Panretin
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
10-04-2019
Charakterystyka produktu
(SPC)
10-04-2019
Sprawozdanie z oceny publicznego
(PAR)
02-07-2018
Składnik aktywny:
alitretinoin
Dostępny od:
Eisai GmbH
Kod ATC:
L01XX22
INN (International Nazwa):
alitretinoin
Grupa terapeutyczna:
Antineoplastic agents
Dziedzina terapeutyczna:
Sarcoma, Kaposi
Wskazania:
Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with acquired-immune-deficiency-syndrome (AIDS)-related Kaposi's sarcoma (KS) when:lesions are not ulcerated or lymphoedematous, and;treatment of visceral KS is not required, and;lesions are not responding to systemic antiretroviral therapy, and;radiotherapy or chemotherapy are not appropriate.
Podsumowanie produktu:
Revision: 17
Status autoryzacji:
Withdrawn
Data autoryzacji:
2000-10-11
Ulotka dla pacjenta
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET: IINFORMATION FOR THE USER
Panretin 0.1% gel
Alitretinoin
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 any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. 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 Panretin is and what it is used for
2.
What you need to know before you use Panretin
3.
How to use Panretin
4.
Possible side effects
5.
How to store Panretin
6.
Contents of the pack and other information
1.
WHAT PANRETIN IS AND WHAT IT IS USED FOR
Panretin belongs to a group of medicines that are related to vitamin A
and known as retinoids.
Panretin is used in patients with AIDS-related Kaposi’s sarcoma (KS)
and is for the treatment of
the KS lesions:
-
that are on the skin only
-
which have not responded to your HIV treatment
-
where the skin or lesion is not broken
-
where the surrounding skin is not swollen
-
if your doctor thinks that other treatments are not suitable for you.
Panretin does not treat KS that is inside the body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PANRETIN
DO NOT USE PANRETIN:
-
if you are allergic to alitretinoin or to similar medicines containing
retinoids
-
if you are allergic to any of the other ingredients of this medicine
(listed in section 6)
-
if you are pregnant
-
if you are planning a pregnancy
-
if you are breast-feeding
-
on KS lesions close to any other skin complaint
TAKE SPECIAL CARE WITH PANRETIN
-
Panretin is not approved for use in children and adolescents under 18
years of age.
-
Do not apply the gel on or near sensitive parts of your body such as
eyes, nostrils, mouth,
lips, vagina, tip of the penis, rectum, o
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Panretin 0.1 % gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of gel contains 1 mg alitretinoin (0.1%).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel.
Clear yellow gel.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Panretin gel is indicated for the topical treatment of cutaneous
lesions in patients with AIDS-
related Kaposi’s sarcoma (KS) when:
-
lesions are not ulcerated or lymphoedematous
-
treatment of visceral KS is not required
-
lesions are not responding to systemic antiretroviral therapy
-
radiotherapy or chemotherapy are not appropriate
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Panretin therapy should only be initiated and maintained by specialist
physicians experienced in
the treatment of patients with KS.
_Men_
Patients should apply Panretin to cutaneous KS lesions using
sufficient gel so as to cover each
lesion with a generous coating.
_Frequency of application_
Patients should initially apply Panretin twice a day to cutaneous KS
lesions. The application
frequency can be increased stepwise to three or four times a day
according to individual lesion
tolerance, allowing no less than two weeks between dose increases. The
frequency of application
should be adjusted for each lesion independently. If application site
toxicity occurs, the
application frequency can be reduced as described below. There are no
data on the efficacy of
Panretin applied less frequently than twice daily.
Local dermal irritation may be graded according to the five-point
scale shown in Table 1.
Guidelines for treatment adjustments necessitated by local dermal
treatment-related toxicity are
specified in Table 2.
3
TABLE 1
GRADING OF LOCAL DERMAL IRRITATION
GRADE
DEFINING CLINICAL SIGNS
0 = No reaction
None
1 = Mild
Definite pink to red coloration
2 = Moderate
Increased redness, possible oedema
3 = Severe
Very red, with oedema, with or without vesiculation
4 = Very severe
Deep red, swelling and oedema wit
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