Dextrose 10 % Solution

DEXTROSE 10 % FRESENIUS contains 100 g dextrose (as dextrose anhydrous) per 1 000 ml. DEXTROSE 10 % FRESENIUS is a hypertonic solution, used in adults and children as a source of calories (energy) for nutrition and water for hydration.

You should not receive DEXTROSE 10 % FRESENIUS if you have:

• an allergy to dextrose, maize or maize products or any other ingredient in DEXTROSE 10 % FRESENIUS (listed in section 6)
• diabetes (high blood sugar) or diabetes insipidus (a disorder of salt and water metabolism characterised by intense thirst and frequent urination)
• hyperosmolar coma (a complication of diabetes mellitus, characterised by excessive thirst, dry mouth or increased urination)
• haemodilution (reduced concentration of red blood cells, characterised by confusion, nausea, vomiting or seizures)
• hyperhydration (leads to dangerously low levels of sodium in your blood, causing more severe symptoms, such as muscle weakness, spasms, cramps or seizures)
• hypervolaemia (too much fluid in the blood, characterised by increased body mass, swelling and shortness of breath)
• hyperlactataemia (characterised by the build-up of lactate causing an excessively low pH to develop in the bloodstream)
• severe kidney failure (characterised by no output of urine (anuria))
• heart failure
• excess fluid in the lungs, brain or stomach area (ascites), causing swelling (oedema)
• other known glucose intolerances (including metabolic conditions that result in higher than normal blood glucose levels)
• bleeding inside your skull or spinal cord
• a severe form of alcohol withdrawal and you are dehydrated
• dehydration (lack of water or fluid)
• glucose-galactose malabsorption syndrome.

If possible, tell your doctor if any of the above applies to you or your child before DEXTROSE 10 % FRESENIUS is administered.

Warnings and precautions

Take special care with DEXTROSE 10 % FRESENIUS. Tell your doctor if any of the below conditions apply to you or your child before DEXTROSE 10 % FRESENIUS is used:

• 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 impaired kidney function or urinary tract obstruction. Dextrose tolerance may be impaired in patients with kidney failure.
• If you have been diagnosed with cardiac decompensation (inability of the heart to maintain adequate circulation).
• If you have hypervolaemia (too much fluid in the blood).
• If you recently had acute ischaemic stroke (when an artery in the brain becomes blocked) or brain injury.
• In infants of low birth mass. Your doctor or health care provider will ensure that DEXTROSE 10 % FRESENIUS is not administered too rapidly and that too high volumes are not infused, as it may possibly result in bleeding in the brain.
• 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. Your doctor will ensure that sufficient sodium and potassium are added, particularly in patients on digoxin therapy.

You will not be expected to give yourself DEXTROSE 10 % FRESENIUS. It will be given to you by a person who is qualified to do so. DEXTROSE 10 % 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 elderly, you are more likely to have decreased renal function and your doctor will carefully select the correct dose and may also monitor your renal function.

If you receive more DEXTROSE 10 % FRESENIUS than you should. Since a health care provider will administer DEXTROSE 10 % 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 10 % FRESENIUS, ask your doctor, health care provider or pharmacist for more information.

If you missed a dose of DEXTROSE 10 % FRESENIUS. Since a health care provider will administer DEXTROSE 10 % FRESENIUS, it is unlikely that the dose will be missed.

DEXTROSE 10 % FRESENIUS can have side effects. Not all side effects reported for DEXTROSE 10 % FRESENIUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving DEXTROSE 10 % 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:

Frequency not known:

• 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 10 % FRESENIUS. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequency not known:

• Pain, vein irritation, vein inflammation with clot formation, or swelling at the injection site during or immediately after the injection.
• Disturbance in electrolyte balance. Your doctor may order regular blood tests to make sure that salts such as sodium, magnesium, potassium and phosphates are present in the correct concentration in your blood.
• Hyponatraemic encephalopathy (central nervous system dysfunction, characterised by headache, nausea, vomiting, disturbed state of mind, confusion, stupor, tremor and seizures).
• Sweating and skin rash.
• Chills, shivering, fever, infection at the site of infusion.
• Swelling and water overload from too rapid or prolonged duration of infusion.
• Hyperglycaemia (too much sugar in the blood). This may also increase urinary output with loss of fluid and electrolytes.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: Health care providers are asked to report any suspected adverse drug reactions to the Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicine’s regulatory authority in the country where the product is marketed. 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 10 % FRESENIUS.

Store all medicines out of reach of children. Store at or below 25 °C. Your health care provider will always inspect containers for intactness of seals and the solution for infusion for discolouration or presence of any visible particulate matter. He or she will not use it if the solution is not clear or if the seals are not intact. If other additives are also prescribed, the final infusion solution will also be inspected by the health care provider for cloudiness or precipitation immediately after mixing, prior to administration and periodically during administration.