JADELLE Implant (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
1. Name of the medicinal product
JADELLE levonorgestrel 2 75 mg subcutaneous implants.
2. Qualitative and quantitative composition
JADELLE consists of two implants to be inserted subdermally. Each implant contains 75 mg levonorgestrel. The release rate of levonorgestrel is about 100 microgram/day at one month after insertion, declining ...
3. Pharmaceutical form
Subcutaneous implant. The implants are flexible, sealed, white to off-white rods, about 43 mm in length and 2.5 mm in diameter.
4.1. Therapeutic indications
Contraception.
4.2. Posology and method of administration
For subcutaneous use. JADELLE is a contraceptive method for long-term (up to five years) use (see Special warnings and precautions for use). Insertion and Removal/Replacement The patient must be informed ...
4.3. Contraindications
Hypersensitivity to levonorgestrel or any other component of JADELLE. Known or suspected pregnancy. Active venous thromboembolic disorder. Presence or history of severe hepatic disease as long as liver ...
4.4. Special warnings and precautions for use
Warnings Clinical trials have shown the contraceptive efficacy of JADELLE implants to decrease after the fourth year of use. Consequently, the removal of JADELLE implants and their change into new implants ...
4.5. Interaction with other medicinal products and other forms of interaction
Effects of other Medicines on JADELLE Interactions can occur with medicines that induce microsomal enzymes, which can result in increased clearance of sex hormones and which may lead to changes in the ...
4.6. Pregnancy and lactation
Pregnancy The implants should be removed if pregnancy occurs during treatment with JADELLE. Extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to ...
4.7. Effects on ability to drive and use machines
No effects on the ability to drive and use machines have been observed.
4.8. Undesirable effects
The following undesirable effects have been reported during clinical trials with JADELLE: Very common undesirable effects (occurring in more than 10% of users): headache, nervousness, dizziness, nausea, ...
4.9. Overdose
There is no experience of overdose with JADELLE. For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).
5.1. Pharmacodynamic properties
The active ingredient in JADELLE implants, levonorgestrel, is a synthetic progestogen. Levonorgestrel released from JADELLE has been shown to affect ovarian function in various ways, ranging from absence ...
5.2. Pharmacokinetic properties
The only active ingredient in JADELLE is levonorgestrel, a progestogen. The implants are inserted subdermally, and they have been shown to provide effective contraception over the intended five years lifetime ...
5.3. Preclinical safety data
The toxicity profile of levonorgestrel is well-established and reveals no particular human health risks beyond those discussed in the Data Sheet. Mutagenicity and biocompatibility testing gave no indication ...
6.1. List of excipients
Silicone elastomers Colloidal anhydrous silica
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
60 Months.
6.4. Special precautions for storage
Store below 30°C.
6.5. Nature and contents of container
The sterile implants are packed in a moulded polyethylene terephtalate blister package sealed with a coated, spunbonded polyethylene film. If the seam of the sterile package is broken, the product should ...
6.6. Special precautions for disposal and other handling
No special requirements. Any unused medicine or waste material should be disposed of in accordance with local requirements. Instructions for Use / Handling Information on insertion and removal is provided ...
7. Marketing authorization holder
Bayer New Zealand Limited, P O Box 2825, Shortland Street, Auckland 1140, New Zealand Free phone 0800 233 988 www.bayer.co.nz
9. Date of first authorization / renewal of the authorization
Date of first approval: 9 September 2015
10. Date of revision of the text
21 September 2020
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