Magnesium Sulfate 50 % w/v Solution for Injection/Concentrate for solution for infusion

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Magnesium sulphate heptahydrate

Saadav alates:

Aurum Pharmaceutical Limited

ATC kood:

B05XA; B05XA05

INN (Rahvusvaheline Nimetus):

Magnesium sulphate heptahydrate

Annus:

50 percent weight/volume

Ravimvorm:

Solution for Injection and Concentrate for Infusion

Retsepti tüüp:

Product subject to prescription which may not be renewed (A)

Terapeutiline ala:

Electrolyte solutions; magnesium sulfate

Volitamisolek:

Marketed

Loa andmise kuupäev:

2006-05-26

Infovoldik

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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
seiziures in patients with severe pre-eclamsia (
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
medicines, including medicines obtained without a
prescription.
Medicines which may interact with Magnesium
Sulfate Injection include:
• CNS depressants (medicines that act on the central
nervous
system to cause drowsiness)
• digitalis (a medicine used to treat heart problems)
• muscle relaxants e.g. tubocurarine
• nifedipine (a medicine used to treat high blood
pressure)
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist

Toote omadused

Health Products Regulatory Authority
11 April 2019
CRN008WP0
Page 1 of 5
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 and control generalised seizures in patients with severe
pre- eclampsia or eclampsia
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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).
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).
Paedriatric population
Magnesium Sulfate 50% w/v Solution for Injection or Infusion should
not be given to children.
Elderly
Dosage for the elderly is similar to that for younger adults
Renal impairment:
Appropriate reductions in dosage should be made for patients with
renal impairment.
_b)_ _Preventi