0.9 % w/v Sodium Chloride Injection BP

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Sodium chloride

Dostupné z:

B. Braun Medical Limited

ATC kód:

V07AB

INN (Medzinárodný Name):

Sodium chloride

Dávkovanie:

0.9 percent weight/volume

Forma lieku:

Solution for injection

Typ predpisu:

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

Terapeutické oblasti:

Solvents and diluting agents, incl. irrigating solutions

Stav Autorizácia:

Marketed

Dátum Autorizácia:

1987-04-08

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
B. Braun Melsungen AG · 34209 Melsungen, Germany
0.9% w/v Sodium Chloride Injection BP
Sodium chloride
5/13600370/0120
schwarz
Format = 210 x 297 mm (DIN A4)
2 Seiten
Lätus
982
IE___5
5/13600370/0120
GIF – MPc, MPb
Production site: Berlin
Font size: 9.5 pt.
G 121557
B|BRAUN
_Pregnancy_
As the concentrations of sodium and chloride are similar to that in
human body no harmful effects are to be expected if the product is
used as indicated.
_Breast-feeding_
As the concentration of sodium and chloride are similar to that in
human body no harmful effects are to be expected if the product
is used as indicated. 0.9% w/v Sodium Chloride Injection BP can be
used during breast-feeding, if required.
DRIVING AND USING MACHINES
0.9% w/v Sodium Chloride Injection BP has no influence on the ability
to drive and use machines.
3. HOW TO USE 0.9% W/V SODIUM CHLORIDE INJECTION BP
The medicinal product is used to prepare injections (preparations
administered by a syringe). It will be administered into your vein
(intravenous use), into your muscle (intramuscular use) or under your
skin (subcutaneous use).
_Dosage_
The amount of the medicinal product that you will be given depends
on the instructions given for the drug to be dissolved or diluted.
IF YOU USE MORE 0.9% W/V SODIUM CHLORIDE INJECTION BP THAN
YOU SHOULD:
An overdose could lead to abnormally high fluid, sodium and chloride
levels in your blood and high levels of acidic substances in your
blood
(your blood getting sour).
In such a case your injection will be stopped immediately.
Additionally
you may be given water tablets to increase your urine flow. Your
blood electrolyte levels will be monitored continuously. Your doctor
will decide on further medication or other measures to normalise your
electrolyte levels, water balance and acid-base balance.
If you have any further questions on the use of this medicine, ask
your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although

Súhrn charakteristických

Health Products Regulatory Authority
25 February 2020
CRN0092RS
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
0.9 % w/v Sodium Chloride Injection BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains
Sodium Chloride 9 mg
_Electrolyte concentrations:_
Sodium 154 mmol/l
Chloride 154 mmol/l
_ _
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless aqueous solution
Theoretical osmolarity 308 mOsm/l
Acidity (titration to pH 7.4) < 0.3 mmol/l
pH 4.5‑7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Solvent or diluent for compatible medicinal products.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage, Route of administration and the duration of use depend on the
instructions given for the medicinal product to be
dissolved or diluted.
Method of administration
Intravenous, intramuscular or subcutaneous use.
For the use of this solution as solvent/diluent for compatible
medicinal products, the instructions for use relating to the
medicinal product to be added must be observed.
4.3 CONTRAINDICATIONS
0.9% w/v Sodium Chloride Injection BP must not be administered to
patients with

severe hypernatraemia

severe hyperchloraemia
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
0.9% w/v Sodium Chloride Injection BP should only be administered with
caution in cases of:

hypernatraemia
Health Products Regulatory Authority
25 February 2020
CRN0092RS
Page 2 of 4

hyperchloraemia
Clinical monitoring should include checks of the serum ionogram, the
acid-base status and water balance.
Please note: The safety information of the additive provided by the
respective manufacturer have to be taken into account.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
_Medicinal products causing sodium retention_
The concomitant use of sodium-retaining drugs (e.g. corticosteroids,
non-steroidal anti-inflammatory agents) may lead to
oedema.
4.6 FERTILITY, PREGNANCY AND LACTATION
Pregnancy
The