Paclitaxel Moosmann 6mg/ml concentrate for solution for infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

paclitaxel

Available from:

Actavis Italy S.p.A.

ATC code:

L01CD01

INN (International Name):

paclitaxel

Dosage:

6mg/ml

Pharmaceutical form:

concentrate for solution for infusion

Units in package:

glass vial 5ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-06-22

Summary of Product characteristics

15140019en-rev
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Paclitaxel Moosmann 6 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate for solution for infusion contains 6 mg
paclitaxel.
Each vial of 5 ml concentrate contains 30 mg paclitaxel.
Each vial of 16.7 ml concentrate contains 100 mg paclitaxel.
Each vial of 25 ml concentrate contains 150 mg paclitaxel.
Each vial of 50 ml concentrate contains 300 mg paclitaxel.
Excipients:
Each ml of concentrate contains 385 mg ethanol 50% and 527 mg
macrogolglycerol ricinoleate 35 (Ph.Eur.)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless to pale yellow, slightly viscous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ovarian carcinoma
As first-line chemotherapy for ovarian cancer, paclitaxel is indicated
for treatment
of patients with advanced ovarian carcinoma or with a residual tumour
(> 1 cm)
following laparotomy, in combination with cisplatin.
As second-line chemotherapy for ovarian cancer, paclitaxel is
indicated for
treatment of metastatic ovarian carcinoma after standard,
platinum-based drugs
have failed.
Breast carcinoma
In the adjuvant setting, Paclitaxel Moosmann 6 mg/ml is indicated for
treatment of
patients with node-positive breast carcinoma following anthracycline/
cyclophosphamide (AC) therapy. Adjuvant treatment with Paclitaxel
Moosmann 6
mg/ml should be regarded as an alternative to prolonged AC therapy.
Paclitaxel Moosmann 6 mg/ml is indicated as first-line chemotherapy
for locally
advanced or metastatic breast cancer either in combination with an
anthracycline
in patients in whom anthracycline therapy is appropriate, or in
combination with
trastuzumab in patients with an overexpression of human epidermal
growth
factor receptor 2
- 2 -
15140019en-rev
2
(HER2) of level 3+ as determined by immunohistochemistry and in whom
an
anthracycline is not suitable (see section 4.4 and 5.1).
As a single agent, Paclitaxel Moosman