Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Glucose may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for 2. What you need to know before you are given Glucose 20% w/v Solution for Infusion
Glucose 20% w/v Solution for Infusion You should NOT be given Glucose 20% w/v Solution for Infusion if you:
Warnings and precautions Talk to your doctor, nurse or pharmacist before being given the infusion if you:
Other medicines and Glucose 20% w/v Solution for Infusion Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines especially the following medicines which increase the effect of vasopressin and the risk of a low sodium level (hyponatraemia):
Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before using this medicine.
Driving and using machines You should not drive or use machinery if you are affected by the administration of Glucose 20% w/v Solution for Infusion.
3. How Glucose 20% w/v Solution for Infusion is given to you Your nurse or doctor will give you the infusion. Your doctor will decide the correct dosage for you and how and when the infusion will be given.
If you think you were given more Glucose 20% w/v Solution for Infusion than you should Since the infusion 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 infusion. 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).
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.
——————————————————————————————————————————————————————————The following information is intended for healthcare professionals only:
hameln
Glucose 20% w/v Solution for Infusion This is a summary of the information regarding the presentation, preparation and stability of Glucose 20% w/v Solution for Infusion. Please refer to the Summary of Product Characteristics for full prescribing and other information.
Presentation: Glucose 20% w/v Solution for Infusion is a clear and colourless to slightly yellow sterile solution supplied in clear, colourless glass infusion bottles with a nominal value of 100ml.
Stability: From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Special handling information:
Route of administration:
Glucose 20% is provided in a concentration that is ready for administration. Do not use after the expiry date which is stated on the bottle after "EXP". The expiry date refers to the last day of that month.
Intravenous injection or infusion
Special precautions for storage: Do not store above 25°C. Keep the bottle in the outer carton in order to protect from light.
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.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse: This includes any possible
to you 4. Possible side effects 5. How to store Glucose 20% w/v Solution for Infusion 6. Contents of the pack and other information
1. What Glucose 20% w/v Solution for Infusion is and what it is used for Glucose 20% w/v Solution for Infusion is a sterile solution of glucose in water and is used to:
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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.
Glucose 20% w/v Solution for Infusion 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. The expiry date refers to the last day of the month. Your infusion will be stored at less than 25°C and protected from light. The nurse or doctor will check that the infusion is not past its expiry date before giving you the infusion.
What Glucose 20% w/v Solution for Infusion contains The active substance is glucose (20% w/v or 200 g/l) in a sterile solution. The other excipients are hydrochloric acid and sterile water for injections.
What Glucose 20% w/v Solution for Infusion looks like and contents of the pack Glucose 20% w/v Solution for Infusion is supplied in 100 ml clear glass vials with rubber stopper and cap packed in cartons to contain either 1 vial, 10 vials or 25 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder: hameln pharma ltd Nexus, Gloucester Business Park Gloucester, GL3 4AG United Kingdom
Manufacturer: Siegfried Hameln GmbH Langes Feld 13 31789 Hameln Germany hameln rds s.r.o. Horná 36 90001, Modra Slovak Republic
For any information about this medicine, please contact the Marketing Authorisation Holder This leaflet was last revised in 12/2021 46637/51/21
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Glucose 20% w/v Solution for Infusion comes as infusion. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Glucose 20% w/v Solution for Infusion is glucose.
Medicines with the same active substance, strength and form include: 5% GLUCOSE INTRAVENOUS INFUSION SOLUTION, Potassium Chloride 0.15 % w/v and Glucose 10 % w/v Solution for Infusion BP, Potassium Chloride 0.15 % w/v and Glucose 5% w/v Solution for Infusion -BP. In total there are 26 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Glucose 20% w/v Solution for Infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Glucose 20% is hypertonic (in vitro tonicity, in a container) and provides a source of calories in a minimal volume of water. Glucose 20% is frequently used in both adults and children to restore blood glucose concentrations in the treatment of hypoglycaemia resulting from insulin excess or from other causes.
Glucose 20% may be used to provide temporary relief from the symptoms of cerebral oedema and from hypoglycaemic coma. Hyperosmotic Glucose with or without insulin may also correct hyperkalaemia in renal failure.
Dosage of Glucose depends on the age, weight, clinical condition of the patient.
Fluid and acid base balance, serum glucose, serum sodium, and other electrolytes may need to be monitored before and during administration, especially in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonists due to the risk of hyponatraemia.
Monitoring of serum sodium is particularly important for physiologically hypotonic fluids (in vivo tonicity). Glucose 20 % may become extremely hypotonic after administration due to glucose metabolism in the body (see sections 4.4, 4.5, 4.8 and 5.2).
Posology
Adults and the elderly
For the treatment of hypoglycaemia.
Administer 100 ml of Glucose 20% (at 400 ml/hour over 15 minutes).
As an energy source and in carbohydrate depletion.
Up to 3 Litres per day dependent on the needs of the patient.
Paediatric population
Only to be used under the supervision of a paediatrician
Method of administration
Glucose 20% must be administered by the intravenous route; it must not be administered by subcutaneous or intramuscular route. Except in the emergency treatment of severe hypoglycaemia, Glucose 20% should be administered via a central vein.
Glucose 20% is provided in a concentration that is ready for administration.
Glucose 20% is contraindicated in patients with:
• hypersensitivity to the active substance or to any excipients listed in section 6.1 and known allergy to corn or corn products
• the glucose – galactose malabsorption syndrome
• anuria or intraspinal or intracranial haemorrhage, or ischaemic stroke and in patients with delirium tremens if such patients are already dehydrated
• hyperglycaemic coma.
Rapid administration of hypertonic glucose solutions may produce substantial hyperglycaemia and hyperosmolar syndrome; patients should be observed for signs of mental confusion and loss of consciousness, especially those patients with chronic uraemia or carbohydrate intolerance.
Prolonged use in parenteral nutrition may affect insulin production; blood and urine glucose should be monitored.
Glucose 20 % intravenous infusion is a hypertonic solution (in vitro, in a container). In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolism (see section 4.2 and 5.2).
Depending on the tonicity of the solution, the volume and rate of infusion and depending on a patient's underlying clinical condition and capability to metabolize glucose, intravenous administration of glucose can cause electrolyte disturbances most importantly hypo- or hyperosmotic hyponatraemia.
Hyponatraemia:
Patients with non-osmotic vasopressin release (e.g. in acute illness, pain, post-operative stress, infections, burns, and CNS disease), patients with heart, liver and kidney diseases and patients exposed to vasopressin agonists (see section 4.5) are at risk of acute hyponatraemia upon infusion of hypotonic fluids.
Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (brain oedema) characterized by headache, nausea, seizures, lethargy and vomiting. Patients with brain oedema are at particular risk of severe, irreversible and life-threatening brain injury.
Children, women in the fertile age and patients with reduced cerebral compliance (e.g. meningitis, intracranial bleeding, and cerebral contusion) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.
Intravenous administration of Glucose 20% may result in other electrolyte disturbances such as hypokalaemia, hypophosphataemia and hypomagnesaemia (see sections 4.2 and 4.8).
Special care should be taken during injection to avoid leakage into the surrounding tissue.
The effects of insulin are reversed by glucose.
Drugs increasing vasopressin effect, listed below, lead to reduced renal electrolyte free water excretion and increase the risk of hospital acquired hyponatraemia following inappropriately balanced treatment with i.v. fluids (see sections 4.2, 4.4 and 4.8):
•
Drugs stimulating vasopressin release, e.g.: carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3.4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics
•
Drugs potentiating vasopressin action, e.g.: NSAIDs , cyclophosphamide
•
Vasopressin analogues, e.g.: desmopressin, oxytocin, vasopressin, terlipressin
Other medicinal products increasing the risk of hyponatraemia also include diuretics in general and antiepileptics such as oxcarbazepine.
There is no, or inadequate evidence of safety of the drug in human pregnancy, but it has been in wide use for many years without apparent harmful consequence. Intravenous glucose may result in foetal insulin production, with an associated risk of rebound hypoglycaemia in the neonate. Infusions of glucose administered during Caesarean section and labour should be used with caution, and should not exceed 5-10g glucose/hour.
Glucose 20% should be administered with special caution for pregnant women during labour particularly if administered in combination with oxytocin due to the risk of hyponatraemia (see section 4.4, 4.5 and 4.8).
None known.
Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (<1/10,000), Not known (cannot be estimated from the available data)
System Organ Class (SOC)
Adverse reaction (MedDRA term)
Frequency
Metabolism and nutrition disorders
Hospital acquired hyponatraemia *
Hyperglycaemia**
Hypokalaemia
Hypophosphataemia
Hypomagnesaemia
Fluid and electrolyte imbalance.
Not known
Nervous system disorders
Hyponatraemic encephalopathy*
Not known
General disorders and administration site conditions
Pain at the injection site
Vein irritation
Venous thrombosis
Phlebitis
Not known
* Hospital acquired hyponatraemia may cause irreversible brain injury and death due to development of acute hyponatraemic encephalopathy (see sections 4.2 and 4.4).
** Hyperglycaemia (possibly indicated by mental confusion or loss of consciousness) and glycosuria may occur as a result of the rate of administration or metabolic insufficiency. If undetected and untreated hyperglycaemia can lead to dehydration, hyperosmolar coma and death.
The administration of glucose without adequate levels of thiamine may precipitate overt deficiency states e.g. Wernicke's encephalopathy. Sodium retention, oedema, pulmonary oedema and congestive heart failure may be induced in patients with severe under-nutrition.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Overdose of Glucose 20% may lead to hyperglycaemia and glycosuria leading to dehydration, hyperosmolar coma and death.
The blood levels of glucose can be reduced by slow infusion of insulin. Careful monitoring of blood glucose levels would be necessary.
Ask anything about Glucose 20% w/v Solution for Infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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