Zitat von European Medicines AgencyAlles anzeigenThe CHMP
noted that efficacy and safety of EMLA in the paediatric population has not indisputably been demonstrated and was of the view that
information regarding the non-recommendation
for the use of EMLA on genital skin for children is missing and should
also be introduced in section 4.2,
4.4
and 5.1.
The paediatric work sharing SE/W/008/pdWS/001 Assessment Report also
states that the available data on the use
of EMLA for circumcision demonstrate insufficient analgesic efficacy for this indication
thus deletion of a respective wording
in section 4.4 as proposed by the MAH was supported. The non-recommendation
for circumcision was introduced in section
s 4.2
, 4.4 and 5.1.
Zitat von European Medicines AgencySafety and efficacy for the use of EMLA on genital skin and genital mucosa have not been established in children younger than 12 years. Available paediatric data do not demonstrate adequate efficacy for circumcision.
http://www.ema.europa.eu/docs/en_GB/doc…WC500180464.pdf
Und was behauptet die englischsprachige Wikipedia, Stichwort "Emla"?
Zitat von WikilügiaCircumcision
Lidocaine/prilocaine eutectic mixture is used during circumcision in newborn boys and is considered efficacious and safe for the prevention of pain from circumcision.
Mit Verweis auf - tätä! - die berüchtigte unethische Taddio-Kinderquäl-Studie "Sponsored by Hersteller"
"efficacious", sicherlich. Aber nur für Astra, nicht für die kleinen Jungen.
"Prevention" ist so was von dreist. Natürlich kann Emla keine Schmerzen verhindern. Die Babys brüllen ja auch bei Applikation der Alibi-Salbe.