Glucose Intravenous Infusion BP 5% w/v solution for infusion

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Glucose

Inapatikana kutoka:

B. Braun Melsungen AG

ATC kanuni:

B05BA; B05BA03

INN (Jina la Kimataifa):

Glucose

Kipimo:

5 percent weight/volume

Dawa fomu:

Solution for infusion

Dawa ya aina:

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

Eneo la matibabu:

Solutions for parenteral nutrition; carbohydrates

Idhini hali ya:

Marketed

Idhini ya tarehe:

1998-02-06

Taarifa za kipeperushi

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 controlledhigh 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 not be use

Tabia za bidhaa

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.
Clear, colourless or almost colourless, aqueous solution.
Energy:
837kJ/l
200kcal/l
Theoretical osmolarity:
278 mOsm/l
Acidity titre (titration to pH 7.4):
< 0.5 mmol/l
pH:
3.5 – 5.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vehicle solution for compatible electrolyte concentrates and medicinal
products.
For use in prophylactic and replacement therapy requiring the use of
glucose.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 5% w/v may become extremely hypotonic after administration
due to glucose metabolisation in the body
(see sections 4.4. 4.5 and 4.8).
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
The volume to be chosen depends on the desired concentration of the
medicinal product for which the solution is to be
used as vehicle, 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.
H
E