Cinacalcet Devatis 60 mg Film-coated Tablet

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Cinacalcet hydrochloride 66.12mg equivalent to cinacalcet 60 mg

Beschikbaar vanaf:

Devatis Limited

Dosering:

60 mg

farmaceutische vorm:

Film coated tablet

Samenstelling:

Active: Cinacalcet hydrochloride 66.12mg equivalent to cinacalcet 60 mg Excipient: Colloidal silicon dioxide Crospovidone Magnesium stearate Microcrystalline cellulose Opadry Clear OY-29020 Purified water Sheffcoat green L TN 1264G49 Starch

Prescription-type:

Prescription

therapeutische indicaties:

May be used to treat the biochemical manifestations of secondary hyperparathyroidism in adult patients with end stage renal disease, receiving dialysis. Cinacalcet hydrochloride should be used as an adjunctive therapy.

Product samenvatting:

Package - Contents - Shelf Life: Blister pack, PVC/PCTFE/Al blisters - 28 tablets - 60 months from date of manufacture, no storage statement needed

Autorisatie datum:

2017-08-14

Bijsluiter

CINACALCET Devatis
30 mg/60 mg/90 mg Film Coated Tablets
MODULE 1.3.2 CONSUMER MEDICINE INFORMATION
(CMI)
DEVATIS LIMITED Property-Strictly confidential
Page 1 / 6
Version: V03/December 2021
CINACALCET DEVATIS 30 MG, 60 MG & 90 MG FILM COATED TABLETS
_Cinacalcet hydrochloride _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using CINACALCET
Devatis Film Coated Tablets.
This leaflet answers some common questions about CINACALCET Devatis
Film Coated Tablets. 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 CINACALCET Devatis
Film Coated Tablets against the benefits he/she expects it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING CINACALCET DEVATIS FILM COATED
TABLETS, ASK YOUR DOCTOR,
NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE
. You may need to read it again.
WHAT CINACALCET DEVATIS FILM COATED TABLETS IS USED FOR
CINACALCET
is used to treat:

a condition called secondary hyperparathyroidism
(high-per-pear-a-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, PTH keeps your calcium and
phosphorus levels normal by moving the
right amounts of calcium and phosph

Productkenmerken

CINACALCET Devatis
30 mg/60 mg/90 mg Film Coated Tablets
MODULE 1.3.1 NEW ZEALAND DATA SHEET
DEVATIS LIMITED Property-Strictly confidential
Page 1 / 15
Version: V04/December 2021
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
CINACALCET Devatis 30 mg, 60 mg & 90 mg Film-Coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each 30 mg tablet contains 33.06 mg of cinacalcet hydrochloride
(equivalent to 30 mg cinacalcet).
Each 60 mg tablet contains 66.12 mg of cinacalcet hydrochloride
(equivalent to 60 mg cinacalcet).
Each 90 mg tablet contains 99.18 mg of cinacalcet hydrochloride
(equivalent to 90 mg cinacalcet).
EXCIPIENT WITH KNOWN EFFECT:
Each 30 mg tablet contains 0.3 mg of lactose
Each 60 mg tablet contains 0.6 mg of lactose
Each 90 mg tablet contains 0.9 mg of lactose
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Light green, oval film-coated tablets, marked with “30”, “60”
or “90” on one side respectively.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CINACALCET
Devatis
may
be
used
to
treat
the
biochemical
manifestations
of
secondary
hyperparathyroidism in patients with end stage renal disease,
receiving dialysis. CINACALCET Devatis
should be used as adjunctive therapy.
CINACALCET Devatis is indicated for the treatment of hypercalcemia in
patients with parathyroid carcinoma.
CINACALCET Devatis 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
_DOSE _
PATIENTS WITH END STAGE RENAL DISEASE RECEIVING DIALYSIS_ _
CINACALCET Devatis reduces PTH while simultaneously lowering Ca×P,
calcium and phosphorus levels in
patients receiving dialysis.
_ _
The recommended starting dose for adults is 30 mg once per day.
_ _
CINACALCET Devatis should be titrated every 2 to 4 weeks to a maximum
dose of 180 mg once daily to
achieve a target PTH between 15.9 and 31.8 pmol/L (150-300 pg/mL).
_ _
In chronic kidney dis