Plasma-Lyte 148 (pH 7.4) 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 (pH 7.4) Solution for Infusion’, but will be referred to as `Plasma-Lyte 148 (pH 7.4) infusion’ throughout the remainder of this leaflet.

1. What Plasma-Lyte 148 (pH 7.4) Infusion is and what it is used for
2. What you need to know before you use Plasma-Lyte 148 (pH 7.4) Infusion
3. How to use Plasma-Lyte 148 (pH 7.4) Infusion
4. Possible side effects
5. How to store Plasma-Lyte 148 (pH 7.4) Infusion
6. Contents of the pack and other information

• 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)
• a deficiency of acid secretion in the stomach (hypochlorhydria)
• hypersensitivity to the active substances or to any of the ingredients listed in section 6

Talk to your doctor or nurse before receiving Plasma-Lyte 148 (pH 7.4) infusion 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”)
• 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 or brain disease
  • you have diseases linked to your heart, liver, kidneys or central nervous system
  • because you are taking certain medicines (see also below “Other medicines and Plasma-Lyte 148 (pH 7.4) 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
• higher levels of chloride in the blood than normal (hyperchloraemia)
• higher levels of sodium in the blood than normal (hypernatraemia)
• lower levels of calcium in the blood than normal (hypocalcaemia)
• 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

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)
• your acid-base balance (the acidity of the blood and urine)

Although Plasma-Lyte 148 (pH 7.4) Infusion contains potassium, it does not contain enough to treat severe potassium deficiency (very low blood plasma levels).

Plasma-Lyte 148 (pH 7.4) Infusion contains substances that can cause metabolic alkalosis (making the blood too alkaline).

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.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

The use of the following medicines is not recommended while you are receiving an infusion of Plasma-Lyte 148 (pH 7.4) Infusion:

• potassium-sparing diuretics (certain water tablets, e.g. amiloride, spironolactone, triamterene, potassium canrenoate)
• 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 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
• 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 Plasma-Lyte 148 (pH 7.4) 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 for advice before taking this medicine.

You may receive Plasma-Lyte 148 (pH 7.4) 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 breastfeeding you should:

• consult your doctor
• 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 148 (pH 7.4) 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

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 148 (pH 7.4) 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 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 substances are:

• 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
• sodium hydroxide

Plasma-Lyte 148 (pH 7.4) Solution for 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:

• 500 ml
• 1000 ml

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

• 1 bag of 500 ml
• 20 bags of 500 ml
• 1 bag of 1000 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 for Great Britain:

Manufacturers for Ireland and Malta: