| Ingredients: | ademethionine 1,4-butanedisulfonate |
| Application: | injectable |
| Type of formulation: | vitamin and mineral |
Characters
Powder: A white to slightly yellow powder free of foreign particles.
Solvent: A clear, colorless to yellowish liquid free of foreign particles with a characteristic odor of the components.
Prepared solution: A clear, slightly yellow to yellow solution free of foreign particles with a characteristic odor of the components.
Composition
1 vial with powder contains;
Active substance:
- Ademethionine 1.4-butanedisulfonate: 0.38 g
Excipients: 1 vial with solvent (2.85 mL), which contains L-lysine, sodium hydroxide, methyl parahydroxybenzoate, propyl parahydroxybenzoate, water for injection.
Pharmacological Properties
АТСvet code: QА05 Bile and liver therapy.
Ademethionine 1.4-butanedisulfonate is a salt of ademethionine. Ademethionine is a natural amino acid that is a part of all tissues and body fluids. It is involved in many basic metabolic processes of the body. Ademethionine is a methyl group donor in biological transmethylation reactions, activates transsulfuration, and is a precursor of physiological thiol compounds (cysteine, taurine, glutathione, coenzyme A, etc.). The transfer of methyl groups (transmethylation) of ademethionine is an important metabolic process in the synthesis of cellular phospholipid membranes and affects membrane fluidity.
Ademethionine is able to penetrate the hematoencephalic barrier. High concentrations of ademethionine affect transmethylation processes, which are important in brain tissue, due to the effect on the metabolism of catecholamines (dopamine, epinephrine, norepinephrine), indolamines (serotonin, melatonin) and histamine. Glutathione, the most powerful antioxidant in the liver, plays an important role in hepatic detoxification. Ademethionine increases the level of hepatic glutathione in animals with liver damage. Due to this, the drug has hepatoprotective, antidepressant, antioxidant, detoxifying, regenerating and antifibrosing effects.
Folic acid and vitamin B12 are essential co-nutrients in the metabolism and accumulation of ademethionine.
Ademethionine exerts choleretic and cholecinetic effects, has detoxifying, regenerating, antioxidant, antifibrosing and neuroprotective properties. The drug replenishes the deficiency of S-adenosyl-L-methionine (ademethionine) and stimulates its production in all body environments. The highest concentration of ademethionine is found in the liver and brain. It is present in the body's metabolic processes and important biochemical reactions: transmethylation, transsulfation, transamination. It has been proven effective in hepatopathies caused by various hepatotoxic drugs.
The bioavailability of the product after intramuscular administration is 96%. The maximum serum concentration is reached after parenteral administration in 45 minutes. DETOXOL is slightly bound to plasma proteins (≤5%). There is a significant increase in the concentration of ademethionine in the cerebrospinal fluid. DETOXOL is metabolized in the liver. The process of synthesis, utilization and re-formation of ademetionine is called the ademetionine cycle. In the first step of this cycle, adenylyl-dependent methylases use ademethionine as a substrate for the production of S-adenosylhomocysteine, which is hydrolyzed to homocysteine and adenosine by S-adenosylhomocysteine hydrolyzase. Homocysteine, accordingly, undergoes reverse transformation to methionine by transferring a methyl group from 5-methyltetrahydrofolate. In turn, methionine can be converted to ademethionine, completing the cycle.
Unmetabolized ademethionine is excreted via the urine and feces.
Indications
Treatment of dogs and cats suffering from chronic hepatitis, intrahepatic cholestasis, fatty degeneration, hepatic encephalopathy, toxic lesions of various etiologies, infectious and invasive diseases accompanied by liver damage, during periods of intensive drug load; for liver detoxification, accelerating hepatocyte regeneration, improving bile flow, preventing fatty or fibrous liver degeneration, and normalizing metabolism.
Dosage and administration
The powder is dissolved in the special solvent attached immediately before use. The medicinal product (freshly prepared solution) is administered intravenously dropwise; if not possible, intramuscularly immediately after preparation.
For intravenous administration, a freshly prepared solution of the medicinal product should be diluted in 250 mL of a 0.9% sodium chloride solution or a 5% glucose solution and administered slowly, dropwise, for 1-2 hours.
The product should not be mixed with alkaline solutions and solutions containing calcium ions.
A diluted product should not be stored.
The temperature of the prepared solution should not exceed 25 °C.
Dogs
15-25 mg of the active substance per 1 kg of animal body weight.
1 vial of the product is designed for an animal weighing about 20 kg.
The product should be administered once a day, preferably in the morning, given its tonic effect.
Cats
20-30 mg of the active substance per 1 kg of animal body weight.
Product dosage is shown in Table 1 below.
Animal body weight, kg | Dosage of product (freshly prepared solution), mL |
Up to 2,0 | 0,3 - 0,45 |
2,0 to 5,0 | 0,45 - 0,68 |
Over 5,0 | 0,75 |
Cats are administered twice daily intravenously, dropwise, immediately after preparation.
The course of treatment depends on the complexity of the animal's condition. The minimum recommended period of treatment is 3 days. In severe cases or in case of chronic disease, depending on the conclusion of a veterinarian, the course of treatment may be 6 days or more.
Contraindications
Hypersensitivity to any of the components of the product.
Disorder of cyanobalamin and/or folic acid metabolism in animals.
Do not administer the product to pregnant cats!
Precautions
Adverse effects
In some cases, the following adverse effects are possible: diarrhea, injection site reactions, malaise, depression, peripheral edema, hyperthermia and skin rash, itching.
Interaction with other medicinal products and other forms of interaction
Do not mix with alkaline solutions or solutions containing calcium ions!
It is not recommended to mix the product in the same syringe with other medicinal products.
Do not combine the product with other veterinary medicinal products.
Overdose (symptoms, emergency procedures, antidotes)
Cases of adverse effects of the product caused by a single overdose are unknown.
In rare cases, allergic manifestations such as skin rashes, itching and swelling; diarrhea, malaise, depression and hyperthermia may occur. In case of their occurrence, the use of the product should be terminated and symptomatic therapy should be prescribed.
Special precautions to be taken by the person administering the medicinal product to animals
Personal protective equipment (respirator, gloves) must be worn when working with the product.
Contact with the eyes of the solvent or therapeutic (prepared) solution causes irritation, so they should be immediately rinsed with running water. Wash hands after handling the product. In case of accidental administration to a human, immediately seek medical advice, providing him/her with the Package Insert for familiarization.
How supplied
Make НС-1, НС-2, УСП-1 neutral glass vials fitted the vials with rubber septa and sealed with aluminum crimp caps.
Three 0.38-g glass vials of powder and three 2.85-mL glass vials of solvent are packed in a cardboard box.
Storage
Store at between 10 °С and 25 °С. Keep out of reach of children.
Failure to comply with the storage temperature regime may reduce the efficacy of the product or lead to complete destruction of the active substance!
Shelf life
24 months.
For animal treatment only!
Marketing authorization holder and finished product manufacturer:
Vetsintez, LLC
30 Taras Bobanyich St., Kharkiv 61001, Ukraine