GLUCOSE 5% FREEFLEX glucose 2.5g/50mL injection bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glucose, Quantity: 2.5 g

Available from:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

glucose monohydrate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; sodium hydroxide; hydrochloric acid

Administration route:

Intravenous

Units in package:

70 bags per carton, 40 bags per carton, 60 bags per carton, 65 bags per carton

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

The solutions are indicated for intravenous fluid therapy designed to correct deficiencies in energy levels. Glucose 5% is also used to correct hydration levels. The solutions may also be used as solvents for intravenously administered drugs where compatibility has been established.

Product summary:

Visual Identification: Clear colourless to slightly yellow solution; Container Type: Bag; Container Material: Other composite material; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2008-12-16

Patient Information leaflet

GLUCOSE 5% & 10% FREEFLEX INJECTION
1
GLUCOSE 5% AND 10% FREEFLEX
INJECTION
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING GLUCOSE 5% AND 10% FREEFLEX INJECTION ?
Glucose 5% and 10% Injection contains the active ingredient Glucose.
Glucose Injection is used to is used to treat dehydration and low
blood sugar levels.
Ask your doctor if you have any questions about why this medicine has
been prescribed for you.
For more information, see Section 1. Why am I using Glucose 5% and 10%
Freeflex? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE GLUCOSE 5% AND 10% FREEFLEX INJECTION?
Glucose Injection will only be used if the solution is clear or
slightly yellow, free of particles.
It should not be administered after the expiry date printed on the
pack, if the pack is torn or shows signs of tampering.
You should not be given Glucose Injection if you are pregnant or
breastfeeding unless your doctor says so.
For more information, see Section 2. What should I know before I use
Glucose 5% and 10% Freeflex? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING ANY OTHER MEDICINES,
INCLUDING ANY THAT YOU BUY WITHOUT A PRESCRIPTION FROM
YOUR PHARMACY, SUPERMARKET OR HEALTH FOOD SHOP.
Your doctor or pharmacist can tell you what to do if you are taking
any of these medicines.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE GLUCOSE 5% AND 10% FREEFLEX INJECTION?
Glucose will be given to you by your doctor or a nurse by infusion or
drip in the vein. Your doctor will have
experience in injecting Glucose Injection and will choose the best
dose for you
More instructions can be found in Section 4. How do I use Glucose 5%
and 10% Freeflex? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING GLUCOSE 5% AND 10% FREEFLEX INJECTION ?
THINGS YOU
SHOULD DO
•
Tell your doctor or phar

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – GLUCOSE 5% & 10%
FREEFLEX (SOLUTION FOR INJECTION)
1
NAME OF THE MEDICINE
Glucose
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucose 10% is a sterile hypertonic solution of glucose 10% w/v in
Water for Injections,
containing no preservatives. pH 3.5 to 6.5.
Glucose 5% Freeflex is a sterile isotonic solution of glucose 5% w/v
in Water for Injections,
containing no preservatives. pH 3.5 to 6.5.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for Injection
Clear colourless to slightly yellow solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The solutions are indicated for intravenous fluid therapy designed to
correct deficiencies in
energy levels. Glucose 5% is also used to correct hydration levels.
The solutions may also be
used
as
solvents
for
intravenously
administered
drugs
where
compatibility
has
been
established.
4.2
DOSE AND METHOD OF ADMINISTRATION
Glucose 5% Injection may be administered intravenously via a
peripheral vein. The maximum
rate at which glucose can be administered without producing glycosuria
is 0.5 g/kg/h.
Glucose 10% Injection is hypertonic and should preferably be
administered via an IV catheter
in a large central vein. If a peripheral vein is used a large arm vein
should be selected and the
infusion site changed daily. The rate of infusion should not exceed
0.5 g/kg/h to avoid
glycosuria.
The dose of glucose is dependent on the age, weight and fluid,
electrolyte, glucose and acid-
base balance of the patient.
Solutions containing glucose should not be administered through the
same lines as those
containing whole blood due to the risk of haemolysis and clumping. It
does not contain
antimicrobials. For use in one patient, on one occasion only. Residue
should be discarded.
2
Care should be taken with intravenous administration and injection
technique to avoid
injection site reactions and infections.
4.3
CONTRAINDICATIONS
Glucose is contraindicated in the following:
•
diabetic coma where blood s