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Sodium Chloride 0.18% And Glucose 4% Intravenous Infusion

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sodium Chloride 0.18% and Glucose 4% Intravenous Infusion

Read all of this leaflet carefully before you start taking 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 get 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 and Glucose Intravenous Infusion is and what it is used for

2.    Before you are given Sodium Chloride and Glucose Intravenous Infusion

3.    How you are given Sodium Chloride and Glucose Intravenous Infusion

4.    Possible side effects

5.    How Sodium Chloride and Glucose Intravenous Infusion is stored

6.    Further information

1. WHAT SODIUM CHLORIDE AND GLUCOSE INTRAVENOUS INFUSION IS AND WHAT IT IS USED FOR

Sodium chloride (salt) helps to maintain the correct balance of fluid in and around the body's cells and tissues. Sodium chloride can be given by intravenous infusion (into a vein) to patients suffering from water loss or lack of sodium. Glucose is a simple sugar, which provides a source of energy.

Sodium Chloride and Glucose Intravenous Infusion is used where there has been excessive fluid loss from the body (dehydration) with carbohydrate loss.

in this leaflet Sodium Chloride 0.18% and Glucose 4% Intravenous Infusion will be referred to as Sodium Chloride and Glucose intravenous infusion

2. BEFORE YOU ARE GIVEN SODIUM CHLORIDE AND GLUCOSE INTRAVENOUS INFUSION

You should not receive Sodium Chloride and Glucose Intravenous Infusion if:

•    you are allergic (hypersensitive) to any of the ingredients of Sodium Chloride and Glucose Intravenous infusion mentioned in section 6 (for symptoms of an allergic reaction please refer to section 4).

•    you have a kidney, heart, or liver disorder. Your doctor will check this.

Take special care with sodium chloride and Glucose Intravenous infusion if:

•    there is a continued loss of electrolytes (salts) from the blood.

Sodium Chloride and Glucose Intravenous Infusion should not be given too rapidly, particularly in infants and the elderly. Your doctor will make sure that Sodium Chloride and Glucose intravenous Infusion is given to you correctly.

Your doctor or nurse will ensure the solution is clear and free from particles before use.

Taking 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.

The following drugs should not be mixed with Sodium Chloride and Glucose Intravenous infusion:

-    amiodarone (used for heart rhythm disorders)

-    amphotericin B (for fungal infections)

-    amsacrine (a chemotherapy drug)

Sodium nitroprusside (a drug used to reduce very high blood pressure)

Pregnancy and breast-feeding

The use of Sodium Chloride and Glucose Intravenous Infusion may be considered during pregnancy and breastfeeding as advised by your healthcare professsional. Sodium Chloride and Glucose Intravenous Infusion should be given to pregnant and breastfeeding women only if necessary.

Driving and using machines

Sodium Chloride and Glucose Intravenous Infusion has no effect on driving or using machines.

3. HOW YOU ARE GIVEN SODIUM CHLORIDE AND GLUCOSE INTRAVENOUS INFUSION

Sodium Chloride and Glucose Intravenous infusion will be given to you in hospital. You will receive your medicine by infusion (IV drip). The amount and rate at which the infusion is given depends on your requirements. Your doctor will decide on the correct dose for you to receive. Your doctor will be able to check the effect of the treatment on dehydration by the relief of your symptoms, monitoring your blood pressure, and by measuring the volume and concentration of your urine.

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

if you receive more Sodium Chloride and Glucose intravenous infusion than you should

It is very unlikely that you will receive more solution than you should as Sodium Chloride and Glucose Intravenous Infusion will be given to you in hospital and you will be monitored closely, if you suspect an overdosage with Sodium Chloride and Glucose Intravenous Infusion you should look for the symptoms/side effects described in section 4 of this leaflet. You should immediately inform you doctor describing the symptoms.

4.    POSSIBLE SIDE EFFECTS

Like all medicines Sodium Chloride and Glucose intravenous infusion can cause side effects, although not everybody gets them.

Sodium Chloride and Glucose intravenous infusion may cause severe allergic reactions. If you get any of the following symptoms after receiving this medicine you should contact your doctor immediately:

•    skin rash

•    swelling of the face, lips or tongue

•    shortness of breath

It is unlikely that you will receive more of a Sodium Chloride and Glucose Intravenous Infusion than you should as Sodium Chloride and Glucose intravenous infusion will be given to you in hospital by healthcare professionals. Possible side effects of an overdosage of Sodium Chloride and Glucose Intravenous Infusion include: nausea, vomiting, diarrhoea, abdominal cramps, thirst and weakness.

The following side effects have also been reported:

•    loss of potassium from the blood. Your doctor may give you potassium supplements.

•    Thrombosis (the formation of a clot) may occur in the vein where the infusion is given. The symptoms of thrombosis include:

• pain, swelling, and redness at the blood clot site

-    an itchy rash at the clot site

-    warm skin around the clot

-    a mild fever

-    major veins that stand out from your skin

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

5.    HOW SODIUM CHLORIDE AND GLUCOSE INTRAVENOUS INFUSION IS STORED

Keep out of the reach and sight of children.

Your doctor and hospital pharmacist are responsible for the correct storage,

use and disposal of Sodium Chloride and Glucose Intravenous Infusion.

Sodium Chloride and Glucose Intravenous Infusion should be stored between 2°C and 25°C.

The solution must not be used after the expiry date shown on the label.

The expiry date refers to the last day of that month.

Any solution remaining after treatment should be disposed of using the approved hospital procedures.

6. FURTHER INFORMATION

what Sodium Chloride and Glucose intravenous infusion contains

Sodium Chloride and Glucose Intravenous Infusion contains: sodium chloride, glucose, water for injections, hydrochloric acid, and sodium hydroxide.

The concentration of each active ingredient can be seen in the name of product.

What Sodium Chloride and Glucose intravenous Infusion looks like and the contents of the pack

Sodium Chloride and Glucose Intravenous Infusion is a clear solutions of sodium chloride and glucose in water. The solution is contained in a sealed tube-shaped polythene container (500 ml) with a'twist-off' seal at one end and a ring tab at the opposite end. Sodium Chloride Glucose Intravenous Infusion is also available in sealed plastic 500ml and 1000ml containers known as a Kabipac® bottle.

Not all pack types may be marketed.

Marketing Authorisation Holder

Fresenius Kabi Limited Cestrian Court, Eastgate Way,

Manor Park, Runcorn,

Cheshire, WA71 NT. UK.

Manufacturer:

Terumo BCT Limited,

Old Belfast Road, Millbrook,

Larne, Co. Antrim, BT40 2SH. UK

This leaflet was last revised in July 2013.

V002/TM


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