Dextrose 50 % Solution

DEXTROSE 50 % FRESENIUS belongs to a group of medicines known as carbohydrate solutions for parenteral nutrition. Dextrose is a type of sugar also called glucose. DEXTROSE 50 % FRESENIUS is used to expand blood volume in cases of shock and bleeding, and to counteract dehydration.

You should not be given DEXTROSE 50 % FRESENIUS:

• if you are allergic (hypersensitive) to dextrose (glucose) or any of the other ingredients of DEXTROSE 50 % FRESENIUS (listed in section 6)
• if you are allergic to maize or maize products
• if your kidneys fail to produce urine or if you have kidney failure
• if you have bleeding inside the skull or spine
• if your body can’t absorb the sugars known as glucose and galactose
• if you are a diabetic.

Warnings and precautions

Special care should be taken with DEXTROSE 50 % FRESENIUS. Tell your doctor or health care provider before being given DEXTROSE 50 % FRESENIUS:

• if you have suffered an acute stroke caused by a blockage in an artery that supplies blood to the brain, as high blood glucose levels can increase the chance of brain damage and impair recovery
• if you have diabetes (high blood sugar)
• if you have an intolerance to carbohydrates
• if you are undernourished
• if you have low levels of thiamine (vitamin B1) or phosphates (a mineral) in your blood
• if you suffer from haemodilution (an increase in the fluid content of blood, leading to a lower concentration of red blood cells)
• if you have sepsis (serious infection)
• if you suffer from trauma or shock
• if you have metabolic acidosis (build-up of acid in your body due to kidney failure)
• if you are severely dehydrated
• if you have signs of mental confusion or are unconscious
• if you have chronic uraemia (a chronic kidney disease with high levels of urea in your blood).

If you are acutely ill, have pain, post-operative stress, infections, burns, diseases of your central nervous system, heart, liver and kidney and if you are on medicines increasing the effect of vasopressin (a hormone which regulates the amount of body fluids), you are at particular risk of developing acute hyponatraemia (abnormally low level of sodium in your blood) when given DEXTROSE 50 % FRESENIUS. Acute hyponatraemia can lead to encephalopathy (brain oedema), characterised 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 of childbearing potential and patients with meningitis or brain bleeding are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.

Other medicines and DEXTROSE 50 % FRESENIUS

Always tell your health care provider if you are taking any other medicine. (This includes complementary or traditional medicines.)

You will not be expected to administer DEXTROSE 50 % FRESENIUS to yourself. Your doctor or health care provider will administer DEXTROSE 50 % FRESENIUS to you for a specific condition. Your doctor will decide what dosage, how often and how long you will receive DEXTROSE 50 % FRESENIUS. This depends on your condition and other factors, such as your blood pressure and the amount of urine excreted. DEXTROSE 50 % FRESENIUS should not be given through the same infusion equipment as whole blood.

If you receive more DEXTROSE 50 % FRESENIUS than you should Since a health care provider will administer DEXTROSE 50 % FRESENIUS, he/she will control the dosage. However, in the event of overdosage your doctor will manage the symptoms of the overdosage.

If you missed a dose of DEXTROSE 50 % FRESENIUS Since a health care provider will administer DEXTROSE 50 % FRESENIUS, it is unlikely that a dose will be missed.

DEXTROSE 50 % FRESENIUS can have side effects. Not all side effects reported for DEXTROSE 50 % FRESENIUS are included in this leaflet. Should your general health worsen, or you experience any untoward effects while receiving DEXTROSE 50 % FRESENIUS, please consult your doctor, pharmacist or other health care provider for advice.

If any of the following happens, stop receiving DEXTROSE 50 % FRESENIUS immediately:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to DEXTROSE 50 % FRESENIUS. You may need urgent medical attention.

Tell your doctor as soon as possible if you experience any of the following reactions after receiving DEXTROSE 50 % FRESENIUS:

Frequency not known:

• Abnormally low sodium level (hyponatraemia) in your blood, which can lead to a serious condition called hospital-acquired hyponatraemia. It may cause irreversible brain damage, due to the development of acute hyponatraemic encephalopathy (brain swelling, with symptoms such as headache, feeling sick (nausea), vomiting, seizures, tiredness and lack of energy).
• Hyperglycaemia (a higher than normal level of sugar in your blood and there may also be sugar in your urine). If this happens you may feel tired and confused or lose consciousness. You may also feel thirsty and pass urine more frequently.
• Fluid and electrolyte imbalance.
• Pain and irritation at the injection site.
• Inflammation of the vein with formation of a clot (phlebitis).
• Low levels of potassium (hypokalaemia), magnesium (hypomagnesaemia) and phosphates (hypophosphataemia) in the blood, which will be indicated by blood tests.
• Dehydration (thirsty, dry mouth, tiredness, light-headedness).
• Glucose in the urine (extreme hunger or thirst, more frequent urination).

If you are administered DEXTROSE 50 % FRESENIUS and you have low levels of thiamine (vitamin B1) in your blood, you may develop Wernicke’s encephalopathy (a condition where you may feel confused and unsteady on your feet). If you are administered DEXTROSE 50 % FRESENIUS and you are severely undernourished, your body may retain water and salt, your skin may swell, you may have difficulty in breathing and you may experience heart failure. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of DEXTROSE 50 % FRESENIUS.

• Store in a dry place, at or below 25 °C.
• Protect from light.
• Store all medicines out of reach of children.
• Unused portions of the solution should be discarded.