Sodium Chloride 0.9 % w/v and Glucose 5% w/v Solution for 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.

This medicine is called 'Sodium Chloride 0.9% w/v & Glucose 5% w/v Solution for Infusion BP', but will be referred to as 'Sodium Chloride 0.9 & Glucose 5 Infusion' throughout the remainder of this leaflet.

1. What Sodium Chloride 0.9 & Glucose 5 Infusion is and what it is used for
2. What you need to know before you are given Sodium Chloride 0.9 & Glucose 5 Infusion
3. How you will be given Sodium Chloride 0.9 & Glucose 5 Infusion
4. Possible side effects
5. How to store Sodium Chloride 0.9 & Glucose 5 Infusion
6. Contents of the pack and other information

• when you know you are allergic to the product
• when there is too much fluid in the spaces around the cells of the body (extracellular hyperhydration)
• when there is a larger volume of blood in the blood vessels than there should be (hypervolaemia)
• more fluid and sodium than normal in the body (fluid and sodium retention)
• severe kidney problems that mean you produce less urine than usual or none at all (oliguria or anuria)
• uncompensated heart failure. This is heart failure that is not adequately treated and causes symptoms such as:
  • shortness of breath
  • swelling of the ankles
• higher levels of sodium in the blood than normal (hypernatraemia)
• higher levels of chloride in the blood than normal (hyperchloraemia)
• build up of fluid under the skin, affecting all parts of the body (general oedema)
• liver disease that causes fluid to build up within the abdomen (ascitic cirrhosis)
• diabetes that is not adequately treated, allowing your blood sugar levels to rise above normal (uncompensated diabetes)
• other states of glucose intolerance, for example:
  • metabolic stress (when the body's metabolism does not function correctly, e.g. due to severe illness)
  • hyperosmolar coma (unconsciousness). This is a type of coma that can occur if you have diabetes and do not receive enough medicine.
  • a very high amount of sugar in the blood (significant hyperglycaemia)
  • higher levels of lactate in the blood than normal (hyperlactataemia)

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

• a disorder in which the blood becomes too alkaline (metabolic alkalosis)
• muscle weakness and periodic paralysis due to low thyroid activity (thyrotoxic periodic paralysis)
• rapid loss of water from the body e.g. due to vomiting or diarrhoea
• being on a low potassium diet for a long time
• taking certain medications, see below: "Other medicines and Sodium Chloride 0.9 & Glucose 5 Infusion"
• a disorder in which the blood becomes too acidic (metabolic acidosis)
• 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 Sodium Chloride 0.9 & Glucose 5 Infusion")
  This may increase the risk of low levels 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.

Conditions associated with sodium retention, fluid overload and oedema, such as:

• aldosteronism (a disease that causes high levels of a hormone called aldosterone) associated with:
  • poor liver function or liver disease that causes fluid to build up within the abdomen (ascitic cirrhosis)
  • high blood pressure (hypertension)
  • heart failure
  • poor kidney function
• high blood pressure during pregnancy (pre-eclampsia)
• any other condition associated with sodium retention (when the body retains too much sodium), such as treatment with steroids (see also below, "Other medicines and Sodium Chloride 0.9 & Glucose 5 Infusion")
• allergy, in particular to corn (Sodium Chloride 0.9 & Glucose 5 Infusion contains sugar derived from corn)

The infusion may cause:

• changes in the concentrations of the chemicals in the blood (electrolyte disturbances)
• build up of fluid under the skin, affecting all parts of the body (general oedema), around the ankles (peripheral oedema) or in the lungs (pulmonary oedema)
• a higher amount of sugar in the blood than normal (hyperglycaemia)

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

• the amount of chemicals such as sodium and chloride in your blood (your plasma electrolytes)
• the amount of sugar (glucose)

As Sodium Chloride 0.9 & 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 you insulin to reduce the blood sugar levels

This is particularly important:

• if you are diabetic
• if you have not been eating well or have been drinking too much alcohol for a long time
• 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 had head injury within the past 24 hours

Your doctor will take into account if you are receiving parenteral nutrition (nutrition given by infusion into a vein). During long-term treatment with Sodium Chloride 0.9 & Glucose 5 Infusion, you may need to be given extra nutrition. Your doctor should also monitor the level of potassium in your blood to avoid this becoming lower than normal (hypokalaemia).

Special care should be taken when giving this solution to children, infants, and newborns (especially premature babies and those with low birth weight). Children, infants and newborns may not have a good ability to handle the chemicals in the solution.

Newborns — especially those born premature and with 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 solutions containing glucose 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, late onset bacterial and fungal infection, damage to the eye (retinopathy of prematurity), infections in the intestinal track (necrotizing enterocolits), lung problems (bronchopulmonary dysplasia), prolonged hospital stay and death.

Children are at higher risk for having or developing a too low sodium concentration in their blood (hyponatraemia). Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, swelling of the brain (cerebral oedema) and death. Acute hyponatraemic encephalopathy is a serious complication, especially in children. Your doctor knows this and will closely monitor the amount of chemicals such as sodium and chloride in your child's blood (plasma electrolytes).

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

It is particularly important that you inform your doctor if you are taking:

• corticosteroids (anti-inflammatory medicines)

These medicines can cause the body to accumulate sodium and water, leading to:

• tissue swelling due to fluid collection under the skin (oedema)
• high blood pressure (hypertension)

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).

Other medicines that can affect or be affected by Sodium Chloride 0.9/Glucose 5 Infusion:

• lithium (used to treat psychiatric illnesses)
• insulin (used to treat diabetes)
• beta blockers (heart tablets)

Sodium Chloride 0.9 & 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.

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.

Sodium Chloride 0.9 & Glucose 5 Infusion can be used during breastfeeding.

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.

Sodium Chloride 0.9 & Glucose 5 Infusion does not affect your ability to drive or use machines.

If you are given too much Sodium Chloride 0.9 & Glucose 5 Infusion (over-infusion) or if it is given too fast, this may lead to the following symptoms:

• high levels of sugar in the blood (hyperglycaemia) Symptoms include:
  • dry mouth due to lack of water in body tissues (dehydration)
  • thirst
  • fatigue
  • frequent urination due to increased urine production (osmotic diuresis)
  • blurred vision
• low levels of sodium in the blood (hyponatraemia). Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, swelling of the brain (cerebral oedema) and death
• high blood levels of sodium (hypernatraemia). If this occurs, the most serious effect is a reduction in the water content of the brain (dehydration of the brain). This causes drowsiness and confusion and may lead to fits (convulsions), unconsciousness (coma), stopping breathing (respiratory failure) and even death.
  Other symptoms include:
  
  • thirst
  • dry mouth and eyes
  • fever
  • rapid heart rate (tachycardia)
  • high blood pressure (hypertension)
  • headache
  • dizziness
  • restlessness
  • irritability
  • weakness.
• build-up of fluid in the body causing swelling (oedema).

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

If a medicine has been added to your Sodium Chloride 0.9 & 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 nurse. This includes any possible side effects not listed in this leaflet. If any side effects occur, the infusion must be stopped.

You can also report side effects directly (see details 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

Malta

Ireland:

The active substances are:

• sugar (glucose): 50 g per litre
• sodium chloride: 9 g per litre

The only other ingredient is water for injections.

Sodium Chloride 0.9 & 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:

• 250 ml
• 500 ml
• 1000 ml

The bags are supplied in cartons. Each carton contains one of the following quantities:

• 30 bags of 250 ml
• 20 bags of 500 ml
• 10 bags of 1000 ml
• 12 bags of 1000 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturers in Great Britain:

Manufacturers In Ireland: