Pemetrexed 100 DOSA
Pemetrexed 100 mg (as disodium pemetrexed)
Pemetrexed 500 DOSA
Pemetrexed 500 mg (as disodium pemetrexed)
Lyophilised injection for intravenous infusion only
Argentine Industry - Dispense under prescription
Composition:
PEMETREXED 100 DOSA
Each glass bottle contains: pemetrexed (as disodium permetrexed) 100 mg, mannitol, 10% hydrochloric acid solution and/or 10% sodium hydroxide solution for pH adjustment.
PEMETREXED 500 DOSA
Each glass bottle contains: pemetrexed (as disodium permetrexed) 500 mg, mannitol, 10% hydrochloric acid solution and/or 10% sodium hydroxide solution for pH adjustment.
Therapeutic indications:
Malignant pleural mesothelioma:
In combination with cisplatin, PEMETREXED DOSA is indicated for the treatment of patients with unresectable malignant pleural mesothelioma who have not received prior chemotherapy.
Non-microcytic lung cancer:
In combination with cisplatin, PEMETREXED DOSA is indicated for the first-line treatment of patients with locally advanced or metastatic non-microcytic lung cancer, except those patients with predominantly squamous cell histology (see Pharmacodynamic Properties).
In single therapy, PEMETREXED DOSA is indicated as maintenance treatment of patients with locally advanced or metastatic non-microcytic lung cancer, except those patients with predominantly squamous cell histology whose disease has not progressed immediately after a platinium-based chemotherapy regimen. The first-line treatment must include a double combination of a platinum agent with gemcitabine, paclitaxel, or docetaxel (see Pharmacodinamic Properties).
In single therapy, PEMETREXED DOSA is indicated for the second-line treatment of patients with locally advanced or metastatic non-microcytic lung cancer, except those patients with predominantly squamous cell histology (see Pharmacodinamic Properties).
Dose and administration:
PEMETREXED DOSA must be administered under the supervision of a physician qualified for the use of antineoplasic chemotherapy.
PEMETREXED DOSA in combination with cisplatin:
The recommended dose of PEMETREXED DOSA is 500 mg/m2 of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle. The recommended dose of cisplatin is 75 mg/m2 (BSA) administered as a perfusion over 2 hours, approximately 30 minutes after completing the pemetrexed perfusion, on the first day of each 21-day cycle.
Patients should receive appropriate hydration prior to and/or after receiving cisplatin (see also cisplatin Summary of Product Characteristics for the specific dosing).
PEMETREXED DOSA used as single-agent:
For patients with non-microcytic lung cancer who have not received prior chemotherapy, the recommended PEMETREXED DOSA dose is 500 mg/m2 (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Pharmacological Information:
Incompatibilities
Pemetrexed is physically incompatible with diluents containing calcium, including lactated ringer injection and ringer injection. Since there is no other compatibility study of this product with any other drug or diluent, pemetrexed must not be administered in combination.
How supplied:
PEMETREXED 100 DOSA
1 glass bottle packaged in a carton
PEMETREXED 500 DOSA
1 glass bottle packaged in a carton
KEEP OUT OF THE REACH OF CHILDREN
Medicinal specialty authorized by the Ministry of Health
Store at room temperature (15 – 30 ºC)
Certificate No. 56303
Laboratorio DOSA S.A.
Girardot 1369, (C1427AKC) City of Buenos Aires
Argentine Republic
Pharmaceutical Directo: María C. Terzo, Pharmacist
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