00000 5028-G D05028

H Injection of the pack and other Contents Information

can also report side effects directly via the Yellow Yellow reportcan also directly side effects the via or Scheme www.mhra.gov.uk/yellowcard at: Card or in the Google Play Card Yellow MHRA for search can By reporting you side effects, Store. App Apple of this on the safety information more help provide medicine. 5. Magnesium Sulfate store to ow of children. reach and Keep out of the sight Injection Sulfate Magnesium This should not be used after the expiry on the carton which is printed date doctorThe or nurse and ampoule label after EXP. the expirywill check that on the label has not date the injection administering you. to passed before 6. Injection Magnesium Sulfate contains What Sulfate is Magnesium active substance The Sulfate 1g Magnesium 2ml contains Heptahydrate Mg2+) (4mmol Heptahydrate Heptahydrate Sulfate 2.5g Magnesium 5ml contains (10mmol Mg2+) Heptahydrate Sulfate 5g Magnesium 10ml contains (20mmol Mg2+) injection, for water are other ingredients The acid and sodium hydroxide. hydrochloric Injection and Magnesium Sulfate looks like What of the pack contents injection/ solution for sterile Magnesium Sulfate solution infusion is a clear, solution for for concentrate 5ml and 10ml glass ampoules. supplied in 2ml, packed in each carton.10 ampoules are be marketed. may Not all pack sizes Holder Authorisation Marketing Ltd Pharmaceuticals Aurum Road Bampton RM3 8UG Hill Romford Harold KingdomUnited Manufacturer Macarthys Ltd Laboratories Road Bampton Hill Harold RM3 8UG Romford KingdomUnited The expiry date refers to the last day of that month. of that day the last to expiryThe refers date 25°C. above Do not store injection the solution for opening the ampoule, After must be used immediately. the injection ampoule containing will only be The injection the if any is left and you over used for doctor/nurse will dispose of it. Product Licence No: PL 12064/0013 This leaflet was last revised in October 2019 100mm Measurement Verification Bar Verification 100mm Measurement in vision weakness wed wed reflexes t attack (shortnesst attack chest pain, of breath, red red speech wed wed breathing owsiness w phosphate levels in the blood levels w phosphate igh blood sugars causing severe dehydration dehydration igh blood sugars causing severe llergic reactions such as shortness llergic of breath, regular or slow heartbeat or slow regular roblems with the balance of salts and water in of salts and water with the balance roblems onfusion oma emporarily low blood pressure low emporarily P

eeling or being sick eeling thirsty the blood. This may lead to thirst (which may be thirst (which may lead to may This the blood. and dry restlessness severe), mouth, tiredness, reports been isolated have There muscle weakness. in mothers and their blood calcium levels of low use and prolonged new-born babies following sulphate high doses of magnesium lo (Hypophosphataemia) double slur IV/IM injection f flushing of the sk f loss/slo t dr c muscle slo ir P wheezing or difficulty breathing; swelling of the breathing; wheezing or difficulty or other parts tongue lips, of the body;face, rash, on the skin. or hives itching dehydration). (Hyperosmolar and/or dizzy) faint feeling A H Hear c

• • • • • • • • • • • • • • • • during pregnancy. • • . sweating . dizziness . headache of injection the site . pain and burning at following and tingling . risk of itching heartbeat. rapid 4. ossible sideeffects can cause side this medicine Like all medicines, although not everybodyeffects, gets them. doctor if you or nurse immediately your Contact of the following: get any Recurrent Convulsions: In both the IM and IV InIM and IV both the Convulsions: Recurrent a further 2-4g recur, if convulsions regimens, 2g weight, woman’s on the (depending MgSO4 5 min. IV over is given than 70Kg MgSO4 if less Renal Failure: must Caution failure. in renal Doses be reduced must excretory the renal exceeding be observed prevent to in 20g not exceed dosage should The capacity. solution or 80mmol of48 hours (100ml of a 20% ions). magnesium Elderly with in patients except No special recommendation kidney problems. little Magnesium much or too too given are If you InjectionSulfate are whilst you you to given this medicine will be As too given will be you it is unlikely that in hospital, doctor if you your tell however, little, much or too concerns. any have Other side effects: Reporting of side effects talk to side effects, child gets any If or your you includes any This pharmacist nurse. or doctor, your You in this leaflet. possible side effects not listed Continued overleaf Continued uscle relaxants e.g. tubocurarine e.g. relaxants uscle ypnotics ( e.g. nitrazepam) ( e.g. ypnotics minoglycoside antibacterialsStreptomycin) (such as minoglycoside alcium channel blockers e.g. nifedipine or nifedipine blockers e.g. alcium channel H will be given

Opioids ( e Opioids H M C high blood treat (medicines used to nimodipine calcium ion imbalance in result which could pressure) causing abnormal muscle function. A • • • • morphine) .g. • Pregnancy, breast-feeding and fertility breast-feeding Pregnancy, may you think or breast-feeding, pregnant If are you ask your a baby, have planning to or are be pregnant taking this before advice doctor or pharmacist for trying or pregnant are doctor if you your Tell medicine. Injection Sulfate Magnesium pregnant. become to doctor considers if your you to will only be given to the the outweighs risk the benefit of treatment and effects blood calcium levels Low baby. developing have bone density, such a reduced on the bones, given been reported whose mothers were in babies than 5-7 more for continuously sulphate magnesium during pregnancy. days sulfate It magnesium administer is not advisable to unless considered during pregnancy or breast-feeding under medical and it must be administered essential, supervision. the baby’s women If used in pregnant and will not be used heart will be monitored rate within 2 hours of delivery. Driving and using machines no known Sulfate effects of are Magnesium There Injection speak Please on driving and using machines. machinery. driving or operating doctor before your to Your doctor will give Magnesium Sulfate Injection Sulfate Magnesium doctor give will Your the muscle or into (intravenous) vein a into you to injection either by or infusion (drip). (intramuscular) much Magnesium Sulfate doctor decide how will Your you. to should be given magnesium levels: of low the treatment For intravenous slow 40g by up to will be given You a period of up to over 5%) infusion (drip) (in glucose 5 days. with eclampsia: fits associated prevent To will be monitored dose you an initial intravenous After either an be given may 24 hours and then you for intramuscular infusion (drip) or regular intravenous injections. Regimen Intramuscular Maintenance A loading dose of 4g MgSO4 IV (usually in 20% min) is 10-15 5min (minimum, preferably solution) over 20mmol 5g MgSO4 (approx. by immediately followed Mg2+) (usually in 50% solution) as a deep IM injection of each buttock. quadrant the upper outer into is a further therapy Maintenance every 5g MgSO4 IM 24h after the last fit (provided for 4h, continued is >16/min, urine output >25ml/h, rate the respiratory and knee present). jerks are Regimen Maintenance Intravenous A loading dose of 4g MgSO4 IV (or in some cases an by is followed as described above, 5g MgSO4 IV, 24h after the last fit. for infusion of 1g/h continued 3. Injection Magnesium Sulfate ow 100mm Measurement Verification Bar Verification 100mm Measurement 5g/10ml, 2.5g/5ml and 1g/2ml 2.5g/5ml 5g/10ml, Magnesium Sulfate Heptahydrate Heptahydrate Sulfate Magnesium w Magnesium Sulfate Injectionw Magnesium Sulfate will be given Injection Sulfate Magnesium store w to hat you need to know before you are given given are you know need to before you hat italis glycosides e.g. digoxin (a medicine used to (a medicine used to digoxin e.g. italis glycosides er from any kidney any problem. er from disease of the muscles causing drooping er from biturates (e.g. amobarbital) (e.g. biturates ontents of the pack and other information ontents ossible side effects W Ho P Ho C W it is used for Injection.Magnesium Sulfate f you have any further doctor ask your any questions, have f you your doctor, to talk the side effects, of get any f you ou suffer from severe kidney failure. severe from ou suffer ou are allergic to Magnesium Sulfate, its salts or any its salts or any Magnesium Sulfate, to allergic ou are Keep this leaflet. You may need to read it again. read to need may You Keep this leaflet. I or pharmacist. I possible side includes any This pharmacist or nurse. in this leaflet. See sectioneffects not listed 4. you are given Magnesium Sulfate given are you Injection and what it is used for and what W W

Dig hearttreat problems) Bar suff double vision, difficulty in speakingeyelids, and and sometimes muscle weakness in the swallowing gravis. arms or legs known as myasthenia y suff y in of this medicine listed of the other ingredients section 6. • • •

Read all of this leaflet carefully before you are you are before this leaflet Read all of carefully important because this medicine it contains given you. for information • • • • · · Magnesium Sulfate 50% w/v Solution for Injection w/v Solution 50% for Magnesium Sulfate During treatment monitored will be routinely blood calcium levels Your whilst taking Magnesium Sulfate. Other Injection medicines and Magnesium Sulfate taking, have doctor are or pharmacist your if you Tell other medicines, take any or might taken recently including medicines obtained without a prescription. Sulfate with Magnesium interact Medicines which may Injection include: Warnings and Precautions Warnings pharmacist or nurse before doctor, your to Talk if you: Sulfate Magnesium receiving You should not be given Magnesium Sulfate Magnesium Sulfate should not be given You Injection if: 2. know before needto you hat 1. Injection Magnesium Sulfate hat is levels Injection low Magnesium Sulfate treat is used to it is not possible for in the blood where of magnesium mouth. be taken by the medicine to by a (fits) caused seizures It prevent also be used to may of pregnancy knownserious complication as eclampsia. hypomagnesaemia. of acute It is used in the treatment 4. 5. 6. What is in this leaflet: What 1. 2. Injection Sulfate Magnesium hat isandwhat 3. PACKAGE LEAFLET: INFORMATION FOR THE USER USER THE FOR INFORMATION LEAFLET: PACKAGE

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