What METALYSE contains
- The active substance is tenecteplase. One vial contains 8,000 units of tenecteplase. One pre-filled syringe contains 8 ml of water for injections.
- The other ingredients are L-arginine, phosphoric acid and polysorbate 20.
- The METALYSE solvent is water for injections.
- Gentamicin is contained as trace residue from the manufacturing process
What METALYSE looks like and contents of the pack
The folding box contains one vial with a lyophilised powder, one ready for use syringe with a solvent, one vial adapter and one needle.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Boehringer Ingelheim International GmbH
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany
Manufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG
Birkendorfer Strasse 65
D-88397 Biberach/Riss
Germany
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgienSCS Boehringer Ingelheim Comm.V TélTel 32 2 773 33 11 LuxembourgLuxemburgSCS Boehringer Ingelheim Comm.V TélTel 32 2 773 33 1
- 359 2 958 79 98 MagyarországBoehringer Ingelheim RCV GmbH Co KGMagyarországi FióktelepeTel. 36 1 299 890
eská republika Boehringer Ingelheim spol. s r.o. Tel 420 234 655 111 MaltaBoehringer Ingelheim Ltd.Tel 44 1344 424 60
Danmark Boehringer Ingelheim Danmark AS Tlf 45 39158888 NederlandBoehringer Ingelheim b.v.Tel 31 0 800 22 55 88
Deutschland Boehringer Ingelheim Pharma GmbH Co. KGTel 49 0 800 77 90 900 NorgeBoehringer Ingelheim Norway KS Tlf 47 66 76 13 0
Eesti Boehringer Ingelheim RCV GmbH Co KGEesti filiaal Tel 372 60 80 940 ÖsterreichBoehringer Ingelheim RCV GmbH Co KGTel 43 1 80 105-
E Boehringer Ingelheim Ellas A.E. T 30 2 10 89 06 300 PolskaBoehringer Ingelheim Sp.zo.o. Tel. 48 22 699 0 69
España Boehringer Ingelheim España S.A. Tel 34 93 404 58 00 PortugalBoehringer Ingelheim, Lda. Tel 351 21 313 53 0
RomâniaBoehringer Ingelheim RCV GmbH Co KGFrance Boehringer Ingelheim France S.A.S. Tél 33 3 26 50 45 33 Viena - Sucursala Bucuresti Tel 40 21 330 99 6
Ireland Boehringer Ingelheim Ireland Ltd. Tel 353 1 295 9620 SlovenijaBoehringer Ingelheim RCV GmbH Co KGPodrunica LjubljanaTel 386 1 586 40 0
Ísland Vistor hf. Sími 354 535 7000 Slovenská republikaBoehringer Ingelheim RCV GmbH Co KGorganizaná zlokaTel 421 2 5810 1211
Italia Boehringer Ingelheim Italia S.p.A. Tel 39 02 5355 1 SuomiFinlandBoehringer Ingelheim Finland Ky PuhTel 358 10 3102 800
Boehringer Ingelheim Ellas A.E. T 30 2 10 89 06 300 SverigeBoehringer Ingelheim ABTel 46 8 721 21 0
United KingdomBoehringer Ingelheim Ltd.Tel 44 1344 424 600Latvija Boehringer Ingelheim Pharma GmbH Prstvniecba Latvij Tel 371 67 240 068
Lietuva
Boehringer Ingelheim RCV GmbH & Co KG
Lietuvos filialas
Tel.: +370 37 473922
This leaflet was last approved in {MM/YYYY}.