Velphoro

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Sucroferric oxyhydroxide

Saatavilla:

Vifor Fresenius Medical Care Renal Pharma France

ATC-koodi:

V03AE05

INN (Kansainvälinen yleisnimi):

sucroferric oxyhydroxide

Terapeuttinen ryhmä:

Drugs for treatment of hyperkalemia and hyperphosphatemia

Terapeuttinen alue:

Hyperphosphatemia; Renal Dialysis

Käyttöaiheet:

Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD).Velphoro is indicated for the control of serum phosphorus levels in paediatric patients 2 years of age and older with CKD stages 4-5 (defined by a glomerular filtration rate

Tuoteyhteenveto:

Revision: 9

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2014-08-26

Pakkausseloste

41
B. PACKAGE LEAFLET
42
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VELPHORO 500 MG CHEWABLE TABLETS
iron as sucroferric oxyhydroxide
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 Velphoro is and what it is used for
2.
What you need to know before you take Velphoro
3.
How to take Velphoro
4.
Possible side effects
5.
How to store Velphoro
6.
Contents of the pack and other information
1.
WHAT VELPHORO IS AND WHAT IT IS USED FOR
Velphoro is a medicine that contains the active substance sucroferric
oxyhydroxide, which is made up
from iron, sugar (sucrose) and starches.
This medicine is used to control high blood phosphate levels
(hyperphosphataemia) in:
•
adult patients who undergo haemodialysis or peritoneal dialysis
(procedures to eliminate toxic
substances from the blood) because of chronic kidney disease;
•
children from 2 years of age and adolescents with chronic kidney
disease stages 4 and 5 (severe
decrease in the ability of the kidneys to work properly) or on
dialysis.
Too much phosphorus in the blood can lead to calcium being deposited
in tissues (calcification). This
can result in stiffening of the blood vessels, making it harder for
the blood to be pumped around the
body. It may also lead to calcium deposits in soft tissues and bone
causing effects such as red eyes,
itchy skin and bone pain.
This medicine works by binding phosphorus from food in your digestive
tract (stomach and intestines).
This reduces the amount of phosphorus that can be absorbed into the
bloodstream and

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Velphoro 500 mg chewable tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains sucroferric oxyhydroxide corresponding
to 500 mg iron.
The sucroferric oxyhydroxide contained in one tablet is comprised of
polynuclear iron (III)-
oxyhydroxide (containing 500 mg iron), 750 mg sucrose and 700 mg
starches (potato starch and
pregelatinised maize starch).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
Brown, circular tablets embossed with PA500 on one side. Tablets have
a 20 mm diameter and a
thickness of 6.5 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Velphoro is indicated for the control of serum phosphorus levels in
adult chronic kidney disease
(CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD).
Velphoro is indicated for the control of serum phosphorus levels in
paediatric patients 2 years of age
and older with CKD stages 4-5 (defined by a glomerular filtration rate
<30 mL/min/1.73 m²) or with
CKD on dialysis.
Velphoro should be used within the context of a multiple therapeutic
approach, which could include
calcium supplement, 1,25-dihydroxy vitamin D
3
or one of its analogues, or calcimimetics to control
the development of renal bone disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Starting dose for adults and adolescents (_
≥
_12 years of age) _
The recommended starting dose is 1,500 mg iron (3 tablets) per day,
divided across the meals of the
day.
_Titration and maintenance for adults and adolescents (_
≥
_12 years of age) _
Serum phosphorus levels must be monitored and the dose of sucroferric
oxyhydroxide up or down
titrated in increments of 500 mg iron (1 tablet) per day every 2 – 4
weeks until an acceptable serum
phosphorus level is reached, with regular monitoring afterwards.
In clinical practice, treatment will be based on the need to control
serum phosphorus levels, though
patients who respond to Velphoro therapy usu