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

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Glucose; Sodium chloride

Tillgänglig från:

B. Braun Medical Limited

ATC-kod:

B05BB; B05BB02

INN (International namn):

Glucose; Sodium chloride

Dos:

0.18 and 4 percent weight/volume

Läkemedelsform:

Solution for infusion

Receptbelagda typ:

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

Terapiområde:

Solutions affecting the electrolyte balance; electrolytes with carbohydrates

Bemyndigande status:

Marketed

Tillstånd datum:

1983-04-01

Bipacksedel

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

Produktens egenskaper

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