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instruktioner for dispensering af radioaktive lÆgemidler
instructions for preparation of radiopharmaceuticals

dispensering fra forordning (ef) nr. 966/2012
derogation from regulation (eu) no 966/2012

nedenstående retningslinjer for dispensering og opbevaring er specifikke for aldesleukin.
the dispensing and storage directions below are specific to aldesleukin.

(2) dispensering for krav om legalisering af dokumenter mellem medlemsstater
(2) dispensing with the formalities for the legalisation of documents between member states

nationale eller andre specifikke måder til ordination og dispensering af erivedge
national or other applicable specific arrangements for a prescription for erivedge to be dispensed

dispensering af fortyndet il-2 (aldesleukin) til den enkelte patient
dispensing of dilute il-2 (aldesleukin) for each patient

bemærk: dispensering af aldesleukin skal udføres under kontrollerede aseptiske forhold.
note: dispensing of aldesleukin must be carried out under controlled aseptic conditions.

for at opnå en tilstrækkelig mængde til nøjagtig dispensering indeholder hvert hætteglas en overfyldning på 0,3 ml.
to provide sufficient volume to allow accurate dispensing, each vial is formulated to contain an overfill of 0.3 ml.

for at opnå en tilstrækkelig mængde til nøjagtig dispensering indeholder hvert hætteglas med thyrogen en overfyldning på 0,2 ml.
to provide sufficient volume to allow accurate dispensing, each vial of thyrogen is formulated to contain an overfill of 0.2 ml.

medlemsstaterne fastsætter de nærmere bestemmelser for dispensering i henhold til artikel 13 og 14, herunder alternative hensigtsmæssige foranstaltninger og betingelser.
member states shall draw up detailed rules for granting derogations, as provided for in articles 13 and 14, including alternative appropriate measures and conditions.

for mig er det vigtigt at opnå en gensidig anerkendelse af registreringer og godkendelser i medlemslandene i den europæiske union og at udvide anvendelsesformerne til parenteral dispensering med be-
in my view, mutual recognition of registrations and authorisations in the member states of the european union is important, as is extending the forms of use to parenteral administration,

det er vigtigt med omhyggelig rengøring af alt glasudstyr, kanyler osv., der anvendes til dispensering af det radioaktivt mærkede stof, for at sikre at det er uden spormetalurenheder.
it is important that all glassware, syringe needles etc, used for the preparation of the radiolabelled compound are thoroughly cleaned to ensure freedom from such trace metal impurities.

for mig er det vigtigt at opnå en gensidig anerkendelse af registreringer og godkendelser i medlemslandene i den europæiske union og at udvide anvendelsesformerne til parenteral dispensering med bevarelse af allerede gældende strenge afprøvningsbetingelser vedrørende kvalitet og sikkerhed for forbrugeren.
in my view, mutual recognition of registrations and authorisations in the member states of the european union is important, as is extending the forms of use to parenteral administration, while adhering to the stringent conditions governing quality and safety tests for the consumer which are already in force now.

der skal udvises særlig opmærksomhed ved nøjagtig beregning af norvir-dosis, overførsel af medicinordinationer, information om dispensering og doseringsinstruktioner for at minimerer risikoen for medicineringsfejl og overdosering.
special attention should be given to the accurate calculation of the dose of norvir, transcription of the medication order, dispensing information and dosing instructions to minimize the risk for medication errors and overdose.

dispensering og fordøjelse begynder automatisk, når der trykkes på blenderens startknap, efterfulgt af filtrering. efter 10-13 minutter er processen fuldført, og den stopper automatisk.
when the start button on the blender is turned on, the process of dispensing and digestion starts automatically, followed by filtration after 10 to 13 minutes the process is completed and stops automatically.

medlemsstaterne fastsætter de nærmere bestemmelser for dispensering i henhold til stk. 1, idet de tager hensyn til, hvilke dyresundhedsmæssige garantier der kan opnås, og fastlægger alternative hensigtsmæssige foranstaltninger.
member states shall draw up detailed rules for applying the derogations provided for in paragraph 1, taking account of the animal health guarantees which may be obtained and shall provide for alternative appropriate measures.

medlemsstaterne fastsætter de nærmere bestemmelser for dispensering i henhold til stk. 1 og 3, idet de tager hensyn til, hvilke dyresundhedsmæssige garantier der kan opnås, og fastlægger alternative hensigtsmæssige foranstaltninger.
member states shall draw up detailed rules for applying the derogations provided for in paragraphs 1 and 3, taking account of the animal health guarantees which may be obtained and shall provide for alternative appropriate measures.

vores gruppe går ligeledes ind for- men det har mine kolleger også allerede sagt- betingelserne for anvendelse, skader fra 1 milliard euro eller 0,5% af bnp, 50%' s omgående udbetaling, tre måneders frist for indsendelse af ansøgninger, muligheder for dispensering for særligt hårdt ramte regioner.
in the same way, as my fellow members have already said, we are also, as a group, in favour of applying them to damage in excess of eur 1 billion or 0.5% of gdp, 50% to be paid out at once, a three-month deadline for submission of applications, and the possibility of derogations for regions that are particularly severely affected.