Parareg

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

cinacalcet

Saatavilla:

Dompé Biotec S.p.A.

ATC-koodi:

H05BX01

INN (Kansainvälinen yleisnimi):

cinacalcet

Terapeuttinen ryhmä:

Calcium homeostasis

Terapeuttinen alue:

Hypercalcemia; Parathyroid Neoplasms; Hyperparathyroidism

Käyttöaiheet:

Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1).Reduction of hypercalcaemia in patients with:-parathyroid carcinoma.- primary HPT for whom parathyroidectomy would be indicated on the basis of serum calciumlevels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

Tuoteyhteenveto:

Revision: 6

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2004-10-22

Pakkausseloste

B. PACKAGE LEAFLET
57
Medicinal product no longer authorised
PACKAGE LEAFLET : INFORMATION FOR THE USER
PARAREG 30 MG FILM-COATED TABLETS
PARAREG 60 MG FILM-COATED TABLETS
PARAREG 90 MG FILM-COATED TABLETS
Cinacalcet
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It m
ay harm them, even if their
symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET
1.
What Parareg is and what it is used for
2.
Before you take Parareg
3.
How to take Parareg
4.
Possible side effects
5
How to store Parareg
6.
Further information
1.
WHAT PARAREG IS AND WHAT IT IS USED FOR
Parareg works by controlling the levels of parathy
roid 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).
Parareg is used:
•
to treat secondary
hyperparathyroidism in patients with kidney disease on dialysis.
•
to reduce high levels of calcium
in the blood (hypercalcaemia) in patients with parathyroid
cancer
•
to reduce high levels of calcium in the blood (hypercalcaemia) in
patients with primary
hyperparathyroidism who still have high calcium levels after removal
of the parathyroid gland
or when removal of the gland is not possible.
In primary and secondary hyperparathyroidism too much PTH is produced
by the parathyroids. This
can cause the loss of calcium in the bones, which can lead to bone
pain and fractures, problems with
blood and heart vessels, kidney stones, mental illness and coma.
2.
BEFORE YOU TAKE PARAREG
DO NOT TAKE PARAREG:
•
DO NOT
take Parareg if y
ou are
ALLERGIC
(hypersensitive) to cinacalcet or any of the oth

Valmisteyhteenveto

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Parareg 30 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg cinacalcet (as hydrochloride).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
30 mg: Light green, oval, film-coated tablets marked “AMGEN” on
one side and “30” on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of secondary hyperparathyroidism (HPT) in patients with
end-stage renal disease (ESRD)
on m
aintenance dialysis therapy.
Parareg may be used as part of a therapeutic regim
en including phosphate binders and/or Vitamin D
sterols, as appropriate (see section 5.1).
Reduction of hypercalcaemia in patients with:
•
parathyroid carcinoma.
•
prim
ary 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use. It is recommended that Parareg be taken with food or
shortly after a meal, as studies have
shown that bioavailability of cinacalcet is increased when taken with
food (see section 5.2). Tablets
should be taken whole and not divided.
Hepatic impairment
No change in starting dose is necessary. Parareg should be used with
caution in
_ _
patients with m
oderate
to severe hepatic impairment and treatment should be closely monitored
during dose titration and
continued treatment (see sections 4.4 and 5.2).
SECONDARY HYPERPARATHYROIDISM
Adults and elderly (> 65 years)
The recommended starting dose for adults is 30 mg once per day
. Parareg should be titrated every 2 to
4 weeks to a maximum dose of 180 mg once daily to achieve a target
parathyroid hormone (PTH) in
dialysis patients of between 150-300 pg/ml (15.9-31.8 pmol/l) in the
intact PTH (iPTH) assay. PTH
levels should be assessed at least 12 hours