AIRING is a type of hormonal insert that is placed in the vagina for the purpose of birth control.
The drug product is composed of a core of ethylene-vinyl acetate copolymer (28% vinyl acetate, EVA28) containing 11.7 mg of etonogestrel (ENG) and 2.7 mg of ethinylestradiol (EE); surrounded by a membrane of ethylene-vinyl acetate copolymer (9% vinyl acetate, EVA9) that regulates the diffusion of the two hormones in the vaginal cavity. When placed in the vagina, the ring releases etonogestrel and ethinylestradiol at an average amount of 0.120 mg and 0.015 mg respectively per 24 hours, over a period of 3 weeks.
The contraceptive effect of Etonorgestrel/Ethinylestradiol 0.120 mg/0.015 mg per 24 hours, the vaginal delivery system is based on various mechanisms, the most important of which is the inhibition of ovulation.
It is a progressive method of contraception that uses the vaginal route of hormone administration. In this case, hormones do not pass through the digestive tract, there is no primary passage through the liver. Vaginal administration of hormones with a constant release of a well-defined low dose of hormones provides a stable hormonal background without peaks and drops during the day, which gives a more regular cycle compared to even tablets containing 15 mcg of Ethinylestradiol. Also, the vaginal route of administration ensures the confidentiality of the method.
Method of use: AIRING is for intravaginal usage. Each ring is to be used for one cycle; a cycle consists of 3 weeks of ring use followed by a one-week ring-free interval.
Age: AIRING is designed for women of childbearing age for contraception. *Full version of SmPC and PIL will be placed after obtaining the Marketing Authorization.
Marketing Authorisation Holder: Aicore Life Sciences B.V. Boxbergerweg 119, 7431 PM Diepenveen, the Netherlands Tel.: +31611923166, e-mail: firstname.lastname@example.org
Manufacturer: Mithra Pharmaceuticals CDMO S.A. Zoning de l’Arbre Saint-Michel, Rue de l’Expansion, 57, 4400 Flemalle, Belgium