Lonsurf 15mg6.14mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Trifluridine; Tipiracil hydrochloride

Saadav alates:

Servier Laboratories Ltd

ATC kood:

L01BC59

INN (Rahvusvaheline Nimetus):

Trifluridine; Tipiracil hydrochloride

Annus:

15mg ; 6.14mg

Ravimvorm:

Tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 08010300; GTIN: 5017476241108 5017476242105

Toote omadused

OBJECT 1
LONSURF
Summary of Product Characteristics Updated 06-Sep-2017 | Servier
Laboratories Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
Section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Lonsurf 15 mg/6.14 mg film-coated tablets
Lonsurf 20 mg/8.19 mg film-coated tablets
2. Qualitative and quantitative composition
Lonsurf 15 mg/6.14 mg film-coated tablets
Each film-coated tablet contains 15 mg trifluridine and 6.14 mg
tipiracil (as hydrochloride).
_Excipient with known effect _
Each film-coated tablet contains 90.735 mg of lactose monohydrate.
Lonsurf 20 mg/8.19 mg film-coated tablets
Each film-coated tablet contains 20 mg trifluridine and 8.19 mg
tipiracil (as hydrochloride).
_Excipient with known effect _
Each film-coated tablet contains 120.980 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Lonsurf 15 mg/6.14 mg film-coated tablets
The tablet is a white, biconvex, round, film-coated tablet, with a
diameter of 7.1 mm and a thickness of
2.7 mm, imprinted with '15' on one side, and '102' and '15 mg' on the
other side, in grey ink.
Lonsurf 20 mg/8.19 mg film-coated tablets
The tablet is a pale red, biconvex, round, film-coated tablet, with a
diameter of 7.6 mm and a thickness of
3.2 mm, imprinted with '20' on one side, and '102' and '20 mg' on the
other side, in grey ink.
4. Clinical particulars
4.1 Therapeutic indications
Lonsurf is indicated for the treatment of adult patients with
metastatic colorectal cancer (CRC) who have
been previously treated with, or are not considered candidates for,
available therapies including
fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies,
anti-VEGF agents, and anti-EGFR
agents.
4.2 Posology and method of administration
Lonsurf should be prescribed by physicians experienced in the
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