0.18%w/v Sodium Chloride and 4.0% w/v Glucose Intravenous Infusion BP, (Viaflo Container)

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Sodium chloride; Anhydrous glucose

Beszerezhető a:

Baxter Holding B.V.

ATC-kód:

B05XA; B05XA31

INN (nemzetközi neve):

Sodium chloride; Anhydrous glucose

Adagolás:

0.18/4 percent weight/volume

Gyógyszerészeti forma:

Solution for infusion

Terápiás terület:

Electrolyte solutions; electrolytes in combination with other drugs

Engedélyezési státusz:

Marketed

Engedély dátuma:

2007-08-24

Betegtájékoztató

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 0.18% w/v
& Glucose 4% w/v Solution for Infusion BP, but will
be referred to as Sodium Chloride 0.18 & Glucose 4
Infusion throughout the remainder of this leaflet.
What is in this leaflet:
1.
What Sodium Chloride 0.18 & Glucose 4
Infusion is and what it is used for
2.
What you need to know before you are given
Sodium Chloride 0.18 & Glucose 4 Infusion
3.
How you will be given Sodium Chloride 0.18 &
Glucose 4 Infusion
4.
Possible side effects
5.
How to store Sodium Chloride 0.18 & Glucose 4
Infusion
6.
Contents of the pack and other information
1. What Sodium Chloride 0.18 & Glucose 4
Infusion is and what it is used for
Sodium Chloride 0.18 & Glucose 4 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 0.18 & Glucose 4 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 0.18 & Glucose 4
Infusion
Do NOT receive Sodium Chloride 0.18 & Glucose
4 Infusion if you are suffering from any of the
following conditions
•
when you know you are allergic to the product
•
when there is too much fluid in the spaces around
the cells of the body (extracellular hyperhydration)
•
when there is a larger volume

Termékjellemzők

Health Products Regulatory Authority
24 September 2020
CRN008LNL
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
0.18%w/v Sodium Chloride and 4.0% w/v Glucose Intravenous Infusion BP,
(Viaflo Container)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium chloride: 1.80 g/l
Glucose (as monohydrate): 40.00 g/l
Each ml contains 1.8 mg sodium chloride and 40 mg glucose (as
monohydrate).
mmol/l (approx): Na+: 30 Cl
-
: 30
approximately: 668 kJ/l (or 160 kcal)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Sterile, non-pyrogenic, clear, colourless, aqueous Solution for
Infusion.
pH: 3.5-5.5 and osmolarity (approx): 284 m0sm/l
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sodium Chloride 0.18 % and Glucose 4% solution is used in the
following indications:
Dehydration treatment due to a moderated loss of sodium and chloride
(vomiting, diarrhoea, renal disorders, overuse of
diuretics) in cases where a source of energy is required (particularly
starvation).
Paediatric Population
This product should only be used in paediatric specialist settings
(such as renal, hepatic and cardiac units, high dependency
units and intensive care units) for intravenous fluid therapy
requiring the use of 0.18% sodium chloride and 4% glucose to
maintain fluid and electrolyte balance.
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) a