Pemetrexed STADA 25mg/ml, concentraat voor oplossing voor infusie

Nchi: Uholanzi

Lugha: Kiholanzi

Chanzo: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Viambatanisho vya kazi:

PEMETREXED

Inapatikana kutoka:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC kanuni:

L01BA04

INN (Jina la Kimataifa):

PEMETREXED

Dawa fomu:

Concentraat voor oplossing voor infusie

Tungo:

ARGININE, (L-) ; CITROENZUUR 0-WATER (E 330) ; CYSTEÏNE (L-) ; PROPYLEENGLYCOL (E 1520) ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE,

Njia ya uendeshaji:

Intraveneus gebruik

Eneo la matibabu:

Pemetrexed

Bidhaa muhtasari:

Hulpstoffen: ARGININE, (L-); CITROENZUUR 0-WATER (E 330); CYSTEÏNE (L-); PROPYLEENGLYCOL (E 1520); STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE;

Idhini ya tarehe:

2018-03-21

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
PEMETREXED STADA 25MG/ML
concentraat voor oplossing voor infusie
pemetrexed
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Pemetrexed STADA is and what it is used for
2. What you need to know before you use Pemetrexed STADA
3. How to use Pemetrexed STADA
4. Possible side effects
5. How to store Pemetrexed STADA
6. Contents of the pack and other information
1 WHAT PEMETREXED STADA IS AND WHAT IT IS USED FOR
Pemetrexed STADA is a medicine used in the treatment of cancer.
Pemetrexed STADA 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.
Pemetrexed
STADA
is
also
given
in
combination
with
cisplatin
for
the
initial
treatment of patients with advanced stage of lung cancer.
Pemetrexed STADA 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.
Pemetrexed STADA 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 PEMETREXED STADA
DO NOT USE PEMETREXED STADA

if you are ALLERGIC TO PEMETREXED OR ANY OF THE OTHER INGREDIENTS of
this medicine
(listed in section 6).

if you are BREAST-FEEDING; you must discontinue breast-feeding during
treatment with
Pemetrexed STADA.

if you have recently received or are about to receive a VACCINE
AGAINST YELLOW FEVER.
WARNINGS AND PRECAUTIONS
T

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Pemetrexed STADA 25mg/ml, concentraat voor oplossing voor infusie
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of concentrate contains 25 mg pemetrexed (as pemetrexed
diarginine)
One vial of 4 ml concentrate contains 100 mg pemetrexed (as pemetrexed
diarginine).
One vial of 20 ml concentrate contains 500 mg pemetrexed (as
pemetrexed diarginine).
One vial of 40 ml concentrate contains 1,000 mg pemetrexed (as
pemetrexed diarginine).
Excipient(s) with known effect
One vial of 4 ml concentrate contains 140.0 mg propylene glycol.
One vial of 20 ml concentrate contains 700.0 mg propylene glycol.
One vial of 40 ml concentrate contains 1,400.0 mg propylene glycol.
For the full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless to slightly yellow to brown, brown yellow or green
yellow solution.
The pH of the concentrate is between 8.3 and 9.0.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Malignant pleural mesothelioma
[Product name] in combination with cisplatin is indicated for the
treatment of chemotherapy
naïve patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
[Product name] 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).
[Product name] 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).
[Product name] 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
Posology