Mimpara

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

cinacalcet hydrochloride

Tillgänglig från:

Amgen Europe B.V.

ATC-kod:

H05BX01

INN (International namn):

cinacalcet

Terapeutisk grupp:

Calcium homeostasis

Terapiområde:

Hypercalcemia; Parathyroid Neoplasms; Hyperparathyroidism

Terapeutiska indikationer:

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.Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate.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 treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

Produktsammanfattning:

Revision: 25

Bemyndigande status:

Authorised

Tillstånd datum:

2004-10-22

Bipacksedel

71
B. PACKAGE LEAFLET
72
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MIMPARA 30 MG FILM-COATED TABLETS
MIMPARA 60 MG FILM-COATED TABLETS
MIMPARA 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 Mimpara is and what it is used for
2.
What you need to know before you take Mimpara
3.
How to take Mimpara
4.
Possible side effects
5.
How to store Mimpara
6.
Contents of the pack and other information
1.
WHAT MIMPARA IS AND WHAT IT IS USED FOR
Mimpara 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).
Mimpara 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.
Mimpara is used in children aged 3 years to less than 18 years of age:
•
to treat secondary hyperparathyroidism in patients with serious kidney
disease who need
dialysis to clear their blood of waste products, whose condition is
not controlled with other
treatments.
In primary and secondary hyperpa

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Mimpara 30 mg film-coated tablets
Mimpara 60 mg film-coated tablets
Mimpara 90 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mimpara 30 mg film-coated tablets
Each tablet contains 30 mg cinacalcet (as hydrochloride).
_Excipient with known effect _
Each tablet contains 2.74 mg of lactose.
Mimpara 60 mg film-coated tablets
Each tablet contains 60 mg cinacalcet (as hydrochloride).
_Excipient with known effect _
Each tablet contains 5.47 mg of lactose.
Mimpara 90 mg film-coated tablets
Each tablet contains 90 mg cinacalcet (as hydrochloride).
_Excipient with known effect _
Each tablet contains 8.21 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Mimpara 30 mg film-coated tablets
Light green, oval (approximately 9.7 mm long and 6.0 mm wide),
film-coated tablet marked “AMG”
on one side and “30” on the other.
Mimpara 60 mg film-coated tablets
Light green, oval (approximately 12.2 mm long and 7.6 mm wide),
film-coated tablet marked “AMG”
on one side and “60” on the other.
Mimpara 90 mg film-coated tablets
Light green, oval (approximately 13.9 mm long and 8.7 mm wide),
film-coated tablet marked “AMG”
on one side and “90” on the other.
3
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).
Mimpara 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 adult