Porontazin 1 microgram, zachte capsules

Ülke: Hollanda

Dil: Hollandaca

Kaynak: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktif bileşen:

PARICALCITOL 1 µg/stuk

Mevcut itibaren:

Regiomedica GmbH Teichstrasse 66 D-79539 LÖRRACH (DUITSLAND)

ATC kodu:

H05BX02

INN (International Adı):

PARICALCITOL 1 µg/stuk

Farmasötik formu:

Capsule, zacht

Kompozisyon:

BUTYLHYDROXYTOLUEEN (E 321) ; ETHANOL 96 % 0,7 mg/stuk ; GELATINE (E 441) ; GLYCEROL (E 422) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD,

Uygulama yolu:

Oraal gebruik

Terapötik alanı:

Paricalcitol

Ürün özeti:

Hulpstoffen: BUTYLHYDROXYTOLUEEN (E 321); ETHANOL 96 % 0,7 mg/stuk; GELATINE (E 441); GLYCEROL (E 422); TITAANDIOXIDE (E 171); TRIGLYCERIDEN MIDDELLANGE KETEN; WATER, GEZUIVERD;

Yetkilendirme tarihi:

2014-04-10

Bilgilendirme broşürü

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PORONTAZIN 1 MICROGRAM, ZACHTE CAPSULES
PORONTAZIN 2 MICROGRAM, ZACHTE CAPSULES
paricalcitol
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Porontazin is and what it is used for
2.
What you need to know before you take Porontazin
3.
How to take Porontazin
4.
Possible side effects
5.
How to store Porontazin
6.
Contents of the pack and other information
1.
WHAT PORONTAZIN IS AND WHAT IT IS USED FOR
Porontazin contains the active substance paricalcitol, which is a
synthetic form of active vitamin D.
Active vitamin D is required for the normal functioning of many
tissues in the body, including the
parathyroid gland and bones. In people who have normal kidney
function, this active form of vitamin D is
naturally produced by the kidneys, but in kidney failure the
production of active vitamin D is markedly
reduced. Porontazin therefore provides a source of active vitamin D,
when the body cannot produce enough
and helps to prevent the consequences of low levels of active vitamin
D, namely high levels of parathyroid
hormone which can cause bone problems. Porontazin is used in adult
patients with kidney disease Stages 3, 4
and 5 and children aged 10 to 16 years with kidney disease Stages 3
and 4.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PORONTAZIN
DO NOT TAKE PORONTAZIN:
-
if you are
ALLERGIC
to paricalcitol or to any of the other ingredients of this medicine
(listed in section 6).
-
if you have very high levels of
CALCIUM
or
VITAMIN D
in your blood.
Your doc

Ürün özellikleri

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Porontazin 1 microgram, zachte capsules
Porontazin 2 microgram, zachte capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule Porontazin 1 microgram contains 1 microgram paricalcitol
Each capsule Porontazin 2 microgram contains 2 micrograms paricalcitol
Excipients with know effect:
Each capsule Porontazin 1 microgram contains 0.7 mg ethanol
Each capsule Porontazin 2 microgram contains 1.4 mg ethanol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, soft.
Porontazin 1 microgram are white to off-white, oval, soft-gelatin
capsules containing a clear oily liquid.
Porontazin 2 microgram are red, oval, soft-gelatin capsules containing
a clear oily liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Porontazin is indicated in adult and paediatric patients 10 to 16
years of age for the prevention and treatment
of secondary hyperparathyroidism associated with chronic kidney
disease Stages 3 and 4.
Porontazin is indicated in adult patients for the prevention and
treatment of secondary hyperparathyroidism
associated with chronic kidney disease Stage 5 in patients who are on
haemodialysis or peritoneal dialysis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
CHRONIC KIDNEY DISEASE (CKD) STAGES 3 AND 4
Porontazin should be administered once a day, either daily or three
times a week taken every other day.
INITIAL DOSE
The initial dose is based on baseline intact parathyroid hormone
(iPTH) levels.
TABLE 1. INITIAL DOSE
BASELINE IPTH LEVEL
DAILY DOSE
THREE TIMES A WEEK DOSE*
≤ 500 pg/ml (56 pmol/l)
1 microgram
2 micrograms
> 500 pg/ml (56 pmol/l)
2 micrograms
4 micrograms
* To be administered no more frequently than every other day
2
DOSE TITRATION
Dosing must be individualised based on serum or plasma iPTH levels,
with monitoring of serum calcium and
serum phosphorus.
Table 2 presents a suggested approach for dose titration.
TABLE 2. DOSE TITRATION
IPTH LEVEL RELATIVE TO BASELINE
DOSE ADJUSTMENT AT 2 TO