Document: leaflet MAH GENERIC_PL 03551-0088 change

• leaflet MAH GENERIC_PL 00116-0334
• leaflet MAH GENERIC_PL 03551-0088

---

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.

-    If any of the side effects gets 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 0.9 % w/v Intravenous Infusion BP is and what it is used for

2.    Before you are given this medicine

3.    How to use this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Further information

1.    WHAT SODIUM CHLORIDE 0.9 % W/V INTRAVENOUS INFUSION BP IS AND WHAT IT IS USED FOR

This medicine is a solution for infusion, that is administered to you through a cannula placed into a vein.

It will be given to you by infusion when you are lacking water and salt or it is used as a vehicle to deliver other medications.

2.    BEFORE YOU ARE GIVEN THIS MEDICINE

YOU SHOULD NOT RECEIVE THIS MEDICINE

•    if you have swelling of the lower limbs due to too much water in your body tissues (hyperhydration).

The polyethylene plastic bottle contains a significant volume of air. To avoid risk of air embolism, expel all air before pressure infusion.

SPECIAL CARE WILL BE TAKEN WITH THIS MEDICINE if you have any of the following:

•    heart disease

•    kidney problems

•    abnormally low levels of potassium in your body fluids and tissues (hypokalaemia)

•    abnormally high levels of sodium in your body fluids and tissues (hypernatraemia)

Sodium Chloride 0.9 % w/v Intravenous Infusion BP

Sodium Chloride

•    abnormally high levels of chloride in your blood (hyperchloraemia)

•    swelling of the limbs, too much water in your body tissues (generalised oedema)

•    lung disease or congestion of or water on the lungs (pulmonary oedema)

•    high blood pressure (hypertension)

•    eclampsia (a disorder that may occur during pregnancy, including swelling, protein in urine and high blood pressure)

TAKING OR USING OTHER MEDICINES

If you are taking any medicines, tell your doctor, so that the amount of Sodium Chloride 0.9 % w/v Intravenous Infusion BP can be adjusted accordingly.

Especially if you are taking drugs that lower sodium excretion, the amount of Sodium Chloride 0.9 % w/v Intravenous Infusion BP will be adjusted carefully.

If you receive medicines that contain lithium, special care will be taken to keep your sodium level normal.

PREGNANCY AND BREAST-FEEDING 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 or use machines.

3. HOW TO USE THIS MEDICINE

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.

The medicine will be administered to you by infusion through a vein.

While you receive this medicine by infusion, your 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 lower dosage, dependent upon their age.

BlBRAUN

10.07.14 07:23

5/436464/Version2

IF YOU HAVE RECEIVED MORE SODIUM CHLORIDE 0.9 % W/V INTRAVENOUS INFUSION BP THAN YOU SHOULD

It is unlikely that you receive an overdose of the solution as your dose will be determined by a doctor. Yet if you have received too much of the solution, your infusion will be stopped immediately and additionally you may be given medication to normalise your fluid and salt levels.

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 0.9 % w/v Intravenous Infusion BP can cause side effects although not everybody gets them.

Side effects are mainly associated with the administration of large amounts of the solution.

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, 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

•    headaches, dizziness

•    restlessness

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

•    diarrhoea or pain in your abdomen

•    pain or tenderness at the injection site

•    dry mouth or feeling thirsty

•    sweating or feeling feverish

If any of the side effects gets 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 THIS MEDICINE

Keep this medicine out of the reach and sight of children. It could harm them.

Do not use this medicine 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.

This medicine is for single use only. Discard any unused medicine.

This medicinal product does not require any special storage conditions.

This medicine should be clear in appearance. Do not use if it is cloudy or if the container has been damaged. 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 0.9 % w/v Intravenous Infusion BP contains

•    The active substance is sodium chloride.

1000 ml of the solution contain 9.0 g of sodium chloride.

•    The other ingredient is water for Injections

What Sodium Chloride 0.9 % w/v Intravenous Infusion BP looks like and contents of the pack

This medicine is a solution for infusion (a solution for administration through a cannula placed into a vein). It is a clear colourless sterile solution of sodium chloride in water.

It is supplied in polyethylene plastic bottles holding 50 ml, 100 ml, 250 ml, 500 ml or 1000 ml of solution available in the pack sizes 20 x    50 ml    10    x    500 ml

20 x    100 ml    10    x    1000 ml,

10 x 250 ml

or in plastic bags holding

100 ml, 250 ml, 500 ml or 1000 ml of solution

available in the pack sizes:

20 x    100 ml    20    x    500 ml

20 x    250 ml    10    x    1000 ml

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 approved in July 2014.

BlBRAUN

B. Braun Melsungen AG

34209 Melsungen, Germany

436464_Soidum_EP_GIF_A5_GB_5_Version_2.indd 2