Cinacalcet Accordpharma

Ország: Európai Unió

Nyelv: angol

Forrás: EMA (European Medicines Agency)

Aktív összetevők:

cinacalcet hydrochloride

Beszerezhető a:

Accord Healthcare S.L.U.

ATC-kód:

H05BX01

INN (nemzetközi neve):

cinacalcet

Terápiás csoport:

Calcium homeostasis

Terápiás terület:

Hyperparathyroidism

Terápiás javallatok:

Secondary hyperparathyroidismAdultsTreatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.Paediatric populationTreatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4.4).Cinacalcet Accordpharma may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1).Parathyroid carcinoma and primary hyperparathyroidism in adultsReduction of hypercalcaemia in adult patients with:parathyroid carcinoma.primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

Termék összefoglaló:

Revision: 3

Engedélyezési státusz:

Authorised

Engedély dátuma:

2020-04-03

Betegtájékoztató

45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CINACALCET ACCORDPHARMA 30 MG FILM-COATED TABLETS
CINACALCET ACCORDPHARMA 60 MG FILM-COATED TABLETS
CINACALCET ACCORDPHARMA 90 MG FILM-COATED TABLETS
cinacalcet
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cinacalcet Accordpharma is and what it is used for
2.
What you need to know before you take Cinacalcet Accordpharma
3.
How to take Cinacalcet Accordpharma
4.
Possible side effects
5.
How to store Cinacalcet Accordpharma
6.
Contents of the pack and other information
1.
WHAT CINACALCET ACCORDPHARMA IS AND WHAT IT IS USED FOR
Cinacalcet Accordpharma contains the active ingredient cinacalcet,
which works by controlling the
levels of parathyroid hormone (PTH), calcium and phosphorous in your
body. It is used to treat
problems with organs called parathyroid glands. The parathyroids are
four small glands in the neck,
near the thyroid gland, that produce parathyroid hormone (PTH).
Cinacalcet Accordpharma is used in adults:
-
to treat secondary hyperparathyroidism in adults with serious kidney
disease who need dialysis
to clear their blood of waste products.
-
to reduce high levels of calcium in the blood (hypercalcaemia) in
adult patients with parathyroid
cancer.
-
to reduce high levels of calcium in the blood (hypercalcaemia) in
adult patients with primary
hyperparathyroidism when removal of the gland is not possible.
Cinacalcet Accordpharma is used in children aged 3 years to less than
18 years of age:
-
t

Termékjellemzők

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Cinacalcet Accordpharma 30 mg film-coated tablets
Cinacalcet Accordpharma 60 mg film-coated tablets
Cinacalcet Accordpharma 90 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg, 60 mg or 90 mg cinacalcet (as
hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Cinacalcet Accordpharma 30 mg film-coated tablets
Light green coloured, oval shaped (approximately 9.65 mm long and 6.00
mm wide), biconvex, film-
coated tablets debossed with "HB1" on one side and plain on other
side.
Cinacalcet Accordpharma 60 mg film-coated tablets
Light green coloured, oval shaped (approximately 12.20 mm long and
7.60 mm wide), biconvex, film-
coated tablets debossed with "HB2" on one side and plain on other
side.
Cinacalcet Accordpharma 90 mg film-coated tablets
Light green coloured, oval shaped (approximately 14.00 mm long and
8.70 mm wide), biconvex, film-
coated tablets debossed with "HB3" on one side and plain on other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Secondary hyperparathyroidism
_ _
_Adults _
Treatment of secondary hyperparathyroidism (HPT) in adult patients
with end-stage renal disease
(ESRD) on maintenance dialysis therapy.
_Paediatric population _
Treatment of secondary hyperparathyroidism (HPT) in children aged 3
years and older with end-stage
renal disease (ESRD) on maintenance dialysis therapy in whom secondary
HPT is not adequately
controlled with standard of care therapy (see section 4.4).
Cinacalcet Accordpharma may be used as part of a therapeutic regimen
including phosphate binders
and/or Vitamin D sterols, as appropriate (see section 5.1).
3
Parathyroid carcinoma and primary hyperparathyroidism in adults
Reduction of hypercalcaemia in adult patients with:

parathyroid carcinoma.

primary HPT for whom parathyroidectomy would be indicated on the basis
of serum calcium
levels (as defined by relevant treatme