Vesanoid 10 mg soft capsules

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Tretinoin

Saadav alates:

Cheplapharm Arzneimittel GmbH

ATC kood:

L01XF01

INN (Rahvusvaheline Nimetus):

Tretinoin

Annus:

10 milligram(s)

Ravimvorm:

Capsule, soft

Retsepti tüüp:

Product subject to prescription which may not be renewed (A)

Terapeutiline ala:

Cytostatic-differentiating agent

Volitamisolek:

Marketed

Loa andmise kuupäev:

1996-12-03

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
VESANOID
10 MG SOFT CAPSULES
Tretinoin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you 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 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 Vesanoid is and what it is used for
2.
What you need to know before you take Vesanoid
3.
How to take Vesanoid
4.
Possible side effects
5
How to store Vesanoid
6.
Contents of the pack and other information
1.
WHAT VESANOID IS AND WHAT IT IS USED FOR
Vesanoid contains a medicine called tretinoin. This belongs to a group
of medicines called
‘retinoids’. These medicines are similar to vitamin A.
Vesanoid is used to treat a type of blood problem called ‘acute
promyelocytic leukaemia’. It
works by slowing the growth of certain types of diseased blood cells.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VESANOID
DO NOT TAKE VESANOID IF YOU ARE ALLERGIC TO:
•
tretinoin or any of the other ingredients of this medicine (listed in
section 6)
•
other ‘retinoid’ medicines. These include isotretinoin, acitretin
and tazarotene
•
peanuts or soya. This is because Vesanoid contains soya-bean oil.
DO NOT TAKE VESANOID IF:
•
you are pregnant, planning to become pregnant or breast-feeding (see
section 2, Pregnancy,
breast-feeding and fertility)
•
you are taking vitamin A, tetracyclines or retinoids.
DO NOT TAKE THIS MEDICINE IF ANY OF THE ABOVE APPLY TO YOU. IF YOU ARE
NOT SURE, TALK TO
YOUR DOCTOR OR PHARMACIST BEFORE TAKING VESANOID.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Vesanoid if:
•
you have any other illness
•
you have ever

Toote omadused

Health Products Regulatory Authority
11 September 2023
CRN00CXP6
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vesanoid 10 mg soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
1 soft capsule contains 10 mg of tretinoin (all-_trans_ retinoic acid,
ATRA)
Excipients with known effect:
1 soft capsule contains 107.92 mg of soya-bean oil.
1 soft capsule contains 1.93 - 2.94 mg sorbitol.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsule, soft
Oval, bi-coloured orange-yellow/reddish-brown capsules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vesanoid (tretinoin) is indicated in combination with arsenic trioxide
or chemotherapy for the treatment of patients with acute
promyelocytic leukaemia (APL) which is newly diagnosed, relapsed or
refractory to chemotherapy (see sections 4.2 and 5.1).
Treatment regimens
Combination of tretinoin with chemotherapy or arsenic trioxide is
known to be effective and to induce very high rates of
haematologic remission in patients with genetically confirmed APL,
i.e. patients whose blasts harbour the t(15;17) by
karyotyping or FISH or the PML-RARa fusion as detected by PCR. Thus,
genetic confirmation of diagnosis is mandatory.
Combination treatment with arsenic trioxide has been shown an
effective treatment option in patients with newly diagnosed
low-to-intermediate risk APL. However, because APL is characterised by
high risk of early haemorrhagic death, current
recommendations dictate that treatment with tretinoin is started as
soon as possible upon morphologic suspicion only.
For the selection of treatment strategy the relapse risk - indicated
by pre-therapeutic white blood cell count (WBC) and platelet
count (Sanz score) with high-risk (WBC > 10 x 10
9
/L), intermediate risk (WBC ≤ 10 x 10
9
/L, platelet count ≤ 40 x 10
9
/L), and low
risk (WBC ≤ 10 x 10
9
/L, platelet count > 40 x 10
9
/L) - should be taken into consideration.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For all thera