Rheumocam 1.5 mg/ml, oral suspension for dogs

QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
Active substance: Meloxicam 1.5 mg
Excipient: Sodium benzoate 5 mg.

PHARMACEUTICAL FORM  Oral suspension.

Target species: Dogs.

Indications for use, specifying the target species
Alleviation of inflammation and pain in acute and chronic musculoskeletal disorders in dogs.

Contraindications
Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such as irritation and bleeding, liver, heart or kidney disease or bleeding disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs less than 6 weeks of age.

Special warnings
None.

Special precautions for use
Use in animals that are dehydrated, hypovolemic or hypotensive should be avoided as this carries a potential risk of increased renal toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to animals :
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Adverse reactions (frequency and seriousness)
Typical adverse reactions associated with NSAIDs such as loss of appetite, vomiting, diarrhoea, occult gastrointestinal bleeding, lethargy and renal failure have been reported occasionally. In very rare cases, haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.
These adverse reactions generally occur within the first week of treatment and are in most cases transient in nature, disappearing after the end of treatment, however, in very rare cases they may be severe or fatal.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought.

Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Interactions with other medicinal products or other forms of interaction
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with a high level of protein binding may compete with protein binding, thus leading to toxic effects. Rheumocam should not be administered together with other NSAIDs or glucocorticosteroids.
Previous treatment with anti-inflammatory substances may lead to additional or increased adverse effects, therefore it is advisable that treatment with such veterinary medicinal products be discontinued at least 24 hours before starting treatment. On the other hand, the establishment of the withdrawal period should be made taking into account the pharmacological properties of the veterinary medicinal products previously used.

Amounts to be administered and route of administration
Shake well before use.
Administer mixed with food.
Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment will be continued by oral administration once daily (at 24-hour intervals) with a maintenance dose of 0.1 mg meloxicam/kg body weight. Particular care must be taken to ensure accuracy of dosing. The suspension can be administered using the Rheumocam measuring syringe provided in the package.
The syringe is adaptable to the dropper of the bottle and has a scale graduated in kg body weight corresponding to the maintenance dose (i.e. 0.1 mg meloxicam/kg body weight).
Volume to be administered according to the dog's weight:
Body weight (kg) Maintenance dose (ml)
                  7.5 0.5
                  15 1
                  22.5 1.5
                  30 2
                  37.5 2.5
                  45 3
                  52.5 3.5
                  60 4                  

Thus, for the initiation of treatment on the first day, a volume twice that of the maintenance dose will be required.
Clinical response normally occurs within 3 to 4 days. If no clinical improvement occurs, treatment should be discontinued after a maximum of 10 days.
Overdose (symptoms, emergency procedures, antidotes), as appropriate
In case of overdose, symptomatic treatment should be initiated.

Waiting time
Not applicable.

PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Non-steroidal anti-inflammatory and antirheumatic products (oxicams).

Pharmacodynamic properties
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class, which acts by inhibiting prostaglandin synthesis, thus exerting anti-inflammatory, analgesic, antiexudative and antipyretic effects. It reduces leukocyte infiltration into inflamed tissue. It also, to a lesser extent, inhibits collagen-induced platelet aggregation. In vitro and in
vivo studies have demonstrated that meloxicam exerts a stronger inhibitory effect on cyclooxygenase-2 (COX-2) than on cyclooxygenase-1 (COX-1).

Pharmacokinetic properties
Absorption
Meloxicam is completely absorbed after oral administration, and peak plasma concentrations are achieved after approximately 7.5 hours. If the product is used according to the recommended dosage regimen, stable plasma concentrations of meloxicam are reached on the second day of treatment.
Distribution
Within the therapeutic dose range, there is a linear relationship between the administered dose and the plasma concentration obtained. Approximately 97% of the amount of meloxicam binds to plasma proteins. The volume of distribution is 0.3 l/kg.
Metabolism
Meloxicam is found mainly in plasma and is also a product predominantly excreted in the bile, while only traces of the basic active substance are found in the urine. Meloxicam is metabolized with the production of an alcohol, an acid derivative and several polar metabolites. All important metabolites have been shown to be pharmacologically inactive.
Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75% of the administered dose is eliminated in the faeces, the remainder being eliminated in the urine.

PHARMACEUTICAL PARTICULARS
List of excipients: Sodium saccharinate; Sodium carboxymethyl cellulose; Colloidal silicon dioxide; Citric acid monohydrate; Sorbitol solution; Disodium hydrogen phosphate dodecahydrate; Sodium benzoate; Honey flavor.

Incompatibilities None known.