PACKAGE LEAFLET:

INFORMATION FOR THE USER

B. Braun Melsungen AG ■ 34209 Melsungen ■ Germany

Read all of this leaflet carefully before you start using this medicine.

-    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

In this leaflet:

1.    What Sodium Chloride 0.45% w/v Intravenous Infusion BP is and what it is used for

2.    Before you use Sodium Chloride 0.45% w/v Intravenous Infusion BP

3.    How to use Sodium Chloride 0.45% w/v Intravenous Infusion BP

4.    Possible side effects

5.    How to store Sodium Chloride 0.45% w/v Intravenous Infusion BP

6.    Further information

1.    WHAT SODIUM CHLORIDE 0.45 W/V INTRAVENOUS INFUSION BP IS AND WHAT IT IS USED FOR

Sodium Chloride 0.45% w/v Intravenous Infusion BP is a solution of salt. It is mainly used for supply of fluid while providing also a certain amount of salt (electrolyte).

It will be given to you by infusion (by a vein drip) when you are dehydrated and require fluids.

2.    BEFORE YOU USE SODIUM CHLORIDE 0.45 W/V INTRAVENOUS INFUSION BP

YOU SHOULD NOT RECEIVE THIS MEDICINE if you have any of the following:

•    swelling of the limbs, to too much water in your body tissues (hyperhydration)

•    abnormally low levels of electrolytes in your body fluids and tissues due to loss of fluid (hypotonic dehydration).

This container contains a significant volume of air. To avoid risk of air embolism, this product must not be administered by pressure infusion.

SPECIAL CARE SHOULD BE TAKEN WITH THIS MEDICINE

if you have any of the following:

•    abnormally low levels of sodium in your body fluids and tissues (hyponatraemia)

•    hypertension

•    heart, lung, or kidney disease.

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Sodium Chloride 0.45% w/v

Intravenous Infusion BP

Sodium chloride

TAKING OR USING OTHER MEDICINES

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, so that the amount of Sodium Chloride 0.45% w/v Intravenous Infusion BP can be adjusted accordingly.

In particular, tell your doctor if you are on medication with

•    medicines that contain lithium

•    any medicines making you retain sodium and water, like cortisones or other medicines acting similarly.

PREGNANCY AND BREAST-FEEDING

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

If you think you are likely to be pregnant, tell your doctor immediately. This medicine can be given while you are pregnant if your doctor considers it necessary.

Breast-feeding

If you are breast feeding, tell your doctor immediately. This medicine can be given while you are breast feeding if your doctor considers it necessary.

DRIVING AND USING MACHINES

This medicine has no influence on the ability to drive and use machines

3. HOW TO USE SODIUM CHLORIDE 0.45 W/V INTRAVENOUS INFUSION BP

The medicine will be administered to you by infusion (a drip) into a vein.

The amount of the medicine that you will be given will be determined by your doctor and will depend on your age, weight and clinical condition.

While you receive this medicine your blood glucose, and electrolyte (salt) levels and water balance will be monitored routinely.

The normal maximum dosage for an adult is 40 ml/kg body weight/day.

Children will receive a reduced dosage dependent upon their age or body weight, respectively.

B BRAUN

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IF YOU RECEIVED MORE SODIUM CHLORIDE 0.45% W/V INTRAVENOUS INFUSION BP THAN YOU SHOULD

It is unlikely that this happens as your infusion will be controlled by a doctor or nurse.

Yet if overdose occurs, you may experience disorders of fluid balance and serum electrolytes, swelling and heart or circulation disorders.

Further symptoms are described below (4. Possible side effects).

The therapy to normalise your condition will be determined by your doctor.

It may include stopping of the infusion and administration of suitable medicines to treat the symptoms observed. In extreme situations you may also need dialysis. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Sodium Chloride 0.45% w/v Intravenous Infusion BP can cause side effects, although not everybody gets them.

If any of the following happen, tell your doctor immediately or go to the emergency department at your nearest hospital:

•    difficulty in breathing

•    sudden severe chest pain

•    slowing or quickening of your heart beat

•    high blood pressure (hypertension)

•    bad fainting attacks, convulsions (fits) or collapse

•    weakness, paralysis, spasms, motor disturbances (of muscular movements)

•    very marked numbness, swelling or heaviness of your limbs

•    cold skin or grey pallor

•    difficulty in swallowing

•    confusion.

Tell your doctor if you notice any of the following side effects:

•    nausea (feeling sick), vomiting (being sick)

•    diarrhoea or pain in the belly

•    pain or tenderness at the site of injection

•    dry mouth or feeling thirsty

•    sweating or feeling feverish

•    headaches, dizziness

•    restlessness.

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov. uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE SODIUM CHLORIDE 0.45 W/V INTRAVENOUS INFUSION BP

Keep your medicine out of the reach and sight of children. Your medicine could harm them.

Do not use Sodium Chloride 0.45% w/v Intravenous Infusion BP after the expiry date which is stated on the label and the outer carton. The expiry date refers to the last day of that month.

Do not store above 25 °C.

This medicine should be clear in appearance. Do not use if it is cloudy or if the container has been damaged. This medicine is for single use only. Discard any unused medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Sodium Chloride 0.45% w/v Intravenous Infusion BP contains

•    The active substance is sodium chloride.

1000 ml of solution contain 4.50 g of sodium chloride

•    The other ingredient is water for injections.

What Sodium Chloride 0.45% w/v Intravenous Infusion BP looks like and contents of the pack

This medicine is a solution for infusion (for administration by a vein drip).

It is a clear colourless sterile solution of sodium chloride in water.

It is supplied in polyethylene bottles containing 500 ml or 1000 ml, each available in packs of 10 bottles

Marketing Authorisation Holder

B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany

Manufacturer

B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen, Germany

or

B. Braun Medical S.A.

Carretera de Terrassa 121 08191 Rubi, Barcelona, Spain

This leaflet was last revised in June 2014.

B. Braun Melsungen AG

34209 Melsungen, Germany

445627_SodChl045_A5GIF_GB_122.indd 2 11.07.14 07:18