Melovem 30MG/ML 100ML, Meloxicam

MELOVEM 30 MG/ML 100 ML

Solution for injection for cattle (calves and young cattle) and pigs.

COMPOSITION
Each ml contains:
active substance: meloxicam 30 mg,
Excipient(s): Benzyl alcohol 20 mg.

THERAPEUTIC ACTION
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxycams class, which acts by inhibiting the synthesis of prostaglandins, thus exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects. Meloxicam also has anti-endotoxin properties, as it has been shown to inhibit the production of thromboxane b2, induced by the administration of E. coli endotoxin to calves and pigs.

INDICATIONS
Cattle: indicated for use in acute respiratory infection, together with appropriate antibiotic treatment, to reduce clinical symptoms in cattle;
Indicated for use in diarrhoea, in combination with oral rehydration treatment, to reduce clinical symptoms in calves over one week of age and in young non-lactating cattle.
Pigs: indicated for use in non-infectious locomotor disorders, to reduce the symptoms of lameness and inflammation.

CONTRAINDICATIONS
It is not for use in animals with liver, heart or kidney disease or bleeding disorders, nor in cases where there is evidence of ulcerogenic gastrointestinal damage.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
In the case of treatment for diarrhoea in cattle, it is not used for animals less than one week of age.

Special precautions for use in animals:
If side effects occur, treatment should be stopped and advice sought from a veterinarian.
Avoid use in animals in a very strong state of dehydration, hypovolaemia or hypotension, which require parenteral rehydration, as this would imply a potential risk of renal toxicity.

ADVERSE REACTIONS
In cattle and pigs, the subcutaneous as well as intramuscular route of administration is well tolerated; In clinical studies, only mild transient swelling at the injection site was observed following subcutaneous administration in less than 10% of cattle herds.
In very rare cases, anaphylactic reactions may occur, which can be serious (including fatal) and must be treated symptomatically.
The frequency of adverse reactions is defined using the following convention:
-Very common (more than 1 in 10 animals experiencing side effects during treatment).
-Common (more than 1 but less than 10 animals per 100 animals).
-Uncommon (more than 1 but less than 10 animals per 1000 animals).
-Rare (more than 1 but less than 10 animals out of 10,000 animals).
-Very rare (less than 1 animal in 10,000 animals, including isolated reports).
If you notice any serious reactions or other effects that are not listed in this leaflet, please inform your veterinarian.

Target species:
Cattle and pigs.

USE DURING PREGNANCY, LACTATION
Cattle:
It can be used during the gestation period.
Swine:

It can be used during pregnancy and lactation.
Interactions with other medicinal products or other forms of interaction:
The product should not be administered concomitantly with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or anticoagulant agents.

Dosage for each species, route of administration and method of administration:
Cattle:
Single subcutaneous injection at a dose of 0.5 mg meloxicam/kg body weight (e.g. 2.5 ml/150 kg body weight) in combination with antibiotic treatment or oral rehydration treatment, as appropriate.
Swine:
Single intramuscular injection at a dose of 0.4 mg meloxicam/kg body weight (e.g. 2.0 ml/150 kg body weight) in combination with antibiotic treatment, as appropriate. If necessary, a second dose of meloxicam may be given after 24 hours.

Recommendations for correct administration:

Avoid introducing contaminants during administration.
When treating groups of animals, use a suction needle to avoid excessive perforation of the stopper. The maximum number of perforations should be limited to 20.

Waiting time:
Cattle: Meat and offal: 15 days;
Milk: 5 days;
Pigs: Meat and offal: 5 days.

Special precautions to be taken by the person administering the veterinary medicinal product:
In animals, accidental self-injection can cause 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 present the product leaflet or label to the doctor.

SIDE EFFECTS AND ADVERSE EFFECTS
Transient swelling at the injection site following subcutaneous administration has been commonly reported in clinical trials in cattle. Swelling at the injection site can be painful.
In very rare cases, anaphylactoid reactions may occur, and they must be treated symptomatically.

SPECIAL WARNINGS
Treatment of calves with Melovem with 20 minutes of trimming, reduces postoperative pain. Melovem administered alone will not provide an adequate level of pain relief during the decoupling procedure. In order to achieve an adequate level of pain relief during surgery, it is necessary to administer an appropriate analgesic at the same time.
Interactions with other medicinal products and other forms of interaction:

The product should not be administered concomitantly with glucocorticosteroids, other non–steroidal anti–inflammatory drugs or anticoagulant agents.

Overdose:
In case of overdose, symptomatic treatment should be initiated.

Presentation:
Cardboard box with 1 vial for solution for injection, 100 made of colorless glass.