CARBOSIN 150 INJECTION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Teva Pharmaceuticals (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

INJECTION

Composition:

EACH 1 ml SOLUTION CONTAINS CARBOPLATIN 10 mg

Authorization status:

Registered

Authorization date:

1997-01-05

Patient Information leaflet

PAGE 1 OF 6
SCHEDULING STATUS
S4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
CARBOSIN 50 Solution for Injection contains 50 mg CARBOPLATIN
CARBOSIN 150 Solution for Injection contains 150 mg CARBOPLATIN
CARBOSIN 450 Solution for Injection contains 450 mg CARBOPLATIN
CARBOSIN 600 Solution for Injection contains 600 mg CARBOPLATIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE CARBOSIN
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your
pharmacist.
CARBOSIN 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.
1. WHAT CARBOSIN CONTAINS:
_Active ingredients:_
CARBOSIN 50 contains 50 mg carboplatin (10 mg/ml) as the active
ingredient.
CARBOSIN 150 contains 150 mg carboplatin (10 mg/ml) as the active
ingredient.
CARBOSIN 450 contains 450 mg carboplatin (10 mg/ml) as the active
ingredient.
CARBOSIN 600 contains 600 mg carboplatin (10 mg/ml) as the active
ingredient.
_Inactive ingredients:_
Mannitol and water for injection
2. WHAT CARBOSIN IS USED FOR:
Carboplatin belongs to a group of medicines known as alkylating
agents. It has anti-tumour
properties and it is used to treat patients with advanced or recurrent
ovarian cancer. There is limited
evidence to support the use of CARBOSIN in small lung cancer and
cancer of the head and neck.
PAGE 2 OF 6
CARBOSIN is to be administered only by or under the immediate
supervision of your doctor.
3. BEFORE RECEIVING CARBOSIN:
ALWAYS TELL YOUR HEALTHCARE PROFESSIONAL IF YOU ARE TAKING ANY OTHER
MEDICINE. (THIS INCLUDES
COMPLEMENTARY OR TRADITIONAL MEDICINES.)
IF YOU ARE PREGNANT OR BREASTFEEDING YOUR BABY, PLEASE CONSULT YOUR
DOCTOR, PHARMACIST OR
OTHER HEALTH CARE PROFESSIONAL FOR ADVICE BEFORE TAKING THIS MEDICINE.
The following should be considered before you start treatment with
CARBOSIN:
ALLERGIES-
Tell your doctor if you have ever had any unusual or allergic reaction
to carboplatin, cisplatin, or a

Summary of Product characteristics

PAGE 1 OF 12
SCHEDULING STATUS:
S4
PROPRIETARY NAMES AND DOSAGE FORMS:
CARBOSIN 50 Solution for Injection
CARBOSIN 150 Solution for Injection
CARBOSIN 450 Solution for Injection
CARBOSIN 600 Solution for Injection
COMPOSITION:
_Active ingredients: _
CARBOSIN 50 contains 50 mg carboplatin (10 mg/ml)
CARBOSIN 150 contains 150 mg carboplatin (10 mg/ml)
CARBOSIN 450 contains 450 mg carboplatin (10 mg/ml)
CARBOSIN 600 contains 600 mg carboplatin (10 mg/ml)
_Inactive ingredients: _
Mannitol and water for injection_ _
_ _
PHARMACOLOGICAL CLASSIFICATION:
A 26 Cytostatic agents PAGE 2 OF 12
PHARMACOLOGICAL ACTION:
Carboplatin [cis-diammine (1,1-cyclobutane-dicarboxylato) platinum] is
a platinum co-ordination compound with
anti-tumour properties. It is soluble in water at concentrations below
15 mg/ml.
Carboplatin has biochemical properties similar to that of cisplatin,
thus producing predominantly interstrand and
intrastrand DNA crosslinks.
PHARMACOKINETICS:
In patients with creatinine clearances of 60 ml/min or greater given
carboplatin at doses of 300 to 500 mg/m
2
,
the plasma concentrations of carboplatin decay in a biphasic manner
with mean alpha and beta half-
lives of 1,6 hours and 3,0 hours, respectively. The total body
clearance, apparent volume of distribution, and
mean residence time for carboplatin are 73 ml/min, 16 L, and 3,5
hours, respectively.
Carboplatin exhibits linear, dose-independent pharmacokinetics in
patients with creatinine clearances > 60
ml/min.
The major route of elimination of carboplatin is renal excretion.
Patients with creatinine clearances of about 60
ml/min or greater, excrete 70 % of the dose of carboplatin in the
urine, with most of this occurring within 12
to 16 hours.
In patients with creatinine clearances of less than 60 ml/min,
carboplatin renal and total body clearances
decrease progressively. Doses of carboplatin, therefore, should be
reduced in patients with creatinine
clearance < 60 ml/min (see “DOSAGE AND DIRECTIONS FOR USE”).
INDICATIONS:
Carboplatin is indicated for the t