BIAFINE

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

TROLAMINE

Διαθέσιμο από:

J-C HEALTH CARE LTD

Φαρμακολογική κατηγορία (ATC):

D03XA

Φαρμακοτεχνική μορφή:

CREAM

Σύνθεση:

TROLAMINE 0.67 %W/W

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

Not required

Κατασκευάζεται από:

JNTL CONSUMER HEALTH (FRANCE) S.A.S., FRANCE

Θεραπευτικές ενδείξεις:

Soothes burns, sunburns, sores and wounds.

Ημερομηνία της άδειας:

2021-06-30

Φύλλο οδηγιών χρήσης

_ _
1_ _
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS)
- 1986
The medicine is dispensed without a doctor’s prescription
BIAFINE, CREAM FOR SKIN APPLICATION
ACTIVE INGREDIENT
Trolamine 0.67% w/w
Inactive and allergenic ingredients: see section 6
_“Further Information”_
and section 2 "_Before using the _
_medicine_".
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.
Use this medicine in accordance with the instructions in the dosage
section in this leaflet. Consult the
pharmacist if you need further information. Refer to the doctor if
signs of the illness worsen or do not
improve.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Soothes superficial burns, sunburns and superficial wounds.
Therapeutic group: SKIN PROTECTOR (D. Dermatology).
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
YOU ARE SENSITIVE (ALLERGIC) TO THE ACTIVE INGREDIENT OR TO ANY OF THE
ADDITIONAL
INGREDIENTS CONTAINED IN THE MEDICINE (SEE DETAILS IN SECTION 6
–
“FURTHER
INFORMATION”).
•
You have a haemorrhagic wound (with bleeding).
•
You have an infected wound.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR
THEIR
OPINION.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
Talk to your doctor or pharmacist before using BIAFINE, cream for skin
application.
If you have a burn with blistering or extensive burn, or if you have a
deep or extensive wound, medical
consultation is essential before applying any medicine to the wound.
This medicine does not provide protection from the sun.
This medicine should not be used as a skincare cream for healthy skin.
Do not apply near the eyes.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR
THEIR
OPINION.
CHILDREN
Not applicable.
INTERACTIONS/REACTIONS BETWEEN OTHER MEDICINES AND BIAFINE, CREAM FOR
SKIN APPLICATION
! IF YOU ARE TAKING, OR HAVE RECENTLY TAKEN, OTHER MEDIC

Αρχείο Π.Χ.Π.

_ _
1_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BIAFINE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trolamine - 0.67% w/w
Excipient(s) with known effect: propylene glycol, potassium sorbate,
sodium methyl parahydroxybenzoate
(E 219), sodium propyl parahydroxybenzoate (E 217), Yerbatone aroma.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Cream for skin application.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Soothes burns, sunburns, sores and wounds.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
•
IN CASE OF BURNS:
Apply a one-half centimeter layer of Biafine on and around the
affected area.
Reapply the cream regularly in order to maintain a fixed amount on the
affected area.
Note: In case of burns
–
Cool immediately with cold running water on the burn for 10
minutes, then apply a thick layer of the cream. In case of deep or
extensive burns
–
medical
treatment needs to be received.
•
SKIN WOUNDS:
Generally, a thick layer should be applied on and around the wound
without rubbing.
Maintain a thick layer until the wound forms a scab. A physician may
recommend a suitable
dressing.
•
SECONDARY REACTIONS AFTER RADIATION THERAPY (ERYTHEMA, DRY OR MOIST
DESQUAMATION,
"HARDENING OF THE SKIN", ETC., WITH OR WITHOUT PAIN):
Do not apply Biafine 3-4 hours prior to a radiation session.
Apply Biafine immediately following the first radiation session.
•
WHEN THE SKIN IS NOT DAMAGED:
If there are no medical instructions
–
apply Biafine three times a day.
•
WHEN THE SKIN IS CRACKED (MOIST DESQUAMATION), NON-INFECTED WOUNDS:
Apply Biafine according to the instructions for treating wounds. If
the wound is large,
disinfect it before applying Biafine. A physician may recommend a
suitable dressing.
Note:
Sometimes three applications a day are not sufficient. In such cases,
the doctor may
recommend an additional two applications a day, one after you wake up
in the morning, if
you do not have a session that morning (if you do have a session
scheduled for that s