FORMULA:
Each ampule of Melbek amp. contains 15 mg of meloxicam as active ingredient in 1.5 ml of injection solution.

Pharmacodynamic properties:
Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) of the enolic acid group, which exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models.

INDICATIONS:
Melbek amp. is indicated for relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis.

CONTRAINDICATIONS:
Melbek amp. is contraindicated in patients with known hypersensitivity to meloxicam.
Melbek amp. should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS / PRECAUTIONS).

WARNINGS / PRECAUTIONS:
Gastrointestinal (GI) Effects
Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status.

Pregnancy and Nursing Mothers
Pregnancy risk factor: C/D (3rd trimester)
In late pregnancy, as with other NSAIDs, meloxicam should be avoided because it may cause premature closure of the ductus arteriosus.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Melbek amp., a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

DOSAGE and ADMINISTRATION:
Recommended daily dosage is 1 ampule.
Recommended daily dosage is 7.5 mg, when it is necessary to avoid side effects.
The maximum recommended daily dosage for Melbek amp. is 15 mg (1 ampule).
In dialysis patients with advanced kidney disease, treatment with Melbek amp. is not recommended.
The duration of the treatment is 2 to 3 days. If necessary, oral dosage forms may be used afterwards.

HOW SUPPLIED:
Melbek amp. 15 mg / 1.5 ml Ampule; presented in packages of 3 ampules.

OTHER PHARMACEUTICAL DOSAGE FORMS:
Melbek Fort Tablets, presented in blisters of 10 and 30 tablets, containing 15 mg meloxicam.
Melbek Tablets, presented in blisters of 10 and 30 tablets, containing 7.5 mg meloxicam.