CLOFARABINA 1 mg /Ml Koncentrat Do Roztworu Infuzyjnego

Treść ulotki

1. Clofarabina medac 1 mg/ml concentrate for solution for infusion
   1. What is Clofarabina medac and what is it used for
   2. What you need to know before using Clofarabina medac
   3. How to use Clofarabina medac
   4. Possible side effects
   5. How to store Clofarabina medac
   6. Contents of the pack and other information

Clofarabina medac 1 mg/ml concentrate for solution for infusion

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.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

• 1. What Clofarabina medac is and what it is used for
• 2. What you need to know before you use Clofarabina medac
• 3. How to use Clofarabina medac
• 4. Possible side effects
• 5. How to store Clofarabina medac
• 6. Contents of the pack and other information

1. What is Clofarabina medac and what is it used for

Clofarabina medac contains the active substance clofarabine. Clofarabine belongs to a group of
medicines called antineoplastic agents. It works by slowing down the growth of abnormal white blood cells and
eventually killing them. It works best on cells that are multiplying rapidly, such as
cancer cells.
Clofarabina medac is used for the treatment of children (≥ 1 year of age), adolescents and
young patients up to 21 years of age with acute lymphoblastic leukemia (ALL) for whom previous treatments
have not worked or have stopped working. Acute lymphoblastic leukemia is
caused by the abnormal growth of certain types of white blood cells

2. What you need to know before using Clofarabina medac

Do not use Clofarabina medac

• if you are allergic toclofarabine or any of the excipients of this medicine (listed in section 6);
• if you are breastfeeding(read the “Pregnancy and breastfeeding” section below);
• if you have severe kidney or liver problems.

Inform the doctor if any of these conditions apply to you. If you are the parent of
a child undergoing treatment with Clofarabina medac inform the doctor if any of these
conditions apply to your child.

Warnings and precautions
Talk to your doctor before using Clofarabina medac.

Inform the doctor if any of these conditions apply to you. Clofarabina medac may not be suitable for you:

• if you have developed severe reactionsafter using this medicine previously;
• if you have a kidney diseaseor have had one in the past;
• if you have a liver diseaseor have had one in the past;
• if you have a heart diseaseor have had one in the past.

Immediately inform the doctor or healthcare professionalif any of the following happens to you because it may be necessary to stop treatment:

• if you have a fever or high temperature - as clofarabine reduces the number of blood cells produced by the bone marrow, you may be more likely to develop an infection;
• if you have difficulty breathing, breathe rapidly or feel short of breath;
• if you feel that your heart rate is changing;
• if you suffer from dizziness (feeling lightheaded) or fainting: this may be a symptom of low blood pressure;
• if you have nausea or diarrhea (loose stools);
• if your urine is darker than normal - it is important to drink plenty of water to prevent dehydration;
• if a rash with blisters or mouth ulcers develops;
• if you lose your appetite, feel unwell, vomit, have diarrhea, dark urine and pale stools, stomach pain, jaundice (yellowing of the skin and eyes), or feel generally unwell; these may be symptoms of liver inflammation (hepatitis) or liver damage (liver failure);
• if you pass little or no urine, or feel sleepy, nauseous, vomit, have shortness of breath, loss of appetite and/or weakness (these may be signs of acute kidney failure / renal failure).

If you are the parentof a child undergoing treatment with Clofarabina medac, inform the doctor if any of
the above conditions apply to your child.

During treatment with Clofarabina medac, at regular intervals the doctor will perform blood tests and other tests to monitor your health. Due to the way this
medicine works, it will affect the condition of your blood and other organs.

Talk to your doctor about contraception. Men and women of childbearing age must use effective contraceptive methods during and after treatment. See the “Pregnancy and breastfeeding” section below. Clofarabina medac can damage male and female reproductive organs. Ask your
doctor to explain what you can do to protect yourself so that you can conceive.

Children
Safe and effective dose recommendations for children under 1 year of age have not been
established.

Other medicines and Clofarabina medac
Tell your doctor if you are taking or have recently taken:

• medicines for heart disease;
• any medicine that changes your blood pressure;
• medicines that affect the liver or kidney;
• any other medicine, even those available without a prescription.

Pregnancy and breastfeeding
Clofarabine should not be used during pregnancy unless it is clearly necessary.

Women who are able to become pregnant: you must use effective contraception during
treatment with clofarabine. If used by pregnant women, clofarabine can harm the
unborn child. If you are pregnant or become pregnant during treatment with clofarabine,
seek immediate medical attention.
Men must also use effective contraception when they themselves or their partner
are undergoing treatment with clofarabine.
If you are breastfeeding, you must stop breastfeeding before starting treatment and
must not breastfeed during treatment or within 3 months of finishing treatment.

Driving and operating machinery
Do not drive or use tools or machinery if you feel dizzy, lightheaded or faint.

Clofarabina medac contains sodium chloride
Each vial contains 180 mg of sodium chloride, which is equivalent to 3.08 mmol (or 70.77 mg)
of sodium. If you are on a controlled sodium diet, you should take this into account.

3. How to use Clofarabina medac

Treatment with Clofarabina medac has been prescribed to you by a qualified doctor experienced in the
treatment of leukemia.

The doctor will calculate the right dose for youbased on your height, weight and health status. Before
it is administered to you, Clofarabina medac will be diluted in a sodium chloride solution (water and
salt). Tell your doctor if you are following a controlled sodium diet because this
may affect how the medicine is given.

The doctor will administer Clofarabina medac once a day for 5 daysvia infusion,
through a long, thin tube that enters a vein (drip) or a small medical device
inserted under the skin (port-a-cath), if one has been implanted in you (or the child). The infusion will be
administered to you over 2 hours. If you (or the child) weigh less than 20 Kg, the infusion time
may be longer.
The doctor will monitor your health and may adjust the dose based on your
response to treatment. It is important to drink plenty of water to avoid dehydration.

If you use more Clofarabina medac than you should
If you think that the medicine has been administered to you in an excessive amount, inform your
doctor immediately.

If you forget to use Clofarabina medac
The doctor will tell you when the medicine should be administered to you. If you think you have missed
a dose, inform your doctor immediately.
If you have any doubts about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• anxiety, headache, fever, fatigue;
• nausea and vomiting, diarrhea, (soft stools);
• hot flushes, itching and inflamed skin, inflammation of the mucous membranes such as the mouth and other areas;
• infections may be more frequent than normal since Clofarabina medac can reduce the number of certain types of blood cells present in the body;
• skin rashes possibly itchy, reddened skin, painful or peeling skin, even on the palms of the hands and soles of the feet, or small reddish or purple spots under the skin.

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

• blood infections, pneumonia, herpes zoster, implant infections, mouth infections, such as candidiasis and cold sores;
• changes in blood test values, changes in white blood cells;
• allergic reactions;
• feeling of thirst and darker or less urine than normal, decreased or loss of appetite, weight loss;
• agitation, irritability or restlessness;
• feeling of numbness or weakness in the arms and legs, skin insensitivity, drowsiness, dizziness, tremor;
• hearing problems;
• fluid accumulation around the heart, rapid heartbeat;
• low blood pressure, swelling due to large bruises;
• bleeding from the smallest blood vessels (capillaries), rapid breathing, nosebleeds, difficulty breathing, shortness of breath, cough;
• vomiting blood, stomach pain, anal pain;
• brain bleeding, stomach, intestinal or lung bleeding, mouth or gum bleeding, mouth ulcers, inflammation of the mouth mucosa;
• yellowing of the skin and eyes (also called jaundice) or other liver disorders;
• bruising, hair loss, changes in skin color, increased sweating, dry skin and other skin problems;
• pain in the chest wall or bones, neck or back, pain in the limbs, muscles or joints;
• blood in the urine;
• organ failure, pain, increased muscle tension, fluid retention and swelling in some parts of the body, including the arms and legs, changes in mental status, feeling of warmth, feeling of cold, feeling out of tune;
• Clofarabina can affect the levels of certain substances in the blood. The doctor will perform periodic blood tests to check the proper functioning of the body;
• liver damage (hepatic insufficiency);
• little or no urine, drowsiness, nausea, vomiting, shortness of breath, loss of appetite and/or weakness (possible signs of acute renal failure or kidney failure).

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

• inflammation of the liver (hepatitis).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 Clofarabina medac

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 of the vial and on the
pack after EXP. The expiry date refers to the last day of that month.
Do not freeze.
The diluted concentrate is chemically and physically stable in PVC bags for 3 days at 2-8 °C and at
room temperature (up to 25°C). From a microbiological point of view, the product must be
used immediately. If not used immediately, the storage times in use and the
conditions prior to use are the responsibility of the user and normally should not
exceed 24 hours at a temperature of 2 to 8°C, unless the dilution has been carried out under
controlled and validated aseptic conditions.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to eliminate medicines that
you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Clofarabina medac contains

• The active ingredient is clofarabine. Each ml contains 1 mg of clofarabine. Each 20 ml vial contains 20 mg of clofarabine.
• The other excipients are sodium chloride, hydrochloric acid (for pH adjustment) and water for injections.

Description of the appearance of Clofarabina medac and contents of the pack
Clofarabina medac is a concentrate for infusion solution. It is a clear, almost
colourless solution, which is prepared and diluted before use. It is available in 20 ml glass vials. The
vials contain 20 mg of clofarabine and are packaged in a carton. The vials may
or may not be wrapped in a protective pouch. Each carton contains 4 vials, but it is possible
that not all packs are marketed.

Marketing Authorisation Holder
medac pharma s.r.l.
via Viggiano 90
00178 Rome
Italy

Manufacturer
S.C. SINDAN-PHARMA S.R.L.
11th Ion Mihalache Boulevard
Bucharest 1
011171
Romania

This medicinal product has been granted an “exceptional circumstances” authorisation.

This means that, due to the rarity of the disease, complete information on

this medicinal product is not available.
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The following information is intended only for healthcare professionals:
Special precautions for administration
Clofarabina medac 1 mg/ml concentrate for solution for infusion must be diluted before
administration. It must be filtered through a sterile 0.2 micrometer syringe filter and then
diluted with sodium chloride 9 mg/ml (0.9%) for intravenous infusion to reach a total volume
according to the examples reported in the following table. However, the final dilution volume may vary
depending on the patient's clinical condition and at the physician's discretion. (If a
0.2 micrometer syringe filter cannot be used, the concentrate must be pre-filtered with a 5
micrometer filter, diluted and then administered through an inline 0.22 micrometer filter).
The diluted concentrate should be a clear and colourless solution. It must be visually inspected
for the presence of particles and colour change before
administration.
The diluted concentrate is chemically and physically stable for 3 days at a temperature between
2-8 °C and at room temperature (up to 25°C). From a microbiological point of view, it should be
used immediately. If not used immediately, the storage times and conditions
before use are the responsibility of the user and should not normally exceed
24 hours between 2-8 °C unless the dilution has taken place under controlled and
validated aseptic conditions. Do not freeze.
Instructions for handling
Procedures for the correct handling of antineoplastic agents must be observed. Cytotoxic
medicines must be handled with caution.
The use of disposable gloves and protective clothing is recommended when handling clofarabine. If the
product comes into contact with eyes, skin or mucous membranes, rinse immediately with plenty of
water.
Clofarabina should not be handled by pregnant women.
Disposal
Clofarabina is for single use only.
Any unused medicinal product or waste material must be disposed of in accordance with
local requirements.