Sodium chloride 5 mmol/ml Oral Solution

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Sodium chloride

Dostępny od:

Syri Pharma Limited t/a Thame Laboratories

Kod ATC:

A12CA01

INN (International Nazwa):

Sodium chloride

Dawkowanie:

5 millimole(s)/millilitre

Forma farmaceutyczna:

Oral solution

Dziedzina terapeutyczna:

sodium chloride

Status autoryzacji:

Not marketed

Data autoryzacji:

2018-11-30

Ulotka dla pacjenta

VAR/IA-005
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PACKAGE LEAFLET: INFORMATION FOR THE USER
SODIUM CHLORIDE 5MMOL/ML ORAL SOLUTION
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 pharmacist. 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 chloride
6. Contents of the pack and other information
1.
WHAT SODIUM CHLORIDE IS AND WHAT IT IS USED FOR
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.
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

Charakterystyka produktu

Health Products Regulatory Authority
02 May 2023
CRN00DFXZ
Page 1 of 5
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.
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 immediately before
administration.
_Renal impairment_
Dose adjustment may be necessary de