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Date: Saturday, May 21, 2022 5:10

Description: MSD-AH
Release 4.48
Finadyne® Transdermal 50 mg/ml pour-on solution for cattle
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Topical
Active ingredient: Flunixin Meglumine
Product:Finadyne® Transdermal 50 mg/ml pour-on solution for cattle
Product index: Finadyne® Transdermal
Cattle - milk: 36 hours
Cattle - meat: 7 days
Withdrawal notes: See datasheet for further information.
Qualitative and quantitative composition
Each ml contains:
Active substance:
Flunixin: 50 mg equivalent to 83 mg flunixin meglumine
Excipients:
Levomenthol: 50 mg
Allura red AC (E129): 0.2 mg
For a full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Pour-on solution.
Clear red liquid free from haziness and visible particles.
Clinical particulars
Target species
Cattle
Indications for use
For the reduction of pyrexia associated with bovine respiratory disease.
For the reduction of pyrexia associated with acute mastitis.
For the reduction of pain and lameness associated with interdigital phlegmon, interdigital dermatitis and digital dermatitis.
Contraindications
Do not use in animals suffering from cardiac, hepatic or renal disease, or where there is evidence of gastrointestinal ulceration or bleeding.
Do not use in severely dehydrated, hypovolaemic animals as there is a potential risk of increased renal toxicity.
Do not use the product within 48 hours before expected parturition in cows.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
Apply only to dry skin and prevent exposure to wetting for at least 6 hours after application.
In case of bacterial infections, concurrent antibiotic therapy should be considered.
Special precautions for use
See also section “Use during pregnancy, lactation or lay”.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are known to have the potential to delay parturition through a tocolytic effect by inhibiting prostaglandins that are important in signalling the initiation of parturition. The use of the product in the immediate post-partum period may interfere with uterine involution and expulsion of foetal membranes resulting in retained placentae.
Safety studies have not been conducted in bulls intended for breeding. Laboratory studies in rats have not shown any evidence of reproductive toxicity. Use only in accordance with a benefit/risk assessment by the responsible veterinarian.
Use in pre-ruminating and in aged animals may involve additional risk. If such use cannot be avoided, animals may require a reduced dosage and careful clinical management.
Apply only to undamaged skin.
Operator warnings
Non-Steroidal Anti-inflammatory Drugs (NSAIDs) may cause hypersensitivity (allergy).
People with known hypersensitivity to NSAIDs should avoid contact with the product.
The product has been shown to cause severe and irreversible eye damage and to cause slight skin irritation. Ingestion of, or dermal contact with the product may be harmful.
Avoid contact with eyes, including hand-to-eye contact. Avoid contact with the skin. Avoid contact with the treated area (allowing for spreading of the product) without protective gloves, for at least three days or until the application site is dry (if longer). Avoid children getting access to the product or treated animals.
Personal protective equipment consisting of impermeable gloves, protective clothing and approved safety glasses should be worn when using this product.
In case of accidental ingestion or mouth contact, immediately rinse the mouth with plenty of water and seek medical advice.
In case of eye contact, rinse eyes immediately with copious amounts of clean water and seek medical advice.
In case of skin contact, wash thoroughly with soap and water.
Do not smoke, eat or drink while handling the product. Wash hands after use.
Adverse reactions
Transient swelling, erythema, dandruff, broken/brittle hair, hair thinning, alopecia or skin thickening have been commonly reported at the application site. No specific treatment is generally required.
Some animals may display temporary signs of irritation, agitation or discomfort following application of the product. In very rare cases anaphylactic reactions, which may be serious, may occur and should be treated symptomatically.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy or lactation
Can be used during pregnancy and lactation except for 48 hours prior to parturition.
Due to an increased risk of retained placentae, the product should only be administered within the first 36 hours post-partum following a benefit/risk assessment performed by the responsible veterinarian and treated animals should be monitored for retained placentae.
Interactions
Do not administer other NSAIDs concurrently or within 24 hours of each other.
Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects. Concurrent administration of potentially nephrotoxic drugs should be avoided.
Amounts to be administered and administration route
Pour-on use. For single application. The recommended treatment dose is 3.33 mg flunixin/kg body weight (equivalent to 1 ml/15 kg body weight). The dosing chamber of the bottle is calibrated in kilograms of body weight. To ensure administration of a correct dose, body weight should be determined as accurately as possible.
Practice the administration instructions a few times to become familiar with operating the package before dosing animals.
Step 1: On first use remove cap and peelable seal from the dosing chamber. Do not remove cap from the bottle
Step 2: Hold the bottle upright and at eye level while slowly and gently squeezing the bottle to fill the dosing chamber to the selected mark.
Step 3: Pour the measured volume on the midline of the animal’s back extending from the withers to tail head. Localised application to smaller areas should be avoided.
Finadyne Transdermal 50mg/ml pour-on solution for cattle: Dosage Guide
Description: h-886
Description: h-887
Description: h-888
Overfill reduction instructions (see diagram)
Finadyne Transdermal 50 mg/ml pour-on solution for cattle: Overfill reduction instructions
Description: h-889
Description: h-890
Description: h-891
Description: h-892
Recommended pour-on location
Description: h-904
Overdose
Localised dermal inflammatory reactions and necrosis have been reported at 5 mg/kg.
Erosive and ulcerative abomasal lesions were observed in animals administered the product at 3 times the recommended treatment dose.
Occult faecal blood was observed in some animals administered the product at 5 times the recommended treatment dose.
No emergency procedures are necessary.
Withdrawal periods
Meat and offal: 7 days.
Milk: 36 hours.
Due to the possibility of cross-contamination of non-treated animals with this product due to grooming (licking), treated animals should be kept separately from non-treated animals throughout the withdrawal period. Non-compliance with this recommendation may lead to residues in non-treated animals.
Pharmacological particulars
ATCvet code: QM01AG90
Pharmacotherapeutic group:
Anti-inflammatory and anti-rheumatic products; non-steroids; fenamates; flunixin.
Pharmacodynamic properties
The active substance flunixin (as a meglumine salt) is a carboxylic acid, non-steroidal anti-inflammatory drug (NSAID) with non-narcotic analgesic and antipyretic activities. It demonstrates potent inhibition of the cyclo-oxygenase system (COX-1 and COX-2). COX converts arachidonic acid to instable cyclic endoperoxides, which are converted to prostaglandins, prostacyclin and tromboxane. The inhibition of the synthesis of such components is responsible for the analgesic, antipyretic and anti-inflammatory properties of flunixin meglumine.
In one study, Finadyne Transdermal was investigated in 64 cows with mastitis and efficacy for reducing rectal temperature was compared to placebo, which was used in 66 cows. At six hours post-treatment 95.3% of cows treated with Finadyne Transdermal showed a decrease in rectal temperature of more than 1.1°C, compared with 34.9% in the placebo group. After 6 hours, when antibiotic treatment had been added, there were no differences in rectal temperature between the groups.
Pharmacokinetic properties
After dermal application, flunixin is moderately absorbed through the skin of cattle (bioavailability about 44%). In cattle (except for calves), volumes of distribution are generally low due to the high degree (approximately 99%) of plasma protein binding. The apparent plasma elimination half-life following pour-on administration is about 7.8h. The metabolism of flunixin is rather limited, most of the drug corresponding to the unchanged parent compound and the remaining metabolites derived from hydroxylation. In cattle, elimination occurs primarily through biliary excretion.
After pour-on treatment, faster absorption of flunixin was observed in warmer conditions compared to colder conditions. In warm conditions (environmental temperatures between 13 °C and 3 0°C) the Tmax was about 2 hours whereas it was about 6 hours in cold conditions (environmental temperatures between -3 °C and 7 °C).
Anti-pyretic effect has been demonstrated from 4 hours after application of the product.
Pharmaceutical particulars
Excipients
Pyrrolidone, Levomenthol, Propylene glycol dicaprylocaprate, Allura red AC (E129) and Glycerol monocaprylate.
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening of the immediate package: 6 months.
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Immediate packaging
High density polyethylene (HDPE) bottles with polypropylene (PP) closures which have a peelable foil laminate induction innerseal and a liner. The bottles are equipped with a graduated dosing chamber and are supplied individually in a cardboard carton.
3 container sizes: 100 ml, 250 ml and 1000 ml.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
UK: Vm 01708/4608
Significant changes
Date of the first authorisation or date of renewal
08 May 2014.
Date of revision of the text
August 2020.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Finadyne Transdermal 1x250ml:
GTIN:8713184134035
GTIN description:Finadyne Transdermal 1x100ml:
GTIN:8713184134028