Locoid 1mg/g cream for topical use

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

hydrocortisone (hydrocortisone 17-butyrate)

Available from:

Temmler Italia S.r.L.

ATC code:

D07AB02

INN (International Name):

hydrocortisone (hydrocortisone 17-butyrate)

Dosage:

1mg/g

Pharmaceutical form:

cream for topical use

Units in package:

aluminium tube 30g

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2017-06-08

Summary of Product characteristics

LOCOID
®
(hydrocortisone-17-butyrate)
CTD Module 1
Cream, ointment and cutaneous solution
Section 1.3: Product Information
SmPC NL – Locoid range MA transfer – 21-Jun-2016
1 of 5
1.
NAME OF THE MEDICINAL PRODUCT
Locoid ointment, ointment 1 mg/g
Locoid Lipocream, cream 1 mg/g
Locoid cream, cream 1 mg/g
Locoid scalp lotion, lotion 1 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Locoid ointment, Locoid Lipocream and Locoid cream contain 1 mg/g and
Locoid scalp lotion contains 1
mg/ml hydrocortisone-17-butyrate.
The Locoid ointment is hydrophobic (greasy); Locoid Lipocream and
Locoid cream contain buffered oil-
in-water emulsions (Locoid Lipocream has more fat, Locoid cream has
more water). Locoid scalp lotion
is a buffered, somewhat viscous solution based on isopropanol-water.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Locoid ointment is an ointment, Locoid Lipocream and Locoid are creams
and Locoid scalp lotion is a
solution for cutaneous use.
Locoid ointment, Locoid Lipocream and Locoid cream are all white.
Locoid scalp lotion is clear and
colourless.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTICAL INDICATIONS
Superficial, corticosteroid-sensitive skin conditions that are not
caused by micro-organisms and that are
expected to respond insufficiently to will respond to mildly active
products.
Aftercare or maintenance treatment of dermatoses that were suppressed
before with a stronger product.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
Apply a bit of Locoid to the skin 1-3 times a day. After improvement
of the condition, application once
daily or 2 to 3 times per week is usually sufficient. In general, do
not use more than 30-60 g per week.
Apply Locoid in a thin layer equally on the affected skin areas. To
improve the penetration in the skin, a
mild massage may be performed carefully.
Occlusion may be necessary to achieve better therapeutic results.
4.3
CONTRAINDICATIONS

Skin conditions caused by:
-
bacterial infections (e.g. pyodermias, luetic and tuberculous
processes)
-
viral inf