MAGNASPARTATE Powder for oral solution (2016)
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Περιεχόμενα
Name of the medicinal product
Magnaspartate 243 mg powder for oral solution.
Qualitative and quantitative composition
Each 6.5 g sachet of powder contains magnesium aspartate dihydrate equivalent to 243 mg (10 mmol) of magnesium. Excipient(s) with known effect: Each sachet contains 2.706g sucrose. For the full list of ...
Pharmaceutical form
Powder for oral solution. White powder with a peach/apricot-like flavour.
Therapeutic indications
Treatment and prevention of magnesium deficiency, as diagnosed by a doctor. Magnaspartate is indicated in adults, children and adolescents aged from 2 years.
Posology and method of administration
Posology Adults (>18 years) 1-2 sachets daily (243-486 mg magnesium or 10-20 mmol magnesium) Children and adolescents: 10 to 18 years 1 sachet daily, (243 mg magnesium or 10 mmol magnesium) Children: 4-10 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe renal impairment (glomerular filtration rate <30 ml/min). Disorders of Cardiac conduction (bradycardia). ...
Special warnings and precautions for use
In the case of confirmed magnesium deficiency, concomitant hypocalcaemia and hypokalaemia should be suspected and corrected if confirmed since magnesium deficiency is frequently secondary to those conditions. ...
Interaction with other medicinal products and other forms of interaction
As magnesium and other medicinal products may mutually influence each others absorption, a time interval of 2 to 3 hours should generally be respected if possible. This specifically applies to: Cellulose ...
Fertility, pregnancy and lactation
Pregnancy A large amount of data on pregnant women over 16 weeks gestation (more than 1000 pregnancy outcomes) indicate no malformative nor feto/neonatal toxicity of magnesium. Magnaspartate can be used ...
Effects on ability to drive and use machines
Magnaspartate has no or negligible influence on the ability to drive and use machines.
Undesirable effects
The evaluation of undesirable effects is based on the following frequencies: 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); ...
Overdose
In the case of intact renal function, magnesium toxication due to oral overdose of magnesium is not expected. Only in the case of severe renal insufficiency a cumulation of magnesium may arise in combination ...
Pharmacodynamic properties
Pharmacotherapeutic group: Mineral Supplements, magnesium ATC code: A12CC05 Magnesium is a cofactor in >300 enzymatic reactions. It acts as an essential co-factor for all ATP-binding enzymes. Magnesium ...
Pharmacokinetic properties
Absorption Intestinal absorption is not directly proportional to magnesium intake but is dependent mainly on magnesium status. The lower the magnesium level, the more magnesium is absorbed in the gut: ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...
List of excipients
Sucrose Citric acid monohydrate Peach/apricot flavour Saccharin sodium Silica, colloidal anhydrous
Incompatibilities
Media to be used for reconstitution; see section 4.2.
Shelf life
Shelf life: 3 years. Use immediately following reconstitution.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Sachets. Laminated foil (Paper/Aluminium/Polyethylene). 10 sachets.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Kora Corporation Ltd t/a Kora Healthcare, Swords Business Park, Swords, Co. Dublin, Ireland
Marketing authorization number(s)
PL 39972/0002
Date of first authorization / renewal of the authorization
07/11/2014
Date of revision of the text
July 2016
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