Megluxin




Tässä Megluxinin määräaikainen erityislupa.

PART 1B: SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

MEGLUXIN
Flunixin meglumine 50 mg/ml, in solution for injection.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of product contains:

Active substance:

Flunixin (meglumine) 50.000 mg

Excipient:

Sodium metabisulphite 1.640 mg

For a full list of excipient, see section 6.1.

3. PHARMACEUTICAL FORM:

Solution for injection.

4. CLINICAL PARTICULARS

4.1. Target species

Bovine, equine and porcine (breeders).

4.2. Indications for use, specifying the target species

Bovine: Indicated for controlling acute inflammation and controlling the pyrexia associated with bovine respiratory disease.

Equine: Indicated for the relief of the inflammation and pain associated with musculoskeletal disorders in acute and chronic states, and for the relief of visceral pain associated with colic.

Porcine: Indicated as an aid for treating the mammitis-metritis-agalaxy syndrome (MMA) of sows.
4.3. Contraindications

Do not use in animals with hepatic-renal illness.
Do not use when signs of bloody discrasias are present.
Do not use in animals that show hypersensitivity to flunixin meglumine.
Do not use in dehydrated, hypovolemic of hypotense animals.

4.4. Special warnings for each target species

- The cause of the inflammation, pain or of the colic must be determined and concomitantly treated.

- Horses used in races and competitions should not be allowed to participate when they are in need of treatment and horses that have been treated recently should submit to local regulations. All necessary precautions should be taken to ensure compliance with the rules of competition. In case of any doubt, a urine analysis is advisable.

4.5 Special precautions for use

Special precautions for use in animals

- Administer the product at room temperature (+15 to +25 ºC).

- Intravenous administration should be done very slowly.

- Avoid intra-arterial administration to horses and cows. Horses accidentally injected intra-arterially may show adverse reactions such as ataxia, uncoordination, hyperventilation, excitation and muscular weakness.

- Water consumption during treatment and the animals’ state of hydration should be watched during treatment, because there is greater risk of renal damage in cases of dehydration.

- Do not exceed the recommended dosage or duration of treatment.

- Use on animals younger than six weeks old or very old animals entails an additional risk. If it is not possible to avoid doing so, the animals should be given a reduced dose and given careful clinical follow-up.

- In intramuscular applications in swine, avoid depositing the product in the adipose tissue.

It is preferable to not administer NSAIDs that inhibit the synthesis of prostaglandins to animals undergoing general anaesthesia until they are totally recovered.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

- In case of contact with skin, wash immediately with water.

- To prevent possible reactions, avoid contact with skin. Gloves should be used while applying.

- The product can cause reactions in those persons sensitive to it. In cases of known hypersensitivity to NSAIDs, do not handle the product. Reactions may be quite important.

- Do not allow the product to become contaminated while handling it.

- Acute pain and inflammation may occur in the case of accidental self-injection. Clean and disinfect the wound immediately, seek medical advice immediately and show the package insert or the label to the physician.

4.6. Adverse reactions (frequency and seriousness)

Local reactions may occur locally after intramuscular administration.

4.7. Use during pregnancy, lactation or lay

Pregnancy:

There are no specific studies on the target species, which means the risk/benefit analysis, should be assessed by the veterinarian before using it on gestating females.

4.8. Interaction with other medicinal products and other forms of interaction

- Do not administer jointly, or with a difference of less than 24 hours, with other non-steroid anti-inflammatory drugs.

- Some NSAIDs can bond in a large measure to plasmatic proteins and displace other drugs with affinity for bonding to them, which may cause toxic effects. This interaction is important for drugs with a narrow therapeutic margin: oral anticoagulants, methotrexate and some anticonvulsants such as phenytoin.

- It may diminish the effect of some antihypertensives by inhibiting the synthesis of prostaglandins. Among them the diuretics, IECA, ARA and β-blockers should be pointed out.

- Simultaneous administration with potentially nephrotoxic drugs should be avoided, especially cyclosporin.

- It may diminish renal elimination of some drugs and increase their toxicity, as occurs with methotrexate, aminoglycosides and Li salts.

4.9. Amounts to be administered and administration route

Administration route:

Intravenous in bovine and equine.
Intramuscular in swine.

Posology:

Bovine: Control of acute inflammation and the pyrexia associated with bovine respiratory disease: 2.2 mg of flunixin (meglumine)/kg b.w. every 24 hours for a maximum of 3 days (equivalent to 0.44 ml of MEGLUXIN/10 kg b.w.).

Equine: Relief of inflammation and pain associated with musculoskeletal disorders in chronic and acute states: 1.1 mg of Flunixin (meglumine)/kg b.w. every 24 hours for a maximum of 5 days (equivalent to 0.22 ml of MEGLUXIN/10 kg b.w.).

Relief from the visceral pain associated with: 1.1 mg of flunixin (meglumine)/kg b.w. (equivalent to 0.22 ml of MEGLUXIN/10 kg b.w.). The treatment can be repeated once or twice if the symptoms persist.

Swine: Dosage of 2.2 mg of flunixin (meglumine)/kg b.w. by deep intramuscular route (equivalent to 0.44 ml of MEGLUXIN/10 kg b.w.). One or two injections may be administered with a 12-hour separation. The number of treatments (one or two) will depend on the clinical response obtained.

4.10. Overdose (symptoms, emergency procedures, antidotes), if necessary

- May cause anorexia, diarrhoea, gastric ulcers, hypoproteinemia and renal necrosis. In such cases, suspend treatment and apply symptomatic therapy.

- Signs such as lack of coordination and ataxia also appear.

4.11. Withdrawal periods

Bovine: Meat: 14 days; Milk: 2 days.
Equine: Meat: 28 days.
Porcine: Meat: 17 days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiinflamatory and antirheumatic products, non-steroids.
ATCvet code: QM01AG90.

5.1. Pharmacodynamic properties

Flunixin meglumine is a non-steroid anti-inflammatory drug (NSAID) with analgesic and anti-pyretic activity.

Flunixin meglumine acts as a non-selective and reversible inhibitor of cyclooxygenase (COX), an enzyme that converts arachidonic acid into unstable cyclic endoperoxides, which are then transformed into prostaglandins, prostacyclins and thromboxanes. Some of these prostanoids, such as the prostaglandins, participate in the physiopathological mechanisms of inflammation, pain and fever, which means that their inhibition would be responsible for its therapeutic effects. Due to the implication of prostaglandins in other physiological processes, the inhibition of the COX would also be responsible for different adverse reactions such as intestinal or renal damage.

Prostaglandins form part of the complex processes involved in the development of endotoxic shock.

5.2. Pharmacokinetic particulars

Bovine: Flunixin meglumine, when administered intravenously to cattle, in a single dose of 2.2 mg/kg b.w, has a half-life of 4 hours. The maximum plasmatic level of Flunixin (14.9 µg/ml) is obtained in 10 minutes after intravenous administration of a dose of 2.2 mg/kg b.w. to calves, it then decreases to less than 0.1 µg/ml at 24 hours after being administered.

Flunixin meglumine shows a rapid distribution in highly irrigated tissues but equilibrium in tissues with less irrigation is established more slowly.

Flunixin initially undergoes a hydroxylation of the aromatic rings followed by conjugation. Afterwards, the conjugate may undergo an alkaline hydroxylation in the urine, thereby increasing the quantity of the free active ingredient.

Elimination is principally effected by the urinary route. An acid pH of the urine can increase the re-absorption of the drug in the renal tubules.

Equine: Flunixin meglumine, when administered by intravenous route to equids, in a single 1.1 mg/kg dose, has a plasmatic half-life of 2 hours.

Porcine: When administered to sows by intramuscular route at a dosage of 2.2 mg/kg b.w., the maximum plasmatic level is reached before an hour has elapsed and traces remain for 24 hours.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients
Sodium metabisulphite
Sodium hydroxide
Propylene glycol
Water for injections

6.2. Incompatibilities
None known.

6.3. Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf-life after first opening the immediate packaging: 28 days.

6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.

6.5. Nature and composition of immediate packaging
The product is filled in 50 ml or 100 ml Type II coloured glass bottles, closed with elastomer closures and sealed with anodised aluminium caps.

The bottles are labelled and placed in cardboard outer packaging along with the insert.
Not all pack sizes may be marketed

6.6. Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

LABORATORIOS HIPRA, S.A. Avda. la Selva, 135.
17170 - AMER (Girona) SPAIN
Tel. +34 972 430660 - Fax +34 972 430661
e-mail: hipra@hipra.com

8. MARKETING AUTHORISATION NUMBER:

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION:

10. DATE OF REVISION OF THE TEXT: