Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
POVIDONE-IODINE
RAFA LABORATORIES LTD
D08AG02
DRY POWDER SPRAY
POVIDONE-IODINE 2.5 %
DERMAL
Not required
MUNDIPHARMA PHARMACEUTICALS LTD., CYPRUS
POVIDONE-IODINE
As antiseptic for prevention and treatment of infections associated with burns, cuts and scrapes, and for preventive treatment of wounds at risk of infection, e.g. after placement of a suture for wound treatment or after surgery.
2023-10-31
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is sold without a doctor’s prescription BETADINE ® TOPICAL SPRAY ACTIVE INGREDIENT: Povidone Iodine 2.5% (equivalent to 0.25% available iodine). For the list of the other ingredients, please see section 6. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. Use the medicine according to the instructions in the dosage section of this leaflet. Consult your pharmacist if you require additional information. Refer to your doctor if the symptoms get worse or do not improve. 1. WHAT IS THE MEDICINE INTENDED FOR? This medicine is intended for skin disinfection: For treatment and prevention of skin infections as a result of burns, cuts and scrapes. For preventive treatment of wounds that might become infected, e.g.: after surgery or stitches. THERAPEUTIC GROUP: Antiseptics 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: You are sensitive (allergic) to the active ingredient, to iodine, or to any of the other ingredients this medicine contains (for the list of the other ingredients, please see section 6). You suffer from overactive thyroid gland (hyperthyroidism manifested by increase in heart rate and restlessness), or from any other thyroid gland disorder. You suffer from dermatitis herpetiformis (Duhring’s Disease), which is an autoimmune disease with blisters. Do not use together with mercury-containing products or antiseptics based on octenidine. Do not use before and after treatment with radioactive iodine (until completion of the treatment). Do not use before tests with radioactive iodine (thyroid gland scintigraphy). SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: Do not inhale the spray mist. Do not spray into eyes or on areas around the eyes. The spray mist is flammable! Avoid proximity to fire (when spraying a Διαβάστε το πλήρες έγγραφο
1 Betadine Topical Spray-DL-Nov 2018-01 This leaflet format has been determined by the Ministry of Health and the content thereof has been checked and approved in November 2018 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Betadine Topical Spray 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Povidone-iodine 2.5 % For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dry Powder Spray Spray for application on skin. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS As antiseptic for prevention and treatment of infections associated with burns, cuts and scrapes, and for preventive treatment of wounds at risk of infection, e.g. after placement of a suture for wound treatment or after surgery. 4.2. POSOLOGY AND ROUTE OF ADMINISTRATION POSOLOGY The dose is proportionate to the size of the area to be treated. Spray once or multiple times daily on the area to be treated until this is visibly covered with the golden-brown coloured povidone-iodine powder. In the event the Betadine Topical Spray becomes discoloured, it may be reapplied. NEW-BORNS AND INFANTS UNDER 6 MONTHS Betadine Topical Spray may only be used in new-borns and infants up to the age of 6 months after a thorough risk-benefit analysis has been carried out by the doctor, and applied only to a very limited extent (see Section 4.4 Special Warnings and Precautions for Use). ROUTE OF ADMINISTRATION Betadine Topical Spray is intended for external use. 2 Betadine Topical Spray forms a dry film on the treated area and can be washed off easily. Shake the spray can well before use, hold upright and spray from a distance of 15 cm on the area to be treated. The propellant evaporates immediately and the cold sensation experienced when the product is sprayed on quickly disappears. If necessary, a dressing can then be applied on top. DURATION OF ADMINISTRATION Betadine Topical Spray should continue to be administered for as long as there is evidence of an infection or a clear risk of infection. Should an infection recur after treatme Διαβάστε το πλήρες έγγραφο