Paclitaxel Teva 6 mg/ml concentrate for infusion solution EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paclitaxel Teva 6 mg/ml concentrate for solution for infusion EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Paclitaxel Teva is and what it is used for.
What you need to know before using Paclitaxel Teva.
How to use Paclitaxel Teva.
Possible adverse effects.
How to store Paclitaxel Teva.
Contents of the pack and other information.

Paclitaxel Teva concentrate for solution for infusion is administered only by healthcare professionals, who can answer any questions you may have after reading this leaflet.

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

Paclitaxel is an antineoplastic or anticancer medicine. It can interrupt the division and growth of cancer cells.

Paclitaxel Teva is used to treat different types of cancer, such as:

Ovarian carcinoma (advanced or metastatic ovarian carcinoma, residual disease >1 cm after laparotomy)

Either as initial therapy in combination with platinum-containing medicines, such as cisplatin, or as second-line treatment when prior platinum-containing therapies have failed.

Breast carcinoma (treatment of early breast cancer after surgical removal of the primary tumor, advanced or metastatic breast cancer)

As adjuvant treatment, following therapy with anthracycline and cyclophosphamide (AC treatment).

As initial treatment either in combination with a medicine belonging to the anthracycline group in patients for whom anthracycline therapy is indicated, or in combination with a medicine called trastuzumab.

As monotherapy in patients who have not responded to standard anthracycline-based treatments, or in whom such treatment should not be used.

A certain type oflung cancer (non-small cell lung carcinoma)

In combination with cisplatin, in patients who are not candidates for potentially curative surgery and/or radiotherapy.

It is also used to treat a specific type ofAIDS-related cancer**that develops in connective tissue (Kaposi's sarcoma)

When 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 to any of the other ingredients of this medicine (listed in section 6), especially macrogol glycerol ricinoleate.
If you are breastfeeding.
If your liver function is severely impaired.
If your white blood cell count is too low (neutrophils). Your doctor will take a blood sample to check this. If you have severe, uncontrolled, recurrent infections and are being treated for Kaposi's sarcoma.

If any of the above apply to you, talk to your doctor before starting treatment with paclitaxel.

Warnings and precautions:

Talk to your doctor or pharmacist before using Paclitaxel Teva

If you experience severe allergic reactions (e.g., difficulty breathing, shortness of breath, chest tightness, low blood pressure, dizziness, lightheadedness, skin reactions such as rash or swelling).
If you have fever, severe chills, sore throat, or mouth ulcers (signs of bone marrow suppression); your doctor will frequently take blood samples to monitor this.
If you develop mouth sores or redness (signs of mucositis) and are being treated for Kaposi's sarcoma. You may require a lower dose.
If you experience heart problems during treatment with paclitaxel; your doctor should monitor your heart function before starting the next paclitaxel treatment.
If you experience numbness or weakness in your arms and legs (signs of peripheral neuropathy); a reduction in the paclitaxel dose may be necessary.
If you develop severe or persistent diarrhea, with fever and stomach pain, during or shortly after paclitaxel treatment. Your colon may be inflamed (pseudomembranous colitis).
If you have previously received chest radiation therapy (as it may increase the risk of pulmonary inflammation).
If you experience heart problems during treatment with paclitaxel; your doctor must check your heart function before your next paclitaxel treatment.

You will be given several different medications, belonging to the class of corticosteroids (e.g., dexamethasone), antihistamines (e.g., diphenhydramine or chlorpheniramine), and H2 antagonists (e.g., cimetidine or ranitidine) before each paclitaxel treatment. Premedication is necessary to reduce the risk of severe hypersensitivity reactions (see section 4. Uncommon side effects).

Other medicines and Paclitaxel Teva

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. This is because paclitaxel or the other medicine may not work as well as expected, or you may be more likely to experience side effects.

Interaction means that different medicines can affect each other. Consult your doctor when using paclitaxel at the same time as the following: medicines to treat infections (i.e., antibiotics such as erythromycin, rifampicin, etc.: if in doubt whether the medicine you are taking is an antibiotic, ask your doctor, nurse, or pharmacist), and medicines to treat fungal infections (e.g., ketoconazole)
medicines used to help stabilize mood, also called antidepressants (e.g., fluoxetine)
medicines used to treat seizures (epilepsy) (e.g., carbamazepine, phenytoin)
medicines used to help lower lipid levels in the blood (e.g., gemfibrozil)
medicines used for stomach acid or stomach ulcers (e.g., cimetidine)
medicines used to treat HIV and AIDS (e.g., ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, nevirapine)
the medicine called clopidogrel, used to prevent blood clots.
a medicine called rifampicin, an antibiotic used for tuberculosis. The paclitaxel dose may need to be increased.
vaccines: if you have recently been vaccinated or are planning to be vaccinated, inform your doctor. Using paclitaxel together with certain vaccines may lead to serious complications.
cisplatin (to treat cancer): paclitaxel should be administered before cisplatin. Your kidney function may need to be monitored more frequently.
doxorubicin (to treat cancer): paclitaxel should be administered 24 hours after doxorubicin, to avoid high levels of doxorubicin in your body.

If you are being treated with Paclitaxel Teva and doxorubicin or trastuzumab, heart function should be monitored before and during treatment.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Paclitaxel must not be used during pregnancy unless clearly necessary. Paclitaxel may cause fetal harm. Pregnancy must be avoided, and effective contraception used during treatment. If you become pregnant, inform your doctor immediately. Female and male patients of reproductive age, and/or their partners, should use contraception for at least 6 months after treatment with paclitaxel.

Male patients should seek advice about sperm cryopreservation before treatment with paclitaxel due to the possibility of infertility.

Paclitaxel Teva must not be used during breastfeeding. You must stop breastfeeding during treatment with Paclitaxel Teva. Do not resume breastfeeding until your doctor advises you to do so.

Driving and using machines:

There is no reason why you cannot drive between cycles of Paclitaxel Teva, but you should remember that this medicine contains alcohol and it may be inadvisable to drive immediately after a treatment cycle. As in all cases, you must not drive or operate machinery if you feel dizzy or lightheaded.

Consult your doctor, nurse, or pharmacist if you have any doubts.

Paclitaxel Teva contains alcohol and macrogol glycerol ricinoleate

A vial of paclitaxel contains 49.5% v/v (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, equivalent to 396 mg/ml concentrate. The amount in 1 ml of this medicine is equivalent to 10 mg of beer or 4 ml of wine.

The amount of alcohol in this medicine may affect your ability to drive and use machinery, as it may impair your judgment and reaction capacity.

If you have epilepsy or liver problems, consult your doctor or pharmacist before taking this medicine.

The amount of alcohol in this medicine may alter the effect of other medicines. Consult your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine. If you have alcohol addiction, consult your doctor or pharmacist before taking this medicine.

Because this medicine is generally 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 the risk of allergic reactions, you will receive other medications before starting paclitaxel treatment. These medications may be administered as tablets, intravenous infusion, or both.

Your doctor will determine the dose and number of doses to be administered. Paclitaxel Teva is given under the supervision of a physician, who can provide further information.

The amount (dose) of Paclitaxel Teva you will receive is based on your body surface area in square meters (m²), calculated from your height and weight. The dose you receive may also depend on the results of blood tests. Depending on the type and severity of cancer, Paclitaxel Teva will be administered alone or in combination with another anticancer agent (e.g., cisplatin, doxorubicin, trastuzumab). Paclitaxel Teva is administered into a vein (intravenously) as an intravenous infusion over 3 or 24 hours. Typically, Paclitaxel Teva is given every 3 weeks (every 2 weeks in patients with Kaposi's sarcoma), unless otherwise directed by your doctor. Your doctor will inform you about the number of paclitaxel cycles you need to receive. The intravenous needle must remain in the vein during drug administration. If the needle becomes dislodged or comes out, or if the solution leaks into the surrounding tissue outside the vein (you may feel discomfort or pain), inform your doctor or nurse immediately.

Pediatric use

The use of Paclitaxel in children and adolescents (under 18 years of age) is not recommended due to lack of safety and efficacy data.

If you receive more Paclitaxel Teva than you should

There is no known antidote for paclitaxel overdose, so treatment will be symptomatic.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and the amount administered.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible adverse effects

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

Tell your doctor immediately if you notice any signs of an allergic reaction. You may experience one or more of the following:

Redness (rubor)
Skin reactions
Itching (pruritus)
Chest tightness
Shortness of breath or difficulty breathing
Swelling

All of these may be signs of serious adverse effects.

Tell your doctor immediately:

If you have fever, severe chills, sore throat, or mouth ulcers (signs of bone marrow suppression)
If you have numbness or weakness in arms and legs (symptoms of peripheral neuropathy)
If you develop severe or persistent diarrhea, with fever and stomach pain.

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

Infections (mainly urinary tract infections and upper respiratory tract infections: inflammation of the nasal mucosa characterized by nasal congestion, sneezing, and discharge (rhinitis), and inflammation of the throat (pharyngitis), including oral herpes, fungal mouth infection), with fatal outcome in some cases
Blood abnormalities due to bone marrow suppression (myelosuppression)
Low platelet count leading to bruising and tendency to bleed (thrombocytopenia)
Low white blood cell count leading to increased susceptibility to infections (severe leucopenia, severe neutropenia), anemia, bleeding
Mild hypersensitivity reactions (mainly facial flushing and skin rash)
Anorexia
Neuropathies, mainly persistent numbness, tingling, or pain in hands and feet (all symptoms of peripheral neuropathy)*
Insomnia
Paresthesia
Low blood pressure
Nausea, vomiting, diarrhea
Inflammation of the digestive mucosa (mucositis)
Inflammation of the mouth mucosa (stomatitis), abdominal pain
Hair loss (most cases of hair loss occurred within less than one month after starting paclitaxel treatment. When it occurs, hair loss is marked (more than 50%) in most patients)
Joint and muscle pain
Pain
Abnormal fluid accumulation in hands, feet, and face (edema)

*May persist for more than 6 months after discontinuation of paclitaxel treatment

Common: may affect up to 1 in 10 patients

Cold-like syndrome
Blood abnormalities (low white blood cell count) with fever and increased susceptibility to infections (febrile neutropenia)
Depression
Severe neuropathy causing mainly persistent numbness, tingling, or pain in hands and feet (peripheral neuropathy), restlessness, insomnia, abnormal thoughts, sense of perversion, abnormal gait, movement disorders (hypokinesia), decreased sense of touch (hypoesthesia)
Decreased heart rate (bradycardia), increased heart rate (tachycardia), palpitations
Loss of consciousness
Blood vessel dilation causing flushing
Nosebleeds
Dry mouth, mouth ulcers
Black or bloody stools (melena)
Indigestion
Dry skin, itching, acne, transient and mild nail and skin changes
Bone pain
Muscle cramps, muscle weakness, back pain
Dysuria
Mild reactions at the injection site (skin swelling due to fluid retention (edema), pain, redness (erythema), skin hardening (induration), tenderness, discoloration, or swelling of the skin, extravasation (leakage of medication outside the vein) which may lead to cellulitis (inflammation and redness with pain), fibrous tissue formation (cutaneous fibrosis), and skin tissue death (cutaneous necrosis). Reactions at the injection site may be delayed by one to ten days
Chest pain
Chills
Increased levels of certain enzymes in the blood (AST, SGOT)

Uncommon (may affect up to 1 in 100 patients)

Severe infection
Severe drop in blood pressure due to bacteria in the blood, accompanied by paleness, restlessness, rapid pulse, and moist skin (septic shock)
Severe anemia
Delayed hypersensitivity
Severe hypersensitivity reactions (angioedema), requiring treatment (e.g., due to decreased or increased blood pressure, swelling of the face, tongue, or lips, breathing difficulties, generalized rash, chills, back pain, chest pain, rapid heartbeat, stomach pain, pain in hands and feet, sweating)
Weight loss, weight gain
Dry eyes, lazy eye (amblyopia)
Visual field disturbances
Myocardial infarction
Inadequate heart pumping (congestive heart failure)
Heart muscle disorder (cardiomyopathy)
Heart rhythm disorders (rapid heart rate: asymptomatic ventricular tachycardia, tachycardia with bigeminy)
Heart conduction disorders (AV block), sometimes with loss of consciousness
Electrocardiogram abnormalities
High blood pressure
Thrombosis, vein inflammation with blood clot formation in veins, often causing pain and tight, red skin
Discoloration of nails or nail matrix
Marked increase in bilirubin (jaundice)

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

Severe blood infection (sepsis)
Lung inflammation (pneumonia)
Inflammation of the abdominal membrane (peritonitis)
Fever associated with low white blood cell count needed to fight infection (febrile neutropenia)
Severe generalized hypersensitivity reactions, potentially life-threatening (anaphylactic reactions)
Nerve disorders affecting movement, causing muscle weakness in arms and legs (motor neuropathy)
Heart failure
Lack of breathing
Pleural effusion, pneumonia (interstitial pneumonia)
Lung fibrosis, airway blockage (pulmonary embolism), breathing difficulty
Stomach pain due to constipation or intestinal perforation (intestinal obstruction/perforation)
Pancreas inflammation causing severe abdominal and back pain (pancreatitis)
Inflammation of the small intestine possibly causing severe persistent diarrhea (ischemic colitis)
Skin redness
Skin rash, rash with intense itching (pruritus)
Fever
Loss of body fluid (dehydration)
Fluid retention (edema)
Weakness, general malaise
Increased creatinine in blood

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

Unexpected disorder of blood-forming cells (acute myeloid leukemia, myelodysplastic syndrome)
Severe generalized hypersensitivity reactions, potentially life-threatening, with shock
Confusion, involvement of certain nerves (autonomic neuropathy), leading to paralysis of intestinal muscles (paralytic ileus) and sudden drop in blood pressure, sometimes with dizziness, for example, when standing up quickly after sitting or lying down (orthostatic hypotension)
Seizures (epileptic), brain involvement characterized by seizures and reduced consciousness (encephalopathy), coordination problems (ataxia)
Headache
Dizziness
Optic nerve involvement and/or visual disturbances (scintillating scotoma)
Ear damage (ototoxicity), hearing loss, dizziness (vertigo)
Perception of noises (tinnitus)
Irregular and rapid heart rhythm (atrial fibrillation)
Faster heartbeat originating in a specific part of the heart (supraventricular tachycardia)
Shock
Cough
High blood pressure in the lungs
Inflammation of the small intestine possibly causing severe persistent diarrhea (neutropenic colitis, pseudomembranous colitis, necrotizing colitis)
Blood clots in the abdominal membrane (mesenteric thrombosis)
Throat inflammation (esophagitis)
Fluid retention in the abdominal cavity (ascites)
Constipation
Liver function disorders (hepatic necrosis, hepatic encephalopathy), with fatal outcomes reported
Severe hypersensitivity reactions, including fever, red spots on the skin, joint pain and/or eye inflammation (Stevens-Johnson syndrome)
Localized skin necrosis (epidermal necrolysis); irregular redness (exudative) with red spots (erythema multiforme), hives, and blister formation (urticaria)
Nail loss (patients should protect hands and feet from sunlight)
Inflammation of hair follicles (folliculitis)
Skin inflammation with blisters or peeling (exfoliative dermatitis)

Frequency not known: frequency cannot be estimated from available data

Complications caused by waste products from destroyed cancer cells (tumor lysis syndrome)
Fluid accumulation in the eyes (macular edema), flashes in the eyes (photopsia), small spots or particles floating in the visual field (vitreous floaters), increased tear secretion
Inflammation of a vein (phlebitis)
Excessive collagen deposits in the skin (scleroderma)
Autoimmune disease with multiple symptoms, such as red, scaly patches on the skin, joint pain, or fatigue (systemic lupus erythematosus), or red, thick, often scaly rashes and sores that may burn or itch (cutaneous lupus erythematosus)
Redness and swelling of the palms of the hands and soles of the feet, which may lead to skin peeling
Disseminated intravascular coagulation (DIC) has been reported. This is a serious condition causing easy bleeding, easy blood clotting, or both.
Acute inflammatory reaction limited to previously irradiated areas, triggered by the administration of systemic precipitating agents after radiation therapy (recall phenomenon)
Excessive sweating (hyperhidrosis)

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 packaging following “EXP” or “CAD”. The first two digits indicate the month, and the final 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.

Freezing does not have harmful effects on the medicine.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Paclitaxel Teva

The active substance is paclitaxel.

Each ml of Paclitaxel Teva concentrate for solution for infusion contains 6 mg of paclitaxel.

The other components are: macrogol glycerol ricinoleate, anhydrous ethanol, and citric acid.

Appearance of the Product and Contents of the Container

Paclitaxel is a viscous, transparent, colorless or slightly yellow solution. It is supplied in 5 ml, 16.7 ml, 25 ml, and 50 ml vials.

Each 5 ml vial contains 30 mg of paclitaxel.

Each 16.7 ml vial contains 100 mg of paclitaxel.

Each 25 ml vial contains 150 mg of paclitaxel.

Each 50 ml vial contains 300 mg of paclitaxel.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Teva Pharma, S.L.U.
C/Anabel Segura, 11. Edificio Albatros B, 1st floor
28108 Alcobendas (Madrid)
Spain

Manufacturer:

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium
Paclitaxin 6 mg/ml concentrate for solution for infusion (30 mg/5 ml)
Paclitaxin 6 mg/ml concentrate for solution for infusion (100 mg/16.7 ml)
Paclitaxin 6 mg/ml concentrate for solution for infusion (150 mg/25 ml)
Paclitaxin 6 mg/ml concentrate for solution for infusion (300 mg/50 ml)

Estonia
Paclitaxel-Teva

France
Paclitaxel-Teva 6 mg/ml solution to be diluted for infusion

Germany
Paclitaxel-GRY® 6 mg/ml concentrate for the preparation of an infusion solution

Greece
Paxene Paclitaxin

Hungary
Paclitaxel-Teva 6 mg/ml concentrate for infusion solution

Italy
Paclitaxel Teva 6 mg/ml concentrated solution for infusion

Lithuania
Paclitaxel-Teva 6 mg/ml concentrate for infusion solution

Luxembourg
Paclitaxin 6 mg/ml solution to be diluted for infusion (30 mg/5 ml)
Paclitaxin 6 mg/ml solution to be diluted for infusion (100 mg/16.7 ml)
Paclitaxin 6 mg/ml solution to be diluted for infusion (150 mg/25 ml)
Paclitaxin 6 mg/ml solution to be diluted for infusion (300 mg/50 ml)

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 infusion solution EFG

Date of most recent review of this package leaflet: November 2024

This information is intended solely for physicians or healthcare professionals:

Below is a summary of information to assist in the administration of Paclitaxel. The user must have experience in handling and using cytotoxic agents and should be familiar with the Summary of Product Characteristics for Paclitaxel. Refer to guidelines for safe handling of antineoplastic agents.

Handling: As with this type of drug, paclitaxel must be handled with care. Pregnant women should not handle this product.

Dilutions must be performed under aseptic conditions by trained personnel in a designated area. Precautions must be taken to avoid any contact with skin or mucous membranes. Protective gloves must be worn. In case of skin contact, wash the affected area thoroughly with soap and water. Following dermal exposure, tingling, burning sensation, and redness have been reported.

In case of contact with mucous membranes, flush thoroughly with water. In case of inhalation, difficulty in breathing, chest pain, throat burning, and nausea may occur.

If sealed vials are refrigerated or frozen, a precipitate may form which redissolves upon gentle shaking or without shaking when room temperature is reached. This does not affect the quality of the product. If the solution remains cloudy or an insoluble precipitate remains, the vial must be discarded.

After multiple needle insertions and withdrawals, vials maintain microbiological, physical, and chemical stability for up to 28 days at 25°C. Storage under other conditions and durations is the responsibility of the user.

"Chemo-Dispensing Pin" devices or similar should not be used, as they may cause elastomer collapse, resulting in loss of sterility integrity.

Preparation for Intravenous Administration:

Prior to infusion, Paclitaxel Teva must be diluted using aseptic techniques with 0.9% (9 mg/ml) sodium chloride infusion solution, or 5% (50 mg/ml) glucose infusion solution, or a mixture of 5% (50 mg/ml) glucose infusion solution and 0.9% (9 mg/ml) sodium chloride infusion solution, or Ringer's glucose infusion solution containing 5% (50 mg/ml) glucose, to a final concentration of 0.3 to 1.2 mg/ml.

The prepared infusion solution has been shown to be physically and chemically stable for use for 27 hours at 25°C when diluted in a mixture of 0.9% (9 mg/ml) sodium chloride infusion solution and 5% (50 mg/ml) glucose infusion solution, or Ringer's glucose infusion solution containing 5% (50 mg/ml) glucose.

Chemical and physical stability of the prepared infusion solution has been demonstrated for 14 days at 5°C and 25°C when diluted in 5% (50 mg/ml) glucose infusion solution or 0.9% (9 mg/ml) sodium chloride infusion solution.

Microbiological stability of the prepared infusion solution has been demonstrated for 27 hours at 25°C. Storage under other conditions is the responsibility of the user.

After preparation, these solutions may have a slightly cloudy appearance due to the excipient in the formulation, which is not removed by filtration. Paclitaxel must be administered using an in-line filter with a microporous membrane filter of pore size ≤ 0.22 μm. No relevant loss of potency has been observed during simulated release through IV infusion sets with in-line filters.

Isolated cases of precipitation during paclitaxel infusions have been reported, usually toward the end of the 24-hour infusion period. Although the cause of this precipitation has not been established, it is likely related to supersaturation of the diluted solution. To reduce the risk of precipitation, paclitaxel should be administered as soon as possible after dilution, and excessive agitation, vibration, or shaking should be avoided. Infusion sets must be thoroughly flushed before use. The solution should be inspected regularly during infusion, and if precipitation is observed, the infusion must be discontinued.

To minimize patient exposure to DEHP [di-(2-ethylhexyl) phthalate], which may leach from PVC plastic present in bags, infusion sets, or other medical devices, diluted paclitaxel solutions should be stored in non-PVC containers (glass, polypropylene), or plastic bags (polypropylene, polyolefin), and administered using polyethylene infusion sets. The use of filter models incorporating a short PVC inlet/outlet tubing is not considered significant, as the amount of DEHP that may be released is not substantial.

Waste Disposal:
All unused medicinal product and materials used during preparation and administration, as well as any items that may have come into contact with paclitaxel, must be disposed of in accordance with local regulations for handling cytotoxic products.

Administration and Dosage:

Prior to administration, all patients must receive premedication with corticosteroids, antihistamines, and H2 antagonists. The diluted paclitaxel infusion must be administered through an in-line filter that does not contain PVC, with a microporous membrane filter of pore size ≤ 0.22 μm.

The recommended doses for intravenous paclitaxel infusion are as follows:

First-line ovarian cancer: 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 ovarian or breast carcinoma: 175 mg/m² over 3 hours;

Adjuvant breast cancer treatment: 175 mg/m² over 3 hours; following anthracycline and cyclophosphamide (AC) therapy;

First-line breast cancer: 220 mg/m² over 24 hours, 24 hours after doxorubicin (50 mg/m²), or 175 mg/m² over 3 hours, followed by trastuzumab (see Summary of Product Characteristics for trastuzumab);

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 refrigerated, a precipitate may form, which redissolves upon gentle shaking or without shaking when room temperature is reached. This does not affect the quality of the product. If the solution remains cloudy or an insoluble precipitate remains, the vial must be discarded. Freezing does not adversely affect the product.

An expiration date is indicated on the outer packaging and label of the product. Do not use after this date.