METAMIZOLE SODIUM Oral drops, solution (2013)
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Περιεχόμενα
Name of the medicinal product
Metamizole sodium 500 mg/ml oral drops, solution.
Qualitative and quantitative composition
1 ml (20 drops) contains 500 mg metamizole sodium monohydrate. 1 drop contains 25 mg metamizole sodium monohydrate. Excipient with known effect: Metamizole sodium contains 1.5 mmol (or 35 mg) sodium per ...
Pharmaceutical form
Oral drops, solution. Clear, yellow solution with raspberry flavour.
Therapeutic indications
Metamizole sodium is indicated in all age groups apart infants during the first 3 months of life or weighing less than 5 kg in: acute severe pain following trauma or surgery painful colics tumor pain ...
Posology and method of administration
Posology Dosage is determined by the intensity of the pain or fever and individual sensitivity of response to metamizole sodium. It is essential to choose the lowest dose that controls pain and fever. ...
Contraindications
hypersensitivity to the active substance, pyrazolones or pyrazolidines, e.g. medicinal products containing metamizole sodium, propyphenazone, phenazone or phenylbutazone (this also includes patients who ...
Special warnings and precautions for use
Metamizole sodium contains the pyrazolone derivative metamizole sodium, and is associated with the rare but life-threatening risk of shock and agranulocytosis (see section 4.8). Patients who experience ...
Interaction with other medicinal products and other forms of interaction
Concurrent administration of metamizole sodium and chlorpromazine can lead to severe hypothermia. Metamizole sodium can reduce plasma ciclosporin levels. In combined administration, a dose adjustment may ...
Pregnancy and lactation
Pregnancy There are insufficient data available on the use of metamizole sodium in pregnant women. Metamizole sodium crosses the placental barrier. In animal studies, metamizole sodium showed no teratogenic ...
Effects on ability to drive and use machines
Metamizole sodium can have influence on the ability to drive and use machines. In the recommended dose range, no impairment of the ability to concentrate or of responsiveness is known. As a central active ...
Undesirable effects
Very common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Very rare <1/10,000 Not known cannot be estimated from the available data The main undesirable effects of ...
Overdose
Symptoms Acute overdose is followed by nausea, vomiting, abdominal pain, renal impairment/acute renal failure (e.g. with the clinical picture of interstitial nephritis) and, more rarely, central nervous ...
Pharmacodynamic properties
Pharmacotherapeutic group: analgesics; other analgesics and antipyretics; pyrazolones ATC code: N02BB02 Mechanism of action Metamizole sodium is a pyrazolone derivative with analgesic, antipyretic and ...
Pharmacokinetic properties
Absorption Following oral administration, metamizole sodium is rapidly and almost completely absorbed in the gastrointestinal tract. Biotransformation Metamizole sodium is rapidly cleaved to 4-methylaminoantipyrine ...
Preclinical safety data
Subchronic/chronic toxicity Subchronic and chronic toxicity studies have been conducted in various animal species. Rats received 100–900 mg metamizole sodium/kg BW per os for a period of 6 months. At the ...
List of excipients
Disodium phosphate anhydrous Sodium dihydrogen phosphate dihydrate Saccharin sodium Sucralose Raspberry flavour (contains natural flavouring substances; flavouring substances; flavouring preparations; ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 30 months. Shelf life after first opening: 3 months.
Special precautions for storage
Do not refrigerate or freeze.
Nature and contents of container
Dropper container, consisting of amber glass bottle (type III), fitted with a LDPE dropper applicator and closed with a child-resistant, tamper-evident screw cap, consisting of HDPE/polypropylene. Dropper ...
Special precautions for disposal and other handling
No special requirements.
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