Posaconazole Mylan 100 mg gastro-resistant tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Posaconazole

可用日期:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC代码:

J02AC; J02AC04

INN（国际名称）:

Posaconazole

剂量:

100 milligram(s)

药物剂型:

Gastro-resistant tablet

治疗领域:

Triazole derivatives; posaconazole

授权状态:

Marketed

授权日期:

2019-12-06

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
POSACONAZOLE MYLAN 100 MG GASTRO-RESISTANT TABLETS
posaconazole
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, pharmacist, or
nurse.
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Posaconazole Mylan is and what it is used for
2.
What you need to know before you take Posaconazole Mylan
3.
How to take Posaconazole Mylan
4.
Possible side effects
5.
How to store Posaconazole Mylan
6.
Contents of the pack and other information
1.
WHAT POSACONAZOLE MYLAN IS AND WHAT IT IS USED FOR
Posaconazole Mylan contains the active substance posaconazole. This
belongs to a group of
medicines called “antifungals”. It is used to prevent and treat
many different fungal infections.
This medicine works by killing or stopping the growth of some types of
fungi that can cause
infections.
Posaconazole Mylan can be used in adults to treat fungal infections
caused by fungi of the
_Aspergillus _
family
Posaconazole Mylan can be used in adults and children from 2 years of
age weighing more than 40
kg to treat the following types of fungal infections:
•
infections caused by fungi of the
_Aspergillus _
family that have not improved during treatment
with the anti-fungal medicines amphotericin B or itraconazole or when
these medicines
have had to be stopped;
•
infections caused by fungi of the
_Fusarium _
family that have not improved during treatment
with amphotericin B or when amphotericin B has had to be stopped;
•
infections caused by fungi that cause the conditions known as
“chromoblastomycosis” and
“mycetoma” that

产品特点

HealthProductsRegulatoryAuthority
29November2023
CRN00D0YZ
Page1of19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PosaconazoleMylan100mggastro-resistanttablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachgastro-resistanttabletcontains100mgofposaconazole.
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Gastro-resistanttablet
Yellowcoated,capsuleshapedtabletofapproximately17.5mmlengthand6.7mmwidth,debossedwith"100P"ononeside
andplainontheotherside.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PosaconazoleMylanisindicatedforuseinthetreatmentofthefollowingfungalinfectionsinadults(seesection4.2and5.1):

Invasiveaspergillosis
PosaconazoleMylanisindicatedforuseinthetreatmentofthefollowingfungalinfectionsinpaediatricpatientsfrom2years
ofageweighingmorethan40kgandadults(seesections4.2and5.1):

InvasiveaspergillosisinpatientswithdiseasethatisrefractorytoamphotericinBoritraconazoleorinpatientswho
areintolerantofthesemedicinalproducts;

FusariosisinpatientswithdiseasethatisrefractorytoamphotericinBorinpatientswhoareintolerantof
amphotericinB;

Chromoblastomycosisandmycetomainpatientswithdiseasethatisrefractorytoitraconazoleorinpatientswho
areintolerantofitraconazole;

CoccidioidomycosisinpatientswithdiseasethatisrefractorytoamphotericinB,itraconazoleorfluconazoleorin
patientswhoareintolerantofthesemedicinalproducts.
Refractorinessisdefinedasprogressionofinfectionorfailure�