What ALIMTA contains
The active substance is pemetrexed.
ALIMTA 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium). ALIMTA 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium).
After reconstitution, the solution contains 25 mg/ml of pemetrexed. Further dilution by a healthcare provider is required prior to administration.
The other ingredients are mannitol, hydrochloric acid and sodium hydroxide.
What ALIMTA looks like and contents of the pack
ALIMTA is a powder for concentrate for solution for infusion in a vial. It is a white to either light yellow or green-yellow lyophilised powder.
Each pack of ALIMTA consists of one ALIMTA vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Eli Lilly Nederland B.V.
Grootslag 1-5
NL-3991 RA
Houten
The Netherlands
Manufacturer
Lilly France S.A.S.
rue du Colonel Lilly
F-67640 Fegersheim
France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
LuxembourgLuxemburg Eli Lilly Benelux S.A TélTel 32-02 548 84 84 Magyarország Lilly Hungária Kft. Tel 36 1 328 5100 Malta Charles de Giorgio Ltd. Tel 356 25600 500 Nederland Eli Lilly Nederland B.V. Tel 31-0 30 60 25 800 Norge Eli Lilly Norge A.S. Tlf 47 22 88 18 00 Österreich Eli Lilly Ges.m.b.H. Tel 43-0 1 711 780 Polska Eli Lilly Polska Sp. z o.o. Tel. 48 0 22 440 33 00 Portugal Lilly Portugal - Produtos Farmacêuticos, Lda Tel 351-21-4126600 România Eli Lilly România S.R.L. Tel 40 21 4023000 Slovenija Eli Lilly farmacevtska druba, d.o.o. Tel 386 01 580 00 10 Slovenská republika Eli Lilly Slovakia, s.r.o. Tel 421 220 663 111 SuomiFinland Oy Eli Lilly Finland Ab PuhTel 358-0 9 85 45 250 Sverige Eli Lilly Sweden AB Tel 46-0 8 7378800 United Kingdom Eli Lilly and Company Limited Tel 44-0 1256 315000 BelgiqueBelgiëBelgien Eli Lilly Benelux S.A TélTel 32-02 548 84 84 .. - . 359 2 491 41 40 eská republika ELI LILLY R, s.r.o. Tel 420 234 664 111 Danmark Eli Lilly Danmark AS Tlf 45 45 26 60 00 Deutschland Lilly Deutschland GmbH Tel. 49-0 6172 273 2222 Eesti Eli Lilly Holdings Limited Eesti filiaal Tel 372 6 817 280 - .... 30 210 629 4600 España Lilly S.A. Tel 34-91-663 50 00 France Lilly France S.A.S Tél 33-0 1 55 49 34 34 Ireland Eli Lilly and Company Ireland Limited Tel 353-0 1 661 4377 Ísland Icepharma hf. Sími 354 540 8000 Italia Eli Lilly Italia S.p.A. Tel 39- 055 42571 Phadisco Ltd 357 22 715000 Latvija Eli Lilly Holdings Limited prstvniecba Latvij Tel 371 6 7364000 Lietuva Eli Lilly Holdings Limited atstovyb Tel. 370 5 2649600
This leaflet was last approved in
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The following information is intended for medical or healthcare professionals only:
Instructions for use, handling and disposal.
1. Use aseptic techniques during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
2. Calculate the dose and the number of ALIMTA vials needed. Each vial contains an excess of pemetrexed to facilitate delivery of the label amount.
3. ALIMTA 100 mg: Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed. ALIMTA 500 mg: Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Gently swirl each vial until the powder is completely dissolved. The resulting solution is clear and ranges in colour from colourless to yellow or green-yellow without adversely affecting product quality. The pH of the reconstituted solution is between 6.6 and 7.8. Further dilution is required.
4. The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
5. Pemetrexed infusion solutions prepared as directed above are compatible with polyvinyl chloride and polyolefin lined administration sets and infusion bags. Pemetrexed is incompatible with diluents containing calcium, including lactated Ringer?s Injection and Ringer?s Injection.
6. Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.
7. Pemetrexed solutions are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.
Preparation and administration precautions:As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of pemetrexed infusion solutions. The use of gloves is recommended. If a pemetrexed solution contacts the skin, wash the skin immediately and thoroughly with soap and water. If pemetrexed solutions contact the mucous membranes, flush thoroughly with water. Pemetrexed is not a vesicant. There is not a specific antidote for extravasation of pemetrexed. There have been a few reported cases of pemetrexed extravasation, which were not assessed as serious by the investigator. Extravasation should be managed by local standard practice as with other non-vesicants.