Magnesium sulfate 50% (magnesium 2mmol/ml) solution for injection 10ml ampoules

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Magnesium sulfate heptahydrate

थमां उपलब्ध:

magnesium 2mmol/ml) solution for injection 10ml ampoules (Torbay Pharmaceuticals

ए.टी.सी कोड:

B05XA05

INN (इंटरनेशनल नाम):

Magnesium sulfate heptahydrate

डोज़:

500mg/1ml

फार्मास्यूटिकल फॉर्म:

Solution for injection

प्रशासन का मार्ग:

Intramuscular; Intravenous

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 09050103; GTIN: 05060131261973

सूचना पत्रक

PATIENT INFORMATION LEAFLET
MAGNESIUM SULFATE 50% W/V SOLUTION FOR INJECTION OR INFUSION
•
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
KEEP THIS LEAFLET IN A SAFE PLACE, YOU MAY WISH TO READ IT AGAIN.
•
IF YOU HAVE ANY QUESTIONS OR ARE NOT SURE ABOUT ANYTHING, ASK YOUR
DOCTOR OR PHARMACIST.
•
IF ANY SIDE EFFECT GETS SERIOUS, OR IF YOU NOTICE ANY SIDE EFFECTS
NOT LISTED IN THIS LEAFLET, PLEASE TELL YOUR DOCTOR OR PHARMACIST.
IN THIS LEAFLET:
1.
WHAT MAGNESIUM SULFATE SOLUTION FOR INJECTION OR INFUSION IS AND WHAT
IT IS
USED FOR
2.
BEFORE YOU ARE GIVEN MAGNESIUM SULFATE SOLUTION FOR INJECTION OR
INFUSION
3.
HOW MAGNESIUM SULFATE SOLUTION FOR INJECTION OR INFUSION IS USED
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MAGNESIUM SULFATE SOLUTION FOR INJECTION OR INFUSION
6.
FURTHER INFORMATION
1. WHAT MAGNESIUM SULFATE SOLUTION FOR INJECTION OR INFUSION IS AND
WHAT IT IS USED FOR
Magnesium Sulfate, the active ingredient, plays a number of important
roles in the body, and
is involved in the regulation of the nervous and blood systems. This
medicine is a solution
for injection or infusion and is used for magnesium deficiency and
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. BEFORE YOU ARE GIVEN MAGNESIUM SULFATE SOLUTION FOR INJECTION OR
INFUSION
THIS MEDICINE SHOULD NOT BE USED IF YOU:
• Are allergic to magnesium or its salts
• Have suffered from a disease of the brain associated with
cirrhosis of the liver
• Have had liver failure
• Have had kidney failure
• Have myasthenia gravis (a chronic progressive muscular weakness
disease)
• Suffer from heart disease
Check with your doctor if you are concerned about any of the above.
THIS MEDICINE SHOULD BE USED WITH CAUTION IN PATIENTS WHO ARE:
• Suffering from impaired kidney function
TAKING OTHER MEDICINES:
Please tell your doctor if you are taking any other medication
especially digitalis gly

उत्पाद विशेषताएं

OBJECT 1
MAGNESIUM SULFATE 50%W/V SOLUTION FOR
INJECTION OR INFUSION
Summary of Product Characteristics Updated 14-Jul-2017 | Torbay &
South Devon NHS Foundation
Trust
1. Name of the medicinal product
Magnesium Sulfate 50% w/v Solution for Injection or Infusion
2. Qualitative and quantitative composition
Magnesium sulfate (heptahydrate) 50% w/v (approximately 2mmol Mg
2+
/mL).
3. Pharmaceutical form
Solution for injection or infusion.
4. Clinical particulars
4.1 Therapeutic indications
(a) Treatment of magnesium deficiency in hypomagnesaemia.
(b) Prevention and control of generalised seizures in patients with
severe pre-eclampsia or eclampsia.
4.2 Posology and method of administration
Dosages should be adjusted according to the patient's needs and
responses. Plasma levels should also be
monitored during treatment.
(a) TREATMENT OF MAGNESIUM DEFICIENCY IN HYPOMAGNESAEMIA:
Up to 160mmol Mg
2+
by slow intravenous infusion (in glucose 5%) for up to 5 days, may be
required to
replace the deficit (allowing for urinary losses). Concentrations of
no higher than 20% w/v should be
given intravenously.
Treatment may require repetition, for example during prolonged
intravenous nutrition magnesium
deficiency can occur, then parenteral doses of magnesium are of the
order of 10 to 20mmol Mg
2+
daily
(often about 12mmol Mg
2+
daily).
Dosage for the elderly is similar to that for younger adults.
Magnesium Sulfate 50% w/v Solution for
Injection or Infusion should not be given to children. Appropriate
reductions in dosage should be made
for patients with renal impairment.
(b) PREVENTION AND CONTROL OF SEIZURES ASSOCIATED WITH SEVERE
PRE-ECLAMPSIA AND ECLAMPSIA:
An initial intravenous (IV) loading dose of typically 4g
(approximately 16mmol Mg
2+
) given slowly over
a period of 20 minutes or so, at a strength no higher than 20% w/v, is
followed by ideally an IV infusion,
or if this is not possible by regular intramuscular (IM) injections as
follows:
INTRAVENOUS MAINTENANCE REGIMEN: _The loading dose _is followed by an
intravenous inf