Држава: Малта
Језик: Енглески
Извор: Medicines Authority
PIPERONYL BUTOXIDE, DEPALLETHRINE
Laboratoires Omega Pharma France 2 rue Chaintron, BP 850, 92542 Montrouge, France
P03AC52
PIPERONYL BUTOXIDE 4.4 % (W/W) DEPALLETHRINE 1.1 % (W/W)
CUTANEOUS LIQUID
PIPERONYL BUTOXIDE 4.4 % (W/W) DEPALLETHRINE 1.1 % (W/W)
OTC
ECTOPARASITICIDES, INCL. SCABICIDES, INSECTICIDES AND REPELLENTS
Withdrawn
2007-04-12
Réserve Vernis DIRECTIONS FOR USE PRECAUTIONS COMPOSITION BP 850 - 92542 MONTROUGE Cédex FRANCE EB 0HH 30/B LABORATOIRES OMEGA PHARMA FRANCE DATE : SIGNATURE : CONTACT : JAMILA FORMAT : 100% FORMAT : 95X125 MM TÉL. PAO 04 66 81 89 61/ FAX 04 66 81 89 70 - POUR NE PAS RETARDER LE DELAI CONVENU POUR L'IMPRESSION, VEUILLEZ RENVOYER CE BON A TIRER PAR FAX DANS LES 3 JOURS AU PLUS TARD. MERCI A L'ATTENTION DE MME KATHLEEN DECROP - STÉ MEDGENIX - CI-DESSOUS BON À TIRER LE 12 OCTOBRE 2006 IMPRESSION 3 COUL. : VERT PANTONE 374C - VERT PANTONE 347C - NOIR SUPPORT : VINYLE TRANSPARENT BRILLANT OPTION : VERNIS PARTIEL BRILLANT COINS : 1 RÉF. : 9 08 31 83 835/2 BAT 1 : 1 série Прочитајте комплетан документ
Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT PARA SHAMPOO SPECIAL LICE AND NITS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Depallethrine ....................................................................................................................1.1 g Piperonyl Butoxyde...........................................................................................................4.4g per 100 g of solution. 3. PHARMACEUTICAL FORM Shampoo 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications Treatment of pediculus humanus capitis (head lice). 4.2 Dosage and Method of Administration _First day: _apply shampoo to wet hair, and massage the scalp thoroughly (pre-shampoo). Rinse with a lot of water. Repeat the operation and allow shampoo to remain on scalp for five minutes. Rinse. Use a fine-tooth comb to remove dead nits. _Second day:_ repeat the operation in the same conditions. In order to avoid recontamination, we advise you to: – treat other members of your family as well – decontaminate clothes, sheets and objects that have come into direct contact with your hair, by washing them at 60°C. If you cannot wash them, put them into a plastic bag for 48 hours with an insecticide or for 8 days without an insecticide. 4.3 Contraindications Hypersensitivity or intolerance to one of the components. 4.4 Special Warnings and Precautions for Use Avoid contact with eyes and mucous membranes. Page 2 of 3 4.5 Interactions with other drugs and other forms of interaction Not applicable 4.6 Pregnancy and Lactation Not applicable 4.7 Effects on Ability to Drive and Use Machines Not applicable 4.8 Adverse Reactions Rarely observed: red spots and dandruff. Due to the presence of propyl and methyl parahydroxybenzoate, exceptional risk of conta Прочитајте комплетан документ