VELTASSA 8.4 G

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

PATIROMER AS SORBITEX CALCIUM

متاح من:

CTS LTD

ATC رمز:

V03AE09

الشكل الصيدلاني:

POWDER FOR SUSPENSION

تركيب:

PATIROMER AS SORBITEX CALCIUM 8.4 G

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PATHEON INC., CANADA

المجال العلاجي:

PATIROMER CALCIUM

الخصائص العلاجية:

Veltassa is indicated for the treatment of hyperkalaemia in adults

تاريخ الترخيص:

2019-01-07

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACIST'S REGULATIONS
(PREPARATIONS) 1986
This medicine is dispensed with a doctor's prescription only
VELTASSA 8.4 G POWDER FOR ORAL SUSPENSION
VELTASSA 16.8 G POWDER FOR ORAL SUSPENSION
Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium)
Each sachet contains 16.8 g patiromer (as patiromer sorbitex calcium)
For the full list of excipients, see section 6.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
This leaflet contains concise information about the medicine.
If you have any further questions, ask the doctor or the pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their medical condition is the same as yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Veltassa is used to treat adults with high levels of potassium in
their blood.
Too much potassium in the blood can affect how your nerves control
your 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 heart rhythm.
Veltassa works by attaching to potassium in your gut. This way
Veltassa prevents potassium
from entering your bloodstream and lowers potassium levels in your
blood back to normal.
THERAPEUTIC GROUP: Drugs for treatment of hyperkalaemia and
hyperphosphataemia.
2.
BEFORE USING THIS MEDICINE:
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to patiromer or any of the other
ingredients of this medicine
(listed in section 6).
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE:
TALK TO YOUR DOCTOR BEFORE TAKING VELTASSA IF:
•
You have problems swallowing
•
You have severe stomach or bowel problems
•
You have had major surgery on your stomach or bowel.
CHILDREN AND ADOLESCENTS
Do not give Veltassa to children under 18 years, as it has not been
studied in this age group.
TESTS AND FOLLOW-UP
Low blood magnesium can occur when taking Veltassa. Your doctor will
check the magnesium
level in the beginn

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Veltassa 8.4 g powder for oral suspension
Veltassa 16.8 g powder for oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 8.4 g patiromer (as patiromer sorbitex calcium)
Each sachet contains 16.8 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dose is 8.4 g patiromer once daily.
The daily dose may be adjusted in intervals of one week or longer,
based on the serum potassium level
and the desired target range. The daily dose may be increased or
decreased by 8.4 g as necessary to
reach the desired target range, up to a maximum dose of 25.2 g daily.
If serum potassium falls below
the desired range, the dose should be reduced or discontinued.
If a dose is missed, the missed dose should be taken as soon as
possible on the same day. The missed
dose should not be taken with the next dose.
Administration of Veltassa should be separated by 3 hours from other
oral medicinal products (see
section 4.5).
The onset of action of Veltassa occurs 4-7 hours after administration.
It should not replace emergency
treatment for life-threatening hyperkalaemia.
_ _
_Patients on dialysis _
There is limited data on the use of Veltassa in patients on dialysis.
No special dose and administration
guidelines were applied to these patients in clinical studies.
2
_Elderly population (≥65 years of age) _
No special dose and administration guidelines are recommended for this
population.
_Paediatric population _
The safety and efficacy of Veltassa in children aged under 18 years
have not yet been established. No
data are available.
Method of administration
Oral use.
Veltassa should be mixed with wate