ASPLATA 600 mg/60 ml INJECTION

देश: दक्षिण अफ़्रीका

भाषा: अंग्रेज़ी

स्रोत: South African Health Products Regulatory Authority (SAHPRA)

थमां उपलब्ध:

Pharmacare Limited û Woodmead

डोज़:

See ingredients

फार्मास्यूटिकल फॉर्म:

INJECTION

रचना:

EACH 60,0 ml SOLUTION CONTAINS CARBOPLATIN 600,0 mg

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2015-01-10

सूचना पत्रक

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1.3.2 PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
ASPLATA 50 MG/5 ML (injection)
ASPLATA 150 MG/15 ML (injection)
ASPLATA 450 MG/45 ML (injection)
ASPLATA 600 MG/60 ML (injection)
ASPLATA 1000 MG/100 ML (injection)
Carboplatin 10 mg/ ml
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN ASPLATA

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

ASPLATA has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
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WHAT ASPLATA CONTAINS
Each millilitre (ml) of injection solution contains 10 milligrams (mg)
of the active ingredient,
carboplatin.
The other ingredient is water for injection.
WHAT ASPLATA IS USED FOR
ASPLATA is an anti-cancer medicine in the form of solution for
injection (a solution that can be
given as a slow injection via a drip). It contains platinum.
Carboplatin is used in the treatment of
certain types of lung cancer and ovarian cancer.
BEFORE YOU RECEIVE ASPLATA (INJECTION)
DO NOT RECEIVE ASPLATA (INJECTION)
If you are:
-
hypersensitive (allergic) to carboplatin or any similar medicines on
previous occasions
-
suffer from severe kidney disease
-
suffer from hearing impairment
-
Bone marrow depressed
-
Pregnant, trying to become pregnant or breast-feeding your baby.
TAKE SPECIAL CARE WITH ASPLATA (INJECTION)

If you have a history of allergic reactions with platinum containing
products

To ensure the number of cells in your blood does not drop too low.
Your doctor will
regularly check for this

If you have mild renal or liver disease

If you are being given other anti-cancer medicines

If you have been given other medicines that may affect your kidneys or
hearing

If you are older than 65 years old and experience tingling or burning
of the skin
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PREGNANCY AND BREASTFEE

उत्पाद विशेषताएं

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1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS
S4
PROPRIETARY NAME (and dosage form)
ASPLATA 50 MG/5 ML (injection)
ASPLATA 150 MG/15 ML (injection)
ASPLATA 450 MG/45 ML (injection)
ASPLATA 600 MG/60 ML (injection)
ASPLATA 1000 MG/100 ML (injection)
COMPOSITION
Each 1 ml of solution contains 10 mg carboplatin
Other ingredient: Water for injection
PHARMACOLOGICAL CLASSIFICATION
Cytostatic agent
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Carboplatin is a platinum co-ordination compound with antitumour
properties.
Carboplatin has biochemical properties similar to that of cisplatin,
thus producing predominantly
interstrand and intrastrand DNA crosslinks.
The effect is cell-cycle phase non-specific.
PHARMACOKINETIC PROPERTIES
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Following IV administration, carboplatin exhibits biphasic
elimination. Carboplatin exhibits linear,
dose-independent pharmacokinetics.
Carboplatin is mainly eliminated by the kidneys with about 70 % of the
dose being excreted in
the urine within 24 hours (about 12- 16 hours).
Platinum slowly becomes protein bound and is subsequently excreted
with a half life of 5
days or more. The terminal half life of intact carboplatin is reported
to be about 3 to 6 hours.
INDICATIONS
ASPLATA is indicated for the treatment of:

Advanced ovarian carcinoma of epithelial origin in:
a) first line therapy
b) second line therapy, after other treatments have failed

Small cell carcinoma of the lung.
CONTRAINDICATIONS
ASPLATA is contraindicated in:

Patients with hypersensitivity to the carboplatin or to any of the
excipients in ASPLATA
(see COMPOSITION).

Patients with severe pre-existing renal impairment (creatinine
clearance at or below 20
ml/minute).

In hearing impairment, bone marrow depression and in patients with
localised tumoural
bleeding.

Pregnancy is contraindicated hence patients with child bearing or
conceiving potential
should exercise adequate contraception control.
Safety in lactation has not been