LUMEXIA methyl aminolevulinate 160 mg/g cream tube

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

methyl aminolevulinate hydrochloride, Quantity: 200 mg/g (Equivalent: methyl aminolevulinate, Qty 160 mg/g)

Disponibbli minn:

Galderma Australia Pty Ltd

INN (Isem Internazzjonali):

Methyl aminolevulinate hydrochloride

Għamla farmaċewtika:

Cream

Kompożizzjoni:

Excipient Ingredients: self-emulsifying glyceryl monostearate; cetostearyl alcohol; PEG-40 stearate; methyl hydroxybenzoate; propyl hydroxybenzoate; disodium edetate; glycerol; white soft paraffin; cholesterol; isopropyl myristate; Arachis Oil; Almond oil; oleyl alcohol; purified water

Rotta amministrattiva:

Topical

Unitajiet fil-pakkett:

2 g

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

Treatment of thin or non-hyperkeratotic and non-pigmented actinic keratoses on the face and scalp when other registered therapies are unacceptable. Primary treatment of superficial and/or nodular basal cell carcinoma where surgery is considered inappropriate. Treatment of biopsy-proven squamous cell carcinoma in situ (Bowen's disease), where surgery is considered inappropriate. Lumexia is indicated in adults above 18 years of age.

Sommarju tal-prodott:

Visual Identification: Cream to pale brown cream; Container Type: Tube; Container Material: Epoxy-coated Al; Container Life Time: 15 Months; Container Temperature: Store below 8 degrees Celsius (refrigerate); Container Closure: Neither child resistant closure nor restricted flow insert

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2015-06-01

Fuljett ta 'informazzjoni

Lumexia
®
Cream
_Methyl aminolevulinate 160mg/g _
CONSUMER MEDICINE INFORMATION
LUMEXIA Consumer Medicine Information Page 1
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
LUMEXIA. It does not contain
all the available information.
It does not take the place of
talking to your doctor or nurse.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you using
LUMEXIA against the benefits
they expect it will have for
you.
IF YOU HAVE ANY CON
CE
R
N
S
ABOU
T
USING THIS MEDICINE,
ASK
YOUR
DO
C
T
O
R
OR
NURSE
.
KEEP THIS LEAFLET.
You may
need to read it again.
WHAT L U M E X I A IS USED
FOR
LUMEXIA contains the active
ingredient methyl
aminolevulinate (as
hydrochloride) that belongs to
a group of medicines called
antineoplastic agents or
cytotoxic medicines. You may
also hear of these being called
chemotherapy medicines.
LUMEXIA is used for treating
spots on the face and scalp that
are thin and not dark-coloured,
that are at risk of turning into
skin cancer (pre-cancerous
lesions called actinic keratosis,
or AK). It is used when other
treatments are considered
unacceptable. LUMEXIA
is
also used to treat some shallow
basal cell carcinomas (BCCs)
(a form of skin cancer) as well
as Bowen’s disease, when
surgery is not a suitable option.
Bowen’s disease is a
persistent, flat, red-brown
scaly or crusted area on the
skin which is due to a tumour
inside the upper layer of the
skin. If untreated it may spread
or eventually invade deeper
structures of the skin.
LUMEXIA works by killing
cancer or pre-cancer cells by
preventing them from growing
or multiplying. Treatment
consists of application of
Lumexia cream followed by
light exposure (Photodynamic
Therapy or PDT) using either a
red LED lamp (for AK, BCCs
and Bowen’s disease) or
daylight (for AK only). The
affected areas absorb methyl
aminolevulinate from the
cream. By light exposure, the
cancerous cells are destroyed.
Normal skin will not be
affected.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
LUMEXIA HAS BEEN
PRE

Karatteristiċi tal-prodott

Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION -
LUMEXIA
®
(METHYL AMINOLEVULINATE (AS HYDROCHLORIDE) CREAM
1. NAME OF THE MEDICINE
Methyl aminolevulinate (as hydrochloride).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Lumexia
®
cream contains 160 mg/g of methyl aminolevulinate (as hydrochloride).
Other excipients are self-emulsifying glyceryl monostearate,
cetostearyl alcohol,
PEG-40
stearate,
methyl
hydroxybenzoate,
propyl
hydroxybenzoate,
disodium
edetate, glycerol, white soft paraffin, cholesterol, isopropyl
myristate, arachis oil
(peanut oil), almond oil (refined), oleyl alcohol and purified water.
3. PHARMACEUTICAL FORM
Cream
to pale brown cream
.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of thin or non-hyperkeratotic and non-pigmented actinic
keratoses on
the face and scalp when other registered therapies are unacceptable.
Primary treatment of superficial and/or nodular basal cell carcinoma
where surgery
is considered inappropriate.
Treatment of biopsy-proven squamous cell carcinoma in situ (Bowen’s
disease),
where surgery is considered inappropriate.
Lumexia is indicated in adults above 18 years of age.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS (INCLUDING THE ELDERLY)
For treatment of actinic keratoses (AK), one session of photodynamic
therapy
(PDT) should be administered with either red LED light via a suitable
lamp (c-PDT)
or exposure to natural daylight (DL-PDT). Treated lesions should be
assessed after
three months and those with non-complete response should be retreated,
as per
the initial treatment method.
For treatment of basal cell carcinoma (BCC) and squamous cell
carcinoma _in situ_
(Bowen’s disease) two sessions of c-PDT should be administered with
an interval
of one week between sessions.
Treated lesions should be assessed after three months and those with
non-
complete response should be retreated, as per the initial treatment
method. In
clinical trials in BCC, approximately 25-30% of patients required
retreatment at 3
months. In the clinical trial in Bowen’s disea