natgillin/translations-raw huggingface dataset:
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA,
¾ The lack of clinical data to support the combination with theophylline and that such combination is not recommended.
¾ Pomanjkanje kliničnih podatkov, ki bi podpirali kombinacijo s teofilinom, zato takšna kombinacija ni priporočljiva.
¾ The potential risk of malignant tumours and the lack of experience in patients with past history of cancer.
¾ Potencialno tveganje za maligne tumorje in pomanjkanje izkušenj pri bolnikih z anamnezo raka v preteklosti.
Daliresp is contraindicated in patients with moderate or severe liver impairment (Child Pugh B or C).
Daliresp je kontraindiciran pri bolnikih z zmerno ali hudo okvaro jeter (Child Pugh B ali C).
• Copies of the patient card to be given to patients before they receive Daliresp
• Kopije kartic za bolnike, ki naj bi jih bolniki prejeli pred začetkom jemanja zdravila Daliresp
Daliresp is not recommended in patients with a history of depression associated with suicidal ideation or behaviour.
Daliresp ni priporočljiv za bolnike z anamnezo depresije, ki je bila povezana s samomorilnimi mislimi ali vedenjem.
¾ The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g. multiple sclerosis, lupus erythematous, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Daliresp should not be initiated or should be stopped in these patients.
¾ Pomanjkanje izkušenj pri bolnikih z okužbo HIV ali aktivnim hepatitisom, z resnimi imunološkimi boleznimi (npr. multiplo sklerozo, eritematoznim lupusom, multifokalno leukoencefalopatijo) ali na zdravljenju z imunosupresivnimi zdravili (razen kratkotrajnega zdravljenja s sistemskimi kortikosteroidi) in zdravila Daliresp se pri teh bolnikih ne sme uvajati oz. ga je treba ukiniti.
¾ The potential cardiac risk: Daliresp has not been studied in patients in congestive heart failure (NYHA grade 3 and 4); hence, it is not recommended in this population.
¾ Potencialno tveganje za srce: zdravilo Daliresp ni bilo raziskano pri bolnikih s kongestivnim srčnim popuščanjem (NYHA stopnje 3 in 4); za to populacijo ni priporočljiv.
Daliresp should not be initiated or should be stopped in patients with cancers (except basal cell carcinoma).
Zdravila Daliresp se ne sme uvajati oz. ga je treba ukiniti pri bolnikih z rakom (z izjemo bazalnoceličnega karcinoma).
¾ The risk of weight decrease in underweight patients and the need to monitor the body weight at each visit and to stop the treatment in the event of an unexplained and clinically concerning weight decrease.
¾ Tveganje za zmanjšanje telesne mase pri podhranjenih bolnikih, potreba po spremljanju telesne mase ob vsakem obisku in potreba po prekinitvi zdravljenja v primeru nepojasnjenega ali klinično zaskrbljujočega zmanjšanja telesne mase.
The fact that Daliresp is not indicated for the treatment of COPD patients other than those covered by the approved indication, nor for use in patients with asthma or alpha 1 anti trypsine deficiency.
Dejstvo, da zdravilo Daliresp ni indicirano za zdravljenje bolnikov s KOPB, razen tistih, ki ustrezajo odobreni indikaciji, ni primeren za uporabo pri bolnikih z astmo ali pomanjkanjem alfa-1-antitripsina.
That patients should tell their doctor if they develop symptoms indicative of:
Da morajo obvestiti svojega zdravnika, če opazijo simptome, ki so značilni za:
¾ The need to inform patients about the risks of Daliresp and the precautions for safe use.
¾ Obveznost informiranja bolnikov o tveganjih zdravila Daliresp in previdnostnih ukrepih za varno uporabo.
• The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to prescribe Daliresp are provided with an Educational pack.
• Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo imeli ob uvajanju vsi zdravniki, ki bodo predpisovali zdravilo Daliresp, na razpolago izobraževalno gradivo.
¾ The limited or missing information in patients with liver impairment.
¾ Omejene ali pomanjkljive informacije o bolnikih z okvaro jeter.
¾ The potential risk of infections: Daliresp should not be initiated, or treatment should be stopped, in patients with severe acute infectious diseases.
¾ Potencialno tveganje za okužbe: zdravila Daliresp se ne sme uvajati oz. zdravljenje je treba prekiniti pri bolnikih z resnimi oblikami akutnih infekcijskih bolezni.
¾ The risk of psychiatric disorders such as insomnia, anxiety, depression in patients receiving Daliresp and the potential risk of suicide.
¾ Tveganje za psihiatrične motnje, npr. nespečnost, tesnobo, depresijo, pri bolnikih, ki jemljejo zdravilo Daliresp in potencialno tveganje za samomor.
• Summary of Product Characteristics and Patient Information Leaflet for Daliresp
• Povzetek glavnih značilnosti zdravila in Navodilo za uporabo zdravila Daliresp
That Daliresp may cause weight loss and patients should weigh themselves regularly and record their weight on the patient card.
Da zdravilo Daliresp lahko povzroči izgubo telesne mase in, da se morajo redno tehtati ter beležiti svojo telesno maso na kartico za bolnike.
¾ That increased exposure might occur in certain populations and increase the risk of persistent intolerability: o Special populations who have increased PDE4 inhibition such as black non smoking females o Patients concomitantly treated with CYP1A2 inhibitors (such as fluvoxamine) or dual CYP3A4/1A2 inhibitors (such as enoxacin and cimetidine)
¾ Pri določenih populacijah lahko pride do povečane izpostavljenosti in povečanega tveganja za trajno intoleranco: o Posebne populacije s povečano inhibicijo PDE4, npr. temnopolte ženske nekadilke.
on 29 November 2010.
dne 29. novembra 2010.
This summary was last updated in 10-2010.
Povzetek je bil nazadnje posodobljen 10-2010.
This may help to protect against the disease caused by the virus.
To lahko pripomore k zaščiti pred boleznijo, ki jo ta virus povzroča.
It contains parts of influenza (flu) viruses that have been inactivated.
Vsebuje dele virusov influence (gripe), ki so bili inaktivirani.
This vaccine contains some parts of the H5N1 virus.
To cepivo vsebuje nekatere delce virusa H5N1.
However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.
Vendar pa bo med pandemijo cepljenje takih bolnikov morda vseeno upravičeno, če bo na voljo oprema za oživljanje.
In the first study, 21 days after the second injection, around 90% of people aged below 60 years and around 80% of those aged above 60 years had levels of antibodies that would protect them against H5N1.
V prvi študiji je 21 dni po drugi injekciji okoli 90 % ljudi, mlajših od 60 let, in okoli 80 % ljudi, starejših od 60 let, imelo tako raven protiteles, ki bi jih zaščitila pred sevom H5N1.
The vaccine contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Cepivo vsebuje tudi „adjuvans“ (spojino, ki vsebuje olje) za povečanje imunskega odziva.
The vaccine is given by injection into the shoulder muscle in two single doses, at least three weeks apart.
Cepivo se daje z injiciranjem v ramensko mišico z dvema posameznima odmerkoma v časovnem presledku vsaj treh tednov.
When a person is given the vaccine, the immune system recognises the virus parts as ‘foreign' and makes antibodies against them.
Ko oseba prejme cepivo, imunski sistem prepozna delce virusa kot „tujek“ in začne proti njim tvoriti protitelesa.
The vaccine has been developed to provide protection against this strain, so that it can be used before or during a flu pandemic.
Cepivo je bilo razvito za zagotavljanje zaščite pred tem sevom, tako da ga je mogoče uporabiti pred pandemijo gripe ali med njo.
The studies looked at the ability of the vaccine to trigger the production of antibodies (‘immunogenicity') in line with the CHMP criteria for prepandemic vaccines.
V teh študijah so proučevali sposobnost cepiva, da sproži nastajanje protiteles („imunogenost“) v skladu z merili CHMP za prepandemska cepiva.
According to criteria laid down by the CHMP, a prepandemic vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
V skladu z merili, ki jih je določil CHMP, je prepandemsko cepivo ustrezno učinkovito le, če zagotovi zaščitno raven protiteles pri vsaj 70 % ljudi.
This is a type of vaccine to be used to protect against a new strain of flu that may cause a future influenza pandemic.
To je posebna vrsta cepiva za zaščito pred novim sevom gripe, ki lahko povzroči pandemijo gripe v prihodnosti.
Health experts are concerned that a future flu pandemic could be caused by the H5N1 strain of the virus.
Zdravstvene strokovnjake skrbi, da bi lahko naslednjo pandemijo gripe povzročil sev H5N1 virusa.
A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Do pandemije gripe pride, ko se pojavi nov sev virusa gripe, ki se med ljudmi hitro širi, ker proti njemu niso imuni (oziroma pred njim niso zaščiteni).
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, including those found at trace (very low levels) such as egg or chicken protein, ovalbumin (a protein in egg white), kanamycin or neomycin sulphate (antibiotics), formaldehyde and cetyltrimethylammonium bromide.
Zdravila Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics ne smejo prejeti bolniki, ki so kdaj imeli anafilaktično reakcijo (hudo alergijsko reakcijo) na katero koli sestavino cepiva, vključno s katero koli snovjo, ki je v cepivu v sledeh (zelo majhne količine), kot so jajčne ali kokošje beljakovine, ovalbumin (beljakovina v jajčnem beljaku), kanamicin ali neomicinsulfat (antibiotika), formaldehid in cetiltrimetilamonijev bromid.
The CHMP noted that it is likely that a H5N1 strain of the influenza will cause a pandemic in the future.
Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da bo sev H5N1 influence v prihodnosti verjetno povzročil pandemijo.
The full EPAR for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics can be searched for 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 Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The most common side effects with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection (swelling, pain, induration and redness) and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (opaženi pri več kot 1 bolniku izmed 10) so glavobol, mialgija (bolečine v mišicah), reakcije na mestu injiciranja (otekanje, bolečina, zatrdlina in rdečina) in utrujenost.
In the event of an officially declared pandemic caused by the H5N1 strain of the influenza A, people who have already been vaccinated with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (with one or two doses) may be given only one more dose, instead of the two doses recommended for unvaccinated people.
V primeru uradno razglašene pandemije zaradi seva H5N1 gripe A lahko posamezniki, ki so že bili cepljeni z zdravilom Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics (z enim ali dvema odmerkoma), prejmejo samo še en odmerek in ne dveh, kot se priporoča za ljudi, ki predhodno še niso bili cepljeni.
For more information about treatment with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics contains a flu strain called A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14).
Zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics vsebuje sevu virusa gripe A/Vietnam/1194/2004 (H5N1) podoben sev NIBRG-14.
EPAR summary for the public prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Povzetek EPAR za javnost prepandemsko cepivo proti gripi (H5N1) (s površinskim antigenom, inaktivirano, z adjuvansom)
The second study established that Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics should be given as two doses at least three weeks apart.
Druga študija je potrdila, da je treba zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics dati z dvema odmerkoma v presledku vsaj treh tednov.
The applicant presented data on experimental models with vaccines similar to Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Predlagatelj je predstavil podatke o poskusnih modelih s cepivi, podobnimi zdravilu Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
This is a summary of the European public assessment report (EPAR) for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
In one study involving 3,372 people, subjects were given either a seasonal flu vaccine followed by two doses of Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics three weeks apart, or a placebo (a dummy vaccine) followed by two doses of an adjuvanted seasonal vaccine three weeks apart.
V eno študijo je bilo vključenih 3 372 preiskovancev, ki so prejeli cepivo proti sezonski gripi in čez tri tedne dva odmerka cepiva Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics ali pa placebo (cepivo brez zdravilne učinkovine) in čez tri tedne dva odmerka sezonskega cepiva z adjuvansom.
The CHMP decided that Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The studies showed that overall Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics produced an antibody response that met these criteria.
Študije so pokazale, da je na splošno zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics povzročilo odziv protiteles, ki izpolnjuje ta merila.
In the second study involving 240 people, subjects were given Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics using different vaccination schedules.
V drugo študijo je bilo vključenih 240 preiskovancev, ki so prejeli cepivo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics po različnih režimih cepljenja.
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine for use in adults to protect against flu caused by the H5N1 (“bird flu”) strain of the influenza A virus.
Zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics je cepivo za uporabo pri odraslih za zaščito pred gripo, ki jo povzroča sev H5N1 („ptičja gripa“) virusa gripe A. Cepivo se daje le v skladu z uradnimi priporočili.
The European Commission granted a marketing authorisation valid throughout the European Union for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics to Novartis Vaccines and Diagnostics S.r.l.
Evropska komisija je dovoljenje za promet z zdravilom Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, veljavno po vsej Evropski uniji, odobrila podjetju Novartis Vaccines and Diagnostics S.r.l.
Other information about Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Druge informacije o zdravilu Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a ‘prepandemic' vaccine.
Zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics je „prepandemsko“ cepivo.
For the full list of all side effects reported with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, glejte navodilo za uporabo.
Two main studies provided data on vaccination with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics in healthy adults aged below and above 60 years.
V okviru dveh glavnih študij so bili pridobljeni podatki o cepljenju zdravih odraslih, starih manj kot in več kot 60 let, z zdravilom Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
What benefit has Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics shown during the studies?
Kakšne koristi je zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics izkazalo med študijami?
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine.
Zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics je cepivo.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What is the risk associated with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
Kakšna tveganja so povezana z zdravilom Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
What is Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
Kaj je zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
Why has Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics been approved?
Zakaj je bilo zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics odobreno?
How is Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics used?
Kako se zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics uporablja?
How does Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics work?
Kako zdravilo Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics deluje?
The studies varied between 28 days and 13 months.
Študije so trajale od 28 dni do 13 mesecev.
There are 5 different strengths of patch available: 12, 25, 50, 75 and 100 μg/h.
Na voljo so obliži petih različnih jakosti: 12, 25, 50, 75 in 100 μg/h.
In these cases the benefits of such treatment should outweigh the risks (central nervous system depression and respiratory depression).
V teh primerih morajo koristi takega zdravljenja odtehtati tveganja (depresija osrednjega živčevja in respiratorna depresija).
Durogesic (fentanyl) transdermal patches are registered nationally in the following 24 European Economic Area (EEA) countries: Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden and United Kingdom.
Zdravilo Durogesic (fentanil) transdermalni obliži je nacionalno registriran v naslednjih 24 državah članicah Evropskega gospodarskega prostora (EGP): Avstrija, Belgija, Ciper, Češka, Danska, Finska, Francija, Grčija, Hrvaška, Irska, Islandija, Italija, Luksemburg, Madžarska, Malta, Nemčija, Nizozemska, Norveška,
Dose titration and maintenance therapy
Titracija odmerka in vzdrževalno zdravljenje
The expected timeline of treatment is restricted to continuous and long-term opioid treatment of severe chronic pain.
Pričakovani čas zdravljenja je omejen na stalno in dolgotrajno opioidno zdravljenje hude kronične bolečine.
The texts for the subsections absorption, distribution, biotransformation and excretion are considered acceptable.
Kot sprejemljiva so bila ocenjena besedila podpoglavij o absorpciji, distribuciji, biotransformaciji in ekskreciji.
With respect to ‘Special Populations' the text based on the data are justified and were considered to be acceptable with some amendments.
Kar se tiče „Posebnih populacij“, je besedilo, ki temelji na podatkih, upravičeno in z nekaj popravki sprejemljivo.
The proposed listing of most commonly reported adverse reactions from the pooled safety data was considered to be acceptable, with a minor amendment to improve the readability.
Predlagani seznam najpogosteje poročanih neželenih učinkov iz zbranih varnostnih podatkov je bil ocenjen kot sprejemljiv, z manjšim popravkom za boljšo berljivost.