natgillin/translations-raw huggingface dataset:
• Phenobarbital, phenytoin - used to treat epilepsy
• fenobarbital, fenitoin - uporabljata se za zdravljenje epilepsije; • paraaminosalicilna kislina (PAS) - uporablja se za zdravljenje tuberkuloze.
No 2,6-xylidine or o-toluidine was detectable at any time-point in vaginal fluids following local application of the medicinal product in female volunteers.
V nožnični tekočini po lokalnem nanosu zdravila pri ženskih prostovoljkah na nobeni časovni točki ni bilo zaznati 2,6-ksilidina ali o-toluidina.
Each container of 5 ml delivers a minimum of 12 doses.
En 5-ml vsebnik zagotavlja najmanj 12 odmerkov.
In carcinogenicity studies of o-toluidine in rats, mice and hamsters, tumours were observed in several organs.
miših in hrčkih so opazili tumorje v več organih.
Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution
Fortacin 150 mg/50 mg v 1 ml dermalno pršilo, raztopina
At each of the three monthly assessments all subjects completed a Premature Ejaculation Profile (PEP) questionnaire relating to perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse, and interpersonal difficulty relating to ejaculation.
(PEP) glede osebno opaženega nadzora nad ejakulacijo, osebne stiske v povezavi z ejakulacijo, zadovoljstva s spolnim odnosom in medosebnih težav v zvezi z ejakulacijo.
Package leaflet: Information for the user Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution lidocaine/prilocaine
Navodilo za uporabo Fortacin 150 mg/50 mg v 1 ml dermalno pršilo, raztopina lidokain/prilokain
Vulvovaginal burning sensation, hypoaesthesia Uncommon Vulvovaginal discomfort, vaginal pain, vulvovaginal pruritus
Neprijetni občutek v vulvovaginalnem področju, bolečina v nožnici, srbenje vulvovaginalnega področja
- Each spray container of 5 ml delivers a minimum of 12 doses.
- En 5-ml vsebnik zagotavlja najmanj 12 odmerkov.
Reproductive system and breast disorders
Motnje reprodukcije in dojk Pogosto
Medicinal products subject to medical prescription.
Predpisovanje in izdaja zdravila je le na recept.
85.2% of subjects in the Fortacin group achieved a mean IELT of > 1 minute over the course of 3 months of treatment with it, whereas 46.4% of the placebo subjects had a mean IELT of > 1 minute.
85,2 % preiskovancev iz skupine, ki je prejemala zdravilo Fortacin, je doseglo sredino IELT > 1
Uncommon Dysuria
peroralna parestezija
Once the can is held upright (valve up), 1 dose of Fortacin should be applied to the entire glans penis, by actuating the valve 3 times.
Vsebnik držite navpično (ventil obrnjen navzgor) in s tremi potiski ventila na celotno glavico penisa nanesite 1 odmerek zdravila Fortacin.
Mechanism of action
Previdnostni ukrepi
They are very unlikely to happen if it is used as instructed:
Pri uporabi zdravila v skladu z navodili je malo verjetno, da bi se pojavili naslednji simptomi:
Uncommon Anorectal discomfort, oral parasthesia
Neprijetni občutek v anorektalnem področju,
Infections and infestations
Infekcijske in parazitske bolezni Občasno
- Each ml of solution contains 150 mg lidocaine and 50 mg prilocaine - Each spray delivers 50 microlitres which contains 7.5 mg lidocaine and 2.5 mg prilocaine.
- Vsaka razpršitev zagotavlja 50 mikrolitrov, ki vsebujejo 7,5 mg lidokaina in 2,5 mg prilokaina.
Uncommon Genital erythema, ejaculation failure, paraesthesia of male genital, penile pain, penis disorder, pruritus genital
parestezija moških spolovil, bolečine v penisu,
• itching in and around the penis
• rdečina penisa in področja okrog njega;
LIST OF EXCIPIENTS
Presnovek lidokaina
Uncommon Skin irritation
Draženje kože
(methaemoglobinaemia).
Ejaculation, IPE).
Renal and urinary disorders
antagonisti adrenergičnih receptorjev beta);
• Inability to develop or maintain an erection
• nezmožnost ejakulacije med spolnim odnosom; • motnje orgazma;
The plasma levels of lidocaine and prilocaine in male and female subjects were below the level associated with toxicity (5,000 ng/ml).
Absorpcija Ravni lidokaina in prilokaina v plazmi pri moških in ženskih preiskovancih so bile pod ravnjo,
3 inhalers (3 x 60 doses)
3 inhalatorji (3 x 60 odmerkov)
1 inhaler (60 doses)
1 inhalator (60 odmerkov)
Medicinal product no longer authorised
Zdravilo nim a več dovoljenja za promet
MA (EU) number Invented name Strength Pharmaceutical
Izmišljeno ime Jakost ovojnina
The European Commission granted a marketing authorisation valid throughout the European Union for Revatio on 28 October 2005.
Evropska komisija je dovoljenje za promet z zdravilom Revatio, veljavno po vsej Evropski uniji, izdala 28. oktobra 2005.
What measures are being taken to ensure the safe use of Revatio?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Revatio?
The main study in children involved 235 children aged 1 to 17 years with PAH.
V glavno študijo pri otrocih je bilo vključenih 235 otrok, starih od enega do 17 let s PAH.
The full EPAR for Revatio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Revatio je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Revatio
Druge informacije o zdravilu Revatio
Why is Revatio approved?
Zakaj je bilo zdravilo Revatio odobreno?
It is not intended to provide practical advice on how to use Revatio.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
This is a summary of the European public assessment report (EPAR) for Revatio.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Revatio.
It will also ensure that doctors and pharmacists who will prescribe or dispense the solution for injection in each Member State receive information about how it should be used and how to report side effects such as low blood pressure.
Zagotovila bo tudi, da zdravniki in farmacevti, ki bodo predpisovali ali izdajali raztopino za injiciranje v vsaki državi članici, prejmejo informacije o načinu uporabe in načinu poročanja o neželenih učinkih, kot je na primer nizek krvni tlak.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Revatio's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Revatio večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
It must not be started in patients with severe liver disease or severe hypotension (very low blood pressure), or who have recently had a stroke or heart attack, because Revatio has not been studied in these groups of patients.
Ne sme se uvesti pri bolnikih z hudim obolenjem jeter ali hudo hipotenzijo (zelo nizkim krvnim tlakom) ali tistih, ki so nedavno doživeli kap ali srčni napad, saj zdravilo Revatio še bilo proučeno pri teh skupinah bolnikov.
What is Revatio and what is it used for?
Kaj je zdravilo Revatio in za kaj se uporablja?
Revatio was more effective than placebo (a dummy treatment) at improving exercise capacity in one main study in adults and another main study in children.
Zdravilo Revatio se je izkazalo za učinkovitejše od placeba (zdravila brez zdravilne učinkovine) pri izboljšanju telesne zmogljivosti v eni glavni študiji pri odraslih in eni glavni študiji pri otrocih.
What are the risks associated with Revatio?
Kakšna tveganja so povezana z zdravilom Revatio?
The company that markets Revatio will agree with each European Union Member State on how the solution for injection will be distributed.
Družba, ki proizvaja zdravilo Revatio, se bo z državami članicami Evropske unije dogovorila o načinu distribucije raztopine za injiciranje.
In children aged 1 to 17 years, the recommended dose is 10 mg three times a day in children weighing less than 20 kg and 20 mg three times a day in those over 20 kg. Higher doses should not be used.
Pri otrocih v starosti od enega do 17 let je priporočeni odmerek 10 mg trikrat na dan pri otrocih, ki tehtajo manj kot 20 kg ter 20 mg trikrat na dan pri tistih, ki tehtajo več kot 20 kg. Višji odmerek se ne sme uporabiti.
This leads to high blood pressure in the vessels taking blood from the heart to the lungs and reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.
To povzroči visok krvni tlak v žilah, po katerih se pretaka kri iz srca v pljuča, in zniža količino kisika, ki lahko pride v kri v pljučih, zaradi česar je telesna dejavnost otežena.
The solution for injection is for adults who cannot take Revatio tablets or oral suspension for a short period, but whose condition is stable.
Raztopina za injiciranje je namenjena odraslim, ki kratkoročno ne morejo jemati tablet ali peroralne suspenzije, a je njihovo stanje stabilno.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Revatio have also been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Revatio upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
The active substance in Revatio, sildenafil, belongs to a group of medicines called ‘phosphodiesterase type 5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme.
Zdravilna učinkovina v zdravilu Revatio, sildenafil, spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5 (PDE5), kar pomeni, da zavira encim PDE5.
This enzyme is found in the blood vessels of the lungs.
Ta encim je prisoten v krvnih žilah v pljučih.
Adults with class III disease could walk an average of 326 m at the start of the study.
Odrasli z boleznijo razreda III so ob začetku študije lahko prehodili povprečno 326 metrov.
The company also presented the results of studies showing that the tablets were equivalent to the oral suspension (produced similar levels of sildenafil in the blood), and that a 10 mg injection was equivalent to a 20 mg tablet.
Družba je predstavila tudi rezultate, ki so pokazali, da so tablete enakovredne peroralni suspenziji (proizvedena raven sildenafila v krvi je podobna) in da je 10-miligramska injekcija enakovredna 20-miligramskim tabletam.
For more information about treatment with Revatio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Revatio preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Before treatment, adults with class II disease could walk an average of 378m in 6 minutes.
Pred zdravljenjem so bolniki z boleznijo razreda II povprečno prehodili 378 metrov v šestih minutah.
What benefits of Revatio have been shown in studies?
Kakšne koristi je zdravilo Revatio izkazalo v študijah?
Revatio must not be taken with nitrates (medicines used to treat angina), or with medicines that could affect the way that Revatio is broken down in the body, such as ketoconazole or itraconazole (antifungal medicines) and ritonavir (used to treat HIV infection).
Zdravilo Revatio se ne sme jemati skupaj z nitrati (zdravili za zdravljenje angine pektoris) ali zdravili, ki lahko vplivajo na razgradnjo zdravila Revatio v telesu, kot sta ketokonazol ali itrakonazol (zdravili za glivične okužbe), in ritonavirjem (ki se uporablja za zdravljenje okužbe z virusom HIV).
In adults, Revatio is taken at a dose of 20 mg three times a day.
Pri odraslih se zdravilo Revatio jemlje v odmerku 20 mg trikrat na dan.
Revatio is a medicine used to treat adults and children from 1 year of age with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries of the lungs).
Zdravilo Revatio se uporablja za zdravljenje odraslih in otrok, starejših od enega leta, s pljučno arterijsko hipertenzijo (PAH, nenormalno visokim krvnim tlakom v pljučnih arterijah).
In adults, Revatio is used in patients with class II (slight limitation of physical activity) or class III (marked limitation of physical activity) PAH.
Pri odraslih se zdravilo uporablja pri bolnikih s pljučno arterijsko hipertenzijo razreda II (rahla omejitev fizične dejavnosti) ali III (znatna omejitev fizične dejavnosti).
How does Revatio work?
Kako zdravilo Revatio deluje?
When it is blocked, a substance called ‘cyclic guanine monophosphate' (cGMP) cannot be broken down, so that it remains in the vessels where it causes relaxation and widening of the blood vessels.
Če je snov, imenovana „ciklični gvanozinmonofosfat“ (cGMP), zavirana, se ne more razgraditi in ostane v žilah, kjer povzroči, da se te sprostijo in razširijo.
Revatio is available as tablets (20 mg), a solution for injection (0.8 mg/ml) and a powder to be made up into an oral suspension (10 mg/ml).
Zdravilo Revatio je na voljo v obliki tablet (20 mg), raztopine za injiciranje (0,8 mg/ml) in praška za pripravo peroralne suspenzije (10 mg/ml).
For practical information about using Revatio, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Revatio naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
After 16 weeks, the maximum volume of oxygen the children used during exercise increased on average by 10.2% with Revatio compared with 0.5% with placebo.
Po 16 tednih se je največji volumen kisika, porabljen med vajo, povečal povprečno za 10,2 % pri otrocih, ki so jemali zdravilo Revatio, v primerjavi s tistimi, ki so jemali placebo.
Change in exercise capacity in this study was measured as the improvement in the maximum volume of oxygen used during exercise after 16 weeks of treatment, in children able to perform the exercise tests.
Spremembe v telesni zmogljivosti v tej študiji so med otroki, ki so lahko opravili test, merili z izboljšanjem največjega volumna kisika, ki ga je otrok porabil med vajo po 16 tednih zdravljenja.
Revatio must not be taken by patients who have ever had a problem with blood flow in the eye called non-arteritic anterior ischaemic optic neuropathy (NAION).
Zdravila Revatio ne smejo jemati bolniki, ki so kadar koli imeli težave z dotokom krvi v oko, imenovanim nearteritična anteriorna ishemična optična nevropatija (NAION).
Revatio can only be obtained with a prescription and treatment should only be started and monitored by a doctor who has experience in the treatment of PAH.
Predpisovanje in izdaja zdravila Revatio je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik z izkušnjami z zdravljenjem pljučne arterijske hipertenzije.
Revatio contains the active substance sildenafil.
Zdravilo Revatio vsebuje zdravilno učinkovino sildenafil.
In adults who cannot take the tablets or oral suspension, the solution for injection is injected into a vein by a doctor or nurse at a dose of 10 mg (12.5 ml) three times a day.
Odrasli, ki ne morejo jemati tablet ali peroralne suspenzije, prejmejo raztopino za injiciranje v odmerku 10 mg (12,5 ml) trikrat na dan v obliki intravenske injekcije, ki jo daje zdravnik ali medicinska sestra.
In children, the most common side effects (which may affect up to 1 patient in 10) are throat and nose infections, headache, vomiting, fever, diarrhoea, flu and nosebleeds.
Najpogostejši neželeni učinki, opaženi pri otrocih (ki lahko prizadenejo do 1 bolnika od 10), so okužbe grla in nosu, glavobol, bruhanje, povišana telesna temperatura, driska, gripa in krvavitve iz nosu.
The CHMP concluded that Revatio provides an alternative treatment option for PAH.
Menil je tudi, da zdravilo Revatio pomeni dodatno možnost zdravljenja za bolnike s PAH.
Lower doses of Revatio may be needed in patients taking some medicines that affect the way Revatio is broken down in the body.
Pri bolnikih, ki jemljejo nekatera zdravila, ki lahko vplivajo na to, kako se zdravilo Revatio razgradi v telesu, bodo morda potrebni nižji odmerki tega zdravila.
For the full list of all side effects reported with Revatio, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Revatio, glejte navodilo za uporabo.
In patients with PAH, sildenafil widens the blood vessels of the lungs, which lowers the blood pressure and improves symptoms.
Sildenafil pri bolnikih s pljučno arterijsko hipertenzijo razširi krvne žile v pljučih, kar zniža krvni tlak in olajša simptome.
The most common side effects with Revatio in adults (which may affect more than 1 patient in 10) are headache, flushing (reddening of the skin), dyspepsia (heartburn), diarrhoea and pain in arm or leg. Side effects are similar with the solution for injection.
Najpogostejši neželeni učinki zdravila Revatio (ki lahko prizadenejo več kot 1 bolnika od 10) so glavobol, zardevanje (pordelost kože), dispepsija (zgaga), driska in bolečine v rokah ali nogah.
PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Pljučna arterijska hipertenzija je izčrpavajoča bolezen, pri kateri pride do hude konstrikcije (zoženja) krvnih žil v pljučih.
After 12 weeks, this distance had increased by 49 m more in the patients taking 20 mg Revatio than in the patients taking placebo.
Po 12 tednih se je pri bolnikih, ki so jemali 20-miligramski odmerek zdravila Revatio, ta razdalja povečala za 49 metrov več kot pri tistih, ki so jemali placebo.
This distance had increased by 45 m more in the patients taking 20 mg Revatio than in those taking placebo after 12 weeks.
Pri bolnikih, ki so jemali 20-miligramski odmerek, se je po 12 tednih ta razdalja povečala za 45 metrov več kot pri tistih, ki so jemali placebo.
How is Revatio used?
Kako se zdravilo Revatio uporablja?
The main study in adults involved 277 patients with PAH, most of whom had class II or class III disease.
V glavno študijo pri odraslih je bilo vključenih 277 bolnikov s pljučno arterijsko hipertenzijo, večina katerih je imela bolezen razreda II ali III. Spremembo v telesni zmogljivosti so merili kot izboljšanje v razdalji, ki jo je bolnik lahko prehodil v šestih minutah po 12 tednih zdravljenja.
--1 1 dose (0.2 ml) contains:
--1 1 odmerek (0,2 ml) vsebuje:
This product contains a genetically modified organism (GMO).
To cepivo vsebuje gensko spremenjene organizme (GSO).
*** fluorescent focus units
*** Fluorescentna fokusna enota
A/Vietnam/1203/2004 (H5N1) strain (A/Vietnam/1203/2004, MEDI 0141000136) 10
A/Vietnam/1203/2004 (H5N1) (A/Vietnam/1203/2004, MEDI 0141000136) 107.0±0.5 FFU***
* propagated in fertilised hens' eggs from healthy chicken flocks.
* Namnožen v oplojenih kokošjih jajcih iz jat zdravih piščancev.
** produced in VERO cells by reverse genetic technology.
** Pridobljen v celicah VERO s tehnologijo reverzne genetike.
Reassortant influenza virus* (live attenuated) of the following strain**:
Reasortirani virus gripe* (živ, oslabljen) seva**:
10 sprayers
10 nosnikov
EU/1/16/1089/001 Pandemic influenza vaccine H5N1 AstraZeneca
EU/1/16/1089/001
Nasal use sprayer (glass) in trays
Pot uporabe Stična ovojnina
(Invented) name
Številka postopka EMA (Izmišljeno) ime
• There are alternative treatments available in the EU.
• V EU so na voljo alternativna zdravljenja.
• Patients who have any questions or concerns should speak to their healthcare professional.
• Bolniki, ki imajo kakršna koli vprašanja ali pomisleke, naj se posvetujejo z zdravnikom.
The review of Inductos was initiated on 23 July 2015 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Pregled zdravila Inductos se je pričel 23. julija 2015 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
It was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.
Opravil ga je Odbor za zdravila za uporabo v humani medicini (CHMP), pristojen za vprašanja v zvezi z zdravili za uporabo v humani medicini.
The CHMP recommendation was sent to the European Commission, which endorsed it and issued a final legally binding decision.
Priporočilo CHMP je bilo poslano Evropski komisiji, ki je priporočilo podprla in izdala končno pravno zavezujočo odločbo.
Inductos was authorised centrally in the EU in September 2002.
Zdravilo Inductos je bilo v EU odobreno po centraliziranem postopku septembra 2002.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 20/11/2015.
Mnenje odbora CHMP je bilo posredovano Evropski komisiji, ki je dne 20/11/2015 izdala končno pravno zavezujočo odločbo, ki velja za vse države članice EU.
The inspectors noted that the manufacturer, located in the United States, did not have adequate measures in place to prevent particle contamination of the sponges.
Inšpektorji so ugotovili, da proizvajalec s sedežem v Združenih državah ne izvaja ustreznih ukrepov za preprečevanje kontaminacije gob z delci.
The new bone tissue grows into the sponge, which is gradually degraded by the body.
Novo kostno tkivo raste v gobo, ki jo telo postopoma razgradi.
Although there is no indication of risk to patients linked to the inspection findings, EMA's Committee for Medicinal Products for Human Use (CHMP) considered that the quality of Inductos cannot be assured with the current manufacturing process.
Kljub temu da ni znakov tveganja za bolnike, povezanih z ugotovitvami inšpekcijskega pregleda, je Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA menil, da s sedanjim proizvodnim procesom ni mogoče zagotoviti kakovosti zdravila Inductos.
Inductos to be suspended in the EU EMA/683814/2015
Začasen umik dovoljenja za promet z zdravilom Inductos v EU EMA/683814/2015
The active substance is dibotermin alfa, a protein that acts on the bone structure and helps with the formation of new bone tissue.
Zdravilna učinkovina je dibotermin alfa, protein, ki deluje na zgradbo kosti in pomaga pri oblikovanju novega kostnega tkiva.
• Problems have been identified with the way the absorbable sponge in Inductos is manufactured.
• Ugotovljene so bile težave z načinom proizvodnje absorpcijske gobe pri zdravilu Inductos.
Suspension will remain until manufacturing issues are resolved
Umik bo veljal, dokler se ne odpravijo težave v proizvodnji
Inductos to be suspended in the EU
Začasen umik dovoljenja za promet z zdravilom Inductos v EU
On 22 October 2015, the European Medicines Agency (EMA) recommended the suspension of Inductos, an implant used to help new bone develop in patients with spinal disc problems and leg fractures.
Evropska agencija za zdravila je 22. oktobra 2015 priporočila začasen umik dovoljenja za promet z zdravilom Inductos, vsadkom, ki se uporablja za pomoč pri razvoju novega kostnega tkiva pri bolnikih, ki imajo težave z medvretenčno ploščico, in tistih, ki so utrpeli zlom noge.
It is used during surgery in patients with damaged spinal discs or leg (tibia) fractures.
Uporablja se med kirurškim posegom pri bolnikih s poškodovano medvretenčno ploščico ali zlomom noge (golenice).
• Although there is no indication of risk to patients, Inductos has been suspended and will no longer be available in the EU until issues with the manufacturing site for the absorbable sponge are solved.
• Kljub temu da ni znakov tveganja za bolnike, je bilo dovoljenje za promet z zdravilom Inductos začasno umaknjeno, kar pomeni, da ne bo več na voljo v EU, dokler se težave, povezane z obratom za proizvodnjo absorpcijske gobe, ne odpravijo.
EMA started a review of Inductos following an inspection by Dutch and Spanish authorities which found the manufacturing site of the absorbable sponge to be non-compliant with manufacturing requirements.
Agencija je pregled zdravila Inductos sprožila po inšpekcijskem pregledu, ki so ga opravili nizozemski in španski organi, pri katerem je bilo ugotovljeno, da proizvodni obrat absorpcijske gobe ni skladen s proizvodnimi zahtevami.
The CHMP therefore concluded that Inductos should be suspended until the manufacturing issues are satisfactorily addressed.
CHMP je zato sklenil, da je treba dovoljenje za promet z zdravilom Inductos začasno umakniti, dokler težave v proizvodnji ne bodo zadovoljivo odpravljene.