CISPLATIN 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance: CISPLATIN

View full screen / Print PDF » Download PDF ⇩

Transcript
Package leaflet: Information for the user

Cisplatin 1mg/ml Concentrate for Solution for Infusion
Read all of this leaflet carefully before
you start taking this medicine because
it contains important information for
you.
•  eep this leaflet. You may need to read
K
it again.
• f you have any further questions, ask
I
your doctor.
•  his medicine has been prescribed for
T
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
f you get any side effects, talk to your
I
doctor. This includes any possible side
effects not listed in this leaflet. See
section 4.
What is in this leaflet
1.  hat Cisplatin is and what it is used for
W
2.  hat you need to know before you use
W
Cisplatin
3. How to use Cisplatin
4. Possible side effects
5. How to store Cisplatin
6.  ontents of the pack and other
C
information
Cisplatin Concentrate for Solution for
Infusion is given only by healthcare
personnel, who can reply to any
questions, which you may have after
reading this package leaflet.
1.  hat Cisplatin is and what it is used
W
for
Cisplatin forms part of a group of
medicines called cytostatics, which are
used in the treatment of cancer. Cisplatin
can be used alone but more commonly
Cisplatin is used in combination with
other cytostatics.
Cisplatin is used to treat cancers of the
testis, ovary, urinary bladder, head and
neck and lung. Cisplatin is used to treat
cervical cancer in combination with
radiotherapy.
Your doctor will be able to provide you
with more information.
2.  hat you need to know before you
W
use Cisplatin
Do not use Cisplatin:
• f you are allergic to cisplatin or any of
i
the other ingredients of this medicine
(listed in section 6)
• f you are allergic to any other medicine
i
that contains platinum compounds
• f you have kidney problems (renal
i
dysfunction)
• f you suffer from dehydration
i
• f you suffer from severe suppression of
i
bone marrow functionality, symptoms
may be extreme tiredness, easy
bruising or bleeding, occurrence of
infections
• f your hearing is impaired
i
• f you suffer from nervous disorders
i
caused by cisplatin
• f you are breast-feeding
i
•  ombined with live vaccines, including
c
yellow fever vaccine
•  ombined with phenytoin in
c
prophylactic use (see “Use of Cisplatin
with other medicines” below).
Warnings and precautions
•  our doctor will carry out tests in order
Y
to determine the levels of calcium,
sodium, potassium and magnesium
in your blood, as well as to check
your blood picture and your liver and
kidney functionality and neurological
function.

•  isplatin should only be administered
C
under the strict supervision of a
specialist doctor experienced in
administrating chemotherapy.
•  our hearing will be tested prior to
Y
each treatment with Cisplatin.
Take special care with Cisplatin:
• f you suffer from a nervous disorder
i
not caused by Cisplatin.
• f you suffer from an infection. Please
i
consult your doctor.
• f you intend to have children (see
i
Pregnancy, breast-feeding and fertility).
With spillage of cisplatin the
contaminated skin must immediately be
washed with water and soap. If cisplatin
is injected outside the blood vessels
the administration must be stopped
immediately. Infiltration of cisplatin in the
skin can result in tissue damage (cellulitis,
fibrosis and necrosis).
Please consult your doctor, even if these
statements were applicable to you at any
time in the past.
Other medicines and Cisplatin
Tell your doctor if you are taking, have
recently taken or might take any other
medicines
•  imultaneous use of medicines that
S
inhibit the bone marrow function or
radiation can potentiate the adverse
effects of cisplatin on the bone marrow.
Your hearing will be tested prior to
each treatment with Cisplatin.
•  isplatin toxicity may increase when
C
administered simultaneously with
other cytostatics (medicine for cancer
treatment), such as bleomycin and
methotrexate.
•  gents to treat high blood pressure
A
(antihypertensives containing
furosemide, hydralazine, diazoxide, and
propranolol) may increase the toxic
effect of Cisplatin on kidneys.

•  isplatin toxicity may severely affect
C
the kidneys when administered
simultaneously with agents that may
cause side effects in the kidneys, such
as those for the prevention/treatment
of certain infections (antibiotics:
cephalosporins, aminoglycosides,
and/or amphotericin B) and contrast
agents.
•  isplatin toxicity may affect hearing
C
faculties when administered
simultaneously with agents that may
have a side effect on hearing faculties,
such as aminoglycosides.
• f you use agents to treat gout during
I
your treatment with cisplatin, then the
dosage of such agents may need to be
adjusted (e.g. allopurinol, colchicine,
probenecid and/or sulfinpyrazone).
•  dministration of drugs that elevate
A
your rate of bodily urine excretion
(loop diuretics) combined with
cisplatin (cisplatin dose: more than
60mg/m², urine secretion: less than
1000ml per 24 hours) may result in
toxic effects on kidneys and hearing.
•  he first signs of hearing damage
T
(dizziness and/or tinnitus) may
remain hidden when – during
your treatment with cisplatin –
you are also being administered
agents to treat hypersensitivity
(antihistamines, such as buclizine,
cyclizine, loxapine, meclozine,
phenothiazines, thioxanthenes and/or
trimethobenzamides).
•  isplatin given in combination with
C
ifosphamide may result in hearing
impairment.
•  he effects of treatment with cisplatin
T
can be reduced through simultaneous
administration of pyridoxine and
hexamethylmelamine.
•  isplatin given in combination with
C
bleomycin and vinblastin may
result in paleness or blue coloration
of the fingers and/or toes (Raynaud`s
phenomenon).
•  dministration of cisplatin prior
A
to treatment with paclitaxel or in
combination with docetaxel may
result in severe nerve damage.
•  he combined use of cisplatin with
T
bleomycin and etoposide may
decrease lithium levels in the blood.
Therefore, lithium levels should be
checked on a regular basis.
•  isplatin reduces the effects of
C
phenytoin on the treatment of
epilepsy.
•  enicillamine may reduce the
P
effectiveness of Cisplatin.
•  isplatin may have an adverse
C
impact on the effectiveness of
agents preventing coagulation
(anticoagulants). Therefore,
coagulation should be checked more
often during combined use.
•  isplatin and ciclosporin may result
C
in suppression of the immune system
with the risk of increased production of
white blood cells (lymphocytes).
•  ou should not receive any
Y
vaccinations containing live viruses
within three months after the end of
treatment with cisplatin.
•  hen undergoing treatment with
W
cisplatin, you should not receive
yellow fever vaccinations (also see
“Do not take Cisplatin”).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before you begin
to use, or are administered Cisplatin.

Cisplatin must not be used during
pregnancy unless clearly indicated
by your doctor. You must use effective
contraception during and at least 6
months after treatment with Cisplatin.
You must not breast-feed while you are
treated with Cisplatin.
Male patients treated with Cisplatin
are advised not to father a child during
treatment and for up to 6 months after
treatment. Further, men are advised to
seek counselling on sperm preservation
before starting treatment.
Driving and using machines
Cisplatin may cause side effects such as
feeling sleepy and/or vomiting. If you
suffer from either of these conditions,
then you should not operate any
machines that require your full attention.
Cisplatin contains sodium
Cisplatin contains 3.5mg sodium per ml.
This should be considered if you have to
keep a low sodium diet.
3. How to use Cisplatin
Dosage and method of administration
Cisplatin should only be given by a
specialist in cancer treatment.
The concentrate is diluted with a sodium
chloride solution or a solution that
contains glucose.
Cisplatin is only given by injection into a
vein (an intravenous infusion).
Cisplatin should not come into contact
with any materials that contain
aluminium. The recommended dosage
of Cisplatin depends on your well-being,
the anticipated effects of the treatment,
and whether or not cisplatin is given on
its own (monotherapy) or in combination
with other agents (combination
chemotherapy).

Continued top of next column
AAAG0920

Continued over page

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

Cisplatin 1mg/ml Concentrate for Solution for Infusion
Preparation and handling of the product
For single use only.
Refer to local cytotoxic guidelines.
Like with all anti-neoplastic products
caution is needed with the processing of
cisplatin. Dilution should take place under
aseptic conditions in a safety box, by
trained personnel in an area specifically
intended for this, and protective coats
and gloves should be used. If no safety
box is available, the equipment should
be supplemented with a mask and
protective glasses. Precautions should be
taken to avoid contact with the skin and
mucous membranes. If skin contact did
occur anyway, the skin should be washed
with soap and water immediately. With
skin contact tingling, burns and redness
have been observed. In case of contact
with the mucous membranes they should
be copiously rinsed with water. After
inhalation dyspnoea, pain in the chest,
throat irritation and nausea have been
reported.
In the event of spillage, operators should
put on gloves and mop up the spilled
material with a sponge kept in the area
for that purpose. Rinse the area twice
with water. Put all solutions and sponges
into a plastic bag and seal it.
Pregnant women must avoid contact
with cytostatic drugs.

Bodily waste matter and vomit should be
disposed with care.
If the solution is cloudy or a deposit that
does not dissolve is noticed, the bottle
should be discarded.
A damaged bottle must be regarded
and treated with the same precautions
as contaminated waste. Contaminated
waste must be stored in waste containers
specifically marked for this. See section
“Disposal”.
Preparation of the intravenous
administration
Take the quantity of the solution that is
needed from the bottle and dilute with at
least 1 litre of the following solutions:
•  odium chloride 9mg/ml (0.9%)
s
•  ixture of sodium chloride 0.9%
m
/ glucose 5% (1:1), (resulting final
concentrations: sodium chloride 0.45%,
glucose 2.5%)
•  odium chloride 0.9% and 1.875%
s
mannitol, for injection (final
concentrations)
•  odium chloride 0.45%, glucose 2.5%
s
and 1.875% mannitol for injection (final
concentrations).
Always look at the injection before use.
Only a clear solution, free from particles
should be administered.
Continued over page

Cisplatin 1mg/ml concentrate for sol for inf leaflet - UK

colours/plates:
1. Black

item no:

AAAG0920

dimensions:

print proof no:

4

124 x 640

pharmacode:

origination date: 15.10.13

min pt size:

3.
4.

8.5pt

5.
6.

originated by:
approved for print/date

2.

DR

revision date:

18.10.13

Technical Approval

revised by:

DR

date sent:

supplier:

Nerviano

technically app. date: 18.10.13

15.10.13

Non Printing Colours
1. Coding area
2.
3.

Cisplatin (monotherapy):
The following dosages are recommended:
•  single dosage of 50 to 120mg/m²
A
body surface, every 3 to 4 weeks.
•  5 to 20mg/m² per day over a 5-day
1
period, every 3 to 4 weeks.
Cisplatin in combination with other
chemotherapeutical agents (combination
chemotherapy):
20mg/m² or more, once every 3 to 4
weeks.
For treatment of cervical cancer cisplatin
is used in combination with radiotherapy.
A typical dose is 40mg/m2 weekly for
6 weeks.
In order to avoid, or reduce, kidney
problems, you are advised to drink
copious amounts of water for a period
of 24 hours following treatment with
Cisplatin.
If you receive more Cisplatin than you
should
Your doctor will ensure that the correct
dose for your condition is given. In case of
overdose, you may experience increased
side effects. Your doctor may give you
symptomatic treatment for these side
effects. If you think you received too
much Cisplatin, immediately contact your
doctor.
If you have any further questions on the
use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them. If you experience
any side effect it is important that you
inform your doctor before your next
treatment.
Tell your doctor immediately, if you
notice any of the following:
•  evere allergic reaction - you may
s
experience a sudden itchy rash (hives),
swelling of the hands, feet, ankles, face,
lips, mouth or throat (which may cause
difficulty in swallowing or breathing),
and you may feel you are going to
faint;
•  evere chest pains possibly radiating
s
to the jaw or arm with sweating,
breathlessness and nausea (heart
attack);
•  ersistent or severe diarrhoea or
p
vomiting;
•  ore lips or mouth ulcer (stomatitis/
s
mucositis);
•  nexplained respiratory symptoms
u
such as non-productive cough,
difficulty in breathing or crackles;
•  umbness or tingling in your fingers or
n
toes;
•  xtreme tiredness;
e
•  bnormal bruising or bleeding;
a
•  igns of infection, such as sore throat
s
and high temperature;
•  ensation of discomfort close to or at
s
the injection site during the infusion.
The following side effects may occur:
Very common (may affect more than 1 in
10 people)
•  ecrease in bone marrow function
d
(which can affect the production of
blood cells)
•  ecrease in white blood cells,
d
which makes infections more likely
(leukopenia)
•  ecrease in blood platelets, which
d
increases the risk of bruising and
bleeding (thrombocytopenia)
•  eduction of red blood cells which can
r
cause weakness and your skin to look
pale (anaemia)
•  educed level of sodium in the blood
r
•  igh temperature
h
•  roblems with your kidneys or urine.
p
Common (may affect up to 1 in 10 people)
•  ast, irregular or slow heart beats
f
•  epsis (blood poisoning)
s
• nflammation of a vein (phlebitis)
i
•  ifficulty breathing (dyspnoea)
d
•  neumonia
p
•  espiratory failure
r
•  edness and inflammation of the skin
r
(erythema, skin ulcer) in the area of the
injection
•  welling (oedema)
s
•  ain at the area of injection
p
•  amage to the nervous system
d
(neurotoxicity).
Uncommon (may affect up to 1 in 100
people)
•  evere allergic reaction (see above)
s
•  earing loss (ototoxicity)
h
•  educed level of magnesium in the
r
blood
•  bnormal sperm production and
a
ovulation
•  ainful breast growth in men
p
(gynaecomastia).
Rare (may affect up to 1 in 1,000 people)
• ncreased risk of acute leukaemia
i
•  onvulsions
c
•  ainting, headache, confusion and loss
f
of vision
• oss of certain types of brain
l
function, including brain dysfunction
characterised by spasms and reduced
level of consciousness
•  eart attack
h
• nflammation of mucous membranes
i
of the mouth (stomatitis)
•  eripheral neuropathy of the sensory
p
nerves, characterised by tickling,
itching or tingling without cause and
sometimes with loss of taste, touch,
sight, sudden shooting pains from the
neck through the back and into the
legs when bending forward
•  problem with the way the body fights
a
diseases (immunosuppression)
•  xcessive cholesterol levels in the
e
blood
• nflammation of the eye nerve
i
combined with pain and reduced
nerve function (optic neuritis)
•  ye movement dysfunction
e
•  oronary artery disease
c
•  igh blood pressure
h
•  ecreased level of blood albumin.
d

Very rare (may affect up to 1 in 10,000
people)
• cardiac arrest
•  eizures.
s
Not known (frequency cannot be
estimated from the available data)
•  igns of infection such as fever or sore
s
throat
•  aemolytic anaemia
h
• nappropriate release of vasopressin
i
hormone (ADH) which may lead to
low sodium in the blood and water
retention
•  lood amylase (enzyme) increased
b
•  ehydration
d
•  educed level of calcium, phosphate,
r
potassium in the blood
•  igh level of uric acid in the blood
h
•  uscle cramping
m
•  pinal disease which may cause a
s
sensation of electric shocks passing
into your limbs
•  rain dysfunction (confusion, slurred
b
speech, sometimes blindness, memory
loss, and paralysis)
•  troke
s
• oss of taste
l
•  roblems with your eyesight (blurred
p
vision, odd colours, loss of vision or eye
pain)
•  inging in the ears or deafness
r
•  eart problems
h
•  nusually cold or white hands and feet
u
•  ingling, numbness or tremor in your
t
hands, feet, arms or legs
•  lood clot in the lung
b
•  ersistent headache
p
•  eeling or being sick
f
• oss of appetite, anorexia
l
•  iccups
h
•  iarrhoea
d
• iver enzymes increased, bilirubin
l
increased
•  air loss
h
•  ash
r
•  xtreme tiredness/weakness
e
•  welling or soreness where the
s
injection was given
•  ramps or spasms
c
•  urning or prickling sensation
b
•  nexpected bruising or bleeding
u
•  aemolytic uraemic syndrome which
h
may cause changes to the kidneys and
blood.
Reporting of side effects
If you get any side effects, talk to your
doctor. This includes any possible side
effects not listed in this leaflet. You can
also report side effects directly via Yellow
Card Scheme, Website: 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 Cisplatin
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 vial and the
outer carton after ‘exp’. The expiry date
refers to the last day of that month.
Keep the vial in the outer carton in order
to protect from light. Do not store above
25°C.
Do not refrigerate or freeze.
If the solution is cloudy or a deposit that
does not dissolve is noticed, the bottle
should be discarded.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.
After dilution:
Chemical and physical in-use stability
has been demonstrated for 24 hours at
15-25°C
From a microbiological point of view, the
product should be used immediately.
6.  ontents of the pack and other
C
information
What Cisplatin contains
The active substance is cisplatin.
1ml of concentrate for solution for
infusion contains 1mg of cisplatin.
One vial of 10ml concentrate for solution
for infusion contains 10mg cisplatin. One
vial of 50ml concentrate for solution for
infusion contains 50mg cisplatin.
The other ingredients are sodium
chloride, hydrochloric acid (for pH
adjustment) and water for injections.
What Cisplatin looks like and contents
of the pack
Cisplatin is a clear, slightly yellow
concentrate for solution for infusion free
from visible particles in glass injection
vials.
Packaging with 1 vial of 10ml of
concentrate, the vial containing 10mg
cisplatin.
Packaging with 1 vial of 50ml of
concentrate, the vial containing 50mg
cisplatin.
Vial will be packed with or without a
protective plastic overwrap
Marketing Authorisation Holder
Caduceus Pharma Ltd.
6th Floor 94 Wigmore Street,
London W1U 3RF
United Kingdom
Manufacturer
S.C. Sindan- Pharma S.R.L
11 Ion Mihalache Blvd,
011171 Bucharest
Romania
This leaflet was last revised in
October 2013

If you would like a
leaflet with larger
text, please contact
01271 385257.

Continued top of next column
AAAG0920
Actavis, Barnstaple, EX32 8NS, UK

DO NOT bring in contact with injection
material that contains aluminium.
DO NOT administer undiluted.
With respect to chemical and physical
stability with use of the undiluted
solutions, see section ”Special precautions
for storage – undiluted solution.”
Disposal
All materials that have been used for the
preparation and administration, or which
have been in contact with cisplatin in any
way, must be disposed of according to
local cytotoxic guidelines.
Remnants of the medicinal products as
well as all materials that have been used
for dilution and administration must be
destroyed according to hospital standard
procedures applicable to cytotoxic
agents and in accordance with local
requirements related to the disposal of
hazardous waste.
Incompatibilities
Do not bring in contact with aluminium.
Cisplatin reacts with metal aluminium to
form a black precipitate of platinum. All
aluminium-containing IV sets, needles,
catheters and syringes should be avoided.
Cisplatin decomposes with solution in
media with low chloride content; the
chloride concentration should at least be
equivalent to 0. 45% of sodium chloride.

Antioxidants (such as sodium
metabisulphite), bicarbonates (sodium
bicarbonate), sulphates, fluorouracil
and paclitaxel may inactivate cisplatin in
infusion systems.
This medicinal product must not be
mixed with other medicinal products
except those mentioned in above
mentioned section “Preparation of the
intravenous administration”.
Special precautions for storage
Medicinal product as packaged for
sale:
Concentrate for solution for infusion
1mg/ml
Undiluted solution: Do not store above
25°C. Do not refrigerate or freeze. Keep
the vial in the outer carton in order to
protect from light. If the solution is not
clear or an undissolvable precipitate is
formed the solution must not be used.
Diluted solution:
Do not store diluted solutions in the
refrigerator or freezer.
After dilution in infusion fluids mentioned
above:
Chemical and physical in-use stability
has been demonstrated for 24 hours at
15-25°C.
From a microbiological point of view,
the product should always be used
immediately.
AAAG0920

Continued top of next column

Cisplatin 1mg/ml concentrate for sol for inf leaflet - UK

colours/plates:
1. Black

item no:

AAAG0920

dimensions:

print proof no:

4

124 x 640

pharmacode:

origination date: 15.10.13

min pt size:

3.
4.

8.5pt

5.
6.

originated by:
approved for print/date

2.

DR

revision date:

18.10.13

Technical Approval

revised by:

DR

date sent:

supplier:

Nerviano

technically app. date: 18.10.13

15.10.13

Non Printing Colours
1. Coding area
2.
3.

Expand view ⇕

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.

Hide
(web3)