SILKIS OINTMENT 3 mcgg

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Ingrédients actifs:

CALCITRIOL

Disponible depuis:

GALDERMA SINGAPORE PRIVATE LIMITED

Code ATC:

D05AX03

Dosage:

3 mcg/g

forme pharmaceutique:

OINTMENT

Composition:

CALCITRIOL 3 mcg/g

Mode d'administration:

TOPICAL

Type d'ordonnance:

Prescription Only

Fabriqué par:

LABORATOIRES GALDERMA

Statut de autorisation:

ACTIVE

Date de l'autorisation:

2002-12-30

Notice patient

OINTMENT
CALCITRIOL
COMPOSITION
SILKIS OINTMENT contains 3µg/g calcitriol (BAN, USAN and INN) as the
active ingredient and white soft paraffin, liquid
paraffin and D,L-·-tocopherol as excipients.
PHARMACEUTICAL FORM
SILKIS OINTMENT is for cutaneous use.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES: Calcitriol inhibits the proliferation and
stimulates differentiation of keratinocytes. Calcitriol
inhibits proliferation of T-cells and normalises the production of
various inflammation factors. Topical administration of
SILKIS OINTMENT to patients with plaque psoriasis results in an
improvement of the skin lesions.This effect is noted from 4
weeks after the start of treatment.
PHARMACOKINETIC PROPERTIES: The mean absorption of calcitriol is
estimated at around 10%. Following absorption, both
unchanged calcitriol and metabolites have been demonstrated in plasma.
The effect of the metabolites on calcium
homeostasis is negligible. In most patients, circulating levels of
exogenous calcitriol are below the level of detection
(2pg/ml). In clinical trials, no relevant increase in plasma
calcitriol levels after treatment of large body surface areas of up
to 6,000 cm2 (35% body surface area) was noted.
INDICATIONS AND USAGE
Topical treatment of mild to moderately severe plaque psoriasis
(_psoriasis vulgaris_) with up to 35% of body surface area
involvement.
CONTRA-INDICATIONS
Patients on systemic treatment of calcium deficiency.
Patients with kidney or liver/biliary dysfunction.
Patients with hypercalcaemia or patients with calcium metabolism
problems.
SILKIS OINTMENT must not be used in patients known to be sensitive to
any of the ingredients of the ointment.
UNDESIRABLE EFFECTS
A low incidence of skin irritation (reddening, itching) has been
reported following the use of SILKIS OINTMENT. Such irri-
tation is usually of a temporary nature. If sensitivity or severe
irritation occurs, treatment should be discontinued tempo-
rarily or discontinued altogether. During clinical studies, no
hypercalcaemia was o

Résumé des caractéristiques du produit

O I
N T M E N T
c a l
c i
t r i
o l
Product code: MOCK UP
Product description: SILKIS POM 30
Market: EX2
Article: Leaflet
Flat size: 180x315
Fold size: 180x26,25
PMS 432U
DIELINES
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pre-printed mentions and legal or special labelling constraints.
PLEASE CHECK PROOF CAREFULLY TO ENSURE ALL ELEMENTS ARE CORRECT.
Font size: 8 pt
Pharmacode: TBD
_GRAPHIC DESIGNER: Guillaume ANDRÉ_
_LAUNCHING DEPARTMENT - Z.I. Galderma - 74540 ALBY-SUR-CHERAN -
FRANCE_
1. NAME OF THE MEDICINAL PRODUCT
Silkis 3 µg/g ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of ointment contains 3 µg of calcitriol (INN). For the full
list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Ointment
White, translucent ointment
4.CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Silkis is indicated in
topical treatment of mild to moderately severe plaque psoriasis
(psoriasis vulgaris) with up to 35% of body surface area involvement.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Silkis Ointment should be applied to the psoriasis affected areas
twice per day, once in the morning and once in the evening before
retiring and after washing.
It is recommended that not more than 35% of the body surface be
exposed to daily treatment. Not more than 30 g of ointment should be
used per day. There is
limited clinical experience available for the use of this dosage
regimen of more than 6 weeks.
Paediatric population
There is no experience of the use of Silkis in children (see 4.4.
Special warnings and precautions for use).
Special population
Patients with kidney or liver dysfunction should not use Silkis (see
also 4.3. Contra-indications).
4.3. CONTRA-INDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
Patients on systemic treatment of calcium homeostasis.
Patients with kidney or liver dysfunction.
Patients with hypercalcaemia and patients known to suffer from
abnormal calcium metabolism.
4.4. SPECIAL WARNINGS AND PR