AKM CINACALCET cinacalcet (as hydrochloride) 30 mg film-coated tablet blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

cinacalcet hydrochloride, Quantity: 33 mg (Equivalent: cinacalcet, Qty 30 mg)

Disponible desde:

Pharmacor Pty Ltd

formulario farmacéutico:

Tablet, film coated

Composición:

Excipient Ingredients: magnesium stearate; lactose monohydrate; hyprolose; microcrystalline cellulose; crospovidone; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake

Vía de administración:

Oral

Unidades en paquete:

10, 28

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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

Resumen del producto:

Visual Identification: Light green colored, oval shaped, film coated tablets debossed with "A33" on one side and "30" on other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

2019-01-08

Información para el usuario

AKM Cinacalcet Ver: 03 1
AKM CINACALCET TABLETS
_Cinacalcet hydrochloride _
_ _
AKM Cinacalcet 30 mg Tablets
AKM Cinacalcet 60 mg Tablets
AKM Cinacalcet 90 mg Tablets
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about AKM
Cinacalcet. It does not contain
all the available information. It
does not take the place of
talking to your doctor, nurse or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
AKM Cinacalcet against the
benefits he/she expects it will
have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING AKM
CINACALCET, ASK YOUR DOCTOR,
NURSE OR PHARMACIST.
READ THIS LEAFLET CAREFULLY
BEFORE YOU START AKM
CINACALCET AND KEEP IT WITH
THE MEDICINE. YOU MAY NEED TO
READ IT AGAIN.
WHAT AKM CINACALCET IS
USED
FOR
AKM Cinacalcet is used to
treat:

a condition called secondary
hyperparathyroidism (high-
per-para-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

Ficha técnica

AKM Cinacalcet
Ver: 03
1
AUSTRALIAN PRODUCT INFORMATION
AKM CINACALCET (CINACALCET HYDROCHLORIDE) FILM-COATED TABLETS
1.
NAME OF THE MEDICINE
Cinacalcet hydrochloride.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AKM Cinacalcet 30 mg tablets:
Each film-coated tablet contains Cinacalcet hydrochloride 33 mg
equivalent to Cinacalcet
30 mg.
AKM Cinacalcet 60 mg tablets:
Each film-coated tablet contains Cinacalcet hydrochloride 66 mg
equivalent to Cinacalcet
60 mg.
AKM Cinacalcet 90 mg tablets:
Each film-coated tablet contains Cinacalcet hydrochloride 99 mg
equivalent to Cinacalcet
90 mg.
List of excipients with known effect:
Sugars (as lactose monhydrate)
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Film-coated Tablets
AKM Cinacalcet 30 mg tablets:
Light green colored, oval shaped, film coated tablets debossed with
'A33' on one side and '30'
on other side.
AKM Cinacalcet 60 mg tablets:
Light green colored, oval shaped, film coated tablets debossed with
'A34' on one side and '60'
on other side.
AKM Cinacalcet
Ver: 03
2
AKM Cinacalcet 90 mg tablets:
Light green colored, oval shaped, film coated tablets debossed with
'A35' on one side and
‘90’ on other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cinacalcet
may
be
used
to
treat
the
biochemical
manifestations
of
secondary
hyperparathyroidism (HPT) in patients with end stage renal disease,
receiving dialysis (see
section 5.1 Pharmacodynamic properties, Clinical trials). Cinacalcet
should be used as
adjunctive therapy.
Cinacalcet is indicated for the treatment of hypercalcaemia in
patients with parathyroid
carcinoma.
Cinacalcet
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 (DOSE AND INTERVAL)
PATIENTS WITH END STAGE RENAL DISEASE RECEIVING DIALYSIS
AKM
Cinacalcet
reduces
parathyroid
hormone
(PTH)
while
simultaneously
lowering
Ca x P, calcium and phosphorus levels in