natgillin/translations-raw huggingface dataset:
Leaving the sponges in the tray, UNIFORMLY distribute onto each sponge 1.4 ml dibotermin alfa (rhBMP-2) solution as shown in the illustration (Figure 2).
ENAKOMERNO nanesite 1,4 ml raztopine dibotermina alfa (rhBMP-2) na vsako od obeh gobic kot je prikazano na spodnji shemi (Slika 2).
MARKETING AUTHORISATION HOLDER
Datum podaljšanja dovoljenja za promet:
Following placement, achieve complete soft-tissue coverage of the prepared sponges.
Po implantaciji poskrbite, da pripravljeno gobico popolnoma prekrijete z mehkim tkivom.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
Two sterile 3 ml disposable polypropylene syringes with stainless steel needles attached.
Komplet vsebuje tudi: dve sterilni 3-ml polipropilenski injekcijski brizgi za enkratno uporabo s pritrjeno iglo iz nerjavečega jekla eno sterilno 6-ml polipropilensko injekcijsko brizgo za enkratno uporabo s pritrjeno iglo iz nerjavečega jekla
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega razlitja po koži ali v oči nemudoma sperite.
These swellings are the result of local proliferation of mesenchymal tissue maturing to new bone and are consistent with the pharmacologic activity of rhBMP-2
- povečan nastanek kostnih cist in cist, napolnjenih s tekočino, ki se s časom spremenijo v normalno kostnino - močnejšo oteklino na mestu implantacije so opazili 2-3 tedne po operaciji; otekline so posledica lokalne proliferacije mezenhima, ki zori v novo kostnino, kar je v skladu s farmakološkim delovanjem rhBMP-2.
SOLVENT VIAL LABEL
NALEPKA ZA VIALO Z LIOFILIZATOM
Gently swirl
Resni šepanje
TruScient should only be administered to the fracture site with utmost care.
TruScient skrbno namestite na mesto zloma.
White lyophilisate and a clear colourless solvent.
Bel liofilizat in bister brezbarven vehikel.
Seroma, excessive licking of incision area, joint stiffness, local swelling, skin ulcer, incisional discharge, incisional dehiscence.
Pogosti (pojavijo se pri več kot 1 živali, vendar pri manj kot 10 od 100 živali ) Blagi do zmerni serom, močno lizanje območja rane, otrdelost sklepov, lokalna oteklina, kožna razjeda, izcedek iz rane, dehiscenca rane mehka oteklina, ki na splošno izgine do 6. tedna po operaciji
The two important criteria were:
Dve pomembni merili sta bili:
CHMP's position
Stališče CHMP
Therefore the clinical conclusions should remain the same.
Iz tega razloga ostanejo klinični zaključki nespremenjeni.
Any argumentation based on the data generated at the contract laboratory is inappropriate in view of the number and seriousness of deficiencies.
Vsakršno utemeljevanje na podlagi podatkov, pridobljenih v pogodbenem laboratoriju, je neustrezno z vidika števila in resnosti pomanjkljivosti.
Revalidation of the testosterone method confirmed the confidence in the reliability of the results obtained earlier.
Ponovna validacija testosteronske metode je potrdila zaupanje v zanesljivost predhodno pridobljenih rezultatov.
It needs to be emphasized that the unique small (n=40) pharmacodynamic study performed by the sponsor is meant to substitute for a full clinical development.
Treba je poudariti, da je namen enolične majhne (n = 40) farmakodinamične študije, ki jo izvede sponzor, nadomestiti celoten klinični razvoj.
Data generated and reported in connection with these two studies had to be classified as not credible.
Podatki, ki so bili pridobljeni in o katerih so poročali v povezavi s tema dvema študijama, so bili označeni kot neverodostojni.
• testosterone levels below castration for both products.
• ravni testosterona pod kastracijo pri obeh zdravilih.
Overall, the value and reliability of a retrospective method-validation more than five years after end of GOS/001 and more than two years after end of GOS/002 is highly questionable.
V splošnem sta vrednost in zanesljivost retrospektivne validacije metode več kot pet let po zaključku GOS/001 in več kot dve leti po zaključku GOS/002 zelo sporni.
Considering the above, the CHMP is of the opinion that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
Ob upoštevanju zgoraj navedenega CHMP meni, da informacije, predložene v podporo vlogi, niso v skladu s členom 10 Direktive 2001/83/ES, kakor je bila spremenjena.
During the GCP inspection 19 findings were identified, of which 9 were classified as critical, 7 as major, and 3 as minor.
Po pregledu dobre klinične prakse so oblikovali 19 ugotovitev, od katerih je bilo 9 kritičnih, 7 pomembnih in 3 manj pomembne.
It is an LHRH agonist (analogue of the natural luteinizing hormone-releasing hormone) and suppresses the serum testosterone to castration level to inhibit the growth of hormone-depending prostate carcinoma.
Je agonist LHRH (analog naravnega luteinizirajočega hormona za sproščanje hormonov) in zmanjša raven testosterona v serumu na raven kastracije, s čimer zavira rast hormonsko odvisnega raka prostate.
Goserelin is among others, authorised for patients with advanced prostate cancer where an endocrine treatment is indicated.
Goserelin je med drugim odobren za bolnike z napredovalim rakom prostate, pri katerih je indicirano endokrino zdravljenje.
The main objective of a method validation is to demonstrate the reliability of a particular method for the determination of an analyte concentration in a specific bioanalytical matrix and should appropriately be performed before analysis of study/subject samples.
Glavni cilj validacije metode je dokazati zanesljivost določene metode za določanje koncentracije analita v specifični bioanalitični matrici, kar je treba ustrezno izvajati pred analizo vzorcev študije/snovi.
These included insufficient validation of the bioanalytical methods, deletion of raw data by re-injection of samples, inconsistent manual reintegration of chromatograms, lack of crucial acceptance criteria for analyses and an insufficient quality management by the sponsor.
Med te kršitve sodijo nezadostna validacija bioanalitičnih metod, brisanje surovih podatkov s ponovnim injiciranjem vzorcev, nedosledna ročna ponovna integracija kromatogramov, pomanjkanje bistvenih meril sprejemljivosti analiz ter nezadostno upravljanje kakovosti, ki ga opravi sponzor.
The Committee further considers that it is not possible, on the basis of the data submitted in support of this application, to establish a positive benefit-risk balance for this product and that, in these circumstances, the marketing of the product constitutes a risk to public health.
Odbor tudi meni, da na podlagi podatkov, predloženih v podporo tej vlogi, ni mogoče vzpostaviti pozitivnega razmerja med tveganji in koristmi za to zdravilo in da v tej okoliščinah trženje zdravila pomeni tveganje za javno zdravje.
The magnitude of deviation of results from actual serum concentration cannot be estimated.
Obsega odstopanja rezultatov od dejanske koncentracije v serumu ni mogoče oceniti.
Important aspects such as the difficulty of endogeneous testosterone levels in female blank plasma were only considered in the retrospective validation report with additional testing on either pre-treated or pre-selected matrix.
Pomembni vidiki, kot so težave z endogenimi ravnmi testosterona v osnovni plazmi žensk, so bili obravnavani le v poročilu o retrospektivni validaciji z dodatnim preskušanjem na predhodno zdravljeni ali predhodno izbrani matrici.
Since testosterone levels measured were either below or close to limit of quantitation (0.1 ng/ml) and clearly below the castration level of 0.5 ng/ml clinical efficacy is ensured even if the analytical method is not sufficiently precise.
Ker so bile izmerjene ravni testosterona pod mejo kvantifikacije ali blizu nje (0,1 ng/ml) in bistveno pod kastracijsko ravnjo 0,5 ng/ml, je klinična učinkovitost zagotovljena, tudi če analitična metoda ni dovolj natančna.
Overall summary of the scientific evaluation of Goserelin cell pharm 3,6 mg Implantat and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Goserelin cell pharm 3,6 mg Implantat in z njim povezanih imen (glejte Dodatek I)
It was the aim of the inspection to verify whether the clinical studies GOS/001/C and GOS/002/C were conducted in compliance with GCP and applicable regulations and whether the validity and quality of the submitted data are adequate.
Namen pregleda je bil preveriti, ali sta bili klinični študiji GOS/001/C in GOS/002/C izvedeni v skladu z dobro klinično prakso in veljavnimi predpisi ter ali sta veljavnost in kakovost predloženih podatkov ustrezni.
During the evaluation of the marketing authorisation application of some goserelin-containing medicinal products inconsistencies were recognised (e.g. assignment of patients to blood samples unclear).
Med vrednotenjem vloge za pridobitev dovoljenja za promet z nekaterimi zdravili, ki vsebujejo goserelin, so bile odkrite neskladnosti (npr. nejasna merila za razvrščanje bolnikov pri vzorčenju krvi).
The performance of a GCP-valid clinical and bioanalytical study is required to support application under such legal basis.
Izvedba klinične in bioanalitične študije v skladu z dobro klinično prakso je potrebna v podporo vlogi na takšni pravni podlagi.
• comparable AUC of testosterone after sufficient treatment days for MAH's product and comparator
• primerljiva vrednost AUC testosterona po zadostnem številu dni zdravljenja z zdravilom imetnika dovoljenja za promet z zdravilom in primerjalnim zdravilom;
• The Committee agreed that the bioanalytical studies submitted by the MAHs were not conducted in accordance with GCP as required by Annex I of Directive 2001/83/EC as amended and the nature of the findings is such that the conduct of the studies and their results cannot be relied on to maintain the marketing authorisation.
• Odbor se je strinjal, da bioanalitične študije, ki so jih predložili imetniki dovoljenja za promet z zdravilom, niso bile izvedene v skladu z dobro klinično prakso, kot določa Priloga I Direktive 2001/83/ES, kakor je bila spremenjena, ugotovitve pa so takšne, da se glede ohranitve dovoljenja za promet z zdravili ni mogoče zanesti na izvedbo študij in na njihove rezultate.
• The Committee considered the referral triggered under Article 36 of Directive 2001/83/EC for Goserelin cell pharm 3,6 mg Implantat and associated names as listed in Annex I.
• Odbor je upošteval napotitveni postopek, sprožen v skladu s členom 36 Direktive 2001/83/ES, za zdravilo Goserelin cell pharm 3,6 mg Implantat in povezana imena, kot določa Priloga I.
The contract laboratory performed the analysis of the plasma samples for the clinical studies GOS/001/C and GOS/002/C.
V pogodbenem laboratoriju je bila izvedena analiza vzorcev plazme iz kliničnih študij GOS/001/C in GOS/002/C.
Scientific conclusions and grounds for suspension of the marketing authorisation(s) presented by the EMA
Znanstveni zaključki in podlaga za začasni umik dovoljenj(a) za promet z zdravilom, ki jih je predstavila Evropska agencija za zdravila
In view of the number and the seriousness of the deficiencies, the extent of deviations of the measured serum concentrations of both, goserelin and testosterone from the actual concentrations, cannot be estimated.
Glede na število in resnost pomanjkljivosti ni mogoče oceniti razsežnosti odstopanja izmerjenih koncentracij goserelina in testosterona v serumu od dejanskih koncentracij.
In view of all these facts the MAH requested the CHMP to confirm the acceptability of the existing clinical package for goserelin and maintain the marketing authorization for the concerned products.
Ob upoštevanju vseh teh dejstev je imetnik dovoljenja za promet z zdravilom pozval CHMP k potrditvi sprejemljivosti obstoječega kliničnega paketa za goserelin in k ohranitvi dovoljenja za promet z zadevnimi zdravili.
These inconsistencies led to a Good Clinical Practice (GCP) inspection of the contract laboratory by the German authority (BfArM).
Zaradi teh neskladnosti je nemški pristojni organ (BfArM) izvedel pregled dobre klinične prakse v pogodbenem laboratoriju.
Due to the observed critical and major findings in the studies GOS/001/C and GOS/002/C, a GCP compliant conduct could not be confirmed.
Zaradi opaženih kritičnih in pomembnih ugotovitev v študijah GOS/001/C in GOS/002/C skladnosti z dobro klinično prakso ni bilo mogoče potrditi.
The MAH believes that the impact of these analytical findings on the conclusions of the clinical studies is limited, because clinical efficacy in both studies is based on a comparison of testosterone levels attained during treatment for the MAH's product and the comparator drug.
Imetnik dovoljenja za promet z zdravilom meni, da je vpliv teh analitičnih ugotovitev na zaključke kliničnih študij omejen, saj klinična učinkovitost obeh študij temelji na primerjavi ravni testosterona, doseženih med zdravljenjem z zdravilom imetnika dovoljenja za promet z zdravilom in s primerjalnim zdravilom.
Therefore, neither the comparative study design nor the cited results of the study can compensate for the breach of the legal requirements to provide GCPcompliant studies in support of a MAA.
Zato niti primerjalna študija niti navedeni rezultati študije ne morejo odtehtati kršitev pravnih zahtev, da bi bilo na ta način mogoče zagotoviti študije v skladu z dobro klinično prakso v podporo vlogi za pridobitev dovoljenja za promet z zdravilom.
Based on the totality of data submitted, the CHMP considered that therapeutic equivalence with Zoladex had not been demonstrated and as such the benefit risk ratio for this generic product was considered negative until the MAH can demonstrate therapeutic equivalence with the reference product.
Na podlagi vseh predloženih podatkov je CHMP menil, da terapevtska enakovrednost zdravilu Zoladex ni bila dokazana ter da je razmerje med tveganji in koristmi za to generično zdravilo negativno, vse dokler imetnik dovoljenja za promet z zdravilom ne dokaže terapevtske enakovrednosti referenčnemu zdravilu.
The results of these studies were submitted in a number of marketing authorisation applications of goserelin-containing generic medicinal products to demonstrate therapeutic equivalence with the reference product Zoladex in the course of a MAA under Article.
Rezultati teh študij so bili predloženi v številnih vlogah za pridobitev dovoljenja za promet z generičnimi zdravili, ki vsebujejo goserelin, da bi se dokazala terapevtska enakovrednost zdravila referenčnemu zdravilu Zoladex v okviru vloge za pridobitev dovoljenja za promet z zdravilom iz člena 10(3), tj. hibridne vloge.
The MAH agreed with the authorities that GCP violations have happened at the bioanalytical testing facility of the contract laboratory and has taken extensive measures to correct these facts for future clinical trials.
Stališče imetnika dovoljenja za promet z zdravilom Imetnik dovoljenja za promet z zdravilom se je strinjal z organi, da je bila v pogodbenem laboratoriju za izvajanje bioanalitičnega preskušanja kršena dobra klinična praksa, in je sprejel obsežne ukrepe za odpravo tovrstnih kršitev v prihodnjih kliničnih preskušanjih.
Therefore, the Committee recommends the suspension of the marketing authorisations, subject to the conditions outlined in Annex III of the Opinion.
Odbor zato ob upoštevanju pogojev iz Dodatka III k Mnenju priporoča začasni umik dovoljenj za promet z zdravilom.
Analytical inadequacies would affect comparator and MAH's product in the same way: Since the clinical efficacy was based on a comparison between two products analytical errors would be expected to affect both products in the same way.
Ker je klinična učinkovitost temeljila na primerjavi obeh zdravil, bi bilo pričakovati, da analitične napake vplivajo na obe zdravili v enaki meri.
Critical violations of fundamental standards of ICH GCP and internationally accepted laboratory standards during the bioanalytical analyses of the blood samples from both GOS/001 (1-month depot formulation) and GOS/002 (1 and 3-month depot formulation) were uncovered.
V obeh študijah GOS/001 (enomesečna depo formulacija) in GOS/002 (eno- in trimesečna depo formulacija) so bile med izvajanjem bioanalitičnih analiz vzorcev krvi ugotovljene kritične kršitve temeljnih standardov dobre klinične prakse ICH in mednarodno sprejetih laboratorijskih standardov.
Invented Name Strength Pharmaceutical Form
(Izmišljeno) ime Jakost Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
3 pre-filled syringes
3 napolnjene injekcijske brizge
3 pre-filled pens
3 napolnjeni injekcijski peresniki
This summary was last updated in October 2017.
Povzetek je bil nazadnje posodobljen oktobra 2017.
In the future, if
Če bodo živali v prihodnje
Vaccination campaigns are conducted normally twice a year in spring and autumn for consecutive years, until at least 2 years after the last confirmed case of rabies in the area.
Kampanje cepljenja se običajno izvajajo dvakrat letno, spomladi in jeseni, in sicer vsako leto, dokler ne mineta vsaj dve leti od zadnjega potrjenega primera stekline na tem območju.
The baits are distributed by land or air and the vaccination area should be larger than 5,000 km2.
Vabe se polagajo po kopnem ali iz zraka, območje cepljenja pa naj bo večje od 5 000 km2.
The protection against the virus lasts at least 6 months.
Zaščita pred virusom traja vsaj šest mesecev.
The full EPAR for Rabitec can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Rabitec je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Protection lasts at least 6 months after vaccination.
Zaščita traja vsaj šest mesecev po cepljenju.
It is not intended to provide practical advice on how to use Rabitec.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Appropriate measures should be taken to prevent contamination such as wearing protective clothes and disposable rubber gloves, since the vaccine has been prepared with modified live virus.
Za preprečevanje kontaminacije je treba izvesti ustrezne ukrepe, kot je nošenje zaščitnih oblačil in gumijastih rokavic za enkratno uporabo, saj je cepivo pripravljeno z modificiranim živim virusom.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Rabitec's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Rabitec večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
It presents a risk for people since it can be transmitted by bites or saliva from an infected animal.
Pomeni tveganje za ljudi, saj se lahko prenaša z ugrizi ali slino okužene živali.
This is a summary of the European public assessment report (EPAR) for Rabitec.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rabitec.
The baits should be handled with care.
Z vabami je treba ravnati previdno.
In case of skin or eye contact with the vaccine fluid the affected area should be rinsed immediately with water.
V primeru stika tekočine cepiva s kožo ali očmi je treba prizadeto področje nemudoma izprati z vodo.
What benefits of Rabitec have been shown in studies?
Kakšne koristi je zdravilo Rabitec izkazalo v študijah?
Why is Rabitec approved?
Zakaj je bilo zdravilo Rabitec odobreno?
To protect rabies free areas, vaccination may also be carried out at the border of these areas (vaccination belts) or in the form of spot vaccinations.
Za zaščito območij, kjer stekline ni, se cepljenje lahko izvaja na meji teh območij (cepitveni pas) ali v obliki točkovnih cepljenj.
Rabitec rabies virus vaccine (live)
Rabitec cepivo proti virusu stekline (živo)
The number of baits distributed depends on the density of the fox and raccoon dog population and the nature of the vaccination area.
Število položenih vab je odvisno od gostote populacije lisic in rakunastih psov ter narave območja cepljenja.
What is Rabitec and what is it used for?
Kaj je zdravilo Rabitec in za kaj se uporablja?
When a fox or raccoon dog chews a bait and the vaccine is released in the animal's mouth, the immune system recognises the virus as ‘foreign' and makes defences against it.
Ko lisica ali rakunasti pes prežveči vabo in se cepivo sprosti v usta živali, imunski sistem prepozna virus kot tujek in proti njemu tvori protitelesa.
Rabitec is a vaccine.
Zdravilo Rabitec je cepivo.
animals are exposed to the rabies virus, the immune system will be able to respond more quickly, which will help to protect against the disease.
izpostavljene virusu stekline, se bo njihov imunski sistem lahko hitreje odzval, kar bo živali pomagalo pri zaščiti pred boleznijo.
What are the risks associated with Rabitec?
Kakšna tveganja so povezana z zdravilom Rabitec?
Laboratory studies showed that around 90% of foxes and raccoon dogs produce antibodies against the rabies virus within 15 days of eating the bait.
Laboratorijske študije so pokazale, da v 15 dneh po zaužitju vabe protitelesa proti virusu stekline tvori približno 90 % lisic in rakunastih psov.
For the full list of restrictions, see the package leaflet.
Znanih neželenih učinkov ni. Za celoten seznam omejitev glejte navodilo za uporabo.
Rabies is a life threatening viral disease that causes inflammation in the brain.
Steklina je smrtno nevarna virusna bolezen, ki povzroča vnetje možganov.
Safety information has been included in the summary of product characteristics and the package leaflet for Rabitec, including the appropriate precautions to be followed by healthcare professionals and people who handle the product or come into contact with it.
V povzetek glavnih značilnosti zdravila Rabitec in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in osebe, ki ravnajo z zdravilom ali pridejo v stik z njim.
Rabitec is available as a liquid (suspension) contained in a bait pellet scented with fish meal to be chewed.
Zdravilo Rabitec je na voljo v obliki tekočine (suspenzije) v peletu vabe z vonjem po ribah, ki ga žival prežveči.
Rabitec is a veterinary vaccine used to protect wild foxes and raccoon dogs against rabies.
Zdravilo Rabitec je cepivo za uporabo v veterinarski medicini, ki se uporablja za zaščito lisic in rakunastih psov pred steklino.
Other information about Rabitec?
Druge informacije o zdravilu Rabitec
For more information about treatment with Rabitec, read the package leaflet.
Za več informacij o zdravljenju z zdravilom Rabitec preberite navodilo za uporabo.
Rabitec contains a modified live rabies virus which has been weakened so that it does not cause disease.
Zdravilo Rabitec vsebuje modificiran živ virus stekline, ki je bil oslabljen tako, da ne povzroča bolezni.
Rabitec contains a weakened rabies virus that does not cause the disease.
Zdravilo Rabitec vsebuje oslabljen virus stekline, ki ne povzroča bolezni.
How is Rabitec used?
Kako se zdravilo Rabitec uporablja?
How does Rabitec work?
Kako zdravilo Rabitec deluje?
Medical advice should be sought immediately and the package leaflet or label shown to the doctor, who should follow WHO recommendations for rabies exposure.
Nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
The European Commission granted a marketing authorisation valid throughout the EU for Rabitec on 1 December 2017.
Evropska komisija je dovoljenje za promet z zdravilom Rabitec, veljavno po vsej Evropski uniji, izdala
Sandoz Farmacêutica Lda.
Portugalska Sandoz Farmacêutica Lda.
This summary was last updated in 08-2016.
Povzetek je bil nazadnje posodobljen MM-2016.
Atazanavir Mylan is available as capsules (150 mg, 200 mg and 300 mg).
Zdravilo Atazanavir Mylan je na voljo v obliki kapsul (150 mg, 200 mg in 300 mg).
It blocks an enzyme called protease, which is needed for the virus to multiply.
Zavira encim, imenovan proteaza, ki je potreben za razmnoževanje virusa.