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

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Magnesium sulphate heptahydrate

可用日期:

Ethypharm

ATC代码:

B05XA; B05XA05

INN（国际名称）:

Magnesium sulphate heptahydrate

剂量:

50 percent weight/volume

药物剂型:

Solution for injection/infusion

治疗领域:

Electrolyte solutions; magnesium sulfate

授权状态:

Marketed

授权日期:

2006-05-26

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
MAGNESIUM SULFATE 50% W/V SOLUTION FOR INJECTION/CONCENTRATE FOR
SOLUTION FOR INFUSION
Magnesium Sulfate Heptahydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
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 seizures in patients
with severe pre-eclampsia (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
medic

产品特点

Health Products Regulatory Authority
27 February 2023
CRN008LFM
Page 1 of 4
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 further seizures associated with eclampsia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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).
_b) To prevent further seizures associated with eclampsia:_
An initial intravenous (IV) loading dose is followed for 24h by either
an IV infusion, or regular intramuscular (IM) injections.
INTRAMUSCULAR MAINTENANCE REGIMEN
A loading dose of 4g MgSO
4
(approx. 16mmol Mg
2+
) IV (usually in 20% solution) over 5min (minimum, preferably 10-15
min) is
followed immediately by 5g MgSO
4
(approx. 20mmol Mg
2+
) (usually in 50% solution) as a deep IM injection into the upper
outer quadrant of each buttock.
Maintenance therapy is a further 5g MgSO
4
(approx. 20mmol Mg
2+
) IM every 4h, continued for 24h after the last fit (provided
the respiratory rate is