Glucose 5% Intravenous Infusion BP

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Glucose 5% Infusion is and what it is used for
2. What you need to know before you are given Glucose 5% Infusion
3. How you will be given Glucose 5% Infusion
4. Possible side effects
5. How to store Glucose 5% Infusion
6. Contents of the pack and other information

• diabetes that is not adequately treated, allowing your blood sugar levels to rise above normal (uncompensated diabetes)
• states of glucose intolerance, for example:
  when the body’s metabolism does not function correctly, e.g. due to severe illness (metabolic stress)
• hyperosmolar coma (unconsciousness). This is a type of coma that can occur if you have diabetes and do not receive enough medicine.
• a higher amount of sugar in the blood than normal (hyperglycaemia)
• a higher level of lactate in the blood than normal (hyperlactataemia)
• intolerance (hypersensitivity) to glucose. This is can occur in patients with an allergy to corn.

If another medicine is added to your solution for infusion, always read the Package Leaflet of that medicine. This way you can check to see if that medicine is safe for you to take.

Please tell your doctor if you have or have had any of the following medical conditions:

• excess water in the body (water intoxication)
• if you are diabetic or have high levels of sugar in the blood (hyperglcaemia)
• if your kidneys do not work as well as normal
• if you have sepsis, trauma or shock
• low levels of electrolytes (sodium, potassium, phosphorus, magnesium) in the blood
• head injury within the past 24 hours
• if you have recently had a stroke (acute ischaemic stroke). High levels of sugar in the blood can worsen the effects of stroke and affect recovery
• if you have metabolic disturbances due to starvation or due to a diet which does not provide the right proportion of the necessary nutrients (malnutrition)
• if you have low levels of thiamine (vitamin B1) in your body. This can happen if you suffer from chronic alcoholism.
• allergy to corn (Glucose 5% Infusion contains sugar derived from corn)
• if you have a condition that could cause high levels of vasopressin, a hormone regulating fluid in your body. You may have too much vasopressin in your body because, for example,
  • you have had a sudden and serious illness,
  • you are in pain,
  • you have had surgery,
  • you have infections, burns, brain disease
  • diseases linked to your heart, liver, kidneys or central nervous system,
  • because you are taking certain medicines (see also below “Other medicines and Glucose 5% Infusion”).

This may increase the risk of low level of sodium in your blood and can lead to headache, nausea, seizures, lethargy, coma, swelling of the brain and death. Brain swelling increases the risk of death and brain damage. People who are at higher risk of brain swelling are:

• children
• women (particularly if you are of a fertile age)
• people who have problems with their brain fluid levels, for example, because of meningitis, bleeding in the skull or a brain injury.

When you are given this infusion, your doctor will take blood and urine samples to monitor:

• the amount of electrolytes, such as potassium in your blood (your plasma electrolytes)
• the amount of sugar (glucose)
• the amount of fluid in your body (your fluid balance)
• the acidity of the blood and urine (changes in acid-base balance)

As Glucose 5% Infusion contains sugar (glucose), it can cause a high level of sugar in the blood (hyperglycaemia). If this occurs, your doctor may:

• adjust the speed of infusion
• give insulin to reduce the blood sugar levels
• if necessary, give extra potassium

Glucose 5% Infusion must not be given through the same needle as a blood transfusion. This can damage the red blood cells or cause them to clump together.

Your doctor will take into account if you are receiving parenteral nutrition (nutrition given by infusion into a vein).

During long term treatment with Glucose 5% Infusion you may need to be given extra nutrition.

Glucose 5% Infusion should be given with special care in children.

Children must be given Glucose 5% Infusion by a doctor or nurse. The amount given must be decided by a doctor specialising in the care of children and will depend upon the child’s age, weight, and condition. If the Glucose 5% Infusion is used to deliver or dilute another medicine, or if other medicines are given at the same time, this may also affect the dose.

When this infusion is given to children the child’s doctor will take blood and urine samples to monitor the amount of electrolytes, such as potassium, in the blood (plasma electrolytes).

Newborns, especially those born premature and with a low birth weight, are at increased risk of developing a too low or too high level of sugar in the blood (hypo- or hyperglycaemia) and, therefore, need close monitoring during treatment with intravenous glucose solutions to ensure adequate control of the sugar levels in order to avoid potential long term adverse effects. Low sugar levels in newborns can cause prolonged seizures, coma and brain damage. High sugar levels have been associated with bleeding into the brain, bacterial and fungal infection, damage to the eye (retinopathy of prematurity), infections in the intestinal track (necrotizing enterocolitis), lung problems (bronchopulmonary dysplasia), prolonged length of hospital stay and death.

When administered to a newborn baby, the solution bag could be connected to an infusion pump device, which allows exact delivery of the required quantity of solution across the defined time interval. Your doctor or nurse will be monitoring the device to ensure safe administration.

Children (including neonates and older children) who are given Glucose 5% Infusion are at higher risk of developing a low sodium level in the blood (hypoosmotic hyponatraemia) and a disorder affecting the brain due to low plasma levels of sodium (hyponatraemic encephalopathy).

Tell your doctor or nurse if you are using, have recently used or might use any other medicines.

Glucose 5% Infusion and other medicines taken at the same time can affect each other.

Do not take Glucose 5% Infusion with certain hormones (catecholamines) including adrenaline or steroids as they can increase the level of sugar in your blood.

Some medicines act on the hormone vasopressin. These may include:

• anti-diabetic medication (chlorpropamide)
• cholesterol medicine (clofibrate)
• some cancer drugs (vincristine, ifosfamide, cyclophosphamide)
• selective serotonin reuptake inhibitors (used to treat depression)
• antipsychotics or opioids for severe pain relief
• medicines for pain and/or inflammation (also known as NSAIDs)
• medicines that imitate or strengthen the effects of vasopressin such as desmopressin (used to treat increased thirst and urination), terlipressin (used to treat bleeding of the gullet) and oxytocin (used to induce labour)
• anti-epileptic medication (carbamazepine and oxcarbazepine)
• diuretics (water tablets).

You should ask your doctor about what you can eat or drink.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.

Pregnancy

Glucose 5% Infusion can be used during pregnancy. However, caution should be taken when glucose solution is used during child birth.

Fertility

There are no adequate data of the effect of Glucose 5% Infusion on fertility. However, no effect on fertility is expected.

Lactation

There are no adequate data of using Glucose 5% Infusion during breast-feeding. However, no effect on breast-feeding is expected. Glucose solution can be used during breast-feeding.

If another medicine is to be added to your solution for infusion during pregnancy or breast-feeding you should:

• consult your doctor
• read the Package Leaflet of the medicine that is to be added

Ask your doctor or nurse for advice before driving or using machines.

If you are given too much Glucose 5% Infusion (over-infusion) or it is given too fast, this may lead to the following symptoms:

• build up of liquid in the tissues causing swelling (oedema) or water intoxication with lower than normal amounts of sodium in the blood (hyponatraemia)
• an increase in the amount of urine you produce (osmotic diuresis)
• the blood becomes too concentrated (hyperosmolarity)
• a loss of water from the body (dehydration)
• a high blood sugar level (hyperglycaemia)
• sugar in the urine (hyperglycosuria)

If you develop any of these symptoms you must inform your doctor immediately. Your infusion will be stopped or reduced. Insulin should be administered and you will be given treatment depending on the symptoms.

If a medicine has been added to your Glucose 5% Infusion before over-infusion occurs, that medicine may also cause symptoms. You should read the Package Leaflet of the added medicine for a list of possible symptoms.

Your doctor will decide when to stop giving you this infusion.

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below. By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom:

Via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Ireland:

Malta

• The active substance is sugar (glucose): 50 g per litre.

The only other ingredient is water for injections.

Glucose 5% Infusion is a clear solution, free from visible particles. It is supplied in polyolefin/polyamide plastic bags (Viaflo). Each bag is wrapped in a sealed, protective, outer plastic overpouch

The bag sizes are:

• 50 ml
• 100 ml
• 250 ml
• 500 ml
• 1000 ml

Pack sizes:

• 50 bags of 50 ml per carton.
• 75 bags of 50 ml per carton.
• 1 bag of 50 ml.
• 50 bags of 100 ml per carton.
• 60 bags of 100 ml per carton.
• 1 bag of 100 ml.
• 30 bags of 250 ml per carton.
• 1 bag of 250 ml.
• 20 bags of 500 ml per carton.
• 1 bag of 500 ml.
• 10 bags of 1000 ml per carton.
• 12 bags of 1000 ml per carton.
• 1 bag of 1000 ml.

Not all pack sizes may be marketed

Marketing Authorisation Holder:

United Kingdom

Ireland and Malta

Manufacturers for Great Britain:

Manufacturers for Ireland and Malta: