Advanced search

Report side effect

Report a suspected side effect or falsified product to the MHRA Yellow Card scheme.
Go to {yellow_card_logo} site
{arrow_up} Back to top

Sterile Sodium Chloride Concentrate BP 30% w/v

Active Ingredient:
sodium chloride
Company:  
Martindale Pharma, an Ethypharm Group Company See contact details
About Medicine
{medical_services}
Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
{arrow_left}
{arrow_right}
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
{info_black}
Last updated on emc: 14 Feb 2022
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL1883/6158.

{printer} Print patient leaflet as text only
{printer} Print patient leaflet in large text

Sterile Sodium Chloride Concentrate 30% w/v (ampoule)

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sterile Sodium Chloride Concentrate 30% w/v

Concentrate for Solution for Infusion Sodium Chloride

Read all of this leaflet carefully before you are given this medicine.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1. What Sterile Sodium Chloride Concentrate is and what it is used for
2. What you need to know before you use Sterile Sodium Chloride Concentrate
3. How to use Sterile Sodium Chloride Concentrate
4. Possible side effects
5. How to store Sterile Sodium Chloride Concentrate
6. Contents of the pack and other information

1. What Sterile Sodium Chloride Concentrate is and what it is used for

Sodium Chloride belongs to a group of medicines called electrolytes. The balance of the electrolytes in the body is essential for normal function of our cells and our organs.

Sterile Sodium Chloride Concentrate, when diluted, is used to put electrolytes back into your body. Electrolytes are lost through too much sweating, prolonged diarrhoea or vomiting. This can eventually lead to excess water loss from the body (dehydration).

2. What you need to know before you use Sterile Sodium Chloride Concentrate
Do not use Sterile Sodium Chloride Concentrate if:
  • you are allergic (hypersensitive) to Sodium Chloride

If you are unsure about being given this medicine or you have any questions, talk to your doctor or nurse.

Warnings and precautions

Talk to your doctor or nurse before using Sterile Sodium Chloride Concentrate if:

  • you have heart disease or other heart problems
  • you suffer from water retention
  • you suffer from high blood pressure
  • you suffer kidney problems
  • you suffer from water on the lungs
  • you suffer from a serious complication of pregnancy known as pre-eclampsia (the symptoms of which include 2 or more of the following; high blood pressure, fluid retention or protein in the urine).
  • you suffer from diabetes

Special care should be taken when Sterile Sodium Chloride Concentrate is given to children and the elderly.

If any of the above apply to you or your child please tell your doctor before you are given Sterile Sodium Chloride Concentrate

Other medicines and Sterile Sodium Chloride Concentrate

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Medicines which may interact with Sterile Sodium Chloride Concentrate include:

  • streptomycin sulphate, a medicine used to treat tuberculosis and other bacterial infections

If you have any doubts about whether this medicine should be administered to you, consult your doctor or nurse.

Pregnancy and breast-feeding

Sterile Sodium Chloride Concentrate is usually suitable for use whilst you are pregnant or breast-feeding however you should ask your doctor for advice before you are given this medicine.

Driving and using machines

There are no known effects of having Sterile Sodium Chloride Concentrate on driving or using machines.

3. How to use Sterile Sodium Chloride Concentrate
Adults, the elderly and children

Your doctor will decide the amount of Sterile Sodium Chloride Concentrate you need depending on your age, weight and general health. You will be given Sterile Sodium Chloride Concentrate into a vein (intravenously) once it has been diluted.

If you are given more Sterile Sodium Chloride Concentrate than you should be

As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns.

4. Possible side effects

Like all medicines, Sterile Sodium Chloride Concentrate can cause side effects, although not everybody gets them.

Possible side effects include:

  • feeling or being sick
  • stomach pains
  • diarrhoea
  • feeling thirsty
  • a dry mouth or eyes
  • sweating
  • fever
  • a fast or irregular heartbeat
  • kidney problems
  • water on the lungs
  • water retention (the symptoms of which include swelling of the ankles or shortness of breath)
  • headache
  • dizziness
  • feeling restless or irritable
  • feeling weak
  • muscle twitching and stiffness
  • feeling sleepy or confused
  • fits
  • breathing difficulties

Infants may experience the following side effects:

  • fits
  • breathing quickly
  • flared nostrils (caused by difficulty breathing)
  • coma

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sterile Sodium Chloride Concentrate

Keep out of the sight and reach of children.

Do not use Sterile Sodium Chloride Concentrate after the expiry date which is printed on the carton and ampoule label after EXP. The doctor or nurse will check that the expiry date on the label has not been passed before administering the injection to you. The expiry date refers to the last day of that month.

Store below 25°C

The ampoule containing the injection will only be used for you and if any injection is left over the doctor/ nurse will dispose of it.

6. Contents of the pack and other information
What Sterile Sodium Chloride Concentrate contains

The active substance is Sodium Chloride 300mg/ml

The other ingredient is water for injections. Sterile Sodium Chloride Concentrate may also contain hydrochloric acid or sodium hydroxide.

What Sterile Sodium Chloride Concentrate looks like and contents of the pack

Sterile Sodium Chloride Concentrate 30% w/v, Concentrate for Solution for Infusion is a clear colourless solution supplied in 2ml and 10ml clear glass ampoules. Each pack contains 10 ampoules.

Manufacturer
Martindale Pharmaceuticals
Bampton Road
Harold Hill
Romford
Essex
RM3 8UG
UK

Marketing Authorisation Holder in UK
Martindale Pharmaceuticals Ltd
Bampton Road
Harold Hill
Romford
Essex
RM3 8UG
UK

If you would like any more information, or you would like the leaflet in a different format, please contact Medical Information at the above address.

This leaflet was last approved in November 2021

Product License Number: PL 01883/6158

Martindale Pharmaceuticals
Bampton Road
Harold HIll
Romford
RM3 8UG
United Kingdom

D05651

Martindale Pharma, an Ethypharm Group Company
Company image
Address
Jupiter House, Mercury Park, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0HH, UK
WWW
http://ethypharm.co.uk/
Telephone
+44 (0) 1277 266 600
Medical Information e-mail
[email protected]