Cisplatin Concentrate for Soln for Inf 1mg/ml (10ml vial)

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

CISPLATIN

Inapatikana kutoka:

Fresenius Kabi Oncology PLC Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom

ATC kanuni:

L01XA01

INN (Jina la Kimataifa):

CISPLATIN 1 mg/ml

Dawa fomu:

CONCENTRATE FOR SOLUTION FOR INFUSION

Tungo:

CISPLATIN 1 mg/ml

Dawa ya aina:

POM

Eneo la matibabu:

ANTINEOPLASTIC AGENTS

Idhini hali ya:

Withdrawn

Idhini ya tarehe:

2016-03-10

Taarifa za kipeperushi

CISPLATIN - PACK INSERT - IRELAND+UK
(Travesh Sharma) D:\Europe\Cisplatin\Ireland+UK\July 2014\Cisplatin -
Pack Insert - Ireland+UK.indd
SIZE:
455 X 315 MM
6 AUGUST 2014 11:38 AM
VER. 05
TIMES NEW ROMAN 9 PTS.
Black
xxxxxx
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V002
THE FOLLOWING INFORMATION IS
INTENDED FOR HEALTHCARE PROFESSIONALS
ONLY:
PREPARATION AND HANDLING OF THE
PRODUCT
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:
•
sodium chloride 9 mg

Tabia za bidhaa

Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cisplatin 1 mg/ml concentrate for solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of concentrate for solution for infusion contains 1 mg of
cisplatin.
One vial of 10 ml concentrate for solution for infusion contains 10 mg
of cisplatin.
One vial of 20 ml concentrate for solution for infusion contains 20 mg
of cisplatin.
One vial of 50 ml concentrate for solution for infusion contains 50 mg
of cisplatin.
One vial of 100 ml concentrate for solution for infusion contains 100
mg of cisplatin.
Excipient(s) with known effect:
Each ml of solution contains 0.1 to 0.2 millimoles per ml of sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless to pale yellow solution.
The pH is between 3.5 to 6.5.
The osmolarity is between 250 to 400 mOsmol/L.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cisplatin is intended for the treatment of:
•
advanced or metastatic testicular cancer
•
advanced or metastatic ovarian cancer
•
advanced or metastatic bladder carcinoma
•
advanced or metastatic squamous cell carcinoma of the head and neck
Page 2 of 18
•
advanced or metastatic non-small cell lung carcinoma
•
advanced or metastatic small cell lung carcinoma.
Cisplatin is indicated in combination with radiotherapy in the
treatment of cervical
carcinoma.
Cisplatin can be used as monotherapy and in combination therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND CHILDREN:
The cisplatin dosage depends on the primary disease, the expected
reaction, and on whether
cisplatin is used for monotherapy or as a component of combination
chemotherapy. The
dosage directions are applicable for both adults and children.
For monotherapy, the following two dosage regimens are recommended:
•
Single dose of 50 to 120 mg/m² body surface every 3 to 4 weeks;
•
15 to 20 mg/m²/day for five days, every 3 to 4 weeks.
If cisplatin is used in combin