Erlotinib Medical Valley 25 mg Filmdragerad tablett

국가: 스웨덴

언어: 스웨덴어

출처: Läkemedelsverket (Medical Products Agency)

유효 성분:

erlotinibhydroklorid

제공처:

Medical Valley Invest AB

ATC 코드:

L01EB02

INN (International Name):

erlotinib hydrochloride

복용량:

25 mg

약제 형태:

Filmdragerad tablett

구성:

natriumlaurilsulfat Hjälpämne; erlotinibhydroklorid 27,317 mg Aktiv substans; laktosmonohydrat Hjälpämne

처방전 유형:

Receptbelagt

제품 요약:

Förpacknings: Blister, 30 tabletter; Burk, 30 tabletter

승인 상태:

Godkänd

승인 날짜:

2019-04-29

환자 정보 전단

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE
USER
Erlotinib Medical Valley 25 MG FILM-COATED
TABLETS
Erlotinib Medical Valley 100 MG FILM-COATED
TABLETS
Erlotinib Medical Valley 150 MG FILM-COATED
TABLETS
Erlotinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [Invented name] is and what it is used for
2.
What you need to know before you take [Invented name]
3.
How to take [Invented name]
4.
Possible side effects
5.
How to store [Invented name]
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[Invented name] contains the active substance erlotinib. [Invented
name] is a medicine used to treat
cancer by preventing the activity of a protein called epidermal growth
factor receptor (EGFR). This
protein is known to be involved in the growth and spread of cancer
cells.
[Invented name] is indicated for adults. This medicine can be
prescribed to you if you have non-small
cell lung cancer at an advanced stage. It can be prescribed as initial
therapy or as therapy if your
disease remains largely unchanged after initial chemotherapy, provided
your cancer cells have
specific EGFR mutations. It can also be prescribed if previous
chemotherapy has not helped to stop
your disease.
This medicine can also be prescribed to you in combination with
another treatment called gemcitabine
if you have cancer of the pancreas at a metastatic stage.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [INVENTED NAME]
DO NOT TAKE [INVENTED NAME]:
•
if you are allergic to erl

제품 특성 요약

PRODUKTRESUMÉ
1.
LÄKEMEDLETS NAMN
Erlotinib Medical Valley 25 mg filmdragerade tabletter
Erlotinib Medical Valley 100 mg filmdragerade tabletter
Erlotinib Medical Valley 150 mg filmdragerade tabletter
2.
KVALITATIV OCH KVANTITATIV SAMMANSÄTTNING
_Erlotinib Medical Valley 25 mg filmdragerade tabletter_
En filmdragerad tablett innehåller erlotinibhydroklorid motsvarande
25 mg erlotinib.
_Erlotinib Medical Valley 100 mg filmdragerade tabletter_
En filmdragerad tablett innehåller erlotinibhydroklorid motsvarande
100 mg erlotinib.
_Erlotinib Medical Valley 150 mg filmdragerade tabletter_
En filmdragerad tablett innehåller erlotinibhydroklorid motsvarande
150 mg erlotinib.
_Erlotinib Medical Valley 25 mg filmdragerade tabletter_
Hjälpämnen med känd effekt: Varje filmdragerad tablett innehåller
18 mg laktosmonohydrat som
motsvarar 17mg laktos.
_Erlotinib Medical Valley 100 mg filmdragerade tabletter_
Hjälpämnen med känd effekt: Varje filmdragerad tablett innehåller
71 mg laktosmonohydrat som
motsvarar 68 mg laktos.
_Erlotinib Medical Valley 150 mg filmdragerade tabletter_
Hjälpämnen med känd effekt: Varje filmdragerad tablett innehåller
107 mg laktosmonohydrat som
motsvarar 102 mg laktos.
För fullständig förteckning över hjälpämnen, se avsnitt 6.1.
3.
LÄKEMEDELSFORM
Filmdragerad tablett.
Erlotinib Medical Valley 25 mg filmdragerade tabletter är vita,
runda, bikonvexa tabletter med en
diameter på cirka 5,7 mm, märkta med ett ”H” på ena sidan och
”28” på andra sidan.
Erlotinib Medical Valley 100 mg filmdragerade tabletter är vita,
runda, bikonvexa tabletter med en
diameter på cirka 8,8 mm, märkta med ett ”H” på ena sidan och
”21” på andra sidan.
Erlotinib Medical Valley 150 mg filmdragerade tabletter är vita,
runda, bikonvexa tabletter med en
diameter på cirka 10,5 mm, märkta med ett ”H” på ena sidan och
”22” på andra sidan.
4.
KLINISKA UPPGIFTER
4.1
TERAPEUTISKA INDIKATIONER
Icke-småcellig lungcancer (Non-Small Cell Lung Cancer, NSCLC)
Erlotinib Medical Val