Torisel

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Temsirolimus

Saatavilla:

Pfizer Europe MA EEIG

ATC-koodi:

L01XE09

INN (Kansainvälinen yleisnimi):

temsirolimus

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Carcinoma, Renal Cell; Lymphoma, Mantle-Cell

Käyttöaiheet:

Renal-cell carcinomaTorisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have at least three of six prognostic risk factors.Mantle-cell lymphomaTorisel is indicated for the treatment of adult patients with relapsed and / or refractory mantle-cell lymphoma (MCL).

Tuoteyhteenveto:

Revision: 33

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2007-11-19

Pakkausseloste

36
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
SOLVENT VIAL
1.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Solvent for Torisel
IV use
2.
METHOD OF ADMINISTRATION
See package leaflet
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Lot
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
2.2 ml
6.
OTHER
Contains: polysorbate 80 (E 433), macrogol 400, anhydrous ethanol.
37
B. PACKAGE LEAFLET
38
Package leaflet: Information for the patient
Torisel 30 mg concentrate and solvent for solution for infusion
temsirolimus
Read all of this leaflet carefully before you are given this medicine
because it contains important
information for you
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any
possibleside effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Torisel is and what it is used for
2. What you need to know before you receive Torisel
3. How Torisel is given
4. Possible side effects
5. How to store Torisel
6. Contents of the pack and other information
1.
What Torisel is and what it is used for
Torisel contains the active substance temsirolimus.
Temsirolimus is a selective inhibitor of the enzyme mTOR (mammalian
target of rapamycin) that
blocks tumour cell growth and division.
Torisel is used to treat the following types of cancer in adults:
-
Advanced cancer of the kidney (renal cancer).
-
Previously treated mantle cell lymphoma, a type of cancer affecting
the lymph nodes.
2.
What you need to know before you receive Torisel
Do not use Torisel
-
if you are allergic to temsirolimus, to polysorbate 80 or to any of
the other ingredients listed in
section 6.
-
if you are allergic to sirolimus (used to prevent the body from
rejecting transplanted kidneys)
since sirolimus is released from temsirolimus in the body.
-
if you have mantle cell lymphoma and liver problems.
Warnings and precautions
Talk to your doctor, phar

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Torisel 30 mg concentrate and solvent for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of concentrate for solution for infusion contains 30 mg
temsirolimus.
After first dilution of the concentrate with 1.8 ml of solvent, the
concentration of temsirolimus is
10 mg/ml (see section 4.2).
Excipients with known effect
Ethanol

1 vial of concentrate contains 474 mg of anhydrous ethanol which is
equivalent to
394.6 mg/ml (39.46% w/v).

1.8 ml of the solvent provided contains 358 mg anhydrous ethanol which
is equivalent to
199.1 mg/ml (19.91% w/v).
Propylene glycol

1 vial of concentrate contains 604 mg of propylene glycol which is
equivalent to 503.3 mg/ml
(50.33% w/v).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate and solvent for solution for infusion (sterile
concentrate).
The concentrate is a clear, colourless to light-yellow solution, free
from visible particulates.
The solvent is a clear to slightly turbid, light-yellow to yellow
solution, free from visible particulates.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Renal cell carcinoma
Torisel is indicated for the first-line treatment of adult patients
with advanced renal cell carcinoma
(RCC) who have at least three of six prognostic risk factors (see
section 5.1).
Mantle cell lymphoma
Torisel is indicated for the treatment of adult patients with relapsed
and/or refractory mantle cell
lymphoma (MCL) (see section 5.1).
4.2
Posology and method of administration
This medicinal product must be administered under the supervision of a
physician experienced in the
use of antineoplastic medicinal products.
3
Posology
Patients should be given intravenous diphenhydramine 25 mg to 50 mg
(or similar antihistamine)
approximately 30 minutes before the start of each dose of temsirolimus
(see section 4.4).
Treatment with Torisel should continue until the patient is no longer
clinically benefiting from therapy
or until