KERENDIA finerenone 10 mg film-coated tablet blister pack

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

finerenone, Quantity: 10 mg

Доступна с:

Bayer Australia Ltd

Фармацевтическая форма:

Tablet, film coated

состав:

Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; hypromellose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; purified water; purified talc; titanium dioxide; iron oxide red

Администрация маршрут:

Oral

Штук в упаковке:

14, 98, 28, 100

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

KERENDIA is indicated to delay progressive decline of kidney function and to reduce the risk of cardiovascular mortality and morbidity in adults with chronic kidney disease (with albuminuria) associated with Type 2 diabetes, in addition to standard of care (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).

Обзор продуктов:

Visual Identification: Pink, oval-oblong tablet with a length of 10 mm and a width of 5 mm, marked '10' on one side and 'FI' on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Статус Авторизация:

Registered

Дата Авторизация:

2021-11-25

тонкая брошюра

KERENDIA® CMI V1.0
1
KERENDIA®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
T
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING KERENDIA?
KERENDIA contains the active ingredient finerenone. KERENDIA works by
blocking hormones that can damage the kidneys and
heart. KERENDIA is used to treat adults with chronic kidney disease
and type 2 diabetes. Chronic kidney disease is when your
kidneys keep getting worse at removing waste and fluids from your
blood. Type 2 diabetes is when your body cannot keep
your blood sugar levels normal. KERENDIA slows the worsening of kidney
damage.
For more information, see Section 1. Why am I using KERENDIA?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE KERENDIA?
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
KERENDIA?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with KERENDIA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE KERENDIA?
Take 1 tablet per day with or without food. Your doctor may tell you
to take 20 mg or 10 mg once per day, depending on your
blood test results.
More instructions can be found in Section 4. How do I use KERENDIA?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING KERENDIA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
KERENDIA.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly without checking with your
doctor.
DRIVING OR USING
MACHINES
•
KERENDIA has no effect on your ability to drive or use machines.
LOOKING AFTER
YOUR MEDICINE
•
Store KERENDIA in a cool dry place away

Характеристики продукта

This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected
adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
KERENDIA
® (FINERENONE) FILM-COATED TABLETS
Kerendia
®
PI V1.0; CCDS 1
Page 1 of 18
▼
1
NAME OF THE MEDICINE
finerenone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
KERENDIA 10mg film-coated tablet contains 10 mg finerenone
KERENDIA 20mg film-coated tablet contains 20 mg finerenone
KERENDIA contains lactose monohydrate
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
•
KERENDIA 10 mg film-coated tablet
Pink, oval-oblong tablet with a length of 10 mm and a width of 5 mm,
marked ´10´ on one side and
´FI´ on the other side
•
KERENDIA 20 mg film-coated tablet
Yellow, oval-oblong tablet with a length of 10 mm and a width of 5 mm,
marked ´20´ on one side
and ´FI´ on the other side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
KERENDIA is indicated to delay progressive decline of kidney function
in adults with chronic kidney
disease associated with Type 2 diabetes (with albuminuria), in
addition to standard of care (see
Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE (DOSE AND INTERVAL)
The recommended target dose of KERENDIA is 20 mg once daily.
INITIATION OF TREATMENT
Initiation of KERENDIA treatment is recommended when serum potassium
≤ 4.8 mmol/L.
For monitoring of serum potassium, see ‘Continuation of
treatment.’
If serum potassium > 4.8 to 5.0 mmol/L, initiation of KERENDIA
treatment may be considered with
additional serum potassium monitoring within the first 4 weeks based
on patient characteristics and
serum potassium levels (see Section 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE).
Kerendia
®
PI V1.0; CCDS 1
Page 2 of 18
If serum potassium > 5.0 mmol/L, initiation of KERENDIA treatment is
not recommended (see
Secti