euthanasia, immediately begin actions supporting respiration, administer oxygen and analeptics.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
People with diagnosed hypersensitivity to barbiturates should avoid contact with the product.
Particular caution should be taken to avoid direct contact during administration. If the product gets into the airways, immediately go into fresh air. In the case of the contact of the product with the skin, wash the site with water and soap and change clothes if they have been stained with the product. In the case of the contact of the product with eyes, immediately wash eyes with plenty of water. On swallowing of the product, subcutaneous or intramuscular administration, its rapid absorption occurs. After swallowing of the product or parenteral administration, you should always immediately seek medical help and show the leaflet or the package to a physician. A person exposed to the effect of the product should not drive due to the possibility of sedation, breathlessness and changes in arterial blood pressure and should remain under the supervision of another person.
Information for physicians
The product contains pentobarbital in such an amount that injection or consumption of 2.5 ml may cause serious symptoms from the central nervous system in an adult person. One gram of pentobarbital (which nearly corresponds to 7 ml of the product) may cause a person’s death. Symptomatic treatment and treatment consisting in maintaining primary life functions should be applied in a person who has been exposed to the effect of the product.
Consumption of meat of animals subjected to euthanasia using Morbital is dangerous. This might cause deep narcosis or death. This also applies to meat subjected to heat processing as barbiturates are resistant to high temperatures. Therefore, corpses of euthanized animals must not be intended for consumption by other animals, but should be disposed of in accordance with valid regulations.
If the product is used in pregnant females, the death of the mother causes the death of the foetus.
Interactions with other medicinal products and other forms of interaction:
Barbiturates intensify the inhibitory effect on neurotransmission in the neuromuscular junction induced by d-tubocurarines and hexamethonium. Moreover, pentobarbitone and streptomycin induce additive reactions causing dilatation of vessels, mainly renal vessels. Intravenous administration of a calcium solution removes the vasodilating effect allowing the use of sodium pentobarbitone in animals treated with streptomycin. Interactions with some amino glycosides were also demonstrated.
Overdose (symptoms, procedures concerning immediate help and antidotes):
Since no studies of the conformity of this veterinary medicinal product have been conducted, this product must not be combined with other medicinal veterinary 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.
Orange glass type II bottle containing 100 ml of the product, closed with a bromobutyl rubber stopper and secured with an aluminium cap, packaged single in a cardboard box.
Subject to medical prescription – prescription drug
To be administered under veterinary supervision.
To be administered under veterinary supervision.
Possession and sales of the product are set out in regulations concerning preparation containing intoxicants or psychotropic substances.
For more information about this veterinary medicinal product, contact the Marketing Authorization Holder.
Marketing Authorization Holder and manufacturer responsible for batch release:
Biowet Puławy Sp. z o.o
ul. H. Arciucha 2, 24-100 Puławy
tel./fax (81) 886 33 53, tel. (81) 888 91 00
2015-11-27 urpl (Office for Registration of Medicinal Products) decision