Trimovate cream

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Clobetasone butyrate; Oxytetracycline calcium; Nystatin

Dostupno od:

Ennogen Healthcare Ltd

ATC koda:

D07CB

INN (International ime):

Clobetasone butyrate; Oxytetracycline calcium; Nystatin

Doziranje:

500microgram/1gram ; 30mg/1gram ; 100000unit/1gram

Farmaceutski oblik:

Cutaneous cream

Administracija rute:

Cutaneous

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 13040000; GTIN: 5000123104352

Uputa o lijeku

NUMBER OF FINGERTIP UNITS NEEDED
CHILDS AGE
FACE
ARM
LEG
FRONT
BACK
AND NECK
AND HAND
AND FOOT
INCLUDING
BUTTOCKS
3-6 months
1
1
1.5
1
1.5
1-2 years
1 ½
1 ½
2
2
3
3-5 years
1 ½
2
3
3
3 ½
6-10 years
2
2 ½
4 ½
3 ½
5
Trimovate Cream
CLOBETASONE 17-BUTYRATE, CALCIUM OXYTETRACYCLINE AND NYSTATIN
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Trimovate is and what it is used for
2
What you need to know before you use Trimovate
3
How to use Trimovate
4
Possible side effects
5
How to store Trimovate
6
Contents of the pack and other information
1
WHAT TRIMOVATE IS AND WHAT IT IS USED FOR
Trimovate contains three different active substances called
clobetasone
butyrate, calcium oxytetracycline and nystatin.
Clobetasone butyrate belongs to a group of medicines called
corticosteroids.
It helps to reduce redness, swelling and irritation of the skin.
Calcium oxytetracycline (an antibiotic) and nystatin (an antifungal)
are
medicines used to fight infections. They fight certain bacterial and
fungal
infections of the skin.
Trimovate is used in adults, the elderly, children and infants to help
reduce
the redness and itchiness of certain skin problems, such as eczema,
nappy
rash and dermatitis where infection may be a problem.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE TRIMOVATE
DO NOT USE TRIMOVATE:
!
if you are allergic to clobetasone butyrate, calcium oxytetracycline
or
oxytetracycline, nystatin or any of the other ingredients of this
medicine
(listed in section 6)
!
to tre

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Trimovate Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trimovate Cream is a yellow water-miscible cream containing
clobetasone 17-
butyrate 0.05% w/w, oxytetracycline 3.0% w/w as calcium
oxytetracycline and
nystatin 100,000 units per gram.
Excipients with known effect:
Cetostearyl alcohol
Chlorocresol
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clobetasone 17-butyrate is a moderately potent topical corticosteroid
indicated for
adults, elderly, children and infants for the relief of the
inflammatory and pruritic
manifestations of steroid responsive dermatoses. Nystatin is a polyene
antifungal.
Oxytetracycline is a broad spectrum antibiotic.
Topical preparations combining clobetasone with nystatin and
oxytetracycline are
indicated for the treatment and management of steroid responsive
dermatoses where
candidal or bacterial infection is present, suspected or likely to
occur.
These include the following:
-
Atopic dermatitis
-
Nappy rash
-
Intertrigo
-
Anogenital pruritis
-
Seborrhoeic dermatitis
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS, ELDERLY, CHILDREN AND INFANTS
For topical use only.
Creams are especially appropriate for moist or weeping surfaces.
Apply thinly and gently rub in using only enough to cover the entire
affected area
once or twice a day for up to seven days.
If the infection worsens, treatment and diagnosis should be
re-evaluated as soon as
possible.
If the condition does not improve within seven days, treatment and
diagnosis should
be re-evaluated.
Treatment should not be continued for more than seven days without
medical
supervision.
Allow adequate time for absorption after each application before
applying an
emollient. Patients should be advised to wash their hands after
applying clobetasone
with nystatin and oxytetracycline, unless it is the hands that are
being treated.
Rebound of pre-existing dermatoses can occur with abrupt
discontinu