Glucose 10% w/v Solution for Infusion

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

GLUCOSE MONOHYDRATE

可用日期:

Baxter Healthcare Limited

ATC代码:

B05BA03

INN（国际名称）:

GLUCOSE MONOHYDRATE

药物剂型:

SOLUTION FOR INFUSION

组成:

GLUCOSE MONOHYDRATE 100 milligram(s)/millilitre

处方类型:

POM

治疗领域:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

授权状态:

Authorised

授权日期:

2010-06-15

资料单张

1a
2. WHAT YOU NEED TO KNOW BEFORE
YOU ARE GIVEN GLUCOSE 10%
INFUSION
DO NOT RECEIVE GLUCOSE 10% 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)
•
hyperosmolar coma (unconsciousness). This is a type
of coma that can occur if you have diabetes and do
not receive enough medicine.
•
thinning of the blood due to the addition of too much
fluid (haemodilution)
•
when there is too much fluid in the spaces around the
cells of the body (extracellular hyperhydration)
•
when there is a larger volume of blood in the blood
vessels than there should be (hypervolaemia)
•
a higher level of sugar in the blood than normal
(hyperglycaemia)
•
a higher level of lactate, a chemical found in the
blood, than there should be (hyperlactataemia)
•
severe kidney failure (when your kidneys do not work
well and you require dialysis)
•
uncompensated heart failure. This is heart failure
that is not adequately treated and causes symptoms
such as:
– shortness of breath
– swelling of the ankles
•
build up of fluid under the skin, affecting all parts
of the body including your brain and lungs (general
oedema)
•
liver disease that causes fluid to build up within the
abdomen (ascitic cirrhosis).
•
any condition which affects the way your body
controls your sugar level
•
to be sensitive (hypersensitivity) to glucose. This is
potential manifestations in patients with allergy to
corn.
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,
pharmacist 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.
This medicine is called ‘Glucose 10% w/v Solution
for Infusion’, but will be referred to as ‘Glucose 10%
i

产品特点

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISITCS
1.
NAME OF THE MEDICINAL PRODUCT
Glucose 10% w/v Solution for Infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucose (as monohydrate): 100.00 g/l
Each ml contains 100 mg glucose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles.
Osmolarity: 555 mOsm/l (approx.)
pH:
3.5 to 6.5
Calorific value: 1680 kJ/l (or 400 kcal/l) (approx.)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Glucose 10% w/v Solution for Infusion is indicated for:
Supply of carbohydrate alone or, as required, during parenteral
nutrition.
Prevention and treatment of hypoglycaemia.
Rehydration in case of water loss and dehydration states in patients
with high carbohydrate need.
Dilution of compatible medicinal products.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Page 2 of 15
The dosage and rate of administration of Glucose 10% w/v Solution for
Infusion are determined by
several factors including the indication for use and the patient’s
age, weight and clinical condition.
_ADULTS AND ELDERLY: _
The recommended doses in Table 1 serve as a guideline for an average
adult with a body weight of
approximately 70 kg.
TABLE 1.
GUIDANCE ON THE DOSE FOR ADMINISTRATION TO AN ADULT (70KG)(*)
INDICATION
INITIAL DAILY DOSE
RATE OF ADMINISTRATION
RECOMMENDED
DURATION OF
TREATMENT
Supply of
Carbohydrate
alone or, as
required,
during parenteral
nutrition
From 500 ml to 3000
ml/day
(from 7 to 40 ml/kg/day)
The
recommended
maximum
administration
rate
should
not
exceed the
patient’s glucose
oxidation, as this may cause
hyperglycaemia: 5
mg/kg/min
(3 ml/kg/h)
No limit on
duration -
dependent on
the
clinical
condition
of the patient
Prevention and
treatment of
hypoglycaemia
Rehydration in
case of water loss
and
dehydration
states in patients
with high
carbohydrate
need
Dilution of
compatible
medicinal
products
From 50 to 250 ml per
dose
Dependent on the nature of
the
additive
Dependent on
the
nat