MAGNESIUM SULFATE 20% w/v Solution for infusion (2018)
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Περιεχόμενα
Name of the medicinal product
Magnesium Sulfate 20% w/v solution for infusion.
Qualitative and quantitative composition
Magnesium sulfate heptahydrate 200 mg/ml (approximately 0.8 mmol Mg<sup>2+</sup>/ml). For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for infusion. Clear and colourless solution, pH 5.5-7.0.
Therapeutic indications
Treatment of magnesium deficiency in hypomagnesaemia. Prevention of recurrent seizures in eclampsia.
Posology and method of administration
Posology Dosage should be tailored according to the individual patients needs and responses. Plasma magnesium concentrations should be measured to determine the rate and duration of infusion and should ...
Contraindications
Hypersensitivity to magnesium and its salts. Renal failure. Hepatic encephalopathy, hepatic failure. Parenteral magnesium salts should generally be avoided in patients with heart block.
Special warnings and precautions for use
Magnesium salts should be administered with caution to patients with impaired renal function and appropriate dosage reduction should be made. See section 4.2. Magnesium sulfate should not be used in hepatic ...
Interaction with other medicinal products and other forms of interaction
Muscle Relaxants: non-depolarising muscle relaxants such as tubocurarine are enhanced by parenteral magnesium salts. Nifedipine: profound hypotension was produced in two women who were given oral Nifedipine. ...
Fertility, pregnancy and lactation
Pregnancy As eclampsia may be life-threatening to mother and baby, magnesium sulfate may be administered in this condition. Magnesium crosses the placenta and may produce hypotonia, hypoflexia, hypotension. ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Immune system disorders: Hypersensitivity reactions. Excessive administration of magnesium leads to the development of symptoms of hypermagnesaemia which may include: Metabolism and Nutritional disorders: ...
Overdose
Signs Clinical signs of overdosage will be those of hypermagnesaemia, see section 4.8. Treatment Appropriate action should be taken to reduce the blood level of magnesium. Neuromuscular blockade associated ...
Pharmacodynamic properties
Pharmacotherapeutic group: electrolyte solutions ATC code: B05XA05 Mechanism of action Magnesium is the second most abundant cation in intracellular fluid and is an essential body electrolyte. It is a ...
Pharmacokinetic properties
Distribution The concentration of magnesium in plasma is normally tightly regulated in the range of 0.75-0.95mmol/l. When given intravenously, Magnesium Sulfate has an immediate onset of action, and its ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber additional to those already included in other sections of the SPC.
List of excipients
Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions. The product must be used immediately after the opening of the container and the storage of opened ampoules should be avoided.
Nature and contents of container
Transparent and colourless 10 ml glass ampoule type I. The ampoules are inserted into polypropylene blisters and packed in carton boxes. Each carton box contains 10 ampoules.
Special precautions for disposal and other handling
Magnesium sulfate can be diluted with Glucose 5% and Sodium chloride 0.9% solutions. Disposal: No special requirements.
Marketing authorization holder
Synchrony Pharma Ltd, Business & Technology Centre, Bessemer Drive, Stevenage, SG1 2DX, United Kingdom
Marketing authorization number(s)
PL 39280/0007
Date of first authorization / renewal of the authorization
21/03/2018
Date of revision of the text
21/03/2018
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