Electrolyte solution for maintenance with glucose Galenica Senese

Package leaflet: Information for the user

ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE

infusion solution I
ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE
infusion solution II
Sodium chloride, potassium acetate, magnesium acetate tetrahydrate, glucose monohydrate
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE is and what it is used for
2. What you need to know before using it
3. How to use ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE
4. Possible side effects
5. How to store ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE
6. Contents of the pack and other information

1. What ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE is and what it is used for

ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE is an infusion solution for direct injection into a vein (intravenous infusion) containing a combination of active substances: sodium chloride, potassium acetate, magnesium acetate tetrahydrate, glucose monohydrate.
This medicinal product is indicated to provide water and electrolytes to the body in situations where a caloric intake must be ensured, and for the treatment of mild to moderate metabolic acidosis, a condition characterized by increased blood acidity.

2. What you need to know before using ELETTROLITICA BILANCIATA DI MANTENIMENTO CON

GLUCOSIO GALENICA SENESE
Do not use ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA
SENESE

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6);
• if you have high levels of potassium in the blood (hyperkalemia) or reduced ability to eliminate potassium (potassium retention);
• if you have severe liver problems (severe hepatic insufficiency) leading to inability to metabolize the acetate ion;
• if you have severe kidney problems (severe renal failure);
• if you have difficulty urinating (oliguric renal failure, anuria);
• if you have serious heart problems (severe myocardial disease);
• if you have an increased blood pH (metabolic and respiratory alkalosis);
• if you have breathing difficulties (respiratory rate less than 16 breaths per minute);
• if you have a high tendency for blood to clot (hypercoagulability);
• if you are taking cardiac glycosides, medicines used to treat heart conditions;
• if you are experiencing bleeding into the spinal cord or brain tissue (spinal or intracranial hemorrhage);
• if you suffer from mental disorders characterized by hallucinations, tremors, sweating (delirium tremens), especially if you are dehydrated;
• if you have low fluid levels in the body (dehydration);
• if the patient is in a coma;
• if you have a disease of the adrenal glands (Addison's disease) and are not receiving treatment for it;
• if you experience painful muscle cramps in conditions of intense heat (heat cramps).
  In case of blood transfusions, this medicine must not be administered through the same infusion catheter as whole blood due to the possible risk of red blood cell aggregation (pseudoagglutination).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before being administered ELETTROLITICA
BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE
This medicine must be administered by very slow intravenous infusion
(intravenous infusion), as high concentrations of potassium may lead to death due to loss of heart function (cardiac depression), irregular heartbeat (arrhythmias), up to cardiac arrest (see section “How to use ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE”).

Due to the presence of sodium, this medicine must be administered with caution in the following cases:

• if you have heart problems (congestive heart failure, cardiac insufficiency) or kidney problems (severe renal failure, reduced kidney function);
• if you have fluid accumulation (edema with salt retention), either in the lungs (pulmonary edema) or associated with swelling of the legs and ankles (peripheral edema);
• if you are taking heart medications (cardiotropic drugs) or anti-inflammatory corticosteroid or corticotropin medicines;
• if you have high blood pressure (hypertension);
• if you have a condition called pre-eclampsia, characterized by high blood pressure, swelling due to fluid accumulation, and protein in the urine, or other conditions caused by sodium accumulation.

Due to the presence of potassium, this medicine must be administered with caution in the following cases:

• if you have kidney problems (renal failure), as this may worsen potassium retention;
• if you have heart problems (cardiac insufficiency) and/or are taking other heart medications (digitalis);
• if you have an adrenal gland disease (adrenal insufficiency);
• if you have liver problems (hepatic insufficiency);
• if you suffer from a disorder characterized by sudden episodes of muscle weakness (familial periodic paralysis);
• if you have a condition characterized by muscle stiffness (congenital myotonia);
• if you have recently undergone surgery (early postoperative phase).

Due to the presence of magnesium, this medicine must be administered with caution in the following cases:

• if you have kidney problems (renal failure);
• if you have heart problems (cardiac insufficiency) and are taking other heart medications (digitalis);
• if you have a muscle disease (myasthenia gravis);
• if you are being treated with sedatives, hypnotics (central nervous system depressants), or drugs used to block muscles during surgery (neuromuscular blockers).

During treatment, serum magnesium levels must be monitored frequently to prevent excessive increases.
Due to the presence of acetate, the medicine must be used with caution in the following cases:
if you have an increased blood pH (metabolic and respiratory alkalosis).

• if you have elevated acetate levels in the blood, such as in cases of liver problems (mild or moderate hepatic insufficiency).

Due to the presence of glucose, the medicine must be administered with caution in the following cases:

• if you have diabetes mellitus or glucose intolerance;
• if you are taking anti-inflammatory corticosteroid medicines (corticosteroids or corticotropin).

During treatment, your doctor will monitor your blood and urine glucose levels and, if necessary, administer insulin to minimize the risk of increased blood glucose (hyperglycemia) and glucose in the urine (glycosuria).
Talk to your doctor, pharmacist, or nurse before being administered ELETTROLITICA
BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE if you are in any of the following conditions that may cause high levels of vasopressin, a hormone that regulates your body fluids:

• acute illness
• pain
• recent surgery
• infections, burns
• brain diseases
• liver, heart, and kidney diseases
  This may increase the risk of low sodium levels in the blood (hyponatremia), with symptoms such as headache, nausea, seizures, drowsiness, vomiting, and cerebral edema, which may lead to death. Cerebral edema may occur with higher risk:
• in children
• in women (especially if of childbearing age)
• in cases of meningitis, intracranial bleeding, or cerebral contusion.
  During treatment with this medicine, your doctor must periodically monitor heart function via electrocardiograms and blood electrolyte concentrations (plasma osmolarity), glucose levels (blood glucose), fluids, and blood pH (acid-base balance). Blood pressure and osteotendinous reflexes will also be monitored to detect any potential respiratory muscle paralysis.

This medicine must be used immediately after opening the container. The solution must be clear, colorless or slightly straw-yellow, and free of visible particles. It is intended for single, uninterrupted administration, and any remaining solution must not be used.
Children
This medicine must be administered with caution in children, particularly in newborns and low-body-weight children, as blood glucose levels may increase (hyperglycemia). Furthermore, in low-body-weight children, rapid or excessive intravenous infusion may cause an increase in blood electrolyte concentration (serum osmolarity) and cerebral bleeding due to rupture of blood vessels (intracerebral hemorrhage).
Other medicines and ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE
Inform your doctor or nurse if you are using, have recently used, or might use any other medicine.
This medicine must be administered with caution if you are taking:

• medicines used to lower blood pressure such as potassium-sparing diuretics, ACE inhibitors, or other medicines that reduce aldosterone levels, because they may lead to increased potassium in the blood (hyperkalemia). In such cases, blood potassium levels must be closely monitored, especially if you have kidney problems;
• anti-inflammatory steroid medicines (corticosteroids) that may cause sodium and water retention, leading to fluid accumulation (edema) and increased blood pressure (hypertension). Corticosteroids and corticotropin are associated with reduced sugar tolerance, potentially unmasking latent diabetes mellitus; careful monitoring is required if glucose is administered concurrently;
• medicines acting on the vasopressin hormone, e.g.:
• chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs, cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin, diuretics in general, and antiepileptics such as oxcarbazepine, as they may increase the risk of hyponatremia;
• medicines that depress the central nervous system, such as barbiturates, narcotics, or other hypnotics (or systemic anesthetics). In such cases, dosage must be carefully adjusted, as magnesium enhances the central nervous system depressant effect;
• heart medications (cardiac glycosides, digoxin, digitoxin) that may lead to heart rhythm disturbances (arrhythmias);
• medicines used to block muscles during surgery (competitive and depolarizing neuromuscular blockers), such as rocuronium, as their effects may be enhanced by magnesium chloride;
• aminoglycoside antibiotics, used to treat bacterial infections;
• eltrombopag, a medicine used to treat low platelet counts in the blood;
• labetalol, a medicine used to treat heart rhythm disturbances (arrhythmias);
• medicines used to treat high blood pressure (isradipine, felodipina, nicardipine, and nifedipine), because concurrent use with magnesium may cause a significant drop in blood pressure (hypotension).

Fertility, pregnancy, and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor before being administered this medicine.
This medicine must not be used during pregnancy or breastfeeding unless absolutely necessary.
Due to the presence of magnesium, this medicine must not be administered within 2 hours before delivery. If magnesium chloride is administered (especially for more than 24 hours before delivery), newborns may show signs of magnesium toxicity, including neuromuscular and respiratory depression.
This medicine must be administered with particular caution during labor, especially when used in combination with a hormone called oxytocin, due to the risk of hyponatremia (see sections 2 and 4).
Driving and using machines
This medicine does not affect the ability to drive or use machinery.
ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE
contains sodium metabisulfite.
This medicine contains sodium metabisulfite, which may rarely cause severe hypersensitivity reactions and bronchospasm, particularly in sensitive individuals and/or those with asthma.

3. How to use ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE

GALENICA SENESE
This medicinal product will be prepared by a doctor, pharmacist, or nurse and will not be mixed with, nor administered simultaneously to, other incompatible medicinal products.
This medicinal product must be administered by specialized medical personnel as a very slow intravenous infusion (intravenous infusion). It must not be injected via other routes of administration (intramuscular, subcutaneous, or into perivascular tissues).
The dose will be adjusted according to age, body weight, blood electrolyte levels, and your overall health condition.
After administration of the medicinal product, remain lying down for a short period of time.
Infusions that are too rapid may cause local pain, and the infusion rate must be adjusted according to your needs.
Administration must be stopped if you experience pain or redness at the injection site, as this could be due to leakage of the medicinal product from the vein (drug extravasation).

Use in children
In children, the safety and efficacy of this medicinal product have not been established.
The dosage and rate of glucose administration must be determined based on the patient's age, weight, and clinical condition. Particular caution is required in neonates and underweight children (see section “Children”).

Preparation of the medicinal product: Use the solution immediately after opening the container. It is intended for single, uninterrupted administration; any remaining residue must not be used.
Shake well before administration. Do not use the medicinal product if the solution is not clear and colourless or slightly yellowish, or if particles are present.
Observe all standard precautions to maintain sterility before and during intravenous infusion.

If you use more ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE than you should
Since this medicinal product will be administered by a doctor or trained healthcare professional, it is unlikely that you will receive an excessive dose. However, if you think that you have been given an excessive dose of ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE, inform your doctor or another healthcare professional immediately.

Following administration of an excessive dose of this medicinal product, the following may occur:

• Increased potassium levels in the blood, which may lead to death due to heart damage (cardiac depression, arrhythmias, or arrest);
• Increased sodium levels and increased blood volume (hypervolemia). If blood sodium levels rise too much, internal organ dehydration may occur, particularly in the brain, along with fluid accumulation in the cerebral circulation, lungs (pulmonary edema), and legs and ankles (peripheral edema).
  Following administration of high doses of magnesium, the following symptoms of intoxication may occur: flushing, sweating, reduced blood pressure (hypotension), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), reduced body temperature (hypothermia), circulatory collapse, cardiac and central nervous system depression that may progress to respiratory paralysis. Magnesium intoxication manifests as a sudden increase in blood pressure, breathing difficulties (respiratory paralysis), and loss of the leg extension response following a percussion stimulus (patellar reflex).
  Prolonged administration of glucose may lead to accumulation of intracellular fluids (hyperhydration) and solute overload.

In case of overdose, the doctor must immediately discontinue administration of the medicinal product and initiate corrective therapy to reduce blood glucose and excess electrolyte levels, and restore acid-base balance if necessary.

If you have any doubts about the use of this medicinal product, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur:
Not known (frequency cannot be estimated from the available data):

• allergic reactions and urticaria;
• gastrointestinal disorders, nausea, vomiting, diarrhoea, abdominal pain, constipation, intestinal disorders (delayed intestinal transit and paralytic ileus);
• thirst, reduced salivation, metallic taste, chalky taste;
• neuromuscular disorders, muscle rigidity, altered limb sensation (paraesthesias), paralysis of certain muscles such as respiratory muscles (flaccid paralysis), weakness;
• confusion, headache, dizziness, restlessness, irritability;
• seizures, coma, death;
• cerebral haemorrhage;
• brain damage caused by poor blood circulation (cerebral ischaemia);
• drowsiness, confusional states, mental disorders;
• irregular heartbeat (arrhythmias), increased heart rate (tachycardia), decreased heart rate (bradycardia), conduction disturbances, disappearance of the P wave, widening of the QRS complex on electrocardiogram, syncope, ventricular fibrillation, cardiac arrest;
• reduction or increase in blood pressure (hypotension, hypertension), swelling of legs and ankles (peripheral oedema), hot flushes, sweating, and shock;
• increased levels of sodium (hypernatraemia), potassium (hyperkalaemia), and chloride (hyperchloraemia) in the blood;
• increased blood volume (hypervolaemia) and blood osmolarity (hyperosmolarity);
• reduced levels of calcium in the blood (hypocalcaemia);
• increased blood pH (alkalosis);
• breathing difficulties (dyspnoea, respiratory arrest);
• fluid accumulation in the lungs (pulmonary oedema) and air accumulation around the membrane surrounding the lung (pneumothorax);
• reduced tear production;
• kidney problems (renal failure) and excessive urine production (polyuria);
• muscle weakness;
• increased metabolic rate, increased blood glucose levels (hyperglycaemia), decreased blood glucose levels (hypoglycaemia), increased insulin levels, increased adrenaline levels;
• fever, infection at the infusion site, local pain or reaction, redness, skin rashes, venous irritation, formation of blood clots in veins (venous thrombosis);
• inflammation of veins (venous phlebitis) extending from the infusion site;
• leakage of the injected solution out of the vein (extravasation);
• tissue damage and tissue death (tissue necrosis);
• inflammation due to pus accumulation (abscesses);
• reduced sodium levels in the blood (hospital-acquired hyponatraemia)*;
• cerebral oedema which may lead to brain damage (hyponatraemic encephalopathy)*.

*Hospital-acquired hyponatraemia may cause irreversible brain damage and death due to the development of acute hyponatraemic encephalopathy.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. Contents How to store ELETTROLITICA BILANCIATA DI MANTENIMENTO CON

GLUCOSIO GALENICA SENESE
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging after “EXP.”.
The expiry date refers to the last day of that month.
Store below 30°C.
Keep in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE Infusion Solution I contains
GALENICA SENESE
Infusion Solution I

• The active substances are: sodium chloride, potassium acetate, magnesium acetate tetrahydrate, glucose monohydrate. 1000 ml of solution contain 2.34 g of sodium chloride, 0.98 g of potassium acetate, 0.32 g of magnesium acetate tetrahydrate, 55 g of glucose monohydrate (equivalent to 50 mg of glucose). Each litre of solution contains 40 mEq of sodium, 10 mEq of potassium, 3 mEq of magnesium, 40 mEq of chloride, 13 mEq of acetate and 278 mmol of glucose. pH: 5.0 – 7.0.
• The other components are: sodium metabisulfite, hydrochloric acid, water for injections.

Infusion Solution II

• The active substances are: sodium chloride, potassium acetate, magnesium acetate tetrahydrate, glucose monohydrate. 1000 ml of solution contain 2.34 g of sodium chloride, 1.28 g of potassium acetate, 0.32 g of magnesium acetate tetrahydrate, 55 g of glucose monohydrate (equivalent to 50 mg of glucose). Each litre of solution contains 40 mEq of sodium, 13 mEq of potassium, 3 mEq of magnesium, 40 mEq of chloride, 16 mEq of acetate and 278 mmol of glucose. pH: 5.0 – 7.0.
• The other components are: sodium metabisulfite, hydrochloric acid, water for injections.

Description of the appearance of ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE and contents of the pack
ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE
Infusion Solution I is available in packs containing:
1 glass vial of 100 ml, 250 ml, 500 ml and 1000 ml of infusion solution.
1 plastic bag of 100 ml, 250 ml, 500 ml and 1000 ml of infusion solution.
ELETTROLITICA BILANCIATA DI MANTENIMENTO CON GLUCOSIO GALENICA SENESE
Infusion Solution II is available in packs containing:
1 glass vial of 100 ml, 250 ml, 500 ml and 1000 ml of infusion solution.
1 and 20 polypropylene vials of 500 ml of infusion solution.
1 plastic bag of 100 ml, 250 ml, 500 ml and 1000 ml of infusion solution.

Marketing Authorisation Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord, 351
53014 Monteroni D’Arbia (SI)
Italy

The following information is intended exclusively for physicians or healthcare professionals

Dosage and administration
The solution is hypertonic with respect to blood and must be administered by intravenous infusion with caution and at a controlled infusion rate.
Shake well before administration.
The dose depends on the patient's age, body weight, clinical condition and electrolyte status.
The medicinal product should be administered only in patients with intact renal function and at a rate not exceeding 10 mEq of potassium per hour and 0.4–0.8 g of glucose per kg of body weight per hour.
Adults
Generally, the infusion rate is approximately 500 mL/hour.
Children
In children, the safety and efficacy of the medicinal product have not been established.
Glucose dosage and infusion rate must be adjusted according to the patient’s age, weight and clinical condition. Particular caution is required in pediatric patients, especially in neonates or children with low body weight (see section 4.4).
Do not inject intramuscularly, subcutaneously or into perivascular tissues.
Infusion must be discontinued if the patient experiences pain or redness at the injection site, as this may indicate drug extravasation.
Infusions that are too rapid may cause local pain, and the infusion rate should be adjusted according to patient tolerance.
It is advisable for the patient to remain lying down for a short period after administration.
Monitoring of electrolyte balance, serum glucose, serum sodium and other electrolytes may be necessary before and during administration, particularly in patients with non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant therapy with vasopressin agonists, due to the risk of hyponatremia.
Monitoring of serum sodium is particularly important for physiologically hypotonic solutions.
Elettrolitica bilanciata di mantenimento con glucosio Galenica Senese solution for infusion I and Elettrolitica bilanciata di mantenimento con glucosio Galenica Senese for infusion II may become extremely hypotonic after administration due to glucose metabolism in the body.
Intravenous glucose infusions are generally isotonic solutions. However, in the body, glucose-containing solutions may become physiologically extremely hypotonic due to the rapid metabolism of glucose (see section 4.2).
Depending on the tonicity of the solution, volume and frequency of infusion, the patient’s underlying clinical condition and glucose metabolism capacity, intravenous administration of glucose may cause electrolyte disturbances, particularly hypo- or hyperosmolar hyponatremia.
Hyponatremia:
Patients with non-osmotic vasopressin release (e.g. during acute illness, pain, post-operative stress, infections, burns and central nervous system disorders), patients with cardiac, hepatic or renal diseases, and patients treated with vasopressin agonists (see section 4.5) are particularly at risk of acute hyponatremia following infusion of isotonic solutions.
Acute hyponatremia may cause acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, lethargy and vomiting. Patients with cerebral edema are at particular risk of severe, irreversible and life-threatening brain damage.
Children, women of childbearing age and patients with reduced cerebral compliance (e.g. meningitis, intracranial hemorrhage and cerebral contusion) are particularly at risk of severe, life-threatening cerebral edema caused by acute hyponatremia.
Incompatibilities
If used to dilute medicinal products, consult a pharmacist, if available, before adding any additives; always consider the characteristics of the products to be added; use aseptic techniques.
Due to the presence of glucose, the medicinal product is incompatible with:

• cyanocobalamin;
• kanamycin sulfate;
• sodium novobiocin;
• sodium warfarin;

Furthermore, there are conflicting opinions regarding the compatibility of glucose with hydroxyethyl starch (hetastarch).
Ampicillin and amoxicillin are stable in glucose solutions only for a short period.
Due to the presence of magnesium, the medicinal product is incompatible with solutions containing alcohol (at high concentrations), heavy metals, carbonates and bicarbonates, sodium hydrocortisone, succinates, phosphates, polymyxin B sulfate, procaine hydrochloride, calcium salicylate, clindamycin phosphate and tartrates, as precipitates may form. Potential incompatibility is often influenced by changes in reactant concentrations and solution pH.
Management of overdose
Immediately discontinue the infusion and initiate corrective therapy for hyperglycemia and to reduce plasma levels of ions in excess, and restore acid-base balance if necessary (see section 4.4).
The patient should be closely monitored for any signs and symptoms related to the administered medicinal product, with appropriate symptomatic and supportive measures provided as needed.
In case of severe hypernatremia, loop diuretics may be used.
In case of hyperkalemia, intravenous glucose (with or without insulin) or sodium bicarbonate may be administered.
In case of magnesium intoxication presenting with respiratory paralysis, artificial ventilation is required. To counteract the effects of hypermagnesemia, intravenous calcium should be administered (10–20 mL of a 5% solution). Subcutaneous administration of 0.5–1 mg of physostigmine may be helpful.
Elevated plasma electrolyte levels may require dialysis.
In case of excessive glucose administration, reassess the patient’s clinical condition and implement appropriate corrective measures.
Special precautions for disposal and handling
Shake well before administration. Do not use the medicinal product if the solution is not clear and colorless or slightly yellowish, or if it contains particles.
Adopt all standard precautions to maintain sterility before and during intravenous infusion.
Unused medicinal product and waste materials derived from such medicinal product must be disposed of in accordance with local regulations.
For further information, consult the Summary of Product Characteristics.