Termolin
| Product Group | : | Anti-Inflammatory |
| Pharmaceutical Form | : | Solution for Injection |
| Active Ingredient | : | Flunixin Meglumine |
| Target Type | : | Cattle, Horse |
| Package Form | : | 50 - 100 ml |
For Animal Use Only
- Composition - Pharmacological Properties
- Indications – Usage
- Undesirable Effects – Warnings
For Animal Use Only
TERMOLİN
Solution for Injection
Non-Steroid Anti-inflammatory, Antirheumatic
COMPOSITION
Termolin Solution for Injection is a colorless, clear, odorless, sterile solution containing Flunixin meglumine equivalent to 50 mg Flunixin base per ml.
PHARMACOLOGICAL PROPERTIES
Termolin Solution for Injection has a strong analgesic, anti-inflammatory and antipyretic effects of non-narcotic and non-steroidal nature. Flunixin meglumine inhibits the production of prostaglandin synthetase, which is necessary for prostaglandin production, while also blocking the effect of prostaglandins on the CNS, reducing or completely eliminating the symptoms of inflammation, pain and fever. It reaches peak plasma concentration rapidly after intravenous and intramuscular administration. Bio-half-life: 1.6 hours in horses, 3.7 hours in dogs, 8-10 hours in cattle.
The peak plasma concentration of Flunixin meglumine, which was administered intramuscularly at a dose of 2.2 mg/kg bw/day for 2 days in cattle, reached 17.1-18.3 µg/ml after 5 minutes, and decreased to 0.36-0.65 µg/ml after 2 hours. Approximately 90% of the total radioactivity (61% in faeces, 29% in urine) is excreted unchanged within 24 hours.
The bioavailability of Flunixin meglumine given at a dose of 2.2 mg/kg, orally and subcutaneously for 3 days in dairy cows, was 53% and 75%, respectively, when compared with intravenous use. The residue in milk is usually low, decreasing to 0.05-0.06 mg/l (MRLs for milk: 0.04 mg/l) after 9 hours. The plasma half-life of intravenous administration of a dose of 1.1 mg/kg/day in horses is 1.6 hours, and the drug can be measured in plasma for 8 hours and in urine for 48 hours. Only 14% of the administered drug can be excreted in the urine within the first 24 hours. Thanks to this pharmacokinetic feature, since its effect in horses lasts for 24-36 hours, it can maintain its versatile effectiveness all day long with a single injection. When a dose of 1.1 mg/kg/day is administered intramuscularly, 21% of the dose is excreted in the stool and 57% in the urine (in unchanged form) over a period of 96 hours.
AREA OF USE / INDICATIONS
In horses:
It is applied as a single dose in the treatment of tendon, musculoskeletal system inflammation, pain and lameness, and colic aches and pains caused by smooth muscle spasms of internal organs. It also provides a supportive and helpful effect in the treatment of diseases involving inflammation and pain symptoms.
In cattle:
It is used as a single dose in acute mastitis, musculoskeletal system inflammation and pain, spasms of smooth muscles. In this case, Termolin reduces the amount of lactic acid in blood and tissues, prevents hypotension, improves venous return to the heart and reduces damage to vascular endothelial cells. It is used as a support to the main treatment in E.coli septicemia (colibacillosis of newborns). It is also useful in preventing inflammation after corneal surgery.
USAGE AND DOSAGE
In horses:
The daily dose is 1.1 mg/kg bw (1 ml Termolin per 45 kg body weight) by intramuscular or intravenous route. The maximum duration of treatment is 5 days. The drug effect continues for 24-36 hours, starting within 2 hours, with a peak level in 12-16 hours. Intravenous administration is recommended for immediate relief of colic pain and relief of the animal. The effect starts in 15 minutes. If the pain reoccurs, the dose can be repeated. Supportive treatment should be considered here. Following the application of flunixin meglumine, colic pains were relieved within 15 minutes in 37% of horses and within 30 minutes in 74% of horses.
In cattle:
It is preferably administered intravenously. Daily dose: 2.2 mg/kg bw (2 ml Thermoline for 45 kg body weight), maximum duration is 5 days. As a support in E.coli septicemia and endotoxin treatment, half-dose (1.1 mg/kg bw) medication can be repeated at 8-hour intervals if necessary. It should be used together with other main and supportive treatments by determining the causes in acute inflammations.
SPECIAL CLINICAL INFORMATION AND SPECIAL WARNINGS FOR TARGET SPECIES
Use in race horses should be discontinued 1 week before the race. It is not recommended for those with kidney, liver and heart failure. Injections into the arteries should be avoided. Ataxia, incoordination, hyperventilation, hysteria and muscle weakness can be seen in horses with intra-arterial injections. These symptoms are temporary and disappear in a few minutes without any intervention.
UNDESIRED EFFECTS
The recommended therapeutic doses should not be exceeded. Prolonged use may cause gastrointestinal irritation and ulceration in severe cases. After the application, local swelling, sweating and hardening may be seen at the application site. Studies in rats and rabbits showed no effects on teratogenic, mutagenic, carcinogenic, maternotoxic, foetotoxic and fertility performance.
DRUG INTERACTIONS
It should not be used together with other non-steroidal anti-inflammatory drugs (NSAIDs) or should be used every 24 hours.
SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE
Although it is not possible to overdose in practice, since it is generally used as a single dose; at very high doses: salivation, vomiting, respiratory distress, muscle tremor, gastrointestinal ulceration and peritonitis, changes in blood and urine chemistry may occur. Symptomatic treatment should be performed according to the clinical picture.
RESIDUAL WARNINGS FOR FOOD PRODUCING ANIMALS
Drug Residue Elimination Period: During the treatment and 21 days after the last application, the animals cannot be sent to slaughter. The milk obtained during 5 days (10 milkings) is not offered for human consumption.
CONTRAINDICATIONS
It should not be used in hypovolemic animals except in cases of endotoxemia or septic shock. It should not be used in animals with gastrointestinal ulcers. Long-term use of non-steroidal anti-inflammatory drugs predisposes to gastrointestinal ulcers. It should not be used in animals younger than 6 weeks of age and in animals with renal, hepatic and heart failure. Non-steroidal anti-inflammatory drugs that inhibit prostaglandin synthesis should not be administered to animals under general anesthesia.
Use during pregnancy: Contraindicated in pregnant animals.
GENERAL PRECAUTIONS
Consult your veterinarian before use. It should be stored away from children. Keep away from foodstuffs. In case of unexpected effect, consult your veterinarian. Do not buy or use products with damaged packaging.
PRECAUTIONS TO BE TAKEN AND RECOMMENDATIONS FOR PHYSICIANS
Apply using gloves. Wash your hands with water after spraying.
STORAGE CONDITIONS AND SHELF LIFE
The opened package should be consumed within 1 month. Shelf life is 2 years when stored at room temperature (15°C-25°C) and protected from light.
TRADE DRESS
It is offered for sale in honey-colored vials of 10, 20, 50 and 100 ml in cardboard boxes.
PLACE AND CONDITIONS OF SALE
Sold in veterinary offices and pharmacies with a veterinarian's prescription (VHR).
APPROVAL DATE OF THE PROSPECTUS: 27.03.2013
T.R. MINISTRY OF AGRICULTURE AND FORESTRY MARKETING AUTHORIZATION DATE AND NO: 26.12.2003-12/091
NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER
Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.
Malıköy Başkent OSB Mah. 26. Cad. No: 34/A - Sincan - ANKARA - TÜRKİYE
MANUFACTURER COMPANY NAME AND ADDRESS
Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.
Malıköy Başkent OSB Mah. 26. Cad. No: 34/A - Sincan - ANKARA - TÜRKİYE
