Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
TROLAMINE
J-C HEALTH CARE LTD
D03XA
CREAM
TROLAMINE 0.67 %W/W
TOPICAL
Not required
JNTL CONSUMER HEALTH (FRANCE) S.A.S., FRANCE
Soothes burns, sunburns, sores and wounds.
2021-06-30
_ _ 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 Olvassa el a teljes dokumentumot
_ _ 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 Olvassa el a teljes dokumentumot