Dextrose 5 % Solution

DEXTROSE 5 % FRESENIUS contains 50 g dextrose (as dextrose monohydrate) per 1 000 ml. DEXTROSE 5 % FRESENIUS solution is used in adults and children as a source of calories (energy) for nutrition and water for hydration. It is also used to dilute or to deliver other medicines that can be given by infusion.

You should not receive DEXTROSE 5 % FRESENIUS if you:

• have an allergy to dextrose or any other ingredient in DEXTROSE 5 % FRESENIUS (listed in section 6)
• have an allergy to maize or maize products
• have the glucose - galactose malabsorption syndrome
• have been told that you have high levels of lactate in the blood
• have diabetes that is not adequately treated, allowing your blood sugar levels to rise above normal (uncompensated diabetes)
• have states of glucose intolerance, for example: when your body’s metabolism does not function correctly, e.g. due to severe illness (metabolic stress)
• have the following condition: hyperosmolar coma (unconsciousness). This is a type of coma that can occur if you have diabetes and do not receive enough medicine.
• have a higher amount of sugar in the blood than normal (hyperglycaemia)
• have a higher level of lactate in the blood than normal (hyperlactataemia).

If possible, tell your doctor if any of the above applies to you before you receive DEXTROSE 5 % FRESENIUS.

Warnings and precautions

Take special care with DEXTROSE 5 % FRESENIUS. Tell your doctor if any of the below conditions apply to you or your child before DEXTROSE 5 % FRESENIUS is used:

• if you have recently had an operation
• if you have been bleeding inside your skull or spine
• if you have diabetes, malnutrition, thiamine (vitamin B1) deficiency, carbohydrate intolerance, sepsis, shock or trauma. Rapid infusion may cause a high blood sugar concentration
• if you have recently had a stroke (an artery in the brain became blocked)
• if you have impaired kidney function or urinary tract obstruction. Dextrose tolerance may be impaired in patients with kidney failure
• if you suffer from alcoholism
• if you are dehydrated (lack of water or fluid)
• if you have hypervolaemia (too much fluid in the blood). Electrolyte and fluid balance are easily disturbed in pre-term babies. Your doctor will ensure that fluid intake, urine output and serum electrolytes are monitored closely.

You will not be expected to give yourself DEXTROSE 5 % FRESENIUS. It will be given to you by a person who is qualified to do so. DEXTROSE 5 % FRESENIUS will be slowly infused (dripped) into a vein through a small bore needle.

Your doctor will determine your or your child’s dose, the rate at which it is infused and for how long this should be continued. You will be carefully monitored and your dose adjusted according to your or your child’s medical condition, body mass and response.

If you are given too much or too little DEXTROSE 5 % FRESENIUS Since a health care provider will administer DEXTROSE 5 % FRESENIUS, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. If you have any further questions on the use of DEXTROSE 5 % FRESENIUS, ask your doctor, health care provider or pharmacist for more information. If you forget to use DEXTROSE 5 % FRESENIUS Since a health care provider will administer DEXTROSE 5 % FRESENIUS, it is unlikely that the dose will be missed.

DEXTROSE 5 % FRESENIUS can have side effects. Not all side effects reported for DEXTROSE 5 % FRESENIUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving DEXTROSE 5 % FRESENIUS, please consult your doctor, pharmacist or other health care provider for advice. Tell your doctor or health care provider immediately if you notice the following:

• swelling of the hands, feet, ankles, face, lips, 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 5 % FRESENIUS. You may need urgent medical attention. Tell your doctor if you notice any of the following:

• Pain, vein irritation, vein inflammation with clot formation, or swelling at the injection site during or immediately after the injection.
• Passing abnormally large volumes of dilute urine.
• High concentration of sugar in the blood. This may increase urinary output with loss of fluid and electrolytes and you may feel thirsty, tired and confused.
• Disturbance in electrolyte (mineral salts) balance. Your doctor may order regular blood tests to check your sodium, magnesium, potassium and phosphates concentrations.
• Swelling and water overload (your skin may swell and you may have difficulty breathing).

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 via the “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 5 % FRESENIUS.

Store all medicines out of reach of children. Store at or below 25 ºC. DEXTROSE 5 % FRESENIUS will be appropriately stored in the hospital ward or dispensary.