GLUCOSE

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

GLUCOSE ANHYDROUS

可用日期:

Fresenius Kabi Limited

ATC代码:

B05BA03

INN（国际名称）:

GLUCOSE ANHYDROUS

剂量:

10 %w/v

药物剂型:

Solution for Infusion

处方类型:

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

治疗领域:

carbohydrates

授权状态:

Not Marketed

授权日期:

2004-01-09

资料单张

2
Pregnancy and breast-feeding
GLUCOSE 10 % can be used during pregnancy or 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.
Driving and using machines
Not relevant.
3. HOW TO USE GLUCOSE 10 %
You will receive your medicine by slow intravenous infusion ('IV
drip').
The rate at which the infusion is given and the volume infused will
depend
on your own specific requirements. Your doctor will decide on the
correct
dose for you to receive.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The following undesirable effects may occur very rarely (affects less
than 1 user in 10,000):
• hyperglycaemia (too much sugar in the blood),
• polyuria (frequent emission of urine)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via;
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel.: [phone]
Fax: [phone]
Website: www.hpra.ie
e-mail: [e-mail]
By reporting side effects you can help provide more
information on the safety of this medicines.
5. HOW TO STORE GLUCOSE 10 %
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
label after EXP. The expiry date refers to the last day of that month.
Do not store above 25 °C.
Your doctor or nurse will ensure the solution is clear and free from
particles before use.
Any solution remaining after treatment should be discarded.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.
1
Read all of this leaflet carefully before you start using this
medicine because it contains
important information for you.
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产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucose 10 % w/v Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucose
anhydrous...........................................................................
100 g/l
As glucose
monohydrate...................................................................
110 g/l
Each ml contains 100 mg anhydrous glucose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, non coloured to slightly yellow.
Osmolality:.........................................................................
580 mosmol/kg
Osmolarity:............................................................................
555 mosmol/l
Carbohydrate caloric content: 400 kcal/l
pH = 3.5 - 6.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicine is indicated in the following situations:
-
Rehydration when there is loss of water greater than loss of sodium
chloride and other osmoles.
-
Prevention of dehydration.
-
Vehicle for other medicines during the preoperative, peroperative and
immediate postoperative periods.
-
Prevention and treatment of ketosis during malnutrition.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Intravenous infusion by peripheral or central vein.
Posology is to be adapted according to patient's clinical status, body
weight, diet and any possible other treatments.
Infusion rate must not exceed a volume corresponding to 0.5 g of
glucose per minute.
4.3 CONTRAINDICATIONS
Administration of this medicine is contraindicated in the following
cases:
-
Water overload.
-
Glucose intolerance.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_SPECIAL WARNINGS:_
Use a slow infusion rate because of the risk of undesirable osmotic
diuresis.
Before use, check that the container is undamaged and that the
solution is clear.
Any damage or partially used container must be discarded.
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