PACLITAXEL 6 mg /Ml Concentrate For Infusion Solution

Зміст інструкції

1. Paclitaxel Teva 6 mg/ml concentrate for solution for infusion
   1. What is Paclitaxel Teva and what is it 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 6 mg/ml concentrate for solution for infusion

Paclitaxel

Equivalent medicinal product

Read this leaflet carefully before you start 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.
• 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 you get any side effects, even those not listed in this leaflet, tell 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 you use 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 Tevaconcentrate for solution for infusion can only be prescribed by

healthcare professionals to whom any questions relating to the information

contained in this leaflet can be addressed.

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

Paclitaxel Teva is an antineoplastic or antitumor agent. It can block the division and
growth of cancer cells.
Paclitaxel Teva is used to treat several types of tumors, such as:

Ovarian carcinoma(advanced or expanding ovarian cancer, residual tumor >1 cm after

laparotomy)
Both as initial therapy in combination with platinum-containing medicines or cisplatin, or
as second-line treatment in case of failure of other platinum-based therapies.

Breast cancer(treatment of early-stage breast cancer after surgical removal

of the primary tumor, advanced or expanding breast cancer)
As adjuvant therapy after 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 not been successful or for whom this
type of treatment is not indicated.

Some types oflung cancer(non-small cell lung cancer)
Together with cisplatin in patients unsuitable for surgical removal and/or radiotherapy.

This medicine is also used in the treatment of a particular type ofcancer related
to AIDSthat develops in connective tissue (Kaposi's sarcoma),in case of failure of
other treatments, such as liposomal anthracyclines.

2. What you need to know before using Paclitaxel Teva

Do not use Paclitaxel Teva

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

If you are in any of these situations, talk to 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, decreased blood pressure, dizziness, lightheadedness, skin reactions such as rash or swelling).
• if you have a fever, severe chills, sore throat or mouth ulcers (signs of myelosuppression), your doctor will frequently check your blood.
• if you have an inflamed or red mouth (signs of mucositis) and are being treated for Kaposi's sarcoma. You may need a lower dose.
• if you experience heart problems during treatment with Paclitaxel Teva; your doctor should check your heart function before the next treatment with Paclitaxel Teva.
• if you have numbness, tingling, or weakness in your arms and legs (signs of peripheral neuropathy); a reduction in the dose of Paclitaxel Teva may be necessary.
• if you develop severe or persistent diarrhea, with fever and stomach pain, during or shortly after treatment with Paclitaxel Teva. Your colon may be inflamed (pseudomembranous colitis).
• if you have received previous radiation to the chest (because it may increase the risk of lung inflammation).

Before each treatment with Paclitaxel Teva, you will be premedicated with several other medicines,
belonging to the class of corticosteroids (for example dexamethasone), antihistamines (such
as diphenhydramine or chlorphenamine) and H2 antagonists (such as cimetidine or
ranitidine). Premedication is necessary to reduce the risk of severe hypersensitivity reactions (see section 4. Possible side effects, uncommon).

Other medicines and Paclitaxel Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. This is because Paclitaxel Teva or other medicines
may not work as expected or you may be more likely to experience side
effects.
Interaction means that different medicines can affect each other. Talk to your doctor
if you are using paclitaxel at the same time as 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 not sure if the medicine you are taking is an antibiotic), including medicines for the treatment of fungal infections (e.g. ketoconazole)
• medicines used to help stabilize your mood, also called antidepressants (e.g. fluoxetine)
• medicines used for the treatment of seizures (epilepsy) (e.g. carbamazepine, phenytoin)
• medicines used to help 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: tell your doctor if you have been recently vaccinated or are planning to be vaccinated. The use of Paclitaxel Teva together with some vaccines may cause serious complications
• cisplatin (for treating tumors): Paclitaxel Teva must be administered before cisplatin. Your kidney function may need to be checked more frequently
• doxorubicin (for treating tumors): Paclitaxel Teva must be administered 24 hours after doxorubicin, to avoid high levels of doxorubicin in the body.

If you are treated with a combination of Paclitaxel Teva and doxorubicin or trastuzumab,
care must be taken in monitoring heart function before and during
treatment.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your
doctor or pharmacist for advice before taking this medicine.
Paclitaxel Teva must not be used during pregnancy unless it is strictly
necessary.
Paclitaxel can cause harm to the fetus. Avoid becoming pregnant and use effective
contraception during treatment. If you become pregnant, inform your doctor promptly. Both
male and female patients of childbearing potential, and/or their partners, must use
contraception for at least six months after treatment with Paclitaxel Teva.
Male patients should inquire about sperm cryopreservation before
treatment with Paclitaxel Teva due to the possibility of infertility.
Paclitaxel Teva must not be used if you are breastfeeding. Stop breastfeeding during
therapy with Paclitaxel Teva. Do not resume breastfeeding without your doctor's permission.

Driving and operating machinery
It is not necessary 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 should not drive if you experience dizziness or mental
confusion.
If in doubt, consult your doctor, nurse or pharmacist.

Paclitaxel Teva contains alcohol and castor oil ethoxylated
One 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 impair the ability to drive vehicles or operate
machinery. This is because alcohol can impair judgment and how quickly
you react to stimuli.
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 have an alcohol dependence, talk to your doctor before taking this medicine.
Because this medicine is usually administered slowly over 3 or 24
hours, the effects of alcohol may be reduced.
Castor oil ethoxylated may cause serious reactions (allergic).

3. How to use Paclitaxel Teva

To minimize allergic reactions, you will be given other medications before
Paclitaxel Teva. These medications may be in tablet form or as an intravenous infusion, or
both.
The doctor will decide which and how many doses you should take. Paclitaxel Teva must be
administered under the supervision of a doctor, who can provide more information.
The amount (dose) of Paclitaxel Teva that will be administered to you depends on your body
surface area in square meters (m²). This is calculated based on your height and weight. The
administration dose will also depend on the results of your blood tests.
Depending on the type and severity of the tumor, Paclitaxel Teva will be administered to you
alone or in combination with other anticancer agents (e.g. cisplatin, doxorubicin,
trastuzumab). Paclitaxel Teva is injected via intravenous drip (intravenous use)
for a period of 3 to 24 hours. It is usually administered every 3 weeks (2 weeks in
patients with Kaposi's sarcoma), unless the doctor decides otherwise. The doctor will
inform you about the number of Paclitaxel Teva cycles you need to receive.
The needle must remain in the vein during the administration of the medication. If the needle
comes out of the vein or loosens, or if the solution leaks from the vein into the tissues (in
which case you will feel discomfort or pain), immediately inform the doctor or nurse.

Use in children
Due to the lack of data on its 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 Paclitaxel Teva overdose. You will receive treatment for
your symptoms.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Among others, the following side effects may occur:

Immediately inform your doctor if you notice any signs of allergic reactions. These
may include one or more of the following:

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

Immediately inform your doctor

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

myelosuppression)

• if you have numbness or weakness in your arms and legs (signs of peripheral neuropathy)
• if you develop severe or persistent diarrhea, 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 characterized by a stuffy nose, sneezing and secretions (rhinitis) and inflammation of the throat (pharyngitis) and including herpes simplex, fungal infection of the mouth) (with reported cases of fatal outcomes)
• abnormalities in blood composition due to bone marrow suppression (myelosuppression)
• platelet deficiency with resulting bruising and a tendency to bleed (thrombocytopenia)
• white blood cell deficiency followed by increased susceptibility to infections (severe leukopenia, severe neutropenia), anemia, bleeding
• mild hypersensitivity reactions (mainly facial redness and skin rash)
• anorexia
• neuropathy, numbness, tingling or pain in hands and feet consistently (all symptoms of peripheral neuropathy)*
• drowsiness
• paresthesia
• low blood pressure
• nausea, vomiting, diarrhea
• inflammation of the mucous membranes (mucositis)
• inflammation of the oral mucous membranes (stomatitis), abdominal pain
• hair loss (most cases of hair loss occur less than a month after starting paclitaxel. When this happens, hair loss is pronounced (greater than 50%) in most patients
• muscle pain and joint pain
• pain
• abnormal accumulation of fluid in the hands, feet, and face (edema). *These may persist for more than 6 months after stopping paclitaxel

Common: (may affect up to 1 in 10 people

• flu-like syndrome
• blood disorder (white blood cell deficiency) accompanied by fever and increased susceptibility to infections (febrile neutropenia)
• depression
• severe form of neuropathy that gives rise mainly to constant numbness, tingling or constant pain in hands and feet (peripheral neuropathy), nervousness, insomnia, disturbed thinking, taste abnormalities, abnormal gait, motor disorders (hypokinesia), reduced sense of touch (hypoesthesia)
• slowed heart rate (bradycardia), accelerated heart rate (tachycardia), palpitations
• loss of consciousness
• vasodilation with resulting flushing
• nosebleeds
• dry mouth, mouth ulceration
• black and bloody stools (melena)
• indigestion
• dry skin, itching, acne, mild and transient nail and skin abnormalities
• bone pain
• leg cramps, muscle weakness, back pain
• discomfort during urination
• mild reactions at the injection site (skin swelling due to fluid retention (edema), pain, redness (erythema), skin hardening (induration), tenderness, skin discoloration or swelling, extravasation (leakage of drug from the vein) which can cause cellulitis (painful swelling and redness), formation of marks (cutaneous fibrosis) and skin tissue death (epidermal necrosis). The appearance of reactions at the injection site may be delayed from one week to ten days
• chest pain
• chills
• increased levels of certain enzymes in the blood (AST, SGOT).

Uncommon: may affect up to 1 in 100 people

• severe infection
• severe drop in blood pressure due to bacterial infection in the blood accompanied by pallor and restlessness, increased heart rate and moist skin (septic shock)
• severe anemia
• hypersensitivity (delayed)
• severe allergic reactions (angioedema) requiring treatment (e.g. low or high blood pressure, swelling of the face, tongue or lips, breathing problems or widespread rash, chills, back and chest pain, rapid heart rate, stomach pain, pain in hands and feet, sweating)
• weight loss, weight gain
• dry eyes, lazy eye (amblyopia)
• visual field disorders
• myocardial infarction
• heart failure
• heart muscle disorders (cardiomyopathy)
• heart rate disorders (fast heartbeat: asymptomatic ventricular tachycardia, bigeminy tachycardia)
• heart conduction disorders (AV block) sometimes followed by loss of consciousness
• electrocardiogram abnormalities
• high blood pressure
• thrombosis, inflammation of the veins with formation of blood clots often felt as hard and painful with reddened skin
• nail or nail bed discoloration
• severe increase in bilirubin (jaundice).

Rare: may affect up to 1 in 1,000 people

• severe blood poisoning (sepsis)
• lung inflammation (pneumonia)
• inflammation of the abdominal membrane (peritonitis)
• fever associated with a decrease in the number of specific white blood cells needed to fight infection (febrile neutropenia)
• severe, generalized allergic reactions and potentially fatal (anaphylactic reactions)
• involvement of motor nerves resulting in weakness of arms and legs (motor neuropathy)
• heart failure
• shortness of breath
• pleural effusion, pneumonia (interstitial pneumonia)
• pulmonary fibrosis, blockage of the airways (pulmonary embolism), difficulty breathing
• stomach pain caused, for example, by constipation or the presence of ulcers in the intestine (intestinal obstruction/perforation)
• inflammation of the pancreas, causing severe pain in the abdomen and back (pancreatitis)
• inflammation of the large intestine with possible severe and continuous diarrhea (ischemic colitis)
• skin redness
• skin rash, very itchy rash (pruritus)
• fever
• fluid loss (dehydration)
• fluid retention (edema)
• weakness, general malaise
• increased creatinine in the blood.

Very rare: may affect up to 1 in 10,000 patients

• severe disorders of the hematopoietic cells of the bone marrow (acute myeloid leukemia, myelodysplastic syndrome)
• severe, generalized allergic reactions and potentially fatal followed by shock
• confusion, defect of some nerves (autonomic neuropathy) which can cause paralysis of the intestinal muscles (paralytic ileus) and a sudden drop in blood pressure with possible dizziness as a result, for example, from moving quickly from a sitting or lying position to an upright position (orthostatic hypotension)
• seizures, brain disorders characterized, for example, by convulsions and loss of consciousness (encephalopathy), coordination disorders (ataxia)
• headache
• dizziness
• optic nerve and/or vision disorders (scotoma scintillans)
• damage to the ears (ototoxicity), hearing loss, dizziness (vertigo)
• ringing in the ears (tinnitus)
• irregular and accelerated heartbeat (atrial fibrillation)
• increased heartbeat originating from a specific part of the heart (supraventricular tachycardia)
• shock
• cough
• high blood pressure in the lungs
• inflammation of the large intestine with possible severe and continuous diarrhea (neutropenic colitis, pseudomembranous colitis, necrotizing colitis)
• formation of blood clots in the abdominal membrane (mesenteric thrombosis)
• inflammation of the esophagus (esophagitis)
• accumulation of fluid in the abdominal cavity (ascites)
• constipation
• liver function disorders (liver necrosis, hepatic encephalopathy) with reported cases of death
• severe hypersensitivity reactions with fever, appearance of red spots on the skin, joint pain and/or eye inflammation (Stevens-Johnson syndrome)
• local skin necrosis (epidermal necrosis), skin rash with moist skin and red and irregular patches (erythema multiforme), hives and formation of wheals (urticaria)
• nail loss (patients undergoing therapy should protect their hands and feet from the sun)
• inflammation of the hair follicles (folliculitis)
• inflammation of the skin with blisters or scaling (exfoliative dermatitis).

Not known (frequency cannot be estimated based on available data)

• complications caused by the products of the decomposition of tumor cells that are dying (tumor lysis syndrome)
• fluid accumulation in the eyes (macular edema), flashes of light in the eyes (photopsia), small spots or the presence of dust in the visual field (floaters), increased tear production
• inflammation of a vein (phlebitis)
• excessive collagen deposits in the skin (scleroderma)
• autoimmune disease with multiple symptoms, such as red and scaly patches on the skin, joint pain or fatigue (systemic lupus erythematosus) or skin rashes and red, thick and often scaly sores that can burn or itch (cutaneous lupus erythematosus)
• redness and swelling of the palms of the hands or soles of the feet that can cause skin peeling
• disseminated intravascular coagulation, or “DIC”. This is a serious condition that causes people to bleed too easily, blood clots to form too easily, or both
• acute inflammatory reaction limited to areas previously irradiated, triggered by the administration of precipitating systemic agents after radiotherapy (recall phenomenon)
• excessive sweating (hyperhidrosis).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
please tell your doctor or pharmacist. You can also report side effects
directly through the national system at: 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 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 vial and the packaging
after “do not use after” or “Exp.”. The first two numbers indicate the month, while the last
numbers indicate the year. The expiry date refers to the last day of the month.
This medicine does not require any particular storage temperature, store
in the original packaging. Storage in a freezer does not damage the product.
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 Teva contains

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

Description of the appearance of Paclitaxel Teva and contents of the pack
Paclitaxel Teva is a clear, viscous solution, colourless or pale yellow. It is available in
vials of 5 ml, 16.7 ml, 25 ml and 50 ml.
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

Manufacturer
Pharmachemie B.V.
Swensweg 5
P.O. Box 552,
2003 RN Haarlem, Netherlands

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Belgium Paclitaxin 6 mg/ml concentrate for solution for infusion
Estonia Paclitaxel-Teva 6 mg/ml concentrate for preparation of infusion solution
France Paclitaxel-Teva 6 mg/ml solution for dilution for perfusion
Germany Paclitaxel-GRY® 6 mg/ml Concentrate for the preparation of an
infusion solution
Greece Paxene Paclitaxin 6 mg/ml dense solution for preparation of solution
for infusion
Hungary Paclitaxel-Teva 6 mg/ml concentrate for solution for infusion
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 for dilution for perfusion
Paclitaxin 6 mg/ml solution for dilution for perfusion (30mg/5ml).
Paclitaxin 6 mg/ml solution for dilution for perfusion (100mg/16.7ml)
Paclitaxin 6 mg/ml solution for dilution for perfusion (150mg/25ml)
Paclitaxin 6 mg/ml solution for dilution for perfusion (300 mg/50ml).
Netherlands Paclitaxin concentrate for intravenous solution 6 mg/ml
Slovenia Paclitaxin 6 mg/ml, concentrate for solution for infusion
Spain Paclitaxel Teva 6 mg/ml, concentrate for solution for perfusion
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The following information is intended exclusively for healthcare professionals or
healthcare operators:
The following summarizes information useful for the administration of Paclitaxel Teva. Those administering the infusion must be experienced in handling and using cytotoxic agents and be familiar with the pharmacological characteristics of Paclitaxel Teva. Reference should be made to guidelines on the safe use of antineoplastic agents.

Handling:as with all antineoplastic agents, caution is advised when handling Paclitaxel Teva. Pregnant women should not come into contact with cytotoxic agents. Dilution must be carried out under aseptic conditions by specialized personnel in a dedicated area. Suitable protective gloves must be worn. Appropriate precautions must be taken to avoid contact with skin and mucous membranes. If contact with the skin occurs, wash thoroughly with soap and water. Tingling, burning and redness have been observed after topical exposure. If contact with mucous membranes occurs, they should be rinsed thoroughly with water. Following inhalation, dyspnea, chest pain, sore throat and nausea have been reported.
If unopened vials are stored in the refrigerator or freezer, precipitation may form which redissolves with gentle agitation or as soon as 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 should be discarded.
Following multiple needle insertions and product withdrawals, the vials remain microbiologically, chemically and physically stable for up to 28 days at 25°C. Other storage times and conditions during use are the responsibility of the user.
The ‘Chemo-Dispensing Pin’ or similar piercing devices with tips that may cause the cap to fall inside the vial, resulting in loss of product sterility, should not be used.

Preparation for intravenous administration:before infusion, Paclitaxel Teva must be
diluted using aseptic techniques in 9 mg/ml (0.9%) sodium chloride solution or 50 mg/ml (5%) glucose solution or a mixture of
9 mg/ml (0.9%) sodium chloride solution and 50 mg/ml (5%) glucose solution ,or Ringer's solution for infusion containing 50 mg/ml (5%) of
glucose, to a final concentration of 0.3 to 1.2 mg/ml.
The chemical and physical stability during use of the solution prepared for
infusion has been shown to be 27 hours at 25°C when diluted in 0.9% sodium chloride solution
(9 mg/ml) and 50 mg/ml glucose solution, or Ringer's solution for infusion containing 50 mg/ml (5%) glucose.
The chemical and physical stability during use of the solution prepared for
infusion diluted in 50 mg/ml glucose solution (5%) or in 9 mg/ml
(0.9%) sodium chloride solution has been shown to be 14 days at 5°C and 25°C.
The microbiological stability during use of the infusion solution
has been shown to be 27 hours at 25°C. Other storage times and conditions during use are the
responsibility of the user.
After dilution, solutions may show turbidity, attributable to the vehicle of the
formulation, 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 following simulated release of the solution
through EV tubes containing an in-line filter.
Rare reports 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 clarified, it is probably related to supersaturation of the
diluted solution. To reduce 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 should be flushed thoroughly before
use. During the infusion, the appearance of the solution should be examined regularly and
the infusion should be stopped if precipitation is present.
To minimize patient exposure to DEHP [di-(2-ethylhexyl) phthalate], which may
leak from PVC-plasticized infusion materials, diluted solutions of paclitaxel
should be stored in containers made of materials other than PVC (glass, polypropylene) or
plastic bags (polypropylene, polyolefin) and administered through polyethylene administration sets. The use of filter devices incorporating short-form inlet and/or outlet tubes made of PVC did not result in significant DEHP losses.

Disposal:all equipment used for preparation and administration or that
otherwise comes into contact with Paclitaxel Teva must be disposed of in accordance with
current regulations regarding the handling of cytotoxic substances.

Administration and dosage
All patients must be premedicated with corticosteroids, antihistamines and H antagonists
before treatment. The diluted solution of Paclitaxel Teva must be administered
using equipment not containing PVC with an in-line filter with a microporous membrane
≤ 0.22 µm.
The recommended doses for intravenous infusion of Paclitaxel Teva are:
First-line treatment of
ovarian cancer: 135 mg/m for 24 hours followed by cisplatin 75
mg/m ; or
175 mg/m for 3 hours followed by cisplatin 75
mg/m ;
Second-line treatment of ovarian cancer or breast cancer: 175 mg/m for 3 hours;
As adjuvant treatment in
breast cancer: 175 mg/m for 3 hours; followed by anthracycline and cyclophosphamide (AC) therapy;
First-line treatment of
breast cancer: 220 mg/m for 24 hours, 24 hours after
administration of doxorubicin (50 mg/m );
175 mg/m for 3 hours after administration of
trastuzumab (see the summary of
product characteristics);
Non-small cell lung cancer: 175 mg/m for 3 hours followed by cisplatin 80
mg/m ;
AIDS-related Kaposi's sarcoma: 100 mg/m for 3 hours.

Storage
No special storage conditions are required. If the product is placed in
the refrigerator, a precipitate may form which redissolves with gentle agitation
or as soon as 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 should be discarded.
Refrigeration does not affect the product.
The expiry date is stated on the outer packaging and on the vial label. Do
not use the product after this date.