SODIUM CHLORIDE 0.9% W/V INTRAVENOUS INFUSION BP

Active substance: SODIUM CHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Sodium Chloride 0.9% w/v Intravenous Infusion BP
Active substance: sodium chloride
Read all of this leaflet carefully before you are given this medicine
because it contains important information for you.
• 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.

• high blood pressure (hypertension)
• build up of fluid under the skin, particularly around the
ankles (peripheral oedema)
• build up of fluid in the lungs (pulmonary oedema)
01809
• high blood pressure during pregnancy (pre-eclampsia)
• raised production of the hormone aldosterone (aldosteronism)
• any other condition associated with sodium retention (when the
body retains too much sodium), such as treatment with steroids
(See also below “Other medicines and Sodium 0.9 Infusion”).

This medicine is called Sodium Chloride 0.9% w/v Intravenous Infusion
BP, but will be referred to as Sodium 0.9 Infusion throughout the
remainder of this leaflet.

When you are given this infusion, your doctor will take blood and urine
samples to monitor:
• the amount of fluid in your body
• your vital signs
• the amount of chemicals such as sodium and potassium in your
blood (your plasma electrolytes).

What is in this leaflet:
1. What Sodium 0.9 Infusion is and what it is used for
2. What you need to know before you are given Sodium 0.9
Infusion
3. How you will be given Sodium 0.9 Infusion
4. Possible side effects
5. How to store Sodium 0.9 Infusion
6. Contents of the pack and other information

Your doctor will take into account if you are receiving parenteral
nutrition (nutrition given by infusion into a vein). During long term
treatment with Sodium 0.9 Infusion you may need to be given extra
nutrition.

1. What Sodium 0.9 Infusion is and what it is used for

Other medicines and Sodium 0.9 Infusion

Sodium 0.9 Infusion is a solution of sodium chloride in water. Sodium
chloride is a chemical substance (often called “salt”) found in the
blood.

Sodium 0.9 Infusion with food and drink

Tell your doctor or nurse if you are using, have recently used or might
use any other medicines.

You should ask your doctor about what you can eat or drink.

Sodium 0.9 Infusion is used to treat:
• a loss of body water (dehydration)
• a loss of sodium from the body (sodium depletion)

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Tell your doctor if you are pregnant or breast-feeding. You may receive
Sodium 0.9 Infusion if you are pregnant or breast-feeding. The amount
you are given must be carefully controlled by your doctor.

Situations that may cause sodium chloride and water loss include:
• when you cannot eat or drink, due to illness or after surgery
• pronounced sweating due to high fever
• extensive skin loss, as can occur in severe burns.

However, if another medicine is to be added to your solution for infusion
during pregnancy or breast-feeding you should:
• consult your doctor
• read the Patient Information Leaflet of the medicine that is to be
added.

Sodium 0.9 infusion may also be used to deliver or to dilute other
medicines for infusion.

2. What you need to know before you are given
Sodium 0.9 Infusion

Driving and using machines
Sodium 0.9 Infusion does not affect your ability to drive or use
machines.

Do NOT receive Sodium 0.9 Infusion if you are suffering
from any of the following conditions

3. How you will be given Sodium 0.9 Infusion

• higher levels of chloride in the blood than normal (hyperchloraemia)
• higher levels of sodium in the blood than normal (hypernatraemia).

Sodium 0.9 Infusion will be given to you by a doctor or nurse. Your
doctor will decide on how much you need and when it is to be given.
This will depend on your age, weight, condition, the reason for
treatment and whether or not the infusion is being used to deliver or
dilute another medicine.

If a medicine has been added to Sodium 0.9 Infusion, the Patient
Information Leaflet of the added medicine must be consulted to
determine whether or not you can receive the solution.

Warnings and Precautions

The amount you are given may also be affected by other treatments
you are receiving.

Please tell your doctor if you have or have had any of the following
medical conditions:
• any type of heart disease or poor heart function
• poor kidney function

You should NOT be given Sodium 0.9 Infusion if there are particles
floating in the solution or if the pack is damaged in any way.

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Sodium 0.9 Infusion will usually be given to you through a plastic tube
attached to a needle in a vein. Usually a vein in your arm is used to
give you the infusion. However, your doctor may use another method to
give you the medicine.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

When you are given Sodium 0.9 Infusion, your doctor will perform
blood tests to monitor your blood levels of:
• electrolytes (such as sodium, and chloride) and other chemical
substances that are normally in your blood like creatinine
(a breakdown product from the muscles).

The side effects that may occur due to the administration technique
include:
• fever (febrile response)
• infection at the site of infusion
• local pain or reaction (redness or swelling at the site of infusion)
• irritation and inflammation of the vein into which the solution is
infused (phlebitis). This can cause redness, pain or burning and
swelling along the path of the vein into which the solution is
infused.
• the formation of a blood clot (venous thrombosis) at the site of
infusion which causes pain, swelling or redness in the area of the
clot
• escape of the infusion solution into the tissues around the vein
(extravasation). This can damage the tissues and cause scarring.
• an excess of fluid in the blood vessels (hypervolaemia).

Any unused solution should be thrown away. You should NOT be given
an infusion of Sodium 0.9 Infusion from a bag that has been partly
used.

If you receive more Sodium 0.9 Infusion than you should
If you are given too much Sodium 0.9 Infusion (over-infusion), this may
lead to the following symptoms:
• nausea (feeling sick)
• vomiting
• diarrhoea (loose stools)
• stomach cramps,
• thirst
• dry mouth
• dry eyes
• sweating
• fever
• rapid heart rate (tachycardia)
• raised blood pressure (hypertension)
• kidney failure (renal failure)
• fluid collection in the lungs making it difficult to breathe
(pulmonary oedema)
• fluid collection under the skin, particularly around the ankles
(peripheral oedema)
• stopping breathing (respiratory arrest)
• headache
• dizziness
• restlessness
• irritability
• weakness
• muscular twitching and stiffness
• convulsions
• acidification of the blood (acidosis), leading to tiredness, confusion,
lethargy and increased breathing rate.

If a medicine has been added to the solution for infusion, the added
medicine may also cause side effects. These side effects will depend
on the medicine that has been added. You should read the Patient
Information Leaflet of the added medicine for a list of possible
symptoms.
Please tell your doctor or nurse if you notice any listed or unlisted side
effects. If any side effects occur, the infusion must be stopped.

5. How to store Sodium 0.9 Infusion
Keep this medicine out of the sight and reach of children.
50 ml and 100 ml bags: Do not store above 30°C.
250 ml, 500 ml and 1000 ml bags: This medicinal product does not
require any special storage conditions.
Sodium 0.9 Infusion should NOT be given to you after the expiry date
which is stated on the bag after EXP. The expiry date refers to the last
day of that month.

Product name,strength,composition
(API & excipients)

If you have any further questions on the use of this product, ask your
doctor or nurse.

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Storage Conditions and Shelf-Life

Your doctor will decide when to stop giving you this infusion.

Barcodes, Symbols and Reimbursement Information

RA Proofreading Checklist

Stop receiving your Sodium 0.9 Infusion

Consistency check with all figures
cited in the product information

If a medicine has been added to your Sodium 0.9 Infusion before
over-infusion occurs, that medicine may also cause symptoms. You
should read the Patient Information Leaflet of the added medicine for a
list of possible symptoms.

Compliance with National
Regulations

If you develop any of these symptoms you must inform your doctor
immediately. Your infusion will be stopped and you will be given
treatment depending on the symptoms.

Product Information proofread as
per RA SOP CE-RAPV-009

You should not be given Sodium 0.9 Infusion, if there are particles
floating in the solution or if the unit is damaged in any way.

Baxter Manufacturing Sp. z.o.o.
42 B Wojciechowska Str.
20-704 Lublin
Poland

6. Contents of the pack and other information
What Sodium 0.9 Infusion contains
The active substance is sodium chloride: 9 g per litre.

This leaflet was last revised in 07/2012.

The only other ingredient is water for injections.

For information about Sodium 0.9 Infusion or to request
this leaflet in formats such as audio or large print
please contact the Marketing Authorisation Holder:
Tel: +44 (0)1635 206345.

What Sodium 0.9 Infusion looks like and contents of the
pack
Sodium 0.9 Infusion is a clear solution, free from visible particles. It
is supplied in polyolefin/polyamide plastic bags (Viaflo). Each bag is
wrapped in a sealed, protective, outer plastic overpouch.
The bag sizes are:
• 50 ml
• 100 ml
• 250 ml
• 500 ml
• 1000 ml
Pack sizes:
50 bags of 50 ml per carton
1 bag of 50 ml
50 bags of 100 ml per carton
1 bag of 100 ml
30 bags of 250 ml per carton
1 bag of 250 ml
20 bags of 500 ml per carton
1 bag of 500 ml
10 bags of 1000 ml per carton
1 bag of 1000 ml
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder:
Send all enquiries to this address
Baxter Healthcare Ltd.
Caxton Way
Thetford Norfolk IP24 3SE
United Kingdom
Manufacturers:
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium
Baxter Healthcare Ltd.
Caxton Way
Thetford Norfolk IP24 3SE
United Kingdom
Bieffe Medital S.A.
Ctra de Biescas, Senegüé
22666 Sabiñánigo (Huesca)
Spain
Baxter Healthcare S.A.
Moneen Road
Castlebar
County Mayo
Ireland
Bieffe Medital S.p.A.
Via Nuova Provinciale
23034 Grosotto (SO)
Italy

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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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