MELFALAN 50 mg Порошок И Раствор Для Инъекционного/Инфузионного Раствора

Содержание инструкции

1. Melfalan SUN 50 mg powder and solvent for injectable solution/for infusion
   1. What is Melfalan SUN and what it is used for
   2. What you need to know before you are given Melfalan SUN
   3. How Melfalan SUN is administered
   4. Possible side effects
   5. How to store Melfalan SUN
   6. Package Contents and Other Information

Melfalan SUN 50 mg powder and solvent for injectable solution/for infusion

melfalan

Generic medicine

Read this leaflet carefully before using 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 or nurse.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

• 1. What Melfalan SUN is and what it is used for
• 2. What you need to know before you are given Melfalan SUN
• 3. How Melfalan SUN is administered
• 4. Possible side effects
• 5. How to store Melfalan SUN
• 6. Contents of the pack and other information

1. What is Melfalan SUN and what it is used for

Melfalan SUN contains a medicine called melfalan, which belongs to a group of medicines called
cytotoxic (or also chemotherapeutic). Melfalan SUN is used to treat tumors. It works by reducing the number of
abnormal cells produced by the body.
Melfalan SUN is used for:

• multiple myeloma (a form of cancer that develops from cells in the bone marrow called plasma cells. Plasma cells help fight infections and disease by producing antibodies)
• advanced ovarian cancer
• childhood neuroblastoma (malignant tumor of the nervous system)
• malignant melanoma (skin cancer)
• soft tissue sarcoma (malignant tumor of muscles, fat tissues, fibrous tissues, blood vessels or other supporting tissues of the body). Talk to your doctor if you do not feel better or if you feel worse.

2. What you need to know before you are given Melfalan SUN

DO NOT receive Melfalan SUN if any of the following applies to you. Tell your doctor if:

• you are allergic to melfalan or any of the other ingredients of this medicine (listed in section 6)
• you are breastfeeding.

Warnings and precautions
Before treatment with Melfalan SUN, tell your doctor if any of the following applies to you:

• you have had or are currently undergoing radiotherapy or chemotherapy
• you have a kidney problem
• you are going to receive or have recently received a vaccination. This precaution is necessary because some vaccines (for example against poliomyelitis, measles, mumps and rubella) could cause you to develop an infection if you receive them while being treated with Melfalan SUN.
• you have a blood clot in your leg (thrombosis), in your lung (pulmonary embolism) or anywhere else in your body, or have had one in the past
• you have a condition that increases your risk of developing a blood clot in your arteries
• men treated with Melfalan SUN must not father children during treatment and for the 3 months afterwards.

Other medicines and Melfalan SUN
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those bought without a prescription.
In particular, tell your doctor or nurse if you are taking any of the following medicines

• other cytotoxic medicines (chemotherapy)
• nalidixic acid (an antibiotic used to treat urinary tract infections)
• cyclosporine (used to prevent rejection after a transplant, to treat certain skin conditions such as psoriasis and eczema, or to treat rheumatoid arthritis)
• vaccines that contain live organisms (see Warnings and precautions)
• in children, busulfan (used to treat certain types of cancer).

Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before you are given this medicine.

Pregnancy
Treatment with Melfalan SUN is not recommended during pregnancy because it can cause permanent harm to the fetus. If you are already pregnant, it is important that you see your doctor before you are given Melfalan SUN. The doctor will assess the risks and benefits of treatment with Melfalan SUN for you and the baby.
Reliable contraceptive precautions should be used to avoid pregnancy while you or your partner are receiving this injection/infusion.

Breastfeeding
It is not known whether Melfalan SUN is excreted in breast milk. Do not breastfeed while being treated with Melfalan SUN.

Fertility
Melfalan SUN may have effects on the ovaries or sperm, which can cause infertility (inability to have a child). In women, the menstrual cycle may stop (amenorrhoea) and in men a complete absence of sperm (azoospermia) may be observed following treatment with Melfalan SUN. Therefore, men are advised to seek advice regarding semen preservation before treatment.

Male and female contraception
Men treated with Melfalan SUN are recommended not to father children during treatment and for the 3 months afterwards. Talk to your doctor if you want to use effective and reliable contraception.

Driving and using machines
The effects on the ability to drive and operate machines have not been studied in patients taking this medicine. It is not expected that this medicine will affect the ability to drive or operate machines.

Melfalan SUN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially “sodium-free”.

Melfalan SUN contains ethanol (alcohol)
This medicine contains ethanol (alcohol) 5%, equivalent to 10 ml of beer or 2.4 ml of wine per dose.
May be harmful to alcoholics.
Should be taken into consideration in pregnant or breastfeeding women, children and high-risk groups, such as patients with liver disease or epilepsy.

Melfalan SUN contains propylene glycolIt may cause symptoms similar to those caused by alcohol.

3. How Melfalan SUN is administered

Melfalan SUN will only be administered to you by doctors or nurses experienced in administering
chemotherapies.

Method of administration
Melfalan SUN can be administered

• as an infusion (drip) into a vein
• into an artery, administered to a specific part of the body (perfusion).

How much Melfalan SUN is administered
The doctor will decide how much Melfalan SUN will be administered to you. The amount of Melfalan SUN depends on

• your body weight or your body surface area (a specific measurement that takes into account weight and build)
• other medicines you are taking
• your disease
• your age
• whether or not you have kidney problems.

When Melfalan SUN is administered to you, the doctor will regularly perform blood tests to
check the number of cells in your blood. The doctor may change the dose following the results of these
tests.

Risk of blood clots(thromboembolic events)
The doctor will decide whether you need to be given preventive treatment for blood clots in the
veins. This precaution will be taken within the first 5 months of treatment or if you have an increased risk
of developing a blood clot in the veins.

Use in children
Melfalan SUN is used only rarely in children. No dosage guidelines are available for children.

Use in the elderly
No specific dosage adjustments are foreseen for the elderly.

Use in patients with kidney impairment
If you have kidney problems, the doctor will generally give you a lower dose than other adults.

If you are given too much MelfalanSUN
Because the doctor will administer Melfalan SUN to you, it is unlikely that you will receive too much. If you think you have
been given too much medicine or if you have missed a dose, tell your doctor or nurse.

If you forget to use Melfalan SUN
Because the doctor will administer Melfalan SUN to you, it is unlikely that you will forget a dose of the medicine.
If you think you have forgotten a dose, skip it and the next one will be given to you at the next scheduled date.
Do not use a double dose to make up for a missed dose.

If you stop using Melfalan SUN
If you feel you need to stop using this medicine, talk to your doctor first.
If you have any further questions about the use of 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.
manifest.

Serious side effects
Seek immediate medical attention or go to the hospital if you experience any of the
following:

• allergic reaction, signs may include:
• rash, blisters or hives on the skin
• swelling of the face, eyelids or lips
• sudden wheezing and feeling of tightness in the chest
• collapse (due to cardiac arrest)
• any sign of fever or infection (sore throat, mouth sores or urinary problems)
• any bruising or unexpected bleeding or feeling of extreme fatigue, dizziness or shortness of breath, because these signs could mean that an insufficient amount of a certain type of blood cell is being produced
• sudden feeling of unwellness (even with normal temperature)
• pain, stiffness or weakness in the muscles and your urine is darker than normal or brown or red when you are given Melfalan SUN directly into an arm or a leg.

Immediately inform your doctor if you experience symptoms of blood clots in the veins, especially in the
legs. Symptoms may include swelling, pain and redness of the leg. Blood clots
can move along the blood vessels to the lungs, causing chest pain and difficulty breathing.

Other side effects include:
Very common side effects (may affect more than 1 in 10 people)

• fever
• decreased number of blood cells and platelets
• feeling sick (nausea), vomiting and diarrhoea
• mouth sores (at high doses of Melfalan SUN)
• hair and eyelash loss (at high doses of Melfalan SUN)
• tingling or warmth at the site where Melfalan SUN was injected
• muscle problems, such as wasting and pain when Melfalan SUN is given directly into an arm or a leg.

Common side effects (may affect up to 1 in 10 people)

• hair loss at the usual doses of Melfalan SUN
• high levels in the blood of a chemical called urea in people with kidney problems treated for myeloma
• muscle problem, which can cause pain, contraction, tingling, burning or numbness, called compartment syndrome. It can occur when Melfalan SUN is given directly into an arm or a leg.

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

• a condition characterized by a low number of red blood cells because they are destroyed prematurely. It can cause extreme fatigue, shortness of breath, dizziness, headache or yellowing of the skin or whites of the eyes
• lung problems, which can cause coughing or wheezing and difficulty breathing
• liver problems, which can be detected with blood tests or cause jaundice (yellowing of the whites of the eyes and skin)
• mouth sores at normal doses of Melfalan SUN
• rashes or itching.

Not known (frequency cannot be estimated from the available data).

• leukaemia (cancer of the blood)
• in women: stopping of menstruation (amenorrhoea)
• in men: absence of sperm in the semen (azoospermia)
• death of muscle tissue (muscle necrosis)
• breakdown of muscle fibres (rhabdomyolysis)
• formation of a blood clot, so-called thrombus, in a deep vein, especially in the legs (deep vein thrombosis) and blockage of a pulmonary artery (pulmonary embolism).

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

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 label and the outer packaging
after Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C. Do not refrigerate. Keep the vial in the outer packaging
to protect the medicine from light.
Melfalan SUN will be prepared for use by a healthcare professional. Once prepared, it must be used
immediately and must not be stored or refrigerated.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Melfalan SUN contains

• The active ingredient is melfalan hydrochloride. Each vial contains melfalan hydrochloride equivalent to 50 mg of melfalan.
• The other ingredients are povidone and hydrochloric acid. Melfalan is dissolved in 10 ml of solvent before being injected. The solvent contains water for injections, sodium citrate, propylene glycol and anhydrous ethanol.

Description of the appearance of Melfalan SUN and contents of the pack
Each pack of Melfalan SUN contains one vial of Melfalan SUN powder and one vial of
solvent. The powder vial contains 50 mg of the active ingredient melfalan in powder form and the solvent
vial contains 10 ml of solvent in which to reconstitute (dissolve) the powder. The powder is from white to
off-white in color, lyophilized or compacted, and the solvent is a clear and colorless liquid/solution. After
reconstitution with 10 ml of solvent, the resulting solution contains 5 mg/ml of melfalan.

Marketing Authorisation Holder
AIC Holder:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Representative for Italy:
Sun Pharma Italia Srl - - Viale Giulio Richard, 1 - 20143 Milan

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
S.C. Terapia S.A.
124 Fabricii Street
400632, Cluj-Napoca
Cluj County
Romania

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Austria: Melphalan SUN
Denmark: Melphalan SUN
Germany: Melphalan SUN
France: Melphalan SUN
Italy: Melfalan SUN
Netherlands: Melfalan hydrochloride SUN
Norway: Melphalan SUN
Sweden: Melphalan SUN
United Kingdom: Melphalan

The following information is intended exclusively for physicians or healthcare professionals
Safe handling of Melfalan SUN:
Melfalan SUN must be prepared for administration by trained personnel who are familiar with its
characteristics and the procedures for safe handling. Before starting, refer to local guidelines for cytotoxic
drugs. For instructions on administration, see section 4.2 of the Summary of Product Characteristics.
Melfalan SUN must be prepared for use in an aseptic unit of a pharmacy equipped with a suitable vertical
laminar flow cabinet. If this is not available, a dedicated room adjacent to the hospital ward or outpatient
clinic may be used.
Personnel preparing or handling Melfalan SUN must wear the following protective clothing:
disposable surgical latex or polyvinyl chloride gloves of suitable quality (rubber gloves are not
suitable);
surgical masks of suitable quality;
protective goggles which must be washed thoroughly with water after use;
disposable gown.
Additional appropriate clothing will be required in an aseptic environment.
Any spillage of the solution must be treated immediately (by personnel wearing appropriate protective
clothing), cleaning with disposable paper towels which must then be disposed of in high-risk containers in
accordance with current local regulations. Contaminated surfaces must be washed with plenty of water.
If Melfalan SUN solution comes into contact with the skin, wash immediately with soap and
plenty of cold water. In such cases, it is advisable to seek medical advice.
If contact with the eyes occurs, IMMEDIATELY wash the eyes with sodium chloride irrigation and
seek medical advice immediately. If sodium chloride solution is not available, a large amount of water may be used.
Pregnant or breastfeeding personnel must not handle Melfalan SUN.
Preparation of Melfalan SUN solution
Melfalan SUN must be prepared at 25°C, reconstituting the lyophilized/compacted powder with the provided
solvent/diluent.
Reconstitution
It is important that both the lyophilized/compacted powder and the solvent are at room temperature before
starting reconstitution. Warming the diluent with your hands can promote reconstitution. 10 ml of this
vehicle must be added rapidly, in a single amount, to the vial containing the lyophilized powder and the vial must be
immediately shaken vigorously (for about 1 minute) until a clear solution without visible particles is obtained. Each
vial must be reconstituted individually in this way. The resulting solution contains the equivalent of 5 mg per ml of
melfalan anhydrous and has a pH of approximately 6.5.

Melfalan SUN solution has limited stability and must be prepared immediately before use.
The reconstituted solution must not be refrigerated as this will cause precipitation.
Mixing
Immediately draw up the reconstituted solution with a concentration of 5 mg/ml of melfalan anhydrous from the
reconstituted vial and, using a new 10 ml syringe, add it to the infusion bag containing 0.9% sodium chloride for
intravenous infusion. Mix this diluted solution thoroughly by manual rotation to obtain a nominal concentration of
0.45 mg/ml of melfalan anhydrous.
When further diluted in an infusion solution, melfalan has reduced stability and the rate of
degradation increases rapidly with increasing temperature. If melfalan is infused at a
temperature of approximately 25°C, the total time between preparation of the injectable solution and
completion of the infusion must not exceed 1.5 hours.
Melfalan is not compatible with infusion solutions containing dextrose and it is recommended that only 0.9%
weight/volume sodium chloride for infusion be used.
If any turbidity or crystallization appears in the reconstituted or diluted solutions, the preparation must
be discarded.
Disposal
Any unused solution after one hour must be disposed of in accordance with standard guidelines for the
handling and disposal of cytotoxic drugs.
Disposal of sharps, such as needles, syringes, administration kits and vials, must be carried out
in rigid containers labelled with an adequate hazard warning. Personnel involved in
disposal must be aware of the precautions to be observed and the material must be destroyed by
incineration, if appropriate.