GLUCOSE 5% W/V INTRAVENOUS INFUSION

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

GLUCOSE MONOHYDRATE

Disponibil de la:

Baxter Healthcare Limited

Codul ATC:

B05BA03

INN (nume internaţional):

GLUCOSE MONOHYDRATE

Dozare:

5.0 Anhyd %w/v

Forma farmaceutică:

Solution for Infusion

Tip de prescriptie medicala:

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

Zonă Terapeutică:

carbohydrates

Statutul autorizaţiei:

Marketed

Data de autorizare:

2003-05-16

Prospect

ARTWORK DESIGN CENTRE
Version: 01
Draft: 1st
Artworker: B. Chantry
Date: 08 sep 2016
Errors: Yes / No
PR1:
Errors: Yes / No
PR2:
Sign:
Sign:
Date:
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Comments:
EMEA ARTWORK DESIGN CENTRE
ARTWORK APPROVAL
1st DRAFT
LAYOUT AND FORMAT
APPROVAL
PLANT APPROVAL
HALLE ONLY
Country
Name
Signature
Date
Applicable for pages ___ to ___ (and pages ___ to ___ for TIL)
DRAFT
CB-30-02-246
1
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 s

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucose 5% w/v Intravenous Infusion BP, polyolefin/polyamide bag.
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 a 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.
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