Leaflet: information for the user

Paclitaxel Teva 6mg/ml concentrated solution for EFG infusion

Read this leaflet carefully before you start using the 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 should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

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

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

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

Both as initial therapy in combination with platinum-containing medications, cisplatin, or as second-line treatment when other platinum-containing treatments have failed.

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

In adjuvant treatment, after receiving treatment with anthracycline and cyclophosphamide (AC treatment).

As initial treatment both in combination with an anthracycline medication in patients for whom anthracycline treatment is indicated or in combination with a medication called trastuzumab.

In monotherapy, in patients who have not responded to standard treatments with anthracyclines, or in whom this 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 radiation therapy.

It is also used to treat a special form ofcancer related to HIV/AIDSthat develops in connective tissue (Kaposi's sarcoma)

When other treatments such as liposomal anthracyclines have failed

Do not usePaclitaxel Teva:

• If you are allergic (hypersensitive) to paclitaxel or any of the other components of this medication (listed in section 6), especially ricinoleate of macrogolglycerol.
• If you are breastfeeding.
• If your liver function is severely reduced.
• If your white blood cell count is too low (neutrophils). Your doctor will take a blood sample to check it. If you have recurrent and uncontrolled severe infections, and are being treated for Kaposi's sarcoma.

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

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Paclitaxel Teva

• If you experience severe allergic reactions (e.g., difficulty breathing, shortness of breath, chest tightness, low blood pressure, dizziness, sensation of spinning, skin reactions such as exanthema or inflammation).
• If you have fever, intense chills, sore throat, or mouth ulcers (signs of bone marrow suppression); your doctor will take blood samples frequently to check it.
• If you have mouth sores or redness (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; your doctor should monitor your heart function before starting the next treatment with paclitaxel.
• If you experience numbness or weakness in arms and legs (signs of peripheral neuropathy); a reduction in paclitaxel dose may be necessary.
• If you develop severe or persistent diarrhea, with fever and stomach pain, during or after treatment with paclitaxel. Your colon may be inflamed (pseudomembranous colitis).
• If you have previously received radiation therapy in the chest (as it may increase the risk of lung inflammation).
• If you experience heart problems during treatment with paclitaxel; your doctor should check your heart function before the next treatment with paclitaxel.

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 treatment with paclitaxel. Premedication is necessary to reduce the risk of severe hypersensitivity reactions (see section 4. Possible adverse effects, infrequent).

Other medications and Paclitaxel Teva

Inform your doctor if you are using, have used recently, or may need to use any other medication, even those purchased without a prescription. This is because paclitaxel or the other medication may not work as expected, or you may be more likely to have an adverse effect.

• Interaction means that different medications can influence each other. Consult your doctor when using paclitaxel at the same time as the following:medications to treat infections (e.g., antibiotics such as erythromycin, rifampicin, etc.: in case of doubt about whether the medication you are taking is an antibiotic, ask your doctor, nurse, or pharmacist), and medications to treat fungal infections (e.g., ketoconazole)
• medications used to help stabilize mood, also called antidepressants (e.g., fluoxetine)
• medications used to treat seizures (epilepsy) (e.g., carbamazepine, phenytoin)
• medications used to help reduce the level of lipids in the blood (e.g., gemfibrozil)
• medications used to treat stomach acid or stomach ulcers (e.g., cimetidine)
• medications used to treat HIV and AIDS (e.g., ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, nevirapine)
• a medication called clopidogrel, used to prevent blood clots.
• a medication called rifampicin, an antibiotic used to treat tuberculosis. You may need to increase the dose of paclitaxel.
• vaccines: if you have been recently vaccinated, or if you are planning to be vaccinated, inform your doctor. The use of paclitaxel with some vaccines may lead to severe complications.
• cisplatin (to treat cancer): paclitaxel should be administered before cisplatin. You may need to monitor your kidney function 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 treated with Paclitaxel Teva and doxorubicin or trastuzumab; your doctor should monitor your heart function before and during treatment.

Pregnancy, breastfeeding, and fertility

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

Paclitaxel should not be used during pregnancy, except when clearly necessary. Paclitaxel can cause fetal damage. Avoid pregnancy and use effective contraception during treatment. If you become pregnant, inform your doctor immediately. Male and female patients of childbearing age, and/or their partners should use contraception during at least 6 months after treatment with paclitaxel.

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

Paclitaxel Teva should not be used during breastfeeding. You should stop breastfeeding during treatment with Paclitaxel Teva. Do not resume breastfeeding until your doctor tells you to.

Driving and operating machinery:

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

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

Paclitaxel Teva contains alcohol and ricinoleate of macrogolglycerol

Each vial of paclitaxel contains 49.5% v/v (ethanol).

This medication contains 2 g of alcohol (ethanol) in each vial of 5 ml, 7 g in each vial of 16.7 ml, 10 g in each vial of 25 ml, and 20 g in each vial of 50 ml, which is equivalent to 396 mg/ml concentrated. The amount in 1 ml of this medication is equivalent to 10 mg of beer or 4 ml of wine.

The amount of alcohol contained in this medication may affect your ability to drive and operate machinery due to the fact that it may alter your judgment and reaction time.

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

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

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medication. If you have a history of alcohol addiction, consult your doctor or pharmacist before taking this medication.

Since this medication is usually administered slowly over 3 or 24 hours, it is possible that the effects of alcohol may be reduced.

Ricinoleate of macrogolglycerol may cause severe allergic reactions.

To minimize the risk of allergic reactions, before starting treatment with paclitaxel, you will receive other medications. These medications may be administered in the form of tablets, intravenous infusion, or both.

Your doctor will determine the dose and number of doses that should be administered to you. Paclitaxel Teva is administered under the supervision of a doctor, who can provide you with more information.

The amount (dose) of Paclitaxel Teva that will be administered to you will bebased on your body surface area in square meters (m2). It is calculated from your height and weight. The dose you receive will also depend on the results of blood tests. Depending on the type and severity of cancer, you will receive Paclitaxel Teva alone or in combination with another cancer agent (e.g. cisplatin, doxorubicin, trastuzumab). Paclitaxel Teva is administered via a vein (intravenous) by infusion over 3 or 24 hours. Normally, Paclitaxel Teva is administered every 3 weeks (2 weeks in patients with Kaposi's sarcoma), unless your doctor decides otherwise. Your doctor will inform you about the number of paclitaxel cycles you need to receive. The needle must remain in the vein while the medication is being administered. If the needle comes out or falls out, or the solution leaks into the tissue outside the vein (you may feel discomfort or pain), inform your doctor or nurse immediately.

Pediatric use

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

If you receive more Paclitaxel Teva than you should

There is no known antidote for paclitaxel overdose, so you will receive treatment for symptoms.

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

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

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

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

•Redness (rubor).

•Skin reactions.

•Itching (pruritus).

•Chest tightness.

•Lack of breath or difficulty breathing.

•Inflammation.

All of these can be signs of serious side effects.

Inform your doctor immediately:

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

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

• Infection (mainly urinary tract and upper respiratory tract infections: nasal mucosa inflammation characterized by nasal congestion, sneezing, and secretion (rhinitis) and throat inflammation (pharyngitis) including herpes simplex, fungal mouth infection), with fatal outcome in some cases
• Blood content alteration due to bone marrow suppression (myelosuppression)
• Lack of platelets causing bruises and bleeding tendency (thrombocytopenia)
• Lack of white blood cells causing increased susceptibility to infections (severe leukopenia, severe neutropenia), anemia, hemorrhage
• Mild hypersensitivity reactions (mainly facial flushing and skin rash)
• Loss of appetite
• Neuropathies, mainly persistent numbness, tingling, or pain in hands and feet (all symptoms of peripheral neuropathy)*
• Insomnia
• Paresthesia
• Low blood pressure
• Nausea, vomiting, diarrhea
• Mucosal inflammation (mucositis)
• Mouth inflammation (stomatitis), abdominal pain
• Hair loss (most cases of hair loss occurred within less than a month after starting paclitaxel treatment. When it occurs, hair loss is severe (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 paclitaxel treatment is stopped

Common: may affect up to 1 in 10 patients

• Common cold-like syndrome
• Blood alteration (bone marrow suppression) with fever and increased susceptibility to infections (febrile neutropenia)
• Depression
• Severe form of peripheral neuropathy causing mainly persistent numbness, tingling, or pain in hands and feet (peripheral neuropathy), nervousness, insomnia, abnormal thoughts, sense of perversion, abnormal gait, movement disorders (hypokinesia), decreased sense of touch (hypoesthesia)
• Bradycardia, tachycardia, palpitations
• Loss of consciousness
• Dilation of blood vessels causing flushing
• Nasal bleeding
• Dry mouth, mouth ulcers
• Black stools with blood (melena)
• Indigestion
• Skin dryness, itching, acne, mild and transient alterations of nails and skin
• Bone pain
• Muscle cramps, muscle weakness, back pain
• Urination difficulties
• Mild reactions at the injection site (skin swelling due to fluid retention (edema), pain, redness (erythema), skin hardening (induration), sensitivity, skin discoloration or swelling, extravasation (drug leakage outside the vein) that may cause cellulitis (inflammation and redness with pain), skin fibrosis, and skin necrosis. Injection site reactions may be delayed by up to 1 week to 10 days
• Chest pain
• Chills
• Increased certain enzymes in blood (AST, SGOT).

Uncommon (may affect up to 1 in 100 patients)

• Severe infection
• Severe decrease in blood pressure due to a bacterial infection in the blood, accompanied by pallor and agitation, rapid pulse, moist skin (septic shock)
• Severe anemia
• Delayed hypersensitivity
• Severe hypersensitivity reactions (angioedema), which require therapy (e.g., decreased or increased blood pressure, facial swelling, tongue or lip swelling, respiratory problems, generalized rash, chills, back pain, chest pain, rapid heart rate, stomach pain, hand and foot pain, sweating.)
• Weight loss, weight gain
• Dry eyes, wandering eye (amblyopia)
• Visual field alteration
• Myocardial infarction
• Heart failure (congestive heart failure)
• Cardiomyopathy
• Cardiac rhythm disorders (rapid heart rate: asymptomatic ventricular tachycardia, bigeminy tachycardia)
• Heart conduction disorders (AV block), sometimes with loss of consciousness
• Electrocardiogram alterations
• High blood pressure
• Thrombosis, inflammation of veins with the formation of blood clots in veins, which often causes pain and tense and red skin
• Nail or nail matrix discoloration
• Severe bilirubin increase (jaundice)

Rare (may affect up to 1 in 1,000 patients)

• Severe infection in the blood (sepsis)
• Pneumonia
• Peritonitis
• Fever associated with a decrease in white blood cells necessary to fight an infection (febrile neutropenia)
• Severe generalized hypersensitivity reactions with possible life-threatening risk (anaphylactic reactions)
• Motor neuropathy, causing muscle weakness in arms and legs
• Heart failure
• Respiratory failure
• Pleural effusion, interstitial pneumonia
• Pulmonary fibrosis, pulmonary embolism, breathing difficulty
• Abdominal pain caused by constipation or intestinal perforation (intestinal obstruction/perforation)
• Pancreatitis, causing intense abdominal and back pain
• Ischemic colitis, with possible severe and persistent diarrhea
• Skin redness
• Rash, intense itching (pruritus)
• Fever
• Dehydration
• Edema
• Weakness, general malaise
• Increased creatinine in blood.

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

• Unexpected blood cell disorder (acute myeloid leukemia, myelodysplastic syndrome)
• Severe generalized hypersensitivity reactions with possible life-threatening risk and shock
• Confusion, affection of certain nerves (autonomic neuropathy), leading to intestinal muscle paralysis (ileus paralytic) and sudden drop in blood pressure, sometimes with dizziness, caused for example, by quickly standing up after sitting or lying down (orthostatic hypotension)
• Seizures, brain affection characterized by convulsions and loss of consciousness (encephalopathy), coordination problems (ataxia)
• Headache
• Dizziness
• Affection of the optic nerve and/or visual alterations (scintillating scotoma)
• Ear damage (ototoxicity), hearing loss, dizziness (vertigo)
• Perception of sounds (tinnitus)
• Irregular and rapid heart rhythm (atrial fibrillation)
• Heartbeat originating from a specific part of the heart (supraventricular tachycardia)
• Shock
• Cough
• Pulmonary hypertension
• Ischemic colitis, with possible severe and persistent diarrhea
• Thrombosis of the mesenteric membrane
• Esophagitis
• Ascites
• Constipation
• Liver function disorder (hepatic necrosis, hepatic encephalopathy), with reported fatal cases
• Severe hypersensitivity reactions, including fever, skin rash, joint pain, and/or eye inflammation (Stevens-Johnson syndrome)
• Necrotic skin lesions (necrolytic erythema); irregular redness (exudative) with red spots (erythema multiforme), urticaria, and blister formation (urticaria)
• Nail loss (patients should protect their hands and feet from the sun)
• Folliculitis
• Dermatitis exfoliativa

Frequency not known:The frequency cannot be estimated from available data

• Complications produced by the waste products of destroyed cancer cells (tumor lysis syndrome)
• Fluid accumulation in the eyes (macular edema), flashes in the eyes (photopsia), small points or particles floating in the visual field (vitreous floaters), increased tear secretion
• 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 red, thick, and 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 that may cause skin peeling
• Disseminated intravascular coagulation (DIC) has been reported. It is a serious condition that makes people bleed easily, form blood clots easily, or both.
• Acute inflammatory reaction limited to previously irradiated areas that is triggered by the administration of precipitating systemic agents after radiation therapy (recall phenomenon)
• Excessive sweating (hyperhidrosis)

Reporting of adverse reactions

If you experience any of the adverse reactions, consult your doctor or pharmacist, even if they are possible adverse reactions not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use, Website: www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the vial and on the packaging after “EXP” or “CAD”. The first two numbers indicate the month, the last numbers indicate the year. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature, store in the original packaging.

Freezing does not have any adverse effects on the medication

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Paclitaxel Teva Composition

The active ingredient is paclitaxel.

Each milliliter of Paclitaxel Teva concentrated for solution for infusion contains 6 mg of paclitaxel.

The other components are: ricinoleate of macrogolglycerol, anhydrous ethanol, and citric acid.

Appearance of the product and contents of the package

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

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 some sizes of packaging may be commercially available.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11. Edificio Albatros B, 1st floor.

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing:

Pharmachemie B.V.

Swensweg 5, P.O. Box 552

2003 RN Haarlem

Netherlands

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

BelgiumPaclitaxin 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)

EstoniaPaclitaxel-Teva

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

GermanyPaclitaxel-GRY 6 mg/ml Concentrate for the preparation of an infusion solution

GreecePaxene Paclitaxin

HungaryPaclitaxel-Teva 6 mg/ml concentrate for solution for infusion

ItalyPaclitaxel Teva 6 mg/ml concentrated solution for infusion

LithuaniaPaclitaxel-Teva 6 mg/ml concentrate for solution for infusion

LuxembourgPaclitaxin 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)

NetherlandsPaclitaxin concentrate for intravenous solution 6 mg/ml

SloveniaPaclitaxin 6 mg/ml, concentrate for solution for infusion

SpainPaclitaxel Teva 6 mg/ml, concentrated solution for infusion EFG

Last review date of this leaflet:November 2024

This information is intended solely for medical professionals or healthcare professionals:

The following is a summary of information to assist in the administration of Paclitaxel. You should have experience in handling and using cytotoxics and be familiar with the Paclitaxel Technical Dossier. Refer to the guidelines for safe handling of antineoplastic agents.

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

The dilutions will be carried out in aseptic conditions by experienced personnel in a specific area. Precautions should be taken to avoid all contact with the skin and mucous membranes. You should wear protective gloves. In case of skin contact, the affected area should be washed with water and soap. After topical exposure, tingling, burning sensation, and redness have been described.

In case of mucous membrane contact, wash abundantly with water. In case of inhalation, difficulty breathing, chest pain, burning sensation in the throat, and nausea may occur.

If the closed vials are refrigerated or frozen, a precipitate may form that redissolves by gently shaking or without shaking when the ambient temperature is reached. This does not affect the quality of the product. If the solution remains turbid or a precipitate remains insoluble, the vial should be discarded.

After multiple insertions and removals of needles, the vials maintain microbiological, physical, and chemical stability for up to 28 days at 25°C. Storage under other conditions and times are the responsibility of the user.

Do not use the "Chemo-Dispensing Pin" or similar devices, as they may cause the collapse of the elastomer, resulting in loss of sterility integrity.

Preparation for intravenous administration:

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

It has been demonstrated that the prepared infusion solution is physically and chemically stable for use during 27 hours at 25°C, when diluted in a mixture of 9 mg/ml (0.9%) sodium chloride solution for infusion and glucose solution for infusion 50 mg/ml (5%) or Ringer's solution for infusion with 50 mg/ml (5%) glucose.

It has been demonstrated that the prepared infusion solution is chemically and physically stable for use during 14 days at 5°C and 25°C, when diluted in 50 mg/ml (5%) glucose solution for infusion and 9 mg/ml (0.9%) sodium chloride solution for infusion.

It has been demonstrated that the prepared infusion solution is microbiologically stable for use during 27 hours at 25°C. Storage under other conditions will be the responsibility of the user.

After preparation, these solutions may present a slight turbidity that is attributed to the excipient of the preparation and which does not disappear by filtration. Paclitaxel should be administered through a filter in series provided with a microporous membrane filter, with pores 0.22 μm. No significant losses of potency have been observed after simulated release of the solution through IV infusion equipment with a filter in series.

Cases of precipitation have been reported during paclitaxel infusions, usually towards the end of the 24-hour infusion period. Although the cause of this precipitation has not been established, it is likely related to the oversaturation 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 equipment should be thoroughly washed before use. During infusion, the appearance of the solution should be regularly examined, and in case of precipitation, infusion should be interrupted.

To minimize the patient's exposure to DEHP (di-(2-ethylhexyl) phthalate) that may be formed by leaching of PVC plastic present in PVC bags, infusion equipment, or other medical instruments, paclitaxel diluted solutions should be stored in non-PVC containers (glass, polypropylene), or plastic bags (polypropylene, polyolefin), and administered with a polyethylene equipment. The use of filters with a short plastic PVC outlet/inlet tube is not significant, as the amount of DEHP that may be released is not significant.

Disposal of residues:All residues of the medicinal product and elements used in the preparation and administration, and those that may have come into contact with paclitaxel, must comply with local regulations regarding the handling of cytotoxic products.

Administration and dosage:

Before administration, all patients should receive a premedication with corticosteroids, antihistamines, and H2 antagonists. The diluted Paclitaxel solution for infusion should be administered through a filter in series that does not contain PVC, with a microporous membrane filter, 0.22 μm.

The recommended doses for intravenous infusion of paclitaxel 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 cancer:175 mg/m2 over 3 hours;

Adjuvant breast cancer:175 mg/m2 over 3 hours; after treatment with anthracyclines and cyclophosphamide (AC);

First-line breast cancer:220 mg/m2 over 24 hours, 24 hours after doxorubicin (50 mg/m2), 175 mg/m2 over 3 hours, after trastuzumab (see trastuzumab Technical Dossier);

Non-small cell lung cancer:175 mg/m2 over 3 hours, followed by cisplatin 80 mg/m2;

Kaposi's sarcoma associated with AIDS:100 mg/m2 over 3 hours.

Storage:

No special storage conditions are required. If refrigerated or frozen, a precipitate may form that redissolves by gently shaking or without shaking when the ambient temperature is reached. This does not affect the quality of the product. If the solution remains turbid or a precipitate remains insoluble, the vial should be discarded. Freezing does not adversely affect the product.

A date of expiration is indicated on the outer packaging and product label. It should not be used after this date.