Glucose 5% w/v Solution for Infusion

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Glucose anhydrous

Доступно од:

Fresenius Kabi Limited

АТЦ код:

B05BA; B05BA03

INN (Међународно име):

Glucose anhydrous

Дозирање:

5 percent weight/volume

Фармацеутски облик:

Solution for infusion

Тип рецептора:

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

Терапеутска област:

Solutions for parenteral nutrition; carbohydrates

Статус ауторизације:

Not marketed

Датум одобрења:

2004-01-09

Информативни летак

2
Pregnancy and breast-feeding
GLUCOSE 5 % can be used during pregnancy or breast-feeding.
However, you should tell your doctor if you are pregnant, if you think
you
are pregnant or if you are breast-feeding.
3. HOW YOU ARE GIVEN GLUCOSE 5 %?
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, GLUCOSE 5 % can cause side effects,
although not everybody gets them.
The following undesirable effects may occur very rarely :
• hyperglycaemia (too much sugar in the blood),
• polyuria (frequent emission of urine)
If any of the side effects gets serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE GLUCOSE 5 %?
Keep out of the reach and sight of children.
Do not use GLUCOSE 5 % after the expiry date which is
stated on the label after EXP.
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.
6. FURTHER INFORMATION
What GLUCOSE 5 % contains?
• The active substance is:
Glucose anhydrous...................................................50
g/l
As glucose monohydrate .........................................55 g/l
Osmolality:................................................300
mosmol/kg
Osmolarity: ..................................................278
mosmol/l
Carbohydrate caloric content: 200 kcal/l
pH = 3.5 – 6.5
• The other ingredients are: hydrochloride acid (concentrated),
sodium hydroxide, water for injections.
1
Read all of this leaflet carefully before you start using this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If any of the side effects gets serious, or if you notice any side
effects

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucose 5% w/v Solution for Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucose
anhydrous...........................................................................
50 g/l
As glucose
monohydrate...................................................................
55 g/l
Each ml contains 50 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.
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.
Osmolality:
300 mosmol/kg
Osmolarity:
278 mosmol/l
Carbohydrate caloric content:
200 kcal/l
pH =
3.5 - 6.5
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