البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
PIRENOXINE SODIUM
Farmigea S.p.A Via G.B. Oliva, 8 56121 Pisa, Italy
S01XA
PIRENOXINE SODIUM 0.376 mg
EYE DROPS
PIRENOXINE SODIUM 0.376 mg
POM
OPHTHALMOLOGICALS
Withdrawn
2007-03-02
120 X 240 NERO CODICE DECA I I I X I 40 FARMIGEA N° 2 DEL 23 - 11 - 2016 PIRFALIN 3/(1)5 912702/01 120 X 27 CLIENTE / Customer : BOZZA DEL / Proof date : PRODOTTO / Product : CARTA / Paper : MECCANOGRAFICA SENZA LEGNO F.TO POSA STESA / Size flat : STAMPA SU LATO / Printing : DIREZIONE FIBRA PARALLELA AL LATO / Fiber parallel to side : LUNGO ( MM.) COLORI / Fold No. : NOTE / Notes : CODICE / Code : GR/MQ / Gr/mq : F.TO POSA PIEGATA / Size folden : BIANCA / Top side : VOLTA / Reverse side : FORMANOVA COMPOSITION _The freeze-dried powder contains:_ _Active substance: _Pirenoxine sodium 0.376 mg. _Excipients_: Taurine. Solvent for eye drops: Polyvinyl Alcohol; Succinic acid; Sodium succinate; Sodium chloride, Benzalko- nium chloride; Disodium edetate, water for injections. PHARMACEUTICAL FORM AND CONTENTS: Eye drops, powder and solvent for solution. Bottle containing 7 ml of solvent with dropper container of freeze-dried powder. PHARMACOTHERAPEUTIC GROUP Anti-cataract agent. MARKETING AUTHORISATION HOLDER(S) Farmigea S.p.A, Via G. B. Oliva 6/8, 56121 – Pisa, Italy MANUFACTURER Tubilux Pharma S.p.A., Via Costarica, 20/22 - Pomezia (Rome), Italy INDICATIONS Senile cataract. CONTRAINDICATIONS Confirmed individual hypersensitivity to any of the product’s ingredients. PRECAUTIONS FOR USE To be used under direct medical supervision. The product must be used for external use only. Toxic phenomena may present if accidentally swallowed or used at high doses for long periods. Do not apply in the presence of eye inflammation or lesions. INTERACTIONS WITH OTHER MEDICINES None known. KEEP OUT OF THE REACH OF CHILDREN. DOSAGE Apply 1-2 drops to the affected eye 4 times a day, following the doctor’s prescription. UNDESIRABLE EFFECTS Pirenoxine in the pharmaceutical form eye drops, powder and solvent for solution is usually well tolerated. INSTRUCTIONS FOR USE 1. Remove the plastic ring as shown. 2. Press the cap down until stop. 3. Shake by turning the bottle upside-down 3 or 4 times. 4. Instil by squeezing the bottle. CAU اقرأ الوثيقة كاملة
Page 1 of 3 1. NAMEOFTHE MEDICINAL PRODUCT PIRFALIN FREEZE-DRIED EYE DROPS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 7 ML RECONSTITUTED EYE DROPS CONTAIN, ACTIVE SUBSTANCE: Pirenoxine sodium 0.376mg _For Excipients see paragraph 6.1_ 3. PHARMACEUTICAL FORM Freeze-dried eye drops 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Senile cataract. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply in the affected eye 1-2 drops of Pirfalin, four times a day according to medical prescription. 4.3 CONTRA-INDICATIONS Individual hypersensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE. In case of accidental swallowing or extended use in excessive doses, toxic problems may occur. Avoid application if there are lesions or inflammations of the eye. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Known to discolour soft contact lenses. KEEP THE MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN. 4.5 INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION Not known. 4.6 PREGNANCY AND LACTATION For women who are pregnant or breastfeeding, in the absence of clinical data, despite the favourable results of animal experiments, the use of this medication is advisable only under direct medical supervision. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINERY None. 4.8 UNDESIRABLE EFFECTS Pirenoxine is normally well tolerated in its pharmaceutical form of freeze-dried eye drops. 4.9 OVERDOSE No overdose reactions have ever been observed. 5. PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES The pharmacological properties of Pirenoxine, the sole active ingredient of Pirfalin, have been اقرأ الوثيقة كاملة