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1. Paclitaxel Medac 6 Mg/Ml Concentrate For Solution For Infusion
2. Paclitaxel Medac 6 Mg/Ml Concentrate For Solution For Infusion

PACKAGE LEAFLET: INFORMATION FOR THE USER

Paclitaxel medac 6 mg/ml

concentrate for solution for infusion

Paclitaxel

Read all of this leaflet carefully before you are

given this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you.

Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2.    Before you are given Paclitaxel medac

3.    How Paclitaxel medac will be given to you

4.    Possible side effects of Paclitaxel medac

5.    How to store Paclitaxel medac

6.    Further information

1. WHAT PACLITAXEL MEDAC IS AND WHAT IT IS USED FOR

This medicinal product is used for treatment of cancer. It can be cancer in the ovaries or breast cancer. This medicinal product may also be used for a special cancer in the lungs (advanced non-small-cell lung cancer, NSCLC) in patients who cannot be treated with surgery and/or radiotherapy.

Paclitaxel medac may also be used for a special cancer, called Kaposi's sarcoma, which may be associated with AIDS ([Acquired Immuno-Deficiency Syndrome] caused by an HIV disease) where other treatments i.e. liposomal anthracyclines have not worked.

Paclitaxel medac works by stopping cell division and is used to prevent the growth of cancer cells.

2. BEFORE YOU ARE GIVEN PACLITAXEL MEDAC

Paclitaxel medac will not be administered

•    if you are hypersensitive (allergic) to paclitaxel or any of the other ingredients of Paclitaxel medac especially macrogolglycerol ricinoleate.

•    if your white blood cell count is too low (neutrophils). This is measured by health care personnel.

•    if you are breast-feeding.

•    if you have Kaposi's sarcoma and concurrent, serious, uncontrolled infections.

Take special care with Paclitaxel medac

•    This medicinal product should be used under the supervision of a doctor who has experience of anti-cancer medicines.

•    During administration of Paclitaxel medac the infusion site will be monitored closely for possible infiltration of infusion liquid into the surrounding tissue.

•    Before you are treated with Paclitaxel medac you will receive supporting medicines consisting of corticosteroids, antihistamines and H₂-antagonists (see section 3. How Paclitaxel medac will be given to you).

•    If Paclitaxel medac is used with other anti-cancer medicines (e.g. cisplatin, doxorubicin or trastuzumab) it should be given prior to cisplatin and trastuzumab but after doxorubicin.

•    Hypersensitivity has been seen in < 1 % of the patients (see section 4. Possible side effects of Paclitaxel medac). If the reaction is serious, the treatment will be stopped immediately.

•    Your blood count should be monitored frequently during the treatment.

•    If you get certain cardiac problems (cardiac conduction disorder) during the treatment you should be monitored continuously as long as the treatment is ongoing.

•    If you should be treated with a combination with other anti-cancer medicines like doxorubicin

or trastuzumab it is of special importance to monitor the cardiac function.

•    If you experience damage to your peripheral nerves (e.g. loss of muscle strength, diminished sensation, numbness, tingling, pain) your doctor may consider reducing the dose in the next treatment cycles.

•    If you have severe liver impairment you must not be treated with Paclitaxel medac.

•    When Paclitaxel medac is given to you in combination with radiotherapy of the lung, development of interstitial pneumonitis (inflammation in the lung connective tissue) has been seen.

•    The doctor should avoid giving Paclitaxel medac in an artery because serious tissue reactions have been seen in animals.

•    If you experience severe or persistent diarrhoea you should contact your doctor.

•    If you have Kaposi's sarcoma and severe inflammation of the mucous membrane occurs.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription since other medicinal product may affect your treatment with Paclitaxel medac. Paclitaxel may be used together with cimetidine (H₂-antagonist).

Special care should be observed if you are taking the following medicines during a course of treatment with paclitaxel: erythromycin, rifampicin (antibiotics), fluoxetine (antidepressant), gemfibrozil (lipid-lowering medicine), carbamazepine, phenytoin, phenobarbital (anti-epileptics), efavirenz, and nevirapine and receiving protease inhibitors (medicine for the treatment of AIDS).

If Paclitaxel medac is used in combination with cisplatin, it is recommended to administer paclitaxel before cisplatin.

If Paclitaxel medac is used in combination with doxorubicin, it is recommended to administer paclitaxel after doxorubicin.

Taking Paclitaxel medac with food and drink

Paclitaxel medac does not affect the intake of food and drinks.

Pregnancy and breast-feeding

Pregnancy

Tell your doctor if you are pregnant, think you may be pregnant or consider becoming pregnant before you receive treatment with paclitaxel. Do not use Paclitaxel medac if you are pregnant unless clearly indicated by your doctor.

This medicine may cause birth defects if either partner is taking it at the time of conception or if it is taken during pregnancy.

Use contraception whilst you are receiving treatment with paclitaxel and for six months after treatment has finished.

If pregnancy occurs during treatment, or within the six months after treatment has finished, inform your treating physician immediately.

Paclitaxel can make men infertile. Therefore, male patients treated with paclitaxel are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment.

Breast-feeding

It is not known if paclitaxel passes into breast milk. You must not breast-feed while you are being treated with Paclitaxel medac. Thus you should stop breast-feeding during the entire treatment with Paclitaxel medac. Do not restart breast-feeding until your doctor tells you it is safe to do so.

Driving and using machines

It is not investigated if treatment with Paclitaxel medac affects the ability to drive. Paclitaxel medac contains alcohol (395 mg/ml) therefore you should consider not to drive or use machines immediately after you have been treated. Ask your doctor for advice.

Important information about some of the ingredients of Paclitaxel medac

This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 20 g per dose, equivalent to 52 cl beer or 21 cl wine per dose.

This amount may be harmful for patients suffering from alcoholism.

This should also be taken into account in high-risk groups such as patients with liver disease or epilepsy.

The amount of alcohol in this medicinal product may alter the effects of other medicines.

The amount of alcohol in this medicinal product may impair your ability to drive or use machines. Paclitaxel medac contains macrogolglycerol ricinoleate which can cause an allergic reaction.

3. HOW PACLITAXEL MEDAC WILL BE GIVEN TO YOU

Paclitaxel medac will be given under supervision of a doctor, who can give you more information.

Method of administration

Paclitaxel medac will be first diluted. The ready-to-use solution for infusion is then administered into a blood vessel as an intravenous infusion (into a vein from a drip).

Dosage

Your doctor has decided which dose and how many doses you will be given. The dose depends on the type and severity of the cancer being treated and on your height and weight from which the doctor will work out your body surface area in square meters (m²). In addition, the results of your blood tests and your medical condition will be taken into account.

If necessary, your doctor will adjust the dosage during the treatment.

The dose will be given over a period of 3 or 24 hours. Paclitaxel medac is usually given every three weeks (2 weeks in patients with Kaposi's sarcoma).

You may also receive a specific pre-treatment with several different medicines (dexamethasone and diphenhydramine or chlorpheniramine and cimetidine or ranitidine) before every treatment with Paclitaxel medac. This pre-treatment is necessary in order to prevent severe allergic reactions (see section 4. Possible side effects of Paclitaxel medac).

If you have a tumour in the ovaries, additional treatment is often given using the cancer medicine cisplatin.

If you have tumours in the breast this medicinal product may be combined with trastuzumab or doxorubicin, which like Paclitaxel medac are used for the treatment of cancer.

Use in children

Paclitaxel is not recommended for use in children below 18 years due to lack of data on safety and efficacy.

If you use more Paclitaxel medac than you should

If you think you have been given too much Paclitaxel medac, tell your doctor straight away. The expected symptoms of an overdose are overall reduction of blood cells (bone marrow suppression), numbness or abnormal sensations in your arms and legs (peripheral neuropathy) and inflammation of the membranes lining the digestive tract (mucositis).

If you have any further questions on the use of this product, ask your doctor.

4. POSSIBLE SIDE EFFECTS OF PACLITAXEL MEDAC

The side effects are listed by incidence in line with the following table: more than 1 treated in 10 1 to 10 treated in 100 1 to 100 treated in 1,000 1 to 1,000 treated in 10,000 less than 1 treated in 10,000 cannot be estimated from the available data

Like all medicines, Paclitaxel medac can cause side

effects, although not everybody gets them.

Very common:

•    Infection (mainly urinary tract infections and infections in the upper respiratory tract) with reported cases of fatal outcome.

•    Reduced (haematopoietic) function of the bone marrow (myelosuppression), severe lowering of white blood cells counts which may make you more likely to develop infections (neutropenia, leukopenia), you may notice that you become tired and your skin colour becomes pale which may be a sign of a lowering of the red blood cells (anaemia), lowering of platelets counts which can cause unusual bleeding (for example nose bleeds) or unexplained bruising (thrombocytopenia).

•    Mild allergic reactions such as flush and rash.

•    Nervous lesions (mainly of peripheral nerves) which may appear as tingling, numbness and/or pain in the arms, legs, hands or feet.

•    Low blood pressure (you may begin to feel light-headed and faint and begin to sweat).

•    Diarrhoea, vomiting, nausea, inflammation of mucous membranes (mucositis).

•    Hair loss (alopecia).

•    Pain in the joint and muscles (arthralgia, myalgia).

Common:

•    Changes in heart rhythm (bradycardia).

•    Transient mild nail and skin changes.

•    Injection site reactions (including localised swelling [oedema], pain, redness [erythema], induration, occasionally accidentally administration of the intravenously [IV] infused medicinal product into the surrounding tissue [extravasation] can result in an inflammation of the connective tissue underlying the skin [cellulites], connective tissue changes [skin fibrosis] and cell death [skin necrosis]). In some cases, the onset of the injection site reaction either occurred during a prolonged infusion or was delayed by a week to 10 days.

•    Increase in liver enzymes (AST, alkaline phosphatase).

Uncommon:

•    Life-threatening complication of blood poisoning (septic shock).

•    Significant allergic reactions requiring treatment (e.g. low blood pressure, painful subcutaneous swellings on your skin or mucosa [angioneurotic oedema], you may become breathless or

have trouble breathing [respiratory distress], generalised urticaria [wheals], chills, back pain, chest pain, speeding up of your heart [tachycardia], abdominal pain, pain in the limbs, sweating [diaphoresis] and high blood pressure).

•    Heart attack, impairment of heart muscle, which may cause difficulty breathing or chest pain (cardiomyopathy), changes in normal heart rate (such as AV-block and syncope, asymptomatic ventricular tachycardia, tachycardia with extrasystole).

•    Blood clots (thrombosis), high blood pressure, acute thrombosis with inflammation of the vascular wall (thrombophlebitis).

•    Increase of bilirubin (jaundice).

Rare:

•    Blood poisoning (sepsis), inflammation of the peritoneum (peritonitis), inflammation of the lungs (pneumonia)

•    Severe lowering of white blood cells counts associated with fever (febrile neutropenia).

•    Severe allergic (anaphylactic) reactions.

•    Motor neuropathy which may result in weakness of the arms and legs.

•    Cardiac failure.

•    Diminished pulmonary function (respiratory failure), narrowing and blockage of the blood vessels in the lungs which may cause shortness of breath (pulmonary embolism), inflammatory reaction of the lung tissue with connective tissue changes and tissue hardening (lung fibrosis), inflammation of the lungs (interstitial pneumonia), shortness of breath (dyspnoea), scarring of the lung and fluid around the lungs (pleural effusion).

•    Blockage of the bowel, hole in the bowel wall (all of which usually cause abdominal pain), bloody stools associated with abdominal pain or fever which can be a sign of a serious bowel inflammation (ischemic colitis), severe persistent abdominal pain radiating to the back with vomiting (pancreatits).

•    Itching (pruritus), rash, redness (erythema).

•    Fever (pyrexia), dehydration, weakness (asthenia), swelling due to accumulation of fluid in body tissues (oedema), feeling and being sick (malaise).

•    Increase in blood creatinine.

Very rare:

•    Malignant disease of the blood (acute myeloid leukaemia), malignant change of blood formation (myelodysplastic syndrome).

•    Life-threatening allergic (anaphylactic) shock.

•    Loss of appetite (anorexia).

•    Confusion.

•    Epileptic fits (grand mal seizures), nerve damage in the inner organs (autonomic neuropathy), impairment of brain function (encephalopathy), convulsions, dizziness, difficulty coordinating movement (ataxia), headache.

•    Impaired vision, particularly in patients who have received higher doses than recommended.

•    Loss of hearing, impaired hearing (ototoxicity), ringing in the ear (tinnitus), unsteadiness (vertigo).

•    Disordered heart rhythm (known as atrial fibrillation, supraventricular tachycardia).

If you experience any palpitation, breathlessness or chest pain, please contact your doctor immediately.

•    Shock.

•    Cough.

•    Blood clots in the tissue responsible for connecting the jejunum and ileum, parts of the small intestine, to the back wall of the abdomen (mesenteric thrombosis), severe persistent or bloody diarrhoea associated with abdominal pain and/or fever, which can be a sign of a serious bowel inflammation (pseudomembranous colitis), inflammatory intestinal disease (neutropenic colitis), abdominal swelling (ascites), inflammation of the oesophagus (oesophagitis), constipation.

•    Liver damage (hepatic necrosis, hepatic encephalopathy) (both with reported cases of fatal outcome).

•    Widespread blistering rash causing ulcers of the skin, mouth and genital area and fever (Stevens-Johnson syndrome), skin peeling and fever (epidermal necrolysis), a symmetrical red raised rash usually on the limbs (erythema multiforme), abnormal reddening, flaking, and thickening of the skin (exfoliative dermatitis), wheals (urticaria), discoloured nails or nail bed and detachment

of the nail plate from the nail bed (onycholysis). You should avoid exposing your hands and feet excessively to sunlight during the therapy.

Not known:

•    Tumour lysis syndrome (this is characterized by metabolic complications that are caused by the massive and abrupt release of cellular components into the blood following the rapid lysis of cancer cells).

•    Macular oedema which may cause blurred vision in the area of sharpest vision, photopsia (perception of light phenomena such as lightning, sparks or fibrillation), vitreous floaters (small black spots, stains or thread-like structures which float slowly in the visual field).

•    Phlebitis (inflammation of a vein).

•    Scleroderma (this is a group of various rare diseases that are associated with a hardening of the connective tissue of the skin alone or the skin and internal organs [especially the digestive tract, lungs, heart and kidneys]).

•    Systemic lupus erythematosus (severe skin disease with disturbance of the general condition, painful blistering of the skin especially in the area of the mouth, eyes and genitals).

If any of the side effects gets serious, or if you

notice any side effects not listed in this leaflet,

please tell your doctor or pharmacist.

5. HOW TO STORE PACLITAXEL MEDAC

Do not store above 25 °C.

Store in the original package in order to protect from light.

Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the label.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Paclitaxel medac contains

•    The active substance is paclitaxel.

1 ml concentrate for solution for infusion contains 6 mg paclitaxel.

•    The other ingredients are: Macrogolglycerol ricinoleate, Ethanol, anhydrous (395 mg/ml), Citric acid, anhydrous

What Paclitaxel medac looks like and contents of the pack

Paclitaxel medac is a clear, colourless to light yellowish viscous solution.

30 mg paclitaxel in 5 ml solution.

100 mg paclitaxel in 16.7 ml solution.

300 mg paclitaxel in 50 ml solution.

600 mg paclitaxel in 100 ml solution.

Each vial is packed separately in a box. Multi-pack with 10 boxes is also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

medac

Gesellschaft fur klinische Spezialpraparate mbH Fehlandtstr. 3 20354 Hamburg Germany

Manufacturer

medac

Gesellschaft fur klinische Spezialpraparate mbH Fehlandtstr. 3

20354    Hamburg Germany

and

AqVida GmbH Kaiser-Wilhelm-Str. 89

20355    Hamburg Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Czech Republic Paclimedac 6 mg/ml koncentrat pro pripravu infuznfho roztoku Denmark    Paclimedac, koncentrat til

injeksionsv$ske 6 mg/ml

Germany    Taxomedac 6 mg/ml Konzentrat zur

Herstellung einer Infusionslosung Lithuania    Paclimedac 6 mg/ml

koncentratas infuziniam tirpalui Poland    Paclimedac 6 mg/ml    koncentrat do

sporzgdzania roztworu do infuzji Portugal    Paclitaxel GP-Pharm    6 mg/ml

concentrado para solugao para perfusao

Slovak Republic Paclimedac 6 mg/ml infuzny koncentrat

Spain    Paclitaxel GP-Pharm    6 mg/ml

concentrado para solucion para perfusion

United Kingdom Paclitaxel medac 6 mg/ml

concentrate for solution for infusion

This leaflet was last approved in 10/2014

The following information is intended for medical or healthcare professionals only:

The current national guidelines for handling of anti-cancer medicines should be followed.

Handling: As with all anti-cancer medicines, caution should be exercised when handling paclitaxel. The dilution should be done by trained personnel in specially designated areas under aseptic conditions. Adequate protective gloves should be used. Precautions should be taken in order to avoid contact with the skin and mucous membrane. In case of contact with the skin the area must be rinsed with soap and water. After topical exposure tingling and burning sensation and redness have been observed. In the event of contact with mucous membranes, they should be rinsed immediately with water. Dyspnoea, chest pain, burning throat and nausea have been reported after inhalation.

Refrigerated storage of unopened vials can lead to precipitates, which re-dissolve with little or no agitation when the preparation has reached room temperature. The quality of the product is not affected. The vial should be discarded if the solution remains cloudy or if an insoluble precipitate is found.

Storage after opening:

Following multiple needle entries and product withdrawals, the vial maintains microbial, chemical and physical stability for up to 28 days at 25 °C. Other storage times and conditions are the responsibility of the user.

Use of the Chemo-Dispensing Pin or Spike is not recommended since it can damage the stopper, resulting in a loss of sterility.

Preparation of the solution for infusion:

Prior to infusion the paclitaxel should be diluted under aseptic conditions. Paclitaxel is diluted with 0.9% NaCl solution or 5% glucose solution or 5% glucose/0.9% NaCl solution or Ringer’s solution plus 5% glucose solution to a concentration of 0.3 - 1.2 mg/ml.

Storage after dilution:

Diluted solution for infusion has been shown to be chemically and physically stable for up to 72 hours at 25 °C.

From a microbiological point of view, diluted solutions should be used immediately. If the product is not used immediately the storage time and condition are the responsibility of the user. Diluted solutions should not be stored in a refrigerator.

After dilution the solution may be cloudy. This is attributed to the formulation vehicle and is not removed by filtration. Paclitaxel should be infused through an in-line filter with a micro porous membrane with a pore diameter not larger than 0.22 pm. Testing of an infusion system using an in-line filter revealed no significant losses in potency.

There have been rare reports of precipitates during the infusion of paclitaxel, usually at the end of a 24-hour infusion. Even though the cause of the precipitation is not known it may be due to possible supersaturating of the solution. In order to reduce the risk of precipitation paclitaxel should be used as quickly as possible after dilution and excessive vibration or shaking should be avoided. The infusion sets should be flushed thoroughly before use. The appearance of the solution should be checked frequently during the infusion, and the infusion stopped if precipitates appear.

In order to minimise the exposure of the patients to DEHP (di-(2-ethylhexyl)phthalate), which may leach from pVc infusion bags, sets, and other medical equipments, diluted paclitaxel solution for infusion should be stored in non-PVC bottles (glass, polypropylene) or plastic containers (polypropylene, polyolefin) and administered through polyethylene-lined infusion sets. Filters (e.g. Ivex-2®) with short PVC inlets and outlets have not resulted in significant leaching of DEHP.

Disposal: All items used in the preparation, administration or otherwise coming into contact with paclitaxel must be disposed of in accordance with local guidelines for disposal of anti-cancer medicines.

90106-VBGB

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