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Document: leaflet MAH GENERIC_PL 01502-0005R change

• leaflet MAH GENERIC_PL 01502-0005R
• leaflet MAH GENERIC_PL 01502-0075

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Patient Information Leaflet

Glucose Intravenous Infusion 50% w/v

Where to find information in this leaflet

1.    What Glucose Intravenous Infusion 50% w/v is and what it is used for

2.    Before you are given Glucose Intravenous Infusion 50% w/v

3.    How to use Glucose Intravenous Infusion 50% w/v

4.    Possible side effects

5.    Storing Glucose Intravenous Infusion 50% w/v

6.    Further information

1.    What Glucose Intravenous Infusion 50% w/v is and what it is used for

Glucose Intravenous Infusion 50% w/v is a sterile

solution of glucose in water and is used to:

•    restore blood glucose levels.

•    provide temporary relief from the symptoms of a swollen brain and comas due to low blood sugar.

•    correct high blood potassium levels and some forms of low sodium blood levels.

2.    Before you are given Glucose Intravenous

Infusion 50% w/v

You should NOT be given Glucose

Intravenous Infusion 50% w/v if you:

•    Are sensitive or allergic to Glucose Intravenous Infusion 50% w/v or any of the other ingredients in this injection.

•    You are allergic to corn or corn products.

•    You have glucose-galactose malabsorption syndrome.

•    You have been bleeding in the spine or brain.

•    You cannot pass urine.

•    You have had a stroke.

•    You have a condition known as Delerium Tremens - uncontrolled bouts of shaking after stopping drinking alcohol.

Please tell your doctor or nurse before

being given the injection if you:

•    are a diabetic

•    are under-nourished

•    have low levels of phosphates (a mineral) or thiamine (vitamin B1) in your blood

•    have an infection

•    have had a recent injury

•    are dehydrated

Using other medicines:

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy or breast feeding:

Please tell your doctor or nurse before being given this injection if you are pregnant or breast feeding. The doctor will then decide if the injection is suitable for you.

Driving and using machines:

You should not drive or use machinery if you

are affected by the administration of Glucose Intravenous Infusion 50% w/v .

3. How to use Glucose Intravenous Infusion 50% w/v

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given.

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, you must tell the person giving you the injection.

4. Possible side effects Like all medicines, Glucose Intravenous Infusion 50% w/v can cause side effects, although not everybody gets them.

•    You may suffer from vein clots, inflammation of the veins, local pain at the injection site.

•    You may develop hyperglycaemia (a higher than normal level of sugar in your blood and there may also be sugar in your urine). If this happens you may feel tired and confused or lose consciousness. You may also feel thirsty and pass urine more frequently.

•    You may develop an imbalance in the level of fluid and of certain minerals in your body. You may develop low potassium, phosphate and magnesium blood levels.

•    If you are administered glucose and you have low levels of thiamine (vitamin B1) in your blood you may develop Wernicke's encephalopathy a condition where you may feel confused and unsteady on your feet.

•    If you are administered glucose and you are severely under-nourished your body may retain water and salt. Your skin may swell and you may have difficulty in breathing.

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse: This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme - website: www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy. By reporting side effects you can help provide more information on the safety of this medicine.

5.    Storing Glucose Intravenous Infusion 50% w/v

Your injection will be stored at less than 25°C and protected from light. The nurse or doctor will check that the injection is not past its expiry date before giving you the injection.

6.    Further information

What Glucose Intravenous Infusion 50% w/v contains:

This injection contains the active ingredient glucose (50% w/v or 500 g/l) in a sterile solution. This injection contains the following inactive ingredients: Sterile water for injections.

What Glucose Intravenous Infusion 50% w/v looks like and contents of the pack:

Glucose Intravenous Infusion 50% w/v is supplied in 20 ml clear glass ampoules (10 ampoules per carton) and in a 50 ml clear glass vial packed in cartons to contain either 10 vials or 25 vials.

Not all pack sizes may be marketed.

The marketing authorisation number of this medicine is: PL 01502 0005R

Marketing Authorisation Holder:

hameln pharmaceuticals ltd

Gloucester

United Kingdom

Manufacturer:

hameln pharmaceuticals gmbh

Langes Feld 13

31789 Hameln

Germany

Hameln rds a.s

Horna 36, 900 01 Modra

Slovak Republic

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last revised in March 2014

43871/43850/11/14

43871_43850_11_14_Leaflet-Glucose-50pc.indd 2 07/05/2014 12:33:23