Can only be used in animal health
DICLOVET
Injectable Solution
Veterinary Non-steroidal Anti-inflammatory
COMPONENTS: DICLOVET Solution for Injection is a clear, colorless or pale yellow sterile solution containing 50 mg diclofenac sodium as the active ingredient and 20 mg benzyl alcohol as a preservative in each ml.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties: Diclofenac is a non-steroidal anti-inflammatory (NSAI) with analgesic (pain relieving), anti-spasmotic (preventing spasms) and antipyretic (fever-reducing) properties. It has an effect on the level of arachidonic acid metabolism by inhibiting the cyclooxygenase enzyme, which is responsible for the synthesis of prostaglandins, prostacyclins and thromboxanes.
Pharmacokinetic properties: When administered intramuscularly in cattle, absorption is rapid and its maximum concentration in the blood is recorded 2 hours after the first injection. (Cmax 7009 µg equivalent/kg) remains in the bloodstream for 24 – 48 hours. When administered intramuscularly in horses, its maximum blood concentration is recorded 1 hour after the first injection (Cmax 1.9 µg/ml) and diclofenac remains in the blood circulation for 36-48 hours. Diclofenac binds strongly to plasma proteins and is characterized by a not too high volume of distribution. This means that it stays longer, especially in the central region. The compound is metabolized at the liver level and enters the entero-hepatic (intestinal-liver) circulation. Elimination of diclofenac and its metabolites occurs mainly through the kidneys and biliary tract.
AREA OF USE/INDICATIONS
DICLOVET Injectable Solution in cattle and horses; It is used as anti-inflammatory (anti-inflammatory), analgesic (pain reliever) and anti-pyretic (fever reducer). Post-traumatic or non-traumatic rheumatic inflammation (with or without secondary bacterial infections) and degeneration, acute or chronic lameness (arthritis, ligament inflammation (desmitis), tendinitis, muscle inflammation (myositis)) It is used for treatment purposes in cases of It is used as a support for high fever (especially in horses) and inflammatory and degenerative, simple or complicated conditions of the respiratory tract (such as bronchopneumonia), genital organs and udder (such as mastitis and metritis) caused by bacterial factors.
USAGE AND DOSAGE
The pharmacological dose of diclofenac sodium is administered parenterally at 2.5 mg/kg body weight. Practically, the dose is adjusted to 5ml/100kg body weight/day in cattle and horses. Treatment should be continued for 1-3 days. Although intramuscular administration is recommended in all cases, intravenous administration should only be used in emergencies.
SPECIFIC CLINICAL INFORMATION AND WARNINGS FOR TARGET SPECIES
Loss of appetite (anorexia) has been observed in horses after use at recommended doses, and bleeding and liver disorders have been observed when administered in doses twice the normal dose. In such cases, treatment should be discontinued immediately and a veterinarian consulted. If vomiting or blood in the stool occurs as a result of gastrointestinal symptoms and bleeding at the beginning of treatment, treatment should be discontinued and a veterinarian consulted.
Use during pregnancy, lactation and ovulation: It is not recommended for use in the last periods of pregnancy (last 3 months of pregnancy in cattle and horses) unless necessary. As with all NSAIs, it may affect the mechanism during birth due to its effects on prostaglandin synthesis.
UNDESIRED EFFECTS
Vomiting and diarrhea may occur at the beginning of treatment, but there is no evidence of intolerance to the drug in cattle. Effects such as itching, edema, bronchial constriction and allergic reactions such as cold (rhinitis) and stomach and intestinal bleeding may be observed. If blood is observed in vomit or feces, treatment should be discontinued and a veterinarian should be consulted. When applied at recommended doses, temporary, painful swelling and bleeding, and rarely abscess and necrosis, may occur at the injection site.
DRUG INTERACTIONS
Digoxin should not be used together with furosemide and other diuretics, acetylsalicylic acid, coumarin group anticoagulants. Side effects may occur when administered with other systemic non-steroidal anti-inflammatory drugs.
SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE
Diclofenac sodium may cause slow or rapid breathing, nausea, vomiting, diarrhea and skin rashes when administered in high doses. Gastrointestinal bleeding symptoms and liver disorders were observed in horses at twice the recommended dose. The ulcerogenic effect, which can be seen in all NSAIs, can be prevented with active substances that protect the gastric mucosa and H2 receptor blocker drugs (cimetidine, ranitidine, famotidine, etc.) that can prevent acid secretion in the stomach.
RESIDUE WARNINGS IN ANIMALS WITH FOOD VALUE
Drug Residue Washout Period (D.R.W.P): During the treatment and following the last drug application, cattle raised for meat should not be sent to slaughter until 15 days later. Cow milk obtained during the treatment and 6 days (12 milkings) after the last drug application cannot be used for human consumption.
CONTRAINDICATIONS
It should not be administered to animals with hypersensitivity to diclofenac or its excipients. The use of diclofenac sodium is contraindicated in gastrointestinal pathologies, especially in cases of ulcerative lesions. Diclofenac can make symptoms more pronounced and even cause bleeding. It is contraindicated in cases of kidney and liver failure and in animals suffering from bleeding.
GENERAL WARNINGS
Consult your veterinarian before use and if any unexpected effects occur. Keep away from foodstuffs and out of the reach of children. Do not purchase or use products whose shelf life has expired or whose packaging is damaged.
PRECAUTIONS TO BE TAKEN BY THE PRACTITIONER AND SUGGESTIONSS FOR THE PHYSICIANS
In case of accidental contact of the drug with the eyes, the eyes should be rinsed with plenty of drinking water, and in case of contact with the skin, the hands should be washed with soap and water. During the application of the drug, protective equipment (gloves, glasses, etc.) should be used and asepsis and antisepsis rules should be observed. In case of accidental self-injection, it may cause symptoms such as vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus or convulsions. In this case, the nearest health institution should be consulted with the drug package insert. There is no known antidote. Treatment of poisoning is carried out symptomatically.
STORAGE CONDITIONS AND SHELF LIFE
Shelf life is 48 months when stored in its original packaging below 25°C. Once opened, it should be used within 28 days below 25°C and should not be stored in the refrigerator and/or deep freezer. The stopper can be pierced a maximum of 20 times.
WARNINGS FOR END OF USE DISPOSAL AND NON-TARGET SPECIES
Diclofenac is toxic to some bird species. Unused or leftover product must be disposed of in accordance with the relevant legislation. Water resources such as streams, rivers and ponds should not be polluted with these materials, they should not be disposed of with household waste, and care should be taken to ensure that they do not mix with the sewage system. Diclofenac is toxic to some bird species. Unused or leftover product must be disposed of in accordance with the relevant legislation. Water resources such as streams, rivers and ponds should not be polluted with these materials, they should not be disposed of with household waste, and care should be taken to ensure that they do not mix with the sewage system.
TRADE DRESS
It is presented in a 50 and 100 ml transparent Type II glass bottle closed with a white flip-off cap and a red rubber stopper in a cardboard box.
SALES LOCATION AND CONDITIONS
It is sold in pharmacies, veterinary offices, polyclinics and animal hospitals with a veterinarian’s prescription (VHR).
