LONSURF 20 MG8.19MG

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

TIPIRACIL AS HYDROCHLORIDE; TRIFLURIDINE

제공처:

MEDISON PHARMA LTD

ATC 코드:

L01BC59

약제 형태:

FILM COATED TABLETS

구성:

TIPIRACIL AS HYDROCHLORIDE 8.19 MG; TRIFLURIDINE 20 MG

관리 경로:

PER OS

처방전 유형:

Required

Manufactured by:

ANDERSONBRECON (UK) LTD

치료 영역:

TRIFLURIDINE, COMBINATIONS

치료 징후:

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.

승인 날짜:

2020-03-10

환자 정보 전단

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

제품 특성 요약

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