Bortezomib Zentiva

Patient Information Leaflet: User Information

Bortezomib Zentiva, 1 mg, powder for solution for intravenous injection

Bortezomib

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Bortezomib Zentiva and what is it used for
• 2. Important information before using Bortezomib Zentiva
• 3. How to use Bortezomib Zentiva
• 4. Possible side effects
• 5. How to store Bortezomib Zentiva
• 6. Contents of the pack and other information

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

Bortezomib Zentiva contains the active substance bortezomib, which is a so-called "proteasome inhibitor". Proteasomes play a crucial role in controlling cell function and development. By disrupting their function, bortezomib can lead to the death of cancer cells.
Bortezomib Zentiva is used to treat multiple myeloma (a type of bone marrow cancer) in patients aged 18 years and over:

• as a single medicine or in combination with other medicines: pegylated liposomal doxorubicin or dexamethasone in patients whose disease has progressed after at least one previous treatment and in whom hematopoietic stem cell transplantation was not successful or not possible;
• in combination with melphalan and prednisone in patients who have not been previously treated and do not qualify for high-dose chemotherapy with hematopoietic stem cell transplantation.
• in combination with dexamethasone or dexamethasone with thalidomide in patients who have not been previously treated and qualify for high-dose chemotherapy with hematopoietic stem cell transplantation (induction therapy).

Bortezomib Zentiva is used to treat mantle cell lymphoma (a type of cancer that affects the lymph nodes) in patients aged 18 years and over in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone, in patients who have not been previously treated and do not qualify for hematopoietic stem cell transplantation.

2. Important information before using Bortezomib Zentiva

When not to use Bortezomib Zentiva

• 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 severe lung or heart disease.

Warnings and precautions

Before starting treatment with Bortezomib Zentiva, discuss with your doctor if you:

• have a low number of red or white blood cells;
• have bleeding disorders and (or) a low platelet count;
• experience diarrhea, constipation, nausea, or vomiting;
• have a history of fainting, dizziness, and lightheadedness;
• have kidney disease;
• have moderate to severe liver function disorders;
• have a history of numbness, tingling, and pain in hands and feet (symptoms of neuropathy);
• have heart disease or blood pressure problems;
• have shortness of breath or cough;
• have seizures;
• have shingles (around the eyes or widespread on the body);
• experience symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, loss of vision, and shortness of breath;
• experience memory loss, thinking disorders, difficulty walking, or vision loss. These may be symptoms of a severe brain infection, and your doctor may recommend further tests and monitoring.

The patient must undergo regular blood tests before and during treatment with Bortezomib Zentiva to regularly check the blood cell count.
If the patient has mantle cell lymphoma and is receiving Bortezomib Zentiva with a medicine containing rituximab, tell your doctor:

• if you suspect you have a hepatitis B virus infection or have had it in the past. In a few cases, patients who had hepatitis B infection may have had recurring episodes of hepatitis, which could be fatal. If you have a history of hepatitis B, your doctor will closely monitor you for signs of active hepatitis B.

Before starting treatment with Bortezomib Zentiva, read the package leaflets of all medicinal products you are taking during treatment to obtain information about them.
If you are taking thalidomide, you must exclude pregnancy and then use effective contraception (see section Pregnancy and breastfeeding).

Children and adolescents

Bortezomib Zentiva should not be used in children and adolescents, as it is not known how the medicine works in this age group.

Bortezomib Zentiva and other medicines

Tell your doctor about all medicines you are taking or have recently taken, and about medicines you plan to take.
In particular, inform your doctor if you are taking medicines containing any of the following active substances:

• ketokonazole, 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 anti-diabetic medicines.

Pregnancy and breastfeeding

Bortezomib Zentiva should not be used during pregnancy unless absolutely necessary.
Both men and women receiving Bortezomib Zentiva must use effective contraception during and for 3 months after completing treatment. If, despite using these methods, the patient becomes pregnant, they should immediately inform their doctor.
Women should not breastfeed during treatment with Bortezomib Zentiva. It is necessary to discuss with your doctor the safe timing of returning to breastfeeding after treatment.
Thalidomide causes birth defects and fetal death. When using Bortezomib Zentiva in combination with thalidomide, patients must follow the "Thalidomide Pregnancy Prevention Program" (see thalidomide package leaflet).

Driving and using machines

Bortezomib Zentiva may cause fatigue, dizziness, fainting, and blurred vision. If these symptoms occur, do not drive or operate tools or machines; even if symptoms do not occur, caution should still be exercised.

3. How to use Bortezomib Zentiva

Your doctor will adjust the appropriate dose of Bortezomib Zentiva based on the patient's height and weight (body surface area). The most commonly used initial dose of Bortezomib Zentiva is 1.3 mg/m2 body surface area, administered twice a week.
Your doctor may change the dose and total number of treatment cycles based on the patient's response to treatment, the occurrence of side effects, and additional diseases (e.g., liver disease).
Relapsed multiple myeloma
If Bortezomib Zentiva is administered as a single medicine, the patient will receive 4 doses of Bortezomib Zentiva intravenously on days 1, 4, 8, and 11, followed by a 10-day rest period.
The described 21-day period (3 weeks) is considered one treatment cycle. The patient will receive up to 8 cycles (24 weeks).
The patient may also receive Bortezomib Zentiva in combination with pegylated liposomal doxorubicin or dexamethasone.
When Bortezomib Zentiva is administered in combination with pegylated liposomal doxorubicin, the patient will receive Bortezomib Zentiva intravenously during the 21-day treatment cycle, and pegylated liposomal doxorubicin will be administered at a dose of 30 mg/m2 in an intravenous infusion after Bortezomib Zentiva injection on day 4 of the 21-day cycle.
The patient may receive up to 8 cycles (24 weeks).
When Bortezomib Zentiva is administered in combination with dexamethasone, the patient will receive Bortezomib Zentiva intravenously during the 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 Bortezomib Zentiva treatment cycle lasting 21 days. The patient may receive up to 8 cycles (24 weeks).
Previously untreated multiple myeloma
If the patient has not been previously treated for multiple myeloma and does notqualify for hematopoietic stem cell transplantation, they will receive Bortezomib Zentiva in combination with melphalan and prednisone.
In this case, the treatment cycle lasts 42 days (6 weeks). The patient will receive 9 cycles (54 weeks).

• During cycles 1-4, Bortezomib Zentiva is administered twice a week, on days: 1, 4, 8, 11, 22, 25, 29, and 32.
• 11, 22, 25, 29, and 32.
• During cycles 5-9, Bortezomib Zentiva is administered once a week, 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.
• 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 been previously treated for multiple myeloma and qualifiesfor hematopoietic stem cell transplantation, they will receive Bortezomib Zentiva intravenously in combination with dexamethasone or dexamethasone with thalidomide as induction therapy.
When Bortezomib Zentiva is administered with dexamethasone, the patient will receive Bortezomib Zentiva intravenously during the 21-day cycle, and dexamethasone will be administered orally at a dose of 40 mg on days 1, 2, 3, 4, 8, 9, 10, and 11 of the 21-day Bortezomib Zentiva treatment cycle. The patient may receive up to 4 cycles (12 weeks).
When Bortezomib Zentiva is administered with dexamethasone and thalidomide, the treatment cycle lasts 28 days (4 weeks). Dexamethasone will be administered orally at a dose of 40 mg on days 1, 2, 3, 4, 8, 9, 10, and 11 of the 28-day Bortezomib Zentiva treatment cycle, and thalidomide will be administered orally once a day at a dose of 50 mg up to day 14 of the first cycle, and if the dose is tolerated, it will be increased to 100 mg on days 15-28 and may be further increased to 200 mg per day from the second cycle.
The patient may receive up to 6 cycles (24 weeks).
Previously untreated mantle cell lymphoma
If the patient has not been previously treated for mantle cell lymphoma, they will receive Bortezomib Zentiva intravenously in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone.
Bortezomib Zentiva is administered intravenously on days 1, 4, 8, and 11, followed by a "rest period" without medication administration. 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 Zentiva 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 Zentiva treatment cycle.

How Bortezomib Zentiva is administered

This medicine is administered intravenously only. Bortezomib Zentiva will be administered by a healthcare professional with experience in the use of cytotoxic medicines.
The powder of Bortezomib Zentiva must be dissolved before administration. The preparation of the medicine is carried out by a healthcare professional. Then, the prepared solution is injected intravenously quickly, over 3 to 5 seconds.

Overdose of Bortezomib Zentiva

Since this medicine is administered by a doctor or nurse, it is unlikely that the patient will receive too much medicine.
If this happens, the doctor will monitor the patient for any side effects.

4. Possible side effects

Like all medicines, Bortezomib Zentiva can cause side effects, although not everybody gets them.
Some of these side effects may be serious.
If you are receiving Bortezomib Zentiva for multiple myeloma or mantle cell lymphoma, you should immediately tell your doctor if you experience any of the following symptoms:

• muscle cramps, muscle weakness;
• confusion, loss 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 pressure.

Treatment with Bortezomib Zentiva can very often cause a decrease in the number of red and white blood cells and platelets in the patient's blood. Therefore, the patient must undergo regular blood tests before and during treatment with Bortezomib Zentiva to regularly check the blood cell count. The patient may experience a decrease in:

• platelet count, which may lead to bruising or bleeding that is not caused by injury (e.g., gastrointestinal bleeding, bleeding from the mouth and gums, or cerebral hemorrhage);
• red blood cell count, which may lead to anemia, characterized by symptoms such as fatigue and pallor;
• white blood cell count, which may lead to increased susceptibility to infections or flu-like symptoms.

If you are receiving Bortezomib Zentiva for multiple myeloma, you may experience the following side effects:

Very common side effects(may affect more than 1 in 10 people):

• hypersensitivity, numbness, tingling, or burning sensation of the skin, pain in hands or feet due to nerve damage;
• decrease in red and (or) white blood cell count (see above);
• fever;
• nausea or vomiting, loss of appetite;
• constipation, which may occur with or without bloating (the severity of symptoms may be significant);
• diarrhea: if it occurs, the patient should drink more water than usual, and the doctor may recommend taking additional medicines to control diarrhea;
• fatigue, feeling of weakness;
• muscle pain, bone pain.

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

• low blood pressure, sudden drop in blood pressure when standing up, which may lead to fainting;
• high blood pressure;
• decreased 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, e.g., around the eyes or widespread on the body);
• chest pain and shortness of breath during exercise;
• various types of rash;
• itching, skin rash, or dry skin;
• flushing of the face or broken blood vessels;
• redness of the skin;
• dehydration;
• heartburn, bloating, belching, gas, abdominal pain, gastrointestinal bleeding;
• liver function disorders;
• mouth or lip ulcers, dry mouth, mouth or throat pain;
• weight loss, loss of taste;
• muscle spasms, muscle weakness, bone pain;
• blurred vision;
• infection of the outer layer of the eye and the inner surface of the eyelid (conjunctivitis);
• nosebleeds;
• difficulty sleeping, sweating, anxiety, mood swings, depression, restlessness, or excitement, changes in mental state, disorientation;
• swelling, including around the eyes and other parts of the body.

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

• heart failure, heart attack, chest pain;
• kidney failure;
• vein inflammation, blood clots in veins and lungs;
• blood clotting disorders;
• circulatory failure;
• inflammation of the sac surrounding the heart (pericarditis) or fluid in the pericardium;
• infections, including urinary tract infections, flu, herpes, ear and soft tissue infections;
• bleeding from the gastrointestinal tract, bleeding from mucous membranes, e.g., from the mouth, vagina, or gums;
• nerve disorders;
• paralysis, seizures, falls, movement disorders, abnormal, changed, or weakened sensation (touch, hearing, taste, smell), attention disorders, tremors, twitching;
• joint inflammation, including joint pain in the fingers, toes, and jaw;
• lung disorders that make breathing difficult. Some of these include difficulty breathing, shortness of breath, shortness of breath at rest, shallow breathing, or cessation of breathing, wheezing;
• hiccups, speech disorders;
• increased or decreased urine production (due to kidney damage), painful urination, or blood/protein in the 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 that can affect salt and water absorption;
• hyperthyroidism;
• insulin deficiency or resistance to normal insulin levels;
• eye irritation or inflammation, excessive tearing, eye pain, dry eyes, eye infections, stye (hordeolum), eyelid redness and swelling, eye discharge, vision disorders, eye bleeding;
• lymph node enlargement;
• joint stiffness or muscle stiffness, feeling of heaviness, groin pain;
• hair loss and abnormal hair structure;
• allergic reactions;
• redness or pain at the injection site;
• mouth sores;
• mouth or throat infections, mouth or esophageal ulcers, stomach and intestinal ulcers, sometimes with accompanying pain and bleeding, poor intestinal motility (including obstruction), abdominal discomfort, and esophageal discomfort, difficulty swallowing, vomiting blood;
• skin infections;
• bacterial and viral infections;
• tooth infections;
• pancreatitis, bile duct obstruction;
• genital pain, erectile dysfunction disorders;
• weight gain;
• thirst;
• hepatitis;
• disorders related to the injection site or use of a venous catheter;
• skin reactions and disorders (which can be severe and life-threatening), skin ulcers;
• bruises, falls, and injuries;
• a condition characterized by small red or purple spots (usually on the legs) to large spots similar to bruises under the skin;
• mild cysts;
• a severe reversible brain disorder that includes seizures, high blood pressure, headache, fatigue, confusion, blindness, or other vision disorders.

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

• heart disease, including heart attack, angina;
• flushing;
• discoloration of the veins;
• inflammation of the spinal cord;
• ear disorders, ear bleeding;
• hypothyroidism;
• Budd-Chiari syndrome (clinical symptoms caused by blockage of liver veins);
• abnormal or changed intestinal function;
• brain bleeding;
• jaundice (yellowing of the skin and eyes);
• severe allergic reaction (anaphylactic shock) with symptoms such as difficulty breathing, chest pain or tightness, and (or) dizziness or fainting, severe itching of the skin or hives, facial, lip, tongue, and (or) throat swelling, which may cause difficulty breathing and swallowing, collapse;
• breast disorders;
• vaginal ulcers;
• genital swelling;
• alcohol intolerance;
• weight loss, loss of body mass;
• increased appetite;
• fistula;
• joint effusion;
• ganglion cyst (a type of cyst that forms on the joint membrane);
• bone fractures;
• muscle fiber breakdown leading to further complications;
• liver swelling, liver bleeding;
• kidney cancer;
• a skin condition similar to psoriasis;
• skin cancer;
• skin pallor;
• increased platelet count or plasma cells (a type of white blood cell);
• blood clots in small blood vessels (microangiopathic thrombosis);
• abnormal reaction to blood transfusion;
• partial or complete loss of vision;
• decreased libido;
• excessive salivation;
• exophthalmos;
• photosensitivity;
• increased respiratory rate;
• rectal pain;
• gallstones;
• hernia;
• injuries;
• brittle or weak nails;
• abnormal protein deposition in organs;
• coma;
• intestinal ulcers;
• multi-organ failure;
• death;
• severe nerve inflammation that can cause paralysis and breathing difficulties (Guillain-Barré syndrome).

If you are receiving Bortezomib Zentiva in combination with other medicines for mantle cell lymphoma, you may experience the following side effects:
Very common side effects(may affect 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;
• diarrhea;
• mouth ulcers;
• constipation;
• muscle pain, bone pain;
• hair loss and abnormal hair structure;
• fatigue, feeling of weakness;
• fever.

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

• shingles (localized, e.g., around the eyes or widespread on the body);
• herpes virus infection;
• bacterial and viral infections;
• respiratory tract infections, bronchitis, wet cough, flu-like symptoms;
• fungal infections;
• hypersensitivity (allergic reaction);
• insulin deficiency or resistance to normal insulin levels;
• fluid retention;
• sleep disorders;
• loss of consciousness;
• altered level of consciousness, confusion;
• dizziness;
• rapid or slow heart rate, high blood pressure, sweating;
• abnormal vision, blurred vision;
• heart failure, heart attack, chest pain, discomfort in the chest, rapid or slow heart rate;
• high or low blood pressure;
• sudden drop in blood pressure when standing up, which may lead to fainting;
• shortness of breath during exercise;
• cough;
• hiccups;
• ringing or discomfort in the ears;
• gastrointestinal bleeding;
• heartburn;
• abdominal pain, belching;
• difficulty swallowing;
• infection or inflammation of the stomach or intestines;
• abdominal pain;
• mouth or lip ulcers, throat pain;
• liver function changes;
• itching;
• redness;
• rash;
• muscle spasms;
• urinary tract infections;
• limb pain;
• swelling, including around the eyes and other parts of the body;
• chills;
• redness and pain at the injection site;
• general feeling of illness;
• weight loss;
• weight gain.

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

• hepatitis;
• severe allergic reaction (anaphylactic reaction), which may include symptoms such as difficulty breathing, chest pain or tightness, and (or) dizziness or fainting, severe itching of the skin or hives, facial, lip, tongue, and (or) throat swelling, which may cause difficulty breathing and swallowing, collapse;
• movement disorders, paralysis, tremors;
• dizziness;
• hearing loss, deafness;
• lung disorders that make breathing difficult. Some of these include difficulty breathing, shortness of breath, shortness of breath at rest, shallow breathing, or cessation of breathing, wheezing;
• blood clots in the lungs;
• jaundice (yellowing of the skin and eyes);
• stye (hordeolum), eyelid redness and swelling.

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

• blood clots in small blood vessels (microangiopathic thrombosis).

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Al. Jerozolimskie 181 C, 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 authorization holder or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

• Side effects can also be reported to the marketing authorization holder or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bortezomib Zentiva

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and carton, after "EXP".
Store the vial in the outer carton to protect from light.
No special storage instructions are required for this medicine.
Solution after dilution
From a microbiological point of view, the diluted solution should be used immediately after preparation. If not used immediately, the user is responsible for the storage time and conditions. The solution shows chemical and physical stability for 8 days at 25°C, 60% relative humidity, or 15 days at 5±3°C, stored in the dark, both in the vial and in the polypropylene syringe.

6. Contents of the pack and other information

What Bortezomib Zentiva contains

• The active substance is bortezomib. Each vial contains 1 mg of bortezomib (as a mannitol and boronic acid ester).
• The other ingredients are: mannitol (E 421).

After reconstitution, 1 ml of the solution for injection contains 1 mg of bortezomib.

What Bortezomib Zentiva looks like and contents of the pack

Bortezomib Zentiva powder for solution for injection is a white or off-white lyophilized powder or powder.
Bortezomib Zentiva 1 mg is available in glass vials with a bromobutyl rubber stopper and an aluminum seal with a plastic flip-off cap, in a cardboard box.
Each pack contains 1 vial for single use.
Marketing authorization holder
Zentiva, k.s.
U Kabelovny 130, 102 37 Prague 10, Czech Republic
Manufacturer
Synthon Hispania SL, Castelló 1101, Las Salinas, Barcelona, 08830, Spain, Synthon s.r.o. Blansko, Brnenska 32/c.p.597, 678 01 Blansko, Czech Republic

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, please contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw, tel.: +48 22 375 92 00
Date of last revision of the leaflet:February 2021
The following information is intended for healthcare professionals only:

1. PREPARATION OF THE SOLUTION FOR INTRAVENOUS INJECTION

Caution: Bortezomib Zentiva is a cytotoxic product. When handling the product and preparing it for use, caution should be exercised. To protect against skin contact with the product, the use of gloves and other protective clothing is recommended.
AS Bortezomib Zentiva DOES NOT CONTAIN PRESERVATIVES, ASEPTIC TECHNIQUES MUST BE STRICTLY FOLLOWED WHEN HANDLING THE PRODUCT.

• 1.1. Preparation of the 1 mg vial: add 1 mlof sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Zentiva powder. Reconstitution of the lyophilized powder takes less than 2 minutes.

The resulting solution will have a concentration of 1 mg/ml. After reconstitution, the solution will be clear and colorless, with a pH between 4 and 7. There is no need to check the pH of the solution.

• 1.2. Before administration, visually inspect the solution for particulate matter and discoloration. If particulate matter or discoloration is observed, the solution should be discarded. Check the concentration on the vial to ensure that the correct dose is administered intravenously(1 mg/ml).
• 1.3. The reconstituted product does not contain preservatives and should be used immediately after preparation. However, the chemical and physical stability of the prepared solution is maintained for 8 days at 25°C, 60% relative humidity, or 15 days at 5±3°C, stored in the dark, both in the vial and in the polypropylene syringe. If the diluted solution is not administered immediately, the responsibility for the storage time and conditions before administration lies with the user.

2. ADMINISTRATION

• The appropriate volume of the reconstituted solution should be withdrawn based on the dose calculated according to the patient's body surface area.
• Before administration, confirm the dose and concentration of the medicine in the syringe (check that the syringe is labeled for intravenous administration).
• The solution should be administered as an intravenous bolus injection over 3 to 5 seconds.
• The intravenous line should be flushed with a small amount of sterile 9 mg/ml (0.9%) sodium chloride solution for injection after administration of Bortezomib Zentiva.

Bortezomib Zentiva 1 mg powder for solution for injection is for INTRAVENOUS USE ONLY. Intrathecal administration has resulted in death.

3. DISPOSAL OF THE PRODUCT

The vial is for single use only, and any unused solution should be discarded.
Dispose of any unused product or waste material in accordance with local requirements.