KYLEENA
As listed in the register: KYLEENA
19.5 mg · insert (extended-release)
- Prescription only
- Urinary and reproductive system, hormones
- Active substance
- Levonorgestrel
- Made by
- Bayer Inc
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (Skyla). It describes the substance, not this exact product.
The local mechanism by which continuously released LNG contributes to the contraceptive effectiveness of Skyla has not been conclusively demonstrated.
Studies of Skyla and similar LNG IUS prototypes have suggested several mechanisms that prevent pregnancy: thickening of cervical mucus preventing passage of sperm into the uterus, inhibition of sperm capacitation or survival, and alteration of the endometrium.
Following absorption, LNG is extensively metabolized.
About 45% of LNG and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-03-04
Safety of the active substance
From the US prescribing label for the same active substance (Skyla). It describes the substance, not this exact product.
- The use of Skyla is contraindicated when one or more of the following conditions exist:.
- Pregnancy or suspicion of pregnancy [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.1 )].
- For use as post-coital contraception (emergency contraception).
- Congenital or acquired uterine anomaly including fibroids, that distorts the uterine cavity.
The most common adverse reactions reported (>10% users) are bleeding pattern alterations, vulvovaginitis, abdominal/pelvic pain, acne/seborrhea, headache/migraine, ovarian cyst and dysmenorrhea/uterine spasm.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
Spain1 matching products
NetherlandsNo exact match for this strength and form
Details
| Made by | Bayer Inc |
|---|---|
| Active substance | Levonorgestrel |
| Used in | Urinary and reproductive system, hormones |
| Strength | 19.5 mg |
| Form | insert (extended-release) |
| Classification | G02BA03 · Urinary and reproductive system, hormones |
| Route | intrauterine |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Marketed |
| Marketed | Yes, according to the register |
| DIN | 02459523 |
| DPD drug code | 94684 |
Source: Drug Product Database · 2026-09-30 · not reviewed by a clinician
Contains information licensed under the Open Government Licence – Canada. Reuse terms: Open Government Licence – Canada.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.