MAG 2 * OS GRAT 20BUST 2.25G

MAG 2 * OS GRAT 20BUST 2.25G

Therapeutic indications

Magnesium deficiency states.

Dosage and method of use

Dosage For adults only:3 vials or 3 single-dose sachets of solution or 2 sachets of powder per day.Pediatric populationIn children, the dosage can be established by the doctor previously consulted. Warning: use only for short periods of treatment.Instructions for Use MAG2 1.5 g / 10 ml oral solution: It is advisable to shake before use. To open the vial, twist the top and pull it off. Take the contents of the vial as it is or dilute it in water.MAG2 2.25 g powder for oral solution: Dissolve the contents of one sachet in water.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe renal insufficiency (creatinine clearance less than 30 mL / min). Not to be administered in subjects undergoing digitalis therapy.

Side effects

The following convention has been used for the classification of undesirable effects: very common ≥ 1/10; common ≥ 1/100 and Gastrointestinal disorders. Frequency not known: gastrointestinal disturbances, diarrhea, abdominal pain.Skin and subcutaneous tissue disorders. Frequency not known: skin reactions.Disorders of the immune system.Frequency not known: hypersensitivity. Exceptional cases of individual intolerance to magnesium have been reported, which can be treated with oral or parenteral antihistamines.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse.

Special warnings

In case of concomitant calcium deficiency, the magnesium deficiency must be corrected before administering supplemental calcium. In patients with moderate renal insufficiency it is necessary to reduce the dosage and monitor renal function and magnesaemia due to the risk associated with hypermagnesaemia. The possibility of cardiovascular depression occurring during treatment should be considered. Each vial of MAG2 solution contains 3.5 g of sucrose. Each single-dose sachet of MAG2 solution contains 3.5 g of sucrose. Each sachet of MAG2 powder contains 2.985 g of sucrose. If taken in accordance with the recommended dose, the daily intake of sucrose corresponds to 10.5 g for the vials and single-dose sachets of solution and 5.97 g for the powder sachets. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. MAG2 oral solution contains parahydroxybenzoates (sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate): it can cause allergic reactions (even delayed). MAG2 vials, single-dose sachets of solution and powder for oral solution contain less than 1 mmol (23 mg) sodium per vial or sachet, ie essentially “sodium-free”.

Pregnancy and breastfeeding

There are limited data on the use of MAG2 in pregnant women. However, no conclusions can be drawn as to whether MAG2 use is safe during pregnancy. MAG2 can only be used during pregnancy if the potential benefits to the mother outweigh the potential risks, including those to the fetus. Magnesium is considered compatible with breastfeeding.

Expiration and retention

Oral solution: store below 25 ° C.Powder for oral solution: This medicinal product does not require any special storage conditions.

Interactions with other drugs

In case of concomitant treatment with oral tetracyclines, the administration of MAG2 should be delayed for at least 3 hours. Quinolones should be administered at least 2 hours before or 6 hours after administration of magnesium products to avoid interference with their absorption. The concomitant administration of products based on magnesium and cholecalciferol (vitamin D3) can lead to the onset of hypercalcemia. The concomitant use of preparations containing calcium or phosphate salts is not recommended as these products prevent intestinal absorption of magnesium. Simultaneous intake of magnesium-based products with CNS depressants can potentiate the CNS effects of magnesium and should be carefully evaluated.

Overdose

Signs and symptomsOverdose of oral magnesium does not, in general, induce toxic reactions in the presence of normal renal function. However, magnesium poisoning can develop in severe kidney failure. The toxic effect is mainly dependent on serum magnesium levels and the signs are as follows: drop in blood pressure, nausea, vomiting, CNS depression, decreased reflexes, ECG abnormalities (eg heart rhythm disturbances), onset of respiratory depression, coma, cardiac arrest, respiratory paralysis, anuric syndrome and neuromuscular transmission disorders.TherapyTreatment should include rehydration with restoration of abundant diuresis or forced diuresis. In the presence of renal insufficiency, hemodialysis or peritoneal dialysis is required.

Active principles

One vial of oral solution contains: active principle: magnesium pidolate 1,500 g (corresponding to 122 mg of Mg ion⁺⁺).Excipients with known effects: sucrose, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate. One single-dose sachet of oral solution contains:active principle: magnesium pidolate 1,500 g (corresponding to 122 mg of Mg ion⁺⁺).Excipients with known effects: sucrose, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate. One sachet of powder for oral solution contains: active principle: magnesium pidolate 2,250 g (corresponding to 184 mg of Mg ion⁺⁺).Excipients with known effects: sucrose. For the full list of excipients, see section 6.1.

Excipients

MAG2 1.5 g / 10 ml oral solution Sucrose, orange flavor,sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, purified water.MAG2 2.25 g powder for oral solutionSaccharin sodium, citric acid monohydrate,sucrose, lemon flavor.