Paclitaxel Teva

Package leaflet: Information for the user

Paclitaxel Teva 6 mg/ml concentrate for solution for infusion

Paclitaxel
Generic medicine
Read this entire 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, consult your doctor.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

Paclitaxel Teva concentrate for solution for infusion can only be prescribed by
healthcare professionals to whom you may direct any questions regarding the information
contained in this leaflet.

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

Paclitaxel Teva is an antineoplastic or anticancer agent. It can block the division and growth of cancer cells.
Paclitaxel Teva is used to treat several types of tumours, such as:
Ovarian carcinoma (advanced or progressive ovarian cancer, residual tumour >1 cm after
laparotomy)
Either as initial therapy in combination with platinum- or cisplatin-containing medicines, or
as second-line treatment following failure of other platinum-based therapies.
Breast cancer (treatment of early-stage breast cancer after surgical removal of the
primary tumour, advanced or progressive breast cancer)
As adjuvant therapy following treatment with anthracyclines and cyclophosphamide (AC).
As initial therapy in combination with a medicine from the anthracycline group in patients
suitable for treatment with this class of medicines, or together with trastuzumab.
Alone in patients in whom anthracycline therapy has failed or for whom this type of treatment is not indicated.
Some types of lung cancer (non-small cell lung cancer)
In combination with cisplatin in patients unsuitable for surgical resection and/or radiotherapy.
This medicine is also used to treat a specific type of AIDS-related cancer arising in
connective tissue (Kaposi’s sarcoma), in cases where other treatments, such as liposomal anthracyclines, have failed.

2. What you need to know before using Paclitaxel Teva

Do not use Paclitaxel Teva

• if you are allergic (hypersensitive) to paclitaxel or any of the other ingredients of this medicine (listed in section 6), especially macrogol glycerol ricinoleate
• if you are breastfeeding
• if you have severely impaired liver function
• if you have a very low white blood cell count (neutrophils). Your doctor will take blood samples to check this.
• if you have concurrent, severe and uncontrolled infections, and are being treated for Kaposi's sarcoma.

If you are in any of these situations, please speak with your doctor before starting treatment with
Paclitaxel Teva.
Warnings and precautions
Talk to your doctor before using Paclitaxel Teva

• if you experience severe allergic reactions (for example, difficulty breathing, shortness of breath, chest discomfort, drop in blood pressure, dizziness, lightheadedness, skin reactions such as rash or swelling).
• if you have fever, severe chills, sore throat or mouth ulcers (signs of myelosuppression); your doctor will frequently monitor your blood.
• if you have red or inflamed mouth (signs of mucositis) and are being treated for Kaposi's sarcoma. You may require a lower dose.
• if you develop heart problems during treatment with Paclitaxel Teva; your doctor should check your heart function before the next treatment with Paclitaxel Teva.
• if you experience numbness, tingling sensations, or weakness in your arms and legs (signs of peripheral neuropathy); a dose reduction of Paclitaxel Teva may be necessary.
• if you develop severe or persistent diarrhoea, with fever and stomach pain, during or shortly after treatment with Paclitaxel Teva. Your colon may be inflamed (pseudomembranous colitis).
• if you have previously received chest radiation (as this may increase the risk of pulmonary inflammation).

Before each Paclitaxel Teva treatment, you will be premedicated with several other medicines,
belonging to the class of corticosteroids (e.g. dexamethasone), antihistamines (e.g.
diphenhydramine or chlorpheniramine) and H-\antagonists (e.g. cimetidine or
ranitidine). Premedication is necessary to reduce the risk of severe hypersensitivity reactions
(see section 4. Possible side effects, not common).
Other medicines and Paclitaxel Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This is because Paclitaxel Teva or other medicines may not work as intended, or you may be more likely to experience side effects.
An interaction means that different medicines can affect each other. Talk to your doctor if you are using paclitaxel together with any of the following:

• medicines for the treatment of infections (i.e. antibiotics such as erythromycin, rifampicin, etc.; ask your doctor, nurse or pharmacist if you are unsure whether the medicine you are taking is an antibiotic), including medicines for the treatment of fungal infections (e.g. ketoconazole)
• medicines used to stabilise mood, 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 reflux or stomach ulcers (e.g. cimetidine)
• medicines used for the treatment of HIV and AIDS (e.g. ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, nevirapine)
• a medicine called clopidogrel used to prevent blood clots
• a medicine called rifampicin, an antibiotic used for tuberculosis. An increase in the dose of Paclitaxel Teva may be necessary
• vaccines: inform your doctor if you have recently been vaccinated or are planning to be vaccinated. Using Paclitaxel Teva together with certain vaccines may cause serious complications
• cisplatin (for treating tumours): Paclitaxel Teva must be administered before cisplatin. Your kidney function may need to be monitored more frequently
• doxorubicin (for treating tumours): Paclitaxel Teva must be administered 24 hours after doxorubicin, to avoid high levels of doxorubicin in the body.

If you are being treated with a combination of Paclitaxel Teva and doxorubicin or trastuzumab,
careful monitoring of cardiac function before and during treatment is required.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, or are planning a pregnancy, consult your
doctor or pharmacist before taking this medicine.
Paclitaxel Teva must not be used during pregnancy unless strictly necessary.
Paclitaxel may cause harm to the unborn baby. Avoid becoming pregnant and use effective contraception during treatment. If you become pregnant, inform your doctor immediately.
Female and male patients of reproductive age, and/or their partners, must use contraception for at least six months after treatment with Paclitaxel Teva.
Male patients should discuss sperm cryopreservation with their doctor before starting treatment with Paclitaxel Teva due to the risk of infertility.
Paclitaxel Teva must not be used if you are breastfeeding. You must stop breastfeeding during treatment with Paclitaxel Teva. Do not restart breastfeeding without your doctor's permission.
Driving and using machines
There is no need to stop driving between treatment cycles with Paclitaxel Teva, but you should remember that this medicine contains alcohol, and it is advisable not to drive immediately after treatment. In any case, you must not drive if you experience dizziness or mental confusion.
If in doubt, consult your doctor, nurse or pharmacist.
Paclitaxel Teva contains alcohol and macrogol glycerol ricinoleate
A vial of Paclitaxel Teva contains 49.5 vol% alcohol (ethanol).
This medicine contains 2 g of alcohol (ethanol) in each 5 ml vial, 7 g in each 16.7 ml vial, 10 g in each 25 ml vial and 20 g in each 50 ml vial, which is equivalent to 396 mg/ml. The amount in 1 ml of this medicine is equivalent to 10 ml of beer or 4 ml of wine.
The amount of alcohol in this medicine may affect your ability to drive vehicles or operate machinery. This is because alcohol may impair your judgment and reaction speed.
If you have epilepsy or liver problems, talk to your doctor or pharmacist before taking this medicine.
The amount of alcohol in this medicine may alter the effects of other medicines. Talk to your
doctor or pharmacist if you are taking other medicines.
If you are pregnant, talk to your doctor or pharmacist before taking this medicine.
If you are alcohol-dependent, talk to your doctor before taking this medicine.
Since this medicine is usually administered slowly over 3 or 24 hours, the effects of alcohol may be reduced.
Macrogol glycerol ricinoleate may cause severe allergic reactions.

3. How to use Paclitaxel Teva

To minimize allergic reactions, you will be given other medicines before Paclitaxel Teva. These medicines may be in tablet form, intravenous infusion, or both.
Your doctor will decide which medicines and what doses you should take. Paclitaxel Teva must be administered under medical supervision, and your doctor can provide further information.
The amount (dose) of Paclitaxel Teva you will receive is based on your body surface area in square meters (m²). This is calculated according to your height and weight. The administered dose may also depend on the results of your blood tests.
Depending on the type and severity of the tumor, Paclitaxel Teva will be administered either alone or in combination with other anticancer agents (e.g. cisplatin, doxorubicin, trastuzumab). Paclitaxel Teva is given by intravenous infusion over a period of 3 to 24 hours. It is usually administered every 3 weeks (every 2 weeks in patients with Kaposi's sarcoma), unless your doctor decides otherwise. Your doctor will inform you about the number of Paclitaxel Teva cycles you should receive.
The needle must remain in the vein during administration of the medicine. If the needle comes out of the vein, becomes loose, or if the solution leaks from the vein into surrounding tissues (in which case you may feel discomfort or pain), inform your doctor or a nurse immediately.
Use in children
Due to lack of data on efficacy and safety, the use of paclitaxel is not recommended in children under 18 years of age.
If you take more Paclitaxel Teva than you should
There are no known antidotes for overdose with Paclitaxel Teva. You will receive treatment for your symptoms.
If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur, among others:
Tell your doctor immediately if you notice any signs of allergic reactions. These
may include one or more of the following:

• flushing,
• skin reactions,
• itching,
• chest discomfort,
• shortness of breath or difficulty breathing,
• swelling. These may all be signs of serious side effects.

Tell your doctor immediately

• if you have fever, severe chills, sore throat or mouth ulcers (signs of
  myelosuppression)

• if you experience numbness or weakness in arms and legs (signs of peripheral neuropathy)

• if you develop severe or persistent diarrhoea, with fever and stomach pain.

Very common: may affect more than 1 in 10 people

• infections (mainly urinary tract and upper respiratory tract infections: inflammation of the nasal mucosa characterised by nasal congestion, sneezing and discharge (rhinitis), and inflammation of the throat (pharyngitis), including herpes simplex, fungal infection of the mouth) (with reported fatal outcomes)
• blood abnormalities due to bone marrow suppression (myelosup游戏副本

5. How to store Paclitaxel Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and outer carton after “Do not use after” or “Exp.”. The first two digits indicate the month, and the last digits indicate the year. The expiry date refers to the last day of the stated month.
This medicine does not require any special storage temperature; store in the original packaging. Storage in the freezer does not damage the product.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Paclitaxel Teva contains

• The active substance is paclitaxel. Paclitaxel Teva concentrate for solution for infusion contains 6 mg of paclitaxel per ml.
• The other components are macrogol glycerol ricinoleate, anhydrous ethanol and citric acid.

Description of the appearance of Paclitaxel Teva and package contents
Paclitaxel Teva is a clear, colourless or pale yellow, viscous solution. It is available in
5 ml, 16.7 ml, 25 ml and 50 ml vials.
Each 5 ml vial contains 30 mg paclitaxel.
Each 16.7 ml vial contains 100 mg paclitaxel.
Each 25 ml vial contains 150 mg paclitaxel.
Each 50 ml vial contains 300 mg paclitaxel.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy
Manufacturer
Pharmachemie B.V.
Swensweg 5
P.O. Box 552,
2003 RN Haarlem, The Netherlands

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium Paclitaxin 6 mg/ml concentrate for solution for infusion
Estonia Paclitaxel-Teva 6 mg/ml concentrate for infusion solution for preparation
France Paclitaxel-Teva 6 mg/ml solution to be diluted for perfusion
Germany Paclitaxel-GRY® 6 mg/ml concentrate for the preparation of an infusion solution
Greece Paxene Paclitaxin 6 mg/ml πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση
Hungary Paclitaxel-Teva 6 mg/ml concentrate for infusion solution
Italy Paclitaxel Teva 6 mg/ml concentrate for solution for infusion
Lithuania Paclitaxel-Teva 6 mg/ml concentrate for infusion solution
Luxembourg Paclitaxin 6 mg/ml solution to be diluted for perfusion
Paclitaxin 6 mg/ml solution to be diluted for perfusion (30 mg/5 ml).
Paclitaxin 6 mg/ml solution to be diluted for perfusion (100 mg/16.7 ml)
Paclitaxin 6 mg/ml solution to be diluted for perfusion (150 mg/25 ml)
Paclitaxin 6 mg/ml solution to be diluted for perfusion (300 mg/50 ml).
The Netherlands Paclitaxin concentrate for intravenous solution 6 mg/ml
Slovenia Paclitaxin 6 mg/ml, concentrate for infusion solution
Spain Paclitaxel Teva 6 mg/ml, concentrate for solution for perfusion

The following information is intended exclusively for medical professionals or

healthcare practitioners:
The following provides a summary of information relevant to the administration of Paclitaxel Teva. The person administering the infusion must be experienced in the handling and use of cytotoxic agents and must be familiar with the pharmacological characteristics of Paclitaxel Teva. Reference should be made to established guidelines for the safe use of antineoplastic agents.
Handling: As with all antineoplastic agents, caution should be exercised when handling Paclitaxel Teva. Pregnant women should not come into contact with cytotoxic agents. Dilution must be performed under aseptic conditions by trained personnel in a designated area. Appropriate protective gloves must be worn. Adequate precautions must be taken to avoid contact with the skin and mucous membranes. In case of skin contact, wash thoroughly with soap and water. Following skin exposure, tingling, burning sensations, and erythema have been reported. In case of contact with mucous membranes, they must be thoroughly rinsed with water. Following inhalation, dyspnea, chest pain, sore throat, and nausea have been reported.
If unopened vials have been stored in a refrigerator or frozen, a precipitate may form, which will redissolve upon gentle agitation or once room temperature has been reached. This does not affect the quality of the product. If the solution remains cloudy or an insoluble precipitate is observed, the vial must be discarded.
Following multiple needle insertions and withdrawals, vials maintain microbiological, chemical, and physical stability for up to 28 days at 25°C. Other storage times and conditions during use are the responsibility of the user.
The use of the 'Chemo-Dispensing Pin' device or similar piercing devices with tips that may cause the stopper to fall into the vial, resulting in loss of product sterility, is not recommended.
Preparation for intravenous administration: Prior to infusion, Paclitaxel Teva must be diluted using aseptic techniques in either 9 mg/ml (0.9%) sodium chloride solution for infusion, 50 mg/ml (5%) glucose solution for infusion, a mixture of 9 mg/ml (0.9%) sodium chloride solution for infusion and 50 mg/ml (5%) glucose solution for infusion, or Ringer's solution for infusion containing 50 mg/ml (5%) glucose, to a final concentration of 0.3 to 1.2 mg/ml.
It has been demonstrated that the chemical and physical stability during use of the prepared infusion solution is 27 hours at 25°C when diluted in either 0.9% (9 mg/ml) sodium chloride solution for infusion and 50 mg/ml (5%) glucose solution for infusion, or Ringer's solution for infusion containing 50 mg/ml (5%) glucose.
It has been demonstrated that the chemical and physical stability during use of the infusion solution diluted in either 50 mg/ml (5%) glucose solution for infusion or 9 mg/ml (0.9%) sodium chloride solution for infusion is 14 days at 5°C and at 25°C.
It has been demonstrated that the microbiological stability during use of the infusion solution is 27 hours at 25°C. Other storage times and conditions during use are the responsibility of the user.
After dilution, solutions may appear slightly cloudy due to the formulation vehicle, which is not removed by filtration. Paclitaxel Teva must be administered through an in-line filter with a microporous membrane ≤ 0.22 µm. No significant loss of potency has been observed during simulated release of the solution through IV tubing containing an in-line filter.
Rare cases of precipitation during paclitaxel infusions have been reported, usually towards the end of a 24-hour infusion period. Although the cause of this precipitation has not been fully elucidated, it is likely related to supersaturation of the diluted solution. To minimize the risk of precipitation, Paclitaxel Teva should be used as soon as possible after dilution, and excessive agitation, vibration, or shaking should be avoided. Infusion sets must be thoroughly flushed before use. During infusion, the solution should be visually inspected regularly, and the infusion must be stopped immediately if precipitation is observed.
To minimize patient exposure to DEHP [di-(2-ethylhexyl)phthalate], which may leach from plasticized PVC infusion materials, diluted paclitaxel solutions must be stored in vials made of non-PVC material (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene administration sets. The use of filter devices incorporating short PVC inlet and/or outlet tubing has not resulted in significant DEHP leaching.
Disposal: All equipment used in the preparation and administration of Paclitaxel Teva, or that otherwise comes into contact with it, must be disposed of in accordance with current regulations governing the handling of cytotoxic compounds.
Administration and dosage
All patients must be premedicated with corticosteroids, antihistamines, and H-_antagonists prior to treatment. The diluted solution of Paclitaxel Teva must be administered using non-PVC equipment with an in-line filter with a microporous membrane ≤ 0.22 µm.
Recommended intravenous doses for Paclitaxel Teva are:
First-line treatment of
ovarian carcinoma: 135 mg/m² over 24 hours followed by cisplatin 75 mg/m²; or
175 mg/m² over 3 hours followed by cisplatin 75 mg/m²;
Second-line treatment of ovarian
carcinoma or breast cancer: 175 mg/m² over 3 hours;
Adjuvant treatment of
breast cancer: 175 mg/m² over 3 hours; followed by therapy with
anthracyclines and cyclophosphamide (AC);
First-line treatment of
breast cancer: 220 mg/m² over 24 hours, administered 24 hours after
doxorubicin (50 mg/m²);
175 mg/m² over 3 hours after
trastuzumab administration (see summary of product characteristics);
Non-small cell lung cancer: 175 mg/m² over 3 hours followed by cisplatin 80 mg/m²;
AIDS-related Kaposi's sarcoma: 100 mg/m² over 3 hours.
Storage
No special storage conditions are required. If the product is refrigerated, a precipitate may form, which redissolves upon gentle agitation or once room temperature is reached. This does not affect the quality of the product. If the solution remains cloudy or an insoluble precipitate is observed, the vial must be discarded.
Refrigeration does not compromise the product.
The expiry date is indicated on the outer packaging and on the vial label. Do not use after this date.