Rx Item-Skyla 14Mcg 24Hr Kit 1 By Theracom Bayer

SKYLA- levonorgestrel intrauterine device
Bayer HealthCare Pharmaceuticals Inc.
1 INDICATIONS AND USAGE

Skyla� is indicated to prevent pregnancy for up to 3 years.

The system should be replaced after 3 years if continued use is desired.
2 DOSAGE AND ADMINISTRATION

Skyla contains 13.5 mg of levonorgestrel (LNG) released in vivo at a rate of approximately 14 mcg/day after 24 days. This rate decreases progressively to 5 mcg/day after 3 years. The average in vivo release rate of LNG is approximately 6 mcg/day over a period of 3 years.

Skyla must be removed by the end of the third year and can be replaced at the time of removal with a new Skyla if continued contraceptive protection is desired.

Skyla is supplied within an inserter in a sterile package (see Figure 1) that must not be opened until required for insertion [see Description (11)]. Do not use if the seal of the sterile package is broken or appears compromised. Use strict aseptic techniques throughout the insertion procedure.
DOSAGE FORMS AND STRENGTHS

Skyla is a LNG-releasing IUS consisting of a T-shaped polyethylene frame with a steroid reservoir containing a total of 13.5 mg LNG.

RX ITEM-Skyla 14Mcg 24Hr Kit 1 By Therac
NDC 50419-0422-01 UPC/GTIN No.3-50419-42201-7 Mfg.Part No.42201

Skyla 14Mcg 24Hr Kit 1 By Theracom Bayer
BRAND: SKYLA NDC: 50419-0422-01,50419042201 UPC: 3-50419-42201-7,350419422017 Theracom/Bayer

LEVONORGESTREL INTRAUTERI
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