Meloxidolor - patient leaflet, side effects, dosage

Patient leaflet - Meloxidolor

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Meloxidolor 5 mg/ml solution for injection for dogs, cats, cattle and pigs

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder :

Le Vet Beheer B.V.

Wilgenweg 7

3421 TV Oudewater

The Netherlands

Manufacturer responsible for the batch release :

Produlab Pharma B.V.

Forellenweg 16

4941 SJ Raamsdonksveer

The Netherlands

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Meloxidolor 5 mg/ml solution for injection for dogs, cats, cattle and pigs meloxicam

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

One ml contains:

Active substance:

Meloxicam 5 mg

Excipient:

Ethanol 150 mg

Clear yellow solution.

4. INDICATION(S)

Dogs:

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.

Cats:

Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.

Cattle:

For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.

For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age.

For the relief of post-operative pain following dehorning in calves.

Pigs:

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.

For the relief of post-operative pain associated with minor soft tissue surgery such as castration.

5. CONTRAINDICATIONS

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in dogs and cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in dog and cats less than 6 weeks of age nor in cats of less than 2 kg.

Do not use in cattle and pigs suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions. For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

Do not use in pigs less than 2 days old.

See also Section 12.

6. ADVERSE REACTIONS

For dogs and cats:

Typical adverse reactions of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have rarely been reported. In very rare cases elevated liver enzymes have been reported.

In very rare cases, haemorrhagic diarrhoea, haematemesis and gastrointestinal ulceration have been reported. These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.

For cattle and pigs:

Only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.

In very rare cases anaphylactic reactions, which may be serious (including fatal), may occur and should be treated symptomatically.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:

– very common (more than 1 in 10 animals treated displaying adverse reactions)
– 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).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

Dogs, cats, cattle (calves) and pigs

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Dosage for each species

Dogs:

Musculo-skeletal disorders:

Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight).

Oral suspensions of meloxicam for dogs may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight, 24 hours after administration of the injection. Reduction of post-operative pain (over a period of 24 hours):

Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.

Cats:

Reduction of post-operative pain:

Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia.

Cattle:

Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 10 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.

Pigs:

Locomotor disorders:

Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2 ml/25 kg body weight). If required, a second administration of meloxicam can be given after 24 hours.

Reduction of post-operative pain:

Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body weight) before surgery.

9. ADVICE ON CORRECT ADMINISTRATION

Particular care should be taken with regard to the accuracy of dosing including the use of an appropriate dosing device and careful estimation of body weight.

Avoid introduction of contamination during use. The stopper should not be punctured more than 20 times.

10. WITHDRAWAL PERIOD(S)

Cattle: meat and offal: 15 days

Pigs: meat and offal: 5 days

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.

Shelf-life after first opening the container:28 days.

12. SPECIAL WARNING(S)

Special warnings for each target species:

Treatment of piglets with Meloxidolor before castration reduces post-operative pain. To obtain pain relief during surgery co-medication with an appropriate anaesthetic/sedative is needed.

To obtain pain relief for cattle and pigs during surgery co-medication with an appropriate anaesthetic/sedative/analgesic is needed.

To obtain the best possible pain relieving effect post-surgery Meloxidolor should be administered 30 minutes before surgical intervention.

Treatment of calves with Meloxidolor 20 minutes before dehorning reduces post-operative pain. Meloxidolor alone will not provide adequate pain relief during the dehorning procedure.

Special precautions for use in animals:

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there may be a potential risk of renal toxicity.

During anaesthesia, monitoring and fluid therapy should be considered as standard practice.

Any oral follow-up therapy using meloxicam or other NSAIDs should not be administered in cats, as appropriate dosage regimens for such follow-up treatments have not been established.

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

Accidental self-injection may give rise to pain. People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

The veterinary medicinal product should not be administered by pregnant women or women of childbearing potential as Meloxicam may be harmful to the foetus and unborn child.

Pregnancy and lactation:

Dogs and cats: Do not use in pregnant or lactating dogs or cats.

Cattle: Can be used during pregnancy.

Pigs: Can be used during pregnancy and lactation.

Interactions with other medicinal products and other forms of interaction:

For dogs and cats:

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Meloxidolor must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic drugs should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or subcutaneaous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.

For cattle and pigs:

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.

Overdose (symptoms, emergency procedures, antidotes):

In case of overdose symptomatic treatment should be initiated.

Incompatibilities:

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

15.

OTHER INFORMATION

Package size:

Colourless type I glass vial of 10 ml, 20 ml or 100 ml, closed with a rubber stopper and sealed with an aluminium cap.

Multi-packs of 5 × 20 ml and 10 × 20 ml.

Not all pack sizes may be marketed.

PACKAGE LEAFLET:

Meloxidolor 20 mg/ml solution for injection for cattle, pigs and horses

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder :

Le Vet Beheer B.V.

Wilgenweg 7

3421 TV Oudewater

The Netherlands

Manufacturer for the batch release :

Produlab Pharma B.V.

Forellenweg 16

4941 SJ Raamsdonksveer

The Netherlands

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Meloxidolor 20 mg/ml solution for injection for cattle, pigs and horses meloxicam

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

One ml contains:

Active substance:

Meloxicam 20 mg

Excipient:

Ethanol 150 mg

Clear yellow solution.

4. INDICATIONS

Cattle:

For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.

For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.

For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.

For the relief of post-operative pain following dehorning in calves.

Pigs:

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.

For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.

Horses:

For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.

For the relief of pain associated with equine colic.

5. CONTRAINDICATIONS

Do not use in horses less than 6 weeks of age.

Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

Meloxidolor - patient leaflet, side effects, dosage

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Patient leaflet - Meloxidolor