Glucose 5% Intravenous Infusion BP

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

GLUCOSE MONOHYDRATE

Предлага се от:

Baxter Healthcare Limited

АТС код:

B05BA03

INN (Международно Name):

GLUCOSE MONOHYDRATE

Лекарствена форма:

SOLUTION FOR INFUSION

Композиция:

GLUCOSE MONOHYDRATE 50 g/l

Вид предписание :

POM

Терапевтична област:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Статус Оторизация:

Authorised

Дата Оторизация:

2010-08-19

Листовка

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GLUCOSE 5% W/V INTRAVENOUS INFUSION BP
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 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.
WHAT IS IN THIS LEAFLET:
1.
What Glucose 5% Infusion is and what it is used for
2.
What you need to know before you are given Glucose 5% Infusion
3.
How you will be given Glucose 5% Infusion
4.
Possible side effects
5.
How to store Glucose 5% Infusion
6.
Contents of the pack and other information
1.
WHAT GLUCOSE 5% INFUSION IS AND WHAT IT IS USED FOR
Glucose 5% Infusion is a solution of sugar (glucose) in water. Glucose
is one of the body’s sources
of energy. This solution for infusion provides 200 kilocalories per
litre.
Glucose 5% Infusion is used:
-
as a source of fluid and sugar (carbohydrate )
-
to dilute or to deliver other medicines that can be given by infusion.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GLUCOSE 5% INFUSION
DO NOT RECEIVE GLUCOSE 5% 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)
-
states of glucose intolerance, for example: when the body’s
metabolism does not function
correctly, e.g. due to severe illness (metabolic stress)
-
hyperosmolar coma (unconsciousness). This is a type of coma that can
occur if you have
diabetes and do not receive enough medicine.
-
a higher amount of sugar in the blood than normal (hyperglycaemia)
-
a higher level of lactate in the blood than normal (hyperlactataemia)
-
to be sensitive (hypersensitivity) to glucose. This is potential
manifestations in patients with
allergy to corn.
If another medicine is added to your solut

Данни за продукта

Page 1 of 11
1.
NAME OF THE MEDICINAL PRODUCT
Glucose 5% Intravenous Infusion BP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucose (as monohydrate): 50.0 g/l
Each ml contains 50 mg glucose (as monohydrate)
Approximately 840 kJ/l (or 200 kcal/l)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles.
Osmolarity : 278 mOsm/l.(approx.)
pH : 3.5 – 6.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Glucose 5% is indicated for the treatment of carbohydrate and fluid
depletion.
Glucose 5% is also used as a vehicle and diluent for compatible
medicinal products for parenteral
administration.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology_ _
_Adults, the Elderly and Children: _
The concentration and dosage of glucose solution for intravenous use
is determined by several
factors including the age, weight and clinical condition of the
patient. Serum-glucose concentrations
may need to be carefully monitored.
The recommended dosage for treatment of carbohydrate and fluid
depletion is:
- for adults: 500 ml to 3 litres / 24h
- for babies and children :
- 0-10 kg body weight:
100 ml/kg/24h.
- 10-20 kg body weight:
1000 ml + 50 ml /kg over 10 kg / 24h.
- > 20 kg body weight:
1500 ml + 20 ml / kg over 20 kg / 24h.
_ _
The infusion rate depends on the patient’s clinical condition.
Infusion rate should not exceed the patient’s glucose oxidation
capacities in order to avoid
hyperglycaemia. Therefore, the maximum dose ranges from 5mg/kg/min for
adults to 10-18
mg/kg/min for babies and children depending on the age and the total
body mass.
The recommended dosage when used as a vehicle or diluent ranges from
50 to 250 ml per dose of
medicinal product to be administered.
Page 2 of 11
When Glucose 5% is used as a diluent for injectable preparations of
other drugs, the dosage and the
infusion rate will be principally dictated by the nature and the dose
regimen of the prescribed drug.
_ _
_Paediatric population_
The infusion rate and volume