ROSUZET Composite Pack 10mg+10mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 10mg tablets composite pack

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

rosuvastatin calcium, Quantity: 10.396 mg

Հասանելի է:

ORGANON PHARMA PTY LTD

INN (Միջազգային անվանումը):

Ezetimibe,Rosuvastatin calcium

Դեղագործական ձեւ:

Tablet, film coated

Կազմը:

Excipient Ingredients: microcrystalline cellulose; sodium stearylfumarate; purified talc; macrogol 6000; lactose; colloidal anhydrous silica; maize starch; mannitol; hypromellose; silicon dioxide; titanium dioxide; iron oxide yellow; iron oxide red

Կառավարման երթուղին:

Oral

Միավորները փաթեթում:

20 tablets, 60 tablets

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

Primary Hypercholesterolaemia: ROSUZET Composite Pack is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with rosuvastatin or ezetimibe alone; or - already treated with rosuvastatin and ezetimibe. Homozygous Familial Hypercholesterolaemia (HoFH): ROSUZET Composite Pack is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

Ապրանքի ամփոփագիր:

Visual Identification: Brown, round, film coated tablets with "RSV 10" debossed on one side.; Container Type: Multiple containers; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Լիազորման կարգավիճակը:

Licence status A

Հաստատման ամսաթիվը:

2013-11-26

Տեղեկատվական թերթիկ

ROSUZET COMPOSITE
PACK
_ezetimibe and rosuvastatin calcium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ROSUZET
COMPOSITE PACK. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ROSUZET
COMPOSITE PACK against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ROSUZET
COMPOSITE PACK IS
USED FOR
ROSUZET COMPOSITE PACK
helps to lower cholesterol levels. It is
used in people whose cholesterol
levels are too high and when diet
alone cannot lower these levels
adequately.
_WHAT IS HIGH CHOLESTEROL_
Cholesterol is one of several fatty
substances found in the bloodstream.
Your total cholesterol is made up
mainly of LDL and HDL cholesterol.
LDL cholesterol is often called “bad”
cholesterol because it can build up in
the walls of your arteries forming
plaque. Eventually this plaque build-
up can lead to a narrowing of the
arteries. This narrowing can slow or
block blood flow to vital organs such
as the heart and brain. This blocking
of blood flow can result in a heart
attack or stroke.
HDL cholesterol is often called
“good” cholesterol because it helps
keep the bad cholesterol from
building up in the arteries and
protects against heart disease.
_HOW ROSUZET COMPOSITE_
_PACK WORKS_
ROSUZET COMPOSITE PACK is a
combination pack, which contains
two different medicines. One is
Ezetrol (ezetimibe) and the other is
rosuvastatin (rosuvastatin calcium).
ROSUZET COMPOSITE PACK
reduces elevated total-cholesterol,
LDL ('bad') cholesterol and increases
HDL ('good') cholesterol.
ROSUZET COMPOSITE PACK
works by decreasing the absorption
of cholesterol in the small intestine
and by reducing the amount of
cholesterol made in the liver.
Your doctor may have prescribed
ROSU

Ապրանքի հատկությունները

Page 1 of 32
AUSTRALIAN PRODUCT INFORMATION
ROSUZET COMPOSITE PACK
(EZETIMIBE, ROSUVASTATIN AS CALCIUM)
TABLETS
1
NAME OF THE MEDICINE
Ezetimibe
Rosuvastatin, as calcium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
EZETROL
®
Each tablet of EZETROL for oral administration contains 10 mg
ezetimibe.
List of excipients with known effect:
-
lactose (as monohydrate)
OGN ROSUVASTATIN
OGN ROSUVASTATIN tablets contain 5 mg, 10 mg, 20 mg or 40 mg
rosuvastatin (as
calcium).
List of excipients with known effect:
-
sugars (as lactose)
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
EZETROL
OGN ROSUVASTATIN
ROSUZET COMPOSITE PACK
10 mg + 5 mg
ezetimibe 10 mg
white
to
off-white
capsule
shaped
tablets,
debossed
with “414” on one
side
rosuvastatin (as calcium) 5 mg
Brown, round, film coated tablets.
ROSUZET COMPOSITE PACK
10 mg + 10 mg
rosuvastatin (as calcium) 10 mg
Brown, round, film coated tablets with
“RSV 10” debossed on one side.
ROSUZET COMPOSITE PACK
10 mg + 20 mg
rosuvastatin (as calcium) 20 mg
Brown, round, film coated tablets with
“RSV 20” debossed on one side.
ROSUZET COMPOSITE PACK
10 mg + 40 mg
rosuvastatin (as calcium) 40 mg
Brown, round, film coated tablets with
“RSV 40” debossed on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PRIMARY HYPERCHOLESTEROLAEMIA
ROSUZET COMPOSITE PACK is indicated as adjunctive therapy to diet in
patients with
primary (heterozygous familial and non-familial) hypercholesterolaemia
where use of a
combination product is appropriate in those patients:
•
not appropriately controlled with rosuvastatin or ezetimibe alone; or
Page 2 of 32
•
already treated with rosuvastatin and ezetimibe
HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH)
ROSUZET COMPOSITE PACK is indicated for patients with HoFH. Patients
may also receive
adjunctive treatments (e.g., LDL apheresis).
4.2
DOSE AND METHOD OF ADMINISTRATION
This combination product is not indicated for first-line use.
The patient should be on an appropriate lipid-lowering d