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SODIUM CHLORIDE 1 MMOL/ML ORAL SOLUTION

Active substance(s): SODIUM CHLORIDE

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PACKAGING LEAFLET: INFORMATION FOR THE PATIENT

65mm

Sodium Chloride 1 mmol/ml Oral Solution

260mm

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Please read all of this leaflet carefully before your infant is given this medicine.
• Keep this leaflet. You may need to read it again
• If you have further questions, please ask the hospital doctor who is looking after your infant.
• If you notice any side effects, talk to your doctor. This includes any possible side effects not
listed in the leaflet. See section 4.
What is in this leaflet:
1. What Sodium Chloride 1 mmol/ml Oral Solution is and what it is used for
2. What you need to know before your infant is given Sodium Chloride 1 mmol/ml Oral Solution
3. How Sodium Chloride 1 mmol/ml Oral Solution is given
4. Possible side effects
5. How Sodium Chloride 1 mmol/ml Oral Solution is stored
6. Contents of the pack and other information
1. What Sodium Chloride 1 mmol/ml Oral Solution is and what it is used for:
Sodium Chloride 1 mmol/ml Oral Solution is a source of sodium chloride used to correct hyponatraemia
(low blood sodium levels) in infants. Sodium chloride is found widely in the body, and is important to
normal body functions.
2. What you need to know before your child is given Sodium Chloride 1 mmol/ml Oral Solution:
Your child should not be given this medicine if there is known hypersensitivity (allergy) to any of the
ingredients listed in Section 6.
Warnings and Precautions:
Your child should not be given this medicine if they have:
• Fluid retention
• Heart failure
• Intestinal obstruction
• Aldosteronism (a condition where too much aldosterone [a hormone] is produced)
• Liver or kidney disease
If you think you are affected by any of these consult your doctor or pharmacist before taking this medicine.
Other medicines and Sodium Chloride 1 mmol/ml Oral Solution:
You should tell your child’s doctor if they are having any medicines, including those obtained without a
prescription.
Sodium Chloride 1 mmol/ml Oral Solution Contains Sodium:
Sodium Chloride 1 mmol/ml Oral Solution contains 23 mg sodium per 1 ml of the solution. Equivalent to
58.44 mg of sodium chloride (salt) in 1 ml of the solution.
3. How Sodium Chloride 1 mmol/ml Oral Solution is given.
Warnings:
• Sodium Chloride 1 mmol/ml Oral Solution is given by mouth and must be diluted before use.
• Always give this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
• Shake the Sodium Chloride 1 mmol/ml Oral Solution bottle before use.
• Always ensure the product is added and thoroughly mixed into the drink, breast milk or formula feed
immediately before administration.

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How the medicine should be given - must be diluted before use
Figure 1

Figure 2
Remove the cap
from the bottle
by pressing
down firmly and
turning
anticlockwise.

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Figure 5

Figure 3
Hold the bottle
tightly on a firm
surface and
push the bottle
adaptor into the
neck of the
bottle. Push it
down until it is
flush with the
top of the
bottle.

Figure 6
If there is an air
bubble in the
syringe gently
push the
plunger back
upwards until
the air bubble is
expelled back
into the bottle.

Figure 4
Take the syringe
and put it in the
small hole in the
bottle adaptor.

Figure 7
Then pull the
plunger down
to the
graduation
mark
corresponding
to the quantity
in millilitres (ml)
prescribed by
your doctor.

To fill the
syringe turn the
bottle with the
syringe
attached upside
down. Gently
pull the plunger
down drawing
the medicine
into the the
syringe.

Figure 8
Turn the bottle
the right way up
and remove the
syringe.

Dilute the
medicine by
emptying the
syringe contents
into a drink,
breast milk or
formula feed.
Carefully mix the
drink, milk or
feed to ensure
thorough mixing
of the medicine.

The dose can vary according to need, and your doctor will normally advise how much to give. In the case
of infants this will normally be calculated based on bodyweight in kg. As a guide:
Infants: 3 to 5 mmol/kg (3 to 5 ml of Sodium Chloride 1 mmol/ml Oral Solution per kg) daily in divided
doses. Dosages can be adjusted according to patient requirements.

If your child is given too much:
If your child is accidentally given too much Sodium Chloride 1 mmol/ml Oral Solution it should not be
harmful. However, the side effects described below may become more noticeable. If a large excess is
given, your child should see a doctor or be taken to hospital straight away. Take this medicine with
you. It is particularly important to do this for the very young, or if the child in your care has severe liver
or kidney disease. If signs of side effects are noticed, please tell your doctor.
4. Possible Side Effects:
Side effects from Sodium Chloride 1 mmol/ml Oral Solution can occur when too much is given
accidentally. They should not occur when this medicine is used as described.
Serious Side Effects:
If your child experiences any of the following reactions stop taking Sodium Chloride 1 mmol/ml Oral
Solution and contact your doctor IMMEDIATELY:
• Thirst (Not always obvious in children, especially very young infants)
• Lethargy
• Weakness
• Irritability
• Confusion
• Twitching
In more extreme cases this can lead to:
• Seizures
• Coma
Reporting of side effects:
If you notice any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in the leaflet. You can also report side effects directly via the yellow card scheme, Website:
https://yellowcard.mhra.gov.uk. By reporting side effects you can help provide more information on
the safety of this medicine.
5. How Sodium Chloride 1 mmol/ml Oral Solution is stored:
Keep this bottle tightly closed.
Keep out of reach and sight of children.
Store in the original container and carton.
Do not use this medicine after the expiry date which is stated on the carton and bottle label, or if the
solution appears discoloured or cloudy.
Use within 1 month of first opening.
6. Contents of the pack and other information:
What Sodium Chloride 1 mmol/ml Oral Solution contains:
The active substance is sodium chloride 1 mmol/ml.
Other ingredients are potassium sorbate (E202), citric acid (E330) and purified water.
What this product looks like and contents of the pack:
Sodium Chloride 1 mmol/ml Oral Solution is a clear, colourless liquid in a 100 ml amber glass bottle.
Each pack contains one bottle of solution, a 5ml dosing syringe and a syringe adaptor to fit into the
bottle when measuring the dose.
Marketing Authorisation Holder:
Viridian Pharma Ltd,
Yew Tree House,
Hendrew Lane,
Llandevaud, Newport,
Gwent
NP18 2AB
United Kingdom
Manufacturers:
St Mary’s Pharmaceutical Unit
Cardiff and Vale University Health Board
20 Field Way
Cardiff
CF14 4HY
United Kingdom
Quest Healthcare Solutions Ltd.
Unit 5, Mount Street Business Park,
Mount Street,
Nechells,
Birmingham
B7 5QU
United Kingdom
Marketing Authorisation Number:
20346/0008
This leaflet was approved:
23rd June 2015

VIRSOCv8

148.5mm

100mm Measurement Verification Bar

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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