VARITHENA POLIDOCANOL INJECTABLE FOAM 10MGML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

polidocanol

Available from:

TRANSMEDIC PTE LTD

ATC code:

C05BB02

Pharmaceutical form:

INJECTION

Composition:

polidocanol 10mg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Biocompatibles UK Limited (including sterilization)

Authorization status:

ACTIVE

Authorization date:

2018-02-15

Patient Information leaflet

PLEASE READ ALL PRESCRIBING INFORMATION BEFORE USING
THE PRODUCT.
THE INSTRUCTIONS FOR USE ARE FOR THE ENTIRE VARITHENA
SYSTEM. THERE ARE 2 PACKAGING CONFIGURATIONS:
Option A: Bi-Canister box and Administration Pack*
Option B: Convenience box (Bi-Canister Box +
3 Ancillary Packs + 3 Varithena transfer units)*
*The components in each packaging configuration are to be used
only
in
conjunction
with
each
other
for
activation
of
Varithena.
Administration Packs can be
used
for
either
configuration
for
further
treatment sessions.
N o t
a l l
p r e s e n t a t i o n s
m a y
b e
available
locally
*Not all presentations may be available locally
ALWAYS WRITE THE ACTIVATION DATE AND TIME ON
THE CANISTER AND VERIFY THE PRODUCT HAS NOT
EXPIRED PRIOR TO USE.
Once the Varithena canister has been activated,
the shelf life for the product is thirty (30) days.
Rx Only
A canister of Varithena generates 90mL of f oam which, following
purging instructions contained in this IFU, is sufficient to yield
45mL of
usable foam for injection. The gas mix of the foam is 65:35
O
2
:CO
2
.
WARNINGS:
As the foam fills the syringe and before injecting, inspect the
syringe full of foam for any visible bubbles. If there are any
present,
the
foam
should
be
emptied
into
the
Varithena
transfer unit waste chamber and the syringe refilled.
Do not shake Varithena canisters.
Always
use
a
fresh
pair
of
sterile
gloves
when
handling
the
Bi-Canister and Varithena transfer unit.
A
new
Varithena
transfer
unit
must
be
used
for
each
treatment session.
NOTES: Use a new sterile syringe after each injection. Never fill a
syringe until just before the foam is required. The activated
Varithena
canister should always be stored with a Varithena transfer unit in
place
in the upright position at or
below
30
o
C
in an
appropriately controlled
clean area to limit contamination.
USE FOAM WITHIN 75 SECONDS OF GENERATION OR DISCARD AND GENERATE
NEW FOAM.
Unpacking Varithena:
Option A: Bi-Canister Box and
Administration Pack
FIGURE 1A - Varithena Bi-Canister Box
Varithena Bi-Ca

Summary of Product characteristics

PLEASE READ ALL PRESCRIBING INFORMATION BEFORE USING
THE PRODUCT.
THE INSTRUCTIONS FOR USE ARE FOR THE ENTIRE VARITHENA
SYSTEM. THERE ARE 2 PACKAGING CONFIGURATIONS:
Option A: Bi-Canister box and Administration Pack*
Option B: Convenience box (Bi-Canister Box +
3 Ancillary Packs + 3 Varithena transfer units)*
*The components in each packaging configuration are to be used
only
in
conjunction
with
each
other
for
activation
of
Varithena.
Administration Packs can be
used
for
either
configuration
for
further
treatment sessions.
N o t
a l l
p r e s e n t a t i o n s
m a y
b e
available
locally
*Not all presentations may be available locally
ALWAYS WRITE THE ACTIVATION DATE AND TIME ON
THE CANISTER AND VERIFY THE PRODUCT HAS NOT
EXPIRED PRIOR TO USE.
Once the Varithena canister has been activated,
the shelf life for the product is thirty (30) days.
Rx Only
A canister of Varithena generates 90mL of f oam which, following
purging instructions contained in this IFU, is sufficient to yield
45mL of
usable foam for injection. The gas mix of the foam is 65:35
O
2
:CO
2
.
WARNINGS:
As the foam fills the syringe and before injecting, inspect the
syringe full of foam for any visible bubbles. If there are any
present,
the
foam
should
be
emptied
into
the
Varithena
transfer unit waste chamber and the syringe refilled.
Do not shake Varithena canisters.
Always
use
a
fresh
pair
of
sterile
gloves
when
handling
the
Bi-Canister and Varithena transfer unit.
A
new
Varithena
transfer
unit
must
be
used
for
each
treatment session.
NOTES: Use a new sterile syringe after each injection. Never fill a
syringe until just before the foam is required. The activated
Varithena
canister should always be stored with a Varithena transfer unit in
place
in the upright position at or
below
30
o
C
in an
appropriately controlled
clean area to limit contamination.
USE FOAM WITHIN 75 SECONDS OF GENERATION OR DISCARD AND GENERATE
NEW FOAM.
Unpacking Varithena:
Option A: Bi-Canister Box and
Administration Pack
FIGURE 1A - Varithena Bi-Canister Box
Varithena Bi-Ca