Flukiver Injection is used for the treatment and control of liver fluke in cattle.
Active Ingredient: Closantel
Target Species: Cattle
Administration Method: Subcutaneous injection (under the skin)
Treats and Controls: Liver fluke in cattle
Withdrawal Time:77 days for animals intended for meat and offal, not permitted for use on animals producing milk for human consumption.
Dosage For Cattle:2.5 ml per 50 kg of bodyweight.
|Weight in kg||Dosage in ml||Doses in 250 ml Bottle|
|Up to 50||2.5||100|
|51 - 100||5.0||50|
|101 - 150||7.5||33|
|151 - 200||10.0||25|
|201 - 250||12.5||20|
|251 - 300||15.0||16|
|301 - 350||17.5||14|
|351 - 400||20.00||12|
|401 - 450||22.5||11|
|451 - 500||25.0||10|
|501 - 550||27.5||9|
Always read the label and all enclosed information for Flukiver Injection before administering to animals!
Key Features of Flukiver:
Health Products Regulatory Authority
Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Flunixin (as flunixin meglumine) 50 mg/ml
Phenol 5.0 mg/ml
Sodium formaldehyde Sulphoxylate Dihydrate 2.5 mg/ml
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
A sterile aqueous solution for injection.
4 CLINICAL PARTICULARS
4.1 Target Species
Cattle, horses and pigs
4.2 Indications for use, specifying the target species
Flunixin Injection is indicated for use in cattle and horses in the alleviation of inflammation and pain.
In the horse, Flunixin Injection is indicated for the alleviation of inflammatory signs associated with musculo-skeletal disorders and for the alleviation of visceral pain associated with colic.
In cattle, Flunixin Injection is indicated for the control of acute inflammation associated with respiratory disease.
Flunixin Injection has also been shown to have some benefit in the treatment of acute pulmonary emphysema [fog fever] and as adjunctive therapy in the treatment of acute mastitis.
In pigs, Flunixin Injection is indicated as an adjunctive therapy in the treatment of swine respiratory diseases.
Do not exceed the recommended dose or duration of treatment.
Do not administer to pregnant mares.
Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding, where there is evidence of a blood dyscrasia or hypersensitivity to the product.
4.4 Special warnings for each target species
The cause of the underlying inflammatory condition or colic should be determined and treated with appropriate concomitant therapy.
4.5 Special precautions for use Special precautions for use in animals
Avoid intra-arterial injection. Use in any animals less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided animals may require careful clinical management.
Avoid use in any dehydrated, hypovalaemic or hypotensive animal except in the case of endotoxaemia or septic shock. It is preferable that NSAIDs which inhibit prostaglandin synthesis are not administered to animals undergoing general anaesthesia until fully recovered.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Flunixin meglumine is irritating to the eye.
Avoid contact with the skin and splashes to the eye.
4.6 Adverse reactions (frequency and seriousness)
For this class of drug, untoward effects include gastrointestinal irritation, ulceration and, in dehydrated or hypovolaemic animals, potential for renal damage.
There are occasional reports of collapse following rapid intravenous injection in horses and calves.
4.7 Use during pregnancy, lactation or lay
Flunixin Injection may be used in pregnant and lactating cattle.
Do not administer Flunixin Injection to pregnant mares or pregnant sows.
Safety studies in pregnant mares or pregnant sows have not been conducted.
4.8 Interaction with other medicinal products and other forms of interactions
Monitor drug compatibility closely where adjunctive therapy is required.
Do not administer other non-steroidal anti-inflammatory drugs (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.
4.9 Amounts to be administered and administration route
Flunixin Injection is indicated for intravenous administration to cattle and horses and intramuscular injection to pigs.
For use in equine colic, the recommended dose rate is 1.1 mg flunixin/kg bodyweight equivalent to 1 ml per 45 kg bodyweight. Treatment may be repeated once or twice if colic recurs.
During clinical trials, approximately 10% of the horses required one or two additional treatments. The cause of colic should be determined and treated with concurrent therapy.
For use in musculo-skeletal disorders, the recommended dose rate is 1.1 mg flunixin/kg bodyweight equivalent to 1 ml per 45 kg bodyweight, once daily for up to 5 days according to clinical response.
For use in acute inflammatory conditions, the recommended dose rate is 2.2 mg flunixin/kg bodyweight equivalent to 2 ml per 45 kg bodyweight. Repeat as necessary at 24 hour intervals for up to 5 consecutive days.
For use in pigs, the recommended dose rate is 2.2 mg flunixin/kg bodyweight equivalent to 2 ml per 45 kg bodyweight once by intramuscular injection. Flunixin Injection should be administered as adjunctive therapy in conjunction with a suitable course of antibacterial therapy.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In common with other drugs in this class, overdose is associated with gastrointestinal toxicity.
4.11 Withdrawal period(s)
Meat: Animals must not be slaughtered for human consumption during treatment.
Horses and cattle intended for human consumption may be slaughtered 7 days following treatment.
Pigs intended for human consumption may be slaughtered 24 days following treatment.
Milk for human consumption must not be taken during treatment.
Milk: 36 hours.
Milk intended for human consumption may only be taken from treated cows after 36 hours from the last treatment.
5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
non-steroidal anti-inflammatory drug
ATC vet code:
5.1 Pharmacodynamic properties
Flunixin meglumine is a relatively potent non-narcotic, non-steroidal analgesic with anti-inflammatory, anti-endotoxic and anti-pyretic properties.
Flunixin meglumine acts as a reversible inhibitor of cyclo-oxygenase, an important enzyme in the arachidonic acid cascade pathway which is responsible for converting arachidonic acid to cyclic endoperoxides. Consequently, synthesis of eicosanoids, important mediators of the inflammatory process involved in central pyresis, pain perception and tissue inflammation, is inhibited.
Through its effects on the arachidonic acid cascade, flunixin also inhibits the production of thromboxane, a potent platelet pro-aggregator and vasoconstrictor which is released during blood clotting.
Flunixin exerts its antipyretic effect by inhibiting prostaglandin E2 synthesis in the hypothalamus.
By inhibiting the arachidonic acid cascade pathway, flunixin also produces an anti-endotoxic effect by suppressing eicosanoid formation and therefore preventing their involvement in anti-endotoxin associated disease states.
5.2 Pharmacokinetic particulars
Flunixin was administered intravenously to horses as a single dose of 1.1 mg/kg.
At the first timepoint measured (10 minutes after administration) the plasma concentration was 11.45 micrograms/ml and the elimination half-life was approximately 2 hours.
Flunixin was administered intravenously to cattle as a single dose of 2.2 mg/kg.
At the first timepoint measured (10 minutes after administration) the plasma concentration was 12.32 micrograms/ml and the elimination half-life was approximately 4 hours.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium formaldehyde sulphoxylate dihydrate
Hydrochloric Acid Water for Injections
6.2 Major incompatibilities
3 years. Following withdrawal of the first dose the product should be used within 28 days.
6.4 Special precautions for storage
Do not store above 25°C.
Protect from light.
6.5 Nature and composition of immediate packaging
Flunixin Injection is supplied in 50ml and 100ml type I clear glass vials, complete with bromobutyl bungs and aluminium caps.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations.
7 MARKETING AUTHORISATION HOLDER
Norbrook Laboratories (Ireland) Limited
Rossmore Industrial Estate
8 MARKETING AUTHORISATION NUMBER(S)
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 23rd April 1997
Date of last renewal: 22nd April 2007
10 DATE OF REVISION OF THE TEXT
Injectables should be given according to the manufacturer’s instructions at the recommended injection site.
• Always use a clean, sterile syringe and needle. If using a multiple injection gun, ensure the needle is disinfected between injections, e.g. with an automatic sterilisation system.
• If the site to be injected is dirty, clean the skin and swab with an alcohol-impregnated wipe or cotton wool.
• Before injecting, check the expiry date and read the instructions of the product to be used. Some products need to be shaken before use.
• Use the correct-sized needle according to the size of the animal and site of injection.
• Ensure the animal is adequately restrained before attempting the injection.
• Take care to ensure it is given subcutaneously and not intramuscularly. Raise a fold of skin at the injection site (mainly neck but some are ear) recommended by the product manufacturer and inject carefully into the space created.
• If a large dose is to be delivered, it may be advisable to split the dose between two injection sites. After the injection, briefly massage the site to improve the dispersal of the injected material.
• Dispose of the needle and syringe in appropriate clinical waste and sharps containers.
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