1. Name of the veterinary medicinal product
ORNIPURAL SOLUTION
2. Qualitative and quantitative composition
| Betaine ................. |
15.0 mg |
| Arginine ................ as hydrochloride) |
33.3 mg |
| Ornithine ............... (as hydrochloride) |
11.8 mg |
| Citrulline ................ |
10.0 mg |
| Sorbitol (E420) ............. |
200.0 mg |
| |
|
| Metacresol ............... |
3.0 mg |
Excipient QSP 1 mlFor the full list of excipients, see section "List of excipients".
3. Pharmaceutical form
Solution for injection.
4. Clinical information
4.1. Target species
Horses, cattle, sheep, dogs and cats.
4.2. Indications for use, specifying the target species
In horses, cattle, sheep, dogs and cats:
- Stimulation of hepato-digestive activity during digestive disorders and liver failure.
4.3. Contraindications
Any.
4.4. Special warnings for each target species
Any.
4.5. Special precautions for use
i) Special precautions for use in animals
Any.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
Any.
iii) Other precautions
Any.
4.6. Undesirable effects (frequency and severity)
No.
4.7. Use during pregnancy, lactation or lay
The safety of the product in pregnant or lactating females has not been studied. However, its use during gestation and breastfeeding does not seem to pose any particular problem.
4.8. Drug interactions and other forms of interactions
None known.
4.9. Dosage and route of administration
In adult cattle and horses:
Administer 50 to 100 ml by slow intravenous, intramuscular or subcutaneous route.
In calves and foals:
Administer 1 ml per 5 to 10 kg of bodyweight by slow intravenous, intramuscular or subcutaneous route.
In sheep:
Administer 10 to 15 ml by slow intravenous, intramuscular or subcutaneous route.
In lambs:
Administer 3 to 5 ml by slow intravenous, intramuscular or subcutaneous route.
In dogs and cats:
Administer 2 to 5 ml depending on the size by slow intravenous, intramuscular or subcutaneous route.
Repeat the injections 4 to 5 times every 2 days.
4.10. Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
4.11. Waiting time
Meat and offal: zero days
Milk: zero days
5. Pharmacological properties
Pharmacotherapeutic group: Other digestive and metabolic drugs, amino acids and derivatives.
5.1. Pharmacodynamic properties
The active ingredients in this veterinary medicinal product have hepatoprotective, lipotropic and diuretic properties.
Betaine is a lipotropic factor, participating in the fight against fatty overload and hepatic steatosis of the liver.
Sorbitol is a carbohydrate that improves the intestinal absorption of certain vitamins, including vitamins B12 and B6 and the ferric ion. It is also a nutritious contribution and a diuretic.
Ornithine and citrulline are amino acids used as detoxification factors in the body by activating the urogenesis cycle.
Arginine, another amino acid, is part of the Krebs cycle and also facilitates the urogenesis cycle.
5.2. Pharmacokinetic characteristics
Not known.
6. Pharmaceutical information
6.1. List of excipients
Metacresol
Water for injections
6.2. Major incompatibilities
Not known.
6.3. The duration of the conversation
3 years.
After opening: 28 days.
6.4. Special storage precautions
No special storage conditions.
6.5. Nature and composition of immediate packaging
Glass bottle
6.6. Special precautions to be taken when disposing of unused veterinary medicinal products or waste derived from the use of these medicinal products
Empty packaging and any product residue must be disposed of in accordance with current practices governed by waste regulations.
