OXSORALEN LOT 10MG/ML LOTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

METHOXSALEN

Dostopno od:

VALEANT CANADA LP / VALEANT CANADA S.E.C.

Koda artikla:

D05AD02

INN (mednarodno ime):

METHOXALEN, TOPICAL

Odmerek:

10MG

Farmacevtska oblika:

LOTION

Sestava:

METHOXSALEN 10MG

Pot uporabe:

TOPICAL

Enote v paketu:

30ML

Tip zastaranja:

Prescription

Terapevtsko območje:

PIGMENTING AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0107802001; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2015-08-05

Lastnosti izdelka

1
PRESCRIBING INFORMATION
OXSORALEN
Lotion 1%
(Methoxsalen, USP)
Melanin Repigmentation
Photochemotherapy of Psoriasis and Atopic
Dermatitis
Valeant Canada LP
2150 St-Elzear Blvd., West
Laval, Quebec
H7L 4A8
Canada
Date of Preparation: September 27, 2004
Address Updated: September 04, 2014
Control#: 094181
2
PRESCRIBING INFORMATION
OXSORALEN Lotion 1%
(methoxsalen, USP)
Melanin repigmentation
Photochemotherapy of Psoriasis and Atopic Dermatitis
INDICATIONS
Repigmentation of vitiliginous lesions and treatment of psoriasis and
atopic dermatitis in
combination with high intensity UVA light. Oral route is preferred if
extensive repigmentation
is desired since topical application can only be applied to a small
area at a time.
CONTRAINDICATIONS
Oxsoralen Lotion 1% is contraindicated in patients exhibiting
idiosyncratic reactions to psoralens
or with a history of a sensitivity reaction to the drug; in patients
with diseases associated with
photosensitivity
(e.g.,
lupus
erythematosus,
porphyria
cutanea
tarda,
erythropoietic
protoprophyria, varietate porphyria, xeroderma pigmentosum, albinism,
hydroa vacciniforme,
leukoderma
of
infectious
origin,
polymorphous
light
eruptions),
except
under
special
circumstances; in patients with melanoma or history of melanoma; and
in patients with invasive
squamous cell carcinoma.
Safety in patients 12 years and under, in aphasic people, in pregnant
women or in women of
childbearing age has not been established. No preparation with any
photosensitizing capacity,
internal or external, should be used concomitantly with methoxsalen
therapy.
3
WARNINGS
Methoxsalen is a potent drug capable of producing severe burns if
improperly used. Oxsoralen
Lotion should be applied ONLY by a physician under controlled
conditions as to light exposure
and subsequent light shielding.
OXSORALEN LOTION 1% SHOULD NEVER BE DISPENSED TO A
PATIENT FOR HOME APPLICATION.
Oxsoralen
Lotion
1%
should
be
applied
only
to
small,
well-defined
vitiliginous
lesions,
preferably those lesions that can be protected by clothing