GLUCOSE INTRAVENOUS INFUSION BP 5 %w/v Solution for Infusion

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

GLUCOSE

Предлага се от:

B. Braun Medical Limited

АТС код:

B05

INN (Международно Name):

GLUCOSE

дозиране:

5 %w/v

Лекарствена форма:

Solution for Infusion

Вид предписание :

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

Терапевтична област:

PLASMA SUBSTITUTES AND PERFUSION SOLUTIONS B05BA03 Solutions for parenteral nutrition V07AB Solvents and diluting agents, incl. irrigating solutions

Статус Оторизация:

Authorised

Дата Оторизация:

1983-04-01

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER GLUCOSE INTRAVENOUS INFUSION
BP 5% W/V SOLUTION FOR
INFUSION
Glucose
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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Glucose Intravenous Infusion BP 5% w/v is and what it is used for
2.
What you need to know before you use Glucose Intravenous Infusion BP
5% w/v
3.
How to use Glucose Intravenous Infusion BP 5% w/v
4.
Possible side effects
5.
How to store Glucose Intravenous Infusion BP 5% w/v
6.
Contents of the pack and other information
1.
WHAT GLUCOSE INTRAVENOUS INFUSION BP 5% W/V IS AND WHAT IT IS USED FOR
Glucose Intravenous Infusion BP 5% w/v is a sterile solution of
glucose in water which can be
used to give you fluids and glucose, or can be used as a solution to
dissolve other medicines in.
Glucose Intravenous Infusion BP 5% w/v will be given to you in the
form of a vein drip (that
is, by intravenous infusion).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE GLUCOSE INTRAVENOUS INFUSION BP
5% W/V
YOU WILL NOT RECEIVE GLUCOSE INTRAVENOUS INFUSION BP 5% W/V
If you have:
–
too high blood sugar level (hyperglycaemia) that needs more than 6
units of insulin per
hour to be controlled
–
high levels of lactic acid in your blood (lactic acidosis)
You should not receive large amounts of this solution if you have
–
too much water in your body (hypotonic hyperhydration or isotonic
hyperhydration)
–
acute heart failure (acute congestive heart failure)
–
water in your lungs (pulmonary oedema)
Glucose Intravenous Infusion BP 5% w/v must no

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glucose Intravenous Infusion BP 5% w/v, Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 50 mg glucose as glucose monohydrate.
1000 ml contain 50.0 g glucose (as glucose monohydrate, 55.0 g)
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Infusion.
A clear, colourless, or almost colourless aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
For use in prophylactic and replacement therapy requiring the use of
glucose.
2.
As a vehicle solution for compatible electrolyte concentrates and
medicinal products.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
4.2.1 DOSAGE
PROPHYLACTIC AND REPLACEMENT THERAPY REQUIRING THE USE OF GLUCOSE
The quantity and rate of administration is dependent on the age,
weight, clinical and metabolic conditions of the
patient, concomitant therapy and should be determined by the
consulting physician.
VEHICLE SOLUTION FOR COMPATIBLE MEDICINAL PRODUCTS
When used as a vehicle choose a volume that yields the desired degree
of dilution of the medicament for which
Glucose Intravenous Infusion BP 5 % w/v is to be used as diluent,
having regard to the maximum dose stated below.
Of note, provision of the entire daily fluid supply with this solution
alone is contraindicated. See sections 4.3 and 4.4.
_Adults_
_Maximum daily intake_
Up to 40 ml per kg body weight per day, corresponding to 2 g of
glucose per kg body weight per day.
_Maximum infusion rate_
The maximum infusion rate is up to 5 ml per kg body weight per hour,
corresponding to 0.25 g (250 mg) of glucose per
kg body weight per hour.
When administering this solution the total daily fluid and glucose
requirements should be taken into account.
Theoretical osmolarity:
278 mOsm/l
Energy
837 kJ/l
200 kcal/l
Acidity titre (titration to pH 7.4):
< 0.5 mmol/l/l NaOH
pH:
3.5 – 5.5
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