Bortezomib medac

Leaflet attached to the packaging: information for the user

Bortezomib medac, 3.5 mg, powder for solution for injection

Bortezomib

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Bortezomib medac 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 medac is used to treat multiple myeloma (bone marrow cancer) in patients aged 18 and over:

• as a single drug or in combination with other drugs: pegylated liposomal doxorubicin or dexamethasone in patients whose disease has progressed after at least one previous treatment and for whom hematopoietic stem cell transplantation was unsuccessful 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 treatment).

Bortezomib medac is used to treat mantle cell lymphoma (a type of cancer affecting the lymph nodes) in patients aged 18 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 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 severe lung or heart disease.

Warnings and precautions

Before starting treatment with Bortezomib medac, the patient should discuss with their doctor or pharmacist if they have any of the following conditions:

• low red or white blood cell count;
• bleeding disorders and (or) low platelet count;
• diarrhea, constipation, nausea, or vomiting;
• history of fainting, dizziness, and lightheadedness;
• kidney disease;
• moderate to severe liver function disorders;
• history of numbness, tingling, and pain in the hands and feet (symptoms of neuropathy);
• heart disease or blood pressure disorders;
• shortness of breath or cough;
• seizures;
• shingles (around the eyes or widespread on the body);
• symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, loss of vision, and shortness of breath;
• memory loss, thinking disorders, 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 before and during treatment with Bortezomib medac to systematically check their blood cell count.
If the patient has mantle cell lymphoma and is receiving Bortezomib medac with a drug containing rituximab, they should tell their doctor:

• if they suspect or have had hepatitis B virus infection in the past. In a few cases, patients who had hepatitis B virus infection had recurring episodes of hepatitis, with a possible fatal outcome. If the patient has a history of hepatitis B virus infection, they will be closely monitored by their doctor for symptoms of active hepatitis B virus infection.

Before starting treatment with Bortezomib medac, the patient should carefully read the leaflets of all medicinal products they are taking during treatment to obtain information about them.
If they are taking thalidomide, they should rule out pregnancy and then use effective contraception (see section Pregnancy and breastfeeding).

Children and adolescents

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

Bortezomib medac and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, they should inform their doctor if they 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 antidiabetic drugs.

Pregnancy and breastfeeding

Bortezomib medac should not be used during pregnancy unless absolutely necessary.
Women of childbearing age must use effective contraception during treatment and for 8 months after its completion. If the patient wishes to freeze their eggs before starting treatment, they should discuss this with their doctor.
Men should not father children during treatment with Bortezomib medac and should use effective contraception during treatment and for up to 5 months after its completion. If the patient wishes to donate sperm for preservation before starting treatment, they should consult their doctor.
Patients should not breastfeed during treatment with Bortezomib medac. It is necessary to discuss with the doctor the safe timing of returning to breastfeeding after treatment completion in the patient.
Thalidomide causes birth defects and fetal death. When Bortezomib medac is used in combination with thalidomide, patients must follow the "Thalidomide Pregnancy Prevention Program" (see thalidomide leaflet).

Driving and using machines

Bortezomib medac may cause fatigue, dizziness, fainting, and blurred vision. If these symptoms occur, the patient should not drive or operate tools or equipment; even if symptoms do not occur, they should still exercise caution.

3. How to use Bortezomib medac

The doctor will adjust the appropriate dose of Bortezomib medac for the patient based on their height and weight (body surface area). The most commonly used initial dose of Bortezomib medac is 1.3 mg/m² body surface area, administered twice a week.
The doctor may change the dose and total number of treatment cycles depending on the patient's response to treatment, side effects, and additional diseases (e.g., liver disease).
Progressive multiple myeloma
If Bortezomib medac is administered as a single drug, the patient will receive 4 doses of Bortezomib medac intravenously or subcutaneously on days 1, 4, 8, and 11, followed by a 10-day break in treatment.
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 medac in combination with pegylated liposomal doxorubicin or dexamethasone.
When Bortezomib medac is administered with pegylated liposomal doxorubicin, the patient will receive Bortezomib medac intravenously or subcutaneously during the 21-day treatment cycle, and pegylated liposomal doxorubicin will be administered at a dose of 30 mg/m² body surface area as an intravenous infusion after Bortezomib medac injection on day 4 of the 21-day cycle.
The patient will receive up to 8 cycles (24 weeks).
When Bortezomib medac is administered with dexamethasone, the patient will receive Bortezomib medac intravenously or subcutaneously 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 21-day Bortezomib medac treatment cycle.
The patient will receive up to 8 cycles (24 weeks).
Previously untreated multiple myeloma
If the patient has not been previously treated for multiple myeloma and does not qualify for hematopoietic stem cell transplantation, they will receive Bortezomib medac 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 medac will be administered twice a week on days 1, 4, 8, 11, 22, 25, 29, and 32.
• During cycles 5-9, Bortezomib medac will be administered once a week on days 1, 8, 22, and 29.

Both melphalan (9 mg/m²) and prednisone (60 mg/m²) will be 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 qualifies for hematopoietic stem cell transplantation, they will receive Bortezomib medac intravenously or subcutaneously in combination with dexamethasone or dexamethasone with thalidomide in induction treatment.
When Bortezomib medac is administered with dexamethasone, the patient will receive Bortezomib medac intravenously or subcutaneously 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 medac treatment cycle.
The patient will receive up to 4 cycles (12 weeks).
When Bortezomib medac 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 medac 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 from 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 medac intravenously or subcutaneously in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone.
Bortezomib medac will be administered intravenously or subcutaneously on days 1, 4, 8, and 11, followed by a "rest period" without drug administration. One treatment cycle lasts 21 days (3 weeks).
The patient will receive up to 8 cycles (24 weeks).
The following drugs will be 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 will be 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 or subcutaneously. Bortezomib medac will be administered by medical staff with experience in the use of cytotoxic drugs.
Bortezomib medac must be dissolved before administration. The preparation of the medicine is carried out by medical staff. The prepared solution is then injected into a vein or under the skin. Intravenous injection is rapid and lasts from 3 to 5 seconds. Subcutaneous injection is administered into the thigh or abdomen.

Use 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 too high a dose. If this happens, the doctor will monitor the patient for side effects.

4. Possible side effects

Like all medicines, Bortezomib medac can cause side effects, although not everybody gets them.
Some of these side effects can be serious.
If the patient is receiving Bortezomib medac for multiple myeloma or mantle cell lymphoma, they should immediately tell their doctor if they 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 changes in heart rhythm, high blood pressure, fatigue, fainting;
• cough and difficulty breathing or chest pressure. Treatment with Bortezomib medac 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 have regular blood tests before and during treatment with Bortezomib medac to regularly check their blood cell count. The patient may experience a decrease in:
• platelet count, which can lead to bruising or bleeding that is not caused by injury (e.g., gastrointestinal bleeding, bleeding from the mouth, vagina, or gums, or cerebral hemorrhage);
• red blood cell count, which can lead to anemia, characterized by symptoms such as fatigue and paleness;
• white blood cell count, which can lead to increased susceptibility to infections or flu-like symptoms.

If the patient is receiving Bortezomib medac for multiple myeloma, they 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 the 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 be severe and accompanied by bloating or without bloating (worsening of symptoms may be significant);
• diarrhea: if it occurs, the patient should drink more water than usual; 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 can 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, shortness of breath during exercise;
• various types of rash;
• itching, skin nodules 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 inflammation, dry mouth, mouth ulcers or throat pain;
• 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;
• 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, discomfort in the chest, rapid or slow heart rate;
• kidney failure;
• vein inflammation, blood clots in veins and lungs;
• blood clotting disorders;
• circulatory failure;
• pericarditis (inflammation of the heart sac) 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, or cerebral hemorrhage;
• stroke, seizures, falls, movement disorders, abnormal, changed, or weakened sensation (touch, hearing, taste, smell), attention disorders, tremors, sudden movements;
• joint inflammation, including joint inflammation of the 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 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;
• hair loss and abnormal hair structure;
• allergic reactions;
• redness or pain at the injection site;
• mouth pain;
• infection or inflammation of the mouth, esophagus, stomach, and intestines, sometimes with accompanying pain and bleeding, poor intestinal motility (including obstruction), discomfort in the abdominal and esophageal areas, difficulty swallowing;
• skin infection;
• bacterial and viral infections;
• tooth infection;
• pancreatitis, bile duct obstruction;
• genital pain, erectile dysfunction disorders;
• weight gain;
• thirst;
• hepatitis;
• disorders at the injection site or related to the use of a vascular catheter;
• skin reactions (which can be severe and life-threatening), skin ulcers;
• bruises, falls, and injuries;
• vascular inflammation or bleeding, manifested by small red or purple spots (usually on the legs) to large spots similar to bruises under the skin;
• mild cysts;
• severe reversible disorders of the brain, which include 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 pectoris;
• flushing;
• vein discoloration;
• spinal cord inflammation;
• ear disorders, ear bleeding;
• hypothyroidism;
• Budd-Chiari syndrome (clinical symptoms caused by blockage of liver veins);
• altered or abnormal intestinal motility;
• brain bleeding;
• jaundice (yellowing of the skin and eyes);
• stye (hordeolum), eyelid redness and swelling;

If the patient is receiving Bortezomib medac in combination with other medicines for mantle cell lymphoma, they 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 the 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 heartbeat, 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 can lead to fainting;
• shortness of breath during exercise;
• cough;
• hiccups;
• ringing or discomfort in the ears;
• gastrointestinal bleeding;
• heartburn;
• abdominal pain;
• difficulty swallowing;
• infection or inflammation of the stomach or intestines;
• abdominal pain;
• mouth or lip inflammation, throat pain;
• liver function disorders;
• itching;
• redness of the skin;
• rash;
• muscle cramps;
• 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 can include symptoms such as difficulty breathing, chest pain or tightness, dizziness or fainting, severe itching of the skin or hives, swelling of the face, lips, tongue, or throat, which can cause difficulty swallowing, collapse;
• movement disorders, paralysis, muscle tremors;
• 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 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 clot in small blood vessels (thrombotic microangiopathy).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Bortezomib medac

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and outer packaging, after "EXP".
Store the vial in the outer packaging to protect it from light.
There are no special storage temperature requirements for the medicine.
Diluted solution
Chemical and physical stability of the diluted solution has been demonstrated for 8 days when stored at 25°C and 60% relative humidity or 15 days at 5 +/- 3°C in the dark, both in the vial and in a polypropylene syringe. The solution should be used immediately after preparation. However, if not used immediately, the responsibility for the storage conditions and time before administration lies with the user, and the storage time should not exceed 24 hours at 2-8°C. The diluted solution should be stored in the syringe or vial at 2-8°C and should be used within the recommended storage time.

6. Contents of the packaging and other information

What Bortezomib medac contains

• The active substance of Bortezomib medac is bortezomib. Each vial contains 3.5 mg of bortezomib (as boronic acid ester with mannitol).
• The other ingredient is mannitol (E 421).

Injection solution for intravenous administration:
After dissolution, 1 ml of the injection solution contains 1 mg of bortezomib.
Injection solution for subcutaneous administration:
After dissolution, 1 ml of the injection solution contains 2.5 mg of bortezomib.

What Bortezomib medac looks like and contents of the pack

Bortezomib medac powder for solution for injection is a white or almost white cake or powder.
Bortezomib medac is packaged in a glass vial with a rubber stopper and a blue flip-off cap.
Each pack contains 1 vial for single use.

Marketing authorization 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, nº1
Pol. Las Salinas, Sant Boi de Llobregat
08830 Barcelona
Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark, Finland, Netherlands, Ireland, Germany, Norway, Sweden, Italy: Bortezomib medac
United Kingdom (Northern Ireland): Bortezomib
Date of last revision of the leaflet:04/2025
Information intended for healthcare professionals only:

1. PREPARATION OF THE INJECTION SOLUTION FOR INTRAVENOUS ADMINISTRATION

Caution: Bortezomib medac is a cytotoxic product. When handling the product and preparing it for use, caution should be exercised. To protect against contact with the skin, gloves and other protective clothing are recommended. Since Bortezomib medac does not contain preservatives, strict aseptic techniques must be followed when handling the product.

1.1

Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride injection solution to the vial containing Bortezomib medac powder, using an appropriate syringe, without removing the vial stopper. Dissolution of the lyophilized powder takes less than 2 minutes.
The resulting solution will have a concentration of 1 mg/ml. After dissolution, 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, the solution should be visually inspected for particulate matter and discoloration. If particulate matter or discoloration is observed, the solution should be discarded. Ensure that the correct dose (1 mg/ml) is administered intravenously.

1.3

The reconstituted solution is preservative-free and should be used immediately after preparation. However, the chemical and physical stability of the reconstituted solution has been demonstrated for 8 days when stored at 25°C and 60% relative humidity or 15 days at 5 +/- 3°C in the dark, both in the vial and in a polypropylene syringe. The total storage time of the solution in the syringe should not exceed 24 hours at 2-8°C. If the diluted solution is not used immediately, the responsibility for the storage conditions and time before administration lies with the user.

2. ADMINISTRATION

• After reconstitution, the appropriate volume of the 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).
• Administer the solution as an intravenous bolus injection lasting 3-5 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 injection solution.

Bortezomib medac 3.5 mg powder for solution for injection is administered INTRAVENOUSLY OR SUBCUTANEOUSLY. Do not administer by any other route. Intrathecal administration has resulted in death.

3. DISPOSAL OF THE MEDICINE

The vial is for single use only, and any remaining solution should be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Information intended for healthcare professionals only:

4. PREPARATION OF THE INJECTION SOLUTION FOR SUBCUTANEOUS ADMINISTRATION

Caution: Bortezomib medac is a cytotoxic product. When handling the product and preparing it for use, caution should be exercised. To protect against contact with the skin, gloves and other protective clothing are recommended. Since Bortezomib medac does not contain preservatives, strict aseptic techniques must be followed when handling the product.

4.1

Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile, 9 mg/ml (0.9%) sodium chloride injection solution to the vial containing Bortezomib medac powder, using an appropriate syringe, without removing the vial stopper. Dissolution of the lyophilized powder takes less than 2 minutes.
The resulting solution will have a concentration of 2.5 mg/ml. After dissolution, 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.

4.2

Before administration, the solution should be visually inspected for particulate matter and discoloration. If particulate matter or discoloration is observed, the solution should be discarded. Ensure that the correct dose (2.5 mg/ml) is administered subcutaneously.

4.3

The reconstituted solution is preservative-free and should be used immediately after preparation. However, the chemical and physical stability of the reconstituted solution has been demonstrated for 8 days when stored at 25°C and 60% relative humidity or 15 days at 5 +/- 3°C in the dark, both in the vial and in a polypropylene syringe. The total storage time of the solution in the syringe should not exceed 24 hours at 2-8°C. If the diluted solution is not used immediately, the responsibility for the storage conditions and time before administration lies with the user.

5. ADMINISTRATION

• After reconstitution, the appropriate volume of the 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 subcutaneous administration).
• Administer the solution subcutaneously at an angle of 45-90°.
• The prepared solution is administered subcutaneously into the thigh (right or left) or abdomen (right or left side).
• The injection site should be rotated.
• If a local reaction occurs after subcutaneous injection of Bortezomib medac, it is recommended to administer the solution subcutaneously at a lower concentration (dilution to 1 mg/ml instead of 2.5 mg/ml) or to switch to intravenous administration.

Bortezomib medac 3.5 mg powder for solution for injection is administered INTRAVENOUSLY OR SUBCUTANEOUSLY. Do not administer by any other route. Intrathecal administration has resulted in death.

6. DISPOSAL OF THE MEDICINE

The vial is for single use only, and any remaining solution should be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.