Peritoneal dialysis solution Vantive: detailed information

Package leaflet: Information for the user

PERITONEAL DIALYSIS SOLUTION VANTIVE

Generic medicine
Please read this leaflet carefully before you or your child start using this medicine as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
If you or your child experience any side effects, including any not listed in this leaflet, inform your doctor or nurse. See section 4 Side effects.

Contents of this leaflet:

What SOLUZIONE PER DIALISI PERITONEALE VANTIVE is and what it is used for
What you need to know before you or your child use SOLUZIONE PER DIALISI PERITONEALE VANTIVE
How to use SOLUZIONE PER DIALISI PERITONEALE VANTIVE
Possible side effects
How to store SOLUZIONE PER DIALISI PERITONEALE VANTIVE
Contents of the pack and other information

1. What SOLUZIONE PER DIALISI PERITONEALE VANTIVE is and what it is used for

SOLUZIONE PER DIALISI PERITONEALE VANTIVE is a solution that is introduced into the abdominal cavity, within the space between the skin and the peritoneum, the membrane lining the abdominal organs and the inner walls of the abdomen. This medicinal product enables blood purification within the body by removing fluids and toxic substances contained in the blood.
SOLUZIONE PER DIALISI PERITONEALE VANTIVE is indicated in adults and children of
any age who suffer from:

kidney diseases (acute and chronic renal failure);
fluid overload in the body;
disturbances in electrolyte balance (substances present in the blood);
intoxications by substances that can be removed through a blood purification system (dialysis).

Consult your doctor if you/your child do not feel better or feel worse.

2. What you should know before administering VANTIVE PERITONEAL DIALYSIS SOLUTION to yourself/your child

DO NOT administer VANTIVE PERITONEAL DIALYSIS SOLUTION to yourself/your child

if you/your child are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6);
if you/your child suffer from lactic acid accumulation in the blood (severe lactic acidosis);
if you/your child have non-correctable mechanical defects that prevent effective peritoneal dialysis (PD) or increase the risk of infection;
if you/your child have documented loss of peritoneal function or impaired peritoneal function due to extensive fibrous tissue bands forming between tissues and organs (adhesions);
if you/your child are allergic to corn starch (see section 4 Possible side effects).

Warnings and precautions
Talk to your doctor or nurse before administering VANTIVE PERITONEAL DIALYSIS SOLUTION to yourself/your child.
If you/your child are at higher risk of developing lactic acidosis, for example:

low blood pressure,
severe infection (sepsis),
kidney disease (acute renal failure),
inherited metabolic disorder,
taking metformin (a medicine used to treat diabetes),
taking antiviral medicines (nucleoside/nucleotide reverse transcriptase inhibitors),
your doctor will monitor you/your child for lactic acidosis before and during treatment.

Your doctor will also pay particular attention when prescribing peritoneal dialysis if you/your child have:

Abdominal conditions including:

rupture of the peritoneal membrane or diaphragm following surgery,
inherited abnormalities or trauma until complete healing,
abdominal tumors,
infection of the abdominal wall,
protrusion of an organ through the abdominal cavity (hernias),
intestinal tract lesions at the exit site of feces (fecal fistula),
surgical connection between the intestine and the outside of the body (colostomy or ileostomy),
frequent episodes of diverticula inflammation (outpouchings of the digestive tract),
inflammatory conditions or those caused by inadequate blood flow to the intestine,
kidney diseases (polycystic kidneys with large cysts),
other conditions compromising the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity;

Other conditions including:

implanted aortic prosthesis (aortic graft),
severe lung disease.

Also inform your doctor or nurse if you/your child have diabetes or high levels of nitrogen in the blood: your doctor will carefully evaluate the insulin dosage to be administered to you/your child.
During treatment with VANTIVE PERITONEAL DIALYSIS SOLUTION, you/your child may experience:

inflammation of the peritoneum—a known, although rare, complication of peritoneal dialysis therapy, which can be fatal (encapsulating peritoneal sclerosis) and peritonitis caused by fungal or bacterial infection. If you notice particles or cloudiness in the drained fluid, inform your doctor immediately, as these may be signs indicating peritonitis.
significant losses of proteins, amino acids, and water-soluble vitamins. Your doctor will decide whether replacement therapy is needed.

Laboratory tests
During and sometimes after treatment with this medicine, your doctor will closely monitor the following parameters:

fluid balance and body weight;
blood electrolyte levels (bicarbonate, potassium, magnesium, calcium, and phosphate);
blood test results (including parathyroid hormone);
blood fat and sugar levels (lipidemia and glycaemia).

Carefully follow the instructions for the peritoneal dialysis exchange procedure provided at specialized centers and included in this patient information leaflet.
Incorrect procedure sequence may result in air infusion into the peritoneal cavity, which can cause abdominal pain and/or peritonitis.

Other medicines and VANTIVE PERITONEAL DIALYSIS SOLUTION
Inform your doctor or pharmacist if you/your child are taking, have recently taken, or might take any other medicines.
No interaction studies have been conducted with VANTIVE PERITONEAL DIALYSIS SOLUTION. When prescribing the solution to be used by you/your child, your doctor will consider potential interactions between dialysis treatment and therapies for other existing conditions. Peritoneal dialysis therapy may increase the elimination of certain medicines. If you are taking other medicines, your doctor may adjust their dosages.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or nurse before using this medicine.

Fertility
Use an effective contraceptive method during treatment with VANTIVE PERITONEAL DIALYSIS SOLUTION.

Pregnancy
Your doctor will prescribe VANTIVE PERITONEAL DIALYSIS SOLUTION during pregnancy only if absolutely necessary and will closely monitor you throughout the treatment period.

Breastfeeding
Your doctor will carefully evaluate whether to discontinue breastfeeding or discontinue therapy with VANTIVE PERITONEAL DIALYSIS SOLUTION, taking into account the benefits of breastfeeding for the child and the benefits of therapy for you.

Driving and using machines
If you suffer from severe kidney disease (end-stage renal failure) and are undergoing peritoneal dialysis, you may experience side effects that could impair your ability to drive vehicles or operate machinery.

3. How to use SOLUZIONE PER DIALISI PERITONEALE VANTIVE

Use this medicine for the child exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
SOLUZIONE PER DIALISI PERITONEALE VANTIVE must be administered exclusively by intraperitoneal route. Do not administer through a vein.

Use in continuous ambulatory peritoneal dialysis (CAPD)
The recommended dose is 4 exchanges per day (24 hours).

Use in automated peritoneal dialysis (APD)
The recommended dose is 4–5 exchanges per night and up to 2 exchanges during the day.
The fill volume depends on body size, normally between 2.0 and 2.5 litres.

Dosage
Your doctor will determine and supervise the type of therapy, treatment frequency, exchange volume, dwell time in the peritoneal cavity, and duration of dialysis.

Use in children
Depending on the patient's age, your doctor will carefully evaluate the dosage of SOLUZIONE PER DIALISI PERITONEALE VANTIVE.

Method of administration
Intraperitoneal administration requires the use of a special catheter and a transfer set connecting the bag to the catheter (transfer line).
The "Lineo" connector, which may be part of the "Y" transfer line connected to the double bag, contains povidone-iodine ointment.

To make administration more comfortable, the peritoneal dialysis solution may be warmed to 37°C inside its outer protective wrapper. Perform this using dry heat (e.g. a heating pad or heating plate). To avoid the risk of injury or discomfort, do not heat the solution in water or in microwave ovens.

Once the outer wrapper has been removed, use the medicine immediately.
Do not use/give this medicine if the solution appears cloudy or discoloured, contains particles, shows signs of leakage, or if the seals are not intact.
Use each bag for a single administration only. Discard any unused solution.

Use an aseptic technique throughout the entire bag exchange procedure, as instructed.
Your doctor may prescribe other medicines to be added to SOLUZIONE PER DIALISI PERITONEALE VANTIVE after verifying their compatibility. In such cases, use the solution immediately after adding other medicines.

If you use more SOLUZIONE PER DIALISI PERITONEALE VANTIVE than you should
If an excessive amount of SOLUZIONE PER DIALISI PERITONEALE VANTIVE is infused, you/the child may experience:

abdominal swelling,
abdominal pain,
difficulty breathing (dyspnoea).

Possible consequences of overdose include:

increased blood volume (hypervolemia),
decreased blood volume (hypovolemia),
electrolyte disturbances, or elevated blood sugar levels (hyperglycaemia).

In case of accidental administration of an excessive dose of SOLUZIONE PER DIALISI PERITONEALE VANTIVE, immediately stop the infusion and drain the solution from the peritoneal cavity. Additionally, contact your doctor immediately or go to the nearest hospital.

If you forget to use SOLUZIONE PER DIALISI PERITONEALE VANTIVE
Do not use a double dose to make up for the forgotten dose.

If you stop treatment with SOLUZIONE PER DIALISI PERITONEALE VANTIVE
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, SOLUZIONE PER DIALISI PERITONEALE VANTIVE may cause side effects, although not everyone experiences them.
If you or the child experience signs or symptoms of a suspected allergic reaction, stop the infusion immediately and drain the solution from the peritoneal cavity.

Listed below are the side effects of SOLUZIONE PER DIALISI PERITONEALE VANTIVE, categorized according to the frequency of each listed effect:

Not known (frequency cannot be estimated from the available data)

Decreased blood potassium levels (hypokalaemia)
Fluid retention
Increased blood volume (hypervolaemia)
Decreased blood volume (hypovolaemia)
Decreased blood sodium levels (hyponatraemia)
Dehydration
Decreased blood chloride levels (hypochloraemia)
Increased blood sugar levels (hyperglycaemia)
Altered blood lipid levels (dyslipidaemia)
Increased blood pressure (hypertension)
Decreased blood pressure (hypotension)
Breathing difficulty (dyspnoea)
Inflammation of the peritoneum (encapsulating peritoneal sclerosis, bacterial and fungal peritonitis)
Cloudy dialysate fluid
Vomiting
Diarrhoea
Nausea
Constipation
Abdominal pain, bloating, and abdominal discomfort
Communication between the membrane lining the lungs and the peritoneum (pleuroperitoneal communication)*
Herniation of an organ from the abdominal cavity (hernia)* * related to the dialysis procedure
Skin lesions with loss of the outer layer of skin (Stevens-Johnson syndrome)
Skin irritation (urticaria)
Skin rash of various types (including itchy rash, macular rash, generalized rash)
Itching (pruritus)
Muscle cramps, bone, joint and muscle pain
Generalized swelling and pain (oedema)
Fever
Malaise
Pain at the infusion site
Bacterial and fungal infection of the peritoneum
Infection at the catheter site
Catheter-related complications

Reporting of side effects
If you or the child experience any side effect, including those not listed in this leaflet, consult 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. How to store PERITONEAL DIALYSIS SOLUTION VANTIVE

Keep this medicinal product out of the reach and sight of children.
Do not use this medicinal product after the expiry date stated on the packaging after Expiry. The expiry date refers to the last day of that month.
Do not use this medicinal product if you notice that the solution appears cloudy or discoloured, contains particles, shows signs of leakage, or if the seals are not intact.
Do not freeze. Store the bag tightly closed in the original packaging to protect the medicinal product from light.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

PERITONEAL DIALYSIS SOLUTION VANTIVE
PERITONEAL DIALYSIS SOLUTION VANTIVE is available in various compositions.

The active substances in 1000 ml of peritoneal dialysis solution are listed below: “ Glucose 1.36%, Calcium 1.25 mmol/l, Lactate 40 mmol/l ” Active substance g/l

	m	mmol/l
Sodium
Calcium
Magnesium
Lactate
Chlorides
Glucose

Sodium chloride 5.380
Calcium chloride dihydrate 0.184
Magnesium chloride hexahydrate 0.051
Sodium (S)-lactate 4.483
Glucose monohydrate 15.0
Theoretical osmolarity: 344 mOsmol/l
" Glucose 2.27%, Calcium 1.25 mmol/l, Lactate 40 mmol/l "
Active ingredient g/l mmol/l
Sodium 132
Sodium chloride 5.380 Calcium 1.25
Calcium chloride dihydrate 0.184 Magnesium 0.25
Magnesium chloride hexahydrate 0.051 Lactate 40
Sodium (S)-lactate 4.483 Chloride 95
Glucose monohydrate 25.0 Glucose 126
Theoretical osmolarity: 395 mOsmol/l
" Glucose 3.86%, Calcium 1.25 mmol/l, Lactate 40 mmol/l "
Active ingredient g/l mmol/l
Sodium 132
Sodium chloride 5.380 Calcium 1.25
Calcium chloride dihydrate 0.184 Magnesium 0.25
Magnesium chloride hexahydrate 0.051 Lactate 40
Sodium (S)-lactate 4.483 Chloride 95
Glucose monohydrate 42.5 Glucose 214
Theoretical osmolarity: 483 mOsmol/l
" Glucose 1.36%, Calcium 1.75 mmol/l, Lactate 35 mmol/l "
Active ingredient g/l
mmol/l
Sodium 132
Sodium chloride 5.670
Calcium 1.75
Calcium chloride dihydrate 0.257
Magnesium 0.75
Magnesium chloride hexahydrate 0.152
Lactate 35
Sodium (S)-lactate 3.922
Chloride 102
Glucose monohydrate 15.0
Glucose 75.5
Theoretical osmolarity: 347 mOsmol/l
" Glucose 2.27%, Calcium 1.75 mmol/l, Lactate 35 mmol/l "
Active ingredient g/l
mmol/l
Sodium 132
Sodium chloride 5.670
Calcium 1.75
Calcium chloride dihydrate 0.257
Magnesium 0.75
Magnesium chloride hexahydrate 0.152
Lactate 35
Sodium (S)-lactate 3.922
Chloride 102
Glucose monohydrate 25.0
Glucose 126
Theoretical osmolarity: 398 mOsmol/l
" Glucose 3.86%, Calcium 1.75 mmol/l, Lactate 35 mmol/l "
Active ingredient g/l
mmol/l
Sodium 132
Sodium chloride 5.670
Calcium 1.75
Calcium chloride dihydrate 0.257
Magnesium 0.75
Magnesium chloride hexahydrate 0.152
Lactate 35
Sodium (S)-lactate 3.922
Chloride 102
Glucose monohydrate 42.5
Glucose 214
Theoretical osmolarity: 486 mOsmol/l
pH between 5.0 and 6.5 units.

The other component is water for injections.

Description of the appearance of PERITONEAL DIALYSIS SOLUTION VANTIVE and
pack contents
PERITONEAL DIALYSIS SOLUTION VANTIVE is a clear solution free from visible particles.
PERITONEAL DIALYSIS SOLUTION VANTIVE is a sterile, non-pyrogenic solution, hermetically sealed in flexible transparent bags. Each bag is equipped with an injection port for the possible addition of medications, and a terminal connector for connection to the patient’s line or to the empty drain bag (transfer line).
Each bag is further sealed in a transparent plastic overwrap, which must be removed immediately before using the solution.
PERITONEAL DIALYSIS SOLUTION VANTIVE is available in the following pack sizes:

5 flexible bags of 2000 ml
6 flexible bags of 2000 ml
4 flexible bags of 2500 ml
2 flexible bags of 5000 ml contained in cardboard boxes.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Vantive S.r.l. – – 00142 Rome, Italy.
Manufacturer
Vantive Manufacturing Limited – Moneen Road, Castlebar – County Mayo (Ireland)

The following information is intended exclusively for healthcare professionals:

Dosage
The type of therapy, frequency of treatment, exchange volume, dwell time in the peritoneal cavity, and duration of dialysis must be determined and supervised by the prescribing physician.

Adults
Patients undergoing continuous ambulatory peritoneal dialysis (CAPD) generally perform 4 exchanges per day (24 hours). Patients undergoing automated peritoneal dialysis (APD) generally perform 4–5 exchanges at night and up to 2 exchanges during the day. The fill volume depends on body size, normally between 2.0 and 2.5 liters.

Paediatric population (from newborns up to adolescents aged 18 years)
The recommended fill volume is 800 to 1400 mL/m² per exchange, up to a maximum of 2000 mL as tolerated. In children under 2 years of age, fill volumes of 200 to 1000 mL/m² are recommended.

To avoid the risk of severe dehydration and hypovolemia and to limit protein loss, it is advisable to select the peritoneal dialysis solution with the lowest osmolarity based on the amount of fluid to be removed at each exchange.

It is recommended to choose a VANTIVE PERITONEAL DIALYSIS SOLUTION with a lower glucose concentration when the patient's weight approaches the ideal dry weight.

A VANTIVE PERITONEAL DIALYSIS SOLUTION with a 3.86% glucose concentration is a high osmotic pressure fluid and, if used for every exchange, may cause dehydration (see section 4.4 of the Summary of Product Characteristics).

Method of administration
Precautions to be taken before handling or administering the medicinal product

VANTIVE PERITONEAL DIALYSIS SOLUTION must be administered exclusively by the intraperitoneal route. Do not administer intravenously.
Peritoneal dialysis solutions may be warmed to 37°C in their outer protective packaging to improve patient comfort. This should be done using dry heat (e.g., a heating pad or heating plate). To avoid the risk of patient injury or discomfort, do not heat solutions in water or microwave ovens.
Use an aseptic technique throughout the bag exchange procedure.
Do not administer if the solution appears cloudy or discolored, contains particles, shows signs of leakage, or if seals are not intact.
Check that the drained fluid does not contain fibrin or turbidity, which may be signs indicative of peritonitis.
Each container must be used for a single administration: any unused solution must be discarded.

Special warnings

If peritonitis develops, the choice and dosage of antibiotics should, if possible, be based on identification and sensitivity testing of isolated organisms. Broad-spectrum antibiotics may be indicated before the causative organisms are identified.
Solutions containing glucose must be used with caution in patients with known allergy to maize or maize-based products. Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, may occur due to maize starch allergy. If signs or symptoms of a suspected hypersensitivity reaction occur, immediately discontinue infusion and drain the solution from the peritoneal cavity.
Patients with severe lactic acidosis should not be treated with peritoneal dialysis solutions containing lactate. Patients with conditions known to increase the risk of lactic acidosis [e.g., severe hypotension or sepsis, which may be associated with acute renal failure, congenital metabolic disorders, or treatment with drugs such as metformin and nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)] should be monitored for lactic acidosis before starting and during therapy with lactate-containing peritoneal dialysis solutions.
When prescribing the solution to be used by an individual patient, possible interactions between dialysis treatment and therapy for other concomitant diseases must be considered. Serum levels of potassium, calcium, and magnesium must be closely monitored in patients receiving cardiac glycosides.
In non-diabetic patients, blood glucose levels vary widely, likely due to glucose intolerance caused by uraemia. The risk of developing hyperglycaemia is proportionally increased in diabetic and uraemic patients. In diabetic patients, blood glucose levels must be regularly monitored during and after dialysis with glucose-containing solutions, and insulin dosage or other anti-hyperglycaemic therapies should be adjusted accordingly.

Precautions for use

VANTIVE PERITONEAL DIALYSIS SOLUTION must be administered exclusively by the intraperitoneal route. Do not administer intravenously.
Do not administer if the solution appears cloudy or discolored, contains particles, shows signs of leakage, or if seals are not intact.
Check that the drained fluid does not contain fibrin or turbidity, which may be signs indicative of peritonitis.
Losses of proteins, amino acids, water-soluble vitamins, and other drugs may occur. If necessary, replacement therapy should be initiated.
Fluid balance must be closely monitored, and the patient's body weight must be carefully tracked to avoid over- or under-hydration, which may lead to serious consequences including congestive heart failure, fluid depletion, and shock.
Excessive use of VANTIVE PERITONEAL DIALYSIS SOLUTION with a high glucose concentration during peritoneal dialysis treatment may result in excessive fluid removal from the patient.
Due to the risk of hyperkalaemia, potassium is omitted from peritoneal dialysis solutions. In situations where plasma potassium levels are normal or hypokalaemia is present, addition of potassium chloride (up to concentrations of 4 mEq/L) may be indicated to prevent severe hypokalaemia. Such addition must only be made after careful assessment of serum and total potassium levels and only under medical supervision. Plasma potassium levels in patients receiving digitalis therapy must be frequently evaluated to avoid the risk of cardiac arrest.
Use low-calcium solutions in patients with hypercalcaemia. Patients treated with low-calcium solutions require monitoring of calcium levels to assess for the development of hypocalcaemia or worsening of hypercalcaemia. In such cases, the physician should consider adjusting the dosage of phosphate binders and/or vitamin D and/or vitamin D analogues and/or calcimimetics.
Overfilling of VANTIVE PERITONEAL DIALYSIS SOLUTION into the peritoneal cavity may manifest as abdominal distension/pain and/or dyspnoea.
In case of overfilling with VANTIVE PERITONEAL DIALYSIS SOLUTION, the solution must be drained from the peritoneal cavity.
Incorrect clamping or priming sequences may lead to air infusion into the peritoneal cavity, which may cause abdominal pain and/or peritonitis. Intraperitoneal administration requires the use of a special catheter and a connecting set between the bag and the patient's catheter (transfer line). The "Lineo" connector, which may be part of the Y-transfer line connected to the double bag, contains povidone-iodine ointment.

Overdose
Overdose is possible and may lead to hypervolaemia, hypovolaemia, electrolyte disturbances, or hyperglycaemia.
Excessive use of VANTIVE PERITONEAL DIALYSIS SOLUTION with a 3.86% glucose concentration during treatment may cause significant fluid removal from the patient.

Treatment of overdose:

Hypervolaemia can be managed with hypertonic peritoneal dialysis solutions and fluid restriction. Hypovolaemia can be managed with oral or intravenous fluid replacement, depending on the degree of dehydration.
Electrolyte disturbances should be managed according to the specific disturbance identified by blood testing. The most likely disturbance, hypokalaemia, can be managed by oral potassium administration or by adding potassium chloride to the prescribed peritoneal dialysis solution (refer to section 6.2 of the Summary of Product Characteristics).
Hyperglycaemia in diabetic patients can be managed by adjusting insulin dosage or other anti-hyperglycaemic therapies.

Incompatibilities
Before adding other medicinal products, their compatibility with VANTIVE PERITONEAL DIALYSIS SOLUTION must be verified.

Addition of potassium: In situations where plasma potassium levels are normal or hypokalaemia is present, addition of potassium chloride (up to concentrations of 4 mEq/L) may be indicated to prevent severe hypokalaemia. Such addition must only be made after careful assessment of serum and total potassium levels and only under medical supervision. Plasma potassium levels in patients receiving digitalis therapy must be frequently evaluated to avoid the risk of cardiac arrest.
Addition of insulin: In diabetic patients, blood glucose levels must be regularly monitored and insulin dosage or other anti-hyperglycaemic drugs adjusted accordingly (see section 4.4 of the Summary of Product Characteristics).
Addition of heparin: Interaction studies with heparin have not been conducted. In vitro studies have not shown evidence of incompatibility between heparin and VANTIVE PERITONEAL DIALYSIS SOLUTION.
Addition of antibiotics: In vitro studies have demonstrated stability of the mixture with the following antimicrobial agents: amphotericin B, ampicillin, azlocillin, cephradine, cefazolin, cefepime, cefotaxime, ceftazidime, ceftriaxone, ciprofloxacin, clindamycin, co-trimoxazole, deferoxamine, erythromycin, gentamicin, linezolid, mezlocillin, miconazole, moxifloxacin, nafcillin, ofloxacin, penicillin G, piperacillin, teicoplanin, ticarcillin, tobramycin, and vancomycin. However, aminoglycosides should not be mixed with penicillins due to chemical incompatibility.

Shelf life
2 years
1 year (only for the medicinal product manufactured in Alliston, Canada and North Cove, USA)

Special precautions for storage
Do not freeze. Store the container tightly closed in the original packaging to protect from light.

Special precautions for disposal and handling
Once the outer packaging has been removed, the medicinal product must be used immediately. The solution must be used immediately after addition of medicinal products. Discard any unused portion of the solution.
Unused medicinal product and waste material derived from such medicinal product must be disposed of in accordance with local regulations.