EPIRUBICINA IKMA 2 MG/ML Инъекционный раствор

Содержание инструкции

1. Epirubicina Hikma 2 mg/ml Intravesical Solution/ Injectable Solution
   1. What is Epirubicina Hikma and what is it used for
   2. What you need to know before using Epirubicin Hikma
   3. How to use Epirubicina Hikma
   4. Possible side effects
   5. How to store Epirubicina Hikma
   6. Content of the pack and other information

Epirubicina Hikma 2 mg/ml Intravesical Solution/ Injectable Solution

Epirubicin hydrochloride

Generic medicine

Read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. 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 Epirubicina Hikma is and what it is used for
• 2. What you need to know before you use Epirubicina Hikma
• 3. How to use Epirubicina Hikma
• 4. Possible side effects
• 5. How to store Epirubicina Hikma
• 6. Contents of the pack and other information

1. What is Epirubicina Hikma and what is it used for

• Epirubicina Hikma is an injectable that contains epirubicin hydrochloride. It belongs to a group of medicines called cytotoxic agents used for chemotherapy. Epirubicina Hikma causes cells that are growing actively, such as cancer cells, to slow down or stop their growth and increases the possibility that they will die. This medicine helps to selectively kill cancerous tissue compared to normal healthy tissue.
• Epirubicina Hikma is used to treat a variety of tumors, either alone or in combination with other drugs. The route through which it is administered depends on the type of cancer being treated.
• It has been found particularly useful in the treatment of breast, ovarian, stomach, intestinal and lung cancer.
• Epirubicina Hikma can be introduced directly into the bladder through a tube. This is sometimes used to treat abnormal cells or tumors of the bladder wall. It can be used after other treatments to try to prevent the regrowth of cells.
• You should talk to a doctor if you do not feel better or if you feel worse.

2. What you need to know before using Epirubicin Hikma

Do not useEpirubicin Hikma:

• if you are allergic to epirubicin or any of the other ingredients of this medicine (listed in section 6) or to similar chemotherapy drugs (anthracyclines or anthracenediones)
• if you have infections affecting multiple organs
• if you have a urinary infection
• if you have bladder inflammation
• if you have invasive tumors that penetrate the bladder
• if you have problems with catheterization (your doctor has difficulty inserting a catheter (tube) into your bladder)
• if there is blood in your urine
• if you have a reduced ability to produce blood cells, which leads to a reduced blood cell count, as it may lower them further
• if you have been previously treated with Epirubicin Hikma or similar chemotherapy drugs, as previous treatment with these medicines may increase the risk of side effects.
• if you have recently had a heart attack, reduced heart muscle function, severe irregular heartbeat, sudden chest pain, non-inflammatory heart muscle disease or other serious heart problems in the past, or are currently receiving treatment for this
• if you have severe liver problems
• if you are pregnant or breastfeeding

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Epirubicin Hikma:

• if your liver or kidneys are not working properly
• if you have received or intend to receive a vaccination.
• if you are currently suffering from episodes of acute toxicity such as: acute inflammation of the mouth or reduced white blood cell count or reduced platelet count or infections in general

This will help your doctor decide if the medicine is suitable for you

Other medicines and Epirubicin Hikma:
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, including those obtained without a prescription,
especially the following:

• Cimetidine (a medicine usually used to treat stomach ulcers and heartburn). Cimetidine may make the effects of Epirubicin Hikma stronger.
• Calcium channel blockers (heart medicines)
• Quinine (anti-malarial drug)
• Antibiotics such as sulfonamide or chloramphenicol
• Antiretrovirals (drugs used to treat HIV infection)
• Diphenylhydantoin (a medicine used to treat epilepsy)
• Pain relievers such as aminopyrine derivatives
• Trastuzumab therapy for cancer treatment. Your doctor should avoid using Epirubicin Hikma until 27 weeks after stopping trastuzumab, when possible. If Epirubicin Hikma is used before this time, careful monitoring of heart function is recommended.
• Live vaccines should be avoided in patients who have received epirubicin
• Paclitaxel or docetaxel (drugs used to treat cancer). When paclitaxel is given before epirubicin, it may increase the concentration of epirubicin in the blood. However, when paclitaxel and docetaxel are given together and administered after epirubicin, they do not affect the concentration of epirubicin.
• Dexverapamil (used to treat certain heart disorders)
• Dexrazoxane (used to prevent chronic cumulative cardiotoxicity caused by epirubicin)
• Interferon α2b (used to treat tumors)

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, suspect you may be pregnant or are planning to become
pregnant, ask your doctor for advice before taking this
medicine. Avoid becoming pregnant while you or your partner are being treated with
this medicine. If you are sexually active, you should use an effective contraceptive method to prevent pregnancy during treatment, whether you are
male or female. It can cause birth defects, so it is important
to inform your doctor if you think you may be pregnant.

Breastfeeding
You must stop breastfeeding before starting treatment with this
medicine, as some of the drug may enter your milk and potentially
harm your child.

Fertility
Men: there is a risk of infertility due to therapy with epirubicin and male patients should consider sperm preservation before
starting treatment.
Women: epirubicin can cause cessation of menstrual cycles or early menopause in
premenopausal women.

Driving and operating machinery
There are no particular precautions, provided you feel completely recovered after
hospital treatment and have discussed this with your doctor.

Epirubicin Hikma contains sodium
Epirubicin Hikma 10 mg/5 ml
This medicine contains less than 1 mmol of sodium (23mg) per vial, which is
essentially “sodium-free”.

Epirubicin Hikma 20 mg/10 ml
This medicine contains 34.48 mg of sodium (the main component of table salt) in each vial, equivalent to 1.72% of the maximum recommended daily intake of sodium for an adult.

Epirubicin Hikma 50 mg/25 ml
This medicine contains 86.19 mg of sodium (the main component of table salt) in each vial, equivalent to 4.31% of the maximum recommended daily intake of sodium for an adult.

Epirubicin Hikma 200 mg/100 ml
This medicine contains 344.73 mg of sodium (the main component of table salt) in each vial, equivalent to 17.24% of the maximum recommended daily intake of sodium with the diet for an adult.

3. How to use Epirubicina Hikma

If Epirubicina Hikma is prescribed to you, it will only be administered by doctors or
nurses experienced in administering chemotherapy.
This medicine will normally be administered to you by a doctor or a nurse
through an intravenous infusion (infusion) into a vein. Your doctor will decide which dose
to administer and the number of days of treatment you will receive depending on your
condition.
The dose is decided taking into account your condition, your height and your
weight. From your height and your weight, the doctor will calculate your body surface area,
and that is how your dose is calculated. Epirubicina Hikma can also be
introduced directly into the bladder to treat bladder cancer or to
prevent its recurrence. The dose depends on the type of bladder cancer you have.
When this medicine is injected directly into the bladder, you will be asked
not to drink liquids for 12 hours before treatment to avoid dilution of the
medicine with urine in the bladder.
Although sometimes a treatment cycle may be sufficient, the doctor will often advise you to have further cycles after three or four weeks. Several cycles may be necessary before your disease is under control and you feel better.

Regular checks by your doctor during treatment with Epirubicina Hikma
During treatment, your doctor will perform regular checks on your:

• Blood- to check for a reduced blood cell count, which may require treatment
• Heart function- heart damage can occur when high doses of Epirubicina Hikma are administered. This may not be detected for several weeks, so regular tests may be required during this period
• Liver- using blood tests to check that this medicine does not adversely affect how it works
• Uric acid levels in the blood- Epirubicina Hikma can increase uric acid levels in the blood, which could cause gout. If uric acid levels are too high, another medicine may be given.

If you receive high doses of Epirubicina Hikma
High doses can worsen side effects such as mouth sores or can
decrease the number of white blood cells (which fight infections) and platelets
(these help the blood to clot) in the blood. If this happens,
antibiotics or blood transfusions may be necessary. Mouth ulcers
can be treated to make them less bothersome while they heal.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

• Infections
• Eye inflammation with red and watery eyes
• Reduced red blood cell count (anemia) which may make you feel tired and lethargic
• The white blood cell count (which fight infections) may decrease, increasing the possibility of infections and fever (leukopenia)
• A decrease in platelets (platelets in the blood that help blood to clot) may occur, which could cause bruising or bleeding more easily when injured
• Reduction in the number of certain types of white blood cells - granulocytes and neutrophils (granulocytopenia and neutropenia)
• A reduction of some types of white blood cells accompanied by fever (febrile neutropenia)
• Inflammation of the clear part of the eye, called the cornea
• Hot flashes
• Inflammation of a vein
• Nausea
• Vomiting
• Inflammation of the mucous lining of the mouth
• Diarrhea
• Hair loss
• Skin lesion
• Urine that is red in color 1 to 2 days after the administration of epirubicin
• Absence of menstruation
• Inflammation and painful ulceration of the mucous membranes lining the digestive tract
• General feeling of discomfort
• Fever
• Changes in the levels of certain liver enzymes
• After the direct administration of epirubicin into the bladder, inflammation (cystitis) may occur.

Common: (may affect up to 1 in 10 people)

• Reduced appetite/ loss of appetite
• Loss of water or body fluids
• Serious heart rhythm disturbance (ventricular arrhythmia)
• Disorders in the conduction of the cardiac impulse
• Some forms of heart rhythm disturbances (AV block, bundle branch block)
• Slow heartbeat (bradycardia)
• Insufficient pumping of blood by the heart which can cause shortness of breath, fluid accumulation and abnormal heart rhythm.
• Bleeding
• Skin redness
• Pain behind the sternum, indigestion and difficulty swallowing due to inflammation of the esophagus
• Pain or burning in the gastrointestinal tract
• Inflammation of the mucous membrane of the gastrointestinal tract
• Ulcers in the gastrointestinal tract
• Skin rash, itching
• Abnormal discoloration of the nails
• Skin changes
• Abnormal skin discoloration
• Frequent urination
• Redness at the infusion site
• Chills
• Local reactions such as a burning sensation
• Reduced heart function

Uncommon: (may affect up to 1 in 100 people)

• High fever, chills, general malaise, possible cold arms or legs due to blood poisoning
• Lung infection (pneumonia)
• Some types of blood cancer (acute lymphocytic leukemia, acute myeloid leukemia)
• Blockage of a blood vessel
• Swelling and pain in the legs or arms due to inflammation of a blood vessel, which may include blood clotting
• Blood clots in the lungs causing chest pain and shortness of breath
• Bleeding of the gastrointestinal tract
• Hives
• Skin redness
• Feeling of weakness

Please contact your doctor or nurse immediately if you notice the
following side effects. Although they are rare, these symptoms can be serious:

Rare: (may affect up to 1 in 1000)

• Sudden, potentially life-threatening allergic reaction. Symptoms include sudden signs of allergy such as skin rashes, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing
• Increased level of uric acid in the blood.
• Heart damage (cardiotoxicity)
• Absence of sperm in semen
• Mild dizziness

Not known: (frequency cannot be estimated based on available data)

• Potentially life-threatening condition that occurs when blood pressure is too low due to blood poisoning (septic shock)
• Potentially life-threatening condition in which blood pressure is too low
• Insufficient oxygen supply to the tissue due to inhibition of blood cell production in the bone marrow
• Appearance of dark spots inside the mouth
• Abdominal discomfort
• Skin redness or other sunburn-like reactions if exposed to sunlight or ultraviolet rays
• Changes in the skin where you have previously received radiation treatments

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report
side effects directly through the national reporting system
at:
http://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 Epirubicina Hikma

Store and transport in a refrigerator (between 2°C and 8°C).
Store in the original package, protected from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box
after EXP. The expiry date refers to the last day of that month.
Chemical and physical stability has been demonstrated, after dilution in sodium chloride
0.9% or glucose 5% solution, for 72 hours if stored in a refrigerator.
From a microbiological point of view, the product must be used
immediately. If not used immediately, the storage times and
conditions prior to use are the responsibility of the user and should normally not
exceed 24 hours at a temperature between 2 and 8ºC, unless the
dilution has been carried out under controlled and validated aseptic conditions.
Do not dispose of medicines via wastewater. Ask your pharmacist how
to dispose of medicines you no longer use. These measures will help protect
the environment.

6. Content of the pack and other information

Medicinal product subject to restrictive medical prescription, to be used exclusively
in a hospital environment.

What Epirubicina Hikma contains

• The active ingredient is epirubicin hydrochloride
• The other components are sodium lactate (50% of the solution), hydrochloric acid (1N), to adjust the pH; sodium chloride and water for injections.

Epirubicina Hikma is an intravesical/injectable solution.

Description of the appearance of Epirubicina Hikma and contents of the pack
Red-colored injection solution contained in a transparent glass vial
(Type I glass) with a chlorobutyl rubber stopper and an aluminum cap.
10 mg/5 ml: pack of 1 vial containing 5 ml of solution
20 mg/10 ml: pack of 1 vial containing 10 ml of solution
50 mg/25 ml: pack of 1 vial containing 25 ml of solution
200 mg/100 ml: pack of 1 vial containing 100 ml of solution.
Not all pack sizes may be marketed

Marketing authorization holder and manufacturer
Marketing authorization holder
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, 8, 8A e 8B
Fervença
2705-906 Terrugem SNT
Portugal
Tel.: +351 219608410
e-mail: [email protected]
Manufacturer
THYMOORGAN Pharmazie GmbH
Schiffgraben 23
D-38690 Goslar
Germany
This medicinal product is authorized in the Member States of the EEA with the following names:

The following information is reserved for medical or healthcare professionals only:
Epirubicina Hikma 2 mg/ml Intravesical Solution/ Injectable Solution
Epirubicin hydrochloride
FOR INTRAVENOUS INJECTION OR INTRAVESICAL ADMINISTRATION

Incompatibilities
Prolonged contact with any alkaline pH solution should be avoided,
including solutions containing sodium bicarbonate, as this causes hydrolysis of the
drug. Only the solvents described in the “Instructions for
dilution” section should be used.
Do not mix the injectable solution or the diluted solution with other medicinal products.
Epirubicina should not be mixed with heparin due to physical incompatibility
(precipitation).

Instructions for dilution
The injectable solution can be administered via a continuous intravenous infusion line of saline solution. If, however, the injectable solution needs to be
administered after dilution, the instructions below must be followed.
Epirubicina Hikma can be further diluted in aseptic conditions in 5% glucose or 0.9% sodium chloride and administered by intravenous infusion. The
infusion solution must be prepared immediately before use.
The injectable solution does not contain preservatives and any residue in the vial
must be discarded immediately.

Precautions for handling
This drug is a cytotoxic product, follow local guidelines for instructions
on the safe handling/destruction of cytotoxic products.

Storage
Store and transport in a refrigerator (between 2°C and 8°C).
Store in the original package, protected from light.
Chemical and physical stability has been demonstrated after dilution in 0.9% sodium chloride solution or 5% glucose for 72 hours if stored in a refrigerator.
From a microbiological point of view, the product must be used immediately.
If not used immediately, the storage times during use and the
conditions of storage before use are the responsibility
of the user and should normally not exceed 24 hours at a temperature between 2
and 8 ° C, unless the dilution has taken place under controlled and
validated aseptic conditions.

Marketing authorization holder
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, 8, 8A e 8B
Fervença
2705-906 Terrugem SNT
Portugal
[email protected]