Bortezomib adamed

Bortezomib Adamed 1 mg, powder for solution for intravenous injection
Bortezomibum
Please read the following leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor, pharmacist, or nurse if you have any questions.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Bortezomib Adamed is and what it is used for
Bortezomib Adamed contains an active substance called bortezomib, which is a so-called
"proteasome inhibitor". Proteasomes play an important role in controlling cell functions and their
development process. By interfering with their function, bortezomib may lead to the death of
cancer cells.

Bortezomib Adamed is used in the treatment of multiple myeloma (a cancer of the bone marrow) in
patients over 18 years of age:

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

Bortezomib Adamed is also used in the treatment of mantle cell lymphoma (a type of cancer affecting
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 autologous hematopoietic stem cell transplantation.

2. Important information before using Bortezomib Adamed

When not to use Bortezomib Adamed

• 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 disease.

Warnings and precautions
Inform your doctor if the patient:

• has low red or white blood cell counts;
• has bleeding disorders and/or low platelet count;
• experiences diarrhea, constipation, nausea, or vomiting;
• has previously experienced fainting, dizziness, or lightheadedness;
• has kidney disease;
• has moderate to severe liver function impairment;
• has previously experienced numbness, tingling, or pain in hands and feet (symptoms of neuropathy);
• has heart disease or blood pressure problems;
• experiences shortness of breath or cough;
• has seizures;
• has shingles (around the eyes or disseminated throughout the body);
• shows symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision loss or disturbances, and difficulty breathing;
• experiences memory loss, thinking difficulties, walking problems, or vision loss. These may be symptoms of a serious brain infection, and the doctor may recommend further tests and monitoring.

Regular blood tests must be performed before and during treatment with Bortezomib Adamed to
monitor blood cell counts.

If the patient has mantle cell lymphoma and is receiving rituximab together with Bortezomib Adamed,
inform the doctor:

• if the patient suspects or has had hepatitis virus infection in the past. In some cases, patients with prior hepatitis B virus (HBV) infection have experienced reactivation of hepatitis, which could be fatal. If the patient has a history of HBV infection, they will be closely monitored by the doctor for signs of active HBV.

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

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

Other medicines and Bortezomib Adamed
Inform your doctor about all medicines currently used, recently used, or planned for use.
In particular, inform your doctor if the patient is taking medicines containing any of the following active substances:

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

Pregnancy and breastfeeding
Do not use Bortezomib Adamed during pregnancy unless absolutely necessary.
Both men and women receiving Bortezomib Adamed must use effective contraception during treatment and for 3 months after treatment ends. If pregnancy occurs despite these measures, inform the doctor immediately.
Patients must not breastfeed during treatment with Bortezomib Adamed.
The timing of safe resumption of breastfeeding after treatment should be discussed with the doctor.
Thalidomide causes birth defects and fetal death. When Bortezomib Adamed is used in combination with thalidomide, patients must comply with the requirements of the "Thalidomide Pregnancy Prevention Program" (see the thalidomide package leaflet).

Driving and operating machinery
Bortezomib Adamed may cause fatigue, dizziness, fainting, and blurred vision. If such symptoms occur, the patient must not drive or operate tools or machinery. Even if no symptoms are present, caution should still be exercised.

3. How to use Bortezomib Adamed

The treating physician will adjust the appropriate dose of Bortezomib Adamed for the patient based on the patient's height and body weight (body surface area). The most commonly used starting dose of Bortezomib Adamed is 1.3 mg/m² of 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 Adamed is administered as a single agent, the patient will receive 4 doses of Bortezomib Adamed 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 Adamed in combination with the following medicines: pegylated liposomal doxorubicin or dexamethasone.

When Bortezomib Adamed is administered together with pegylated liposomal doxorubicin, the patient will receive Bortezomib Adamed intravenously during the 21-day treatment cycle, and pegylated liposomal doxorubicin will be administered as an intravenous infusion at a dose of 30 mg/m² after the injection of Bortezomib Adamed on day 4 of the 21-day cycle.
The patient may receive up to 8 cycles (24 weeks).

When Bortezomib Adamed is administered together with dexamethasone, the patient will receive Bortezomib Adamed 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 21-day Bortezomib Adamed 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 Adamed in combination with other medicines: melphalan and prednisone.
In this case, the treatment cycle duration is 42 days (6 weeks). The patient will receive 9 cycles (54 weeks).

• During cycles 1–4, Bortezomib Adamed is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29, and 32.
• During cycles 5–9, Bortezomib Adamed 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 Adamed intravenously in combination with other medicines: dexamethasone or dexamethasone with thalidomide, as induction therapy.

When Bortezomib Adamed is administered with dexamethasone, the patient will receive Bortezomib Adamed 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 Adamed treatment cycle. The patient will receive up to 4 cycles (12 weeks).

When Bortezomib Adamed is administered with dexamethasone and thalidomide, the treatment cycle duration 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 Adamed 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 is increased to 100 mg on days 15–28 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 Adamed intravenously in combination with the following medicines: rituximab, cyclophosphamide, doxorubicin, and prednisone. Bortezomib Adamed is administered intravenously on days 1, 4, 8, and 11, followed by a "rest period" without administration of any drugs. One treatment cycle lasts 21 days (3 weeks). The patient will receive up to 8 cycles (24 weeks).

The following medicines are administered as intravenous infusions on day 1 of each 21-day Bortezomib Adamed 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 Adamed cycle.

How Bortezomib Adamed is administered
This medicine is administered intravenously only. Bortezomib Adamed will be administered by trained medical personnel experienced in handling cytotoxic drugs.
The Bortezomib Adamed powder must be reconstituted before administration. The reconstitution is performed by trained medical personnel. The prepared solution is then administered rapidly intravenously over 3 to 5 seconds.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some of these adverse reactions may be serious.
If the patient is receiving Bortezomib Adamed for the treatment of multiple myeloma or mantle cell lymphoma, inform 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 changes in heart rhythm, high blood pressure, fatigue, fainting;
• cough and difficulty breathing or chest tightness.

Treatment with Bortezomib Adamed may very commonly lead to a decrease in the number of red blood cells, white blood cells, and platelets in the patient's blood. Therefore, blood tests must be performed frequently before and during treatment with Bortezomib Adamed to monitor blood cell counts regularly. The patient may experience a reduction in: platelets, which may lead to a tendency to bruise or bleed without injury (e.g., bleeding from the intestines, stomach, mouth, or gums, or hemorrhage in the brain or liver); red blood cells, which may lead to anemia, associated with symptoms such as fatigue and pallor; white blood cells, which may increase susceptibility to infections or flu-like symptoms.

If the patient is receiving Bortezomib Adamed for the treatment of multiple myeloma, the following adverse reactions may occur:

Very common adverse reactions (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);
• diarrhea: if it occurs, the patient must drink more fluids than usual; the doctor may recommend taking additional medicines to control diarrhea;
• fatigue, feeling of weakness;
• muscle pain, bone pain.

Common adverse reactions (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, 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 intestines 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;
• edema, including around the eyes and in other parts of the body.

Uncommon adverse reactions (may occur in less than 1 in 100 people):

• heart failure, heart attack, chest pain, discomfort in the chest, rapid or slow heart rate;
• kidney failure;
• phlebitis, 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, 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, twitching;
• arthritis, including arthritis of the fingers, toes, and jaw;
• lung disorders causing difficulty breathing. Some of these include: breathing difficulties, shortness of breath, shortness of breath at rest, shallow breathing, or respiratory arrest, wheezing;
• hiccups, speech disorders;
• increased or decreased urine production (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, mouth ulcers, esophagus, stomach, and intestines, sometimes with accompanying pain and bleeding, weak intestinal peristalsis (including obstruction);
• abdominal and esophageal discomfort, difficulty swallowing, vomiting blood;
• skin infection;
• bacterial and viral infections;
• dental infections;
• pancreatitis, biliary duct obstruction;
• genital organ pain, erectile dysfunction;
• weight gain;
• thirst;
• hepatitis;
• injection site reactions or complications related to the use of a vascular catheter;
• 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 the legs) to large bruise-like subcutaneous patches;
• benign cysts;
• severe reversible encephalopathy syndrome, including seizures, high blood pressure, headache, fatigue, confusion, blindness, or other visual disturbances.

Rare adverse reactions (may occur in less than 1 in 1000 people):

• heart diseases including heart attack, angina;
• flushing attacks;
• vein discoloration;
• spinal cord inflammation;
• ear disorders, ear bleeding;
• hypothyroidism;
• Budd-Chiari syndrome (clinical symptoms caused by blockage of hepatic veins);
• altered or abnormal intestinal function;
• brain hemorrhage;
• 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 raised skin nodules, swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing and swallowing, collapse;
• breast disorders;
• vaginal ulceration;
• genital organ swelling;
• alcohol intolerance;
• wasting or weight loss;
• increased appetite;
• fistula;
• joint effusion;
• cyst in the joint lining (ganglion cyst);
• bone fractures;
• rhabdomyolysis (muscle fiber breakdown) leading to further complications;
• liver swelling, liver bleeding;
• kidney cancer;
• skin condition resembling psoriasis;
• 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 cause paralysis and breathing difficulties (Guillain-Barré syndrome).

If the patient is receiving Bortezomib Adamed in combination with other medicines for the treatment of mantle cell lymphoma, the following adverse reactions may occur:

Very common adverse reactions (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;
• diarrhea;
• mouth ulcers;
• constipation;
• muscle pain, bone pain;
• hair loss and abnormal hair structure;
• fatigue, feeling of weakness;
• fever.

Common adverse reactions (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, discomfort in the chest, rapid or slow heart rate;
• high or low blood pressure;
• sudden drop in blood pressure upon changing body position, which may lead to fainting;
• shortness of breath during exertion;
• cough;
• hiccups;
• ringing in the ears, ear discomfort;
• bleeding from the intestines or stomach;
• heartburn;
• mouth pain, sore throat;
• abdominal pain, belching;
• difficulty swallowing;
• infection or inflammation of the stomach or intestines;
• abdominal pain;
• inflammation of the mouth or lips, sore throat, mouth ulcers;
• altered liver function;
• skin itching;
• skin redness;
• rash;
• muscle cramps;
• muscle pain, bone pain;
• urinary tract infection;
• limb pain;
• swelling affecting eyes and other body parts;
• chills;
• redness and pain at the injection site;
• general feeling of illness;
• weight loss;
• weight gain.

Uncommon adverse reactions (may occur in less than 1 in 100 people):

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

Rare adverse reactions (may occur in less than 1 in 1000 people):

• blood clot in small blood vessels (thrombotic microangiopathy).

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

5. How to store Bortezomib Adamed

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and
outer packaging, following "Expiry date (EXP)".
Store the vial in the outer packaging to protect it from light.
No special precautions for temperature storage of the medicinal product are required.

Reconstituted solution
Chemical and physical stability of the medicinal product has been demonstrated for 8 hours when stored in the dark at 25 °C and 60%RH, both in the vial and in a polypropylene syringe.
From a microbiological standpoint, the product should be used immediately after preparation. If not used immediately, the user is responsible for the storage duration and conditions, which should not exceed 24 hours at 2 °C to 8 °C, unless reconstitution/dilution was carried out under controlled aseptic conditions.

Bortezomib Adamed 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 Adamed contains

• The active substance is bortezomib. Each vial contains 1 mg of bortezomib (in the form of mannitol and boric acid ester). After reconstitution, 1 ml of injection solution contains 1 mg of bortezomib.
• Other ingredients (excipients): mannitol (E 421).

What Bortezomib Adamed looks like and contents of the pack
Bortezomib Adamed for injection is a white or off-white lyophilized powder or powder.
Bortezomib Adamed is packed in a 6 ml colorless type I glass vial with a bromobutyl rubber stopper, aluminium seal and a plastic flip-off cap, placed in a cardboard box.
The pack contains 1 single-use vial.

Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Manufacturer:
Synthon Hispania S.L.
Castello, 1
Poligono Las Salinas
08830 Sant Boi de Llobregat
Spain
Synthon s.r.o. Blansko
Brnenska 32/c.p.597, 678 01 Blansko,
Czech Republic
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
04.2021

The following information is intended for healthcare professionals only:

1. PREPARATION OF THE INJECTION SOLUTION FOR INTRAVENOUS ADMINISTRATION
Warning: Bortezomib Adamed is a cytotoxic product. Care must be taken when handling and preparing the medication. To protect against skin contact, the use of gloves and other protective clothing is recommended.
BECAUSE BORTEZOMIB ADAMED DOES NOT CONTAIN PRESERVATIVES, ASEPTIC TECHNIQUES MUST BE STRICTLY FOLLOWED DURING HANDLING.

1.1. Reconstitution of the 1 mg vial: add 1 ml of sterile 9 mg/ml (0.9%) sodium chloride injection solution to the vial containing Bortezomib Adamed powder. Dissolution 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 colourless, 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 particulates or discoloration are observed, the solution must be discarded. Check the concentration marked on the vial to ensure the correct dose (1 mg/ml) will be administered intravenously.

1.3. The reconstituted solution is preservative-free and should be used immediately. However, the chemical and physical stability of the prepared solution is maintained for up to 8 hours prior to administration when stored at 25°C in the original vial and/or syringe. The total storage time of the solution in a syringe must not exceed 8 hours. If the reconstituted solution is not administered immediately after preparation, the person administering the medication is responsible for the storage time and conditions prior to use.
There is no need to protect the reconstituted solution from light.

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 drug in the syringe (ensure 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 injection solution.

BORTEZOMIB ADAMED (1 MG POWDER FOR INJECTION SOLUTION) MUST BE ADMINISTERED
INTRAVENOUSLY ONLY. INTRATHECAL ADMINISTRATION HAS RESULTED IN DEATH.

3. DISPOSAL OF THE MEDICINAL PRODUCT
The vial is for single use only, and any unused portion of the solution must be discarded.
Any unused product or waste material must be disposed of in accordance with local regulations.