Pemetrexed 100mg powder for concentrate for solution for infusion vials

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Pemetrexed disodium

Saadav alates:

Seacross Pharmaceuticals Ltd

INN (Rahvusvaheline Nimetus):

Pemetrexed disodium

Annus:

100mg

Ravimvorm:

Powder for solution for infusion

Manustamisviis:

Intravenous

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF:

Infovoldik

Package
leaflet:
Information
for
the
user
Pemetrexed
Seacross
100
mg
powder
for
concentrate
for
solution
for
infusion
Pemetrexed
Seacross
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 further questions, please ask your doctor, pharmacist or
nurse.
If
you get any side effects, talk
to
your doctor, pharmacist or nurse. This
includes any possible side effects not listed
in
this leaflet. See section
4.
What
is
in
this
leaflet:
1.
What Pemetrexed Seacross is and what it is used for
2. What you need to know before you use Pemetrexed Seacross
3. How to use Pemetrexed Seacross
4. Possible side effects
5. How to store Pemetrexed Seacross
6. Contents
of
the pack and other information
1.
What
Pemetrexed
Seacross
is
and
what
it
is
used
for
Pemetrexed Seacross is a medicine used
in
the treatment
of
cancer.
This medicine 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.
11
is also given
in
combination with cisplatin for the initial treatment
of
patients with advanced stage
of
lung cancer.
Pemetrexed
Seacross 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.
This medicine 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
Seacross
Do
not
use
Pemetrexed
Seacross
•
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.
•
if
you have r

Toote omadused

OBJECT 1
PEMETREXED SEACROSS 100 MG POWDER FOR
CONCENTRATE FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 22-Jan-2018 | Seacross
Pharmaceuticals Ltd
1. Name of the medicinal product
Pemetrexed Seacross 100 mg powder for concentrate for solution for
infusion
2. Qualitative and quantitative composition
Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
After reconstitution (see section 6.6), each vial contains 25 mg/ml of
pemetrexed.
Excipients with known effect:
Each 100 mg vial contains less than 1 mmol (11 mg) of sodium.
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion.
White to either light yellow or green-yellow lyophilised powder.
4. Clinical particulars
4.1 Therapeutic indications
Malignant pleural mesothelioma
Pemetrexed Seacross in combination with cisplatin is indicated for the
treatment of chemotherapy naïve
patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Seacross 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).
Pemetrexed Seacross 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).
Pemetrexed Seacross 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:
Pemetrexed Seacross must only be administered under the supervision of
a physician qualified in the use
of anti-cancer chemotherapy.
Pemetrexed Seacross in combination with cisplatin
The recommended dose of Pemetr