MELFALAN 50 mg Proszek I Rozpuszczalnik Do Roztworu Do Wstrzykiwań

Treść ulotki

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

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

Melfalan

Generic medicine

Read this leaflet carefully before you start to use 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 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 Melfalan Teva is and what it is used for
• 2. What you need to know before you use Melfalan Teva
• 3. How to use Melfalan Teva
• 4. Possible side effects
• 5. How to store Melfalan Teva
• 6. Contents of the pack and other information

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

Melfalan Teva contains the active substance melfalan which belongs to a group of medicines called
cytotoxic agents (also known as chemotherapeutic agents). Melfalan Teva is used to treat cancer. It works
by reducing the number of abnormal cells produced by the body.
Melfalan Teva is used for:

• Multiple myeloma- a type of cancer that develops from cells in the bone marrow called plasma cells. Plasma cells help fight infections and diseases by producing antibodies.
• Advanced ovarian cancer
• Neuroblastoma in childhood- a cancer of the nervous system.
• Malignant melanoma -a skin cancer.
• Soft tissue sarcoma- a cancer of the muscles, fat, fibrous tissue, blood vessels and other connective tissues of the body.

Ask your doctor if you would like further clarification regarding these conditions.

2. What you need to know before you use Melfalan Teva

Do not use Melfalan Teva:

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

If any of the above apply to you, do not take Melfalan Teva. If you are not sure, ask your doctor or
nurse before you are given Melfalan Teva.

Warnings and precautions
Talk to your doctor or nurse before you use Melfalan Teva:

• if you are having or have recently had radiotherapy or chemotherapy;
• if you have kidney problems.

If you are not sure whether any of the above apply to you, ask your doctor or nurse before
you are given Melfalan Teva.

Other medicines and Melfalan Teva
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
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 of organs or tissues following a transplant, or to treat certain skin conditions such as psoriasis and eczema, or rheumatoid arthritis).

Vaccinations during treatment with Melfalan Teva
If you need to be vaccinated, consult your doctor or nurse before receiving the vaccine. This is because
some vaccines (e.g. for poliomyelitis, measles, mumps, rubella) could
cause you an infection if you receive them during treatment with Melfalan Teva.

Pregnancy and breastfeeding
Do not have treatment with Melfalan Teva if you are planning a pregnancy. This applies to both
men and women. Melfalan Teva can damage sperm or eggs. Reliable contraceptive precautions must be
taken to avoid pregnancy while you or your partner are being treated with this medicine. Ask your
doctor for advice.
If you are already pregnant, it is important to consult your doctor before you are
given Melfalan Teva.
Do not breastfeed your baby while you are being treated with Melfalan Teva. Consult your doctor or
midwife.

Melfalan Teva contains ethanol (alcohol), sodium and propylene glycol
This medicine contains 5.1% by volume of ethanol (alcohol), which is up to 2894 mg per dose,
equivalent to 73.4 ml of beer or 30.6 ml of wine.
Harmful for those suffering from alcoholism.
This should be taken into consideration in pregnant or breastfeeding women, children and
high-risk groups, such as patients with liver disease or epilepsy.
This medicine contains 53.5 mg of sodium (the main component of table salt) in
each vial. This is equivalent to 2.7% of the recommended daily intake of sodium for an
adult.
The propylene glycol contained in this medicine can cause symptoms similar to those of alcohol and
increase the likelihood of their occurrence. Your doctor may prescribe further tests
during treatment with this medicine. Do not give this medicine to
children under 5 years of age.

3. How to use Melfalan Teva

Melfalan Teva must only be prescribed by specialist doctors with experience in the treatment of
blood disorders or cancer.
Melfalan Teva will be administered to you:

• by infusion into a vein;
• as a perfusion into a specific part of the body through an artery. The doctor will decide how much Melfalan Teva will be administered to you. The amount of Melfalan Teva will depend on:
• your weight or your body surface area (a specific measurement that considers your weight and height);
• other medicines you are taking;
• your disease;
• your age;
• if you have kidney problems.

During treatment with Melfalan Teva, the doctor will subject you to regular blood tests. This is
necessary to check the number of cells in the blood. The doctor may sometimes modify your
dose based on the results of these tests.

If you use more Melfalan Teva than you should
The doctor will administer Melfalan Teva to you, so it is unlikely that you will receive an excessive dose. If
you think that you have been given an excessive dose or have missed a dose, inform the doctor or
the nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following side effects, contact your specialist or go to hospital immediately:

• allergic reaction, the signs of which may include:
• skin rash, bumps or hives on the skin
• swelling of the face, eyelids or lips
• sudden shortness of breath and a 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 unexpected bruising or bleeding or a feeling of extreme fatigue, dizziness or shortness of breath, as this could mean a reduced production of a certain type of blood cell
• if you feel a suddensense of unwellness (even with a normal temperature)
• if your muscles are painful, stiff or weak andyour urine is darker than usual or brown or red - when Melfalan Teva is administered directly into an arm or leg.

Also, contact your doctor if you experience any of the following side effects that
can also occur with this medicine:

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

• decrease in the number of blood cells and platelets
• feeling unwell (nausea), discomfort (vomiting) and diarrhoea
• ulcers of the oral mucosa - at high doses of Melfalan Teva
• hair loss - at high doses of Melfalan Teva
• a sensation of heat or tingling at the injection site of Melfalan Teva
• muscle problems such as wasting and pain - when Melfalan Teva is administered directly into an arm or leg

Common (may affect up to 1 in 10 people)

• hair loss - at conventional doses of Melfalan Teva
• high concentrations of a chemical substance called urea in the blood - in people with kidney problems being treated for myeloma
• a muscle condition that can cause pain, tightness, tingling, burning or numbness - called compartment syndrome. It can occur when Melfalan Teva is administered directly into an arm or leg

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

• a condition characterized by a reduction in red blood cells due to their premature destruction, which can lead to extreme fatigue, shortness of breath and dizziness and be associated with headache or yellowing of the skin or eyes
• lung problems that can cause coughing or shortness of breath and make breathing difficult
• liver problems that can be detected in blood tests or cause jaundice (yellowing of the whites of the eyes and skin)
• ulcers of the oral mucosa - with conventional doses of Melfalan Teva
• skin rashes or itchy skin With Melfalan Teva, the following side effects can also occur:
• leukemia - cancer of the blood
• in women: cessation of menstruation

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-
avversa. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Melfalan Teva

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 on the packaging
after the wording Exp. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Melfalan Teva is prepared for use by a healthcare professional. Once prepared, it must be
used immediately and must not be stored or refrigerated.

6. Package Contents and Other Information

What Melfalan Teva contains

• The active ingredient is melfalan. Each vial contains 50 mg of melfalan (as melfalan hydrochloride).
• The excipients are Povidone K12 and hydrochloric acid (for pH adjustment). Melfalan Teva is dissolved in a solvent before being injected. The solvent contains sodium citrate, propylene glycol, anhydrous ethanol and water for injections.

Description of the appearance of Melfalan Teva and package contents
Melfalan Teva is available in powder and solvent for injectable/infusion solution. The
powder is lyophilized, with a color ranging from white to off-white; the solvent is a sterile,
transparent and colorless solution.
The active ingredient is contained in a colorless type I glass vial (15 ml) with a type I bromobutyl rubber stopper and an aluminum cap with a polypropylene disc. The vial may
be or not be coated with a protective sleeve.
The solvent is contained in a colorless type I glass vial (10 ml) with a type I bromobutyl rubber stopper and an aluminum cap with a polypropylene disc.
Package: single package containing 1 vial of powder and 1 vial of solvent.

Marketing Authorisation Holder and Manufacturer
Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
Manufacturer
S.C. SINDAN-PHARMA S.R.L.
11th Ion Mihalache Boulevard
011171 Bucharest 1
Romania

This leaflet was last updated in MM/YYYY
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The following information is intended exclusively for physicians or healthcare professionals:

Precautions
MELFALAN TEVA IS A CYTOTOXIC AGENT THAT MUST BE ADMINISTERED
UNDER THE SUPERVISION OF PHYSICIANS EXPERIENCED IN THE ADMINISTRATION OF THIS
TYPE OF MEDICINE. Caution is required during handling and preparation. It is
recommended to wear gloves and other protective clothing to prevent contact with the skin.

Safe handling of Melfalan Teva
Melfalan Teva formulations must be handled in accordance with guidelines for the
handling of cytotoxic drugs.

Preparation
Melfalan Teva solution for injection/infusion should be prepared at room temperature (approximately
25°C), by reconstituting the lyophilized powder with the provided solvent.
It is important that both the lyophilized powder and the solvent are at room temperature before
starting the reconstitution. Warming the diluent in the hand can help with reconstitution. 10 ml of
solvent should be added rapidly, in a single amount, to the vial containing the
lyophilized powder, and the vial should be immediately shaken vigorously (for at least 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/ml of melfalan.
Melfalan Teva is not compatible with infusion solutions containing dextrose. The EXCLUSIVE use of 0.9% p/v sodium chloride intravenous infusion solutions is recommended.
The chemical and physical stability during use of Melfalan Teva is limited and the solution must be
prepared immediately before use. The reconstituted solution (5 mg / ml) must be transferred
into the infusion bag within 30 minutes and the diluted solution must be completely
administered within 1 hour of reconstitution,
The reconstituted solution is a clear solution, from colorless to slightly yellowish, free of
visible particles, with a final pH of approximately 6.5.
Unused medicine and waste materials derived from such medicine must be disposed of in accordance with
current local regulations.

Administration
Unless regional arterial perfusion is indicated, Melfalan Teva is indicated for
intravenous use only.
For intravenous administration, it is recommended that the Melfalan Teva solution be
injected slowly into a rapid infusion solution through a disinfected site.
If direct injection into a rapid infusion is not appropriate, the Melfalan Teva solution may be
administered diluted in an infusion bag.
Care must be taken to avoid possible extravasation of Melfalan Teva and, in case of difficult
peripheral venous access, the use of a central venous catheter should be considered. If
high doses of Melfalan Teva are administered, with or without autologous bone marrow transplantation, administration via a central venous catheter is recommended.
In case of regional arterial perfusion, consult the literature for methodological aspects.

Refer to the Summary of Product Characteristics (SmPC) for further

information.