Glucose Intravenous Infusion Bp 5% W/V

4/419027/0714

PACKAGE LEAFLET: INFORMATION FOR THE USER

B. Braun Melsungen AG ■ 34209 Melsungen, Germany

= 5 % w/v Glucose Intravenous Infusion BP = Solution for Infusion

Glucose monohydrate

Read all of this leaflet carefully before you start using 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, pharmacist or nurse.

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1. What 5 % w/v Glucose Intravenous Infusion BP is and what it is used for

2. What you need to know before you use 5 % w/v Glucose Intravenous Infusion BP

3. How to use 5 % w/v Glucose Intravenous Infusion BP

4. Possible side effects

5. How to store 5 % w/v Glucose Intravenous Infusion BP

6. Contents of the pack and other information

1. What 5 % w/v Glucose Intravenous Infusion BP is and what it is used for

5 % w/v Glucose Intravenous Infusion BP is a solution that contains glucose. It is used to dissolve or dilute medicines that are to be given to you by infusion. 5 % w/v Glucose Intravenous Infusion BP will be given to you in the form of a vein drip (that is, by intravenous infusion).

2. What you need to know before you use 5 % w/v Glucose Intravenous Infusion BP

Do not use 5 % w/v Glucose Intravenous Infusion BP

You will not receive 5 % w/v Glucose Intravenous Infusion BP if you have:

• too high blood sugar level (hyperglycaemia) that needs more than 6 units of insulin per hour to be controlled

• high levels of acidic substances in your blood (metabolic acidosis)

You should not receive large amounts of this solution if you have:

• too much water in your body

• acute heart failure

• water in your lungs

5 % w/v Glucose Intravenous Infusion BP must not be used alone for the treatment of fluid deficits, since it does not contain any salts (electrolytes).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using 5 % w/v Glucose Intravenous Infusion BP.

This medicine must not be used to treat fluid deficits without adequate administration of salts (see also "Do not use 5 % w/v Glucose Intravenous Infusion BP" above), since this may markedly reduce the salt concentration in your blood (in particular potassium and sodium). A lack of salts can lead to problems with your heart and damage your brain. Especially children, elderly patients and patients in poor general condition are at risk.

Adequate supply of salts (in particular potassium and sodium) will be ensured.

Your levels of blood sugar, fluid, electrolytes (particularly potassium) and acid-base balance will be checked to make sure that these are correct during infusion. For this purpose blood samples may be taken from you.

If necessary, your blood sugar will be controlled by insulin administration. Your doctor will consider that your blood potassium level may decrease in this case.

Your doctor will consider very carefully whether this medicine is suitable for you if you have:

• diabetes mellitus

• any kind of impairment of your glucose metabolism (e.g. after operations or injuries)

• impairment of kidney function.

You should not normally receive this medicine if you suffer or have recently suffered from stroke except your doctor considers it essential for your recovery.

If you are also receiving blood transfusions these will be administered to you through another tube.

Your doctor will consider the safety information of the medicine dissolved or diluted in 5 % w/v Glucose Intravenous Infusion BP.

Children

In children, the dose of 5 % w/v Glucose Intravenous Infusion BP should be as low as possible (see also section 3).

Other medicines and 5 % w/v Glucose Intravenous Infusion BP

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Your doctor will consider that some medicines may influence glucose metabolism.

The safety information of the medicine dissolved or diluted in 5 % w/v Glucose Intravenous Infusion BP has to be taken into account.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Your doctor will decide carefully whether or not you should receive this solution if you are pregnant. Your blood sugar will be checked when you receive this medicine.

Breast-feeding

Your doctor will decide carefully whether or not you should receive this solution if you are breast-feeding your child.

Driving and using machines

This medicine has no influence on the ability to drive and use machines. The safety information of the medicine dissolved or diluted in 5 % w/v Glucose Intravenous Infusion BP has to be taken into account.

3. How to use 5 % w/v Glucose Intravenous Infusion BP

This medicine is for intravenous use (that is, it is administered through a cannula placed into a vein). It can be infused into peripheral veins. However, this possibility is limited by the nature of the medicine dissolved or diluted in 5 % w/v Glucose Intravenous Infusion BP.

The amount of solution you receive depends on the concentration of the medicine to be dissolved or diluted. The maximum doses stated below will be considered.

Adults

Maximum daily dose

Up to 40 ml per kg body weight per day, corresponding to 2 g glucose per kg body weight per day.

Maximum infusion rate

The maximum infusion rate is 5 ml per kg body weight per hour, corresponding to 250 mg glucose per kg body weight per hour.

Use in children

If 5 % w/v Glucose Intravenous Infusion BP is given to children, the dose should be as low as possible. Salts have to be supplied as needed.

For adolescents from 15^th year of life, the maximum amount is 40 ml per kg body weight per day.

BlBRAUN

Approval for Printing BlBRAUN Melsungen AG
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Date	Signature
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schwarz

Format = 210 x 297 mm (A4) 2 Seiten

Latus

2071

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4/419027/0714

5 % w/v Glucose Intravenous Infusion BP EP - GIF Standort Rubi

Font size: 9 pt.

G 080629

	⁼or children up to the 14^th year of this medicine will be determined weight:	of life the maximum daily amount according to the age and the body
	Premature babies:	180 ml per kg body weight
	Newborns:	150 ml per kg body weight
	1^st - 2^nd year:	150 ml per kg body weight
	3^rd - 5^th year:	120 ml per kg body weight
	6^th - 10^th year:	100 ml per kg body weight
	11^th - 14^th year:	80 ml per kg body weight

When determining the dose, the total daily fluid intake will be taken into account, according to the following recommendations for children:

5. How to store 5 % w/v Glucose Intravenous Infusion BP

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle and carton labels. The expiry date refers to the last day of that month.

After first opening: Containers once opened must be used immediately. After admixture of additives: From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C.

Do not use this medicine if the solution is not clear and colourless or almost colourless or if the bottle or its closure are damaged.

This medicine does not require any special storage conditions

1^st day of life:	60 - 120 ml per kg body weight
2^nd day of life:	80 - 120 ml per kg body weight
3^rd day of life:	100 - 130 ml per kg body weight
4^th day of life:	120 - 150 ml per kg body weight
5^th day of life:	140 - 160 ml per kg body weight
6^th day of life:	140 - 180 ml per kg body weight
1^st month, before stable growth:	140 - 170 ml per kg body weight
1^st month, with stable growth:	140 - 160 ml per kg body weight
2^nd to 12^th month of life:	120 - 150 ml per kg body weight
2^nd year:	80 - 120 ml per kg body weight
3^rd - 5^th year:	80 - 100 ml per kg body weight
6^th - 12^th year:	60 - 80 ml per kg body weight
13 ^th - 18^th year:	50 - 70 ml per kg body weight

If you receive more 5 % w/v Glucose Intravenous Infusion BP than you should

It is unlikely that this occurs because your doctor will determine your daily doses.

Glucose overdose may result in:

• too high levels of blood sugar,

• glucose losses in urine,

• abnormally high concentrated body fluids,

• impaired consciousness or unconsciousness due to extremely high blood sugar levels or too concentrated body fluids

• fluid deficit.

Fluid overdose may result in excess fluid in the body with:

• increased skin tension,

• heaviness and swelling of legs (venous congestion),

• tissue swelling (possibly with water on the lungs or swelling of the brain)

• abnormally high or low blood electrolyte levels

• disturbances of the acid-base balance.

In case of overdose you may feel sick or suffer from vomiting and spasms. Further signs of overdose may develop depending on the medicine dissolved or diluted in 5 % w/v Glucose Intravenous Infusion BP.

If this occurs, the infusion will be slowed down or stopped.

Your doctor will decide on any further treatment you may need, e.g. administration of insulin, drugs to increase urine output (diuretics) or salts. If you have any further questions on the use of this product, ask your doctor or pharmacist.

6. Other information and content of the pack

What 5 % w/v Glucose Intravenous Infusion BP contains

• The active substance is glucose monohydrate.

Per liter this medicine contains 55 g of glucose monohydrate, equivalent to 50 g of glucose.

• The other ingredient is water for injections.

Energy 837 kJ/l A 200 kcal/l

Theoretical osmolarity 278 mOsm/l

ph 3.5 - 5.5

What 5 % w/v Glucose Intravenous Infusion BP looks like and contents of the pack

5 % w/v Glucose Intravenous Infusion BP is a solution for infusion (for administration by a vein drip).

It is a clear, colourless or almost colourless solution for infusion It comes in:

• colourless plastic (polyethylene) bottles containing 50 ml, 100 ml, 250 ml, 500 ml or l000 ml,

supplied in packs of: 20 x 50 ml, 20 x 100 ml 20 x 250 ml 10 x 500 ml 10 x 1000 ml

Not all pack sizes may be marketed.

For single use only.

Partially used containers must not be reconnected.

After first use, the container and any unused contents should be discarded.

Marketing Authorisation Holder and Manufacturer

B. Braun Melsungen AG Carl-Braun-StraBe 1 34212 Melsungen, Germany

Postal address 34209 Melsungen Germany

Phone: +49-56 61-71-0 Fax: +49-56 61- 71-45 67

This leaflet was last revised in May 2014.

4. Possible side effects

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

If this medicine is used according to the directions given, no side effects are expected.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

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.

B. Braun Melsungen AG

34209 Melsungen Germany

419027_Glucose_EP_GIF_A4_GB_4.indd 2 11.07.14 08:19