PACKAGE LEAFLET: INFORMATION FOR THE USER

Compound Sodium Lactate & Glucose 5% w/v Solution for Infusion

Active substances: glucose, sodium chloride, potassium chloride, calcium chloride dihydrate and sodium

lactate

Read all of this leaflet carefully before you are given using this medicine because it contains important information for you.

-    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.

What is in this leaflet:

1.    What Compound Sodium Lactate/Glucose Infusion is and what it is used for

2.    What you need to know before you are given Compound Sodium Lactate/Glucose Infusion

3.    How you will be given Compound Sodium Lactate/Glucose Infusion

4.    Possible side effects

5.    How to store Compound Sodium Lactate/Glucose Infusion

6.    Contents of the pack and other information

This medicine is called "Compound Sodium Lactate& Glucose 5% w/v Solution for Infusion”, but will be referred to as “Compound Sodium Lactate/Glucose Infusion” throughout the document

1.    What Compound Sodium Lactate/Glucose Infusion is and what it is used for

Compound Sodium Lactate/Glucose Infusion is a solution of the following substances in water:

-    sugar (glucose)

-    sodium chloride

-    potassium chloride

-    calcium chloride dihydrate

-    sodium lactate

Glucose is one of the body’s sources of energy. This solution for infusion provides 200 kilocalories per litre. Sodium, potassium, calcium, chloride and lactate are chemical substances (electrolytes) found in the blood.

Compound Sodium Lactate/Glucose Infusion is used: as a source of carbohydrate (sugar) in the following situations:

-    to treat a loss of body water and chemicals (e.g. by heavy sweating, kidney disorders) to treat you, if the volume of blood in your blood vessels is low (hypovolaemia) or if you have low blood pressure (hypotension).

-    in metabolic acidosis (when the blood becomes too acidic).

2.    What you need to know before you are given Compound Sodium Lactate/Glucose Infusion

Do NOT receive Compound Sodium Lactate/Glucose Infusion if you are suffering from any of the following conditions

-    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 substances in Compound Sodium Lactate/Glucose Infusion

-    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”)

-    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)

Warning and precautions

Compound Sodium Lactate/Glucose Infusion is a hypertonic (concentrated) solution. Your doctor will take this into account when calculating how much solution to give you.

Talk to your doctor or nurse before receiving Compound Sodium Lactate/Glucose 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/Glucose 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”).

-    diabetes (your blood sugar levels will be monitored closely and your insulin treatment may need to be modified)

-    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

-    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 had a head injury less then a day ago

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

-    the amount of chemicals such as sodium and potassium in your blood (your plasma electrolytes)

-    the amount of sugar (glucose)

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

Although Compound Sodium Lactate/Glucose 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/Glucose 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/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.

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

As Compound Sodium Lactate/Glucose 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.

Children

Compound Sodium Lactate/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.

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/Glucose Infusion for a long time, you will be given an extra source of nutrients

Other medicines and Compound Sodium Lactate/Glucose Infusion

Please tell your doctor or nurse if you are taking, have recently taken or might have taken 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/Glucose Infusion (see also section “You must NOT receive Compound Sodium Lactate/Glucose 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)

Other medicines that can affect or be affected by Compound Sodium Lactate/Glucose 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 (aspririn)

-    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)

Compound Sodium Lactate/Glucose Infusion with food and drink

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

Pregnancy and breast-feeding

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/Glucose 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 or nurse.

-    read the Package Leaflet of the medicine that is to be added.

Driving and using machines

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

3. How you will be given Compound Sodium Lactate/Glucose Infusion

You will be given Compound Sodium Lactate/Glucose Infusion by a doctor or nurse. Your doctor will decide on how much you need and when it is to be given. This will depend on your age, weight, condition and the reason for treatment. The amount you are given may also be affected by other treatments you are receiving.

You should NOT be given Compound Sodium Lactate/Glucose Infusion if there are particles floating in the solution or if the pack is damaged in any way.

Compound Sodium Lactate/Glucose Infusion will usually be given to you through a plastic tube attached to a needle in a vein. Usually a vein in your arm is used to give you the infusion. However, your doctor may use another method to give you the medicine.

Any unused solution should be thrown away. You should NOT be given an infusion of Compound Sodium Lactate/Glucose Infusion from a bag that has been partly used.

If you receive more Compound Sodium Lactate/Glucose Infusion than you should

If you are given too much Compound Sodium Lactate/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

-    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 (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

-    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.

-    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)

-    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 Compound Sodium Lactate/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

Stopping your Compound Sodium Lactate/Glucose Infusion

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

If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you have any of the following symptoms you should tell your doctor or nurse immediately. These may signs of a very severe or even fatal hypersensitivity (allergic) reaction called anaphylactic shock:

-    hives (urticaria) which may be localised to a part of the body or widespread

-    skin rash

-    redness of the skin (erythema)

-    itching (pruritus)

-    skin swelling (angioedema)

-    narrowing of the airways causing difficulty breathing (bronchospasm)

-    chest discomfort or pain

-    shortness of breath (dyspnea)

-    fever (pyrexia)

-    nausea

-    coughing

Some reactions may be due to the administration technique:

-    rash or itching (pruritus) of the infusion site

-    local pain or reaction (redness or swelling at the site of infusion)

-    infusion site anesthesia (numbness)

Other side effects noted with similar products (other sodium-lactate containing solutions) include:

•    Other manifestations of hypersensitivity/infusion reactions: Laryngeal oedema (Quincke’s edema), a

slow heartbeat (bradycardia), a fast heartbeat (tachycardia), Blood pressure decreased, Respiratory distress, Flushing, Throat irritation, Skin swelling, pins and needles (paresthesias), reduced sense in the mouth (hypoesthesia oral), altered taste (dysgeusia); Anxiety, Headache, Nasal congestion, Sneezing

•    Changes in the concentrations of the chemicals in the blood (electrolyte disturbances)

•    Higher levels of potassium in the blood than normal (hyperkalemia)

•    A larger volume of blood in the blood vessels than there should be (hypervolemia)

•    Panic Attack

•    Other infusion site reactions: Infection at the site of injection, Phlebitis, Extravasation, Infusion site

inflammation, Infusion site swelling, Infusion site rash, Infusion site pain, Infusion site burning

If a medicine has been added to the solution for infusion, the added medicine may also cause side effects. These side effects will depend on the medicine that has been added. You should read the Patient Information Leaflet of the added medicine for a list of possible symptoms.

Reporting of side effects

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

5.    How to store Compound Sodium Lactate/Glucose Infusion

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

You should NOT be given this medicine after the expiry date which is stated on the bag (eg EXP: MM/YYYY). The expiry date refers to the last day of that month.

You should not be given this medicine, if there are particles floating in the solution or if the unit is damaged in any way.

6.    Contents of the pack and other information

What Compound Sodium Lactate/Glucose Infusion contains

The active substances are:

-    sugar (glucose): 50.00 g per liter

-    sodium chloride: 6.00 g per liter

-    potassium chloride: 0.40 g per liter

-    calcium chloride dihydrate: 0.27 g per liter

-    sodium lactate: 3.20 g per liter

The only other ingredient is water for injections.

What Compound Sodium Lactate/Glucose Infusion looks like and contents of the pack

Compound Sodium Lactate/Glucose Infusion 5% w/v 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:

-    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

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturers

Marketing Authorisation Holder:

Baxter Healthcare Ltd.

Caxton Way,

Thetford Norfolk IP24 3SE United Kingdom

Manufacturers:

Baxter SA

Boulevard Rene Branquart, 80

7860 Lessines

Belgium

Baxter Healthcare Ltd.

Caxton Way,

Thetford Norfolk IP24 3SE United Kingdom

Bieffe Medital S.A.

Ctra de Biescas, Senegue 22666 Sabinanigo (Huesca)

Spain

This leaflet was last revised in April 2014

For information about Compound Sodium Lactate/Glucose Infusion or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder:Tel: + 44 (0)1635 206345

The following information is intended for healthcare professionals only:

Handling and Preparation

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless the solution is clear and the seal is intact. Do not remove unit from overwrap until ready for use. The inner bag maintains the sterility of the product. Administer immediately following the insertion of infusion set.

Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed. Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

The solution is for intravenous administration through a sterile administration set using aseptic technique.

The equipment should be primed with the solution in order to prevent air entering the system.

Additives may be introduced before infusion or during infusion through the injection site. Thorough and careful aseptic mixing of any additive is mandatory. Solutions containing additives should be used immediately and not stored.

Adding other medication or using an incorrect administration technique might cause the appearance of fever reactions due to the possible introduction of pyrogens. In case of adverse reaction, infusion must be stopped immediately.

Discard after single use.

Discard any unused portion.

Do not reconnect partially used bags.

1.    Opening

•    Remove the Viaflo container from the overpouch just before use.

•    Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution, as sterility may be impaired.

•    Check the solution for clarity and absence of foreign matters. If solution is not clear or contains foreign matters, discard the solution.

2.    Preparation for administration

Use sterile material for preparation and administration.

•    Suspend container from eyelet support.

•    Remove plastic protector from outlet port at bottom of container:

■    grip the small wing on the neck of the port with one hand,

■    grip the large wing on the cap with the other hand and twist,

■    the cap will pop off.

•    Use an aseptic method to set up the infusion.

•    Attach administration set. Refer to complete directions accompanying set for connection, priming of the set and administration of the solution.

3.    Techniques for injection of additive medications

Warning: Additives may be incompatible. Check additive compatibility with both the solution and container prior to use. (see Paragraph 5 “Incompatibilities of additive medications” belowf To add medication before administration

•    Disinfect medication port.

•    Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture re-sealable medication port and inject.

Mix solution and medication thoroughly. For high-density medication such as potassium chloride, tap the ports gently while ports are upright and mix.

Caution: Do not store bags containing added medications.

To add medication during administration

•    Close clamp on the set.

•    Disinfect medication port.

•    Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture re-sealable medication port and inject.

•    Remove container from IV pole and/or turn to an upright position.

•    Evacuate both ports by tapping gently while the container is in an upright position.

•    Mix solution and medication thoroughly.

•    Return container to in use position, re-open the clamp and continue administration.

4.    In-use shelf-life: Additives

The chemical and physical stability of any additive at the pH of Compound Sodium Lactate/Glucose Infusion 5% w/v solution in the Viaflo container should be established prior to use.

From a microbiological point of view, the diluted product must be used immediately unless dilution has taken place in controlled and validated aseptic conditions. If not used immediately, in-use storage times and conditions are the responsibility of the user.

5.    Incompatibilities of additive medications

Ceftriaxone must not be mixed with calcium-containing solutions including Compound Sodium Lactate/Glucose Infusion

As with all parenteral solutions, additives may be incompatible, compatibility of these additives with the Compound Sodium Lactate/Glucose Infusion must be assessed before addition. After addition of the additive, incompatibility may become visible by a possible colour change and/or the appearance of precipitates, insoluble complexes or crystals. The Instructions for Use of the medication to be added and other relevant literature must be consulted.

Before adding a substance or medication, verify it is soluble and/or stable in water and that the pH range of Compound Sodium Lactate/Glucose Infusion is appropriate (pH 4.0 to 6.5).

When making additions to Compound Sodium Lactate/Glucose Infusion, aseptic technique must be used. Mix the solution thoroughly when additives have been introduced. Do not store solutions containing additives.

As a guidance the following medications are incompatible with the Compound Sodium Lactate Glucose (non-exhaustive listing):

• Medications incompatible with Compound Sodium Lactate/Glucose Infusion

—    Aminocaproic acid

—    Amphotericin B

—    Ceftriaxone

—    Cortisone acetate

—    Diethylstilbestrol

—    Etamivan

—    Ethyl alcohol

—    Phosphate and carbonate solutions

—    Oxytetracycline

—    Thiopental sodium

—    Versenate disodium

• Medications with partial incompatibility with Compound Sodium Lactate/Glucose Infusion:

—    Tetracycline stable for 12 hours

—    Ampicillin sodium

concentration of 2%-3% stable for 4 hours concentration >3% must be given within 1 hour

—    Minocycline stable for 12 hours

—    Doxycycline stable for 6 hours

Those additives known to be incompatible should not be used.

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