Segosana 45 mg harde capsules

국가: 네덜란드

언어: 네덜란드어

출처: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

유효 성분:

OSELTAMIVIRFOSFAAT 59,1 mg/stuk SAMENSTELLING overeenkomend met ; OSELTAMIVIR 45 mg/stuk

제공처:

Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)

INN (International Name):

OSELTAMIVIRFOSFAAT 59,1 mg/stuk SAMENSTELLING overeenkomend met ; OSELTAMIVIR 45 mg/stuk

약제 형태:

Capsule, hard

구성:

AMMONIA (E 527) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT, AMMONIA (E 527) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT

관리 경로:

Oraal gebruik

승인 날짜:

2020-04-22

환자 정보 전단

Oseltamivir hard capsules NL_en_NL-H-4651_del BRS Wessling 202312
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEGOSANA 45 MG HARDE CAPSULES
oseltamivir
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 any 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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
•
is used for adults, adolescents, children and infants
(including full-term newborn
babies) for TREATING FLU (_influenza_). It can be used when you have
flu symptoms, and the flu virus is
known to be going round in your community.
•
can also be prescribed for adults, adolescents,
children and infants above 1 year of
age for PREVENTING FLU, on a case-by-case basis – for instance, if
you have been in contact with
someone who has flu.
•
may be prescribed for adults, adolescents, children and
infants (including full-term
newborn babies) as PREVENTIVE TREATMENT in exceptional circumstances
– for example, if there is a
global epidemic of flu (a flu _ pandemic_) and the seasonal flu
vaccine may not provide sufficient
protection.
contains _ oseltamivir_, which belongs to a group of
medicines named _ neuraminidase _
_inhibitors_. These medicines prevent the flu virus from spreading
inside the body. They help to ease or
prevent the symptoms of the flu virus i

제품 특성 요약

Oseltamivir hard capsules NL_en_NL-H-4651_EPAR_2020_09
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Segosana 30 mg harde capsules
Segosana 45 mg harde capsules
Segosana 75 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
30 mg hard capsules
Each hard capsule contains oseltamivir phosphate equivalent to 30 mg
of oseltamivir.
45 mg hard capsules
Each hard capsule contains oseltamivir phosphate equivalent to 45 mg
of oseltamivir.
75 mg hard capsules
Each hard capsule contains oseltamivir phosphate equivalent to 75 mg
of oseltamivir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
30 mg hard capsules
Size “4” hard gelatin capsules with light yellow opaque colour
body with black colour band, imprinted with
“M” and light yellow opaque colour cap imprinted with “30 mg”.
The size is approximately 14.37 mm.
45 mg hard capsules
Size “4” hard gelatin capsules with grey opaque colour body with
black colour band, imprinted with “M”
and grey opaque colour cap imprinted with “45 mg”. The size is
approximately 14.37 mm.
75 mg hard capsules
Size “2” hard gelatin capsules with grey opaque colour body with
black colour band, imprinted with “M”
and light yellow opaque colour cap imprinted with “75 mg”. The
size is approximately 17.66 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Treatment of influenza _
Oseltamivir is indicated in adults and children including full term
neonates who present with symptoms
typical of influenza, when influenza virus is circulating in the
community. Efficacy has been demonstrated
when treatment is initiated within two days of first onset of
symptoms.
_Prevention of influenza _
-
Post-exposure prevention in individuals 1 year of age or older
following contact with a clinically
diagnosed influenza case when influenza virus is circulating in the
community.
-
The appropriate use of oseltamivir for prevention of i