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 monohydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for 5 % Glucose Intravenous Infusion BP is a sterile solution of glucose in water which can either be used to give you fluids and glucose, or can be used as a solution to dissolve other medicines in.5 % Glucose Intravenous Infusion BP will be given to you in the form of a vein drip (that is, by intravenous infusion).
e 5 % Glucose Intravenous Infusion BP You will not receive 5 % Glucose Intravenous Infusion BP if you have:
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. Talk to your doctor, pharmacist or nurse before using 5 % Glucose Intravenous Infusion BP. This medicine must not be used to treat fluid deficits without adequate administration of salts (see also "You will not recieve5 % Glucose Intravenous Infusion BP" above), since this may markedly reduce the salt concentrationin 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 sodium and 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:
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)'
Your doctor will consider that some medicines may influence glucose metabolism. The safety information of the medicine dissolved or diluted in 5 % 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. Breast-feeding Your doctor will decide carefully whether or not you should receive this solution if you are breastfeeding your child. Driving and using machines This medicine has no influence on the ability to drive and use machines. The safety information of any medicine dissolved or diluted in 5 % Glucose Intravenous Infusion BP has to be taken into account.
5 % Glucose Intravenous Infusion BP Dosage The amount of 5% Glucose Intravenous Infusion BP you will be given will be determined by your doctor. When this medicine is given to you to supply you with fluids, the amount of solution you receive depends on your age, your weight and your medical and physical status. The maximum doses stated below will be considered. When this medicine is used to dissolve or dilute other medicines given to you, 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. The total daily fluid and glucose requirements will be taken into account. Use in children If 5 % Glucose Intravenous Infusion BP is given to children, the dose should be as low as possible. Salts have to be supplied as needed. See also section 2, 'Children'. For adolescents from 15th year of life, the maximum amount is 40 ml per kg body weight per day. For children up to the 14th year of life the maximum daily amount of this medicine will be determined according to the age and the body weight: Premature babies: 180 ml per kg body weight Newborns: 150 ml per kg body weight 1st – 2nd year: 150 ml per kg body weight 3rd – 5th year: 120 ml per kg body weight 6th – 10th year: 100 ml per kg body weight 11th – 14th 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: 1st day of life: 60 – 120 ml per kg body weight 2nd day of life: 80 – 120 ml per kg body weight 3rd day of life: 100 – 130 ml per kg body weight 4th day of life: 120 – 150 ml per kg body weight 5th day of life: 140 – 160 ml per kg body weight 6th day of life: 140 – 180 ml per kg body weight 1st month, before stable growth: 140 – 170 ml per kg body weight 1st month, with stable growth: 140 – 160 ml per kg body weight 2nd to 12th month of life: 120 – 150 ml per kg body weight 2nd year: 80 – 120 ml per kg body weight 3rd – 5th year: 80 – 100 ml per kg body weight 6th – 12th year: 60 – 80 ml per kg body weight 13th – 18th year: 50 – 70 ml per kg body weight If you received more 5 % Glucose Intravenous Infusion BP than you should It is unlikely that this occurs because your doctor will determine your daily doses. 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). Glucose overdose may result in:
Like all medicines, this medicine can cause side effects, although not everybody gets them. 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. Not known (frequency cannot be estimated from the available data) ● abnormally high or low blood electrolyte levels (salts and minerals in your blood), for instance not enough sodium (hyponatraemia) or not enough potassium (hypokalaemia) 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 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.
5 % 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 or the bag and carton labels. The expiry date refers to the last day of that month. Do not store above 25°C. For storage conditions after admixture of additives see section 6, 'Shelf life after addition of additives'. Only to be used if solution is clear and colourless or almost colourless and if the container and its closure are undamaged. The containers are for single use only. Discard container and any remaining contents after use. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Other information and content of the pack What 5 % Glucose Intravenous Infusion BP contains
837 kJ/l ≙ 200 kcal/l 278 mOsm/l 3.5 – 5.5
What 5 % Glucose Intravenous Infusion BP looks like and contents of the pack 5 % Glucose Intravenous Infusion BP is a solution for infusion (for administration by a vein drip). It is a clear, colourless or almost colourless solutionof glucose in water. It comes in:
Carl-Braun-Straße 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 March 2018 The following information is intended for healthcare professionals only: Incompatibilities Because 5% Glucose Intravenous Infusion BP has an acidic pH, incompatibilities can occur on mixing with other medicinal products and with blood. Erythrocyte concentrates must not be suspended in 5% Glucose Intravenous Infusion BP because of the risk of pseudo-agglutination. Special precautions for disposal and other handling Administration should commence immediately after connecting the container to the giving set or infusion equipment.Before addition of an additive or preparing a nutrient mixture, physical and chemical compatibility must be confirmed. Because 5% Glucose Intravenous Infusion BP has an acidic pH, incompatibilities can occur on mixing with other medicinal products. When adding additives observe usual precautions of asepsis strictly. Shelf life after first opening Once containers are opened the contents must be used immediately. Shelf life after addition 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 unless reconstitution / dilution has taken place in controlled and validated aseptic conditions. For complete information on this medicinal product please refer to the Summary of Product Characteristics.
Glucose 5 % w/v Intravenous Infusion BP 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 5 % w/v Intravenous Infusion BP is glucose monohydrate.
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 5 % w/v Intravenous Infusion BP, 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.
Carbohydrate solution for intravenous liquid therapy
• Vehicle solution for compatible medicinal product.
Posology
Fluid balance, serum glucose, 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 agonist drugs due to the risk of hyponatraemia.
Monitoring of serum sodium is particularly important for physiologically hypotonic fluids. 5 % w/v Glucose Intravenous Infusion BP may become hypotonic after administration due to glucose and metabolisation in the body (see sections 4.4. 4.5 and 4.8).
Of note, provision of the entire daily fluid supply with this solution alone is contraindicated. See sections 4.3 and 4.4.
Carbohydrate solution for intravenous liquid therapy
The dosage depends on the age, weight, clinical and physiological (acid-base balance) conditions of the patient, having regard to the maximum dose states below. The concomitant therapy should be determined by the consulting specialist.
Vehicle solution for compatible medicinal products
The volume to be chosen depends on the desired concentration of the medicinal product for which the solution is to be used as vehicle having regard to the maximum dose stated below.
Adults
Maximum daily intake
Up to 40 ml per kg body weight per day, corresponding to 2 g of glucose per kg body weight per day.
Maximum infusion rate
Up to 5 ml per kg body weight per hour, corresponding to 0.25 g of glucose per kg body weight per hour.
When administering this solution the total daily fluid and glucose requirements should be taken into account.
Paediatric population
The dosage depends on the age, weight, clinical and physiological (acid-base balance) conditions of the patient, the concomitant therapy and should be determined by the consulting specialist.
Generally, dosing of this solution should be as restrictive as possible and must be accompanied by adequate electrolyte substitution. See also sections 4.3 and 4.4.
When administering this solution the total daily fluid and glucose requirements should be taken into account.
The maximum daily dose, in g of glucose per kg body weight and in ml of solution per kg body weight per day, is for:
Pre-term neonates:
18 g per kg body weight
180 ml per kg body weight
Term neonates :
15 g per kg body weight
150 ml per kg body weight
1st – 2nd year:
15 g per kg body weight
150 ml per kg body weight
3rd – 5th year:
12 g per kg body weight
120 ml per kg body weight
6th – 10th year:
10 g per kg body weight
100 ml per kg body weight
11th – 14th year:
8 g per kg body weight
80 ml per kg body weight
When administering this solution, the total daily fluid intake must be taken into account. The recommended daily parenteral fluid intake for children is as follows:
1st day of life:
60 – 120 ml per kg body weight per day
2nd day of life:
80 – 120 ml per kg body weight per day
3rd day of life:
100 – 130 ml per kg body weight per day
4th day of life:
120 – 150 ml per kg body weight per day
5th day of life:
140 – 160 ml per kg body weight per day
6th day of life:
140 – 180 ml per kg body weight per day
1st month, prior to establishment of stable growth:
140 – 170 ml per kg body weight per day
1st month, after establishment of stable growth:
140 – 160 ml per kg body weight per day
2nd – 12th month of life:
120 – 150 ml per kg body weight per day
2nd year:
80 – 120 ml per kg body weight per day
3rd – 5th year:
80 – 100 ml per kg body weight per day
6th – 12th year:
60 – 80 ml per kg body weight per day
13th – 18th year:
50 – 70 ml per kg body weight per day
Method of administration
Intravenous use.
The possibility of peripheral venous infusion depends on the osmolarity of the prepared mixture.
• Hyperglycaemia, not responding to insulin doses of up to 6 units insulin/hour
• Lactic acidosis
If it is necessary to administer large volumes, further contra-indications can arise on account of the fluid load:
- Hypotonic hyperhydration
- Isotonic hyperhydration
- Acute congestive heart failure
- Pulmonary oedema
This solution must not be used alone for fluid supply/rehydration because it does not contain electrolytes. See section 4.4.
Glucose intravenous infusions are usually isotonic solutions. In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolization (see section 4.2).
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 diseases), patients with heart-, liver- and kidney diseases and patients exposed to vasopressin agonists (see section 4.5) are at particular 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.
Serum electrolytes, fluid and acid-base balance should be monitored.
Especially, adequate sodium and – in relation to glucose metabolism – potassium supply should be ensured.
In states of electrolyte deficiencies like hyponatraemia or hypokalaemia the solution must not be used without adequate electrolyte substitution.
In patients with disturbed glucose metabolism, as present e.g. in postoperative or posttraumatic conditions or in patients with diabetes mellitus, 5 % w/v Glucose Intravenous Infusion must be administered with caution, i.e. with frequent monitoring (see below), and dosage must be adapted as required.
States of hyperglycaemia should be adequately monitored and treated with insulin. The application of insulin causes additional shifts of potassium into the cells and may therefore cause or increase hypokalaemia.
Patient monitoring should include regular checks of the blood glucose level, serum electrolytes (especially potassium and sodium) and the acid-base and water balance.
This fluid should also be administered with great caution to patients with renal insufficiency.
Administration of glucose solutions is not recommended after acute ischaemic strokes as hyperglycaemia has been reported to worsen ischaemic brain damage and impair recovery. In prehospital management of acute ischemic stroke, glucose-containing solutions should be avoided unless hypoglycaemia is present or strongly suspected.
Glucose solutions should not be administered through the same infusion equipment, simultaneously, before, or after administration of blood, because of the possibility of pseudo-agglutination.
The infusion of hypotonic fluids such as 5 % w/v Glucose Intravenous Infusion together with the non-osmotic secretion of ADH (in pain, anxiety, the post-operative state, nausea, vomiting, pyrexia, sepsis, reduced circulating volume, respiratory disorders, CNS infections, and metabolic and endocrine disorders) may result in hyponatraemia. Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, cerebral oedema and death, therefore acute symptomatic hyponatraemia (e.g. hyponatraemic encephalopathy) is considered a medical emergency.
Paediatric population
Intravenous fluid therapy should be closely monitored in the paediatric population as they may have impaired ability to regulate fluids and electrolytes. Adequate hydration and urine flow must be ensured and careful monitoring of fluid balance, plasma and urinary electrolyte concentrations are mandatory.
Please note: The safety information of the additive provided by the respective manufacturer has to be taken into account.
Interactions with medicinal products with an influence on glucose metabolism should be considered.
Drugs leading to an increased vasopressin effect.
• The below listed drugs increase the vasopressin effect, leading 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.: Chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3.4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics
• Drugs potentiating vasopressin action, e.g.: Chlorpropamide, 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.
Prescribers should refer to the information provided with the product concerned.
Pregnancy
There are limited data (less than 300 pregnancy outcomes) from the use of glucose monohydrate in pregnant women. Animal studies do not indicate direct or indirect harmful effects at the therapeutic doses with respect to reproductive toxicity (see section 5.3).
5 % w/v Glucose Intravenous Infusion can be used during pregnancy, as long as the blood glucose, electrolyte and fluid balance are carefully controlled and are within the physiologic ranges. 5 % w/v Glucose Intravenous Infusion should be administrated 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).
Breast-feeding
Glucose/metabolites are excreted in human milk, but at therapeutic doses of Glucose B. Braun 50 mg/ml no effects on the breast-fed newborns/infants are anticipated.
5 % w/v Glucose Intravenous Infusion can be used during breast-feeding as indicated.
Fertility
No data available.
5 % w/v Glucose Intravenous Infusion has no influence on the ability to drive and use machines. When used as vehicle solution the safety information of the additive provided by the respective manufacturer has to be taken into account.
Not known (frequency cannot be estimated from the available data)
Metabolism and nutrition disorders:
Not known: Electrolyte imbalance, e.g. hyponatraemia and hypokalaemia
Nervous system disorders :
Not known: Hyponatraemic encephalopathy
Hospital acquired hyponatraemia may cause irreversible brain injury and death due to development of acute hyponatraemic encephalopathy (see sections 4.2 and 4.4).
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.
Symptoms of glucose overdose
Excessive glucose infusions can cause hyperglycaemia, glucosuria, hyperosmolar dehydration and in extreme cases overdose can lead to hyperglycaemic-hyperosmolar coma.
Symptoms of fluid overdose
Fluid overdose may result in hyperhydration with increased skin tension, venous congestion, oedema – possibly also lung or brain oedema – , dilution of serum electrolytes, electrolyte imbalances, notably hyponatraemia and hypokalaemia (see section 4.4), and acid-base imbalances.
Clinical symptoms of water intoxication my occur like nausea, vomiting, spasms.
Further symptoms of overdose may arise depending on the nature of the additive.
Treatment
Depending on type and severity of the disorders:
Immediate stop of infusion, administration of electrolytes, diuretics, or insulin.
For correction of hyponatraemia the following formula can be used:
mmol of Na+ required = (target Na+ level(1) – actual Na+ level) × TBW (2)
(1) should not be lower than 130 mmol/l
(2) TBW: Total body water, calculated as a fraction of body weight: 0.6 in children, 0.6 and 0.5 in non-elderly men and women, respectively, and 0.5 and 0.45 in elderly men and women, respectively
During treatment, serum electrolytes should be monitored.
For treatment of symptoms resulting from overdose of an additive the instructions given by the manufacturer of the respective additive must be followed.
Ask anything about Glucose 5 % w/v Intravenous Infusion BP. 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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