NOTICE
ANSM - Updated on : 16/09/2010
Product name
MAGINJECTABLE 0.8 PER CENT, solution for injection
Magnesium
Box
Please read this leaflet carefully before using this medicine. It contains important information for your treatment.
- If you have any further questions, please ask your doctor or pharmacist.
- Keep this leaflet as you may need to read it again.
- If you need more information or advice, ask your pharmacist.
- If symptoms worsen or persist, consult your doctor.
- If you notice any side effects not mentioned in this leaflet, or if you experience any of the effects mentioned as serious, please tell your doctor or pharmacist.
Leaflet summary
In this leaflet :
1. WHAT IS MAGINJECTABLE 0.8 PER CENT, solution for injection AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING MAGINJECTABLE 0.8 PER CENT, solution for injection?
3. HOW DO I USE MAGINJECTABLE 0.8 PER CENT, solution for injection?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW CAN MAGINJECTABLE 0.8 PER CENT, solution for injection, be used?
6. ADDITIONAL INFORMATION
1. WHAT IS MAGINJECTABLE 0.8 PER CENT, solution for injection AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Pharmacotherapeutic class: MINERAL SUPPLEMENT.
Therapeutic indications
Indicated in the treatment of certain major magnesium deficiencies (during parenteral nutrition).
2. WHAT DO I HAVE TO KNOW BEFORE USING MAGINJECTABLE 0.8 PER CENT, solution for injection?
List of information required before use
Not applicable.
Contraindications
Never use MAGINJECTABLE 0.8 PER CENT, solution for injection in case of:
- certain kidney diseases,
- known allergy to magnesium pidolate or glutamates (related substances).
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take special care with MAGINJECTABLE 0.8 PER CENT, solution for injection:
Special warnings
HYPERTONIC SOLUTION TO BE INJECTED SLOWLY.
Initial intravenous administration should be carried out in hospital.
The infusion rate should not exceed 150 mg/minute, i.e. 6 mmol/minute.
Precautions for use
- monitor blood pressure during intravenous injection and continuous infusion,
- monitor magnesemia; discontinue treatment as soon as it has returned to normal,
- reduce dosage in patients with renal insufficiency, with increased monitoring of renal function, blood pressure and blood glucose.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other drugs
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breast-feeding
Pregnancy and breast-feeding
Pregnancy
This medicine should only be used during pregnancy on the advice of your doctor.
Ask your doctor or pharmacist for advice before taking any medication.
Breast-feeding
Breast-feeding should be avoided during treatment.
Ask your doctor or pharmacist for advice before taking any medication.
Sportsmen
Not applicable.
Effects on ability to drive vehicles or use machines
Not applicable.
List of excipients
Not applicable.
3. HOW TO USE MAGINJECTABLE 0.8 PER CENT, solution for injection
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
Strictly in accordance with medical prescription.
Method of administration
Slow intravenous or intramuscular administration.
Strictly in accordance with medical prescription.
Frequency of administration
Strictly in accordance with medical prescription.
Duration of treatment
Strictly in accordance with medical prescription.
Symptoms and instructions in case of overdose
If you have used more MAGINJECTABLE 0.8 PER CENT, solution for injection than you should have:
TELL YOUR DOCTOR IMMEDIATELY.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, MAGINJECTABLE 0.8 PER CENT, solution for injection is likely to have undesirable effects, although not everyone is subject to them:
- Pain at injection site, vasodilation with sensation of warmth, metallic taste,
- Hypermagnesemia, potentially lethal in cases of severe renal failure or too rapid injection.
- Allergic-type reactions.
DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE MAGINJECTABLE 0.8 PER CENT, solution for injection
Keep out of the reach and sight of children.
Expiration date
Do not use MAGINJECTABLE 0.8 PER CENT, solution for injection after the expiration date stated on the carton.
Storage conditions
After opening: use immediately.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines must not be disposed of down the drain or with household waste. Ask your pharmacist what to do with unused medicines. These measures will help protect the environment.
6. FURTHER INFORMATION
Complete list of active ingredients and excipients
What does MAGINJECTABLE 0.8 PER CENT, solution for injection contain?
The active substance is:
Magnesium pidolate* ........................................................................................................................ 10 g
Per 100 ml injectable solution.
*or magnesium pyrrolidone carboxylate.
Magnesium: 8.14 g/litre
81.4 mg/10 ml ampoule.
Magnesium: 337 mmol/litre
3.37 mmol/10 ml ampoule.
Total osmolarity: 925.6 mOsmol/liter.
The other component is:
Water for injection.
Pharmaceutical form and contents
What is MAGINJECTABLE 0.8 PER CENT, solution for injection and what does it contain?
This medicine is supplied as a solution for injection in ampoules. Boxes of 6, 10, 12, 20 or 100.
Name and address of the marketing authorization holder and of the manufacturing authorization holder responsible for batch release, if different
Holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
Operator
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
Manufacturer
LABORATOIRES COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
or
LABORATOIRE RENAUDIN
ZONE ARTISANALE ERROBI
64250 ITXASSOU
Drug names in member states of the European Economic Area
Not applicable.
Date of approval of the package leaflet
This leaflet was last approved on {date}.
MA under exceptional circumstances
Not applicable.
Internet information
Detailed information on this product is available on the Afssaps (France) website.
Information reserved for healthcare professionals
Not applicable.
Other
Not applicable.