AFLUMYCIN

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

GENTAMICIN SULFATE; PREDNISOLONE

Fáanlegur frá:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC númer:

D07CA03

Lyfjaform:

CREAM

Samsetning:

PREDNISOLONE 0.5 %; GENTAMICIN SULFATE 0.16 %

Stjórnsýsluleið:

DERMAL

Gerð lyfseðils:

Required

Framleitt af:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Meðferðarhópur:

PREDNISOLONE AND ANTIBIOTICS

Lækningarsvæði:

PREDNISOLONE AND ANTIBIOTICS

Ábendingar:

For the treatment of skin inflammation associated with bacterial infection.

Leyfisdagur:

2022-06-30

Upplýsingar fylgiseðill

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS( – 1986
The medicine is dispensed with a doctor’s
prescription only
Aflumycin
Cream
Active ingredients and their quantities
per dosage unit:
Each tube contains:
Prednisolone 0.5%
Gentamicin sulfate 0.16%
Inactive and allergenic ingredients in
the medicine – see section 2 “Important
information about some of the ingredients
of the medicine” and section 6 “Further
information” in the leaflet.
Read the leaflet carefully in its entirety
before using the medicine. This leaflet
contains concise information about the
medicine.
If you have further questions, refer to the
doctor or pharmacist.
This medicine has been prescribed for you.
Do not pass it to others. It may harm them
even if it seems to you that their medical
condition is similar.
1. WHAT IS THE MEDICINE INTENDED
FOR?
The medicine is indicated for the treatment
of skin inflammation associated with
bacterial infection.
Therapeutic group:
The
medicine
contains
two
active
ingredients:
Gentamicin
–
a
broad-spectrum
aminoglycoside antibiotic.
Prednisolone – corticosteroid with an
anti-inflammatory effect.
2. BEFORE USING THE MEDICINE
Do not use the medicine:
• If you are sensitive )allergic( to the
active ingredients or to any of the
additional ingredients in this medicine.
• Do not use in case of viral infections
)e.g.,
herpes
or
chickenpox(
or
tuberculosis.
• If you have a sensitivity to another
topical corticosteroid.
• Do not use to treat a skin reaction to
vaccine administration.
• Do not use to treat acne.
• Do not use to treat skin ulcers.
• Do not use to treat rosacea.
• Do not use to treat atrophic skin
disease.
• Do not use to treat perioral dermatitis.
Special warnings regarding use of the
medicine
• Before treatment with Aflumycin, tell
the doctor if:
- you are pregnant or planning to become
pregnant
- you are breastfeeding or planning to
breastfeed
- you are in need of facial skin treatment
• Use Aflumycin on the skin only. Do n

Vara einkenni

PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Aflumycin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Prednisolone 0.5%
Gentamicin Sulfate 0.16%
Aflumycin dermal cream contains Prednisolone 5 mg/g (0.5%) and
Gentamicin Sulfate 1.
6
mg/g (0.16%).
Excipients with known effect:
Aflumycin contains Cetostearyl alcohol and Benzyl alcohol.
For a full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Dermal white cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of skin inflammation associated with bacterial
infection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Aflumycin is for external topical use only.
Apply a thin layer to the affected skin area 4 times daily.
A gradual dose reduction should be made, according to the physician
instructions.
If clinical improvement is not achieved by one week, the condition
should be assessed.
Infants and children under the age of 4 years
The treatment duration should not exceed 3 weeks, especially in areas
covered by diapers.
ELDERLY (OVER 65 YEARS):
No data available.
PAEDIATRIC USE
In infants and children, plastic pants and napkins may act as
occlusive dressings and increase
absorption. Because of children’s larger skin surface area to
bodyweight ratio, paediatric
patients may demonstrate greater susceptibility to topical
corticosteroid-induced HPA axis
suppression and Cushing’s syndrome than adults. Chronic/long-term
corticosteroid therapy
may interfere with growth and development of children. Use of topical
corticosteroids in
children should be limited to the least amount required for
therapeutic effect.
EFFECTS ON LABORATORY TESTS
No data available.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
-
Aflumycin is contraindicated in viral diseases (e.g. vaccinia,
varicella/herpes zoster) and
when tuberculous or syphilitic processes and post-vaccination skin
reactions are present in
the area to be treated.
-
Aflumycin is contraindicated if rosacea, ulcera, atrophic ski