Read this leaflet carefully before you start taking this medicine.  (DOWNLOAD)

• If you have any further questions, ask your doctor or pharmacist. 
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them,  even if their symptoms are the same as yours. 
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 

1. What Clampex Injection is and what it is used for 
2. Before you use Clampex Injection 
3. How to use Clampex Injection 
4. Possible side effects 
5. How to store Clampex Injection 
6. Further information 

 

1. WHAT CLAMPEX INJECTION IS AND WHAT IT IS USED FOR Clampex Injection is used to treat low levels of magnesium in the blood where it is not  possible for the medicine to be taken by mouth. 

It may also be used to prevent seizures (fits) caused by a serious complication of  pregnancy known as eclampsia. 

It is used in the treatment of acute hypomagnesaemia. 

2. BEFORE YOU USE CLAMPEX INJECTION  

Do not use/You should not be given Clampex Injection if: 

• You are allergic to Magnesium Sulfate and its salts 
• You suffer from severe kidney failure. 

Warnings and Precautions 

Talk to your doctor, pharmacist or nurse before receiving Clampex Injection if you: • Suffer from any kidney problem. 

• Suffer from disease of the muscles causing drooping eyelids, double vision, difficulty  in speaking and swallowing and sometimes muscle weakness in the arms or legs  known as myasthenia gravis. 

During treatment 

Your blood calcium levels should be routinely monitored whilst taking Clampex Injection. 

Using other medicines 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any  other medicines, including medicines obtained without a prescription. Medicines which  may interact with Magnesium Sulfate Injection include: 

• Digitalis glycosides e.g. digoxin (a medicine used to treat heart problems) • Barbiturates (e.g. amobarbital) 
• Opioids (e.g. morphine) 
• Hypnotics (e.g. nitrazepam) 
• Muscle relaxants e.g. tubocurarine

PACKAGE LEAFLET: INFORMATION FOR THE USER 

CLAMPEX INJECTION 

Magnesium Sulphate Heptahydrate Injection 50% w/v 

• Calcium channel blockers e.g. nifedipine or nimodipine (medicines used to treat high  blood pressure) which could result in calcium ion imbalance causing abnormal muscle function. 
• Aminoglycoside antibacterials (such as Streptomycin) 

Pregnancy and breast-feeding 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to  have a baby, ask your doctor or pharmacist for advice before taking this medicine. Tell  your doctor if you are pregnant or trying to become pregnant. 

Clampex Injection will only be given to you if your doctor considers that the benefit of treatment outweighs the risk to the developing baby. Low blood calcium levels and  effects on the bones, such a reduced bone density, have been reported in babies whose  mothers were given magnesium sulphate continuously for more than 5 -7 days during  pregnancy. 

It is not advisable to administer magnesium sulfate during pregnancy or breast-feeding  unless considered essential, and it must be administered under medical supervision. If  used in pregnant women, the baby’s heart rate will be monitored and will not be used  within 2 hours of delivery 

Driving and using machines 

Clampex Injection has no influence on the ability to drive and use machines. 

3. HOW TO USE CLAMPEX INJECTION 

Clampex Injection is administered only by a doctor. 

Dosage 

Pre-eclampsia and eclampsia: 

• Initial dose: 4 g Clampex Injection intravenously over 5 – 15 min. 
• Maintenance dose: 1 g/hour over 24 hours (infusion). 

If only a portion of the ampoule contents is used, the remaining ampoule contents must be  discarded. 

Method and duration of administration: 

For intravenous use 

Do not administer undiluted Clampex Injection 50% w/v concentrate for solution for  injection or infusion into peripheral veins. For slow intravenous injection, a 20% solution  (e.g. 1 ampoule + 15 mL solution for dilution) must be prepared, or a 2% solution (2  ampoules + 480 mL solution for dilution) for a continuous intravenous infusion. As a  solution for dilution, a glucose 5% solution, a 5% xylitol solution or sodium chloride  0.9% solution are suitable. 

It is recommended that the patient be allowed to rest for a further 10-20 minutes after injection. 

In high-dose magnesium sulphate therapy, the following must be verified: 

1. Monitoring of cardiovascular function 
2. Patellar tendon reflexes (knee jerks); these must be maintained. If they can no longer be  elicited, reduce the dose. 
3. Breathing rate should be no less than 16 breaths/minute.

PACKAGE LEAFLET: INFORMATION FOR THE USER 

CLAMPEX INJECTION 

Magnesium Sulphate Heptahydrate Injection 50% w/v 

4. Urine output should be 25 mL per hour or 100 mL every 4 hours. If lower, there is a risk  of hypermagnesaemia (high blood magnesium concentrations). 
5. Ampoules of calcium gluconate 10% must be kept ready as an antidote. 6. If the antidote is not sufficient in life-threatening conditions, intensive care measures must   be taken. Treatment generally lasts for 24 hours. If seizures return, it can be repeated. 

If you use more Clampex Injection than you should 

As this medicine will be given to you whilst you are in the hospital, it is unlikely that you will be given too much or too little. However, tell your doctor if you have any concern. 

4. POSSIBLE SIDE EFFECTS 

Like all medicines, this medicine can cause side effects, although not everybody gets them:  Contact your doctor or nurse immediately if you get any of the following: 

• Allergic reactions such as shortness of breath, wheezing or difficulty breathing; swelling of  the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. • High blood sugars causing severe dehydration (Hyperosmolar dehydration). • Heart attack (shortness of breath, chest pain, feeling faint and/or dizzy) • coma 

Other side effects: 

• Feeling or being sick 
• Flushing of the skin 
• Feeling thirsty 
• Loss/slowed reflexes 
• Temporarily low blood pressure 
• Drowsiness 
• Confusion 
• Muscle weakness 
• Slowed breathing 
• Irregular or slow heartbeat 
• Problems with the balance of salts and water in the blood. This may lead to thirst (which  may be severe), dry mouth, tiredness, restlessness and muscle weakness. There have been  isolated reports of low blood calcium levels in mothers and their new-born babies following prolonged use and high doses of magnesium sulphate during pregnancy. • Low phosphate levels in the blood (Hypophosphataemia) 
• Double vision 
• Slurred speech 
• Sweating 
• Dizziness 
• Headache 
• Pain and burning at the site of injection following IV/IM injection 
• Risk of itching and tingling 
• Rapid heartbeat 

Reporting of side effects 

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side  effects not listed in this leaflet. 

5. HOW TO STORE CLAMPEX INJECTION 

• Keep this medicine out of the sight and reach of children. 
• Store below 30°C

PACKAGE LEAFLET: INFORMATION FOR THE USER 

CLAMPEX INJECTION 

Magnesium Sulphate Heptahydrate Injection 50% w/v 

• Do not use Clampex Injection after the expiry date which is stated on the carton and label  after ‘EXP’. The expiry date refers to the last day of that month. 

Note on shelf life after opening or preparation 

The concentrate for solution for injection or infusion must be used immediately after opening the ampoule. Do not use Clampex Injection if you observe cloudiness or visible particle. 

6. FURTHER INFORMATION 

What Clampex Injection contains 

Each ml of Clampex Injection Contains: 

Magnesium Sulphate Heptahydrate BP 50 % w/v 

What Clampex Injection looks like and content of the pack 

10 x 5ml glass ampoules placed on an ampoule tray in an inner carton.