MOVALIS 15 mg. 1.5 ml. 5 ampoules
The active substance is meloxicam. 1 vial / 1.5 ml / contains 15 mg meloxicam / meloxicam /
Melgumin, glycofural, poloxamer 188, sodium chloride, glycine, sodium hydroxide, water for injections.
Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, Germany.
Manufacturer: Boehringer Ingelheim Espana, SA, Spain.
1. What MOVALIS injection 15 mg / 1.5 ml is and what it is used?
The medicinal product is a solution for injection in vials containing 1.5 ml (there are packs of 5 or 10 ampoules).
Movalis is a nonsteroidal anti-inflammatory agent suitable for use in adults and adolescents 15 years of age. Movalis solution for injection is indicated for the initial and short-term symptomatic treatment of:
ostreoartrit flowing with pain / arthritis, joint disease degeneratinvno /;
ankylosing spondylitis / Bechterew /.
2. Before you take MOVALIS injection 15 mg / 1.5 ml
You should not be taken MOVALIS in the following cases:
in case of hypersensitivity to meloxicam or to any of the excipients in the product. Possible cross-sensitivity to acetylsalicylic acid / aspirin / other NSAIDs / NSAIDs /;
MOVALIS should not be administered to patients with overt symptoms of asthma, nasal polyps, angioedema or urticaria after taking acetylsalicylic acid (aspirin) or other NSAIDs.
The product is not also apply to:
active or recent gastrointestinal ulceration / perforation;
active inflammatory bowel disease (Crohn's disease or ulcerative colitis);
severe hepatic impairment;
severe renal failure without dialysis;
existing gastrointestinal bleeding, recent cerebrovascular bleeding or other bleeding disorders;
severe uncontrolled heart failure;
children and adolescents under 15 years of age;
bleeding, regardless of what type;
blood diseases (contraindication is related to the intramuscular route of administration);
patients undergoing treatment with anticoagulants
MOVALIS is contraindicated for the treatment of postoperative pain in cardiac surgery - Coronary Artery Bypass Graft.
In women who have difficulty conceiving or carrying out research for infertility must cease use of meloxicam.
This product is applied only on prescription and under medical supervision. The product exists in other dosage forms which can be more suitable for your case.
MOVALIS should be used with caution in the following cases:
Before starting treatment with MOVALIS, tell your doctor if you suffer from:
digestive disorders (esophagitis, gastritis, gastric ulcer or duodenal ulcer);
heart failure or hypertension;
heart, liver or kidney disease;
diuretics (water resources), ACE inhibitors, angiotensin II receptor antagonists (medicines for lowering the blood pressure) or recent surgery;
drawn asthma: in some cases it is possible occurrence of allergic reactions to aspirin or other agents from the group of NSAIDs.
It is imperative to stop the treatment and contact a doctor immediately in the following cases:
in the gastro-intestinal bleeding (bleeding from the mouth or in stools, black discoloration of feces);
signs suggestive of hypersensitivity to the drug and in particular, asthma attack, sudden swelling of the face or throat, blistering (see Possible side effects).
Serious skin reactions, some of them fatal, including exfoliative dermatitis syndrome Stevens-Johnson and toxic epidermal necrolysis have been reported very rarely with the use of NSAIDs. Patients are at highest risk of these reactions early in the course of treatment as a reaction occurs in the majority of cases is in the first month of treatment. Must cease use of MOVALIS at first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
Drugs such as MOVALIS may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose and duration of treatment.
If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor.
Pregnancy and lactation:
This medicine is not recommended for use during pregnancy. Its use during lactation should be avoided.
Consult your doctor before use of medicines during pregnancy or lactation.
Driving and using machines:
Use of this product may cause dizziness, drowsiness and visual disturbances rarely.
Using other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taking other medicines, even those obtained without a prescription. It is particularly important to tell your doctor if you are taking oral anticoagulants (anti-clotting drugs) other prostaglandin synthetase inhibitors including glucocorticoids and salicylates (aspirin) other NSAIDs, selective inhibitors of serotonin reuptake (SSRI), heparin (given by injection) Lithium, high doses of methotrexate, ticlopidine, contraception 'water resources, medicines to lower blood pressure, cholestyramine, cyclosporine, oral antidiabetic agents.
3. How to take MOVALIS injection 15 mg / 1.5 ml?
One ampoule daily. Do not exceed the dose of 15 mg daily.
As the possibility of the occurrence of adverse reactions increases with dose and duration of treatment should be administered at the lowest effective dose for the shortest possible period.
The maximum permissible dose MOVALIS in patients with severe renal insufficiency undergoing hemodialysis should not exceed 7.5 mg.
If you think that the effect of MOVALIS is too strong or too weak, talk to your doctor or pharmacist.
Route of administration: intramuscularly.
The solution should be injected immediately after filling the syringe. The solution should be injected deep intramuscularly in the upper rear part of the seat, observing aseptic conditions. In the event that repeated administration is necessary, it is recommended to shift the left and right side.
Before injection, it is important to verify that the tip of the needle is not in a blood vessel.
Injection should be discontinued at the onset of severe pain during treatment.
In the presence of a prosthetic hip, the injection should be done on the other side.
MOVALIS ampoules should not be administered intravenously.
Treatment duration should not exceed 2-3 days. Thereafter, treatment can be continued with other formulations meloxicam / tablet or suppository /.
If you take a higher dose MOVALIS injection 15 mg / 1,5 ml, than you should immediately consult your doctor or pharmacist.
If you forget to take a dose MOVALIS injection 15 mg / 1,5 ml in
no double dose to make up for a missed dose.
4. Possible side effects
Like all medicines, MOVALIS injection of 15 mg / 15 ml can also cause side effects.
Drugs such as MOVALIS may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
More often than 1%: dyspepsia (indigestion), nausea, vomiting, abdominal pain, constipation, flatulence (flatulence), diarrhea.
Between 0.1 and 1%: transient impairment in liver function parameters, belching, oesophagitis (inflammation of the esophagus), ulcers of the stomach or dvanadesetoprastnite hidden or detectable macroscopic gastrointestinal bleeding.
Less than 0.1%: gastrointestinal perforation, colitis, hepatitis, gastritis
Blood and blood-forming organs:
More often than 1%: anemia.
Between 0.1 and 1%, changes in blood counts, including a differential count of the white blood cells, leukopenia (reduction in white blood cell count) and thrombocytopenia (reduced platelet count). Concomitant administration of a potentially myelotoxic drugs, especially methotrexate may be a predisposing factor for the occurrence of cytopenia.
More often than 1%: pruritus (itching of the skin or mucosa), skin rashes.
Between 0.1 and 1%: stomatitis (inflammation of the lining of the mouth), urticaria (hives).
Less than 0.1%: photosensitivity.
In very rare cases, the development of bullous reactions, erythema multiforme syndrome Steven Johnson, toxic epidermal necrolysis (severe skin reactions - rashes) with blisters that can spread throughout the body.
More often from 0.1%, the occurrence of asthma in individuals allergic to aspirin or other NSAIDs.
Central nervous system:
More often than 1%: dizziness, headache.
Between 0.1 and 1%: vertigo, tinnitus, drowsiness.
Less than 0.1%: confusion and disorientation, alteration of mood.
More often than 1%: edema (swelling).
Between 0.1 and 1%: increase in blood pressure, palpitations, flushing.
Between 0.1 and 1%: abnormal renal function parameters (increased serum creatinine and / or serum urea).
Less than 0.1%: acute renal failure.
The use of NSAIDs may be associated with disturbances in micturition, including acute urinary retention.
Less than 0.1%: conjunctivitis, visual disturbances including blurred vision.
Less than 0.1%: angioedema (sudden swelling of the face or throat) and reactions of hypersensitivity and anaphylactic / anaphylactoid reactions (type of allergic immediate reactions), including anaphylactic shock.
Reactions at the injection site:
More often than 1%: swelling at the injection site.
Between 0.1 and 1%: pain at the injection site.
5. Storing MOVALIS injection 15 mg / 1,5 ml
Protect from light.
Keep at temperatures below 30 ° C.
Keep out of reach of children.
Ampoules 15 mg / 1.5 ml.