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PACLITAXEL MEDAC 6 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): PACLITAXEL

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Paclitaxel medac 6 mg/ml · 90106-VBGB · AA · 10.14 · Pharma-Code: 276 (Dummy)
Format: 740 x 132 mm · HKS 44 · Corrective action: KV01_osc_20.10.14

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.

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 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).

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.

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.

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 highrisk 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-touse 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:
Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:

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).

Paclitaxel medac 6 mg/ml · 90106-VBGB · AA · 10.14 · Pharma-Code: 276 (Dummy)
Format: 740 x 132 mm · HKS 44 · Corrective action: KV01_osc_20.10.14

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).

• 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.

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.

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 (StevensJohnson 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.

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.

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.

Marketing Authorisation Holder
medac
Gesellschaft für klinische Spezialpräparate mbH
Fehlandtstr. 3
20354 Hamburg
Germany
Manufacturer
medac
Gesellschaft für klinische Spezialpräparate 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 koncentrát
pro připravu infuzního roztoku
Denmark
Paclimedac, koncentrat til
injeksionsvæske 6 mg/ml
Germany
Taxomedac 6 mg/ml Konzentrat zur
Herstellung einer Infusionslösung
Lithuania
Paclimedac 6 mg/ml
koncentratas infuziniam tirpalui
Poland
Paclimedac 6 mg/ml koncentrat do
sporządzania roztworu do infuzji
Portugal
Paclitaxel GP-Pharm 6 mg/ml
concentrado para solução para
perfusão
Slovak Republic Paclimedac 6 mg/ml
infúzny koncentrát
Spain
Paclitaxel GP-Pharm 6 mg/ml
concentrado para solución para
perfusión
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 μm. 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 polyethylenelined 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
AA

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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