VELTASSA 16.8 G

Country: ইস্রায়েল

ভাষা: ইংরেজি

সূত্র: Ministry of Health

সক্রিয় উপাদান:

PATIROMER AS SORBITEX CALCIUM

থেকে পাওয়া:

CTS LTD

এটিসি কোড:

V03AE09

ফার্মাসিউটিকাল ফর্ম:

POWDER FOR SUSPENSION

রচনা:

PATIROMER AS SORBITEX CALCIUM 16.8 G

প্রশাসন রুট:

PER OS

প্রেসক্রিপশন টাইপ:

Required

Manufactured by:

VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD., SWITZERLAND

Therapeutic area:

PATIROMER CALCIUM

থেরাপিউটিক ইঙ্গিত:

Veltassa is indicated for the treatment of hyperkalaemia in adults

অনুমোদন তারিখ:

2023-12-31

তথ্য লিফলেট

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The 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 of patiromer (as patiromer sorbitex
calcium).
Each sachet contains 16.8 g of patiromer (as patiromer sorbitex
calcium).
For a list of inactive ingredients in the preparation – see section
6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine.
If you have any other questions, refer to 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 it seems to you that their medical condition is similar.
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 the way your nerves control
your muscles. This can
lead to weakness or even paralysis. High potassium levels can result
in abnormal heartbeat,
which can severely affect your heart rhythm.
Veltassa binds to potassium in your gut. This way Veltassa prevents
potassium from reaching
the blood and lowers potassium blood levels back to normal.
THERAPEUTIC CLASS: Medicines for treatment of hyperkalemia and
hyperphosphatemia.
2.
BEFORE USING THE MEDICINE:
DO NOT USE THIS MEDICINE IF:

You are sensitive (allergic) to patiromer or any other ingredient of
this medicine (see
section 6).
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE:
BEFORE TREATMENT WITH VELTASSA, INFORM THE DOCTOR IF:

You have problems swallowing.

You have severe stomach or bowel problems.

You have had major surgery in your stomach or bowel.
CHILDREN AND ADOLESCENTS
Do not give Veltassa to children under 18 years of age, as it has not
been studied in this age
group.
TESTS AND FOLLOW-UP
Taking Veltassa may lead to low magnesium levels in the blood. Your
doctor will check your
magnesium leve

পণ্য বৈশিষ্ট্য

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
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)
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.
_ _
_Special population _
_ _
_Elderly population (≥65 years of age) _
No special dose and administration guidelines are recommended for this
population.
2
_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.
_Paediatric population _
The safety and efficacy of Veltassa in children aged under 18 years
have not yet