PACLITAXEL 6 mg /Ml Koncentrat Do Sporządzania Roztworu Do Infuzji

Treść ulotki

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

Paclitaxel Accord Healthcare Italia

6 mg/ml concentrate for infusion solution
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, 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 any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
The name of your medicine is “Paclitaxel Accord Healthcare Italia 6 mg/ml, concentrate for infusion solution”,

Contents of this leaflet:

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

1. What is Paclitaxel Accord Healthcare Italia and what it is used for

Paclitaxel belongs to a group of anti-cancer medicines called taxanes, which work by inhibiting the growth of cancerous cells.
Paclitaxel Accord Healthcare Italia is used to treat:

Ovarian carcinoma

• As first-line therapy (after initial surgery, in combination with cisplatin, a platinum-containing drug).
• After trying standard platinum-containing medicines without obtaining effects.

Breast carcinoma

• As first-line therapy in case of advanced disease or that has spread to other parts of the body (metastatic disease). Paclitaxel Accord Healthcare Italia is combined with an anthracycline (e.g. doxorubicin) or with a medicine called trastuzumab (for patients for whom anthracyclines are not indicated and with a cancer whose cells carry a protein called HER 2 on the surface; see the
• After initial surgery, following treatment with anthracycline and cyclophosphamide (AC), as additional treatment.
• As second-line treatment for patients who have not responded to standard anthracycline treatments or for whom such treatments cannot be used.

Advanced non-small cell lung carcinoma:
In combination with cisplatin, in cases where surgical therapy or radiotherapy are not indicated.

AIDS-related Kaposi's sarcoma:

• If the attempt with another therapy (i.e. liposomal anthracyclines) has proven ineffective.

2. What you need to know before you use Paclitaxel Accord Healthcare Italia

Do not take Paclitaxel Accord Healthcare Italia in the following cases.
If you are allergic(hypersensitive) to paclitaxel or to any of the other ingredients listed in section 6, especially to castor oil polyoxyl (macrogol glycerol ricinoleate).

If you are breastfeeding.
If you have an excessively low number of white blood cellsin your blood. Your doctor will take blood samples to rule out this condition.

If you have a severe and uncontrolled infectionand Paclitaxel Accord Healthcare Italia is used to treat Kaposi's sarcoma.
If you fall into any of the above cases, consult your doctor before starting treatment with Paclitaxel Accord
Healthcare Italia.
The use of Paclitaxel Accord Healthcare Italia is not recommended in children(under 18 years of age).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Paclitaxel Accord Healthcare Italia.

To minimize allergic reactions, you will be given other medicines before receiving Paclitaxel
Accord Healthcare Italia.
If you experience severe allergic reactions(for example, difficulty breathing, shortness of breath, chest tightness, low blood pressure, dizziness, feeling lightheaded, skin reactions such as rashes or swelling).
If you experience fever, severe tremors, sore throat or mouth ulcers(signs of bone marrow suppression).
If you experience numbness, tingling, prickling, sensitivity to touch or weakness in your arms and
legs(signs of peripheral neuropathy), a reduction in Paclitaxel Accord
Healthcare Italia may be necessary.
If you experience serious liver problems;in this case, the use of Paclitaxel Accord Healthcare Italia is
not recommended.
If you have problems with cardiac conduction.
If you develop severe or persistent diarrhea, with fever and abdominal pain, during or shortly after
treatment with Paclitaxel Accord Healthcare Italia. In this case you may have inflammation of the
colon (pseudomembranous colitis).
If you have previously undergone radiotherapy to the chest(because it may increase the risk of
pneumonia).
If you have redness or oral lesions(signs of mucositis) and are being treated for Kaposi's sarcoma. In
this case you may need a lower dose.

If you think any of the listed conditions apply to you, tell your doctor immediately.
Paclitaxel Accord Healthcare Italia must always be administered intravenously. Administration of
Paclitaxel Accord Healthcare Italia into the arteries can cause inflammation of the arteries and you may experience pain,
swelling, redness and flushing.

Other medicines and Paclitaxel Accord Healthcare Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those obtained without a prescription. This is because Paclitaxel Accord Healthcare Italia or
other medicines may not work as expected, or it may be more likely that side effects occur.
Interaction means that different drugs can influence each other.
Consult your doctor when taking paclitaxel together with any of the following:

• medicines for the treatment of infections (i.e. antibiotics such as erythromycin, etc.; ask your doctor, nurse or pharmacist if you are not sure if the medicine you are taking is an antibiotic), including medicines for the treatment of fungal infections (e.g. ketoconazole other imidazole antimycotics)
• medicines used to stabilize mood, sometimes also called antidepressants (e.g. fluoxetine)
• medicines used to treat seizures (epilepsy) (e.g. carbamazepine, phenytoin)
• medicines used to lower lipid levels in the blood (e.g. gemfibrozil)
• medicines used for heartburn or stomach ulcers (e.g. cimetidine)
• medicines used to treat HIV and AIDS (e.g. ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, nevirapine)
• a medicine called clopidogrel used for the prevention of blood clots
• a drug called rifampicin, an antibiotic used for tuberculosis. It may be necessary to increase the dose of Paclitaxel Accord Healthcare Italia
• vaccines: If you have been recently vaccinated or are planning to get vaccinated, tell your doctor. The use of Paclitaxel Accord Healthcare Italia in combination with some vaccines can lead to serious complications
• doxorubicin(for cancer treatment): Paclitaxel Accord Healthcare Italia must be administered before cisplatin. Kidney function may need to be checked more frequently
• doxorubicin(for cancer treatment): Paclitaxel Accord Healthcare Italia must be administered 24 hours after doxorubicin, to avoid a high level of doxorubicin in the body.

Paclitaxel Accord Healthcare Italia withfood, beverages and alcohol
Paclitaxel Accord Healthcare Italia is not affected by the consumption of food and beverages.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine. Paclitaxel concentrate for solution
for infusion should not be used if you are pregnant unless clearly recommended. This medicine can
cause serious birth defects and therefore you should not become pregnant during treatment with paclitaxel and you and/or
your partner should use effective contraception while receiving treatment with paclitaxel and
up to 6 months after the end of treatment. If pregnancy occurs during treatment, or within six months after
the end of treatment, tell your doctor immediately.
For male patients treated with paclitaxel, it is recommended not to father children during therapy and for six
months after treatment.

Driving and operating machinery
Paclitaxel Accord Healthcare Italia can cause side effects such as fatigue (very common) and dizziness
(common), which can affect your ability to drive and operate machinery. If you experience these
symptoms, do not drive or operate machinery until they have completely resolved. If your
treatment involves the administration of other medicines, you should ask your doctor if you can drive or
operate machinery.
This medicine contains alcohol, and for this reason it may not be prudent to drive immediately after a
treatment cycle.

Important information about some of the excipients in Paclitaxel Accord Healthcare Italia.
Paclitaxel Accord Healthcare Italia contains castor oil(50% of polyethoxylated castor oil), which may
cause severe allergic reactions. If you are allergic to castor oil, talk to your doctor before you are
given Paclitaxel Accord Healthcare Italia.
Paclitaxel Accord Healthcare Italia contains alcohol
This medicine contains 391 mg of alcohol (ethanol) in each ml. The amount of alcohol in this medicine (at the
maximum dose of 220 mg/ m ) is equivalent to 646 ml of beer or 258 ml of wine.
The alcohol contained in this medicine may alter the effects of other drugs. Talk to your doctor or pharmacist if you
are taking other medicines.
In case of pregnancy or breastfeeding, talk to your doctor or pharmacist before taking this medicine.
If you are dependent on alcohol, talk to your doctor or pharmacist before taking this medicine.

3. How to use Paclitaxel Accord Healthcare Italia

• To minimize allergic reactions, you will be given other medicines before receiving Paclitaxel Accord Healthcare Italia. These medicines may be given as tablets or an infusion into a vein, or both.
• You will receive Paclitaxel Accord Healthcare Italia as an infusiondrop by drop into a vein (intravenously), through an in-line filter. Paclitaxel Accord Healthcare Italia will be administered by a healthcare professional, who will prepare the solution for the infusion before it is given to you. The dose you receive will also depend on the results of your blood tests. You will receive Paclitaxel Accord Healthcare Italia alone or in combination with another anticancer drug depending on the type and severity of the cancer.
• Paclitaxel Accord Healthcare Italia must always be administered into one of your veins over a period of 3 or 24 hours. It is usually given every 2 or 3 weeks, unless your doctor decides otherwise. Your doctor will inform you about the number of Paclitaxel Accord Healthcare Italia cycles you need.

If you have any questions about the use of Paclitaxel Accord Healthcare Italia, ask your doctor.

If you have been given more Paclitaxel Accord Healthcare Italia than you should
In case of overdose, there is no known antidote to Paclitaxel Accord Healthcare Italia. You will receive treatment
of your symptoms.

4. Possible side effects

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

Immediately inform your doctor if you notice signs of allergic reactions.One or more of the following signs may occur:
flushing,
skin reactions,
itching,
chest tightness,
shortness of breath or difficulty breathing,
swelling.
All of these manifestations may be a sign of serious side effects.

Inform your doctor immediately:

• If you experience fever, severe tremors, sore throat or mouth ulcers(signs of bone marrow suppression).
• If you experience numbness or weakness in the arms and legs(signs of peripheral neuropathy). These symptoms of neuropathy may persist for more than 6 months after stopping treatment.
• If you develop severe or persistent diarrhea, with fever and stomach pain.

Very common (may affect more than 1 in 10 people)
Minor allergic reactions such as flushing, skin rashes, itching.
Infections: mostly affecting the upper respiratory tract and urinary tract.
Shortness of breath.
Sore throat or mouth ulcers, redness and pain in the mouth, diarrhea, feeling unwell (nausea,
vomiting).
Hair loss (most cases of hair loss occurred less than one month after starting
paclitaxel. When this happens, hair loss is pronounced (more than 50%) in most patients).
Muscle pain, cramps, joint pain.
Fever, severe chills, headache, dizziness, fatigue, paleness, more frequent bleeding or bruising than usual.
Numbness, tingling or weakness in the arms and legs (all symptoms of peripheral neuropathy)*.
Tests may show a decrease in the number of platelets, white blood cells or red blood cells, low blood
pressure.

Common (may affect up to 1 in 10 people)
Mild and temporary changes in nails and skin, reactions at the injection site (swelling, pain and
localized skin redness).
Tests may show a slowing of the heartbeat, a significant increase in liver enzyme levels (alkaline phosphatase and AST – SGOT).

Uncommon (may affect up to 1 in 100 people)
Shock due to infections (known as “septic shock”).
Palpitations, heart dysfunction (AV block), fast heartbeat, heart attack, difficulty
breathing.
Fatigue, sweating, fainting (syncope), significant allergic reactions, inflammation of the veins
caused by a blood clot (thrombophlebitis), swelling of the face, lips, mouth, tongue or throat.
Back pain, chest pain, pain in hands and feet, chills, abdominal pain (stomach ache).
Tests may show a severe increase in bilirubin (jaundice), high blood pressure and blood
clots.
Heart failure.

Rare (may affect up to 1 in 1,000 people)
Reduction in the number of white blood cells with fever and increased risk of infections (febrile neutropenia).
Nerve conditions with a feeling of weakness in the muscles of the arms and legs (motor neuropathy).
Shortness of breath, pulmonary embolism, pulmonary fibrosis, interstitial pneumonia, dyspnea, pleural effusion.
Bowel obstruction, bowel perforation, inflammation of the colon (ischemic colitis), inflammation of the
pancreas (pancreatitis).
Itching, skin rashes, skin redness (erythema).
Blood poisoning (sepsis), peritonitis.
Fever, dehydration, asthenia, edema, general feeling of discomfort.
Severe and potentially life-threatening hypersensitivity reactions (anaphylactic reactions).
Tests may show an increase in creatinine in the blood, which indicates kidney dysfunction.

Very rare (may affect up to 1 in 10,000 people)
Irregular and fast heartbeat (atrial fibrillation, supraventricular tachycardia).
Sudden disturbance in the process of blood cell formation (acute myeloid leukemia, myelodysplastic syndrome).
Disturbances of the optic nerve and/or vision (scintillating scotomas).
Loss or reduction of hearing (ototoxicity), ringing in the ears (tinnitus), dizziness.
Cough.
Blood clot in a blood vessel of the abdomen and intestine (mesenteric thrombosis), inflammation of the
colon sometimes with severe persistent diarrhea (pseudomembranous colitis, neutropenic colitis), water in the abdomen
(ascites), esophagitis, constipation.
Severe hypersensitivity reactions including fever, skin erythema, joint pain and/or
eye inflammation (Stevens-Johnson syndrome), skin exfoliation (toxic epidermal necrolysis), erythema
with irregular red (exudative) spots (multiforme erythema), skin inflammation with blister formation
and exfoliation (exfoliative dermatitis), urticaria, loss of nails (patients undergoing therapy should protect hands
and feet from sunlight).
Loss of appetite (anorexia).
Severe and potentially life-threatening hypersensitivity reactions with shock (anaphylactic shock).
Impairment of liver function (hepatic necrosis and hepatic encephalopathy, both with documented cases of
fatal outcomes).
Confusional state.

Not known (frequency cannot be estimated from available data)

• Hardening/thickening of the skin (scleroderma)
• Sudden constriction of the muscles of the walls of the bronchioles (bronchospasm)
• Metabolic complications after cancer treatment (tumor lysis syndrome)
• Eye disorders, such as thickened and swollen macula (macular edema), flashes of light (photopsia) and spots, dots, patches and "floaters" that float in the field of vision (vitreous mobile bodies)
• Inflammation of the veins (phlebitis)
• Systemic lupus erythematosus
• Severe conditions causing bleeding, blood clots, or both (disseminated intravascular coagulation, DIC). This is a serious condition in which people bleed too easily, or blood clots form too easily, or both.
• redness and swelling of the palms of the hands or soles of the feet that can cause skin peeling

If any of these side effects become serious, or if you notice any side effect not listed in
this leaflet, please tell your doctor.

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 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 Paclitaxel Accord Healthcare Italia

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 cardboard box after “Scad.”. The expiry
date refers to the last day of that month.

Before opening
Do not store above 25 °C. Keep the vial in the outer packaging to protect the
medicine from light.
Freezing does not negatively affect the product.

After opening the package and before dilution (description of conditions)
From a microbiological point of view, after opening the medicine can be stored for a maximum of 28 days at 25 °C.
The user is responsible for the use of other storage times and conditions.

After dilution (description of conditions)
From a microbiological point of view, the diluted product must be used immediately. If not used
immediately, store in a refrigerator (2-8 °C) for no more than 24 hours, unless the dilution has been
carried out under controlled and validated aseptic conditions. For further details on stability after dilution,
consult the section dedicated to healthcare professionals.
Do not use this medicine if you notice a cloudy solution or an insoluble precipitate.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Paclitaxel Accord Healthcare Italia contains
The active ingredient is paclitaxel.
Each ml of concentrate for solution for infusion contains 6 mg of paclitaxel
Each vial contains 5, 16.7, 25, 50 or 100 ml (corresponding to 30, 100, 150, 300 or 600 mg of
paclitaxel respectively).
The excipients are polyoxyethylated castor oil 35 (macrogol ricinoleate glyceride) and anhydrous ethanol.

Description of the appearance of Paclitaxel Accord Healthcare Italia and contents of the pack
Paclitaxel Accord Healthcare Italia is a clear, colourless or slightly yellowish solution, free from visible
particles.
It is available in vials containing 5 ml, 16.7 ml, 25 ml, 50 ml and 100 ml of concentrate for solution for infusion.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice,
Poland

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:

The following information is intended only for healthcare professionals
Preparation of infusion solutions:
Containers and infusion sets used with Paclitaxel Accord Healthcare Italia must be DEHP-free.This
will minimise the patient’s exposure to the plasticiser DEHP [di-(2-ethylhexyl) phthalate], which may be
released from PVC containers or infusion sets. No significant leaching of DEHP was observed with the use of filters incorporating short PVC-plasticised inlet and/or outlet devices (e.g. IVEX-2).

When handling Paclitaxel Accord Healthcare Italia, caution should be exercisedas with all
antineoplastic drugs. When handling vials containing paclitaxel, appropriate protective gloves should always be worn.
Dilution must be carried out under aseptic conditions by trained personnel in a dedicated area.
If contact with the skin occurs, wash with soap and water. If contact with mucous membranes occurs, wash with
plenty of water.
The “Chemo-Dispensing Pin” or similar piercing devices with tips should not be used, as
they may cause the stopper to fall into the vial, resulting in loss of product sterility.

Step 1: dilute the concentrate
Before administration, Paclitaxel Accord Healthcare Italia must be further diluted with the following
solutions (alternatively):

• 0.9% Sodium Chloride solution for injection
• 5% Glucose solution for injection
• 5% Glucose and 0.9% Sodium Chloride solutions for injection
• 5% Glucose solution in Ringer’s solution for injection

The final paclitaxel concentration for infusion must be between 0.3 mg/ml and 1.2 mg/ml.
DEHP-free containers and infusion sets must be used
After dilution, solutions may appear turbid, which is attributable to the vehicle of the formulation and is not
removed by filtration. No significant loss of drug potency was observed after simulated administration of the solution through an infusion set equipped with an in-line filter.

Step 2: administration of the infusion
Before administration, all patients must be premedicatedwith corticosteroids, antihistamines and H antagonists.
Treatment with Paclitaxel Accord Healthcare Italia should not be repeated until the neutrophil granulocyte count is
≥1,500/mm (≥1,000/mm in patients with Kaposi’s sarcoma) and the platelet count is
≥100,000/mm (≥75,000/mm in patients with Kaposi’s sarcoma).
Avoid precipitation of the infusion solution:

• Use as soon as possible after dilution.
• Avoid excessive agitation, vibration and shaking.
• Thoroughly flush infusion sets before use.
• Regularly inspect the appearance of the infused solution and stop the infusion if precipitate is present.

The chemical and physical stability of the diluted solution is demonstrated at 5° and 25 °C for 7 days after dilution in a
5% glucose solution, and for 14 days after dilution in a 0.9% sodium chloride solution for injection.
From a microbiological point of view, the diluted product must be used immediately or stored at 2-8 °C for a
maximum of 24 hours.
Paclitaxel injection must be administered through an appropriate in-line filter with a microporous membrane ≤ 0.2 micrometres. DEHP-free containers and infusion sets must be used. No significant leaching was observed with the use of filters
incorporating short PVC-plasticised inlet and/or outlet devices.

Step 3: disposal
Dispose of unused medicinal product or waste material in accordance with local regulations for the handling of
cytotoxic substances.

Dosage
The recommended doses for intravenous infusion of Paclitaxel Accord Healthcare Italia are as follows:

Treatment with Paclitaxel Accord Healthcare Italia should not be repeated until the neutrophil granulocyte count is
≥1,500/mm (≥1,000/mm in patients with Kaposi’s sarcoma) and the platelet count is
≥100,000/mm (≥75,000/mm in patients with Kaposi’s sarcoma).
In patients who develop severe neutropenia (neutrophils <500/mm for ≥7 days) or severe peripheral neuropathy, the
dose for subsequent cycles should be reduced by 20% (25% in patients with Kaposi’s sarcoma) (see Summary of
Product Characteristics).
Sufficient data are not available to recommend dosage adjustments in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment should not be treated with
Paclitaxel Accord Healthcare Italia (see Summary of Product Characteristics).
The use of Paclitaxel Accord Healthcare Italia is not recommended in children under 18 years of age due to the
lack of safety and efficacy data.