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SODIUM CHLORIDE 0.18% AND GLUCOSE 4% INTRAVENOUS INFUSION

Active substance(s): GLUCOSE / SODIUM CHLORIDE INJECTION / GLUCOSE / SODIUM CHLORIDE INJECTION / GLUCOSE / SODIUM CHLORIDE INJECTION

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0687581_00_UK:0687581_00_UK 09.12.2009 08:06 Seite 1

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

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.

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.

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

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

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

In this leaflet Sodium Chloride 0.18% and Glucose 4% Intravenous Infusion will be
referred to as Sodium Chloride and Glucose Intravenous Infusion.

0687581/00 UK

1

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.

2

0687581_00_UK:0687581_00_UK 09.12.2009 08:06 Seite 3

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

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, WA7 1NT. UK.
Manufacturer:
Fresenius Kabi Deutschland
61346 Bad Homburg v.d.H
Germany
This leaflet was last approved in December 2009

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,

3

4

0687581_00_UK_Ivex:0687581_00_UK_Ivex 09.12.2009 08:08 Seite 1

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

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.

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.

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

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

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

In this leaflet Sodium Chloride 0.18% and Glucose 4% Intravenous Infusion will be
referred to as 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.

Ivex 00

1

2

0687581_00_UK_Ivex:0687581_00_UK_Ivex 09.12.2009 08:08 Seite 3

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

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, WA7 1NT. UK.
Manufacturer:
Ivex Pharmaceuticals Limited,
Old Belfast Road, Millbrook,
Larne, Co. Antrim, BT40 2SH. UK
This leaflet was last approved in December 2009

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,

3

4

Expand Transcript

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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