Kinpeygo

Država: Evropska unija

Jezik: angleščina

Source: EMA (European Medicines Agency)

Aktivna sestavina:

budesonide, micronised

Dostopno od:

Stada Arzneimittel AG

Koda artikla:

A07EA06

INN (mednarodno ime):

budesonide

Terapevtska skupina:

Antidiarrheals, intestinal antiinflammatory / antiinfective agents

Terapevtsko območje:

Glomerulonephritis, IGA

Terapevtske indikacije:

Kinpeygo is indicated for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.

Povzetek izdelek:

Revision: 5

Status dovoljenje:

Authorised

Datum dovoljenje:

2022-07-15

Navodilo za uporabo

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KINPEYGO 4 MG MODIFIED-RELEASE HARD CAPSULES
budesonide
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Kinpeygo is and what it is used for
2.
What you need to know before you take Kinpeygo
3.
How to take Kinpeygo
4.
Possible side effects
5.
How to store Kinpeygo
6.
Contents of the pack and other information
1.
WHAT KINPEYGO IS AND WHAT IT IS USED FOR
Kinpeygo contains the active substance budesonide, a corticosteroid
medicine which mainly acts
locally in the intestine to reduce the inflammation associated with
primary immunoglobulin A (IgA)
nephropathy.
Kinpeygo is used to treat primary IgA nephropathy in adults 18 years
of age or older.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KINPEYGO
_ _
DO NOT TAKE KINPEYGO:
-
If you are allergic to budesonide or any of the other ingredients of
this medicine (listed in
section 6).
-
If you have loss of function of your liver that your doctor has told
you is “severe”.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Kinpeygo:
•
If you are going to have surgery.
•
If you have liver problems.
•
If you are taking or have recently taken corticosteroids.
•
If you have recently had an infection.
•
If you have active or quiescent tuber

Lastnosti izdelka

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse reactions. See section
4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Kinpeygo 4 mg modified-release hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release hard capsule contains budesonide 4 mg.
Excipient(s) with known effect
Each capsule contains 230 mg of sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release hard capsule.
19 mm white coated opaque capsules printed with “CAL10 4MG” in
black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kinpeygo is indicated for the treatment of primary immunoglobulin A
(IgA) nephropathy (IgAN) in adults at
risk of rapid disease progression with a urine protein-to-creatinine
ratio (UPCR) ≥1.5 g/gram.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 16 mg once daily in the morning, at least one
hour before a meal, for 9 months.
When treatment is to be discontinued, the dose should be reduced to 8
mg once daily for 2 weeks of therapy;
the dose may be reduced to 4 mg once daily for an additional 2 weeks,
at the discretion of the treating
physician.
Re-treatment may be considered at the discretion of the treating
physician. Safety and efficacy of treatment
with subsequent courses of Kinpeygo have not been established.
If the patient forgets to take Kinpeygo, the patient should take
Kinpeygo the next day, in the morning as usual.
The patient should not double the daily dose to make up for a missed
dose.
_ _
_ _
_Special populations _
_Elderly _
3
Experience of the use of Kinpeygo in the elderly is limited. However,
from the clinical data available, the
efficacy and safety of Kinpeygo are expected to be similar to that of
other age groups studied.
_Hepatic impairment _
The safety and efficacy of Kinpeygo capsules i