Package leaflet: Information for the patient

Bortezomib Eugia, 3.5 mg, powder for solution for injection
Bortezomibum
Please read this 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.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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

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

Bortezomib Eugia contains a 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
tumor cells.
Bortezomib Eugia 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 worsened (progressed) after at least one prior therapy and in whom autologous hematopoietic stem cell transplantation has failed or is not possible;
in combination with melphalan and prednisone in patients who have not previously been treated and who are not eligible for high-dose cytotoxic chemotherapy followed by autologous hematopoietic stem cell transplantation;
in combination with dexamethasone or dexamethasone with thalidomide in patients who have not previously been treated and who are eligible for high-dose cytotoxic chemotherapy followed by autologous hematopoietic stem cell transplantation (induction treatment).

Bortezomib Eugia is 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 patients who have not previously been treated and who are not eligible for autologous hematopoietic stem cell transplantation.

2. Important information before using Bortezomib Eugia

When not to use Bortezomib Eugia

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
Inform the treating doctor if the patient:

has low numbers of red or white blood cells;
has bleeding disorders and/or low platelet count;
experiences diarrhoea, constipation, nausea, or vomiting;
has previously experienced fainting, dizziness, or lightheadedness;
has kidney diseases;
has moderate to severe liver function disorders;
has previously experienced numbness, tingling, or pain in hands and feet (neuropathy symptoms);
has heart diseases or blood pressure problems;
experiences shortness of breath or cough;
has seizures;
has shingles (around the eyes or disseminated throughout the body);
has symptoms of tumour lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision loss or disturbances, and difficulty breathing;
experiences memory loss, thinking disorders, difficulty walking, 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 in the patient before and during treatment with
Bortezomib Eugia to regularly monitor blood cell counts.
If the patient has mantle cell lymphoma and is receiving Bortezomib Eugia 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 with a history of hepatitis B infection have experienced reactivation of hepatitis B, which could be fatal. If the patient has a history of hepatitis B infection, the doctor will closely monitor for signs of active hepatitis B.

Before starting treatment with Bortezomib Eugia, carefully read the package leaflets of all
medicines taken during treatment to obtain information about them.
If taking thalidomide, pregnancy must be excluded, and effective contraception must be used (see section Pregnancy and breastfeeding).
Children and adolescents
Bortezomib Eugia must not be used in children and adolescents, as its efficacy and safety in this patient group are unknown.
Bortezomib Eugia and other medicines
Inform the doctor about all medicines currently used, recently taken, or planned for use.
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 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 Eugia during pregnancy unless absolutely necessary.
Women of childbearing potential must use effective contraception during treatment and for 8
months after treatment ends. Talk to the doctor if the patient wishes to freeze her eggs before starting treatment.
Men must not father a child during treatment with Bortezomib Eugia and must use effective contraception during treatment and for up to 5 months after treatment ends. Talk to the doctor if the patient wishes to preserve his sperm before starting treatment.
Patients must not breast-feed during treatment with Bortezomib Eugia. The timing of safe resumption of breastfeeding after treatment should be discussed with the doctor.
Thalidomide causes congenital malformations and fetal death. When Bortezomib Eugia is used in combination with thalidomide, patients must comply with the requirements of the "Thalidomide Pregnancy Prevention Programme" (see thalidomide package leaflet).
Driving and operating machinery
Bortezomib Eugia 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 must still be exercised.

3. How to use Bortezomib Eugia

Your doctor will adjust the appropriate dose of Bortezomib Eugia based on the patient's height and body weight (body surface area). The most commonly used starting dose of Bortezomib Eugia is 1.3 mg/m² body surface area (BSA), administered twice weekly.
The doctor 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 (progressive disease)
If Bortezomib Eugia is administered as a single agent, the patient will receive 4 doses of Bortezomib Eugia intravenously or subcutaneously 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 Eugia in combination with either pegylated liposomal doxorubicin or dexamethasone.

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

When Bortezomib Eugia is administered together with dexamethasone, the patient will receive Bortezomib Eugia intravenously or subcutaneously 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 treatment cycle with Bortezomib Eugia. 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 does not qualify for hematopoietic stem cell transplantation, the patient will receive Bortezomib Eugia in combination with melphalan and prednisone.

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

During cycles 1–4, Bortezomib Eugia is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29, and 32.
During cycles 5–9, Bortezomib Eugia is administered once weekly on days 1, 8, 22, and 29.
Both melphalan (9 mg/m² BSA) and prednisone (60 mg/m² BSA) 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 qualifies for hematopoietic stem cell transplantation, the patient will receive Bortezomib Eugia intravenously or subcutaneously in combination with dexamethasone or with dexamethasone and thalidomide as induction therapy.

When Bortezomib Eugia is administered with dexamethasone, the patient will receive Bortezomib Eugia intravenously or subcutaneously 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 each 21-day treatment cycle with Bortezomib Eugia. The patient will receive up to 4 cycles (12 weeks).

When Bortezomib Eugia is administered with thalidomide and dexamethasone, each treatment cycle lasts 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 each 28-day treatment cycle with Bortezomib Eugia. Thalidomide is administered orally once daily at a dose of 50 mg up to day 14 of the first cycle; if this dose is tolerated, it is 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 Eugia intravenously or subcutaneously in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone.

Bortezomib Eugia is administered intravenously or subcutaneously on days 1, 4, 8, and 11, followed by a "rest period" without treatment. Each treatment cycle lasts 21 days (3 weeks). The patient will receive up to 8 cycles (24 weeks).

The following drugs are administered as intravenous infusions on day 1 of each 21-day treatment cycle with Bortezomib Eugia:
rituximab at a dose of 375 mg/m² BSA, cyclophosphamide at a dose of 750 mg/m² BSA, and doxorubicin at a dose of 50 mg/m² BSA.
Prednisone is administered orally at a dose of 100 mg/m² BSA on days 1, 2, 3, 4, and 5 of each treatment cycle with Bortezomib Eugia.

How Bortezomib Eugia is administered
This medicine is administered intravenously or subcutaneously. Bortezomib Eugia will be administered by trained medical personnel experienced in handling cytotoxic drugs. The Bortezomib Eugia powder must be reconstituted before administration. The reconstitution is performed by trained medical personnel. The prepared solution is then injected intravenously or subcutaneously. The intravenous injection is administered rapidly and lasts between 3 and 5 seconds. The subcutaneous injection is administered into the thigh or abdomen.

Overdose of Bortezomib Eugia
Since the medicine is administered by a doctor or nurse, it is highly 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 everyone will experience them.
Some of these side effects may be serious.
If the patient is receiving Bortezomib Eugia 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 change in heart rhythm, high blood pressure, fatigue, fainting;
cough and difficulty breathing or chest tightness.

Treatment with Bortezomib Eugia may very commonly cause a reduction in the number of red and white blood cells and platelets in the patient's blood. Therefore, blood tests must be performed frequently before and during treatment with Bortezomib Eugia to regularly monitor blood cell counts. The patient may experience a decrease in:

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

If the patient is receiving Bortezomib Eugia for the treatment of multiple myeloma, the following side effects may occur:
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 up to 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 malaise, 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 skin 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 abnormalities
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 other parts of the body.

Uncommon side effects (may occur in up to 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
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, changed or reduced sensation (touch, hearing, taste, smell), attention disorders, tremor, twitching
arthritis, including arthritis 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 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 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, stye (hordeolum), red and swollen eyelids, eye discharge, visual disturbances, 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, biliary 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 manifested 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 up to 1 in 1,000 people):

heart diseases including heart attack, angina
severe nerve inflammation which may cause paralysis and breathing difficulties (Guillain-Barré syndrome)
flushing attacks
vein discoloration
spinal cord inflammation
ear diseases, ear bleeding
hypothyroidism
Budd-Chiari syndrome (clinical symptoms caused by obstruction 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 raised skin lumps, 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
synovial cyst (ganglion cyst)
bone fractures
rhabdomyolysis leading to further complications
liver oedema, 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 clots in small blood vessels (thrombotic microangiopathy)
abnormal reaction to blood transfusion
partial or complete vision loss
decreased libido
drooling
exophthalmos
photophobia
increased respiratory rate
rectal pain
gallstones
hernia
cuts
brittle or weak nails
abnormal protein deposition in organs
coma
intestinal ulceration
multi-organ failure
death.

If the patient is receiving Bortezomib Eugia in combination with other medicines for the treatment of mantle cell lymphoma, the following side effects may occur:
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 up to 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, productive 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
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 upon changing position which may lead to fainting
shortness of breath during exertion
cough
hiccups
ringing in ears, ear discomfort
bleeding from intestine or stomach
heartburn
abdominal pain, belching
difficulty swallowing
infection or inflammation of the stomach or intestines
abdominal pain
inflammation or infection of the mouth or lips, sore throat
altered liver function
skin itching
skin redness
rash
muscle cramps
urinary tract infection
limb pain
oedema affecting eyes and other body parts
chills
redness and pain at injection site
general malaise
weight loss
weight gain.

Uncommon side effects (may occur in up to 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 blisters on skin, swelling of 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 lungs
yellowing of skin and eyes (jaundice)
stye (hordeolum), red and swollen eyelids.

Rare side effects (may occur in up to 1 in 1,000 people):

blood clots in small blood vessels (thrombotic microangiopathy)
severe nerve inflammation which may cause paralysis and breathing difficulties (Guillain-Barré syndrome).

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform the doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Side effects can also be reported to the responsible entity.
By reporting side effects, additional information on the safety of this medicine can be collected.

5. How to store Bortezomib Eugia

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and carton after:
EXP. The expiry date refers to the last day of the stated month.
Store the vial in the outer packaging to protect it from light.

Intravenous administration:
Reconstituted solution at 1 mg/mL.
Do not store in the refrigerator.
The prepared solution remains chemically and physically stable for 7 days at 25°C. From a microbiological standpoint, unless the method of opening/reconstitution/dilution excludes the risk of microbiological contamination, the medicine should be used immediately. If the prepared solution is not administered immediately, the person administering the medicine is responsible for the duration and conditions of storage prior to administration to the patient.

Subcutaneous administration:
Reconstituted solution at 2.5 mg/mL.
Do not store in the refrigerator.
The prepared solution remains chemically and physically stable for 7 days at 25°C. From a microbiological standpoint, unless the method of opening/reconstitution/dilution excludes the risk of microbiological contamination, the medicine should be used immediately. If the prepared solution is not administered immediately, the person administering the medicine is responsible for the duration and conditions of storage prior to administration to the patient.

Bortezomib Eugia is intended for single use only. Any unused medicine or waste material should be disposed of in accordance with local regulations.

6. Contents of the pack and other information

What Bortezomib Eugia contains

The active substance is bortezomib. Each vial contains 3.5 mg of bortezomib (as a boronic acid ester with mannitol).
The other ingredient is: mannitol.

Intravenous injection solution:
After reconstitution, 1 ml of intravenous injection solution contains 1 mg of bortezomib.
Subcutaneous injection solution:
After reconstitution, 1 ml of subcutaneous injection solution contains 2.5 mg of bortezomib.
What Bortezomib Eugia looks like and contents of the pack
Bortezomib Eugia is a white or almost white lyophilised powder or caked powder.
Each cardboard pack of Bortezomib Eugia 3.5 mg powder for solution for injection contains a 10 ml vial made of colourless type I glass with a grey bromobutyl rubber stopper, aluminium seal and polypropylene cap.
Pack sizes: 1, 3, 5, 10 vials with or without protective plastic overwrap.
Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Eugia Pharma (Malta) Ltd.
Vault 14, level 2
Valletta Waterfront
Floriana, FRN1914
Malta
e-mail: [email protected]
Manufacturer/Importer:
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Generiques
26 Avenue Tony Garnier
69007 Lyon
France
This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Belgium Bortezomib Eugia 3.5 mg powder for solution for injection / poudre pour solution injectable / Pulver zur Herstellung einer Injektionslösung
France Bortezomib Arrow 3.5 mg poudre pour solution injectable
Germany Bortezomib PUREN 3.5 mg Pulver zur Herstellung einer Injektionslösung
Italy Bortezomib Aurobindo
Netherlands Bortezomib Eugia 3.5 mg, powder for solution for injection
Poland Bortezomib Eugia
Portugal Bortezomib Generis
Spain Bortezomib Aurovitas 3.5 mg powder for injectable solution EFG

Information intended exclusively for healthcare professionals:
1. PREPARATION OF INTRAVENOUS INJECTION SOLUTION
Warning: Bortezomib Eugia is a cytotoxic medicinal product. Care must be taken when handling Bortezomib Eugia and preparing it for use. To avoid contact with the skin, the use of gloves and other protective clothing is recommended.
WHEN HANDLING BORTEZOMIB EUGIA, STRICT ADHERENCE TO ASEPTIC TECHNIQUE IS REQUIRED SINCE THE PRODUCT DOES NOT CONTAIN PRESERVATIVES.
1.1. Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile sodium chloride 9 mg/ml (0.9%) for injection solution to the vial containing Bortezomib Eugia powder, using an appropriate syringe, without removing the vial stopper. The lyophilised powder dissolves in less than 2 minutes.
The concentration of the prepared solution will be 1 mg/ml. The prepared solution will be clear and colourless, with a final pH between 4 and 7. There is no need to check the pH of the solution.
1.2. Visually inspect the solution before administration to ensure it contains no precipitate and is not discoloured. If any discoloration or precipitate is observed, the solution must be discarded. Ensure the correct dose is administered intravenously (1 mg/ml).
1.3. The prepared solution is preservative-free and should be used immediately after preparation. However, chemical and physical stability has been demonstrated for up to 7 days if the solution is stored at 25°C in the original vial and/or syringe. The total storage time of the solution in the syringe prior to administration must not exceed 7 days. If the prepared solution is not used immediately, the person administering the medicinal product is responsible for the storage time and conditions until administration to the patient.
There is no need to protect the prepared solution from light.
2. ADMINISTRATION

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

Bortezomib Eugia 3.5 mg powder for solution for injection MUST BE ADMINISTERED
INTRAVENOUSLY OR SUBCUTANEOUSLY. DO NOT ADMINISTER BY OTHER ROUTES. INTRATHECAL ADMINISTRATION HAS RESULTED IN DEATH.
3. DISPOSAL
The vial is intended 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.

Information intended exclusively for healthcare professionals:
Only the 3.5 mg vial may be administered subcutaneously, as described below.
1. PREPARATION OF SUBCUTANEOUS INJECTION SOLUTION
Warning: Bortezomib Eugia is a cytotoxic medicinal product. Care must be taken when handling Bortezomib Eugia and preparing it for use. To avoid contact with the skin, the use of gloves and other protective clothing is recommended.
WHEN HANDLING BORTEZOMIB EUGIA, STRICT ADHERENCE TO ASEPTIC TECHNIQUE IS REQUIRED SINCE THE PRODUCT DOES NOT CONTAIN PRESERVATIVES.
1.1. Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing Bortezomib Eugia powder, using an appropriate syringe, without removing the vial stopper. The lyophilised powder dissolves in less than 2 minutes.
The concentration of the prepared solution will be 2.5 mg/ml. The prepared solution will be clear and colourless, with a final pH between 4 and 7. There is no need to check the pH of the solution.
1.2. Visually inspect the solution before administration to ensure it contains no precipitate and is not discoloured. If any discoloration or precipitate is observed, the solution must be discarded. Ensure the correct dose is administered subcutaneously (2.5 mg/ml).
1.3. The prepared solution is preservative-free and should be used immediately after preparation. However, chemical and physical stability has been demonstrated for up to 7 days if the solution is stored at 25°C in the original vial and/or syringe. The total storage time of the solution in the syringe prior to administration must not exceed 7 days. If the prepared solution is not used immediately, the person administering the medicinal product is responsible for the storage time and conditions until administration to the patient.
There is no need to protect the prepared solution from light.
2. ADMINISTRATION

After reconstitution, withdraw the appropriate volume of the prepared solution according to the dose calculated based on the patient's body surface area.
Before administration, confirm the dose and concentration of the prepared solution in the syringe (check whether the syringe is intended for subcutaneous administration).
Inject the solution subcutaneously at a 45-90° angle.
The prepared solution is administered subcutaneously in the thigh (right or left) or abdomen (right or left side).
Injection sites should be rotated with each administration.
In case of local reactions after subcutaneous administration of Bortezomib Eugia, it is recommended to administer a less concentrated solution of Bortezomib Eugia subcutaneously (1 mg/ml instead of 2.5 mg/ml) or switch to intravenous administration.

Bortezomib eugia