Carboplatin EBEWE concentrate for solution for infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

carboplatin

Available from:

EBEWE Pharma Ges. m.b.H. Nfg. KG

ATC code:

L01XA02

INN (International Name):

carboplatin

Dosage:

10mg/ml

Pharmaceutical form:

concentrate for solution for infusion

Units in package:

(1) glass vial 450mg/45ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-09-12

Summary of Product characteristics

m12 - en-spc-pl - 7
1
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
CARBOPLATIN EBEWE® 10 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 10 mg of carboplatin.
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless or almost colourless solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Advanced epithelial ovarian carcinoma as:
(a)
First-line treatment
(b)
Second-line treatment, if other treatments have failed;
Small cell and non-small cell lung cancer.
Carboplatin Ebewe is used in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION:
_Carboplatin should only be administered by physicians with experience
in anti-cancer _
_therapy._
Dosage
The recommended dose in previously untreated patients with normal
renal function (i.e.
creatinine clearance > 60 ml/min) is 400 mg/m² as a single dose short
intravenous infusion
(15-60 minutes).
Treatment should not be repeated until 4 weeks not passed since the
previous carboplatin
therapy cycle and/or until the neutrophil count is at least 2,000
cells/mm³ and the platelet
count is at least 100,000 cells/mm³.
In patients with risk factors such as prior myelosuppressive treatment
and low performance
status (ECOG/Zubrod 2-4 or Karnofsky below 80), a starting dose
reduction of 20-25% is
recommended.
During the initial cycles, determination of the haematological nadir
with weekly blood counts
is recommended in order to make a dose adjustment for further
treatments.
Alternatively, the Calvert formula below can be used to determine the
dose:
en-spc-pl
Pg. 1
m12 - en-spc-pl - 7
2
Dose (mg) = desired AUC value (mg/ml x min) x [GFR ml/min + 25]
DOSE (MG) = DESIRED AUC VALUE (MG/ML X MIN) X [GFR ML/MIN + 25]
DESIRED
AUC
VALUE
PLANNED CHEMOTHERAPY
TREATMENT
STATUS
OF
THE
PATIENT
5-7 mg/ml min
monotherapy
No previous treatment
4-6 mg/ml min
monotherapy
With previous treatment
4-6 mg/ml min
Carboplatin plus cyclophosphamide
No previous treatment
N