VELTASSA patiromer (as sorbitex calcium)16.8 g powder for oral suspension sachet

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

patiromer sorbitex calcium, Quantity: 33.6 g (Equivalent: patiromer, Qty 16.8 g)

Доступно од:

Seqirus Pty Ltd

Фармацеутски облик:

Powder, oral

Састав:

Excipient Ingredients: xanthan gum

Пут администрације:

Oral

Јединице у пакету:

30 sachets

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

Veltassa is indicated for the treatment of hyperkalaemia in adults.

Резиме производа:

Visual Identification: Off-white to light-brown powder; occasional white particles may be present; Container Type: Sachet; Container Material: Al laminated with PE/paper; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус ауторизације:

Registered

Датум одобрења:

2017-12-12

Информативни летак

VELTASSA
Page 1 of 3
VELTASSA
®
8.4 G, 16.8 G AND 25.2 G POWDER FOR ORAL SUSPENSION
PATIROMER (AS SORBITEX CALCIUM)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
_ _
This leaflet answers some common
questions about VELTASSA. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the
risks
of
you
being
given
VELTASSA against the expected
benefits it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it
again.
WHAT VELTASSA IS
USED FOR
VELTASSA contains the active
ingredient patiromer (as sorbitex
calcium).
VELTASSA is used to help
remove excessive amounts of
potassium from the blood
(hyperkalaemia). It works by
binding extra potassium in your
digestive tract. This increases the
amount of potassium excreted and
thus lowers potassium levels in
your blood.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
it for another reason.
BEFORE YOU TAKE
VELTASSA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE VELTASSA IF YOU
HAVE AN ALLERGY TO PATIROMER
SORBITEX CALCIUM OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some symptoms of an allergic
reaction include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips or
tongue or other parts of the
body
•
rash, itching, or hives on the
skin
DO NOT TAKE IT AFTER THE EXPIRY
DATE (EXP) PRINTED ON THE PACK.
If you take it after the expiry date
has passed, it may not work as
well.
DO NOT TAKE IT IF THE PACKAGING
IS DAMAGED OR SHOWS SIGNS OF
TAMPERING.
IF YOU ARE NOT SURE WHETHER
YOU SHOULD TAKE VELTASSA,
TALK TO YOUR DOCTOR OR
PHARMACIST.
_ _
_BEFORE YOU START TO TAKE _
_VELTASSA _
TELL YOUR DOCTOR OR PHARMACIST
IF YOU HAVE ALLERGIES TO ANY OTHER
MEDICINES, FOODS, PRESERVATIVES
OR DYES.
TELL YOUR DOCTOR IF YOU HAVE

Карактеристике производа

____________________________________________________________________________________________________
Page 1 of 13
AUSTRALIAN
PRODUCT
INFORMATION
–
VELTASSA
®
(PATIROMER
SORBITEX CALCIUM)
1
NAME OF THE MEDICINE
Patiromer sorbitex calcium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of Veltassa powder for oral suspension contains 8.4 g,
16.8 g or 25.2 g of patiromer
(as sorbitex calcium).
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
Veltassa powder for oral suspension is an 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
DOSE AND METHOD OF ADMINISTRATION
DOSE
The recommended starting dose of Veltassa is 8.4 g patiromer (as
sorbitex calcium) once daily.
Take the prepared Veltassa suspension with or without food and
preferably at the same time
each day.
Adjust the daily dose of Veltassa based on the serum potassium level
and the desired target
range. The daily dose may be increased at 1-week or longer intervals
by increments of 8.4 g,
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 Veltassa 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.
Upon discontinuation of Veltassa, serum potassium levels may rise,
especially if renin
angiotensin aldosterone system (RAAS) inhibitor treatment is continued
(see 4.4 Special
warnings and precautions for use). Therefore, patients should consult
their doctor before
discontinuing this medication.
____________________________________________________________________________________________________
Page 2 of 13
Veltassa should be taken at least 3 hours before or after other oral
medications (see 4.5
Interactions with other medicines and other fo