CINACALCET VIATRIS cinacalcet 30 mg tablet blister pack

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

cinacalcet hydrochloride, Quantity: 33.064 mg

Disponibbli minn:

Alphapharm Pty Ltd

Għamla farmaċewtika:

Tablet

Kompożizzjoni:

Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; povidone; magnesium stearate; crospovidone; titanium dioxide; hypromellose; triacetin; iron oxide yellow; indigo carmine aluminium lake

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

28

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

Cinacalcet Viatris (cinacalcet hydrochloride tablets) may be used to treat the biochemical manifestations of secondary hyperparathyroidism in patients with end stage renal disease, receiving dialysis (see CLINICAL TRIALS). Cinacalcet Viatris (cinacalcet hydrochloride tablets) should be used as adjunctive therapy.,Cinacalcet Viatris (cinacalcet hydrochloride tablets) is indicated for the treatment of hypercalcaemia in patients with parathyroid carcinoma. Cinacalcet Viatris (cinacalcet hydrochloride tablets) may be used to treat the biochemical manifestations of primary hyperparathyroidism in patients for whom parathyroidectomy is not a treatment option.

Sommarju tal-prodott:

Visual Identification: A Green, film-coated, oval, biconvex, beveled edge tablet debossed with M on one side of the tablet and CI30 on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2020-11-03

Fuljett ta 'informazzjoni

CINACALCET MYLAN
_Cinacalcet hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine.
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 this medicine
against the benefits he/she expects it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
READ THIS LEAFLET CAREFULLY BEFORE
YOU START CINACALCET MYLAN
AND KEEP IT WITH THE MEDICINE.
YOU MAY NEED TO READ IT AGAIN.
WHAT CINACALCET
MYLAN IS USED FOR
CINACALCET MYLAN is used to
treat:
•
a condition called secondary
hyperparathyroidism (high-
perpara-THIGH-royd-izm) in
people with kidney disease who
require dialysis treatment.
•
a condition called primary
hyperparathyroidism when
surgical removal of the
parathyroid gland is not a
treatment option.
•
high blood calcium levels in
people with cancer of the
parathyroid gland.
_SECONDARY_
_HYPERPARATHYROIDISM_
Kidney disease can cause a condition
called secondary
hyperparathyroidism, which can have
a big impact on your health. Four
small glands located behind the
thyroid gland in your neck are called
parathyroid glands. They make a
hormone called parathyroid hormone
(PTH). Normally, PTH makes sure
you have just enough calcium and
phosphorus in your blood to keep
your bones, heart, muscles, nerves
and blood vessels working well.
When your kidneys are working
properly, PTH keeps your calcium
and phosphorus levels normal by
moving the right amounts of calcium
and phosphorus in and out of your
bones.
When your kidneys aren't working
properly, the calcium and phosphorus
balance in your body is upset, and
your parathyroid glands send out too
much PTH to your body. This
condition is called secondary
hyperparathyroidism, and it can
cause bone disease and also may be a
risk factor for heart disease and
abnormal calcium deposits in blood
vessels

Karatteristiċi tal-prodott

AUSTRALIAN PRODUCT INFORMATION
CINACALCET MYLAN
_(cinacalcet hydrochloride) film-coated tablet _
1
NAME OF THE MEDICINE
Cinacalcet hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of CINACALCET MYLAN contains either 30 mg, 60 mg or 90 mg
of cinacalcet as the free base
equivalent (corresponding to 33 mg, 66 mg and 99 mg as the
hydrochloride salt, respectively).
Excipients with known effect: sulfites
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
CINACALCET MYLAN 30 mg film-coated tablet: green, film-coated, oval,
biconvex, bevelled edge tablet
debossed with M on one side of the tablet and C130 on the other side.
CINACALCET MYLAN 60 mg film-coated tablet: green, film-coated, oval,
biconvex, bevelled edge tablet
debossed with M on one side of the tablet and C160 on the other side.
CINACALCET MYLAN 90 mg film-coated tablet: green, film-coated, oval,
biconvex, bevelled edge tablet
debossed with M on one side of the tablet and C190 on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CINACALCET
MYLAN
may
be
used
to
treat
the
biochemical
manifestations
of
secondary
hyperparathyroidism
in
patients
with
end
stage
renal
disease,
receiving
dialysis
(see
Section
5.1
Pharmacodynamic Properties - Clinical Trials). CINACALCET MYLAN should
be used as adjunctive
therapy.
CINACALCET MYLAN is indicated for the treatment of hypercalcaemia in
patients with parathyroid
carcinoma.
CINACALCET MYLAN may be used to treat the biochemical manifestations
of primary hyperparathyroidism
in patients for whom parathyroidectomy is not a treatment option.
4.2
DOSE AND METHOD OF ADMINISTRATION
_DOSAGE _
Patients with end stage renal disease receiving dialysis
CINACALCET MYLAN reduces parathyroid hormone (PTH) while
simultaneously lowering Ca x P, calcium
and phosphorus levels in patients receiving dialysis.
The recommended starting dose for adults is 30 mg once per day.
CINACALCET MYLAN should be titrated every 2 to 4 weeks to a maximum
dose of 180 mg once daily to
ach