Glucose 10% w/v Solution for Infusion

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

GLUCOSE MONOHYDRATE

זמין מ:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

קוד ATC:

B05BA03

INN (שם בינלאומי):

GLUCOSE MONOHYDRATE 100 g/l

טופס פרצבטיות:

SOLUTION FOR INFUSION

הרכב:

GLUCOSE MONOHYDRATE 100 g/l

סוג מרשם:

POM

איזור תרפויטי:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

מצב אישור:

Authorised

תאריך אישור:

2010-06-15

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
GLUCOSE 10% W/V SOLUTION FOR INFUSION
Active substance: glucose
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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
This medicine is called ‘Glucose 10% w/v Solution for Infusion’,
but will be referred to as
‘Glucose 10% Infusion’ throughout the remainder of this leaflet.
WHAT IS IN THIS LEAFLET
:
1.
What Glucose 10% Infusion is and what it is used for
2.
What you need to know before you are given Glucose 10% Infusion
3.
How you will be given Glucose 10% Infusion
4.
Possible side effects
5.
How to store Glucose 10% Infusion
6.
Contents of the pack and other information
1.
WHAT GLUCOSE 10% INFUSION IS AND WHAT IT IS USED FOR
Glucose 10% Infusion is a solution of sugar (glucose) in water.
Glucose is one of the body’s
sources of energy. This solution for infusion provides 400
kilocalories per litre.
Glucose 10% Infusion is used to:
-
provide a source of sugar (carbohydrate) alone or, as required, for
parenteral nutrition.
Parenteral nutrition is used to feed patients who are unable to eat.
It is given as a slow
injection (infusion) into a vein
-
prevent or treat a low level of sugar in the blood (hypoglycaemia,
that is causing
symptoms, but is not life-threatening)
-
give you extra fluid if your body does not have enough water (you are
dehydrated), and
you need extra sugar (carbohydrate)
-
water down/dilute other medicines to be given into a vein
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GLUCOSE 10% INFUSION
DO NOT RECEIVE GLUCOSE 10% INFUSION IF YOU ARE SUFFERING FROM ANY OF
THE FOLLOWING
CONDITIONS:
-
diabetes that is not adequately treated, allowing your blood sugar
levels to rise above
normal (uncompensated diabetes)
-
unco

מאפייני מוצר

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1.
NAME OF THE MEDICINAL PRODUCT
Glucose 10% w/v Solution for Infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucose (as monohydrate): 100.00 g/l
Each ml contains 100 mg glucose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles.
Osmolarity: 555 mOsm/l (approx.)
pH:
3.5 to 6.5
Calorific value: 1680 kJ/l (or 400 kcal/l) (approx.)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Glucose 10% w/v Solution for Infusion is indicated for:
Supply of carbohydrate alone or, as required, during parenteral
nutrition.
Prevention and treatment of hypoglycaemia.
Rehydration in case of water loss and dehydration states in patients
with high carbohydrate need.
Dilution of compatible medicinal products.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage and rate of administration of Glucose 10% w/v Solution for
Infusion are determined by
several factors including the indication for use and the patient’s
age, weight and clinical condition.
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Fluid balance, serum glucose, serum sodium and other electrolytes
should 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 10% w/v Solution for
Infusion may become extremely
hypotonic after administration due to glucose metabolisation in the
body (see sections 4.4, 4.5 and 4.8).
_ADULTS AND ELDERLY: _
The recommended doses in Table 1 serve as a guideline for an average
adult with a body weight of
approximately 70 kg.
TABLE 1.
GUIDANCE ON THE DOSE FOR ADMINISTRATION TO AN ADULT (70KG)(*)
INDICATION
INITIAL DAILY DOSE
RATE OF ADMINISTRATION
RECOMMENDED
DURATION OF
TREATMENT
Supply of
Carbohydrate
alone or, as
required,
during