Pemetrexed Waverley 100 mg powder for concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pemetrexed sodium

Available from:

Waverley Pharma Europe Limited

ATC code:

L01BA; L01BA04

INN (International Name):

Pemetrexed sodium

Dosage:

100 milligram(s)

Pharmaceutical form:

Powder for concentrate for solution for infusion

Therapeutic area:

Folic acid analogues; pemetrexed

Authorization date:

2020-02-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER [PRODUCT NAME] <100 MG> [PRODUCT NAME] <500 MG>
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 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 is and what it is used for
2.
What you need to know before you use
3.
How to use
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
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.
This medicine is also given in combination with cisplatin for the
initial treatment of patients with
advanced stage of lung cancer.
This medicine 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
DO NOT USE
-
if you are allergic (hypersensitive) 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 This
medicine.
-
if you have recently received or are about to receive a v

Summary of Product characteristics

Health Products Regulatory Authority
19 August 2020
CRN009Q55
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pemetrexed Waverley 100 mg powder for concentrate for solution for
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
_Excipients with known effect: _
Each vial contains approximately 11 mg sodium.
After reconstitution (see section 6.6), each vial contains 25 mg/ml of
pemetrexed.
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 Waverley in combination with cisplatin is indicated for the
treatment of chemotherapy naive patients with
unresectable malignant pleural mesothelioma.
Non-small cell lung cancer:
Pemetrexed Waverley in combination with cisplatin is indicated for the
first-line treatment of patients with locally advanced or
metastatic non-small cell lung cancer (NSCLC) other than predominantly
squamous cell histology (see section 5.1).
Pemetrexed Waverley 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 Waverley
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 Waverley must only be administered under the supervision of
a physician qualified in the use of anti-cancer
chemotherapy.
Pemetrexed Waverley _in combination with cisplatin_
The recommended dose of Pemetrexed Waverley is 500 mg/m
2
of body surface area (BSA) administered