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40% W/V GLUCOSE INTRAVENOUS INFUSION BP - patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - 40% W/V GLUCOSE INTRAVENOUS INFUSION BP

40% w/v Glucose Intravenous Infusion BP

Glucose

Read all of this leaflet carefully before you start using this medicine.

  • – Keep this leaflet. You may need to read it again.

  • – If you have any further questions, ask your doctor or pharmacist, or nurse.

  • – If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse.


In this leaflet:

  • 1. What 40% w/v Glucose Intravenous Infusion BP is and what it is used for

  • 2. Before you use 40% w/v Glucose Intravenous Infusion BP

  • 3. How to use 40% w/v Glucose Intravenous Infusion BP

  • 4. Possible side effects

  • 5. How to store 40% w/v Glucose Intravenous Infusion BP

  • 6. Further information


1. WHAT 40% W/V GLUCOSE INTRAVENOUS INFUSION BP IS AND WHAT IT IS USED FOR


40% w/v Glucose Intravenous Infusion BP is a solution containing glucose (also called grape sugar or dextrose) for administration in the form of a vein drip.

You may receive this medicine when you are unable to eat normally or when you need high amounts of carbohydrates (sugar) but your fluid intake must be low, for example if your kidneys are not working properly.

You may also be given it if you have abnormally low blood sugar levels.


2. before you use 40% w/v glucose intravenous infusion bp

YOU SHOULD NOT RECEIVE THIS MEDICINE

if you have any of the following:

  • excessively high blood sugar level that needs more than 6 units of insulin per hour to be controlled
  • poorly controlled or uncontrolled diabetes
  • diabetic coma (a state of unconsciousness caused by extremely high blood sugar level)
  • severely impaired blood circulation, i.e. states of shock and circulatory collapse
  • bleeding within the skull or the spinal cord
  • untreated diabetes insipidus (a kidney disorder where you pass large amounts of urine)
  • high levels of acidic substances in your blood
  • severe kidney failure without access to treatment with an artificial kidney
  • too much water in your body tissues (hyperhydration)
  • water in your lungs
  • acute severe heart failure.

SPECIAL CARE WILL BE TAKEN WITH 40% W/V GLUCOSE INTRAVENOUS INFUSION BP

Patients who are acutely ill, with pain, postoperative stress, infections, burns, nervous system, heart, liver and kidney diseases and patients who are on medicines increasing the effect of vasopressin (a hormone which regulates the amount of body fluids), when give 40% w/v Glucose Intravenous Infusion are at particular risk of developing acute hyponatraemia (abnormally low level of sodium in the blood) which can lead to encephalopathy (brain oedema).

Children, women of childbearing potential and patients with serious brain conditions like meningitis (infection of the membranes surrounding the brain) or brain injury are at particular risk of severe and life-threatening brain swelling caused by an acute decrease in blood sodium levels.

You should not normally receive this medicine after you suffered from stroke.


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

Before you receive this medicine any existing disorders of your body’s fluid and salt content such as:

– too low potassium concentration in your blood (hypokalaemia), – water deficiency and excess losses of salts have to be corrected.

Your doctor will exercise special caution if you have

  • diabetes or any other disorder where your body cannot handle glucose properly
  • any kind of impairment of your metabolism (e.g. after operations, injuries, some kinds of organ diseases)
  • high blood volume
  • abnormally high concentrated blood serum (high serum osmolarity)
  • impairment of kidney or heart failure.

Adequate supply of salts, in particular potassium, magnesium, phosphate and vitamins (in particular vitamin B1) will be ensured.

You should not receive full doses of the medicine at the very beginning of your therapy when you are very undernourished, but doses should be increased gradually (see also section “Possible side effects”).

Your treatment should not be stopped abruptly but tapered off in order to avoid a severe drop of the blood sugar level.

You should not receive glucose through the same tube as a blood transfusion.

TAKING OR USING OTHER MEDICINES

Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines especially the following medicines which increase the effect of vasopressin and the risk of a low sodium level (hyponatraemia):

  • Carbamazepine and Oxcarbazepine used to treat epilepsy
  • Vincristine and ifosfamide used as anticancer treatments
  • Cyclophosphamide to treat cancer and autoimmune diseases
  • Selective Serotonin Reuptake Inhibitors (SSRIs) to treat depression
  • Antipsychotics for mental health disorders
  • Opioid pain killers to relieve severe pain
  • Non-steroidal anti-inflammatory drugs (NSAIDs) to relieve mild to moderate pain and to treat inflammation in your body,
  • Desmopressin for the treatment of diabetes insipidus (extreme thirst and the continuous production of large volumes of dilute urine)
  • Oxytocin used during labour
  • Vasopressin and terlipressin used to treat ‘bleeding oesophageal varices’ (enlarged veins in your food pipe caused by liver problems)
  • Diuretics or water tablets (medicines which increase the amount of urine)’

B|BRAUN


Approval for Printing

BlBRAUN Melsungen AG

Approved for Printing

Approved for Printing when corrected

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Date


Signature


Name in capital letters


schwarz

Format = 210 × 297 mm (DIN A4) 2 Seiten



GB___41

41/12260529/0618

IL – GIF

Production site: Melsungen


Font size: 9 pt


G 141404


3. how to use 40% w/v glucose intravenous infusion bp

5. HOW TO STORE 40% W/V GLUCOSE INTRAVENOUS INFUSION BP

The amount of 40% w/v Glucose Intravenous Infusion BP you will be given will be determined by your doctor, depending upon your condition. Your doctor will monitor chemical and fluid balance, glucose and electrolyte levels (including sodium) in your blood before and during treatment, especially in patients with disrupted vasopressin release (a hormone which regulates the amount of body fluids) and in patients taking medicines increasing the action of vasopressin due to the risk of hyponatraemia (abnormal low sodium level in your blood).

For adults the maximum dose is 15 ml/kg bodyweight per day.

For children the dose will be determined according to their age and body weight.

The medicine will be administered to you by infusion (a drip) through a small tube placed in one of your large veins.

If you receive more 40% w/v Glucose Intravenous Infusion BP than you should

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

Overdose may result in too high levels of blood sugar, glucose losses in urine, unconsciousness due to extremely high blood sugar or too concentrated body fluids, excess fluid in the body, and abnormally high or low blood electrolyte levels.

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

Your doctor will decide on any further treatment you may need.

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

4. possible side effects

Like all medicines, 40% w/v Glucose Intravenous Infusion BP can cause side effects, although not everybody gets them.

The following side effects may occur:

Metabolism and nutrition disorders

When you are very undernourished and receive full doses of glucose from the very beginning of intravenous feeding, this could lead to decreases of blood potassium, magnesium and phosphate levels.

A decrease of blood potassium could also occur when you are receiving insulin together with glucose.

Stopping glucose administration suddenly and/or administration of insulin may cause your blood glucose level to drop especially if you have a reduced glucose tolerance.

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

Abnormally low sodium level in your blood can lead to a serious condition called hospital acquired hyponatraemia. It may cause irreversible brain damage and death due to the development of acute hyponatraemic encephalopathy (brain oedema). The symptoms of brain oedema include: headache, feeling sick (nausea), vomiting, seizures, tiredness and lack of energy.’

Blood vessel disorders

Vein inflammation (thrombophlebitis) may be caused by solutions in which the concentration of dissolved substance is above a certain limit value. Added medication should be kept in mind in that respect.

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

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 this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

Keep out of the reach and sight of children.

Do not use 40% w/v Glucose Intravenous Infusion BP after the expiry date which is stated on the label and the outer carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions. Do not use 40% w/v Glucose Intravenous Infusion BP if you notice cloudiness or discoloration of the solution or if the container is damaged.

6. FURTHER INFORMATION

What 40 % w/v Glucose Intravenous Infusion BP contains

The active substance is glucose

1000 ml of the solution contain 400 g of glucose (as glucose monohydrate)

The other ingredients are hydrochloric acid and water for injections

Caloric value 6700 kJ/l A 1600 kcal/l

Theoretical osmolarity 2200 mOsm/l

Titration acidity (to pH 7.4) < 1 mmol/l

pH 3.5 – 5.5

What 40% w/v Glucose Intravenous Infusion BP looks like

and contents of the pack

40% w/v Glucose Intravenous Infusion BP is a sterile solution for infusion (administration by a vein drip).

It is a clear, colourless or slightly yellowish solution of glucose in water.

It is available in plastic (polyethylene) bottles containing 500 ml.

Pack sizes: 10 × 500 ml

Marketing Authorisation Holder

B. Braun Melsungen AG

Carl-Braun-StraBe 1 Postal address:

34212 Melsungen, Germany 34209 Melsungen, Germany

Manufacturer

B. Braun Melsungen AG

Carl-Braun-StraBe 1

34212 Melsungen, Germany

or

B. Braun Medical S.A.

Carretera de Terrassa 121,

08191 Ru^ (Barcelona), Spain

This leaflet was last approved in 02/2018.

B|BRAUN

B. Braun Melsungen AG

34209 Melsungen, Germany

12260529_Glucose IntraInf BP40Pr_IL-GIF_A4__GB41.in­dd 2

20.06.18 08:19

Sources: Original (products.mhra.gov.uk)