FrancophonIA/ELRC3.0 huggingface dataset:
English: NA No dose adjustment needed for abacavir or lamivudine when administered with Exviera + ombitasvir/paritaprevir/ ritonavir.
Slovenian: Prilagoditev odmerka abakavirja ali lamivudina ni potrebna, kadar se sočasno daje s kombinacijo Exviera + ombitasvir/paritap revir/ritonavir.
English: Exviera ombitas vir/parit aprevir/ ritonavi r duloxetine
Slovenian: Exviera + ombitasvir/p aritaprevir/ri tonavir duloksetin
English: Concomitant use is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba je kontraindicirana (glejte poglavje imatinib
English: Very common
Slovenian: Pogosti pruritus
English: nordiazepam
Slovenian: norgestrel
English: ANTIDEPRESSANTS Escitalopram 10 mg single dose
Slovenian: ANTIARITMIKI digoksin enkraten odmerek 0,5 mg
English: Table 9 shows the SVR12 rates for genotype 1a-infected, treatment-naïve subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks in PEARL IV. Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin was not non-inferior to Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin.
Slovenian: Preglednica 9 prikazuje deleže SVR12 pri še nezdravljenih preiskovancih, okuženih z genotipom 1a, ki so v preskušanju PEARL IV 12 tednov dobivali zdravilo Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom ali brez njega.
English: No dose adjustment of Exviera is required in patients with mild hepatic impairment (Child-Pugh A).
Slovenian: Bolnikom z blago okvaro jeter (Child-Pugh A) odmerkov zdravila Exviera ni treba prilagoditi.
English: ↓ dasabuvir ↓ paritaprevir ↓ ombitasvir
Slovenian: ↓ dasabuvir ↓ombitasvir ↓ paritaprevir
English: 200 mg once daily followed by
Slovenian: 200 mg enkrat na dan in nato 200 mg dvakrat na dan
English: NA No dose adjustment needed for sofosbuvir when administered with Exviera + ombitasvir/paritaprevir /ritonavir.
Slovenian: NP Prilagoditev odmerka sofosbuvirja ni potrebna, kadar se sočasno daje s kombinacijo Exviera + ombitasvir/paritapr evir/ritonavir.
English: ↓ dasabuvir ombitasvir paritaprevir norethindrone (progestin only pill) 0.35 mg once daily
Slovenian: dasabuvir ombitasvir paritaprevir duloksetin Posamezen odmerek 60 mg
English: PEARL-II was a randomised, global multicentre, open-label trial conducted in 179 adults with chronic genotype 1b hepatitis C virus infection without cirrhosis who did not achieve SVR with prior treatment with pegIFN/RBV.
Slovenian: odraslih, ki so imeli kronično okužbo z virusom hepatitisa C genotipa 1b brez ciroze in s predhodnim zdravljenjem s pegIFN/RBV niso dosegli SVR.
English: Co-administration of Exviera and ombitasvir/paritaprevir/ ritonavir with rilpivirine once daily should only be considered in patients without known QTprolongation, and without other QTprolongation coadministered medicinal products.
Slovenian: ↑ paritaprevir enkrat na dan pride v poštev le pri bolnikih brez znanega podaljšanja intervala QT in brez sočasne uporabe kakšnih drugih zdravil, ki podaljšajo interval
English: ANTIMYCOBACTERIALS
Slovenian: ŠČITNIČNI HORMONI
English: In a pooled analysis of clinical trials with Exviera and ombitasvir/paritaprevir/ritonavir with and without ribavirin, 1% of subjects experienced serum ALT levels greater than 5 times the upper limit of normal (ULN) after starting treatment.
Slovenian: V kumulativni analizi kliničnih preskušanj zdravila Exviera s kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom ali brez njega se je po začetku zdravljenja zvišanje
English: NA No dose adjustment for cyclobenzaprine required; increase dose if clinically indicated.
Slovenian: Prilagoditev odmerka ciklobenzaprina ni potrebna;
English: ombitas vir/parit aprevir/ ritonavi r alprazolam (1.03-1.15) (1.15-1.55)
Slovenian: Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir (glejte poglavji 4.3 in 4.5).
English: No dose adjustment needed for Exviera + ombitasvir/paritaprevir/ ritonavir.
Slovenian: Prilagoditev odmerka ni potrebna za kombinacijo Exviera + ombitasvir/paritap revir/ritonavir.
English: Posology
Slovenian: Zavrtje
English: Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 16.2% had a body mass index of at least 30 kg/m2; 15.2% had a history of depression or bipolar disorder; 69.3% had IL28B non-CC genotype; 79.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 15.4% had portal fibrosis (F2) and 8.7% had bridging fibrosis (F3); 67.7% had HCV genotype 1a infection; 32.3% had HCV genotype 1b infection.
Slovenian: Zdravljeni preiskovanci (N = 631) so bili mediano stari 52 let (razpon: od 18 do 70); 54,5 % je bilo moških; 5,4 % je bilo črncev; 16,2 % jih je imelo indeks telesne mase vsaj 30 kg/m2; 15,2 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 69,3 % jih je imelo genotip IL28B ne-CC; 79,1 %
English: The EC50 of dasabuvir against genotype 1a-H77 and 1b-Con1 strains in HCV replicon cell culture assays was 7.7 and 1.8 nM, respectively.
Slovenian: Aktivnost v celični kulturi in biokemičnih študijah V preizkusih z replikonsko celično kulturo HCV je bila EC50 dasabuvirja proti sevu genotipa 1a-H77
English: A temporary suspension of fluvastatin and pitavastatin is recommended for the duration of treatment.
Slovenian: Sočasna uporaba s fluvastatinom in pitavastatinom ni priporočljiva
English: The recommended dose is one tablet taken once a day.
Slovenian: Priporočeni odmerek je ena tableta enkrat dnevno.
English: Other information about Qtern
Slovenian: Druge informacije o zdravilu Qtern
English: What measures are being taken to ensure the safe and effective use of Qtern?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Qtern?
English: This is a summary of the European public assessment report (EPAR) for Qtern.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Qtern.
English: The full EPAR for Qtern can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Qtern je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Qtern contains two different active substances, which work in different ways:
Slovenian: Zdravilo Qtern vsebuje dve različni zdravilni učinkovini, ki delujeta na različna načina:
English: Dapagliflozin has been authorised in the European Union (EU) as Forxiga since 2012;
Slovenian: Dapagliflozin je v Evropski uniji (EU) odobren od leta 2012 kot zdravilo Forxiga;
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Qtern's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Qtern večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Qtern have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Qtern, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: It is not intended to provide practical advice on how to use Qtern.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Qtern saxagliptin / dapagliflozin
Slovenian: Qtern saksagliptin/dapagliflozin
English: What benefits of Qtern have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Qtern izkazalo v študijah?
English: What are the risks associated with Qtern?
Slovenian: Kakšna tveganja so povezana z zdravilom Qtern?
English: Dapagliflozin in combination with saxagliptin (the same combination as in Qtern) was evaluated in 3 main studies involving 1,169 adults with type 2 diabetes.
Slovenian: Dapagliflozin so v kombinaciji s saksagliptinom (kar je enaka kombinacija kot v zdravilu Qtern) ocenjevali v treh glavnih študijah, ki so vključevale 1 169 odraslih s sladkorno boleznijo tipa 2.
English: Why is Qtern approved?
Slovenian: Zakaj je bilo zdravilo Qtern odobreno?
English: What is Qtern and what is it used for?
Slovenian: Kaj je zdravilo Qtern in za kaj se uporablja?
English: The CHMP therefore considered that Qtern should only be used in patients already receiving at least one component to avoid over-treatment and so that the value of each component can be judged individually.
Slovenian: Odbor CHMP je zato presodil, da se sme zdravilo Qtern uporabljati samo pri bolnikih, ki že prejemajo vsaj eno učinkovino, da ne pride do čezmernega zdravljenja in da se lahko presodi vrednost vsake učinkovine posebej.
English: • saxagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Slovenian: • saksagliptin je zaviralec dipeptidil-peptidaze-4 (DPP-4).
English: Although both components of Qtern contribute to lowering blood glucose levels, the effects of each may vary in different patients.
Slovenian: Čeprav obe sestavini zdravila Qtern prispevata k zniževanju ravni glukoze v krvi, se učinki vsake posebej med bolniki lahko razlikujejo.
English: On the basis of previous studies with the individual components of Qtern used together with a sulphonylurea, the CHMP also approved the combination of Qtern with a sulphonylurea.
Slovenian: Na podlagi predhodnih študij s posameznimi učinkovinami zdravila Qtern, uporabljenimi skupaj s sulfonilsečnino, je odbor CHMP odobril tudi kombinacijo zdravila Qtern s sulfonilsečnino.
English: For more information about treatment with Qtern, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Qtern preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Qtern is available as tablets (5 mg saxagliptin and 10 mg dapagliflozin) and can only be obtained with a prescription.
Slovenian: Zdravilo Qtern je na voljo v obliki tablet (5 mg saksagliptina in 10 mg dapagliflozina) ter se predpisuje in izdaja le na recept.
English: The most common side effects with Qtern (which may affect more than 1 in 10 people) are upper respiratory tract infection (such as nose and throat infections) and, when used with a sulphonylurea, hypoglycaemia (low blood glucose levels).
Slovenian: Najpogostejši neželeni učinki zdravila Qtern (ki lahko prizadenejo več kot 1 osebo od 10) so okužbe zgornjih dihal (kot so okužbe nosu in grla) in hipoglikemija (nizke ravni glukoze v krvi).
English: Qtern must not be used in people who are hypersensitive (allergic) to saxagliptin, dapagliflozin, any of the other ingredients or who have ever had a serious allergic reaction to any DPP-4 or SGLT2 inhibitor.
Slovenian: Zdravila Qtern ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) saksagliptin, dapagliflozin ali katero koli drugo sestavino zdravila ali pri katerih se je kdaj v preteklosti pojavila huda alergijska reakcija na zaviralec DPP-4 ali SGLT2.
English: For practical information about using Qtern, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Qtern naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the levels of glucose in the blood or when the body is unable to respond to insulin effectively.
Slovenian: Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne tvori dovolj insulina za uravnavanje ravni glukoze v krvi ali pri kateri se telo ne more učinkovito odzvati nanj.
English: The main measure of effectiveness was the change after 24 weeks of treatment in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Slovenian: Glavno merilo učinkovitosti je bila sprememba ravni snovi v krvi, ki se imenuje glikozilirani hemoglobin (HbA1c), po 24 tednih zdravljenja, kar označuje uspešnost uravnavanja glukoze v krvi.
English: The company also provided studies that were used in the authorisation of Forxiga and Onglyza where saxagliptin or dapagliflozin were used together with a sulphonylurea.
Slovenian: Družba je prav tako predložila študije, ki so bile uporabljene pri odobritvi zdravil Forxiga in Onglyza, pri katerih sta se saksagliptin oziroma dapagliflozin uporabljala skupaj s sulfonilsečnino.
English: For the full list of all side effects reported with Qtern, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Qtern, glejte navodilo za uporabo.
English: As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Slovenian: Zaradi delovanja obeh zdravilnih učinkovin se raven glukoze v krvi zniža, kar prispeva k obvladovanju sladkorne bolezni tipa 2.
English: Qtern is used to treat adults with type 2 diabetes to improve control of their blood glucose (sugar) levels.
Slovenian: Zdravilo Qtern se uporablja za zdravljenje odraslih s sladkorno boleznijo tipa 2 za izboljšanje uravnavanja ravni glukoze (sladkorja) v krvi.
English: How does Qtern work?
Slovenian: Kako zdravilo Qtern deluje?
English: • dapagliflozin works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Slovenian: • dapagliflozin zavira beljakovino v ledvicah, imenovano natrij-glukozni soprenašalec 2 (SGLT2).
English: Regarding its safety profile, Qtern was well tolerated with side effects being characteristic of SGLT2 and DDP-4 inhibitors.
Slovenian: Kar zadeva varnostni profil, so bolniki zdravilo Qtern dobro prenašali, neželeni učinki pa so značilni za zaviralce SGLT2 in DDP-4.
English: Qtern is used in patients whose blood glucose levels are not satisfactorily controlled with:
Slovenian: Zdravilo Qtern se uporablja pri bolnikih, pri katerih ravni glukoze v krvi ni mogoče v zadostni meri uravnavati:
English: The first study included patients whose blood glucose levels were not satisfactorily controlled with metformin alone.
Slovenian: Prva študija je vključevala bolnike, pri katerih ravni glukoze v krvi ni bilo mogoče v zadostni meri uravnati samo z metforminom.
English: It contains the active substances saxagliptin and dapagliflozin.
Slovenian: Vsebuje zdravilni učinkovini saksagliptin in dapagliflozin.
English: Results showed that when saxagliptin and dapagliflozin were taken together with metformin, they decreased HbA1c levels by 1.5 percentage points after 24 weeks, compared with a reduction of 0.9 percentage points with saxagliptin and metformin and 1.2 percentage points with dapagliflozin and metformin.
Slovenian: Rezultati so pokazali, da se je raven HbA1c ob hkratnem jemanju saksagliptina in dapagliflozina z metforminom po 24 tednih znižala za 1,5 odstotne točke, v primerjavi z znižanjem za 0,9 odstotne točke pri jemanju saksagliptina in metformina ter za 1,2 odstotne točke pri jemanju dapagliflozina in metformina.
English: By blocking the action of SGLT2, dapagliflozin causes more glucose to be removed via the kidney, through the urine, thereby reducing the levels of glucose in the blood.
Slovenian: Dapagliflozin z zaviranjem delovanja prenašalca SGLT2 povzroči večje izločanje glukoze prek ledvic z urinom, kar zniža ravni glukoze v krvi.
English: A further study, which included patients not controlled with metformin and saxagliptin, showed that adding dapagliflozin to treatment with saxagliptin and metformin for 24 weeks reduced HbA1c levels by 0.8 percentage points, compared with a reduction of 0.1 percentage points when placebo was added to saxagliptin and metformin.
Slovenian: Še ena študija, ki je vključevala bolnike, pri katerih bolezen z metforminom in saksagliptinom ni bila uravnana, je pokazala, da se je po dodajanju dapagliflozina zdravljenju s saksagliptinom in metforminom v obdobju 24 tednov raven HbA1c znižala za 0,8 odstotne točke, v primerjavi z znižanjem za 0,1 odstotne točke, ko so zdravljenju s saksagliptinom in metforminom dodajali placebo.
English: • metformin, a sulphonylurea and one of the components of Qtern.
Slovenian: • z metforminom, sulfonilsečnino in eno od učinkovin v zdravilu Qtern.
English: • metformin and one of the components of Qtern;
Slovenian: • z metforminom in eno od učinkovin v zdravilu Qtern;
English: How is Qtern used?
Slovenian: Kako se zdravilo Qtern uporablja?
English: The second study included patients whose blood glucose levels were not satisfactorily controlled with metformin and dapagliflozin.
Slovenian: Druga študija je vključevala bolnike, pri katerih ravni glukoze v krvi ni bilo mogoče v zadostni meri uravnati z metforminom in dapagliflozinom.
English: • a sulphonylurea and one of the components of Qtern;
Slovenian: • s sulfonilsečnino in eno od učinkovin v zdravilu Qtern;
English: The CHMP also considered Qtern to be effective at controlling blood glucose levels when used in patients who were not satisfactorily controlled with metformin plus either saxagliptin or dapagliflozin.
Slovenian: Prav tako je menil, da je zdravilo Qtern učinkovito pri uravnavanju ravni glukoze v krvi, kadar se uporablja pri bolnikih, pri katerih bolezen ni v zadostni meri urejena z metforminom v kombinaciji bodisi s saksagliptinom bodisi z dapagliflozinom.
English: The CHMP concluded that Qtern is effective when using it to replace saxagliptin and dapagliflozin taken as separate tablets.
Slovenian: Zaključil je, da je zdravilo Qtern učinkovito, če se uporablja namesto ločenih tablet saksagliptina in dapagliflozina.
English: Results showed that adding saxagliptin to treatment with dapagliflozin and metformin for 24 weeks reduced HbA1c levels by 0.5 percentage points, compared with a reduction of 0.2 percentage points when placebo (a dummy treatment) was added to treatment with dapagliflozin and metformin.
Slovenian: Rezultati so pokazali, da se je po dodajanju saksagliptina zdravljenju z dapagliflozinom in metforminom v obdobju 24 tednov raven HbA1c znižala za 0,5 odstotne točke, v primerjavi z znižanjem za 0,2 odstotne točke, ko so zdravljenju z dapagliflozinom in metforminom dodajali placebo (zdravilo brez zdravilne učinkovine).
English: Qtern can also be used to replace saxagliptin and dapagliflozin taken as separate tablets.
Slovenian: Zdravilo Qtern se lahko uporablja tudi namesto ločenih tablet saksagliptina in dapagliflozina.
English: Invented name Strength Pharmaceutical Form Route of Administration
Slovenian: (Izmišljeno) ime Jakost
English: Packaging Content
Slovenian: Stična ovojnina Vsebina (koncentracija)
English: 4 (4 x 1) vials + 4 (4 x 1) ampoules (multipack) 10 (10 x 1) vials + 10 (10 x 1) ampoules (multipack) 1 pre-filled syringe
Slovenian: 4 (4 x 1) viale + 4 (4 x 1) ampule (skupno pakiranje)
English: 6 (6 x 1) pre-filled syringes (multipack)
Slovenian: 10 (10 x 1) napolnjenih injekcijskih brizg (skupno pakiranje)
English: • The implementation of the 7-day prescription validity rule, in order not to impact on existing national legislation where 7 days validity exists;
Slovenian: • uvedba pravila 7-dnevne veljavnosti recepta, ki ne bo vplivala na obstoječo nacionalno zakonodajo, kjer obstaja 7-dnevna veljavnost;
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC for retinoid-containing medicinal products.
Slovenian: • Odbor za oceno tveganja na področju farmakovigilance (PRAC) je obravnaval postopek v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo retinoide;
English: • Pharmacist checklist;
Slovenian: • farmacevtov kontrolni seznam;
English: Pregnancy is an absolute contraindication for all oral retinoids in the EU.
Slovenian: Nosečnost je absolutna kontraindikacija za vse peroralne retinoide v EU.
English: Furthermore, the PRAC was requested to review any additional risk minimisation measures to ensure that these are optimal in terms of provision of information and delivery of effective risk management that is subject to appropriate monitoring.
Slovenian: Odbor PRAC je bil zaprošen tudi, naj pregleda vse dodatne ukrepe za zmanjšanje tveganja in zagotovi, da so ti ukrepi optimalni v smislu zagotavljanja informacij in učinkovitega obvladovanja tveganja, za katerega se izvaja ustrezno spremljanje.
English: However, there was a consensus that several other factors may contribute to an increased systemic exposure and therefore the risk cannot be excluded.
Slovenian: Soglašali pa so, da k povečani sistemski izpostavljenost lahko prispevajo drugi dejavniki, zato tveganja ni mogoče izključiti.
English: The CHMP clarified that the communication plan should be modified to say ‘healthcare professionals who may be involved in the management of patients treated with retinoids'.
Slovenian: Odbor CHMP je pojasnil, da je treba načrt obveščanja spremeniti tako, da bo navajal „zdravstveni delavci, ki utegnejo biti vključeni v obravnavo bolnikov, zdravljenih z retinoidi“.
English: The PRAC has also recommended that educational materials be distributed via electronic channels such as QR codes, and websites to make better use of the existing technology bearing in mind the young patient population using these products.
Slovenian: Odbor PRAC je priporočil tudi, naj se izobraževalna gradiva distribuirajo po elektronskih kanalih, kot so QR-kode in spletna mesta, s čimer se bolje izkoristi obstoječa tehnologija z mislijo na mlajšo populacijo bolnikov, ki uporabljajo ta zdravila.
English: Therefore, the PRAC agrees that all oral retinoids should contain a warning about the potential risk of neuropsychiatric disorders in line with some key principles.
Slovenian: Zato se odbor PRAC strinja, da morajo vsi peroralni retinoidi vsebovati opozorilo o možnem tveganju za nevropsihiatrične motnje v skladu z določenimi ključnimi načeli.
English: The PRAC noted that despite the introduction of pregnancy prevention measures, including pregnancy prevention programmes (PPPs), cases of pregnancy during treatment with oral retinoid continue to be reported in the EU.
Slovenian: Odbor PRAC je ugotovil, da kljub uvedbi ukrepov za preprečevanje nosečnosti, vključno s programi preprečevanja nosečnosti, v EU še naprej poročajo o primerih nosečnosti med zdravljenjem s peroralnimi retinoidi.
English: Although the underlying risk of psychiatric disorders within the patient populations can be significant, it is advisable that patients taking oral retinoids are warned about the potential risk of psychiatric reactions and the signs and symptoms to look out for.
Slovenian: Čeprav je osnovno tveganje za psihiatrične motnje znotraj populacij bolnikov lahko precejšnje, je priporočljivo, da se bolnike, ki jemljejo peroralne retinoide, opozori o možnem tveganju za psihiatrične učinke ter o znakih in simptomih, na katere morajo biti pozorni.
English: The animal reproductive toxicity data for the oral retinoids demonstrate a typical pattern of retinoid embryopathy.
Slovenian: Podatki o reproduktivni toksičnosti peroralnih retinoidov pri živalih kažejo značilen vzorec retinoidne embriopatije.
English: The data support that for isotretinoin and alitretinoin the information in section 4.4 and 4.8, of the SmPC, should be in line with the agreed outcome of the 2003 Art 30 referral for isotretinoin.
Slovenian: Podatki so v prid dejstvu, da morajo biti informacije za izotretinoin in alitretinoin v poglavjih 4.4 in 4.8 povzetka glavnih značilnosti zdravila v skladu z dogovorjenim izidom napotitve v skladu s členom 30 iz leta 2003 za izotretinoin.
English: The review confirms the already known teratogenic risks associated with the use of oral retinoids in pregnant women.
Slovenian: Pregled potrjuje že znana tveganja za teratogenost, povezana z uporabo peroralnih retinoidov pri nosečnicah.
English: Studies that examine the effects of human pregnancy on systemic absorption of topical retinoids are also lacking.
Slovenian: Prav tako ni študij, ki bi preučevale vpliv nosečnosti pri ljudeh na sistemsko absorpcijo lokalnih retinoidov.