0.18 % w/v Sodium Chloride and 4 % w/v Glucose Intravenous Infusion BP, Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Glucose; Sodium chloride

Available from:

B. Braun Medical Limited

ATC code:

B05BB; B05BB02

INN (International Name):

Glucose; Sodium chloride

Dosage:

0.18 and 4 percent weight/volume

Pharmaceutical form:

Solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Solutions affecting the electrolyte balance; electrolytes with carbohydrates

Authorization status:

Marketed

Authorization date:

1983-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
B. Braun Melsungen AG · 34209 Melsungen, Germany
0.18% w/v Sodium Chloride and
4% w/v Glucose Intravenous Infusion BP
SOLUTION FOR INFUSION
(SODIUM CHLORIDE, GLUCOSE)
378/12261629/0118
schwarz
Format = 210 x 297 mm (A4)
2 Seiten
Lätus
IE___378
378/12261629/0118
GIF – IL
Production site: Melsungen
Font size: 9 pt.
G 111301
B|BRAUN
Your levels of blood sugar, electrolytes (especially potassium) and
acid-
base and water balance will be checked to make sure that these are
cor-
rect before and during infusion.
After major operations or severe injuries (post-traumatic and
post-oper-
ative conditions or in the presence of tissue oxygen deficiency,
abnor-
mally high level of acid in the blood or organ failure) you may not be
able
to metabolise glucose properly (impaired glucose tolerance). Your
blood
sugar level will then be regularly monitored.
Please note:
If this solution is used to dilute or dissolve medicines that are to
be given
to you by a drip into your vein, your doctor will take into account
the
safety information of the additive.
OTHER MEDICINES AND 0.18% W/V SODIUM CHLORIDE AND 4%
W/V GLUCOSE
Tell your doctor if you are using, have recently used or might use any
other medicines.
Your doctor will adjust your dosage if you receive corticosteroids.
Corti-
costeroids may cause an accumulation of sodium and fluid in your body.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may be pregnant or
are plan-
ning to have a baby, ask your doctor for advice before taking this
medicine.
PREGNANCY
Your doctor will decide carefully whether or not you should receive
this
solution if you are pregnant.
Thus special care will be taken if you have a specific disorder that
may
occur during pregnancy, called eclampsia, with the following symptoms:
high blood pressure, cramps, swelling.
Blood sugar levels will be checked regularly.
BREAST-FEEDING
This medicine can be given while you are breast-feeding.
DRIVING AND USING MACHINES
0.18% w/v Sodium C

Summary of Product characteristics

Health≙Products≙Regulatory≙Authority
10≙September≙2019
CRN0099LK
Page≙1≙of≙8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
0.18≙%≙w/v≙Sodium≙Chloride≙and≙4≙%≙w/v≙Glucose≙Intravenous≙Infusion≙BP,≙Solution≙for≙Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1000≙ml≙of≙the≙solution≙for≙infusion≙contain:
Sodium≙chloride ≙1.8≙g
Glucose≙monohydrate ≙44.00≙g
equivalent≙to glucose ≙40.00≙g
_Electrolyte concentrations:_
Sodium≙31≙mmol/l
Chloride≙31≙mmol/l
For≙the≙full≙list≙of≙excipients,≙see≙section≙6.1.
3 PHARMACEUTICAL FORM
Solution≙for≙infusion
Clear,≙colourless,≙upto≙faintly≙straw-coloured≙aqueous≙solution.
Energy ≙668kJ/l≙≙
160kcal/l
Theoretical≙osmolarity: ≙282mOsm/l
Acidity≙(titration≙to≙pH7.4): ≙<0.5mmol/l≙pH: ≙3.5–5.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
§ ≙Hypertonic≙dehydration
§ ≙Partial≙coverage≙of≙energy≙requirements
§
≙Vehicle≙solution≙for≙compatible≙electrolyte≙concentrates≙and≙medicinal≙products
_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
Posology
_Adults_
The≙dose≙is≙adjusted≙according≙to≙the≙individual≙requirements≙of≙fluid,≙electrolyte≙and≙energy.≙Thus≙the≙patient’s≙age,≙weight,≙
clinical≙and≙biological≙(acid-base≙balance)≙conditions≙and≙concomitant≙therapy≙should≙be≙taken≙into≙account.≙Fluid≙balance,≙
serum≙glucose,≙serum≙sodium≙and≙other≙electrolytes≙may≙need≙to≙be≙monitored≙before≙and≙during≙admi