Glucose monohydrate 5% B.Braun Ecobag

Glucose 5% B. Braun Infusion Solution. Active ingredient: Glucose monohydrate. Indications: Used to dissolve and dilute medications to be administered via a cannula inserted into a vein (i.e., via an infusion).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Glucose 5% B. Braun Infusion Solution
Active ingredient: Glucose monohydrate

Read all of the package leaflet carefully before you start using this medicine because it contains important information.

• Keep the package leaflet. You may want to read it again later.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to anyone else. It can harm other people, even if they have the same symptoms as you.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What this package leaflet contains

1. WHAT IS GLUCOSE 5% B. BRAUN INFUSION SOLUTION AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING GLUCOSE 5% B. BRAUN INFUSION SOLUTION?
3. HOW IS GLUCOSE 5% B. BRAUN INFUSION SOLUTION TO BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD GLUCOSE 5% B. BRAUN INFUSION SOLUTION BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

1. WHAT IS GLUCOSE 5% B. BRAUN INFUSION SOLUTION AND WHAT IS IT USED FOR?

Glucose 5% B. Braun Infusion Solution is a glucose solution and is used to dissolve and dilute medications that you are to receive through a cannula inserted into a vein (i.e., via an infusion).

2. WHAT SHOULD YOU KNOW BEFORE USING GLUCOSE 5% B. BRAUN INFUSION SOLUTION?

Glucose 5% B. Braun Infusion Solution must not be used:

• If you have excessively high blood sugar levels (hyperglycemia) that require more than 6 units of insulin per hour to control,
• If your blood is too acidic (metabolic acidosis), you should not receive large amounts of this solution.
• If you have too much water in your body,
• if you are suffering from acute heart failure,
• if you have water in your lungs.

Glucose 5% B. Braun Infusion Solution must not be used alone to treat dehydration, as it does not contain salts (electrolytes).

Warnings and precautions:
Please talk to your doctor, pharmacist, or nurse before using Glucose 5% B. Braun Infusion Solution. This medicine must not be used to treat dehydration without adequate salt replacement (see also "Glucose 5% B. Braun Infusion Solution must not be used" above), as this can significantly reduce the salt concentration in the blood (especially potassium and sodium). A salt deficiency can lead to heart problems and brain damage. Children, elderly patients, and patients in poor general health are particularly at risk. Adequate salt replacement (especially potassium and sodium) will be ensured. Your blood glucose level, fluid and electrolyte concentrations—especially potassium—and acid-base balance will be monitored to ensure they remain within the normal range during the infusion. Blood samples may be taken for this purpose. If necessary, your blood sugar will be adjusted by administering insulin. Your doctor will take into account that in this case your blood potassium levels may decrease.

Your doctor will carefully consider whether this medicine is suitable for you.

• if you have diabetes mellitus,
• if you have any kind of impairment of your glucose metabolism (e.g. after surgery or injury),
• if you have impaired kidney function.

You should generally not receive this medicine if you have had or have recently had a stroke, unless your doctor considers it essential for your recovery. If you are also receiving blood transfusions, these will be administered through a separate tube. Your doctor will take into account the safety instructions for the medicine dissolved or diluted in Glucose 5% B. Braun Infusion Solution.

Children:
In children, the dose of Glucose 5% B. Braun Infusion Solution should be as low as possible (see also section 3).

Using Glucose 5% B. Braun Infusion Solution with other medicines:
Tell your doctor if you are taking, have recently taken, or might take any other medicines. Your doctor will take into account that some medicines can affect glucose metabolism. The safety instructions for the medicine dissolved or diluted in Glucose 5% B. Braun Infusion Solution must be followed.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice before using this medicine. There is limited experience with the use of glucose solutions in pregnant and breastfeeding women. Your doctor will carefully decide whether or not you should receive this solution if you are pregnant or breastfeeding. Your blood glucose level and your electrolyte and fluid balance will be carefully monitored during the infusion. These values should remain within the normal ranges. If another medicine is to be added to your solution, your doctor will separately consider the type of this medicine and its use during pregnancy and breastfeeding.

Driving and using machines:
This medicine has no influence on the ability to drive or use machines. However, the safety instructions for the medicine dissolved or diluted in Glucose 5% B. Braun Infusion Solution must be observed.

3. HOW TO USE GLUCOSE 5% B. BRAUN INFUSION SOLUTION?

This medicine is for intravenous administration (meaning it is given through a cannula inserted into a vein). It can be administered via a vein located in the periphery of the body. However, this possibility is limited by the properties of the medicinal product dissolved or diluted in Glucose 5% B. Braun Infusion Solution. The amount of solution you receive depends on the concentration of the medicinal product being dissolved or diluted. The maximum amounts listed below are taken into account.

Adults:
Maximum daily dose: Up to 40 ml per kilogram of body weight per day, corresponding to 2 g of glucose per kg of body weight per day. Maximum infusion rate: The maximum infusion rate is 5 ml per kg of body weight per hour, corresponding to 250 mg of glucose per kg of body weight per hour.

Use in children:
In children, the dose of Glucose 5% B. Braun Infusion Solution should be as low as possible. Salts must be administered if necessary.

If you have received more Glucose 5% B. Braun Infusion Solution than you should:
This is unlikely to occur, as your doctor determines your daily dose.

A glucose overdose can lead to the following:

• a blood sugar level that is too high
• for the excretion of sugar in the urine,
• unusually highly concentrated bodily fluids,
• disturbances of consciousness or unconsciousness due to extremely high blood sugar levels or concentrated bodily fluids,
• to dehydration.

An overdose of fluids can lead to increased water content in your body in conjunction with:

• increased skin tension,
• Heaviness and swelling of the legs (venous congestion),
• Tissue swelling (possibly with fluid in the lungs or swelling of the brain),
• Disorders of the salt balance,
• Acid-base imbalance disturbances.

In case of an overdose, you may feel ill or experience vomiting and seizures. Other signs of an overdose may develop depending on the amount of the drug dissolved or diluted in Glucose 5% B. Braun infusion solution. If this occurs, the infusion will be slowed down or stopped. Your doctor will decide on any further treatment you may need, such as the administration of insulin, diuretics, or salts.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. The use of this medicine may lower electrolyte levels (e.g., sodium and potassium) in the blood. The frequency of this side effect is not known, as it cannot be estimated from the available data.

Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE GLUCOSE 5% B. BRAUN INFUSION SOLUTION?

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 label. The expiry date refers to the last day of that month. After first opening: Containers must be used immediately after opening. After the addition of excipients: From a microbiological point of view, the product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and would normally not normally exceed 24 hours at 2 to 8°C. Do not use this medicine if the solution is not clear and colorless or almost colorless, or if the bottle or cap is damaged. The medicine does not require any special storage conditions.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Glucose 5% B. Braun Infusion Solution contains:
The active ingredient is glucose monohydrate. This medicinal product contains 55 g of glucose monohydrate per liter, which corresponds to 50 g of glucose. The other ingredient is water for injections. Energy content 837 kJ/l, equivalent to 200 kcal/l. Theoretical osmolarity 278 mOsm/l. pH 3.5–5.5.

What Glucose 5% B. Braun Infusion Solution looks like and contents of the pack:
Glucose 5% B. Braun Infusion Solution (for administration via intravenous drip). It is a clear, colorless or almost colorless infusion solution. The solution is available in:

• Glass bottles: 1 × 250 ml, 10 × 250 ml, 1 × 500 ml, 10 × 500 ml.
• Polyethylene – Bottles: 1 × 100 ml, 10 × 100 ml, 20 × 100 ml, 1 × 250 ml, 10 × 250 ml, 1 × 500 ml, 10 × 500 ml, 1 × 1000 ml, 10 × 1000 ml.
• Sachets: 1 × 100 ml, 20 × 100 ml, 1 × 250 ml, 20 × 250 ml, 1 × 500 ml, 20 × 500 ml, 1 × 1000 ml, 10 × 1000 ml.
• as well as a set consisting of: 1 × 500 ml polyethylene – bottle, infusion set and venipuncture – set.

Not all pack sizes may be marketed. For single use only. Containers that have already been used must not be reconnected, even if they are only partially empty. After first use, the container and any unused contents should be disposed of.

Marketing Authorisation Holder and Manufacturer:
B. Braun Melsungen AG,
Carl-Braun-Straße 1,
34212 Melsungen

Glucose monohydrate 5% B.Braun Ecobag