LONSURF 15 MG6.14 MG

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

TIPIRACIL AS HYDROCHLORIDE; TRIFLURIDINE

Verfügbar ab:

MEDISON PHARMA LTD

ATC-Code:

L01BC59

Darreichungsform:

FILM COATED TABLETS

Zusammensetzung:

TIPIRACIL AS HYDROCHLORIDE 6.14 MG; TRIFLURIDINE 15 MG

Verabreichungsweg:

PER OS

Verschreibungstyp:

Required

Hergestellt von:

ANDERSONBRECON (UK) LTD

Therapiebereich:

TRIFLURIDINE, COMBINATIONS

Anwendungsgebiete:

Colorectal cancerLonsurf is indicated as monotherapy 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.Gastric cancerLonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Berechtigungsdatum:

2020-03-10

Gebrauchsinformation

LONS-PIL-0121 -V2 Page 1 of 9
Lonsurf_PIL_ENG-D18-F
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Lonsurf 15 mg / 6.14 mg
Lonsurf 20 mg / 8.19 mg
Film-coated tablets
Name and quantity of active ingredients:
Lonsurf 15 mg / 6.14 mg
Each film-coated tablet contains:
trifluridine 15 mg
tipiracil (as hydrochloride) 6.14 mg
Lonsurf 20 mg / 8.19 mg
Each film-coated tablet contains:
trifluridine 20 mg
tipiracil (as hydrochloride) 8.19 mg
Inactive ingredients and allergens in this medicine: see section 6
‘Additional information’.
See also ‘Important information about some of this medicine’s
ingredients’ in section 2.
Read the entire leaflet carefully before you start using this
medicine.
This leaflet contains concise information about this medicine.
If you have any further questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others.
It may harm them, even if it seems to you that their illness is
similar to yours.
1.
What is this medicine intended for?
Lonsurf is intended as monotherapy for the treatment of adult patients
with:

metastatic colon or rectal cancer (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 (vascular endothelial
growth factor) agents, and
anti-EGFR (epidermal growth factor receptor) agents

metastatic stomach cancer, including cancer of the junction between
the oesophagus and the
stomach, who have been previously treated with at least two prior
systemic treatment regimens for
advanced disease
Therapeutic group: anticancer, antimetabolites.
Lonsurf contains 2 different active ingredients: Trifluridine and
Tipiracil.

Trifluridine stops the growth of cancer cells.

Tipiracil stops the trifluridine from being broken down by the body,
helping trifluridin

Fachinformation

LONS-SPC-0121-V1 Page 1 of 21
PHYSICIAN’S PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Lonsurf 15 mg/ 6.14 mg
Lonsurf 20 mg/ 8.19 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lonsurf 15 mg/ 6.14 mg:
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:
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
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
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
Colorectal cancer
Lonsurf is indicated as monotherapy 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.
Gastric cancer
Lonsurf is indicated as monotherapy for the treatment of adult
patients with metastatic gastric
cancer including adenocarcinoma of the gastroesophageal junction, who
have been previously
treated with at least two prior systemic treatment regimens for
advanced disease (see section 5.1).
LONS-SPC-0121-V1 Page 2 of 21
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Lonsurf should be prescribed by physicians experienced in the
administration