Ciambra

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

pemetrexed disodium hemipentahydrate

Διαθέσιμο από:

Menarini International Operations Luxembourg S.A.

Φαρμακολογική κατηγορία (ATC):

L01BA04

INN (Διεθνής Όνομα):

pemetrexed

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Carcinoma, Non-Small-Cell Lung; Mesothelioma

Θεραπευτικές ενδείξεις:

Malignant pleural mesothelioma Ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Ciambra is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Ciambra is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.,

Περίληψη προϊόντος:

Revision: 6

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2015-12-02

Φύλλο οδηγιών χρήσης

48
B. PACKAGE LEAFLET
49
PACKAGE LEAFLET: INFORMATION FOR THE USER
CIAMBRA 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
CIAMBRA 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
pemetrexed
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING 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 or pharmacist
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What CIAMBRA is and what it is used for
2.
What you need to know before you use CIAMBRA
3.
How to use CIAMBRA
4.
Possible side effects
5.
How to store CIAMBRA
6.
Contents of the pack and other information
1.
WHAT CIAMBRA IS AND WHAT IT IS USED FOR
CIAMBRA is a medicine used in the treatment of cancer.
CIAMBRA is given in combination with cisplatin, another anti-cancer
medicine, as treatment for
malignant pleural mesothelioma, a form of cancer that affects the
lining of the lung, to patients who
have not received prior chemotherapy.
CIAMBRA is also given in combination with cisplatin for the initial
treatment of patients with
advanced stage of lung cancer.
CIAMBRA can be prescribed to you if you have lung cancer at an
advanced stage if your disease has
responded to treatment or it remains largely unchanged after initial
chemotherapy.
CIAMBRA is also a treatment for patients with advanced stage of lung
cancer whose disease has
progressed after other initial chemotherapy has been used.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CIAMBRA
_ _
DO NOT USE
CIAMBRA
-
if you are allergic (hypersensitive) to pemetrexed or any of the other
ingredients of CIAMBRA
(listed in section 6).
-
if you are breast-feeding; you must discontinue breast-feeding during
treatment with
CIAMBRA.
-
if you have recently received or are about to receive a vaccine
against yellow fever.
50
WARNINGS AND PRECAUTIONS
Talk to your doctor

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
CIAMBRA 100 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder contains 100 mg of pemetrexed (as pemetrexed
disodium hemipentahydrate).
After reconstitution (see section 6.6), each vial contains 25 mg/ml of
pemetrexed.
Excipient with known effect
Each vial contains approximately 11 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to almost white lyophilised powder.
The pH of the reconstituted solution is between 6.6 and 7.8.
The Osmolality of the reconstituted solution is 230-270 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Malignant
pleural mesothelioma
CIAMBRA in combination with cisplatin is indicated for the treatment
of chemotherapy naive patients
with unresectable malignant pleural mesothelioma.
Non-
small cell lung cancer
CIAMBRA in combination with cisplatin is indicated for the first line
treatment of patients with locally
advanced or metastatic non-small cell lung cancer other than
predominantly squamous cell histology
(see section 5.1).
CIAMBRA is indicated as monotherapy for the maintenance treatment of
locally advanced or
metastatic non-small cell lung cancer other than predominantly
squamous cell histology in patients
whose disease has not progressed immediately following platinum-based
chemotherapy (see section
5.1).
CIAMBRA is indicated as monotherapy for the second line treatment of
patients with locally advanced
or metastatic non-small cell lung cancer other than predominantly
squamous cell histology (see section
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
CIAMBRA must only be administered under the supervision of a physician
qualified in the use of
anti-cancer chemotherapy.
3
Posology
_CIAMBRA in combination with cisplatin _
The recommended dose of CIAMBRA is 500 mg/m
2
of body surface area (BSA) administered as an
intravenous infusion over 1