Pfizer (Australia) GLUCOSE INTRAVENOUS INFUSION BP 5% glucose (as monohydrate) 5g/100 mL injection for infusion vial

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

glucose monohydrate, Quantity: 54.99 mg/mL (Equivalent: glucose, Qty 50 mg/mL)

Tillgänglig från:

Pfizer Australia Pty Ltd

Läkemedelsform:

Injection, intravenous infusion

Sammansättning:

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

Administreringssätt:

Intravenous

Enheter i paketet:

100mL x 10

Klass:

Medicine Registered

Receptbelagda typ:

Not scheduled. Not considered by committee

Terapeutiska indikationer:

INDICATIONS AS AT 31 July 2000: For fluid and carbohydrate depletion wherever a non-electrolyte fluid is required. In the treatment of hypoglycaemia. In the treatment of acute diarrhoeal disease. As a vehicle for the administration of other medications.

Produktsammanfattning:

Visual Identification: A clear, colourless solution, free from visible particles.; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Bemyndigande status:

Registered

Bipacksedel

GLUCOSE
INTRAVENOUS
INFUSION BP 5%
_glucose_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Glucose Intravenous
Infusion. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you being given Glucose
Intravenous Infusion against the
benefits they expect it to have for
you.
This medicine is likely to be used
while you are at the clinic or in
hospital. If possible, please read this
leaflet carefully before this medicine
is given to you. In some cases, this
leaflet may be given to you after the
medicine has been used.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT GLUCOSE
INTRAVENOUS INFUSION
IS USED FOR
Glucose is a sugar which provides
energy for the body. It is naturally
present in body fluids and is needed
for normal body function. Glucose
Intravenous Infusion is given to
patients who have low levels of sugar
in their blood or are dehydrated.
Glucose Intravenous Infusion may
also be used for the dilution of other
medicines before injecting them into
the body.
It may be used for the treatment of
other conditions that are not
mentioned above. Your doctor will
be able to tell you about the specific
condition for which you have been
prescribed Glucose Intravenous
Infusion.
BEFORE YOU ARE GIVEN
GLUCOSE INTRAVENOUS
INFUSION
_WHEN GLUCOSE INTRAVENOUS_
_INFUSION MUST NOT BE GIVEN_
You should not be given this
medicine if the packaging is torn or
show signs of tampering or if the
expiry date on the pack has passed.
You will not be given Glucose
Intravenous Infusion if:
1. YOU HAVE AN ALLERGY TO
•
GLUCOSE, OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET
•
CARBOHYDRATES
•
CORN (MAIZE) OR CORN PRODUCTS
2. YOU HAVE OR HAVE HAD THE
FOLLOWING MEDICAL CONDITIONS
•
diabetes
•
difficulty digesting sugar
•
severely dehydrat

Produktens egenskaper

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Supersedes: pfpgluiv10220
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AUSTRALIAN PRODUCT INFORMATION –
PFIZER (AUSTRALIA) GLUCOSE
INTRAVENOUS INFUSION BP 5% (GLUCOSE
(AS MONOHYDRATE))
1.
NAME OF THE MEDICINE
Glucose monohydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains 54.99 mg glucose monohydrate (equivalent
to 50 mg glucose).
When necessary, pH is adjusted with sodium hydroxide and/or
hydrochloric acid. pH is
3.5 to 6.5 and osmolality 250 to 350 mOsm/kg.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Injection, intravenous infusion.
Sterile isotonic preservative-free solutions containing glucose
monohydrate.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
For fluid and carbohydrate depletion wherever a non-electrolyte fluid
is required
•
In the treatment of hypoglycaemia
•
In the treatment of acute diarrhoeal disease
•
As a vehicle for the administration of other medications
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Dosage will be dependent upon individual patient circumstances, such
as age, weight and
clinical condition and is determined by the attending physician.
METHOD OF ADMINISTRATION
The infusion rate should not exceed 0.5 g/kg/hour to avoid potential
glycosuria.
Version: pfpgluiv10921
Supersedes: pfpgluiv10220
Page 2 of 13
Glucose Intravenous Infusion BP 5% may be administered via a
peripheral vein, preferable
large arm vein and the site of infusion should be changed daily if
more than one infusion is
required.
Do not use if any visible particles are observed.
4.3 CONTRAINDICATIONS
•
Patients with clinically significant hyperglycaemia.
•
Glucose-Galactose Malabsorption Syndrome.
•
Diabetic coma where blood sugar levels are excessively high.
•
Avoid use in ischaemic stroke, as under this condition, the induced
lactic acidosis
aggravates the recovery of the damaged brain tissue.
•
Patients who have had head trauma within 24 hours, with blood glucose
concentrations
being closely monitored during intracranial hy