natgillin/translations-raw huggingface dataset:
Protective clothing, acid-resistant gloves and glasses should be worn during treatment.
Med dajanjem zdravila je treba nositi zaščitno obleko in rokavice ter očala, odporne proti kislini.
What are the risks associated with VarroMed?
Kakšna tveganja so povezana z zdravilom VarroMed?
VarroMed is available as a bee-hive dispersion (a liquid for use inside the bee hive) and can be obtained without a prescription.
Zdravilo VarroMed je na voljo kot disperzija za čebeljo družino (tekočina za uporabo znotraj panja) in se izdaja brez recepta.
Varroosis is a disease of honey bees caused by infestation with a parasite called Varroa mite (Varroa destructor).
Varoza je bolezen medonosnih čebel, ki jo povzroča infestacija s parazitom, imenovanim varoja (Varroa destructor).
How both oxalic acid and formic acid work is not well understood.
Način delovanja oksalne kisline in mravljične kisline ni dobro znan.
Other information about VarroMed?
Druge informacije o zdravilu VarroMed
The withdrawal period for honey from honey bees treated with VarroMed for is ‘zero' days, which means there is no mandatory waiting time.
Karenca za med medonosnih čebel, zdravljenih z zdravilom VarroMed, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
Formic acid is thought to kill Varroa mites by blocking the ability of their cells to generate energy; it may also act on mite nerve cells.
Predvideva se, da je učinek oksalne kisline na varoje posledica kislosti zdravila, mravljična kislina pa naj bi varoje uničevala z zaviranjem zmožnosti njihovih celic za presnovo energije, morda pa deluje tudi na živčne celice varoj.
For practical information about using VarroMed, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila VarroMed naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For more information about treatment with VarroMed, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom VarroMed naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
The Varroa mite feeds on the haemolymph (blood) of adult bees and on brood (developing stages of the honey bee) resulting in damage and / or death of bees; the mite can also help spread of viruses and bacteria.
Varoja se hrani s hemolimfo (krvjo) odraslih čebel in z zalego (razvojnimi stopnjami medonosnih čebel), kar povzroči poškodbe in/ali smrt čebel.
VarroMed is a medicine used to treat varroosis in honey bee colonies.
VarroMed je zdravilo, ki se uporablja za zdravljenje varoze v kolonijah medonosnih čebel.
VarroMed contains the active substances oxalic acid dihydrate and formic acid.
Zdravilo VarroMed vsebuje zdravilni učinkovini oksalno kislino dihidrat in mravljično kislino.
VarroMed can be used on colonies with and without brood.
Zdravilo VarroMed se lahko uporablja pri kolonijah z zalego ali brez nje.
The withdrawal period is the time required after administration of a medicine before honey may be used for human consumption.
Karenca je čas, ki mora preteči po dajanju zdravila, preden se lahko med uporabi za prehrano ljudi.
The European Commission granted a marketing authorisation valid throughout the EU for VarroMed on 2 February 2017.
Evropska komisija je dovoljenje za promet z zdravilom VarroMed, veljavno po vsej Evropski uniji, izdala
How is VarroMed used?
Kako se zdravilo VarroMed uporablja?
VarroMed must not be given during nectar flow, when honey is produced by bees, and should not be used when honey chambers are attached to the hive.
Zdravilo VarroMed se ne sme uporabljati med čebeljo pašo, ko čebele proizvajajo med, ali ko so na panj pritrjena medišča.
How does VarroMed work?
Kako zdravilo VarroMed deluje?
VarroMed is trickled onto bees in the brood chamber of the hive.
Zdravilo VarroMed se nakaplja na čebele v presledkih plodišča.
10 ml (3.5 mg/ml) 2 vials
10 ml (3,5 mg/ml) 2 viali
10 ml (3.5 mg/ml) 5 (5 x 1) vials (multipack)
10 ml (3,5 mg/ml) 5 (5 x 1) vial (večje pakiranje)
10 ml (3.5 mg/ml) 1 vial
10 ml (3,5 mg/ml) 1 viala
The referral procedure was initiated on 19 May 2011.
Napotitveni postopek se je začel 19. maja 2011.
PWS is a genetic disorder.
PWS je genetska motnja.
Puberty development is also delayed and often incomplete.
Tudi razvoj v puberteti je zakasnjen in pogosto nepopoln.
The latter two may lead to childhood obesity.
Slednji dve lahko vodita v otroško debelost.
There were no deaths reported.
O smrti niso poročali.
Thus body composition would have been a key endpoint.
Posledično bi morala biti sestava telesa ključna končna točka.
The diagnosis is based on a genetic test and on clinical findings.
Diagnoza temelji na genetskem testu in kliničnih ugotovitvah.
All children were Caucasian.
Vsi otroci so bili belci.
The safety profile of somatropin-containing products is well known.
Varnostni profil zdravil, ki vsebujejo somatropin, je dobro znan.
Scientific conclusions and grounds for refusal presented by the EMA
Znanstveni zaključki in podlaga za zavrnitev, ki jih je predložila Evropska agencija za zdravila
However, the practice of data collection on body composition differed across the three centers.
Vendar pa se je praksa zbiranja podatkov o sestavi telesa med tremi centri razlikovala.
Children with PWS often have concomitant growth hormone deficiency (GHD) (40 to 100%, depending on the provocation test used).
Otroci s PWS imajo pogosto sočasno pomanjkanje rastnega hormona (PRH) (40 do 100 %, odvisno od uporabljenega provokacijskega testa).
Most females with PWS suffer from amenorrhea.
Večina žensk s PWS trpi za amenorejo.
Overall, the retrospective data collected were insufficient and of poor quality.
Na splošno so bili zbrani retrospektivni podatki nezadostni in slabe kakovosti.
One center did not collect body composition data at all and from the other two centers data were only available in 11 children.
En center podatkov o sestavi telesa sploh ni zbiral, podatki drugih dveh centrov pa so bili na voljo le za 11 otrok.
Norditropin was approved in accordance with Article 8(3) of Directive 2001/83/EC.
Zdravilo Norditropin je bilo odobreno v skladu s členom 8(3) Direktive 2001/83/ES.
• The Committee considered the notification of the referral triggered by Denmark under Article 13 of Commission Regulation (EC) No 1234/2008.
• Odbor je preučil obvestilo o napotitvenem postopku, ki ga je sprožila Danska v skladu s členuom13 Uredbe Komisije (ES) št. 1234/2008;
Another point of concern was the fact that based on the wording of the inclusion criteria it was doubtful whether all patients have been included in the study from the respective centres.
Naslednji zadržek je povzročilo dejstvo, da na podlagi besedila vključitvenih kriterijev ni bilo jasno, ali so bili v študijo vključeni vsi bolniki iz zadevnih centrov.
“Improvement of growth and body composition in children with Prader-Willi syndrome (PWS) confirmed by appropriate genetic testing”.
„Izboljšanje rasti in sestave telesa pri otrocih s Prader-Willijevim sindromom (PWS), potrjenim z ustreznim genetskim testiranjem“.
Even children who had only received one dose of Norditropin could be included.
Vključiti je bilo mogoče celo otroke, ki so prejeli le en odmerek zdravila Norditropin.
The efficacy of Norditropin on key secondary endpoints such as body composition and height velocity is unknown.
Učinkovitost zdravila Norditropin pri ključnih sekundarnih končnih točkah, kot sta sestava telesa in hitrost rasti, ni znana.
As the reference and concerned Member States were not able to reach an agreement in respect of the variation, on 20 April 2011, Denmark triggered a referral under Article 13 of Commission Regulation EC No 1234/2008.
Ker referenčna in zadevne države članice niso dosegle sporazuma v zvezi s spremembo, je Danska 20. aprila 2011 sprožila napotitveni postopek v skladu s členom 13 Uredbe Komisije ES št.
Grounds for refusal Whereas
Podlaga za zavrnitev Ob upoštevanju naslednjega:
Safety was assessed by adverse events, HbA1c, IGF-I, haematology, TSH, total T3 and T4, free T3 and T4.
Varnost so ocenili z neželenimi dogodki, HbA1c, IGF-I, hematologijo, TSH, celokupnima T3 in T4, prostima T3 in T4.
In the GHLiquid-1961 study forty-one (41) children in Europe with genetically documented PWS were enrolled (19 girls and 22 boys).
V študijo GHLiquid-1961 je bilo vključenih enainštirideset (41) otrok iz Evrope z genetsko dokumentiranim PWS (19 deklic in 22 dečkov).
Height velocity would also have been a valuable endpoint, however no data are available.
Tudi hitrost rasti bi bila koristna končna točka, a v zvezi z njo ni razpoložljivih podatkov.
The incidence of PWS is 1 in about 10,000 to 29,000 live births.
Pojavi se pri enem od približno 10 000 do 29 000 živorojenih otrok.
Data from 11 out of 41 children were too scarce to draw any conclusion on this endpoint.
Podatki za 11 od 41 otrok so bili prepičli, da bi lahko na njihovi podlagi sklepali na to končno točko.
• The Committee is of the opinion that the data submitted by the MAH in particular to support efficacy are considered limited since they are derived from a retrospective, observational, noncomparative study.
• Odbor meni, da se podatki, ki jih je imetnik dovoljenja za promet predložil posebej za podporo učinkovitosti, štejejo za omejene, saj so izpeljani iz retrospektivne, opazovalne, neprimerjalne študije.
In order to demonstrate efficacy and safety in the applied indication, the application dossier was based on the study GHLiquid-1961.
Kot dokazilo za učinkovitost in varnost za vloženo indikacijo je vloga za pridobitev dovoljenja za promet temeljila na študiji GHLiquid-1961.
Thirty-three (33.26%) adverse events in 17 (41.5%) children were assessed as probably/possibly related to Norditropin treatment.
Triintrideset (33,26 %) neželenih dogodkov pri 17 (41,5 %) otrocih je bilo ocenjenih kot verjetno/mogoče povezanih z zdravljenjem z zdravilom Norditropin.
There was no restriction on the degree of short stature and the children had to be pre-pubertal at start of treatment.
Glede stopnje nizke rasti ni bilo omejitve, otroci pa so morali biti ob začetku zdravljenja v predpubertetnem obdobju.
Hence, 35 of 41 (85%) children with PWS had a height within the reference range for normal children after Norditropin treatment.
Iz tega sledi, da je 35 od 41 (85 %) otrok s PWS imelo višino znotraj referenčnega območja za normalne otroke po zdravljenju z zdravilom Norditropin.
Only 33 children were included in the primary efficacy analysis and selection bias cannot be excluded due to the design of the study.
V analizo primarne učinkovitosti je bilo vključenih le 33 otrok, zaradi zasnove študije pa ni mogoče izključiti pristranskosti izbire.
The number of children with an HSDS above -2 was 19 (46%) children at baseline, 27 (66%) children after 1 year of treatment and 35 (85%) children at last observation.
Število otrok s HSDS nad -2 je bilo 19 (46 %) otrok ob začetku, 27 (66 %) otrok po 1 letu zdravljenja in 35 (85 %) otrok ob zadnjem opazovanju.
The mean age at inclusion was 3.8 years (min 0.4 years; max 12.2 years).
Povprečna starost ob vključitvi je bila 3,8 leta (najnižja 0,4 leta; najvišja 12,2 leta).
The CHMP was requested to give its opinion on whether the marketing authorisations should be varied to include the indication:
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaprosila za mnenje o tem, ali naj bodo dovoljenja za promet z zdravili spremenjena tako, da bodo vključevala indikacijo:
Data on final adult heights are not available.
Podatki o končni višini odraslih oseb niso na voljo.
The CHMP concluded that given the retrospective design of the study, selection bias cannot be excluded.
Odbor CHMP je sklenil, da glede na retrospektivno zasnovo študije ni mogoče izključiti pristranskosti izbire.
The majority of events were of mild/moderate severity.
Neželeni učinki so bili večinoma blagi/zmerni.
Data on change in height velocity were not considered valid, as data on pre-trial height measurements were incomplete.
Podatki o spremembi v hitrosti rasti niso bili upoštevani kot veljavni, saj podatki o meritvah višine pred preskušanjem niso bili popolni.
Norditropin contains somatropin which is a human growth hormone produced by recombinant DNA technology that has received marketing authorisation in the European Union through the Mutual Recognition Procedure (MRP).
Zdravilo Norditropin vsebuje somatropin, ki je humani rastni hormon, pridobljen s tehnologijo rekombinantne DNK, za katerega je bilo pridobljeno dovoljenje za promet z zdravilom v Evropski uniji v postopku z medsebojnim priznavanjem.
Body composition was improved, with an estimated mean increase in body mass of 9.9% and a corresponding reduction in fat mass of 9.9% after 1 year of Norditropin treatment.
Sestava telesa se je izboljšala z ocenjenim povprečnim povečanjem telesne mase za 9,9 % in z ustrezajočim zmanjšanjem maščobne mase za 9,9 % po prvem letu zdravljenja z zdravilom Norditropin.
Sleep apnoea and sudden death have been reported in clinical practice after initiating therapy in patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.
V klinični praksi so poročali o apneji v spanju in nenadni smrti po začetku zdravljenja pri bolnikih s Prader-Willijevim sindromom, pri katerih je bil prisoten en ali več od naslednjih dejavnikov tveganja: huda debelost, anamneza obstrukcije zgornjih dihalnih poti ali apneja v spanju ali neugotovljena okužba dihal.
Height at baseline was only available for 37 patients.
Višina ob izhodišču je bila na voljo le za 37 bolnikov.
In Europe, two recombinant GH products are approved for the treatment of children with PWS.
V Evropi sta za zdravljenje otrok s PWS odobrena dva rekombinantna rastna hormona.
The recommended dose is not the same as the one studied in the GHLiquid-1961 which was chosen at the discretion of the physician and was on average 0.03 mg/kg/day.
Priporočeni odmerek ni enak odmerku, ki je bil preučen v študiji GHLiquid-1961 in izbran po presoji zdravnika, in je bil v povprečju 0,03 mg/kg/dan.
Apart from the aforementioned general deficiency some other aspects of the GHLiquid-1961 study raised concerns to the CHMP namely the validity and the quality of the study results and are summarised below.
Poleg prej omenjene splošne pomanjkljivosti je odbor CHMP izrazil zadržke tudi v zvezi z nekaterimi drugimi vidiki študije GHLiquid-1961, zlasti v zvezi z veljavnostjo in kakovostjo rezultatov študije, ki so povzeti spodaj.
The data from the study that were submitted with the application of Novo Nordisk to support the proposed indication were not considered sufficient (open-label, non-controlled and retrospective study) and of good quality (wide range of doses used, height measurements incomplete) by the objecting Member States.
Podatke iz študije, ki jih je družba Novo Nordisk predložila vlogi v podporo predlagani indikaciji, so ugovarjajoče države članice zavrnile kot nezadostne (odprta, nekontrolirana in retrospektivna študija) in nekakovostne (širok razpon uporabljenih odmerkov, nepopolno merjenje telesne višine).
The inclusion criteria were pre-pubertal children with genetically diagnosed PWS, treated with Norditropin for at least 1 year in the centre.
Vključitveni kriteriji so zajemali predpubertetne otroke z genetsko diagnosticiranim PWS, ki so jih z zdravilom Norditropin vsaj eno leto zdravili v centru.
A total of 128 adverse events were reported in 31 (75.6%) children with PWS during Norditropin exposure (mean exposure 4.1 years, range 0.3 to 9.5 years).
Skupno so poročali o 128 neželenih dogodkih pri 31 (75,6 %) otrocih s PWS v času izpostavljenosti zdravilu Norditropin (povprečna izpostavljenost je znašala 4,1 leta, z razponom od 0,3 do 9,5 leta).
The most frequent probably/possibly related adverse events were scoliosis (in 8 children, 19.5%) and sleep apnoea (in 3 children, 7.3%).
Najbolj pogosti verjetno/mogoče povezani neželeni dogodki so bili skolioza (pri 8 otrocih, 19,5 %) in apneja v spanju (pri 3 otrocih, 7,3 %).
No additional information was given by the MAH on the other PWS children for which informed consent was not obtained.
Imetnik dovoljenja za promet z zdravilom ni podal nobenih dodatnih informacij o drugih otrocih s PWS, za katere ni pridobil prostovoljnega soglasja.
In addition, accepting the same recommended dose as for other GH products was not considered appropriate as Norditropin has not shown comparable efficacy and those two products have different dose recommendations for other indications, i.e. Turner syndrome and chronic renal disease.
Potrditev enakega priporočenega odmerka kot za drugi dve zdravili z rastnim hormonom se je prav tako štela za neustrezno, saj zdravilo Norditropin ni prikazalo primerljive učinkovitosti, povrhu tega pa drugi dve zdravili za druge indikacije, npr. za Turnerjev sindrom in kronično ledvično bolezen, priporočata različne odmerke.
The most frequent adverse events were respiratory tract infections which are common in young children (14.6% of children) and scoliosis which is common in PWS (19.5% of children).
Najpogostejši neželeni učinki so bile okužbe dihalnih poti, ki so pogoste pri mlajših otrocih (14,6 % otrok) in skolioza, ki je pogosta pri PWS (19,5 % otrok).
Regarding efficacy on the basis of the available data the CHMP concluded that the demonstration of efficacy for Norditropin in PWS is based on limited and unreliable data of apparent poor quality.
Na podlagi razpoložljivih podatkov je odbor CHMP v zvezi z učinkovitostjo sklenil, da temelji prikaz učinkovitosti za zdravilo Norditropin pri zdravljenju PWS na omejenih in nezanesljivih podatkih očitne slabe kakovosti.
Short stature, mental retardation, behavioural problems, hormonal dysfunctions, poor muscle tone and hyperphagia as well as hypoactivity are among its features.
Nekatere značilnosti PWS so nizka rast, duševna zaostalost, vedenjske motnje, hormonske motnje, slab mišični tonus, hiperfagija in hipoaktivnost.
The quality of the data was also considered questionable given the fact that basic information such as baseline height was missing in 10% of patients.
Za vprašljivo so ocenili tudi kakovost podatkov, saj so osnovne informacije, denimo izhodiščna višina, manjkale za kar 10 % bolnikov.
• The Committee reviewed all available data submitted by the marketing authorisation holder, to support the safety and efficacy of Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and associated names in the applied indication “Improvement of growth and body composition in children with Prader-Willi syndrome (PWS) confirmed by appropriate genetic testing”.
• Odbor je pregledal vse razpoložljive podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom v podporo varnosti in učinkovitosti zdravil Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro in povezanih imen za vloženo indikacijo „Izboljšanje rasti in sestave telesa pri otrocih s Prader-Willijevim sindromom (PWS), potrjenim z ustreznim genetskim testiranjem“;
The secondary objectives were to evaluate in the same population the change in HSDS from start of treatment to last observation during Norditropin treatment (referenced to a PWS population), change in body composition (lean body mass and fat mass), height velocity (HV) and change in HV.
Sekundarni cilji so bili oceniti spremembe HSDS od začetka zdravljenja do zadnjega opazovanja v okviru zdravljenja z zdravilom Norditropin v isti populaciji (glede na populacijo s PWS), spremembe v sestavi telesa (mršava telesna masa in maščobna masa), hitrost rasti in spremembe v hitrosti rasti.
No data on final adult height were provided.
Podatki o končni višini odraslih oseb niso bili predloženi.
IGF-1 SDS at baseline was only available for 28 patients.
Vrednost standardnega odstopanja (SDS) za IGF-1 ob izhodišču je bila na voljo le za 28 bolnikov.
Taking into consideration the above mentioned data, the CHMP concluded that the provided study GHLiquid-1961 forming the basis for the application to extend the indication for Norditropin in children with PWS was uncontrolled, open-label and retrospective and not in accordance with the methodological standards for pivotal evidence.
Ob upoštevanju zgoraj navedenih podatkov je odbor CHMP zaključil, da je predložena študija GHLiquid-1961, ki predstavlja temelj vloge za razširitev indikacije za zdravilo Norditropin pri otrocih s PWS, nekontrolirana, odprta in retrospektivna študija, ki ni v skladu z metodološkimi standardi za ključni dokaz.
Furthermore, a wide range of doses has been used in the retrospective study (mean dose 0.03 mg/kg/day - up to 0.06 mg/kg/day).
V retrospektivni študiji je bil uporabljen širok razpon odmerkov (povprečni odmerek je bil 0,03 mg/kg/dan vse do 0,06 mg/kg/dan).
In conclusion, the data provided by the MAH in particular to support efficacy are insufficient to sustain the extension of indication in PWS.
Podatki, ki jih je v podporo učinkovitosti predložil imetnik dovoljenja za promet z zdravilom, torej ne zadoščajo za razširitev indikacije pri PWS.
• The Committee is also of the opinion that the particulars submitted in support of the application to extend the indications of Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and associated names do not comply with the requirements of a product authorised on the basis of Article 8(3) of Directive 2001/83/EC.
• Odbor tudi meni, da podrobni podatki, ki so bili predloženi v podporo vlogi za razširitev indikacij za zdravila Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro in povezana imena, niso v skladu z zahtevami zdravila, ki je bilo odobreno na podlagi člena 8(3) Direktive 2001/83/ES;
However, considering requests from some Concerned Member States (CMS) during the CMDh referral, the MAH agreed that the dose recommendation for PWS could be 0.035 mg/kg/day, the same as for the other two GH products approved in the same indication.
Vendar pa se je ob upoštevanju zahtev nekaterih zadevnih držav članic v okviru napotitvenega postopka Usklajevalne skupine za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMDh) imetnik dovoljenja za promet z zdravilom strinjal, da bi lahko bil priporočeni odmerek za PWS 0,035 mg/kg/dan, torej enak kot za drugi dve zdravili z rastnim hormonom, ki sta odobreni za enako indikacijo.
On 14 May 2010, the MAH submitted a type II variation via the MRP for Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro and associated names (DK/H/0001/005-007 and 011016/II/078), to request an extension of the indications.
Dne 14. maja 2010 je imetnik dovoljenja za promet z zdravilom predložil spremembo tipa II v postopku z medsebojnim priznavanjem za zdravila Norditropin SimpleXx, Norditropin NordiFlex, Norditropin FlexPro in povezana imena (DK/H/0001/005-007 in 011-016/II/078), s katero je zaprosil za razširitev indikacij.
In the variation application dossier, the recommended dose from Novo Nordisk for the treatment of short stature and altered body composition in children with PWS was 0.025 to 0.035 mg/kg/day.
V vlogi za spremembo dovoljenja za promet z zdravilom je bil priporočeni odmerek družbe Novo Nordisk za zdravljenje nizke rasti in spremenjene sestave telesa pri otrocih s PWS 0,025 do 0,035 mg/kg/dan.
The primary objective of the study was to investigate changes in height standard deviation score (HSDS) in response to 1 year of Norditropin treatment in children with PWS (referenced to a PWS population).
Primarni cilj študije je bil raziskati spremembe v vrednosti standardnega odklona telesne višine (HSDS) kot odgovor na enoletno zdravljenje z zdravilom Norditropin pri otrocih s PWS (glede na populacijo s PWS).
This was a retrospective, observational, open-label, multicentre, multinational study in children with PWS treated with Norditropin off-label for short stature.
To je bila retrospektivna, opazovalna, odprta, multicentrična, večnacionalna študija pri otrocih s PWS, ki so bili zdravljeni z zdravilom Norditropin zaradi nizke rasti, kar ni navedeno v indikacijah.
Benefit-Risk
Ocena razmerja med koristmi in tveganji