natgillin/translations-raw huggingface dataset:
The CHMP recommended new contra-indications for 20 centrally authorised medicines, and in some instances for the entire classes of centrally authorised medicines (class labelling), including: Viracept (nelfinavir mesilate): co-administration with omeprazole;
CHMP je priporočil nove kontraindikacije za 20 zdravil, za katera je bilo dovoljenje izdano po centraliziranem postopku, in v nekaterih primerih za celotne razrede zdravil, za katera je bilo dovoljenje izdano po centraliziranem postopku (oznaka razreda), med katerimi so naslednja zdravila:
Acomplia (rimonabant): ongoing major depressive illness and/or ongoing antidepressive treatment; Agenerase, Aptivus, Crixivan, Invirase, Kaletra, Norvir, Prezista, Reyataz, Telzir, Viracept (protease inhibitors): concomitant use with oral midazolam (while further directions concerning co administration with parenteral midazolam are provided in the SPC) (class labelling); Pegintron (peginterferon alpha 2b), Viraferonpeg (peginterferon alpha 2b) and Rebetol (ribavirin):
• Agenerase, Aptivus, Crixivan, Invirase, Kaletra, Norvir, Prezista, Reyataz, Telzir, Viracept (zaviralci proteaz): hkratno jemanje z midazolamom za peroralno uporabo (medtem ko so nadaljnja navodila za hkratno parenteralno jemanje midazolama na voljo v povzetku glavnih značilnosti zdravila (SPC)) (oznaka razreda);
All referrals were processed within the legal timeframe.
Vse napotitve so bile obravnavane v zakonskem roku.
Thirteen Community herbal monographs for traditional and well-established herbal medicines were finalised (aniseed, anise oil, bitter-fennel fruit, bitter-fennel-fruit oil, cascara, melissa leaf, passion flower, peppermint oil, primula root, primula flower, rhubarb, sweet-fennel fruit and thyme herb).
13 osnutkov rastlinskih monografij Skupnosti za tradicionalna in dobro uveljavljena zdravila rastlinskega izvora je bilo končanih (plod vrtnega janeža, janeževo olje, olje grenkega navadnega komarčka, krhlika Cascara, list melise, zel pasijonke, olje poprove mete, cvet trobentice, rabarbara, plod sladkega navadnega komarčka in zel timijana).
The CHMP concluded that the benefits of these medicines do not outweigh their risks and therefore recommended that the marketing authorisations for clobutinol-containing medicines be withdrawn throughout the EU (Article 107(2) procedure).
CHMP je sklenil, da koristi teh zdravil ne odtehtajo tveganj, in je zato priporočil, naj se dovoljenja za promet z zdravili, ki vsebujejo klobutinol, umaknejo po vsej EU (postopek iz člena 107(2)).
EPAR summaries for the public
Povzetki evropskih javnih poročil o oceni zdravila (EPAR) za javnost
Concerns over small number of new MRL applications
Zaskrbljenost zaradi majhnega števila novih vlog za najvišje vrednosti ostankov
The overall number of applications for variations to marketing authorisations received in 2007 was significantly higher than in 2006, in part accounted for by the greater number of centrally authorised medicines on the market.
Skupno število prejetih vlog za spremembe dovoljenj za promet z zdravilom je bilo v letu 2007 bistveno večje kot v letu 2006.
Four entries to the list were released for public consultation (aniseed, calendula flower, eleutherococcus root and purple coneflower herb).
Štirje vpisi na seznam so bili objavljeni za namene javnega posvetovanja (plod vrtnega janeža, cvet vrtnega ognjiča, korenina elevterokoka zel škrlatne ehinaceje).
2007 milestones
Mejniki v letu 2007
4.1 GMP, GCP, pharmacovigilance and GLP inspections Increased number of inspections
4.1 Inšpekcijski pregledi dobre proizvodne prakse, dobre klinične prakse, farmakovigilance in dobre laboratorijske prakse
EudraVigilance (In production)
EudraVigilance (v izdelavi)
Use of special authorisation procedures
Uporaba posebnih postopkov za izdajo dovoljenja za promet z zdravilom
EMEA/CHMP think-tank on innovative drug development: final report published
Delovna skupina agencije EMEA/Odbora za zdravila za uporabo v humani medicini o inovativnem razvoju zdravil: objavljeno je bilo končno poročilo
Public-health benefits of medicines recommended for authorisation in 2007
Koristi zdravil, za katera je bilo v letu 2007 izdano priporočilo za izdajo dovoljenja za promet z zdravilom, za zdravje ljudi
Review of mifepristone-containing medicines, following safety and efficacy concerns regarding the use of the approved 600mg dose of mifepristone, as compared to the use of a 200mg dose, in the medical termination of developing intra-uterine pregnancy in sequential use with prostaglandin analogue.
• Presoja zdravil, ki vsebujejo mifepriston, kot rezultat zaskrbljenosti glede varnosti in učinkovitosti uporabe dovoljenega odmerka 600 mg mifepristona za prekinitev maternične nosečnosti z večkratno zaporedno uporabo z analogom prostaglandina v primerjavi z uporabo odmerka 200 mg. CHMP je sklenil, da podatki, ki so na voljo, podpirajo učinkovitost 600miligramskega odmerka mifepristona, ki mu sledi uporaba analogov prostaglandina pri prekinitvi nosečnosti do 63 dni po pojavu amenoreje (izostanku menstruacije).
The CHMP concluded the risks of these medicines outweigh their benefits and recommended the suspension of the marketing authorisations (Article 107(2) procedure).
CHMP je sklenil, da tveganja teh zdravil pretehtajo njihove koristi, in je priporočil začasen umik dovoljenj za promet s temi zdravili (postopek iz člena 107(2)).
EudraPharm (In production)
EudraPharm (v izdelavi)
EudraGMP (In production)
EudraGMP (v izdelavi)
EudraNet (In production)
EudraNet (v izdelavi)
The CHMP recommended the deletion of contra-indications for 12 centrally authorised medicines, and in some instances for the entire class of centrally authorised medicines (class labelling), including: pioglitazone- (Actos, Glustin, Competact, Tandemact) and rosiglitazone- (Avandia, Avandamet,
CHMP je priporočil brisanje kontraindikacij pri 12 zdravilih, za katera je bilo dovoljenje izdano po centraliziranem postopku, in v nekaterih primerih za celotni razred zdravil, za katera je bilo dovoljenje izdano po centraliziranem postopku (oznaka razreda), vključno z naslednjimi:
initiation of treatment of hepatitis C in patients with hepatitis C and HIV co-infection who have cirrhosis and a Child-Pugh score of 6 or higher.
• Pegintron (peginterferon alfa 2b), Viraferonpeg (peginterferon alfa 2b) in Rebetol (ribavirin): začetek zdravljenja hepatitisa C pri bolnikih s hepatitisom C in hkratno okužbo s HIV, ki imajo cirozo in 6 ali več točk po Child-Pughovi lestvici.
EudraCT (In production)
EudraCT (v izdelavi)
Eighty-one PSURs were received in 2007 for centrally authorised medicines.
V letu 2007 je bilo prejetih 81 z zadnjimi podatki dopolnjenih rednih poročil o varnosti za zdravila, za katera je bilo dovoljenje za promet izdano po centraliziranem postopku.
Eudra DataWarehouse (In pre-production)
Podatkovno skladišče Eudra (v predhodni izdelavi)
General contribution
Glavne dejavnosti
However, the CHMP considered that few points merit further clarification.
Vendar je odbor CHMP menil, da nekaj točk zahteva dodatno pojasnitev.
The conditions affecting the marketing authorisations are set out in Annex IV.
Pogoji dovoljenja za promet z zdravilom, so navedeni v Prilogi IV.
The first adrenaline auto-injectors (AAI) were developed and introduced into the medical market approximately 25 years ago in the USA.
Prve samoinjektorje adrenalina so razvili in na trg zdravil v ZDA uvedli pred približno 25 leti.
Auto-injectors were invented in the 1960s following military research in the United States of America (USA).
Samoinjektorje so v 60-tih letih 20. stoletja s pomočjo vojaških raziskav izumili v Združenih državah Amerike (ZDA).
The matter was then referred to the Committee for Medicinal Products for Human Use (CHMP) for a review under Article 31 of Directive 2001/83/EC.
Zadevo so napotili na Odbor za zdravila za humano uporabo (CHMP), ki jo bo pregledal skladno s členom 31 Direktive 2001/83/ES.
The fact that 15% of mothers were unable to ‘fire' the auto-injector successfully supports that patients' training tools need to be improved and that training needs to be repeated at regular intervals.
Ker 15 % mater ni uspelo „sprožiti“ samoinjektorja, je treba izboljšati orodja za usposabljanje bolnikov in usposabljanje ponavljati v rednih presledkih.
• The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for adrenaline auto-injectors.
• odbor CHMP je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za samoinjektorje adrenalina;
The barrier of the fascia lata - the fibrous tissue surrounding the muscle - also needs to be considered.
Upoštevati je treba tudi pregrado s stegensko fascijo (fibrozno tkivo, ki obkroža mišico).
The CHMP noted the lack of clinical evidence from randomised, controlled trials, due to the logistical and ethical problems involved with conducting such trials in emergency situations, particularly with a placebo control.
Odbor CHMP je ugotovil pomanjkanje kliničnih dokazov iz randomiziranih nadzorovanih preskušanj zaradi logističnih in etičnih težav pri izvajanju takih preskušanj v nujnih primerih, predvsem s kontrolno skupino s placebom.
The main clinical data available focus on demonstrating the skin-to-muscle depth (STMD) in adults and children and the CHMP noted that there is inconsistency across the studies with some finding no correlation between STMD and Body Mass Index (BMI) or weight (Song (2005)3, Stecher (2009)4) and others finding a correlation (Bhalla (2013)5, Bewick (2013)6).
Glavni razpoložljivi klinični podatki so osredotočeni na dokazovanje globine med kožo in mišico ({i>skin-to-muscle depth,<i} STMD) pri odraslih ter otrocih, odbor CHMP pa je opazil neskladja med študijami, saj v nekaterih niso ugotovili nobene povezave med STMD in indeksom telesne mase (ITM) ali telesno maso (Song (2005)3, Stecher (2009)4), v drugih pa so odkrili povezavo (Bhalla (2013)5, Bewick (2013)6).
The CHMP agreed that proper training of both patients/carers and healthcare professionals and comprehensive educational materials are of paramount importance.
Odbor CHMP se je strinjal, da so ustrezno usposabljanje za bolnike/negovalce in zdravstvene delavce ter izčrpni izobraževalni materiali izjemno pomembni.
Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the CHMP recommends the variation to the terms of the marketing authorisation for all medicinal products referred to in Annex I and for which the amendments of the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III.
Zato je skladno s členoma 31 in 32 Direktive 2001/83/ES priporočil spremembo pogojev dovoljenj za promet z vsemi zdravili, ki so navedena v Prilogi I, skladno s spremembami ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo, opredeljenimi v Prilogi III.
Results from PK studies (Simons, 19981, 20012) support the guidelines recommendation (e.g. UK Resuscitation Guideline) that an intramuscular injection is the preferred route of administration in the treatment of anaphylaxis as a rapid response is important in ensuring a non-fatal outcome.
Rezultati FK-študij (Simons 19981, 20012) podpirajo priporočila za smernice (npr. Smernico za oživljanje Združenega kraljestva, {i>UK Resuscitation Guideline<i}), ki navajajo, da je intramuskularno injiciranje prednostna pot uporabe pri zdravljenju anafilaksije, saj je hiter odziv pomemben pri zagotavljanju nesmrtnega izida.
They were originally used for the administration in the field of atropine, the antidote to nerve agents in biological weapons.
Prvotno so se uporabljali za terensko injiciranje atropina, protistrupa za snovi v bioloških orožjih, ki delujejo na živčevje.
The STMD is only one factor affecting whether or not the adrenaline reaches the muscle layer.
STMD je samo eden izmed dejavnikov, ki vpliva na to, ali adrenalin doseže mišično plast ali ne.
A key finding of the review was that there is no robust evidence that the administration devices deliver adrenaline intramuscularly in all patients.
Ključna ugotovitev pregleda je bila odsotnost trdnih dokazov, da pripomočki za injiciranje adrenalin dovajajo intramuskularno pri vseh bolnikih.
The experts consulted unanimously agreed that a PK study in humans would be useful in order to gain information on the optimum parameters of administration; the group also noted the possibility to collect PD data in this same study.
Strokovnjaki so se soglasno strinjali, da bi bila FK-študija pri ljudeh koristna za pridobivanje informacij o optimalnih parametrih uporabe; ugotovili so tudi, da je mogoče v isti študiji zbirati tudi FD-podatke.
The CHMP acknowledged that patient/carer compliance with the use of the auto-injectors is also very important as evidenced by the study by Brown J et al (2015)7.
Odbor CHMP je upošteval, da je doslednost bolnika/negovalca pri uporabi samoinjektojev prav tako zelo pomembna, kar so v svoji študiji ugotovili Brown J in sod (2015)7.
The CHMP considered also the results of consultations with healthcare professionals, experts and the Pharmacovigilance Risk Assessment Committee (PRAC).
Prav tako je upošteval rezultate posvetov z zdravstvenimi delavci, strokovnjaki in Odborom za oceno tveganja na področju farmakovigilance (PRAC).
While these non-clinical models have demonstrated that the adrenaline is projected beyond the tip of the needle to a greater or lesser extent the CHMP was of the view that it remains questionable how representative of the human tissue these models are.
Čeprav so s nekliničnimi modeli pokazali, da adrenalin prodre dlje od konice igle v večjem ali manjšem obsegu, je odbor CHMP menil, da je še vedno vprašljivo, ali lahko te modele primerjamo s človeškim tkivom.
Most of the evidence for penetration of adrenaline into the tissue relies on non-clinical data using a gelatin model or a porcine model.
Večina dokazov za prodiranje adrenalina v tkivo temelji na nekliničnih podatkih, ki vključujejo uporabo želatinskega modela ali prašičjega modela.
Clinical Communication 7 Brown J, Tuthill D, Alfaham M et al. (2013) A randomised maternal evaluation of epinephrine autoinjection devices.
Klinična dokumentacija 7 Brown J, Tuthill D, Alfaham M et al. (2013) A randomised maternal evaluation of epinephrine autoinjection devices.
The CHMP also recommended further risk minimisation measures, including educational materials, to be submitted and agreed via risk management plans.
Odbor CHMP je priporočil tudi dodatne ukrepe za zmanjševanje tveganja, vključno z izobraževalnimi gradivi, ki jih je treba predložiti in odobriti prek načrtov obvladovanja tveganja.
However, there is insufficient evidence to ensure, even under optimal circumstances, IM delivery of adrenaline to all patients with the currently available auto-injectors authorised in the EU and, even if the medicine is delivered IM, that exposure from a single injection will be sufficient.
Vendar ni zadostnih dokazov, da je, celo v optimalnih okoliščinah s trenutno razpoložljivimi samoinjektorji, odobrenimi v EU, intramuskularno injiciranje adrenalina zagotovljeno vsem bolnikom, in da tudi, če se zdravilo daje intramuskularno ni nujno, da bo eno injiciranje zadostno.
Until these uncertainties can be resolved, there is a need for more definitive evidence in humans of the speed and extent of delivery of adrenaline into the circulation following use of different adrenaline auto-injectors, from which it may be possible to infer site of delivery.
Dokler te negotovosti ne bodo razrešene, je treba pridobiti več gotovih dokazov pri človeku glede hitrosti in obsega dovajanja adrenalina v krvni obtok po uporabi različnih samoinjektorjev adrenalina, na podlagi katerih bi bilo mogoče zanesljivo določiti mesto dovajanja.
Training and education of both patients/carers and healthcare professionals was considered of paramount importance.
Ključnega pomena sta usposabljanje in izobraževanje bolnikov/negovalcev in zdravstvenih delavcev;
Published clinical data indicate that the rate of absorption is prolonged if the adrenaline is delivered subcutaneously (SC).
Objavljeni klinični podatki kažejo, da je hitrost absorpcije podaljšana, če se adrenalin daje subkutano.
The efficacy of adrenaline in the treatment of anaphylaxis is well-supported by anecdotal and retrospective evidence.
Učinkovitost adrenalina pri zdravljenju anafilaksije je dobro podprta z anekdotičnimi in retrospektivnimi dokazi.
The PRAC considered that there were no identified data sources that would permit a formal epidemiological approach for assessing actual usage or device failure of adrenaline auto-injectors in the EU.
Odbor PRAC ni ugotovil nobenih podatkovnih virov, ki bi omogočali uraden epidemiološki pristop pri ocenjevanju dejanske uporabe ali odpovedi samoinjektorjev adrenalina v EU.
The educational materials include but are not limited to a training device, instructional audio-visual material and a checklist for prescribers aiming to facilitate the discussion between the prescriber and the patient and to provide sufficient information on the optimal way of use, administration and storage of the product.
Izobraževalna gradiva med drugim vključujejo pripomoček za usposabljanje, avdiovizualno gradivo in kontrolne sezname za predpisovalce, ki omogočajo posvet med predpisovalcem ter bolnikom in vsebujejo dovolj informacij za optimalni način uporabe, injiciranja in shranjevanja zdravila.
Adrenaline auto-injectors are indicated in the emergency treatment of severe allergic reactions (anaphylaxis) to e.g. insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise-induced anaphylaxis.
Samoinjektorji adrenalina so indicirani za nujno zdravljenje hudih alergijskih reakcij (anafilaksije) na npr. pike ali ugrize insektov, hrano, zdravila in druge alergene ter idiopatske in s telesno vadbo izzvane anafilaksije.
The use of adrenaline to treat anaphylaxis is established as the recommended first-line treatment.
Uporaba adrenalina za zdravljenje anafilaksije je uveljavljena kot priporočeno zdravljenje prve izbire.
The needle length is another factor and the UK Resuscitation Council Guidelines do suggest a 25mm needle is optimal for intramuscular injection; however the CHMP noted that these guidelines are written for use in the hospital setting where healthcare professionals will generally inject the adrenaline using a manual needle and syringe, not an auto-injector.
Drugi dejavnik je dolžina igle in Smernice odbora Združenega kraljestva za oživljanje navajajo, da je igla dolžine 25 mm optimalna za intramuskularno injiciranje, vendar je odbor CHMP opazil, da so te smernice napisane za uporabo v bolnišničnem okolju, kjer zdravstveni delavci adrenalin navadno injicirajo ročno z iglo ter injekcijsko brizgo in ne s samoinjektorjem.
The safety of adrenaline is also well-established, and it has demonstrated a particularly strong safety profile with intramuscular (IM) administration.
Varnost adrenalina je prav tako dobro uveljavljena, zelo dober varnostni profil pa so dokazali pri intramuskularnem injiciranju.
Variability in skin-to-muscle depth (STMD), gender, needle length and the device mechanism itself are important factors which determine whether the route of delivery is IM or SC.
Spremenljivost globine med kožo in mišico, spol, dolžina igle in mehanizem pripomočka so pomembni dejavniki, ki določajo, ali bo injiciranje intramuskularno ali subkutano.
The CHMP sought the advice of experts on the feasibility of conducting imaging or PK studies or any other trials or tests that could be performed as well as the advice of the PRAC on potential databases or other data sources that might hold information on actual device usage.
Odbor CHMP se je posvetoval s strokovnjaki glede možnosti izvedbe študij s slikanjem ali FK-študij ali katerih koli drugih preskušanj ali preiskav in odborom PRAC glede morebitnih podatkovnih zbirk ali drugih podatkovnih virov, ki bi lahko vsebovali informacije o dejanski uporabi pripomočka.
The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) undertook a review of all authorised adrenaline auto-injectors to evaluate the most effective site for injection, the clarity of instructions for use as well as the most appropriate auto-injector needle length for ensuring intramuscular (IM) delivery of the adrenaline injection.
Regulativna agencija za zdravila in medicinske pripomočke Združenega kraljestva (MHRA) je pregledala vse odobrene samoinjektorje adrenalina, da bi ocenila najučinkovitejše mesto injiciranja, jasnost navodil za uporabo in najprimernejšo dolžino igle v samoinjektorju za zagotavljanje intramuskularnega injiciranja adrenalina.
Other factors such as the mechanism of action (spring loaded or not) and method of administration (swing and jab or place and press) of the device, the angle of placement on the skin and the force used to activate the device also play a part.
Pri tem imajo vlogo tudi drugi dejavniki, kot so mehanizem delovanja (vzmeteni ali ne), način uporabe pripomočka (zamah in vbod ali namestitev in pritisk), kot namestitve na kožo in sila, ki se uporabi za aktivacijo pripomočka.
The CHMP noted the inconsistency amongst studies as to the part played by compression of the tissue.
Odbor CHMP je ugotovil neskladja med študijami glede vloge, ki jo ima stisnjenje tkiva.
Some investigators are of the opinion that even when the needle length is shorter than the STMD, IM injection is still possible as the physical compression of subcutaneous tissue by the force of the device can help to overcome the deficit in needle length.
Nekateri raziskovalci menijo, da je intramuskularno injiciranje mogoče kljub krajši dolžini igle od STMD, saj lahko fizikalna kompresija podkožnega tkiva s silo pripomočka pomaga pri kompenzaciji za prekratko iglo.
On the other hand, other investigators express an opinion that compression may preferentially involve muscle rather than subcutaneous tissue and therefore the needle deficit is not overcome by compression.
Drugi raziskovalci pa menijo, da lahko kompresija vključuje predvsem mišico in ne podkožnega tkiva, zato kompresija ne kompenzira za prekratko iglo.
If IM delivery is insufficient with one injection, administration of a second injection is recommended.
Če je enkratno intramuskularno injiciranje nezadostno, se priporoča še eno injiciranje.
• The CHMP considered that there are multiple factors that may affect whether adrenaline is delivered to the muscle or the subcutaneous tissue when an adrenaline auto-injector is used such as the needle length, the mechanism of action of the device, the angle of placement on the skin, the force used to activate the device and the patient/carer compliance.
• odbor CHMP je menil, da je prisotnih več faktorjev, ki lahko vplivajo na to, ali se ob uporabi samoinjektorja adrenalin dovaja v mišico ali podkožno tkivo, kot so dolžina igle, mehanizem delovanja pripomočka, kot namestitve na koži, sila pri aktivaciji pripomočka in bolnikova/negovalčeva doslednost.
The CHMP has considered the totality of the available non-clinical and clinical evidence on the delivery of adrenaline from adrenaline auto-injectors and on whether the product information contains clear and detailed instructions for appropriate use.
Odbor CHMP je pretehtal vse razpoložljive neklinične in klinične dokaze o dovajanju adrenalina s samoinjektorji ter presodil, ali informacije o zdravilu vsebujejo jasna in podrobna navodila za pravilno uporabo.
The CHMP noted that generally there is a large degree of consistency between the product information for the different auto-injectors in particular as regards main messages such as to seek emergency medical assistance immediately after a single administration, the use with caution in certain patient populations and that adrenaline should be administered intramuscularly in order to maximise the possibility of a positive outcome in the treatment of anaphylaxis.
Odbor CHMP je menil, da so informacije o zdravilih za različne samoinjektorje pretežno skladne, predvsem glede glavnih sporočil, kot so, naj bolnik po enem injiciranju takoj poišče zdravniško pomoč, previdna uporaba pri nekaterih skupinah bolnikov in nujnost intramuskularnega injiciranja adrenalina, da se čim bolj poveča možnost pozitivnega izida pri zdravljenju anafilaksije.