This medicine is a sterile solution of glucose in water which can be used to give you fluids and glucose [Parenteral energy supply, for rehydration & basic Solution], or can be used as a solution to dissolve other medicines in. You may also be given it if you have abnormally low blood sugar levels.

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

• high levels of acidic substances in your blood

• untreated diabetes insipidus (a kidney disorder where you pass large amounts of urine)

• 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 Dextrose 25% W/V Intravenous Infusion BP

Patients who are acutely ill, with pain, postoperative stress, infections, burns, 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 Dextrose 25% w/v  Intravenous Infusion are at particular risk of developing acute hyponatremia (abnormally low level of sodium in the blood) which can lead to encephalopathy (brain edema).

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 (hypokalemia),

– 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 Dextrose 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 Dextrose 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 (hyponatremia):

• 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)

Your doctor will take care only to add drugs or additives to the solution that mix well with it.

Pregnancy and Breast-Feeding

Ask your doctor or pharmacist for advice before taking any medicine. Your doctor will decide carefully whether or not you should receive this solution during pregnancy or breast-feeding.

Driving and Using Machines

This medicine has no influence on the ability to drive and use machines.

The amount of Dextrose 25% w/v Intravenous Infusion BP you will be given will be determined by your doctor, depending upon your condition.

For an adult the maximum dose is 24 ml/kg body weight 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 Dextrose 25% w/v Intravenous Infusion BP than you should

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

Your doctor will monitor chemical and fluid balance, Dextrose 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 hyponatremia (abnormal low sodium level in your blood).

Overdose may result in too high levels of blood sugar, Dextrose 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 Dextrose 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.

Like all medicines, Dextrose 25% w/v 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 Dextrose 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 Dextrose.

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

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

Abnormally low sodium level in your blood can lead to a serious condition called hospital acquired hyponatremia. It may cause irreversible brain damage and death due to the development of acute hyponatremic encephalopathy (brain edema). The symptoms of brain edema 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.

Keep out of the reach and sight of children.

Do not use Dextrose 25% w/v 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 (if not exactly stated).

Do not store above 30°C.

This medicinal product does not require any special storage conditions.

Do not use Dextrose 25% w/v Intravenous Infusion BP if you notice cloudiness or discoloration of the solution or if the container is damaged.