NEXPLANON Implant (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Nexplanon, 68 mg, implant for subdermal use.
Qualitative and quantitative composition
Nexplanon is a radiopaque, non-biodegradable, progestagen-only, flexible implant preloaded in a sterile, disposable applicator. Each radiopaque implant contains 68 mg of etonogestrel; the release rate ...
Pharmaceutical form
Implant for subdermal use. Radiopaque, non-biodegradable, white to off-white, soft, flexible rod with a length of 4 cm and 2 mm in diameter.
Therapeutic indications
Contraception. Safety and efficacy have been established in women between 18 and 40 years of age.
Posology and method of administration
Posology 1 implant, which can be left in place for three years. Paediatric population The safety and efficacy of Nexplanon in adolescents under the age of 18 have not been established. Method of administration ...
Contraindications
Active venous thromboembolic disorder. Known or suspected sex steroid sensitive malignancies. Presence or history of liver tumours (benign or malignant). Presence or history of severe hepatic disease as ...
Special warnings and precautions for use
If any of the conditions/risk factors mentioned below is present, the benefits of progestagen use should be weighed against the possible risks for each individual woman and discussed with the woman before ...
Interaction with other medicinal products and other forms of interaction
Note: The prescribing information of concomitant medications should be consulted to identify potential interactions. Effects of other medicinal products on Nexplanon Interactions can occur with drugs that ...
Pregnancy and lactation
Pregnancy Nexplanon is not indicated during pregnancy. If pregnancy occurs during use of Nexplanon, the implant should be removed. Animal studies have shown that very high doses of progestagenic substances ...
Effects on ability to drive and use machines
On the basis of the pharmacodynamic profile, Nexplanon is expected to have no or negligible influence on the ability to drive or use machines.
Undesirable effects
During the use of Nexplanon, women are likely to have changes in their menstrual bleeding pattern which are unpredictable beforehand. These may include the occurrence of an irregular bleeding pattern (absent, ...
Overdose
An implant should always be removed before inserting a new one. There are no data available on overdose with etonogestrel. There have been no reports of serious deleterious effects from an overdose of ...
Pharmacodynamic properties
Pharmacotherapeutic group: Hormonal Contraceptives for Systemic Use, progestagens ATC code: G03AC08 Mechanism of action The Nexplanon implant is a non-biodegradable, radiopaque, etonogestrel-containing ...
Pharmacokinetic properties
Absorption After the insertion of the implant, etonogestrel is rapidly absorbed into the circulation. Ovulation-inhibiting concentrations are reached within 1 day. Maximum serum concentrations (between ...
Preclinical safety data
Toxicological studies did not reveal any effects other than those, which can be explained on the basis of the hormonal properties of etonogestrel, regardless of the route of administration.
List of excipients
Implant Core: Ethylene vinyl acetate copolymer (28% vinyl acetate, 43 mg) Barium sulfate (15 mg) Magnesium stearate (0.1 mg) Skin: Ethylene vinyl acetate copolymer (15% vinyl acetate, 15 mg)
Incompatibilities
Not applicable.
Shelf life
5 years. Nexplanon should not be inserted after the expiry date as indicated on the primary package.
Special precautions for storage
This medicinal product does not require any special storage conditions. Store in the original blister package.
Nature and contents of container
The blister pack contains one implant (4 cm in length and 2 mm in diameter) which is preloaded in the stainless steel needle of a ready-for-use, disposable, sterile applicator. The applicator containing ...
Special precautions for disposal and other handling
See section 4.2. The applicator is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
Marketing authorization number(s)
PL 00025/0563
Date of first authorization / renewal of the authorization
9 June 1999 / 22 August 2013
Date of revision of the text
28 October 2019
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