Package leaflet: Information for the user

Bortezomib medac 1 mg powder for solution for intravenous injection
Bortezomibum
Please read the entire leaflet carefully before use, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor or pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Contents of the leaflet

What Bortezomib medac is and what it is used for
Important information before using Bortezomib medac
How to use Bortezomib medac
Possible side effects
How to store Bortezomib medac
Contents of the pack and other information

1. What Bortezomib medac is and what it is used for

Bortezomib medac contains the active substance called bortezomib, which is a so-called
proteasome inhibitor. Proteasomes play an important role in controlling cell function and development.
By interfering with their function, bortezomib may lead to the death of cancer cells.

Bortezomib medac is used in the treatment of multiple myeloma (a cancer of the bone marrow) in patients aged at least 18 years:

as a single agent or in combination with other medicines: pegylated liposomal doxorubicin or dexamethasone, in patients whose disease has progressed after at least one prior therapy and for whom stem cell transplantation has failed or is not possible;
in combination with melphalan and prednisone, in patients who have not previously received treatment and who are not eligible for high-dose chemotherapy combined with stem cell transplantation;
in combination with dexamethasone or dexamethasone with thalidomide, in patients who have not previously received treatment and who are eligible for high-dose chemotherapy combined with stem cell transplantation (induction therapy).

Bortezomib medac is also used in the treatment of mantle cell lymphoma (a type of cancer affecting the lymph nodes) in patients aged at least 18 years, in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone, in those who have not previously received treatment and who are not eligible for stem cell transplantation.

2. Important information before using Bortezomib medac

When not to use Bortezomib medac

if the patient is allergic to bortezomib, boron, or any of the other ingredients
of this medicine (listed in section 6);
if the patient has particularly severe lung or heart diseases.

Warnings and precautions
Before starting treatment with Bortezomib medac, discuss with your doctor or pharmacist
if any of the following apply to the patient:

low number of red or white blood cells;
bleeding disorders and (or) low platelet count;
diarrhoea, constipation, nausea or vomiting;
history of fainting, dizziness or lightheadedness;
kidney diseases;
moderate to severe liver function disorders;
history of numbness, tingling or pain in hands and feet (symptoms of neuropathy);
heart diseases or blood pressure disorders;
shortness of breath or cough;
seizures;
shingles (around the eyes or disseminated throughout the body);
tumour lysis syndrome symptoms such as muscle cramps, muscle weakness, confusion, vision loss or disturbances, and difficulty breathing;
memory loss, cognitive disturbances, difficulty walking or vision loss. These may be symptoms of a severe brain infection, and the doctor may recommend further tests and monitoring.

The patient must have regular blood tests performed before and during treatment with Bortezomib medac to monitor blood cell counts systematically.
If the patient has mantle cell lymphoma and is receiving Bortezomib medac together with a medicine containing rituximab, inform the doctor:

if the patient suspects a hepatitis virus infection or has had it in the past. In several cases, patients who had previously been infected with hepatitis B virus (HBV) experienced reactivation of hepatitis, which could be fatal. If the patient has a history of HBV infection, the doctor will closely monitor for signs of active hepatitis B.

Before starting treatment with Bortezomib medac, carefully read the package leaflets of all medicinal products being used during treatment to obtain information about them.
If thalidomide is being taken, pregnancy must be excluded and effective contraception used (see section Pregnancy and breastfeeding).

Children and adolescents
Bortezomib medac should not be used in children and adolescents, as its effects in this patient group are unknown.

Bortezomib medac and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the treating doctor if the patient is taking medicines containing any of the following active substances:

ketoconazole, used to treat fungal infections;
ritonavir, used to treat HIV infection;
rifampicin, an antibiotic used to treat bacterial infections;
carbamazepine, phenytoin or phenobarbital, used to treat epilepsy;
St John’s wort (Hypericum perforatum), used to treat depression and other conditions;
oral antidiabetic medicines.

Pregnancy and breastfeeding
Do not use Bortezomib medac during pregnancy unless absolutely necessary.
Women of childbearing potential must use an effective method of contraception during treatment and for 8 months after treatment ends. If the patient wishes to freeze her eggs (oocytes) before starting treatment, she should discuss this with her doctor. Men should not father children during treatment with Bortezomib medac and must use effective contraception during treatment and for up to 5 months after treatment ends. If the patient wishes to donate sperm for storage before starting treatment, he should consult his doctor.
Patients must not breastfeed during treatment with Bortezomib medac. The timing of safe resumption of breastfeeding after treatment should be discussed with the doctor.
Thalidomide causes congenital malformations and fetal death. When Bortezomib medac is used in combination with thalidomide, patients must comply with the requirements of the "Thalidomide Pregnancy Prevention Programme" (see the thalidomide package leaflet).

Driving and operating machinery
Bortezomib medac may cause fatigue, dizziness, fainting, and blurred vision. If these symptoms occur, the patient must not drive or operate tools or machines. Even if such symptoms do not occur, caution should still be exercised.

3. How to use Bortezomib medac

The treating physician will adjust the appropriate dose of Bortezomib medac for the patient based on the patient's height and body weight (body surface area). The most commonly used starting dose of Bortezomib medac is 1.3 mg/m² body surface area administered twice weekly. The physician may modify the dose and the total number of treatment cycles depending on the patient's response to treatment, occurrence of adverse reactions, and additional medical conditions (e.g. liver disease).

Multiple myeloma
If Bortezomib medac is administered as a single agent, the patient will receive 4 doses of Bortezomib medac intravenously on days 1, 4, 8, and 11, followed by a 10-day treatment break. This 21-day period (3 weeks) is considered one treatment cycle. The patient may receive up to 8 cycles (24 weeks).

The patient may also receive Bortezomib medac in combination with the following medicines: pegylated liposomal doxorubicin or dexamethasone.

When Bortezomib medac is administered together with pegylated liposomal doxorubicin, the patient will receive Bortezomib medac intravenously during a 21-day treatment cycle, and pegylated liposomal doxorubicin will be administered as an intravenous infusion at a dose of 30 mg/m² body surface area after the injection of Bortezomib medac on day 4 of the 21-day cycle.

The patient may receive up to 8 cycles (24 weeks).

When Bortezomib medac is administered together with dexamethasone, the patient will receive Bortezomib medac intravenously during a 21-day treatment cycle, and dexamethasone will be administered orally at a dose of 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 of the 21-day Bortezomib medac treatment cycle.

The patient may receive up to 8 cycles (24 weeks).

Previously untreated multiple myeloma
If the patient has not previously been treated for multiple myeloma and the patient does not qualify for hematopoietic stem cell transplantation, the patient will receive Bortezomib medac intravenously in combination with other medicines: melphalan and prednisone.

In this case, the duration of each treatment cycle is 42 days (6 weeks). The patient will receive 9 cycles (54 weeks).

During cycles 1–4, Bortezomib medac is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29, and 32.
During cycles 5–9, Bortezomib medac is administered once weekly on days 1, 8, 22, and 29.

Both melphalan (9 mg/m²) and prednisone (60 mg/m²) are administered orally on days 1, 2, 3, and 4 of the first week of each cycle.

If the patient has not previously been treated for multiple myeloma and the patient qualifies for hematopoietic stem cell transplantation, the patient will receive Bortezomib medac intravenously in combination with other medicines: dexamethasone or dexamethasone plus thalidomide as induction therapy.

When Bortezomib medac is administered with dexamethasone, the patient will receive Bortezomib medac intravenously in 21-day cycles, and dexamethasone at a dose of 40 mg will be administered orally on days 1, 2, 3, 4, 8, 9, 10, and 11 of the 21-day Bortezomib medac treatment cycle.

The patient will receive up to 4 cycles (12 weeks).

When Bortezomib medac is administered with dexamethasone and thalidomide, the duration of each treatment cycle is 28 days (4 weeks).

Dexamethasone at a dose of 40 mg will be administered orally on days 1, 2, 3, 4, 8, 9, 10, and 11 of the 28-day Bortezomib medac treatment cycle, and thalidomide will be administered orally once daily at a dose of 50 mg up to day 14 of the first cycle; if tolerated, the dose will be increased to 100 mg from days 15 to 28, and may subsequently be increased to 200 mg daily starting from the second cycle. The patient may receive up to 6 cycles (24 weeks).

Previously untreated mantle cell lymphoma
If the patient has not previously been treated for mantle cell lymphoma, the patient will receive Bortezomib medac intravenously in combination with the following medicines: rituximab, cyclophosphamide, doxorubicin, and prednisone.

Bortezomib medac is administered intravenously on days 1, 4, 8, and 11, followed by a "rest period" without administration of medicines. One treatment cycle lasts 21 days (3 weeks). The patient may receive up to 8 cycles (24 weeks).

The following medicines are administered as intravenous infusions on day 1 of each 21-day Bortezomib medac treatment cycle: rituximab at a dose of 375 mg/m², cyclophosphamide at a dose of 750 mg/m², and doxorubicin at a dose of 50 mg/m².

Prednisone is administered orally at a dose of 100 mg/m² on days 1, 2, 3, 4, and 5 of the Bortezomib medac treatment cycle.

How Bortezomib medac is administered
This medicine is administered intravenously only. Bortezomib medac will be administered by trained medical personnel experienced in the use of cytotoxic medicines.

Bortezomib medac must be reconstituted before administration. The preparation of the medicine is carried out by trained medical personnel. The reconstituted solution is then injected into a vein. The intravenous injection is rapid and lasts between 3 and 5 seconds.

Administration of a higher than recommended dose of Bortezomib medac
Since this medicine is administered by a doctor or nurse, it is unlikely that the patient will receive an overdose. However, if this should exceptionally occur, the doctor will monitor the patient for any adverse reactions.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these side effects may be serious.
If the patient is receiving Bortezomib medac for the treatment of multiple myeloma or mantle cell lymphoma, tell the doctor immediately if the patient experiences any of the following symptoms:

muscle cramps, muscle weakness;
confusion, loss or disturbances of vision, blindness, seizures, headaches;
shortness of breath, swelling of the feet or change in heart rhythm, high blood pressure, fatigue, fainting;
cough and difficulty breathing or chest tightness.

Treatment with Bortezomib medac may very commonly lead to a decrease in the number of red and white blood cells and platelets in the patient's blood. Therefore, the patient must have frequent blood tests before and during treatment with Bortezomib medac to regularly monitor blood cell counts. The patient may experience a decrease in:

platelets, which may result in a tendency to bruise or bleed without injury (e.g. bleeding from the intestines, stomach, mouth and gums, or bleeding in the brain or from the liver);
red blood cells, which may lead to anaemia, associated with symptoms such as fatigue and pallor;
white blood cells, which may lead to increased susceptibility to infections or flu-like symptoms.

If the patient is receiving Bortezomib medac for the treatment of multiple myeloma, the patient may experience the following side effects:
Very common side effects (may occur in more than 1 in 10 people):

hypersensitivity, numbness, tingling or burning sensation of the skin, pain in hands or feet due to nerve damage;
decreased number of red and (or) white blood cells (see above);
fever;
nausea or vomiting, loss of appetite;
constipation with or without bloating (symptoms may be severe);
diarrhoea: if this occurs, the patient must drink more fluids than usual; the doctor may recommend taking additional medicines to control diarrhoea;
fatigue, feeling of weakness;
muscle pain, bone pain.

Common side effects (may occur in less than 1 in 10 people):

low blood pressure, sudden drop in blood pressure upon standing which may lead to fainting;
high blood pressure;
reduced kidney function;
headache;
general feeling of being unwell, pain, dizziness, lightheadedness, feeling of weakness or loss of consciousness;
chills;
infections, including: pneumonia, respiratory tract infections, bronchitis, fungal infections, cough with sputum production, flu-like symptoms;
shingles (localized, for example around the eyes, or disseminated throughout the body);
chest pain, shortness of breath during physical exercise;
various types of rashes;
itchy skin, skin nodules or dry skin;
facial flushing or capillary rupture;
redness of the skin;
dehydration;
heartburn, bloating, belching, flatulence, abdominal pain, bleeding from the intestine or stomach;
liver function disorders;
inflammation of the mouth or lips, dry mouth, mouth ulcers or sore throat;
weight loss, loss of taste;
muscle cramps, muscle weakness, limb pain;
blurred vision;
conjunctivitis;
nosebleeds;
difficulty sleeping, sweating, anxiety, mood swings, depressive mood, restlessness or agitation, changes in mental state, disorientation;
oedema, including around the eyes and in other parts of the body.

Uncommon side effects (may occur in less than 1 in 100 people):

heart failure, heart attack, chest pain, feeling of discomfort in the chest, rapid or slow heart rate;
kidney failure;
vein inflammation, blood clots in veins and lungs;
blood coagulation disorders;
circulatory failure;
pericarditis (inflammation of the outer lining of the heart) or fluid in the pericardium;
infections including: urinary tract infections, influenza, herpes, ear infection and connective tissue infection;
blood in stool, bleeding from mucous membranes, e.g. from the mouth, vagina;
cerebral vascular disorders;
paralysis, seizures, falls, movement disorders, abnormal, altered or reduced sensation (touch, hearing, taste, smell), attention disorders, tremor, sudden movements;
joint inflammation, including inflammation of joints in fingers, toes and jaw;
lung disorders making breathing difficult. Some of these include: difficulty breathing, shortness of breath, shortness of breath at rest, shallow breathing, or respiratory arrest, wheezing;
hiccups, speech disorders;
increased or decreased urine output (due to kidney damage), painful urination or blood/protein in urine, fluid retention;
altered level of consciousness, confusion, worsening or loss of memory;
hypersensitivity;
hearing loss, deafness, ringing or discomfort in the ears;
hormonal disorders affecting salt and water absorption;
hyperthyroidism;
insufficient insulin production or resistance to normal insulin levels;
eye irritation or inflammation, excessively watery eyes, eye pain, dry eyes, eye infections, eyelid nodule (sty), redness and swelling of the eyelid, eye discharge, vision disorders, eye bleeding;
enlarged lymph nodes;
joint or muscle stiffness, feeling of heaviness, groin pain;
hair loss and abnormal hair structure;
allergic reactions;
redness or pain at the injection site;
mouth pain;
infection or inflammation of the mouth, oesophagus, stomach and intestines, sometimes with accompanying pain and bleeding, weak intestinal peristalsis (including obstruction), abdominal and oesophageal discomfort, difficulty swallowing, vomiting blood;
skin infection;
bacterial and viral infections;
dental infections;
pancreatitis, bile duct obstruction;
genital organ pain, erectile dysfunction;
weight gain;
thirst;
hepatitis;
injection site reactions or complications related to vascular catheter use;
skin reactions and disorders (which may be severe and life-threatening), skin ulceration;
bruising, falls and injuries;
inflammation or bleeding of blood vessels, manifesting from small red or purple spots (usually on legs) to large bruise-like subcutaneous patches;
benign cysts;
severe reversible posterior encephalopathy syndrome, which includes seizures, high blood pressure, headache, fatigue, confusion, blindness or other visual disturbances.

Rare side effects (may occur in less than 1 in 1000 people):

heart diseases including heart attack, angina;
flushing attacks;
vein discolouration;
spinal cord inflammation;
ear diseases, ear bleeding;
hypothyroidism;
Budd-Chiari syndrome (clinical symptoms caused by blockage of hepatic veins);
altered or abnormal intestinal function;
brain haemorrhage;
yellowing of eyes or skin (jaundice);
severe allergic reaction (anaphylactic shock) with symptoms such as: difficulty breathing, chest pain or tightness, and (or) dizziness/fainting, severe skin itching or skin hives, swelling of the face, lips, tongue and (or) throat which may cause difficulty breathing and swallowing, collapse;
breast diseases;
vaginal ulceration;
genital oedema;
alcohol intolerance;
wasting or weight loss;
increased appetite;
fistula;
joint effusion;
cyst in the joint lining (synovial cyst);
bone fractures;
rhabdomyolysis (muscle fibre breakdown) leading to further complications;
liver oedema, liver bleeding;
kidney cancer;
psoriasis-like skin condition;
skin cancer;
skin pallor;
increased number of platelets or plasma cells (a type of white blood cell);
blood clot in small blood vessels (thrombotic microangiopathy);
abnormal reaction to blood transfusion;
partial or complete vision loss;
decreased libido;
drooling;
exophthalmos (protruding eyes);
photophobia (light sensitivity);
increased respiratory rate;
anal pain;
gallstones;
hernia;
cuts;
brittle or weak nails;
abnormal protein deposition in organs;
coma;
intestinal ulceration;
multi-organ failure;
death;
severe nerve inflammation which may lead to paralysis and breathing difficulties (Guillain-Barré syndrome).

If the patient is receiving Bortezomib medac together with other medicines for the treatment of mantle cell lymphoma, the patient may experience the following side effects:
Very common side effects (may occur in more than 1 in 10 people):

pneumonia;
loss of appetite;
hypersensitivity, numbness, tingling or burning sensation of the skin, pain in hands or feet due to nerve damage;
nausea or vomiting;
diarrhoea;
mouth ulcers;
constipation;
muscle pain, bone pain;
hair loss and abnormal hair structure;
fatigue, feeling of weakness;
fever.

Common side effects (may occur in less than 1 in 10 people):

shingles (localized, for example around the eyes, or disseminated throughout the body);
herpes virus infection;
bacterial and viral infections;
respiratory tract infections, bronchitis, wet cough, flu-like symptoms;
fungal infections;
hypersensitivity (allergic reaction);
insufficient insulin production or resistance to normal insulin levels;
fluid retention;
sleep disturbances;
loss of consciousness;
altered level of consciousness, confusion;
dizziness;
rapid heartbeat, high blood pressure, sweating;
visual disturbances, blurred vision;
heart failure, heart attack, chest pain, feeling of discomfort in the chest, rapid or slow heart rate;
high or low blood pressure;
sudden drop in blood pressure upon changing position which may lead to fainting;
shortness of breath during exertion;
cough;
hiccups;
ringing in the ears, ear discomfort;
bleeding from the intestine or stomach;
heartburn;
abdominal pain, belching;
difficulty swallowing;
infection or inflammation of the stomach or intestines;
abdominal pain;
inflammation of the mouth or lips, sore throat;
altered liver function;
itchy skin;
redness of the skin;
rash;
muscle cramps;
urinary tract infection;
limb pain;
oedema affecting eyes and other body parts;
chills;
redness and pain at the injection site;
general feeling of illness;
weight loss;
weight gain.

Uncommon side effects (may occur in less than 1 in 100 people):

hepatitis;
severe allergic reaction (anaphylactic reaction), symptoms of which may include: difficulty breathing, chest pain or tightness, dizziness or fainting, severe skin itching or skin blisters, swelling of the face, lips, tongue, throat, which may cause difficulty swallowing, collapse;
movement disorders, paralysis, muscle twitching;
dizziness;
hearing loss, deafness;
lung disorders making breathing difficult. Some of these include: difficulty breathing, shortness of breath, shortness of breath at rest, shallow breathing, or respiratory arrest, wheezing;
blood clots in the lungs;
jaundice (yellowing of skin and eyes);
eyelid nodule (sty), redness and swelling of the eyelid.

Rare side effects (may occur in less than 1 in 1000 people):

blood clot in small blood vessels (thrombotic microangiopathy).

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, PL-02-222 Warsaw, Tel.: +48 22 49-21-301, Fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Bortezomib medac

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and outer packaging, following "EXP".
Store the vial in the outer packaging to protect from light.
There are no special requirements regarding storage temperature.
Diluted solution
Chemical and physical stability has been demonstrated for 8 days when stored at 25 °C and 60 % relative humidity, or for 15 days at 5+/-3 °C in the dark, both in the vial and in a polypropylene syringe.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the person administering the medicine is responsible for the duration and conditions of storage. Usually, this time does not exceed 24 hours at a temperature of 2 °C to 8 °C, unless the preparation, dilution, etc. of the solution was carried out under controlled and validated aseptic conditions.
Bortezomib medac is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

6. Contents of the pack and other information

What Bortezomib medac contains

The active substance is bortezomib. Each vial contains 1 mg of bortezomib (as a boronic acid ester with mannitol). After reconstitution, 1 ml of injection solution contains 1 mg of bortezomib.
The other ingredient is: mannitol (E 421).

What Bortezomib medac looks like and contents of the pack
Bortezomib medac powder for solution for injection is a white or almost white solid or powder.
Bortezomib medac is packed in a glass vial with a rubber stopper and a green flip-off cap.
Each pack contains 1 single-use vial.
Marketing Authorisation Holder
medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Tel.: +49 4103 8006-0
Fax: +49 4103 8006-100
Manufacturer
Synthon s.r.o.
Brněnská 32/čp 597
678 01 Blansko
Czech Republic
Synthon Hispania, S.L.
C/ Castelló, n°1
Pol. Las Salinas, Sant Boi de Llobregat
08830 Barcelona
Spain
This medicinal product is authorised in the European Economic Area countries under the
following names:
Netherlands, Italy: Bortezomib medac

Information intended for healthcare professionals only:
1. PREPARATION OF INTRAVENOUS INJECTION SOLUTION
Caution: Bortezomib medac is a cytotoxic product. Care must be taken when handling and preparing the medication. To protect against skin contact, it is recommended to wear gloves and other protective clothing.
SINCE BORTEZOMIB MEDAC DOES NOT CONTAIN PRESERVATIVES, ASEPTIC TECHNIQUES MUST BE STRICTLY FOLLOWED WHEN HANDLING THE MEDICINAL PRODUCT.
1.1 Preparation of the 1 mg vial: carefully add 1 ml of sterile 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing Bortezomib medac powder, using a 1 ml syringe without removing the vial stopper. Reconstitution of the lyophilised powder takes less than 2 minutes.
The resulting concentration will be 1 mg/ml. After reconstitution, the solution will be clear and colourless, with a pH between 4 and 7. There is no need to check the pH of the solution.
1.2 Visually inspect the solution for particles and discoloration before administration. If particles or discoloration are observed, the solution must be discarded. Check the vial label to confirm the concentration (1 mg/ml) to ensure correct dosing via the intravenous route.
1.3 The reconstituted product is preservative-free and should be used immediately. However, the chemical and physical stability of the prepared solution is maintained for up to 8 days prior to administration when stored at 25 °C and 60% relative humidity, or for 15 days when stored at 5±3 °C in the dark, in the original vial and/or syringe. The total storage time of the solution in a syringe must not exceed 24 hours at a temperature of 2 °C to 8 °C. If the diluted solution is not administered immediately after preparation, the person administering the medication is responsible for the storage time and conditions prior to use.
2. ADMINISTRATION

After reconstitution, withdraw the appropriate volume of solution according to the dose calculated based on the patient's body surface area.
Before administration, confirm the dose and concentration of the medication in the syringe (check that the syringe is labelled for intravenous use).
Administer the solution as an intravenous bolus injection over 3 to 5 seconds through a centrally or peripherally inserted intravenous catheter.
The intravenous catheter used for administration should be flushed with a small amount of sterile 9 mg/ml (0.9%) sodium chloride solution.

BORTERZOMIB MEDAC 1 MG POWDER FOR SOLUTION FOR INJECTION MUST BE ADMINISTERED
INTRAVENOUSLY ONLY. DO NOT ADMINISTER BY ANY OTHER ROUTE. INTRATHECAL ADMINISTRATION HAS RESULTED IN DEATH.
3. DISPOSAL OF THE MEDICINAL PRODUCT
The vial is for single use only, and any unused solution must be discarded.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.