natgillin/translations-raw huggingface dataset:
Spherox must not be used in patients with primary generalised osteoarthritis or with advanced osteoarthritis of the knee (conditions causing swelling and pain in the joints) and in patients whose bones in the knee joint are still growing.
Zdravilo Spherox se ne sme uporabljati pri bolnikih s primarnim generaliziranim osteoartritisom ali z napredovalim osteoartritisom kolena (stanjema, ki povzročata otekanje in bolečine v sklepih) ter pri bolnikih, pri katerih kosti v kolenskem sklepu še rastejo.
Why is Spherox approved?
Zakaj je bilo zdravilo Spherox odobreno?
When the spheroids are implanted into the patient's cartilage, they attach to the area of the defect and produce new tissue, thereby repairing the defects in the knee.
Ko se sferoidi vsadijo v bolnikov hrustanec, se pripojijo na poškodovan predel in začnejo tvoriti novo tkivo, s čemer popravijo poškodbo v kolenu.
The materials for other healthcare professionals will include information on how to screen and handle the collected sample and prepare Spherox for implantation, and how to follow patients up and plan the recommended physiotherapy.
Gradivo za druge zdravstvene delavce bo vsebovalo informacije o pregledu odvzetega vzorca in ravnanju z njim, o pripravi zdravila Spherox za implantacijo ter o spremljanju bolnikov in načrtovanju priporočene fizioterapije.
Spherox spheroids of human autologous matrix-associated chondrocytes
Spherox sferoidi humanih avtolognih, na matriks nanesenih hondrocitov
Spherox has been shown to be effective at treating defects in the knee cartilage between 1 and 10 cm2 in size.
Zdravilo Spherox je dokazano učinkovito pri zdravljenju poškodb kolenskega hrustanca velikosti od 1 do 10 cm2.
The training materials for surgeons will include information on how to collect the cartilage sample from patients, perform the operation and follow up their patients.
Gradivo za usposabljanje za kirurge bo vsebovalo informacije o načinu odvzema vzorca hrustanca pri bolnikih, izvedbi kirurškega posega in spremljanju bolnikov.
The most common side effects with Spherox (seen in more than 1 patient in 10) are arthralgia (joint pain) and joint effusion (accumulation of liquid in the knee), which can cause swelling of the joint.
Najpogostejša neželena učinka zdravila Spherox (ki sta se pojavila pri več kot 1 bolniku od 10) sta artralgija (bolečina v sklepu) in sklepni izliv (nabiranje sklepne tekočine v kolenu), kar lahko povzroči otekanje sklepa.
Spherox contains spheroids made from the patient's own healthy cartilage cells.
Zdravilo Spheroid vsebuje sferoide, narejene iz bolnikovih lastnih celic zdravega hrustanca.
It is not intended to provide practical advice on how to use Spherox.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For the full list of all side effects reported with Spherox, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Spherox, glejte navodilo za uporabo.
During arthroscopy, the medicine is placed into the damaged area of the patient's cartilage.
Med artroskopijo se zdravilo vstavi v poškodovani predel bolnikovega hrustanca.
For practical information about using Spherox, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Spherox naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
This allows the chondrocyte spheroids to fill in the cartilage defect.
S tem omogočimo hondrocitnim sferoidom, da zapolnijo poškodbo hrustanca.
Spherox has been shown to improve patients' symptoms and knee function in two studies in adults between 18 and 50 years of age.
Zdravilo Spherox je v dveh študijah pri odraslih, starih od 18 do 50 let, dokazano izboljšalo simptome pri bolnikih in delovanje kolena.
Spherox contains spheroids (spherical aggregates) of chondrocytes, cells found in healthy cartilage.
Zdravilo Spherox vsebuje sferoide (sferične skupke) hondrocitov, tj. celic, ki se nahajajo v zdravem hrustancu.
How does Spherox work?
Kako zdravilo Spherox deluje?
How is Spherox used?
Kako se zdravilo Spherox uporablja?
To prepare the medicine, a small sample is taken by arthroscopy (a type of keyhole surgery) from the patient's cartilage in the knee.
Za pripravo zdravila se z artroskopijo (vrsto posega brez velikega reza v telesu) odvzame majhen vzorec bolnikovega kolenskega hrustanca.
It was to be available as tablets (5, 10, 25 and 50 mg).
Na voljo naj bi bilo v obliki tablet (5, 10, 25 in 50 mg).
The company provided the results of studies on the quality, safety and effectiveness of the medicine, including information from the literature.
Družba je predložila rezultate študij o kakovosti, varnosti in učinkovitosti zdravila, vključno z informacijami iz literature.
The study looked at the ability of the medicine to prevent the disease coming back.
V študiji so preučevali zmožnost zdravila, da prepreči ponovni pojav bolezni.
The Committee was concerned about some elements of the way the main study was carried out and whether these were in accordance with the requirements of good clinical practice (GCP).
Odbor je izrazil zaskrbljenost glede določenih elementov načina izvedbe glavne študije in glede tega, ali so bili ti v skladu z zahtevami dobre klinične prakse.
Other concerns included the possibility of dosing errors because the different strengths of tablet might get confused, the way the stability of the active substance in the tablets had been tested, and inadequate information on the medicine's actions, distribution in the body and risks of interactions with other medicines.
Drugi zadržki so vključevali možnost za napake pri odmerjanju, ker zaradi različnih jakosti tablet lahko pride do pomot, način testiranja stabilnosti zdravilne učinkovine v tabletah in nezadostne informacije o delovanju zdravila, porazdelitvi v telesu in tveganjih za medsebojno delovanje z drugimi zdravili.
Withdrawal of the marketing authorisation application for Elmisol (levamisole)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Elmisol (levamizol)
In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing its application because there were concerns about the main study which would prevent its use to support the application.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da se je za umik vloge odločila zaradi zadržkov o glavni študiji, zaradi katere je ne bi mogli uporabiti kot podporo vlogi.
Levamisole has been used for many years to treat a variety of conditions, including worm infections and cancers.
Levamizol se že dolga leta uporablja za zdravljenje različnih bolezni, vključno s okužbami s črvi in rakom.
Withdrawal of the marketing authorisation application for Elmisol (levamisole) EMA/CHMP/380586/2017
Umik vloge za pridobitev dovoljenja za promet z zdravilom Elmisol (levamizol) EMA/CHMP/380586/2017
Elmisol is a medicine containing the active substance levamisole hydrochloride.
Elmisol je zdravilo, ki vsebuje zdravilno učinkovino levamizolijev klorid.
Nephrotic syndrome is a kidney disease that is marked by presence of large amounts of protein in the urine and results in fluid build-up in the body, with swelling (oedema), high blood pressure and weight gain.
Nefrotski sindrom je ledvična bolezen, za katero so značilne večje količine beljakovin v urinu, njena posledica pa je zastajanje tekočine v telesu z otekanjem (edemom), visokim krvnim tlakom in pridobivanjem telesne mase.
On 29 May 2017, ACE Pharmaceuticals BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Elmisol, for the treatment of nephrotic syndrome.
Družba ACE Pharmaceuticals BV je 29. maja 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Elmisol, namenjenim zdravljenju nefrotskega sindroma.
Levamisole is thought to modify the action of the immune system, helping to control the disease and so reducing the amount of corticosteroids the patient needs.
Levamizol naj bi spremenil delovanje imunskega sistema ter tako pomagal pri nadzoru bolezni in zmanjšal količino kortikosteroidov, ki jih bolnik potrebuje.
Suppressing the immune system with corticosteroid medicines can bring the disease under control, but these medicines can have marked side effects and affect growth in young patients.
Z zaviranjem imunskega sistema s kortikosteroidnimi zdravili lahko bolezen obvladamo, vendar imajo ta zdravila izrazite neželene učinke in pri mladih bolnikih vplivajo na rast.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Elmisol in the proposed indication did not outweigh its risks.
Zato je odbor CHMP v času umika vloge menil, da koristi zdravila Elmisol pri predlagani indikaciji ne odtehtajo z njim povezanih tveganj.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Elmisol.
Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Elmisol.
In patients with nephrotic syndrome, the immune system is believed to attack the kidney in error, resulting in leakage of proteins out of the kidney into urine.
Pri bolnikih z nefrotskim sindromom naj bi imunski sistem pomotoma napadal ledvice, kar privede do uhajanja beljakovin iz ledvic v urin.
Elmisol was to be used in patients in whom symptoms kept coming back after responding to initial treatment with corticosteroid medicines (steroid sensitive nephrotic syndrome).
Zdravilo Elmisol naj bi se uporabljalo pri bolnikih, pri katerih se simptomi po odzivu na začetno zdravljenje s kortikosteroidnimi zdravili ponovno pojavljajo (na steroide odziven nefrotski sindrom).
What was Elmisol expected to be used for?
Za kaj naj bi se zdravilo Elmisol uporabljalo?
What is Elmisol?
Kaj je zdravilo Elmisol?
The main study compared levamisole with placebo (a dummy treatment) in children with nephrotic syndrome that had been brought under control with corticosteroids.
V glavni študiji so primerjali levamizol s placebom (zdravilom brez zdravilne učinkovine) pri otrocih z nefrotskim sindromom, ki je nadzorovan s kortikosteroidi.
How does Elmisol work?
Kako zdravilo Elmisol deluje?
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Elmisol could not have been approved for the treatment of nephrotic syndrome.
Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Elmisol ni mogoče odobriti za zdravljenje nefrotskega sindroma.
Elmisol was to be used in children from 2 years of age to treat nephrotic syndrome.
Zdravilo Elmisol naj bi se uporabljalo pri otrocih, starih 2 leti in več, za zdravljenje nefrotskega sindroma.
Elmisol was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 October 2005 for nephrotic syndrome.
Zdravilo Elmisol je bilo dne 28. oktobra 2005 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje nefrotskega sindroma.
It is not completely understood how levamisole works in nephrotic syndrome, but it is known to affect the immune system (the body's natural defences).
vpliva na imunski sistem (naravni obrambni mehanizem telesa).
Packaging Content Package size Withdrawal Period
Vsebina Velikost pakiranja
Invented name Strength Pharmaceutical
EU številka Izmišljeno ime Jakost
1 bottle
Ovojnina
(Invented) name Strength Pharmaceutical Form Route of Administration
Jakost Farmacevtska oblika
--1 1 dose (0.5 ml) contains approximately:
--1 1 odmerek (0,5 ml) vsebuje približno:
³ adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (0.5 milligrams Al)
adsorbiran na amorfni aluminijev hidroksifosfat sulfat kot adjuvans (0,5 miligrama Al)
² L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology
L1 protein v obliki virusu podobnih delcev, pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae CANADE 3C-5 (sev 1895))
10 syringes
10 brizg
10 syringes + 20 needles
10 brizg + 20 igel
1 syringe + 2 needles
1 brizga + 2 igli
The Agency concluded that the benefits of Perlinring outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Spain, Finland, France, Germany, Hungary, Ireland, Italy, Lithuania, Latvia, the Netherlands, Poland, Portugal, Romania, Slovenia, Slovakia and Sweden, plus Iceland and Norway.
Zaključila je, da so koristi zdravila Perlinring večje od z njim povezanih tveganj in da se dovoljenje za promet lahko izda v Združenem kraljestvu in naslednjih državah članicah EU: v Avstriji, Belgiji, na Hrvaškem, v Češki republiki, na Danskem, v Estoniji, Španiji, na Finskem, v Franciji, Nemčiji, na Madžarskem, Irskem, v Italiji, Litvi, Latviji, na Nizozemskem, Poljskem, Portugalskem, v Romuniji, Sloveniji, na Slovaškem in Švedskem ter v Islandiji in na Norveškem.
The review of Perlinring was initiated at the request of the United Kingdom, under Article 29 of Directive 2001/83/EC.
Pregled zdravila Perlinring se je začel na zahtevo Združenega kraljestva v skladu s členom 29(4) Direktive 2001/83/ES.
This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned' Member States, see list above) where the company has applied for a marketing authorisation.
To je postopek, pri katerem ena država članica („referenčna država članica“, v tem primeru Združeno kraljestvo) oceni zdravilo z namenom izdaje dovoljenja za promet z njim, ki bo veljavno v tej državi in drugih državah članicah (t. i. „zadevnih državah članicah“, glejte seznam zgoraj), v katerih je družba zaprosila za izdajo dovoljenja za promet.
Each ring contains two hormones, etonogestrel and ethinylestradiol, which are slowly released into the blood circulation and prevent the release of eggs from the ovaries.
Vsak obroček vsebuje dva hormona, etonogestrel in etinilestradiol, ki se počasi sproščata v krvni obtok in preprečujeta sproščanje jajčec iz jajčnikov.
Why was Perlinring reviewed?
Zakaj je bilo zdravilo Perlinring pregledano?
The European Commission issued an EU-wide legally binding decision on 18 December 2018.
Evropska komisija je 18. decembra 2018 izdala pravno zavezujoči sklep za vse države članice EU.
medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Dve zdravili sta bioekvivalentni, kadar dosegata enake ravni učinkovine v telesu in se zato pričakuje, da bosta imeli enak učinek.
Perlinring was developed as a generic medicine.
Zdravilo Perlinring je bilo razvito kot generično zdravilo.
Perlinring is a contraceptive vaginal ring used to prevent pregnancy.
Perlinring je kontracepcijski vaginalni obroček, ki se uporablja za preprečevanje nosečnosti.
The Agency therefore concluded that the benefits of Perlinring outweigh its risks and recommended that the marketing authorisation be granted in all concerned Member States.
Agencija je zato zaključila, da koristi zdravila Perlinring odtehtajo z njim povezana tveganja, in priporočila, da se dovoljenje za promet izda v vseh zadevnih državah članicah.
However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to EMA for arbitration on 7 August 2018.
Ker pa države članice niso dosegle soglasja, je britanska regulativna agencija za zdravila 7. avgusta 2018 zadevo napotila na Evropsko agencijo za zdravila v arbitražo.
Based on evaluation of the currently available data, the Agency considered that bioequivalence to the reference medicinal product has been shown for the authorised duration of treatment (3 weeks).
Na podlagi ocene trenutno razpoložljivih podatkov je agencija menila, da je bila bioekvivalentnost z referenčnim zdravilom dokazana za odobreno obdobje trajanja zdravljenja (3 tedne).
Perlinring is used for 21 days (3 weeks) in a row, followed by a 7-day break, after which a new ring should be used.
Zdravilo Perlinring se uporablja 21 dni (3 tedne) zapored, temu pa sledi 7-dnevni premor, po katerem je treba uporabiti nov obroček.
On 18 October 2018, the European Medicines Agency completed a review of Perlinring following a disagreement among EU Member States regarding its authorisation.
Evropska agencija za zdravila je 18. oktobra 2018 zaključila pregled v zvezi z izdajo dovoljenja za promet z zdravilom Perlinring po nesoglasju med državami članicami EU.
The grounds for the referral relate to concerns raised by Germany, France and the Netherlands, that the Nuvaring product information for doctors and patients states that the product continues to be effective if it is used for an additional 4th week.
Razlogi za napotitev se nanašajo na pomisleke, ki so jih izrazili Nemčija, Francija in Nizozemska, in sicer, da je v informacijah o zdravilu Nuvaring, ki so namenjene zdravnikom in bolnikom, navedeno, da je zdravilo še naprej učinkovito, če se uporablja teden dni več, tj. tudi v 4. tednu.
What is Perlinring?
Kaj je zdravilo Perlinring?
Actavis Group PTC EHF submitted Perlinring to the UK medicines agency for a decentralised procedure.
Družba Actavis Group EHF je britanski agenciji za zdravila predložila vlogo za izdajo dovoljenja za zdravilo Perlinring po decentraliziranem postopku.
This means that Perlinring was developed to contain the same active substance and work in the same way as a ‘reference medicine' already authorised in the EU called Nuvaring.
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Nuvaring.
Although the bioequivalence data submitted were sufficient to show that Perlinring is bioequivalent to Nuvaring over a period of 3 weeks, they did not cover the additional 4th week during which the contraceptive ring may still be used, even though this use is not recommended.
Čeprav so predloženi podatki o bioekvivalenci pokazali, da je zdravilo Perlinring bioekvivalentno zdravilu Nuvaring v obdobju treh tednov, pa ti podatki niso zajeli dodatnega 4. tedna, v katerem se kontracepcijski obroček lahko še vedno uporablja, čeprav ta uporaba ni priporočljiva.
In addition, there is enough evidence to expect that Perlinring continues to be effective for an additional 4th week, as is the case for Nuvaring.
Poleg tega je na voljo dovolj dokazov, na podlagi katerih je mogoče pričakovati, da bo zdravilo Perlinring učinkovito tudi v 4. tednu uporabe, kot je to v primeru zdravila Nuvaring.
Bioequivalence data for week 4 were considered necessary by Germany, France and the Netherlands as Perlinring is expected to be used in the same way as Nuvaring.
Nemčija, Francija in Nizozemska so menile, da so podatki o bioekvivalenci za 4. teden potrebni, saj naj bi se zdravilo Perlinring po pričakovanjih uporabljalo na enak način kot zdravilo Nuvaring.
In its application, the company for Perlinring provided data demonstrating that Perlinring is ‘bioequivalent' to Nuvaring over a period of 3 weeks, which is the authorised length of treatment.
Družba je v svoji vlogi predložila podatke, ki dokazujejo, da je zdravilo Perlinring „bioekvivalentno“ zdravilu Nuvaring v obdobju treh tednov, kar je dovoljeno obdobje zdravljenja.
EMEA/458933/2008-EN
EMEA/458933/2008-SL
London, August 2008 EMEA/458933/2008
London, avgust 2008 EMEA/458933/2008
The CVMP Opinion was adopted on 11 October 2007 and the subsequent Commission Decision on 11 January 2008.
Mnenje Odbora za zdravila za uporabo v veterinarski medicini (CVMP) je bilo sprejeto dne 11. oktobra 2007, s tem povezana odločba Komisije pa 11. januarja 2008.
The CVMP started the referral procedure during its meeting of 12-14 September 2006.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je napotitveni postopek začel med svojim zasedanjem od 12. do 14. septembra 2006.
On the basis of the data provided, the CVMP agreed on the following harmonised indications for use:
CVMP je na podlagi predloženih podatkov sprejel naslednje usklajene indikacije za uporabo:
On 8 September 2006, Germany presented to the EMEA a referral under Article 34 of Directive 2001/82/EC, as amended, concerning Methoxasol-T (including associated names), containing trimethoprim and sulfamethoxazole as active ingredient.
Nemčija je dne 8. septembra 2006 Evropski agencija za zdravila predložila napotitev v skladu s členom 34 Direktive 2001/82/ES, kakor je bila spremenjena, za zdravilo Methoxasol-T (in z njim povezana imena), ki vsebuje zdravilni učinkovini trimetoprim in sulfametoksazol.
Methoxasol-T was authorised through a national procedure in The Netherlands in 1999, but a marketing authorisation was refused in Germany in 2001.
Zdravilo Methoxasol-T je dovoljenje za promet pridobilo leta 1999 z nacionalnim postopkom na Nizozemskem, vendar so v Nemčiji vlogo za dovoljenje za promet z zdravilom v letu 2001 zavrnili.
Germany considered that the efficacy of Methoxasol-T as proposed by the applicant was not adequately justified, therefore resulting in a potential serious risk to the target animals.
Nemčija je menila, da predlagatelj v svoji vlogi ni ustrezno utemeljil učinkovitosti zdravila Methoxasol-T, kar je posledično pomenilo možno resno tveganje za ciljne živali.
The CVMP also recommended that the use of the product should be based on culture and sensitivity testing of micro-organisms from diseased cases on farm or from recent previous experience on the farm, as resistance against potentiated sulphonamides may vary.
Priporočil je tudi uporabo zdravila na podlagi testiranja kultur in občutljivosti mikroorganizmov iz obolelih primerov na kmetiji ali nedavnih izkušenj na kmetiji, saj se lahko odpornost na okrepljene sulfonamide spreminja.
OPINION FOLLOWING AN ARTICLE 34 REFERRAL FOR METHOXASOL-T
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 34 ZA ZDRAVILO METHOXASOL-T
The CVMP recommended in relation to the pharmacokinetic properties described that the inclusion of environmental effects should be deleted.
CVMP je v zvezi z opisanimi farmakokinetičnimi lastnostmi priporočil izbris navedbe o okoljskih učinkih.
An intended application for a marketing authorisation of a generic triggered Germany to submit the referral regarding the divergent decisions taken on Methoxasol-T.
Zaradi načrtovane vloge za dovoljenje za promet z generičnim zdravilom je Nemčija sprožila napotitveni postopek zaradi različnih odločitev o zdravilu Methoxasol-T.
• Pigs: treatment and prevention of respiratory infections caused by Actinobacillus pleuropneumoniae susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the herd.
• Prašiči: zdravljenje in preprečevanje okužb dihal, ki jih povzroča bakterija Actinobacillus pleuropneumoniae, občutljiva na trimetroprim in sulfametoksazol, kadar je bila bolezen diagnosticirana v čredi;
Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holder, CVMP concluded that the benefit/risk balance of the product is positive for use in both pigs and broilers subject to recommended changes to the Summary of Product Characteristics and product information, and that the concerns raised by Germany should not prevent the granting of a marketing authorisation.
Ob upoštevanju razlogov za napotitev in odgovorov, ki jih je predložil imetnik dovoljenja za promet, je CVMP zaključil, da je razmerje med koristmi in tveganji za uporabo zdravila pri prašičih in pitovnih piščancih pozitivno, ob upoštevanju priporočenih sprememb v povzetku glavnih značilnosti zdravila in informacijah o zdravilu, ter da izraženi zadržki Nemčije ne bi smeli preprečiti odobritve dovoljenja za promet z zdravilom.