What Atriance contains
- The active substance of Atriance is nelarabine. Each ml of Atriance solution for infusion contains 5 mg of nelarabine. Each vial contains 250 mg of nelarabine.
- The other ingredients are sodium chloride, water for injections, hydrochloric acid/sodium hydroxide
What Atriance looks like and contents of the pack
Atriance solution for infusion is a clear, colourless solution. It is provided in clear glass vials with a non-latex containing rubber stopper and sealed with an aluminium cap.
Each vial contains 50 ml.
Atriance is supplied in packs of 6 vials.
Marketing Authorisation Holder
Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom.
Manufacturer
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations): Harmire Road, Barnard Castle, County Durham DL12 8DT, United Kingdom.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 02 656 21 11 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. BelgiqueBelgien TélTel 32 02 656 21 11
Te. 359 2 953 10 34 Magyarország GlaxoSmithKline Kft. Tel. 36 1 225 5300
Malta GlaxoSmithKline Malta Tel 356 21 238131 eská republika GlaxoSmithKline s.r.o. Tel 420 222 001 111 gsk.czmailgsk.com
Danmark GlaxoSmithKline Pharma AS Tlf 45 36 35 91 00 infoglaxosmithkline.dk Nederland GlaxoSmithKline BV Tel 31 030 6938100 nlinfogsk.com
Deutschland GlaxoSmithKline GmbH Co. KG Tel. 49 089 36044 8701 produkt.infogsk.com Norge GlaxoSmithKline AS Tlf 47 22 70 20 00 firmapostgsk.no
Eesti GlaxoSmithKline Eesti OU Tel 372 6676 900 estoniagsk.com Österreich GlaxoSmithKline Pharma GmbH Tel 43 01 97075 0 at.infogsk.com
GlaxoSmithKline A.E.B.E. 30 210 68 82 100 Polska GSK Commercial Sp. z.o.o. Tel. 48 022 576 9000
España GlaxoSmithKline, S.A. Tel 34 902 202 700 es-cigsk.com Portugal GlaxoSmithKline Produtos Farmacêuticos, Lda. Tel 351 21 412 95 00 FI.PTgsk.com
România GlaxoSmithKline GSK S.R.L. Tel 4021 3028 208 France Laboratoire GlaxoSmithKline Tél 33 01 39 17 84 44 diamgsk.com
Ireland GlaxoSmithKline Ireland Limited Tel 353 01 4955000 Slovenija GlaxoSmithKline d.o.o. Tel 386 01 280 25 00 medical.x.sigsk.com
Ísland GlaxoSmithKline ehf. Tel 354 530 3700 Slovenská republika GlaxoSmithKline Slovakia s. r. o. Tel 421 02 48 26 11 11 recepcia.skgsk.com
Italia GlaxoSmithKline S.p.A. Tel 39 045 9218 111 SuomiFinland GlaxoSmithKline Oy PuhTel 358 010 30 30 30 Finland.tuoteinfogsk.com
GlaxoSmithKline Cyprus Ltd 357 22 89 95 01 Sverige GlaxoSmithKline AB Tel 46 031 67 09 00 info.produktgsk.com
Latvija GlaxoSmithKline Latvia SIA Tel 371 67312687 lv-epastsgsk.com United Kingdom GlaxoSmithKline UK Tel 44 0800 221441 customercontactukgsk.com Lietuva GlaxoSmithKline Lietuva UAB Tel 370 5 264 90 00 info.ltgsk.com
This leaflet was last approved in {MM/YYYY}
This medicine has been authorised under ?exceptional circumstances?.
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.
The following information is intended for medical or healthcare professionals only:
INSTRUCTIONS ON HOW TO STORE AND DISPOSE OF ATRIANCE
Storage of Atriance solution for infusion
This medicinal product does not require any special storage conditions.
Atriance is stable for up to 8 hours at up to 30ºC once the vial is opened.
Instructions for handling and disposal of Atriance
The normal procedures for proper handling and disposal of anti-tumour medicinal products should be adopted, namely:
- Staff should be trained in how to handle and transfer the medicinal product.
- Pregnant staff should be excluded from working with this medicinal product.
- Personnel handling this medicinal product during handling/transfer should wear protective clothing including mask, goggles and gloves.
- All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration. Liquid waste may be flushed with large amounts of water.
- Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.