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QVIDADOTAX 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): DOCETAXEL / DOCETAXEL / DOCETAXEL

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Package leaflet: Information for the patient
concentrate for solution for infusion
Docetaxel
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or your pharmacist.
• If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Docetaxel Amring is and what it is used for
2. What you need to know before you use Docetaxel Amring
3. How to use Docetaxel Amring
4. Possible side effects
5. How to store Docetaxel Amring
6. Contents of the pack and other information
1. What Docetaxel Amring is and what it is used for
The name of this medicine is Docetaxel Amring. Its
common name is docetaxel. Docetaxel is a substance
derived from the needles of yew trees.
Docetaxel belongs to the group of anti-cancer
medicines called taxoids.
Docetaxel Amring has been prescribed by your doctor
for the treatment of breast cancer, special forms of lung
cancer (non-small cell lung cancer), prostate cancer,
gastric cancer or head and neck cancer:
• For the treatment of advanced breast cancer,
Docetaxel Amring could be administered either alone
or in combination with doxorubicin, or trastuzumab,
or capecitabine.

• For the treatment of early breast cancer with
or without lymph node involvement, Docetaxel
Amring could be administered in combination with
doxorubicin and cyclophosphamide.
• For the treatment of lung cancer, Docetaxel Amring
could be administered either alone or in combination
with cisplatin.
• For the treatment of prostate cancer, Docetaxel Amring
is administered in combination with prednisone or
prednisolone.
• For the treatment of metastatic gastric cancer,
Docetaxel Amring is administered in combination with
cisplatin and 5-fluorouracil.
• For the treatment of head and neck cancer, Docetaxel
Amring is administered in combination with cisplatin
and 5-fluorouracil.

your doctor or pharmacist immediately. Your doctor may
stop your treatment immediately.
You will be asked to take premedication consisting of
an oral corticosteroid, such as dexamethasone, one day
prior to Docetaxel Amring administration and to continue
for one or two days after it in order to minimise certain
undesirable effects which may occur after the infusion of
Docetaxel Amring in particular allergic reactions and fluid
retention (swelling of the hands, feet, legs or weight gain).

If you are a man being treated with Docetaxel Amring,
you 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 because
Docetaxel Amring may alter male fertility.

During treatment, you may be given other medicines
to maintain the number of your blood cells.

2. What you need to know before you use Docetaxel
Amring

Other medicines and Docetaxel Amring
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicine, including
medicines obtained without a prescription. This is
because Docetaxel Amring or the other medicine may
not work as well as expected and you may be more
likely to get a side effect.

Docetaxel Amring contains ethanol (alcohol)
1 ml vial:
This medicinal product contains 50 vol % ethanol
(alcohol), i.e. up to 0.395 g (0.5 ml) per vial, equivalent
to 10 ml of beer or 4 ml wine per vial.
4 ml vial:
This medicinal product contains 50 vol % ethanol
(alcohol), i.e. up to 1.58 g (2 ml) per vial, equivalent
to 40 ml of beer or 16 ml wine per vial.
7 ml vial:
This medicinal product contains 50 vol % ethanol
(alcohol), i.e. up to 2.765 g (3.5 ml) per vial, equivalent
to 70 ml of beer or 28 ml wine per vial.
8 ml vial:
This medicinal product contains 50 vol % ethanol
(alcohol), i.e. up to 3.16 g (4 ml) per vial, equivalent
to 80 ml of beer or 33 ml wine per vial.

You must not be given Docetaxel Amring
• if you are allergic (hypersensitive) to docetaxel or any
of the other ingredients of Docetaxel Amring.
• if the number of white blood cells is too low.
• if you have a severe liver disease.
Warnings and precautions
Before each treatment with Docetaxel Amring, you will
have blood tests to check that you have enough blood
cells and sufficient liver function to receive Docetaxel
Amring.
In case of white blood cells disturbances, you may
experience associated fever or infections.

Docetaxel Amring contains alcohol. Discuss with
your doctor if you suffer from alcohol dependency or
liver impairment. See also section “Docetaxel Amring
contains ethanol (alcohol)” below.

Pregnancy, breast-feeding and fertility
Ask your doctor for advice before being given any medicine.
Docetaxel Amring must NOT be administered if you are
pregnant unless clearly indicated by your doctor.

Tell your doctor or your pharmacist if you have vision
problems. In case of vision problems, in particular
blurred vision, you should immediately have your eyes
and vision examined.

You must not become pregnant during treatment
with this medicine and must use an effective method
of contraception during therapy, because Docetaxel
Amring may be harmful for the unborn baby. If
pregnancy occurs during your treatment, you must
immediately inform your doctor.

If you develop acute or worsening problems with your
lungs (fever, shortness of breath or cough), please tell

You must not breast-feed while you are treated with
Docetaxel Amring.

Driving and using machines
No studies on the effects on the ability to drive and use
machines have been performed.

Harmful for those suffering from alcoholism.

3. How to use Docetaxel Amring
Docetaxel Amring will be administered to you by a
healthcare professional.
Usual dose
The dose will depend on your weight and your general
condition. Your doctor will calculate your body surface
area in square meters (m²) and will determine the dose
you should receive.
Method and route of administration
Docetaxel Amring will be given by infusion into one
of your veins (intravenous use). The infusion will last
approximately one hour during which you will be
in the hospital.
Frequency of administration
You should usually receive your infusion once every
3 weeks.
Your doctor may change the dose and frequency
of dosing depending on your blood tests, your
general condition and your response to Docetaxel
Amring. In particular, please inform your doctor in case
of diarrhoea, sores in the mouth, feeling of numbness
or pins and needles, fever and give her/him results of
your blood tests. Such information will allow her/him
to decide whether a dose reduction is needed.

To be taken into account if you are pregnant or if you are
breast-feeding women, in children and high-risk groups
such as patients with liver disease, or epilepsy.

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

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

4. Possible side effects

The amount of alcohol in this medicine may impair your
ability to drive or use machines.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Your doctor will discuss these with you and will explain
the potential risks and benefits of your treatment.

The most commonly reported adverse reactions of
Docetaxel Amring alone are: decrease in the number of
red blood cells or white blood cells, alopecia, nausea,
vomiting, sores in the mouth, diarrhoea and tiredness.
The severity of adverse events of Docetaxel Amring
may be increased when Docetaxel Amring is given in
combination with other chemotherapeutic agents.
During the infusion at the hospital the following allergic
reactions (may affect more than 1 in 10 people) may
occur:
• flushing, skin reactions, itching,
• chest tightness; difficulty in breathing,
• fever or chills,
• back pain,
• low blood pressure.
More severe reactions may occur.
The hospital staff will monitor your condition closely
during treatment. Tell them immediately if you notice
any of these effects.
Between infusions of Docetaxel Amring the following
may occur, and the frequency may vary with the
combinations of medicines that are received.
Very common (may affect more than 1 in 10 people):
• infections, decrease in the number of red (anaemia),
or white blood cells (which are important in fighting
infection) and platelets
• fever: if this happens you must tell your doctor
immediately
• allergic reactions as described above
• loss of appetite (anorexia)
• insomnia
• feeling of numbness or pins and needles
or pain in the joints or muscles
• headache
• alteration in sense of taste
• inflammation of the eye or increased tearing of the eyes

• swelling caused by faulty lymphatic drainage
• shortness of breath
• nasal drainage; inflammation of the throat and nose;
cough
• bleeding from the nose
• sores in the mouth
• stomach upsets including nausea, vomiting and
diarrhoea, constipation
• abdominal pain
• indigestion
• hair loss (in most cases normal hair growth should
return)
• redness and swelling of the palms of your hands or
soles of your feet which may cause your skin to peel
(this may also occur on the arms, face, or body)
• change in the color of your nails, which may detach
• muscle aches and pains; back pain or bone pain
• change or absence of menstrual period
• swelling of the hands, feet, legs
• tiredness; or flu-like symptoms
• weight gain or loss
Common (may affect up to 1 in 10 people):
• oral candidiasis
• dehydration
• dizziness
• hearing impaired
• decrease in blood pressure; irregular or rapid
heart beat
• heart failure
• oesophagitis
• dry mouth
• difficulty or painful swallowing
• haemorrhage
• raised liver enzymes (hence the need for
regular blood tests)
Uncommon (may affect up to 1 in 100 people):
• fainting
• at the injection site, skin reactions, phlebitis
(inflammation of the vein) or swelling

• inflammation of the colon, small intestine; intestinal
perforation
• blood clots
Frequency unknown:
• interstitial lung disease (inflammation of the
lungs causing coughing and difficulty breathing.
Inflammation of the lungs can also develop when
docetaxel therapy is used with radiotherapy)
• pneumonia (infection of the lungs)
• pulmonary fibrosis (scarring and thickening in the
lungs with shortness of breath)
• blurred vision due to swelling of the retina within
the eye (cystoid macular oedema)
• decrease of the sodium in your blood
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on
the safety of this medicine.
5. How to store Docetaxel Amring
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which is
stated on the outer carton and on the label of the vial
after EXP. The expiry date refers to the last day of that
month.
Do not store above 25 °C.
Store in the original package in order to protect from light.
Do not freeze.
Do not throw away any medicines via wastewater. Ask
your pharmacist how to throw away medicines you

no longer use. These measures will help protect the
environment.
6. Contents of the pack and other information
What Docetaxel Amring contains
• The active substance is docetaxel.
Each ml of concentrate for solution for infusion
contains 20 mg docetaxel.
• The other ingredients are polysorbate 80,
ethanol anhydrous and citric acid.
What Docetaxel Amring looks like and contents of
the pack
Docetaxel Amring concentrate for solution for infusion is
a yellow to brownish yellow clear oily solution.
Each box contains one vial of 1 ml concentrate
(20 mg docetaxel).
Each box contains one vial of 4 ml concentrate
(80 mg docetaxel).
Each box contains one vial of 7 ml concentrate
(140 mg docetaxel).
Each box contains one vial of 8 ml concentrate
(160 mg docetaxel).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amring S.A.S.
216 boulevard Saint-Germain
75007 Paris
France
Manufacturer
AqVida GmbH
Kaiser-Wilhelm-Str. 89
20355 Hamburg
Germany
This leaflet was last revised in 03/2017.

The following information is intended for healthcare
professionals only:
PREPARATION GUIDE FOR USE WITH
DOCETAXEL AMRING 20 MG/ML CONCENTRATE
FOR SOLUTION FOR INFUSION

It is important that you read the entire contents of
thisguide prior to the preparation of the Docetaxel
Amring infusion solution
Recommendations for the safe handling:
Docetaxel is an antineoplastic agent and, as with
other potentially toxic compounds, caution should be
exercised when handling it and preparing its solutions.
The use of gloves is recommended.
If Docetaxel Amring concentrate or infusion solution
should come into contact with skin, wash immediately
and thoroughly with soap and water. If it should
come into contact with mucous membranes, wash
immediately and thoroughly with water.
Preparation of the intravenous administration:

Preparation of the infusion solution
DO NOT use other docetaxel medicinal products
consisting of 2 vials (concentrate and solvent) with
this medicinal product
• 
Docetaxel Amring 20 mg/ml concentrate for
solution for infusion, which contains only 1 vial
with 1 ml (20 mg/1 ml).
• 
Docetaxel Amring 20 mg/ml concentrate for
solution for infusion, which contains only 1 vial
with 4 ml (80 mg/4 ml).
• 
Docetaxel Amring 20 mg/ml concentrate for
solution for infusion, which contains only 1 vial
with 7 ml (140 mg/7 ml).

• 
Docetaxel Amring 20 mg/ml concentrate for
solution for infusion, which contains only 1 vial
with 8 ml (160 mg/8 ml).
Docetaxel Amring 20 mg/ml concentrate for solution
for infusion requires NO prior dilution with a solvent
and is ready to add to the infusion solution.
Each vial is for single use. From a microbiological point
of view, the concentrate should be used immediately.
If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the
user and would normally not be longer than 24 hours
at 2 to 8 °C.
Chemical and physical in-use stability of the open vial
has been demonstrated for 4 weeks at 2 to 8 °C.
• More than one vial of concentrate for solution for
infusion may be necessary to obtain the required
dose for the patient.
• Aseptically withdraw the required amount of
concentrate for solution for infusion with a calibrated
syringe fitted with a 21G needle.
In Docetaxel Amring 20 mg/1 ml vial the concentration
of docetaxel is 20 mg/ml.
In Docetaxel Amring 80 mg/4 ml vial the concentration
of docetaxel is 20 mg/ml.
In Docetaxel Amring 140 mg/7 ml vial the concentration
of docetaxel is 20 mg/ml.
In Docetaxel Amring 160 mg/8 ml vial the concentration
of docetaxel is 20 mg/ml.
• Then, inject via a single injection (one shot) into
a 250 ml infusion bag or bottle containing either
5 % glucose solution or sodium chloride 9 mg/ml
(0.9 %) solution for infusion. If a dose greater than
190 mg of docetaxel is required, use a larger volume
of the infusion vehicle so that a concentration of
0.74 mg/ml docetaxel is not exceeded.
• Mix the infusion bag or bottle manually using a
rocking motion.

From a microbiological point of view, the product
should be used immediately. If not used immediately,
in-use storage times and conditions prior to use are
the responsibility of the user and would normally not
be longer than 24 hours at 2 to 8 °C, unless dilution
has taken place in controlled and validated aseptic
conditions. Chemical and physical in-use stability has
been demonstrated in polyolefin bags for 72 hours at
2 to 8°C and for 8 hours at 25 °C. Although contact time
is very little, only non-PVC tubing and administration
sets are recommended for use as precaution.
Docetaxel solution for infusion is supersaturated,
therefore may crystallize over time. If crystals appear,
the solution must no longer be used and shall be
discarded.
• As with all parenteral products, infusion solution
should be visually inspected prior to use, solutions
containing a precipitate should be discarded.
Disposal:
All materials that have been utilised for dilution and
administration should be disposed of according to
standard procedures. Do not throw away any medicines
via wastewater. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

83270-VBGB-EXT
AA

Dossier n° : 161767
PRODUIT

Docetaxel Amring

CODE ARTICLE

MOCKUP

TYPE

NOTICE

DOSAGE

20 mg / ml

PRÉSENTATION

-

PAYS

-

LANGUES

UK

FABRICANT

-

FORMAT

148 x 480 mm

Ref. PLAN

-

COULEURS : 1

HKS 44 K

POLICE(S)

Helvetica Neue LT Com

CORPS minimum

8 pts

LOGICIEL

Indesign CC

CODE BARRES

DATE

15/03/2017

VERSION

3

Expand Transcript

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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