Vegenix

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Vaginal Pessary- Non Sterile for Gynaecological Use


Composition: Natural plant extracts + Vitamin E + Hyaluronic acid 


Formulation: Vaginal Pessary


Classification: Medical Device Class II A in compliance with 93/42/EC as amended by 2007/47/EC – CE 0477 


Applicable harmonised standards: ISO 14971:2009 ISO 15223-1, ISO 10993-1, 10993-5, 10993-10, ISO 13485


CE certified with CE 0477 marking, confirming compliance with EU standards.


INDICATIONS 


Vaginal dryness 


VEGANIX is to be used for all the non-pathological cases related to the vaginal mucus, such as irritation, itch, pain, burning and difficulties in sexual intercourses. VEGANIX effectively hydrates and soothes, avoiding and contrasting the vaginal dryness


Co-adjuvant in not aggressive vaginal disease 


VEGANIX Vaginal Pessary is indicated as lenitive and moisturising co-adjuvant in case of ailment, not aggressive vaginal disease, as not complicated atrophic vaginitis. VEGANIX Vaginal Pessary helps to restore the natural physiological intra-vaginal conditions. 


DOSAGE AND POSOLOGY 

If not differently recommended by the physician, the daily dosage is 1 vaginal pessary, for no longer than 10 consecutive days. If the vaginal diseases persist, consult a physician. To obtain better efficacy and comfort, use the medical device before going to bed.



METHOD OF ADMINISTRATION 

The medical device should be administered only intra-vaginally, immediately after the opening of the aluminium blister. Wash your hands before administration. Open carefully the aluminium sheet, which wraps the pessary, paying attention not to let the pessary fall down. Insert deeply into the vagina by the forefinger. No special applicator is needed. 


CONTRAINDICATIONS 

The use of this medical device is contraindicated in case of known or suspected individual hypersensitivity to any component of the product


WARNING 


  • Do not use the medical device after the expiry date reported on the carton box and on the blister. 

  • Do not use the device if the packaging is damaged. 

  • Do not use it during menstruation or in presence of any abundant vaginal discharges. 

  • Do not use the medical device in concomitance with mechanical or chemical contraceptive methods. 

  • During pregnancy, the medical device can be used only if really necessary and only under medical prescription. 

  • In case of protracted use, sensitization phenomena may occur (rarely). In that case, discontinue the treatment and consult a physician. 


PACKING CONFIGURATION 

Store the medical device protected from light, humidity and heat, below 25°C, preferably in its carton box. Keep out of the reach and sight of children. 

For single use only 

Store below 25°C 


Veganix box and instruction leaflet : 2 languages (English and French)


Each aluminium blister has 5 veganix vaginal Pessary 


Each Veganix box has 2 blisters of each containing 5 vaginal Pessary (10 vaginal Pessary) + instruction leaflet 80 boxes / carton – carton dimensions: 315 x 260 x 270 mm – Gross wt : 2,80 Kg 


50 cartons / Pallet – 80 x 120 x 130 – 165 Kg (including 25 kg tare weight of the pallet)


Shelf Life: 36 months from the date of manufacturing

For more information and inquiries, write to sugant@wanadoo.fr

 

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