Plasma-Lyte 148 & Glucose 5% w/v solution for infusion

• 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 `Plasma-Lyte 148 & Glucose 5% w/v Solution for Infusion’, but will be referred to as `Plasma-Lyte & Glucose Infusion’ throughout the remainder of this leaflet.

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

• higher levels of chloride in the blood than normal (hyperchloraemia)
• higher levels of sodium in the blood than normal (hypernatraemia)
• higher levels of potassium in the blood than normal (hyperkalaemia)
• kidney failure
• heart block (a very slow heart beat)
• disorders in which the blood becomes too alkaline (metabolic or respiratory alkalosis)
• lower levels of calcium in the blood than normal (hypocalcaemia)
• a deficiency of acid secretion in the stomach (hypochlorhydria)
• if you are taking potassium-sparing diuretics (water tablets that cause an accumulation of potassium in the body). Examples are:
  • amiloride
  • potassium canrenoate
  • spironolactone
  • triamterene
    (These medicines may be included in combination medicinal products)
• diabetes that is not adequately treated, allowing your blood sugar levels to rise above normal (uncompensated diabetes)
• 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 higher amount of sugar in the blood than normal (hyperglycaemia)
  • a higher amount of lactate in the blood than normal (hyperlactataemia)
  • hypersensitivity to the active substances or to any of the ingredients listed in section 6.

Plasma-Lyte & Glucose Infusion is a hyper-osmotic (concentrated) solution. Your doctor will take this into account when calculating how much solution to give you.

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

• heart failure
• respiratory failure (lung disease)
• kidney failure
  (special monitoring may be required in the above conditions).
• high blood pressure (hypertension)
• build up of fluid under the skin, particularly around the ankles (peripheral oedema)
• build up of fluid in the lungs (pulmonary oedema)
• high blood pressure during pregnancy (pre-eclampsia or eclampsia)
• aldosteronism (a disease that causes high levels of a hormone called aldosterone)
• any other condition associated with sodium retention (when the body retains too much sodium), such as treatment with steroids (See also below, “Other medicines”).
• diabetes (your blood sugar levels will be monitored closely and your insulin treatment may need to be modified)
• any condition that means you are more likely to have high blood levels of potassium (hyperkalaemia), such as:
  • kidney failure
  • adrenocortical insufficiency (this disease of the adrenal gland affects hormones that control the concentration of chemicals in the body)
  • acute dehydration (a loss of water from the body, e.g. due to vomiting or diarrhoea)
  • extensive tissue damage (as can occur in severe burns)
    (In such cases, close monitoring of your blood potassium level is required)
• myasthenia gravis (a disease that causes progressive muscle weakness)
• recovery after an operation
• head injury within the past 24 hours
• a high pressure within the skull (intracranial hypertension)
• a stroke due to a clot in a blood vessel in the brain (ischaemic stroke)
• If you have problems with the fluid levels in your brain (for example, because of meningitis, bleeding in the skull or a brain injury)
• if you have a condition that could cause high levels of vasopressin, a hormone regulating fluid in your body, such as:
  • a sudden and serious illness or injury
  • you have had surgery
  • brain disease
  • you are taking certain medicines

These conditions may increase the risk of low levels of sodium in your blood, which can lead to headache, nausea, seizures, lethargy, coma and swelling of the brain.

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

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

Although Plasma-Lyte & Glucose Infusion contains potassium, it does not contain enough to treat severe potassium deficiency (very low blood plasma levels).

Plasma-Lyte & Glucose 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.

Plasma-Lyte & Glucose Infusion contains substances that can cause metabolic alkalosis (making the blood too alkaline).

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

• adjust the speed of infusion
• give you insulin to reduce the amount of sugar in your blood

This is particularly important if you are diabetic.

If repeated treatment is required, your doctor will also give you other types of infusions. These will cover the needs of your body for other chemicals and nutrients (food).

If your blood is tested for the presence of a fungus called Aspergillus, the test may detect the presence of Aspergillus even if it is not present.

Plasma-Lyte & Glucose Infusion should be given with special care in children.

Newborns, especially those born premature and with low birth weight, are at increased risk of developing low or high levels of sugar in the blood (hypo or hyperglycemia), which may lead to complications.

Tell your doctor or nurse if you are taking or have recently taken or might take any other medicines.

The following medicines must not be used while you are receiving an infusion of Plasma-Lyte & Glucose Infusion:

• potassium-sparing diuretics (certain water tablets, e.g. amiloride, spironolactone, triamterene, potassium canrenoate) (these medicines may be included in combination medicinal products. See also “You must NOT receive Plasma-Lyte & Glucose Infusion if you are suffering from any of the following conditions” at the start of this section).

The use of the following medicines is not recommended while you are receiving an infusion of Plasma-Lyte & Glucose Infusion:

• angiotensin converting enzyme (ACE) inhibitors (used to treat high blood pressure)
• angiotensin II receptor antagonists (used to treat high blood pressure)
• tacrolimus (used to prevent rejection of a transplant and to treat some skin diseases)
• cyclosporin (used to prevent rejection of a transplant)

These medicines can increase the concentration of potassium in your blood. This can be life-threatening. A rise in your blood potassium levels is more likely to occur if you have kidney disease.

Some medicines can increase the risk of side effects due to low levels of sodium in the blood.

These medicines may include:

• some cancer drugs
• selective serotonin reuptake inhibitors, (used to treat depression)
• antipsychotics
• opioids
• medicines for pain and/or inflammation (also known as NSAIDs)
• certain medicines against epilepsy
• oxytocin (drug used during the treatment of women undergoing pregnancy, childbirth and post pregnancy care)
• diuretics.

Other medicines that can affect or be affected by Plasma-Lyte & Glucose Infusion:

• corticosteroids (anti-inflammatory medicines)
• carbenoxolone (an anti-inflammatory medicine used to treat stomach ulcers)
• neuromuscular blocking agents (e.g. tubocurarine, suxamethonium and vecuronium). These are medicines used in surgical operations and are controlled by your anaesthetist.
• acetylcholine
• aminoglycosides (a type of antibiotic)
• nifedipine (used to treat high blood pressure and chest pain)
• acidic medicines including:
  • salicylates used to treat inflammation (aspirin)
  • sleeping tablets (barbiturates)
  • lithium (used to treat psychiatric illnesses)
• alkaline (basic) medicines including:
  • sympathomimetics (stimulant medicines such as ephedrine and pseudoephedrine, used in cough and cold preparations)
  • other stimulants (e.g. dexamphetamine, phenfluramine)

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.

You may receive Plasma-Lyte & Glucose Infusion if you are pregnant or breast-feeding. Your doctor will monitor the levels of chemicals in your blood and the amount of fluid in your body.

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

• consult your doctor. Parallel administration of medicine called oxytocin during labour may cause a decrease in sodium levels in the blood (increase the risk of hyponatraemia)
• read the Package Leaflet of the medicine that is to be added.

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

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

• water and/or sodium (salt) overload with build up of liquid in the tissues (oedema) causing swelling
• pins and needles in the arms and legs (paresthesia)
• muscle weakness
• an inability to move (paralysis)
• an irregular heartbeat (cardiac arrhythmias)
• heart block (a very slow heartbeat)
• cardiac arrest (the heart stops beating; a life threatening situation)
• confusion
• loss of the tendon reflexes
• reduced breathing (respiratory depression)
• feeling sick (nausea)
• vomiting
• flushing (redness) of the skin
• thirst
• low blood pressure (hypotension)
• drowsiness
• a slow heartbeat (bradycardia)
• coma (unconsciousness)
• acidification of the blood (acidosis), leading to tiredness, confusion, lethargy and increased breathing rate.
• hypokalaemia (lower levels of potassium in the blood than normal) and metabolic alkalosis (when the blood becomes too alkaline) especially in patients with kidney failure
• mood change
• tiredness
• shortness of breath
• stiffness of muscles
• twitching of the muscles
• contractions of muscles
• hyperosmolarity (the blood becomes too concentrated)
• a loss of water from the body (dehydration)
• a high blood sugar level (hyperglycaemia)
• sugar in the urine (hyperglycosuria)
• an increase in the amount of urine you produce (osmotic diuresis)

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 Plasma-Lyte & Glucose 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. You can also report side effects directly via (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

Ireland

UK

Malta

The active substances are:

• glucose (sugar): 55.00 g per litre
• sodium chloride: 5.26 g per litre
• potassium chloride: 0.37 g per litre
• magnesium chloride hexahydrate: 0.30 g per litre
• sodium acetate trihydrate: 3.68 g per litre
• sodium gluconate: 5.02 g per litre

The other ingredients are:

• water for injections
• concentrated hydrochloric acid

Plasma-Lyte & Glucose 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:

United Kingdom

Ireland and Malta

Manufacturers in Great Britain:

Manufacturers In Ireland: