Compound Sodium Lactate 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.

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

This medicine is called “Compound Sodium Lactate Solution for Infusion BP”, but will be referred to as “Compound Sodium Lactate Infusion” throughout the document.

• if you’re a newborn (less than 28 days old) receiving ceftriaxone (an antibiotic)
• if you’re allergic to sodium lactate or any of the other ingredients in Compound Sodium Lactate (listed in section 6)
• 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)
• severe kidney failure (when your kidneys do not work well and you require dialysis)
• 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 potassium in the blood than normal (hyperkalaemia)
• higher levels of calcium in the blood than normal (hypercalcaemia)
• a disorder in which the blood becomes too alkaline (metabolic alkalosis)
• liver disease that causes fluid to build up within the abdomen (ascitic cirrhosis)
• your blood is too acidic which is life-threatening (severe metabolic acidosis)
• a particular type of metabolic acidosis (lactic acidosis)
• severe liver disease (when the liver does not function properly and requires very intensive treatment)
• poor lactate metabolism (this occurs in severe liver disease, as lactate is removed by the liver)
• if you are taking cardiac glycosides (cardiotonics) used to treat heart failure, such as digitalis or digoxin (see also “Taking other medicines”)

Talk to your doctor or nurse before receiving Compound Sodium Lactate Infusion if you have or have had any of the following medical conditions:

• if you’re receiving ceftriaxone (an antibiotic) (see also “Other medicines and Compound Sodium Lactate Infusion”)
• heart failure
• respiratory failure (lung disease) (special monitoring may be required in the above conditions)
• poor kidney function
• higher levels of chloride in the blood than normal (hyperchloraemia)
• high blood pressure (hypertension)
• build up of fluid under the skin, affecting all parts of the body (general oedema)
• 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)
• a disease that causes high levels of a hormone called aldosterone (aldosteronism)
• higher levels of sodium in the blood than normal (hypernatraemia) or any other condition associated with sodium retention (when the body retains too much sodium), such as treatment with steroids (See also below, “Taking other medicines”)
• heart disease of any type
• any condition that means that 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)
  Close monitoring of your blood potassium levels is required.
• diseases associated with high levels of vitamin D (e.g. sarcoidosis, a disease affecting the skin and internal organs)
• kidney stones
• poor liver function
• diabetes
• 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 ‘Compound Sodium Lactate 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.

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

Although Compound Sodium Lactate Infusion contains potassium, it does not contain enough to treat very low blood plasma levels of potassium (severe potassium deficiency).

Calcium chloride can be harmful if injected into the body tissues. Therefore, the Compound Sodium Lactate Infusion must not be given by injecting it into a muscle (intramuscular injection). Also, your doctor will make every effort to avoid the escape of the solution into the tissues surrounding the vein.

Compound Sodium Lactate 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.

As Compound Sodium Lactate Infusion contains lactate (a substance found in the body), it can make your blood too alkaline (metabolic alkalosis).

Compound Sodium Lactate Infusion should be given with special care to babies less than 6 months of age.

Your doctor will take into account if you are receiving parenteral nutrition (nutrition given by infusion into a vein). If you are given Compound Sodium Lactate Infusion for a long time, you will be given an extra source of nutrients.

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

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

• ceftriaxone (an antibiotic), this should not be given through the same infusion line, unless thoroughly flushed.
• cardiac glycosides (cardiotonics) such as digitalis or digoxin used to treat heart failure, must not be used with Compound Sodium Lactate Infusion (see also section “You must NOT receive Compound Sodium Lactate Infusion if you are suffering from...”). The effects of these drugs can be increased by calcium. This can lead to life threatening changes to the heart rhythm
• 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).

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

• potassium-sparing diuretics (certain water tablets, e.g. amiloride, spironolactone, triamterene) (Note that these medicines may be included in combination medicinal products)
• 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)

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 Compound Sodium Lactate Infusion include:

• thiazide diuretics such as hydrochlorothiazide or chlortalidone
• vitamin D
• bisphosphonates (to treat bone diseases such as osteoporosis)
• fluoride (for the teeth and bones)
• fluoroquinolones (a type of antibiotic, including ciprofloxacin, norfloxacin, ofloxacin)
• tetracyclines (a type of antibiotic, including tetracycline)
• acidic medicines, including:
  • salicylates used to treat inflammation (aspirin)
  • barbiturates (sleeping tablets)
  • lithium (used to treat psychiatric illness)
• 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 of 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.

Compound Sodium Lactate Infusion can be used safely during pregnancy or breast-feeding. Your doctor will monitor the levels of chemicals in your blood and the amount of fluid in your body.

Calcium can reach your unborn baby through the placenta and, after birth, through the breast milk. However, 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 pharmacist for advice before driving or using machines.

If you are given too much Compound Sodium Lactate 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
• hyperkalaemia (higher levels of potassium in the blood than normal) especially in patients with kidney failure, causing symptoms such as:
  • pins and needles in the arms and legs (paraesthesia)
  • 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
  • hypercalcaemia (higher levels of calcium in the blood than normal) causing symptoms such as:
    • a decreased appetite (anorexia)
    • feeling sick (nausea)
    • vomiting
    • constipation
    • abdominal pain
    • mental disturbances such as irritability or depression
    • drinking lots of water (polydipsia)
    • producing more urine than normal (polyuria)
    • kidney disease due to build up of calcium in the kidneys (nephrocalcinosis)
    • kidney stones
    • coma (unconsciousness)
    • chalky taste
    • redness (hot flushes)
    • dilatation of the blood vessels in the skin (peripheral vasodilatation).
• Hypokalaemia (lower levels of potassium in the blood than normal) and metabolic alkalosis (when the blood becomes too basic), especially in patients with kidney failure, causing symptoms such as:
  • mood changes
  • tiredness
  • shortness of breath
  • stiffness of the muscles
  • twitching of the muscles
  • contraction 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 Compound Sodium Lactate 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 effect, talk to your doctor or nurse. This includes any possible side effect not listed in this leaflet.

Ireland: You can also report side effects directly via

UK: You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard

Malta

Website: www.medicinesauthority.gov.mt/adrportal

By reporting side effects, you can help provide more information on the safety of this medicine.

The active substances are:

• sodium chloride: 6.00 g per litre
• potassium chloride: 0.40 g per litre
• calcium chloride dihydrate: 0.27 g per litre
• sodium lactate: 3.20 g per litre.

The only other ingredient is water for injections.

Compound Sodium Lactate 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

Pack sizes:

• 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:

Manufacturers for Great Britian:

Manufacturers for Ireland and Malta: