Entresto 24/26

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Sacubitril/valsartan 50mg (As sodium hydrate complex, contains 24.3 mg sacubitril and 25.7 mg valsartan);  ;  

Boleh didapati daripada:

Novartis New Zealand Ltd

INN (Nama Antarabangsa):

Sacubitril/valsartan 50 mg (equivalent to 24.3mg sacubitril and 25.7 mg valsartan)

Dos:

24.3 mg/25.7 mg

Borang farmaseutikal:

Film coated tablet

Komposisi:

Active: Sacubitril/valsartan 50mg (As sodium hydrate complex, contains 24.3 mg sacubitril and 25.7 mg valsartan)     Excipient: Colloidal silicon dioxide Crospovidone Hyprolose Basic coating premix, white Basic coating premix, red Basic coating premix, black Magnesium stearate Microcrystalline cellulose Purified talc Purified water

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

Novartis Pharma Stein AG

Tanda-tanda terapeutik:

Entresto is indicated in adult patients with chronic heart failure (NYHA Class II-IV). Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. LVEF is a variable measure, so use clinical judgment in deciding whom to treat

Ringkasan produk:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC - 56 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture. The product manufactured at Novartis Farma SpA, Torre Annunziata, Italy. - Blister pack, PA/AL/PVC - 56 tablets - 36 months from date of manufacture stored at or below 30°C protect from moisture

Tarikh kebenaran:

2016-02-18

Risalah maklumat

Entresto®
1
ENTRESTO
®
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.
1.
WHY AM I USING ENTRESTO?
Entresto contains the active ingredients sacubitril and valsartan.
Entresto is used to treat heart failure.
For more information, see Section 1. Why am I using Entresto? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ENTRESTO?
Do not use if you have ever had an allergic reaction to Entresto or
any of the ingredients listed at the end of the CMI. Do not take
Entresto if you are pregnant, taking medicines similar to Entresto or
have severe liver problems.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Entresto? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Entresto 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 ENTRESTO?

Take one tablet in the morning and one tablet in the evening (your
doctor will tell you what strength) either with food or
without food.
More instructions can be found in Section 4. How do I use Entresto? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ENTRESTO?
THINGS YOU SHOULD
DO

Remind any doctor, dentist or pharmacist you visit that you are using
Entresto.

Avoid becoming pregnant while using Entresto.
THINGS YOU SHOULD
NOT DO

Do not stop using this medicine suddenly.

Do not take another medicine for high blood pressure or heart failure
from a class known as
angiotensin converting enzyme inhibitor.
DRIVING OR USING
MACHINES

Entresto may cause dizziness or tiredness in some people.
DRINKING ALCOHOL

There are no known interactions between Entresto and alcohol.
LOOKING AFTER YOUR
MEDICINE

Store it in a cool dry place away from moisture, heat or sunl

Ciri produk

New Zealand Data Sheet
Page
1
of
31
1.
PRODUCT NAME
Entresto 24/26

film-coated tablets
Entresto 49/51

film-coated tablets
Entresto 97/103

film-coated tablets
_(sacubitril/valsartan) _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient:
A salt complex of the anionic forms of sacubitril and valsartan,
sodium cations and water molecules in the molar ratio of 1:1:3:2.5
respectively
Chemical name (IUPAC): Octadecasodium hexakis(4-{[(1
_S_
,3
_R_
)-1-([1,1'-biphenyl]-4-
ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoate)
hexakis(
_N_
-pentanoyl-
_N_
-{[2'-(1H-tetrazol-1-id-5-yl)[1,1'-
biphenyl]-4-yl]methyl}-L-valinate)—water (1/15)
Structure (schematic 2-dimensional):
Molecular formula:
C
288
H
330
N
36
O
48
Na
18
·15H
2
O
Relative molecular mass: 5748.0
CAS number:
936623-90-4
Following oral administration, the salt complex dissociates into:
Sacubitril (AAN)
Valsartan (AAN)
Chemical name
(IUPAC):
4-{[(1
_S_
,3R)-1-([1,1'-Biphenyl]-4-
ylmethyl)-4-ethoxy-3-methyl-4-
oxobutyl]amino}-4-oxobutanoic acid
_N_
-Pentanoyl-
_N_
-{[2'-(1
_H_
-
tetrazol-5-yl)[1,1'-biphenyl]-4-
yl]methyl}-L-valine
Molecular formula:
C
24
H
29
NO
5
C
24
H
29
N
5
O
3
Molecular mass:
411. 5
435.5
New Zealand Data Sheet
Page
2
of
31
Structural formula:
CAS number:
149709-62-6
137862-53-4
Entresto film-coated tablets are available in 3 strengths:
Each Entresto 24/26 film-coated tablet contains 24.3 mg sacubitril and
25.7 mg valsartan
(where both drug substances are combined as a sodium salt hydrate
complex). This has been
rounded to 24 mg/26 mg throughout the document.
Each Entresto 49/51 film-coated tablet contains 48.6 mg sacubitril and
51.4 mg valsartan
(where both drug substances are combined as a sodium salt hydrate
complex). This has been
rounded to 49 mg/51 mg throughout the document.
Each Entresto 97/103 film-coated tablet contains 97.2 mg sacubitril
and 102.8 mg valsartan
(where both drug substances are combined as a sodium salt hydrate
complex). This has been
rounded to 97 mg/103 mg throughout the document.