Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Magnesium sulphate heptahydrate
Ethypharm
B05XA; B05XA05
Magnesium sulphate heptahydrate
50 percent weight/volume
Solution for injection/infusion
Electrolyte solutions; magnesium sulfate
Marketed
2006-05-26
PACKAGE LEAFLET: INFORMATION FOR THE USER MAGNESIUM SULFATE 50% W/V SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION Magnesium Sulfate Heptahydrate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Magnesium Sulfate Injection is and what it is used for 2. What you need to know before you are given Magnesium Sulfate Injection 3. How Magnesium Sulfate Injection will be given 4. Possible side effects 5. How to store Magnesium Sulfate Injection 6. Contents of the pack and other information 1. WHAT MAGNESIUM SULFATE INJECTION IS AND WHAT IT IS USED FOR Magnesium Sulfate Injection is used to treat low levels of magnesium in the blood. It is also used for prevention (and control) of seizures in patients with severe pre-eclampsia (high blood pressure associated with pregnancy) or eclampsia (convulsions as a result of pre-eclampsia). 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MAGNESIUM SULFATE INJECTION YOU SHOULD NOT BE GIVEN MAGNESIUM SULFATE INJECTION IF: • you are allergic to Magnesium Sulfate or to any of the other ingredients in this medicine, listed in section 6 of this leaflet • you suffer from liver or kidney failure • you suffer from a disease of the brain associated with cirrhosis of the liver • you have myasthenia gravis (a chronic progressive muscular weakness disease) • you suffer from heart disease WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before receiving Magnesium Sulfate Injection if you: • you suffer from any liver or kidney problems OTHER MEDICINES AND MAGNESIUM SULFATE INJECTION Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medic Soma hati kamili
Health Products Regulatory Authority 27 February 2023 CRN008LFM Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Magnesium Sulfate 50 % w/v Solution for Injection/Concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml contains Magnesium Sulfate Heptahydrate 0.5g (2mmol Mg 2+) 2ml contains Magnesium Sulfate Heptahydrate 1g (4mmol Mg 2+) 5ml contains Magnesium Sulfate Heptahydrate 2.5g (10mmol Mg 2+) 10ml contains Magnesium Sulfate Heptahydrate 5g (20mmol Mg 2+) Excipients with known effect Each ml solution for injection/Concentrate for solution for infusion contains 3.54mg of sodium For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for Injection Concentrate for solution for infusion Clear, colourless sterile solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of Magnesium deficiency in hypomagnesaemia. To prevent further seizures associated with eclampsia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage should be individualised according to patient's needs and responses. Plasma levels should also be monitored throughout therapy. _a) Treatment of magnesium deficiency in hypomagnesaemia:_ Up to 40g MgSO 4 (equivalent to 160mmol Mg 2+ ) by slow intravenous infusion (in glucose 5%) over up to 5 days, may be required to replace the deficit (allowing for urinary losses). _b) To prevent further seizures associated with eclampsia:_ An initial intravenous (IV) loading dose is followed for 24h by either an IV infusion, or regular intramuscular (IM) injections. INTRAMUSCULAR MAINTENANCE REGIMEN A loading dose of 4g MgSO 4 (approx. 16mmol Mg 2+ ) IV (usually in 20% solution) over 5min (minimum, preferably 10-15 min) is followed immediately by 5g MgSO 4 (approx. 20mmol Mg 2+ ) (usually in 50% solution) as a deep IM injection into the upper outer quadrant of each buttock. Maintenance therapy is a further 5g MgSO 4 (approx. 20mmol Mg 2+ ) IM every 4h, continued for 24h after the last fit (provided the respiratory rate is Soma hati kamili