Sodium chloride 5 mmol/ml Oral Solution

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Sodium chloride

Commercializzato da:

SYRI Limited, t/a Thame Laboratories

Codice ATC:

A12CA01

INN (Nome Internazionale):

Sodium chloride

Dosaggio:

5 millimole(s)/millilitre

Forma farmaceutica:

Oral solution

Tipo di ricetta:

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

Area terapeutica:

sodium chloride

Stato dell'autorizzazione:

Not marketed

Data dell'autorizzazione:

2018-11-30

Foglio illustrativo

READ ALL OF THIS LEAFLET
CAREFULLY BEFORE YOU START
TAKING 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 pharmacist.
►
This medicine has been prescribed for
you only. Do not pass it on to others.
It may harm them, even if their signs
of illness are the same as yours.
►
If you get any side effects, talk to
your doctor or pharmac
ist. This
includes any possible side effects not
listed in this leaflet. See section 4.
The name of your medicine is Sodium
chloride 5mmol/ml Oral Solution but it
will be referred to as Sodium chloride
throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Sodium chloride is and what it
is used for
2.
What you need to know before you
take Sodium chloride
3.
How to take Sodium chloride
4.
Possible side effects
5.
How to store Sodium c
hloride
6.
Contents of the pack and other
information
Sodium chloride is the chemical name for
salt. Sodium is an electrolyte that
regulates the amount of water in your
body. Sodium also plays a part in
transmission of nerve impulses and
muscle contractions.
Sodium chloride is used for the
treatment of sodium chloride deficiency.
ELECTROLYTES
ELECTROLYTES ARE MINERALS IN THE CELLS
AND BLOOD that conduct electrical
impulses and messages. These minerals
can be lost through sweating, excessive
vomiting, diarrhoea and excessive
exercise.
When these electrolytes are not replaced,
conditions such as muscle cramping and
weakness will arise.
PACKAGE LEAFLET: INFORMATION FOR THE USER
SODIUM CHLORIDE 5MMOL/ML ORAL SOLUTION
PIL/IE/MFG012/08/v2
TURN OVER
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SODIUM CHLORIDE
DO NOT TAKE SODIUM CHLORIDE:
► If you have high sodium levels
►
If you have oedema
►
If you have heart disease
► If you have a disorder producing
more aldosterone hormone than
normal
►
If you have a condition where the
heart needs help to maintain blood
circulation
►
If you are taking medication that
causes salt and wa

Scheda tecnica

Health Products Regulatory Authority
06 December 2018
CRN008K3M
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium chloride 5 mmol/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 5mmol (292.2mg) of sodium chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sodium chloride is indicated for the treatment of sodium chloride
deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosing regimen has been empirically derived. It is
therefore
important that dosage selection should be adjusted according to the
age, weight, the
extent of sodium deficit and clinical condition of the patient.
_Adults (including the elderly)_:
A typical oral replacement dose of sodium chloride in chronic
salt-losing conditions
is about 40-80 mmol (8ml-16ml) of sodium daily, given as divided
doses. Serum
sodium concentration in patients should be raised by not more than 10
mmol/L to
12mmol/L of body water during the first 24 hours of treatment or 18
mmol/L/48
hours should be observed.
_Paediatric population_
Dosage in children (1 month to 18 years) should be adjusted to
individual's need.
Typically, children should receive 1-2mmol/kg (0.2-0.4ml/kg) in
divided doses over a
24 hour period.
Health Products Regulatory Authority
06 December 2018
CRN008K3M
Page 2 of 7
Neonates
Treatment with Sodium Chloride 5mmol/ml Oral Solution should only be
initiated
under the supervision of specialist paediatric physicians. Dosage
should be adjusted
if necessary according to clinical need and after plasma sodium
monitoring.
3 to 5 mmol per kg daily in divided doses. Dosages can be adjusted
according to
patient requirements. Example dilutions are 2 mmol diluted in 100ml
formula feed, or
3 to 4 mmol diluted in 100 ml breast milk.
Always ensure the product is added and thoroughly mixed into the
drink, breast milk
or formula feed immediat