Sodium Chloride 0.45% w/v and Glucose 5.0% w/v Solution for Infusion BP

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

GLUCOSE, SODIUM CHLORIDE

Tersedia dari:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

Kode ATC:

B05BB02

INN (Nama Internasional):

GLUCOSE 5 % (W/V) SODIUM CHLORIDE 0.45 % (W/V)

Bentuk farmasi:

SOLUTION FOR INFUSION

Komposisi:

GLUCOSE 5 % (W/V) SODIUM CHLORIDE 0.45 % (W/V)

Jenis Resep:

POM

Area terapi:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Status otorisasi:

Authorised

Tanggal Otorisasi:

2013-03-15

Selebaran informasi

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PACKAGE LEAFLET: INFORMATION FOR THE USER
SODIUM CHLORIDE 0.45 % W/V AND GLUCOSE 5.0% W/V SOLUTION FOR INFUSION
BP
Active substances: sodium chloride, glucose.
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 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 Sodium Chloride 0.45% w/v and Glucose 5.0% w/v
Solution for Infusion BP, but
will be referred to as Sodium Chloride 0.45/Glucose 5.0 Infusion
throughout the remainder of this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Sodium Chloride 0.45/Glucose 5.0 Infusion
is and what it is used for
2.
What you need to know before you are given Sodium Chloride
0.45/Glucose 5.0 Infusion
3.
How you will be given Sodium Chloride 0.45/Glucose 5.0 Infusion
4.
Possible side effects
5.
How to store Sodium Chloride 0.45/Glucose 5.0 Infusion
6.
Contents of the pack and other information
1.
WHAT SODIUM CHLORIDE 0.45/GLUCOSE 5.0 INFUSION IS AND WHAT IT IS USED
FOR
Sodium Chloride 0.45/Glucose 5.0 Infusion is a solution of the
following substances in water:
•
sugar (glucose)
•
sodium chloride (salt).
Glucose is one of the body’s sources of energy. This solution for
infusion provides 200 kilocalories per litre.
Sodium and chloride are chemical substances found in the blood.
Sodium Chloride 0.45/Glucose 5.0 Infusion is used:
•
as a source of carbohydrate (sugar)
•
to treat a loss of body water (dehydration) and chemicals (e.g. by
heavy sweating, kidney disorders)
•
to treat you, if the volume of blood in your blood vessels is low
(hypovolaemia)
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SODIUM CHLORIDE
0.45/GLUCOSE 5.0 INFUSION
DO NOT RECEIVE SODIUM CHLORIDE 0.45/GLUCOSE 5.0 INFUSION IF YOU ARE
SUFFERING FROM ANY OF THE
FOLLOWING CONDITIONS
•
when you kno

Karakteristik produk

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1.
NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.45 % w/v and Glucose 5.0 % w/v Solution for Infusion
BP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride:
4.5 g/l (0.45 % w/v)
Glucose (as monohydrate):
50.00 g/l (5.0 % w/v)
Each ml contains 50 mg glucose (as monohydrate) and 4.5 mg sodium
chloride.
mmol/l:
Na+:
77
Cl-:77
mEq/l:
Na+:
77
Cl-:77
Nutritional value: approximately 840 kJ/l (or 200 kcal/l)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles.
Osmolarity 432 mOsm/l (approx)
pH: 3.5 to 6.5
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sodium Chloride 0.45 % w/v and Glucose 5.0 % w/v solution is indicated
for:
-
Treatment of dehydration or hypovolaemia in cases where supply of
water, sodium chloride and
carbohydrates is required due to restriction of the intake of fluids
and electrolytes by normal
routes.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The choice of the specific sodium chloride and glucose concentration,
dosage, volume, rate and duration
of administration depends on the age, weight, clinical condition of
the patient and concomitant therapy.
It should be determined by a physician. For patients with electrolyte
and glucose abnormalities and for
paediatric patients, consult a physician experienced in intravenous
fluid therapy.
Fluid balance, serum glucose, serum sodium and other electrolytes
should 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. Sodium Chloride 0.45 % w/v and
Glucose 5.0 % w/v solution may
become extremely hypotonic after administration due to glucose
metabolisation in the body (see sections
4.4, 4.5 and 4.8).
Rapid correction of hyponatraemia and hyp