Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Sodium Chloride 0.45 % w/v and Glucose 5 % w/v Intravenous Infusion BP
⚠ This medicine appears to have been discontinued
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 Sodium chloride, Glucose monohydrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %) is a infusion solution, which will be given to you as a venous infusion (drip) by your doctor. It will be given to you
- if you are dehydrated and lose water (hypertonic dehydration) You are given this medicine to provide you with carbohydrates if you are unable to eat and drink normally, especially if your energy needs are high or if you need restriction of fluid intake. This solution may also be used to dissolve or dilute medicines that are to be given to you by a venous infusion (drip).
What you need to know before you take it
e Chloride 4.5 mg/ml (0.45%) and Glucose 50mg/ml (5 %) Do not use Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %):
- if you are allergic to sodium chloride or glucose or any of the other ingredients of this medicine (listed in section 6).
- if you have excessively high body fluid level (hyperhydration)
- if you have fluid and sodium deficit (hypotonic dehydration)
- Head trauma (first 24 hours)
- if you have abnormally high blood sugar level that only responds to high insulin doses or intolerance to glucose Warnings and precautions 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 given Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %) are at particular risk of developing abnormally low levels of sodium in the blood (acute hyponatraemia) which can lead to swelling of the brain (encephalopathy). 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. This medicine must not be used to treat fluid deficits without adequate administration of salts, since this may markedly reduce the salt concentration in your blood. A lack of salts can lead to problems with your heart and damage your brain. Special care should be taken if you have abnormally low level of sodium or potassium in the blood. Then an adequate supply of salts (in particular potassium and sodium) will be ensured. In diabetic patients, the amount of infused glucose has to be taken into account and insulin requirements may be modified. You should not normally receive this medicine if you suffer or have recently suffered from stroke except where your doctor considers it essential for your recovery. Your levels of blood sugar, electrolytes (especially potassium) and acid- base and water balance will be checked to make sure that these are correct before and during infusion. After major operations or severe injuries (post-traumatic and post- operative conditions or in the presence of tissue oxygen deficiency, high blood acidity or organ failure) you may not be able to metabolise glucose properly (impaired glucose tolerance). Then your blood sugar level will be regularly monitored. Please note: If this solution is used to dilute or dissolve medicines that are to be given to you by a venous drip your doctor will take into account the safety information of the additive. Other medicines and Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %) Tell your doctor if you are using, have recently used or might use 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 painNon-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 you excrete)
Your doctor will adjust your dosage if you receive cortisone. Cortisone may cause an accumulation of sodium and fluid in your body.
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 for advice before taking this medicine. Pregnancy Your doctor will decide carefully whether or not you should receive this solution if you are pregnant. Thus special care will be taken if you have a specific disorder that may occur during pregnancy, called eclampsia, with the following symptoms: high blood pressure, cramps, swelling. Blood sugar levels will be checked regularly. Breast-feeding This medicine can be given while you are breast feeding. Driving and using machines Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %) has no influence on the ability to drive and use machines.
How to take it
Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %) Dosage Adults The amount of the medicine that you will be given will be determined by your doctor and will depend on your age, weight, clinical and biological (acid-base-balance) condition and concomitant therapy. Thus your individual requirements of fluid, electrolytes and energy will be taken into account. The normal maximum dosage for an adult is 40 ml/kg body weight/day. The maximum infusion rate is 5 ml per kg body weight per hour. Elderly patients Basically the same dosage as for adults applies. But your doctor will take caution if you are suffering from other diseases often seen with advanced age. Other special patient groups If you have an impaired glucose tolerance (e.g. after surgery, severe in-jury, organ failure, tissue oxygen deficiency etc.) the dosage should be adjusted to keep the blood glucose level close to normal values. In those cases your blood glucose level will be monitored while you receive this solution. Use in children and adolescents Children will receive a dosage dependent upon their age, weight and clinical and biological (acid-base-balance) condition and concomitant therapy. Thus the individual daily requirements of fluid and glucose of your child will be taken into account. If you received more Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %) 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 abnormal low sodium level in your blood (hyponatraemia). Symptoms An overdose may lead to excess fluid in the body (hyperhydration), electrolyte imbalances (especially hypokalaemia and hyponatraemia), acid- base imbalances, and high blood sugar (hyperglycaemia). Clinical symptoms of water intoxication may also occur, such as nausea, vomiting, spasms. Treatment The therapy to normalise your condition will be determined by your doctor. It may include stopping of the infusion, supervision of blood salt level and administration of suitable medicines to treat the symptoms observed (e.g. diuretics, insulin). In extreme situations you may also need dialysis. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS 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 brain oedema (acute hyponatraemic encephalopathy). The symptoms of brain oedema include: headache, feeling sick (nausea), vomiting, seizures, tiredness and lack of energy.' If the product is used as directed, no side effects are to be expected. Yet if you get any side effects, talk to your doctor or nurse. This includes any possible
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 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.
How to store it
Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %) 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 container and carton labels. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Only to be used if solution is clear and colourless up to faintly straw- coloured and the container and its closure are undamaged. This medicine is for single use only. After use discard container and any unused medicine. Containers once opened must be used immediately and must not stored for later 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.
Contents of the pack and other information
What Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %) contains The active substance are sodium chloride and glucose. 1000 ml of the solution contain Sodium chloride 4.5 g Glucose monohydrate 55.0 g equivalent to anhydrous glucose 50.00 g Energy 835 kJ/l ≙ 200 kcal/l Theoretical osmolarity: 432 mOsm/l Acidity (titration to pH 7.4): < 0.5 mmol/l pH: 3.5 – 5.5 The other ingredient is water for injections. What Chloride 4.5 mg/ml (0.45%) and Glucose 25 mg/ml (2.5 %) looks like and contents of the pack It is a clear, colourless up to faintly straw-coloured aqueous solution of sodium chloride and glucose in water. It is supplied in
- Polyethylene (LDPE) bottles, contents: 500 ml, 1000 ml available in packs of 10 x 500 ml, 10 x 1000 ml Marketing Authorisation Holder and Manufacturer B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen Germany Postal address: 34209 Melsungen Germany Phone: +49-5661-71-0 Fax: +49-5661-71-4567 This leaflet was last revised in March 2018 The following information is intended for healthcare professionals only: Method of administration: The solution should not be administered through the same infusion equipment simultaneously, before or after an administration of blood because of the possibility of pseudo-agglutination. Shelf life after dilution: 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 dilution has taken place in controlled and validated aseptic conditions. In patients with chronic hypernatraemia, the serum sodium concentration should not be lowered faster than at a rate of 0.5 mmol×l-1×h-1.
Frequently asked questions about Sodium Chloride 0.45 % w/v and Glucose 5 % w/v Intravenous Infusion BP
How do I take Sodium Chloride 0.45 % w/v and Glucose 5 % w/v Intravenous Infusion BP?
Sodium Chloride 0.45 % w/v and 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.
What is the active substance in Sodium Chloride 0.45 % w/v and Glucose 5 % w/v Intravenous Infusion BP?
The active substance in Sodium Chloride 0.45 % w/v and Glucose 5 % w/v Intravenous Infusion BP is sodium chloride, glucose monohydrate.
Are there equivalent medicines to Sodium Chloride 0.45 % w/v and Glucose 5 % w/v Intravenous Infusion BP?
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.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Sodium Chloride 0.45 % w/v and 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.
Can I get Sodium Chloride 0.45 % w/v and Glucose 5 % w/v Intravenous Infusion BP without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: sodium chloride, glucose monohydrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
• Hypertonic dehydration
• Vehicle solution for compatible electrolyte concentrates and medicinal products
• Partial coverage of energy requirements
4.2. Posology and method of administration
Adults, the Elderly and Children
The dosage depends on the age, weight, clinical and biological (acid-base balance) conditions of the patient, concomitant therapy and should be determined by the consulting physician.
Fluid 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 agonist drugs due to the risk of hyponatraemia.
Monitoring of serum sodium is particularly important for physiologically hypotonic fluids. Sodium Chloride 0.45 % w/v and Glucose 5 % w/v Intravenous Infusion BP for Infusion may become hypotonic after administration due to glucose metabolisation in the body (see sections 4.4. 4.5 and 4.8).
General guidelines
Daily dose:
Up to 40 ml/kg body weight per day, corresponding to 2 g glucose/kg body weight per day.
Infusion and drop rate :
Up to 5 ml/kg body weight per hour, corresponding to 0.25 g glucose/kg body weight per hour.
The prescribing doctor may determine individual adaptation of the dose and infusion rate, especially for children.
Monitoring
Adequate urine flow must be ensured and careful monitoring of serum electrolytes and glucose is essential.
Method of administration
Intravenous infusion
This container contains a significant volume of air. To avoid risk of air embolism, this product must not be administered by pressure infusion.
4.3. Contraindications
Sodium Chloride 0.45 % w/v and Glucose 5 % w/v Intravenous Infusion must not be used in cases of
– hyperhydration
– hypotonic dehydration
– acute ischaemic stroke
– head trauma (first 24 hours)
4.4. Special warnings and precautions for use
Special warnings
In diabetic patients, the amount of infused glucose has to be taken into account and insulin requirements may be modified.
Sodium Chloride 0.45 % w/v and Glucose 5 % w/v Intravenous Infusion should only be administered with caution in cases of:
– hyponatraemia,
– hyperglycaemia,
– renal insufficiency.
Precautions for use
Glucose intravenous infusions are usually isotonic solutions. In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolisation (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 metabolise 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, bums, 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.
The solution should be administered with caution to patients with conditions associated with sodium retention (e.g. hypertension, heart failure).
Clinical supervision should include checks of the serum electrolytes and the water balance. Special attention should be paid to regular monitoring of the serum potassium concentration.
In post-operative and post-traumatic conditions and in conditions of impaired glucose tolerance: only administer with monitoring of blood glucose level.
For correction of hypertonic dehydration, solutions containing not less than 70 mmol/l of sodium should be used. The time for correction should not be shorter than 48 hours.
4.5. Interaction with other medicinal products and other forms of interaction
The solution should not be administered through the same infusion equipment simultaneously, before or after an administration of blood because of the possibility of pseudo-agglutination.
Corticosteroids are associated with the retention of sodium and water.
Medicinal products 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.
4.6. Fertility, pregnancy and lactation
Data from preclinical and clinical studies of the use of this product in these conditions are not available. Therefore Sodium Chloride 0.45 % w/v and Glucose 5 % w/v Intravenous Infusion should be administered with caution during pregnancy and lactation.
It has been suggested that if used during labour, the glucose load on the mother may lead to foetal hyperglycaemia, hyperinsulinaemia, and acidosis, with subsequent neonatal hypoglycaemia and jaundice. Others have found no evidence of such an effect.
Sodium Chloride 0.45 % w/v and Glucose 5 % w/v Intravenous Infusion BP 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).
4.7. Effects on ability to drive and use machines
Not applicable
4.8. Undesirable effects
Undesirable effects are listed according to their frequencies as follows:
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)
Metabolism and nutrition disorders:
Not known: Hospital Acquired Hyponatraemia
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).
Adverse reactions may be associated with the technique of administration including febrile response, infection at the site of injection, local pain or reaction, vein irritation, venous thrombosis or phlebitis.
Adverse reactions may be associated with the medications added to the solution; the nature of the additive will determine the likelihood of any other undesirable effects.
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.
4.9. Overdose
Symptoms
Overdose may result in hyperhydration with increased skin tension, venous congestion, oedema - possibly also lung or brain oedema -, hypokalaemia and acid-base imbalances, and hyperglycaemia.
Retention of excess sodium when there is defective renal sodium excretion may result in pulmonary and peripheral oedema.
Hypernatraemia rarely occurs after therapeutic doses of sodium chloride. The most serious effect of hypernatraemia is dehydration of the brain which causes somnolence and confusion progressing to convulsions, coma, respiratory failure and death. Other symptoms include thirst, reduced salivation and lacrimation, fever, tachycardia, hypertension, headache, dizziness, restlessness, irritability and weakness.
Excessive administration of chloride salts may cause a loss of bicarbonate with an acidifying effect.
Prolonged or rapid administration of hypertonic solutions containing glucose may result in dehydration as a consequence of the induced hyperglycaemia.
Emergency treatment, antidotes
Immediate stop of infusion, administration of diuretics with continuous monitoring of serum electrolytes, correction of electrolyte and acid-base imbalances, administration of insulin if necessary.
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Ask anything about Sodium Chloride 0.45 % w/v and 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.