Инструкция по применению POMALIDOMIDE AUROBINDO
Содержание инструкции
Pomalidomide Aurobindo 1 mg hard capsules, 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules
Generic medicine
Pomalidomide Aurobindo is expected to cause birth defects and may cause
fetal death.
- Do not take this medicine if you are pregnant or might become pregnant.
- Follow the advice on contraception methods described in this leaflet.
Read this leaflet carefully before you start to take this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What Pomalidomide Aurobindo is and what it is used for
- 2. What you need to know before you take Pomalidomide Aurobindo
- 3. How to take Pomalidomide Aurobindo
- 4. Possible side effects
- 5. How to store Pomalidomide Aurobindo
- 6. Contents of the pack and other information
1. What is Pomalidomide Aurobindo and what it is used for
Pomalidomide Aurobindo contains the active substance “pomalidomide”. This medicine is related
to thalidomide and belongs to a group of medicines that act on the immune system (the body’s natural
defenses).
What is Pomalidomide Aurobindo used for
Pomalidomide Aurobindo is used in the treatment of adults with a type of cancer called
“multiple myeloma”.
Pomalidomide Aurobindo is used together with:
- two other medicines, called “bortezomib” (a type of chemotherapeutic medicine) and “dexamethasone” (an anti-inflammatory medicine), in patients who have received at least one other therapy including lenalidomide; or
- one other medicine, called “dexamethasone”, in patients in whom the myeloma has worsened despite at least two other therapies including lenalidomide and bortezomib.
What is multiple myeloma
Multiple myeloma is a type of cancer that affects a certain type of white blood cells (called
“plasma cells”). These cells grow uncontrollably and accumulate in the bone marrow.
This causes damage to the bones and kidneys.
Multiple myeloma is generally incurable. However, treatment can reduce the signs and symptoms of the
disease or make them disappear for a certain period of time. When this happens, it is referred to as “response”.
How does Pomalidomide Aurobindo work
Pomalidomide Aurobindo works in several ways:
- stopping the development of myeloma cells;
- stimulating the immune system to attack cancer cells;
- stopping the formation of blood vessels that feed cancer cells.
The benefit of using Pomalidomide Aurobindo together with bortezomib and dexamethasone
When Pomalidomide Aurobindo is used together with bortezomib and dexamethasone, in patients who have received
at least one other therapy, it can prevent multiple myeloma from getting worse:
- On average, Pomalidomide Aurobindo, used with bortezomib and dexamethasone, prevented the return of multiple myeloma for a period of up to 11 months, compared to 7 months for patients treated with bortezomib and dexamethasone alone.
The benefit of using Pomalidomide Aurobindo together with dexamethasone
When Pomalidomide Aurobindo is used together with dexamethasone, in patients who have received at least
two other therapies, it can prevent multiple myeloma from getting worse:
- On average, Pomalidomide Aurobindo, used with dexamethasone, prevented the return of multiple myeloma for a period of up to 4 months, compared to 2 months for patients treated with dexamethasone alone.
2. What you need to know before taking Pomalidomide Aurobindo
Do not take Pomalidomide Aurobindo
- If you are pregnant or if you think you may be pregnant, or if you are planning a pregnancy, because Pomalidomide Aurobindo is expected to harm the fetus(men and women taking this medicine must read the “Pregnancy, contraception and breastfeeding – information for women and men” section below).
- If there is a possibility that you might become pregnant unless you follow all the necessary measures to avoid pregnancy (see “Pregnancy, contraception and breastfeeding – information for women and men”). If there is a possibility that you might become pregnant, on each prescription your doctor will record that the necessary measures have been taken and will provide you with this confirmation.
- If you are allergic to pomalidomide or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.
If you are not sure whether any of the above conditions apply to you, consult your doctor, your
pharmacist or your nurse before taking Pomalidomide Aurobindo.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Pomalidomide Aurobindo if:
- you have had episodes of blood clots in the past. During treatment with Pomalidomide Aurobindo there is a higher risk of blood clots forming in veins (thrombosis) and arteries. Your doctor may recommend additional treatments (e.g. warfarin) or reduce the dose of Pomalidomide Aurobindo to reduce the likelihood of blood clots forming;
- you have had an allergic reaction in the past, such as rash, itching, swelling, dizziness or difficulty breathing, during treatment with related medicines called “thalidomide” or “lenalidomide”;
- you have had a heart attack, have heart failure, have difficulty breathing, or if you smoke, have high blood pressure or high cholesterol levels;
- you have a high tumor burden throughout the body, including in the bone marrow. This could lead to a condition in which tumors break down and cause unusual levels of chemicals in the blood, which can lead to kidney failure. An irregular heartbeat may also appear. This condition is called tumor lysis syndrome;
- you have or have had neuropathy (nerve damage that causes tingling or pain in the hands or feet).
- you have or have had hepatitis B infection in the past. Treatment with Pomalidomide Aurobindo may cause reactivation of the hepatitis B virus in patients carrying this virus, leading to a recurrence of the infection. Your doctor should check if you have ever had a hepatitis B infection.
- you have or have had any combination of the following symptoms: rash on the face or more widespread, skin redness, high fever, flu-like symptoms, swollen lymph nodes (these are signs of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS), or drug hypersensitivity syndrome, toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome (SJS), see also section 4 “Possible side effects”).
It is important to note that patients with multiple myeloma treated with pomalidomide may develop
other types of cancer; therefore, the doctor must carefully assess the benefit and risk when
prescribing this medicine.
At any time during or after treatment, immediately inform your doctor or nurse
if you experience blurred vision, loss of vision or double vision, difficulty speaking, weakness in an
arm or leg, changes in the way you walk or problems with balance, persistent numbness, reduced
sensation or loss of sensation, memory loss or confusion. These may
be symptoms of a serious brain disease that can be fatal, known as
progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment
with Pomalidomide Aurobindo, inform your doctor of any changes in these symptoms.
At the end of treatment, you must return all unused capsules to the pharmacist.
Pregnancy, contraception and breastfeeding – information for women and men
The following instructions must be followed, as indicated in the Pomalidomide Aurobindo Pregnancy
Prevention Program.
Women and men taking Pomalidomide Aurobindo must not start a pregnancy or
conceive a child, because pomalidomide is expected to harm the fetus. You and your partner must use effective contraceptive measures during treatment with this medicine.
Women
Do not take Pomalidomide Aurobindo if you are currently pregnant, if you suspect or are planning a
pregnancy, because this medicine is expected to harm the fetus. Before starting
treatment, you must inform your doctor if there is a possibility of becoming pregnant, even
if you think it is unlikely.
If there is a possibility of becoming pregnant:
- You must use effective contraceptive methods for at least 4 weeks before starting treatment, throughout the duration of treatment and for at least 4 weeks after stopping treatment. Consult your doctor about the best contraceptive method for you.
- On each prescription, your doctor will ensure that you understand the measures you need to take to prevent a pregnancy.
- Your doctor will arrange pregnancy tests before treatment, at least every 4 weeks during treatment and at least 4 weeks after the end of treatment.
If you become pregnant despite preventive measures:
- You must stop treatment immediately and consult your doctor immediately.
Breastfeeding
It is not known whether Pomalidomide Aurobindo passes into breast milk. Inform your doctor if you are breastfeeding or
intend to breastfeed. Your doctor will advise you whether to stop or continue breastfeeding.
Men
Pomalidomide Aurobindo passes into human seminal fluid.
- If your partner is pregnant or there is a possibility that she might become pregnant, you must use condoms throughout the duration of treatment and for 7 days after the end of treatment.
- If your partner becomes pregnant during treatment with Pomalidomide Aurobindo, inform your doctor immediately. Your partner should also inform her doctor immediately.
You must not donate seminal fluid or sperm during treatment and for 7 days after the end of
treatment.
Blood donation and blood tests
You must not donate blood during treatment and for 7 days after the end of treatment.
Before and during treatment with Pomalidomide Aurobindo, you will undergo regular blood tests, as this medicine can cause a reduction in blood cells that fight
infections (white blood cells) and cells that stop bleeding (platelets).
Your doctor will ask you to have blood tests:
- before treatment;
- every week for the first 8 weeks of treatment;
- at least once a month thereafter, for the entire duration of treatment with Pomalidomide Aurobindo.
Based on the results of these tests, your doctor may adjust the dose of Pomalidomide Aurobindo
or stop treatment. Your doctor may also adjust or stop treatment
based on your overall health status.
Children and adolescents
The use of Pomalidomide Aurobindo is not recommended in children and adolescents under
18 years of age.
Other medicines and Pomalidomide Aurobindo
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines. This is because Pomalidomide Aurobindo can affect the action
of other medicines and other medicines can affect the action of Pomalidomide Aurobindo.
In particular, tell your doctor, pharmacist or nurse before taking Pomalidomide
Aurobindo if you are taking any of the following medicines:
- some antifungal medicines, such as ketoconazole;
- some antibiotics (e.g. ciprofloxacin, enoxacin);
- some antidepressants, such as fluvoxamine.
Driving and operating machinery
Some people may experience fatigue, dizziness, feeling faint, confusion or reduced
alertness when taking Pomalidomide Aurobindo. If this happens, do not drive vehicles and do not use
tools or machinery.
Pomalidomide Aurobindo contains sodium, maltitol and isomaltitol
Sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.
Maltitol and isomaltitol:
If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking
this medicine.
3. How to take Pomalidomide Aurobindo
Pomalidomide Aurobindo must be administered by a doctor experienced in the treatment of
multiple myeloma.
Take the medicine following your doctor’s instructions exactly. If you have any doubts, ask your
doctor, pharmacist or nurse.
When to take Pomalidomide Aurobindo with other medicines
Pomalidomide Aurobindo with bortezomib and dexamethasone
use and their effects.
- Pomalidomide Aurobindo, bortezomib and dexamethasone are taken in “treatment cycles”. Each cycle lasts 21 days (3 weeks).
- Consult the following table to find out what to take each day of the 3-week cycle: o Every day check the chart and find the correct day to know which medicines to take. o Some days you will take all 3 medicines, some days only 2 or 1 medicine and other days no medicine.
POM: Pomalidomide Aurobindo; BOR: Bortezomib; DEX: Dexamethasone
Cycle 1 to 8Cycle 9 onwards
- After completing each 3-week cycle, start a new one.
Pomalidomide Aurobindo with dexamethasone alone
its effects.
- Pomalidomide Aurobindo and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
| Medicine name | |||
| Day | POM | BOR | DEX |
| 1 | ✓ | ✓ | ✓ |
| 2 | ✓ | ✓ | |
| 3 | ✓ | ||
| 4 | ✓ | ✓ | ✓ |
| 5 | ✓ | ✓ | |
| 6 | ✓ | ||
| 7 | ✓ | ||
| 8 | ✓ | ✓ | ✓ |
| 9 | ✓ | ✓ | |
| 10 | ✓ | ||
| 11 | ✓ | ✓ | ✓ |
| 12 | ✓ | ✓ | |
| 13 | ✓ | ||
| 14 | ✓ | ||
| 15 | |||
| 16 | |||
| 17 | |||
| 18 | |||
| 19 | |||
| 20 | |||
| 21 | |||
| Medicine name | |||
| Day | POM | BOR | DEX |
| 1 | ✓ | ✓ | ✓ |
| 2 | ✓ | ✓ | |
| 3 | ✓ | ||
| 4 | ✓ | ||
| 5 | ✓ | ||
| 6 | ✓ | ||
| 7 | ✓ | ||
| 8 | ✓ | ✓ | ✓ |
| 9 | ✓ | ✓ | |
| 10 | ✓ | ||
| 11 | ✓ | ||
| 12 | ✓ | ||
| 13 | ✓ | ||
| 14 | ✓ | ||
| 15 | |||
| 16 | |||
| 17 | |||
| 18 | |||
| 19 | |||
| 20 | |||
| 21 | |||
- Consult the following table to find out what to take each day of the 4-week cycle: o Every day check the chart and find the correct day to know which medicines to take. o Some days you will take both medicines, some days only 1 medicine and other days no medicine.
POM: Pomalidomide Aurobindo; DEX: Dexamethasone
- After completing each 4-week cycle, start a new one.
Pomalidomide Aurobindo dose to be taken with other medicines
Pomalidomide Aurobindo with bortezomib and dexamethasone
- The recommended starting dose of Pomalidomide Aurobindo is 4 mg once a day.
- The recommended starting dose of bortezomib will be established by your doctor based on your height and weight (1.3 mg/m of body surface area).
- The recommended starting dose of dexamethasone is 20 mg per day. However, if you are over 75 years of age, the recommended starting dose is 10 mg per day.
Pomalidomide Aurobindo with dexamethasone alone
- The recommended starting dose of Pomalidomide Aurobindo is 4 mg once a day.
- The recommended starting dose of dexamethasone is 40 mg per day. However, if you are over 75 years of age, the recommended starting dose is 20 mg per day.
| Medicine name | ||
| Day | POM | DEX |
| 1 | ✓ | ✓ |
| 2 | ✓ | |
| 3 | ✓ | |
| 4 | ✓ | |
| 5 | ✓ | |
| 6 | ✓ | |
| 7 | ✓ | |
| 8 | ✓ | ✓ |
| 9 | ✓ | |
| 10 | ✓ | |
| 11 | ✓ | |
| 12 | ✓ | |
| 13 | ✓ | |
| 14 | ✓ | |
| 15 | ✓ | ✓ |
| 16 | ✓ | |
| 17 | ✓ | |
| 18 | ✓ | |
| 19 | ✓ | |
| 20 | ✓ | |
| 21 | ✓ | |
| 22 | ✓ | |
| 23 | ||
| 24 | ||
| 25 | ||
| 26 | ||
| 27 | ||
| 28 | ||
Your doctor may need to reduce the dose of Pomalidomide Aurobindo, bortezomib or dexamethasone or
stop one or more of these medicines based on the results of blood tests, your
general condition, other medicines you may be taking (e.g. ciprofloxacin, enoxacin and
fluvoxamine) and if side effects occur (especially rash or swelling) due to
treatment.
If you have liver or kidney problems, your doctor will monitor your condition very
carefully during treatment with this medicine.
How to take Pomalidomide Aurobindo
- Do not break, open or chew the capsules. If the powder from a broken capsule comes into contact with the skin, wash the skin immediately and thoroughly with water and soap.
- Healthcare professionals, those providing assistance to the patient and family members must wear disposable gloves when handling the blister or capsule. The gloves should then be removed carefully to avoid skin exposure, placed in a sealable polyethylene bag and disposed of in accordance with local regulations. Then wash your hands thoroughly with water and soap. Women who are pregnant or suspected of being pregnant should not handle the blister or capsule.
- Swallow the tablets whole, preferably with water.
- The capsules can be taken with or without food.
- Take the capsules every day at about the same time.
To remove the capsule from the blister, press on one side of the capsule only, pushing it through the
aluminum foil. Do not press on the center of the capsule, otherwise you risk breaking it.

Your doctor will inform you how and when to take Pomalidomide Aurobindo if you have kidney
problems and are undergoing dialysis.
Duration of treatment with Pomalidomide Aurobindo
You should continue the treatment cycles until your doctor tells you to stop the treatment
If you take more Pomalidomide Aurobindo than you should
If you take more Pomalidomide Aurobindo than you should, consult your doctor or go to hospital
immediately. Bring the medicine packaging with you.
If you forget to take Pomalidomide Aurobindo
If you forget to take Pomalidomide Aurobindo on the prescribed day, take the next capsule
as usual the next day. Do not increase the number of capsules to be taken to compensate for
forgetting Pomalidomide Aurobindo the previous day.
If you have any doubts about using this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop taking Pomalidomide Aurobindo and contact your doctor immediately if you experience
any of the following serious side effects – urgent medical treatment may be needed:
- Fever, chills, sore throat, cough, mouth sores, or any other sign of infection (due to a lower number of white blood cells, which fight infections).
- Bleeding or bruising easily, including nosebleeds and bleeding from the intestines or stomach (due to effects on blood cells called “platelets”).
- Fast breathing, fast heartbeat, fever and chills, decreased or absent urination, nausea and vomiting, confusion, loss of consciousness (due to a blood infection called sepsis or septic shock).
- Severe, persistent, or bloody diarrhea (possibly with stomach pain or fever) caused by bacteria called Clostridium difficile.
- Chest pain or pain and swelling in the legs, especially the lower leg or calf (caused by blood clots).
- Shortness of breath (due to severe chest infection, lung inflammation, heart failure or blood clot).
- Swelling of the face, lips, tongue and throat, which can cause difficulty breathing (due to severe types of allergic reactions called angioedema and anaphylactic reaction).
- Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause changes in the appearance or growths on the skin. If you notice any skin changes during treatment with Pomalidomide Aurobindo, tell your doctor as soon as possible.
- Reactivation of hepatitis B infection, which can cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever, and nausea or vomiting. Tell your doctor immediately if you notice any of these symptoms.
- Widespread rash, high temperature, swollen lymph nodes, and involvement of other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome, toxic epidermal necrolysis or Stevens-Johnson syndrome). Stop taking pomalidomide if these symptoms occur and seek medical attention or healthcare immediately. See also paragraph
- 2.
Stop taking Pomalidomide Aurobindo and contact your doctor immediatelyif you experience
any of the serious side effects listed above: urgent medical treatment may be needed.
Other side effects
Very common(may affect more than 1 in 10 people):
- Shortness of breath (dyspnea).
- Lung infections (pneumonia and bronchitis).
- Infections of the nose, sinuses, and throat caused by bacteria or viruses.
- Flu-like symptoms (influenza).
- Low number of red blood cells, which can cause anemia with resulting fatigue and weakness.
- Low levels of potassium in the blood (hypokalaemia), which can cause weakness, muscle cramps, muscle pain, palpitations, tingling or numbness, shortness of breath, mood changes.
- High levels of sugar in the blood.
- Fast and irregular heartbeat (atrial fibrillation).
- Decreased appetite.
- Constipation, diarrhea, or nausea.
- Vomiting.
- Abdominal pain.
- Lack of energy.
- Difficulty falling asleep or staying asleep.
- Dizziness, tremor.
- Muscle spasm, muscle weakness.
- Bone pain, back pain.
- Numbness, tingling, or burning sensation on the skin, pain in the hands or feet (peripheral sensory neuropathy).
- Swelling of the body, including swelling of the arms and legs.
- Skin rashes.
- Urinary tract infection, which can cause a burning sensation when urinating or the need to urinate more often.
Common(may affect up to 1 in 10 people):
- Falls.
- Bleeding inside the skull.
- Reduced ability to move or feel sensations in the hands, arms, feet, and legs due to damage to the nervous system (peripheral sensorimotor neuropathy).
- Numbness, itching, and pins and needles sensation on the skin (paresthesia).
- Feeling dizzy, with difficulty getting up and moving normally.
- Swelling caused by fluid.
- Hives.
- Itchy skin.
- Shingles (herpes zoster).
- Heart attack (chest pain that radiates to the arms, neck, jaw, sweating, shortness of breath, nausea or vomiting).
- Chest pain, chest infection.
- Increased blood pressure.
- Simultaneous reduction in the number of red blood cells, white blood cells, and platelets (pancytopenia) which makes you more prone to bleeding and bruising. You may feel tired, weak and short of breath and are also more likely to develop infections.
- Reduced number of lymphocytes (a type of white blood cells) often caused by infection (lymphopenia).
- Low levels of magnesium in the blood (hypomagnesemia), which can cause fatigue, generalized weakness, muscle cramps, irritability and can cause a lowering of calcium levels in the blood (hypocalcemia), with possible numbness and/or tingling of the hands, feet or lips, muscle cramps, muscle weakness, dizziness, confusion.
- Low levels of phosphate in the blood (hypophosphatemia), which can cause muscle weakness and irritability or confusion.
- High levels of calcium in the blood (hypercalcemia), which can cause slowed reflexes and skeletal muscle weakness.
- High levels of potassium in the blood, which can cause an abnormal heart rhythm.
- Low levels of sodium in the blood, which can cause fatigue and confusion, muscle spasms, seizures or coma.
- High levels of uric acid in the blood, which can cause a form of arthritis called gout.
- Low blood pressure, which can cause dizziness or fainting.
- Painful or dry mouth.
- Altered sense of taste.
- Bloated abdomen.
- Feeling confused.
- Feeling down (depressed mood)
- Loss of consciousness, fainting.
- Blurred vision (cataract).
- Kidney damage.
- Inability to urinate.
- Abnormalities in liver function tests.
- Pelvic pain.
- Weight loss.
- Increased alanine aminotransferase.
Uncommon(may affect up to 1 in 100 people):
- Stroke.
- Inflammation of the liver (hepatitis), which can cause itching, yellowing of the skin and the whites of the eyes (jaundice), pale stools, dark urine, and abdominal pain.
- Breakdown of cancer cells, which causes the release of toxic substances into the bloodstream (tumor lysis syndrome). This can cause kidney problems.
- Thyroid gland not working enough, which can cause symptoms such as fatigue, sluggishness, muscle weakness, slow heartbeat, and weight gain.
- Basal cell carcinoma.
Not known(frequency cannot be estimated from available data):
- Rejection of solid organ transplant (such as heart or liver).
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Pomalidomide Aurobindo
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP.”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use Pomalidomide Aurobindo if you notice damage or signs of tampering with the packaging
of the medicine.
Do not dispose of any medicine in wastewater or household waste. Unused medicine
should be returned to the pharmacist at the end of treatment. This will help protect the environment.
6. Package contents and other information
What Pomalidomide Aurobindo contains
- The active ingredient is pomalidomide. Each hard capsule contains 1 mg of pomalidomide. Each hard capsule contains 2 mg of pomalidomide. Each hard capsule contains 3 mg of pomalidomide. Each hard capsule contains 4 mg of pomalidomide.
The other ingredients are: Maltitol, isomaltitol, crospovidone and sodium stearylfumarate.
Capsule cap: Indigo carmine (E 132) (for 1 mg, 2 mg, 3 mg), titanium dioxide
(E171), gelatin, red iron oxide (E172) (for 4 mg).
Capsule body: Titanium dioxide (E171), gelatin, indigo carmine (E 132) (For 3 mg),
red iron oxide (E172) (For 2 mg and 4 mg), yellow iron oxide (E172) (For 1 mg, 2 mg and
3 mg).
Printing ink (black and white): Shellac, black iron oxide (For 4 mg), potassium
hydroxide, titanium dioxide (E171) (For 1 mg, 2 mg and 3 mg).
Description of the appearance of Pomalidomide Aurobindo and package contents
Pomalidomide Aurobindo 1 mg hard capsules
Yellow-colored powder contained in a gelatin hard capsule, size 3, with a dark blue
opaque cap and an opaque yellow body, with “P1” imprinted in white ink on the cap and smooth body.
Pomalidomide Aurobindo 2 mg hard capsules
Yellow-colored powder contained in a gelatin hard capsule, size 1, with a dark blue
opaque cap and an opaque orange body, with “P2” imprinted in white ink on the cap and smooth body.
Pomalidomide Aurobindo 3 mg hard capsules
Yellow-colored powder contained in a gelatin hard capsule, size 1, with a dark blue
opaque cap and an opaque green body, with “P3” imprinted in white ink on the cap and smooth body.
Pomalidomide Aurobindo 4 mg hard capsules
Yellow-colored powder contained in a gelatin hard capsule, size 0, with a red
opaque cap and a red opaque body, with “P4” imprinted in black ink on the cap and smooth body.
Pomalidomide Aurobindo hard capsules are available in blister packs of 14 and 21 capsules
hard.
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
Marketing authorization holder
Eugia Pharma (Malta) Ltd
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914
Malta
Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmacêutica SA
Rua João de Deus, 19,
2700-487 Amadora
Portugal
Arrow Generiques
26 Avenue Tony Garnier
69007 Lyon
France
This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Belgium: Pomalidomide Eugia 1mg, 2mg, 3mg, 4mg harde capsules / gélules / Hartkapseln
Luxembourg: Pomalidomide Eugia 1mg, 2mg, 3mg, 4mg gélules / Hartkapseln
France: Pomalidomide Eugia 1 mg, gélule
Pomalidomide Eugia 2 mg, gélule
Pomalidomide Eugia 3 mg, gélule
Pomalidomide Eugia 4 mg, gélule
Germany: Pomalidomid Puren 1mg, 2mg, 3mg, 4mg, Hartkapseln
Italy: Pomalidomide Aurobindo
Netherlands: Pomalidomide Eugia 1 mg, harde capsules
Pomalidomide Eugia 2 mg, harde capsules
Pomalidomide Eugia 3 mg, harde capsules
Pomalidomide Eugia 4 mg, harde capsules
Poland: Pomalidomide Eugia.
Portugal: Pomalidomida Eugia
Spain: Pomalidomida Eugia 3 mg cápsulas duras EFG
Pomalidomida Eugia 4 mg cápsulas duras EFG
- Страна регистрации
- Форма выпускаHard capsule, 1 MG
- Код АТХL04AX06
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги POMALIDOMIDE AUROBINDOФорма выпуска: Hard capsule, 1 MGДействующее вещество: ПомалидомидПроизводитель: BRISTOL-MYERS SQUIBB PHARMA EEIGОтпускается по рецептуФорма выпуска: Hard capsule, 1 mgДействующее вещество: ПомалидомидПроизводитель: ACCORD HEALTHCARE, S.L.U.Отпускается по рецептуФорма выпуска: Hard capsule, 1 MGДействующее вещество: ПомалидомидПроизводитель: EVER PHARMA ITALIA S.R.L.Отпускается по рецепту
Аналоги POMALIDOMIDE AUROBINDO в других странах
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Аналог POMALIDOMIDE AUROBINDO в Польша
Аналог POMALIDOMIDE AUROBINDO в Украина
Врачи онлайн по POMALIDOMIDE AUROBINDO
Обсудите применение POMALIDOMIDE AUROBINDO и возможные следующие шаги — по оценке врача.
Получите рецепт на POMALIDOMIDE AUROBINDO онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
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Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
POMALIDOMIDE AUROBINDO требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество POMALIDOMIDE AUROBINDO — Помалидомид. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
POMALIDOMIDE AUROBINDO производится компанией Eugia Pharma (Malta) Limited. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения POMALIDOMIDE AUROBINDO с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить POMALIDOMIDE AUROBINDO в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (Помалидомид) включают IMNOVID, POMALIDOMIDE AKKORD, POMALIDOMIDE EVER PARMA. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.








