Veltassa
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
16-01-2024
Valmisteyhteenveto
(SPC)
16-01-2024
Julkisesta arviointikertomuksesta
(PAR)
16-01-2024
Aktiivinen ainesosa:
patiromer sorbitex calcium
Saatavilla:
Vifor Fresenius Medical Care Renal Pharma France
ATC-koodi:
V03AE09
INN (Kansainvälinen yleisnimi):
patiromer
Terapeuttinen ryhmä:
Drugs for treatment of hyperkalemia and hyperphosphatemia
Terapeuttinen alue:
Hyperkalemia
Käyttöaiheet:
Veltassa is indicated for the treatment of hyperkalaemia in adults.
Tuoteyhteenveto:
Revision: 7
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2017-07-19
Pakkausseloste
39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VELTASSA 1 G POWDER FOR ORAL SUSPENSION
VELTASSA 8.4 G POWDER FOR ORAL SUSPENSION
VELTASSA 16.8 G POWDER FOR ORAL SUSPENSION
VELTASSA 25.2 G POWDER FOR ORAL SUSPENSION
patiromer (as patiromer sorbitex calcium)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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 or your child 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 or your child 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 Veltassa is and what it is used for
2.
What you need to know before you take Veltassa
3.
How to take Veltassa
4.
Possible side effects
5.
How to store Veltassa
6.
Contents of the pack and other information
1.
WHAT VELTASSA IS AND WHAT IT IS USED FOR
Veltassa is a medicine that contains the active substance patiromer.
This medicine is used to treat adults and adolescents aged 12 to 17
years with high levels of potassium
in their blood.
Too much potassium in the blood can affect how nerves control muscles.
This can lead to weakness or
even paralysis. High potassium levels can also result in an abnormal
heartbeat, which can cause
serious effects on your or your child’s heart rhythm.
This medicine works by attaching to potassium in the gut. This
prevents potassium from entering the
bloodstream and lowers potassium levels in blood back to normal.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VELTASSA
_ _
DO NOT TAKE VELTASSA
•
if you or your child are allergic to patiromer or any of the other
ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Veltassa if you
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Veltassa 1 g powder for oral suspension
Veltassa 8.4 g powder for oral suspension
Veltassa 16.8 g powder for oral suspension
Veltassa 25.2 g powder for oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Veltassa 1 g powder for oral suspension
Each sachet contains 1 g patiromer (as patiromer sorbitex calcium)
Veltassa 8.4 g powder for oral suspension
Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium).
Veltassa 16.8 g powder for oral suspension
Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium).
Veltassa 25.2 g powder for oral suspension
Each sachet contains 25.2 g patiromer (as patiromer sorbitex calcium).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension.
Off white to light brown powder, with occasional white particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Veltassa is indicated for the treatment of hyperkalaemia in adults and
adolescents aged 12 to 17 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The onset of action of Veltassa occurs 4 – 7 hours after
administration. It should not replace
emergency treatment for life threatening hyperkalaemia (see section
4.4).
Posology
Veltassa is administrated once daily. The recommended starting dose of
Veltassa varies with age.
Multiple sachets may be used to achieve the desired dose.
The daily dose may be adjusted in intervals of one week or longer,
based on the serum potassium level
and the desired target range. Serum potassium should be monitored when
clinically indicated (see
section 4.4). The duration of treatment should be individualized by
the treating physician based on the
need of serum potassium management. If serum potassium falls below the
desired range, the dose
should be reduced or discontinued.
3
_ _
Administration of Veltassa should be separated by 3 hours from other
oral medicinal products (see
section 4.5).
_Adults_
The recommended starting dose is 8.4 g patiromer
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