Altargo
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
15-03-2019
Charakterystyka produktu
(SPC)
15-03-2019
Sprawozdanie z oceny publicznego
(PAR)
15-03-2019
Składnik aktywny:
retapamulin
Dostępny od:
Glaxo Group Ltd
Kod ATC:
D06AX13
INN (International Nazwa):
retapamulin
Grupa terapeutyczna:
Antibiotics and chemotherapeutics for dermatological use
Dziedzina terapeutyczna:
Impetigo; Staphylococcal Skin Infections
Wskazania:
Short term treatment of the following superficial skin infections: , impetigo;, infected small lacerations, abrasions or sutured wounds. , See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus. Consideration should be given to official guidance on the appropriate use of antibacterial agents.,
Podsumowanie produktu:
Revision: 15
Status autoryzacji:
Withdrawn
Data autoryzacji:
2007-05-24
Ulotka dla pacjenta
23
B. PACKAGE LEAFLET
Medicinal product no longer authorised
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALTARGO 10 MG/G OINTMENT
Retapamulin
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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness seem 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 Altargo is and what it is used for
2.
What you need to know before you use Altargo
3.
How to use Altargo
4.
Possible side effects
5.
How to store Altargo
6.
Contents of the pack and other information
1.
WHAT ALTARGO IS AND WHAT IT IS USED FOR
Altargo ointment contains an antibiotic called retapamulin, which is
used on the skin.
Altargo is used to treat bacterial infections affecting small areas of
skin. Infections that may be treated
include impetigo (which causes crusting scabs on infected areas),
cuts, grazes and stitched wounds.
Altargo is for adults and children aged nine months and older.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ALTARGO
_ _
DO NOT USE ALTARGO
If you are allergic to retapamulin or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Altargo.
If you notice any worsening of the infection or develop increased
redness, irritation or other signs and
symptoms at the site of application you should stop using Altargo and
tell your doctor. See also
section 4 of this leaflet.
If there is no improvement in your infection after two to three days
of treatment contact your doctor.
CHILDREN
Altargo should not be used on children who are less than nine months
old.
Medicinal product no longer authorised
25
OTHER MEDIC
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Altargo 10 mg/g ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains 10 mg retapamulin (1% w/w).
Excipient(s) with known effect:
Each gram of ointment contains up to 20 micrograms of butylated
hydroxytoluene (E321).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ointment.
Smooth, off-white ointment.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short term treatment of the following superficial skin infections in
adults, adolescents, infants and
children (aged from nine months) (see section 5.1):
•
Impetigo.
•
Infected small lacerations, abrasions, or sutured wounds.
See sections 4.4 and 5.1 for important information regarding the
clinical activity of retapamulin
against different types of
_Staphylococcus aureus. _
Consideration should be given to official guidance on the appropriate
use of antibacterial medicinal
products.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (aged 18-65 years), adolescents (aged 12-17 years), infants
and children (aged from nine _
_months to 11 years) _
A thin layer of ointment should be applied to the affected area twice
daily for five days.
The area treated may be covered with sterile bandage or gauze
dressing.
Safety and efficacy have not been established in the following:
•
Impetiginous lesions >10 in number and exceeding 100 cm
2
in total surface area.
•
Infected lesions that exceed 10 cm in length or a total surface area
>100 cm
2
.
Medicinal product no longer authorised
3
In patients aged less than 18 years the total surface area treated
should be no more than 2% of the body
surface area.
Patients not showing a clinical response within two to three days
should be re-evaluated and
alternative therapy should be considered (see section 4.4).
_Special populations _
_Elderly (aged 65 and older) _
No dosage adjustment is necessary.
_ _
_Renal impairment _
No dosage adjustment is necessa
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