Glucose Intravenous Infusion BP 10% w/v, solution for infusion

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Anhydrous glucose

Հասանելի է:

B. Braun Medical Limited

ATC կոդը:

B05BA; B05BA03

INN (Միջազգային անվանումը):

Anhydrous glucose

Դոզան:

10 percent weight/volume

Դեղագործական ձեւ:

Solution for infusion

Ռեկվիզորի տեսակը:

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

Թերապեւտիկ տարածք:

Solutions for parenteral nutrition; carbohydrates

Լիազորման կարգավիճակը:

Marketed

Հաստատման ամսաթիվը:

1992-08-17

Տեղեկատվական թերթիկ

PACKAGE LEAFLET: INFORMATION FOR THE USER
GLUCOSE INTRAVENOUS INFUSION BP 10% W/V SOLUTION FOR INFUSION
Glucose (as glucose monohydrate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
●
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
●
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Glucose Intravenous Infusion BP 10% w/v solution for infusion is
and what it is used for
2.
What you need to know before you receive Glucose Intravenous Infusion
BP 10% w/v solution
for infusion
3.
How to use Glucose Intravenous Infusion BP 10% w/v solution for
infusion
4.
Possible side effects
5.
How to store Glucose Intravenous Infusion BP 10% w/v solution for
infusion
6.
Contents of the pack and other information
1.
WHAT
GLUCOSE
INTRAVENOUS
INFUSION
BP
10%
W/V
SOLUTION
FOR
INFUSION IS AND WHAT IT IS USED FOR
Glucose Intravenous Infusion BP 10% w/v solution for infusion is a
solution that contains
glucose for administration in the form of a vein drip (intravenous
infusion).
You are given this medicine to provide you with carbohydrates if you
are unable to eat and
drink normally.
You may also be given it in order to raise an abnormally low blood
sugar level.
The solution may also be used to dissolve or dilute medicines that are
to be given to you by
infusion.
Glucose solutions can also be used to replace body fluids lost for
example from bleeding,
severe vomiting, severe diarrhoea etc.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE GLUCOSE INTRAVENOUS
INFUSION BP 10% W/V SOLUTION FOR INFUSION
YOU WILL NOT RECEIVE GLUCOSE INTRAVENOUS INFUSION BP 10% W/V SOLUTION
FOR INFUSION
if you have
●
too high blood sugar

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucose Intravenous Infusion BP 10% w/v, solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 0.1 g anhydrous glucose, as glucose monohydrate.
1000 ml of solution contain
500 ml of solution contain
Anhydrous glucose
100.0 g
50.0 g
(equivalent to glucose monohydrate)
110.0 g
55.0 g
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless or almost colourless aqueous solution.
Energy
1675 kJ/l
400 kcal/l
Theoretical osmolarity
555
mOsm/l
Acidity (titration to pH 7.4)
< 0.5 mmol/l
pH
3.5 – 5.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Administration of glucose for caloric support
Vehicle solution for compatible electrolyte concentrates and medicinal
products
Therapy of hypoglycaemia
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
The dosage of the solution depends on the patient’s individual
glucose and fluid requirements.
Fluid balance, serum glucose, and other electrolytes may need to be
monitored before and during administration,
especially in patients with increased non-osmotic vasopressin release
(syndrome of inappropriate antidiuretic hormone
secretion, SIADH) and in patients co-medicated with vasopressin
agonist drugs due to the risk of hyponatraemia.
Monitoring of serum sodium is particularly important for
physiologically hypotonic fluids. Glucose Intravenous
Infusion BP 10% w/v may become extremely hypotonic after
administration due to glucose metabolisation in the body
(see sections 4.4. 4.5 and 4.8).
_Adults and adolescents from 15_
_th_
_year of life_
The maximum daily dose is 40 ml per kg body weight per day,
corresponding to 4 g of glucose per kg body weight per
day.
The maximum infusion rate is 2.5 ml per kg body weight per hour,
corresponding to 0.25g of glucose per kg body
weight per hour.
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