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SODIUM CHLORIDE 0.45% W/V INTRAVENOUS INFUSION BP

Active substance(s): SODIUM CHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

B. Braun Melsungen AG · 34209 Melsungen · Germany

122/445627/0714

Sodium Chloride
0.45% w/v
Intravenous Infusion BP
Sodium chloride

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.

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.

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Dokument = 148 x 210 mm (A5)
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GB___122
Sodium Chloride 0.45% w/v
Intravenous Infusion BP
122/445627/0714
Lätus

Font size: 8 pt.

G 080991

122/445627/0714

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
Postal address
34212 Melsungen
34209 Melsungen
Germany
Germany
Manufacturer
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen, Germany
or
B. Braun Medical S.A.
Carretera de Terrassa 121
08191 Rubí, Barcelona, Spain
This leaflet was last revised in June 2014.

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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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