FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE pergoveris 150 iu/75 iu
Slovenian: PODATKI V BRAILLOVI PISAVI pergoveris 150 i.e./75 i.e.
English: Select your Pergoveris pre-filled pen.
Slovenian: Izberite zdravilo Pergoveris napolnjen injekcijski peresnik.
English: INFORMATION IN BRAILLE pergoveris (450 iu + 225 iu)/0.72 ml pen 17.
Slovenian: PODATKI V BRAILLOVI PISAVI pergoveris (450 i.e. + 225 i.e.)/0,72 ml peresnik
English: • feeling sick or vomiting
Slovenian: • slabost ali bruhanje
English: How Pergoveris works
Slovenian: Kako deluje zdravilo Pergoveris
English: Fig.8
Slovenian: Sl. 8
English: Pergoveris 150 IU/75 IU powder and solvent for solution for injection Follitropin alfa/Lutropin alfa
Slovenian: Pergoveris 150 i.e./75 i.e. prašek in vehikel za raztopino za injiciranje folitropin alfa/lutropin alfa
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 150 IU (equivalent to 11 micrograms) of follitropin alfa* (r-hFSH) and 75 IU (equivalent to 3 micrograms) of lutropin alfa* (r-hLH).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 150 i.e. (kar ustreza 11 mikrogramom) folitropina alfa* (r-hFSH) in 75 i.e. (kar ustreza 3 mikrogramom) lutropina alfa* (r-hLH).
English: seconds to ensure you inject the full dose (Fig. 10).
Slovenian: • Gumb za odmerek držite navzdol vsaj 5 sekund, da injicirate celotni odmerek (sl. 10).
English: There is no relevant indication for the use of Pergoveris in the elderly population.
Slovenian: Zdravilo Pergoveris ni namenjeno za uporabo pri starejših bolnikih.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 300 IU r-hFSH-150 IU r-hLH/0.48 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 300 i.e. r-hFSH-150 i.e. r-hLH/0,48 ml
English: if "0", injection complete if not "0", need second injection Injectthisamount..........usingnewpen
Slovenian: če je "0", je injiciranje končano če ni"0",je potrebna druga injekcija.
English: Exacerbation or aggravation of asthma Gastrointestinal disorders Common:
Slovenian: ponovni izbruhi ali poslabšanje astme
English: Batch
Slovenian: Bat
English: There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple regimens for infertility treatment.
Slovenian: Pri ženskah, ki so se bile v postopku zdravljenja neplodnosti z več zdravili, so poročali o novotvorbah na jajčnikih in drugih delih reprodukcijskega sistema, tako benignih kot malignih.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris (450 IU + 225 IU)/0.72 mL injection Follitropin alfa/Lutropin alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Pergoveris (450 i.e. + 225 i.e.)/0,72 ml injekcija folitropin alfa/lutropin alfa subkutana uporaba
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris (300 IU + 150 IU)/0.48 mL injection Follitropin alfa/Lutropin alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Pergoveris (300 i.e. + 150 i.e.)/0,48 ml injekcija folitropin alfa/lutropin alfa subkutana uporaba
English: Pergoveris (300 IU + 150 IU)/0.48 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa
Slovenian: Pergoveris (300 i.e. + 150 i.e.)/0,48 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin alfa/lutropin alfa
English: How to store Pergoveris
Slovenian: Shranjevanje zdravila Pergoveris
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 150 IU r-hFSH/75 IU r-hLH
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 150 i.e.r-hFSH/75 i.e.r-hLH
English: Excipients: sucrose, arginine monohydrochloride, poloxamer 188, methionine, phenol, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide and concentrated phosphoric acid (for pH adjustment), and water for injections.
Slovenian: Druge sestavine zdravila so: saharoza, argininijev monoklorid, poloksamer 188, metionin, fenol, natrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat monohidrat, natrijev hidroksid in koncentrirana fosforjeva(V) kislina (za uravnavanje pH) ter voda za injekcije
English: Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa
Slovenian: Pergoveris (900 i.e. + 450 i.e.)/1,44 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin alfa/lutropin alfa
English: How to store Pergoveris Keep this medicine out of the sight and reach of children.
Slovenian: Shranjevanje zdravila Pergoveris Zdravilo shranjujte nedosegljivo otrokom!
English: Subcutaneous use.
Slovenian: "enkratno uporabo".
English: • Contains 0.48 mL of Pergoveris solution • Contains 300 IU follitropin alfa and 150 IU lutropin alfa.
Slovenian: • Vsebuje 300 i.e. folitropina alfa in 150 i.e. lutropina alfa.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris (900 IU + 450 IU)/1.44 mL injection Follitropin alfa/Lutropin alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Pergoveris (900 i.e. + 450 i.e.)/1,44 ml injekcija folitropin alfa/lutropin alfa subkutana uporaba
English: Each Pergoveris (900 IU + 450 IU)/1.44 mL pre-filled pen contains 1.44 mL of solution for injection and can deliver six doses of Pergoveris 150 IU/75 IU.
Slovenian: Eno zdravilo Pergoveris (900 i.e. + 450 i.e.)/1,44 ml napolnjen injekcijski peresnik vsebuje 1,44 ml raztopine za injiciranje in lahko zagotovi šest odmerkov zdravila Pergoveris 150 i.e./75 i.e.. Pakiranje z 1 zdravilom Pergoveris (900 i.e. + 450 i.e.)/1,44 ml napolnjen injekcijski peresnik in 14 injekcijskih igel.
English: Check for a droplet of liquid at the tip of the needle.
Slovenian: Preverite, ali na konici injekcijske igle iztekajo kapljice tekočine.
English: Each pre-filled pen contains 450 IU (equivalent to 33 micrograms) of follitropin alfa (r-hFSH) and 225 IU (equivalent to 9 micrograms) of lutropin alfa (r-hLH) in 0.72 mL.
Slovenian: En napolnjen injekcijski peresnik vsebuje 450 i.e. (kar ustreza 33 mikrogramom) folitropina alfa (r-hFSH) in 225 i.e. (kar ustreza 9 mikrogramom) lutropina alfa (r-hLH) v 0,72 ml.
English: 12/06 19:00 450IU + 225 IU
Slovenian: Št. 3 12/06 19:00
English: NAME OF THE MEDICINAL PRODUCT Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in pre-filled pen
Slovenian: IME ZDRAVILA Pergoveris (900 i.e. + 450 i.e.)/1,44 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Each pre-filled pen contains 900 IU (equivalent to 66 micrograms) of follitropin alfa (r-hFSH) and 450 IU (equivalent to 18 micrograms) of lutropin alfa (r-hLH) in 1.44 mL.
Slovenian: En napolnjen injekcijski peresnik vsebuje 900 i.e. (kar ustreza 66 mikrogramom) folitropina alfa (r-hFSH) in 450 i.e. (kar ustreza 18 mikrogramom) lutropina alfa (r-hLH) v 1,44 ml.
English: Setting the dose prescribed by your doctor 6.1.
Slovenian: Nastavitev odmerka, ki ga je predpisal zdravnik.
English: Each Pergoveris (300 IU + 150 IU)/0.48 mL pre-filled pen contains 0.48 mL of solution for injection and can deliver two doses of Pergoveris 150 IU/75 IU.
Slovenian: Eno zdravilo Pergoveris (300 i.e. + 150 i.e.)/0,48 ml napolnjen injekcijski peresnik vsebuje 0,48 ml raztopine za injiciranje in lahko zagotovi dva odmerka zdravila Pergoveris 150 i.e./75 i.e.. Pakiranje z 1 zdravilom Pergoveris (300 i.e. + 150 i.e.)/0,48 ml napolnjen injekcijski peresnik in 5 injekcijskih igel.
English: Pen Volume
Slovenian: Volumen peresnika
English: Immune system disorders
Slovenian: Priprava raztopine
English: Fig. 3
Slovenian: Sl. 3
English: 12/06 19:00 450IU + 225 IU 225IU/ 112.5IU 225
Slovenian: 225 i.e./ 112,5i.e.
English: NAME OF THE MEDICINAL PRODUCT Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in pre-filled pen
Slovenian: IME ZDRAVILA Pergoveris (450 i.e. + 225 i.e.)/0,72 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa
Slovenian: Pergoveris (450 i.e. + 225 i.e.)/0,72 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin alfa/lutropin alfa
English: • Check that the Dose Feedback Window shows
Slovenian: Okno za prikaz odmerka*
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris 150 IU/75 IU powder for solution for injection Follitropin alfa/Lutropin alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Pergoveris 150 i.e./75 i.e. prašek za raztopino za injiciranje folitropin alfa/lutropin alfa s.c.
English: NAME OF THE MEDICINAL PRODUCT Pergoveris (300 IU + 150 IU)/0.48 mL solution for injection in pre-filled pen
Slovenian: IME ZDRAVILA Pergoveris (300 i.e. + 150 i.e.)/0,48 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: How to use your Pergoveris pre-filled pen treatment diary A treatment diary is included on the last page.
Slovenian: Kako uporabljati dnevnik zdravljenja z zdravilom Pergoveris napolnjen injekcijski peresnik
English: GENERAL CLASSIFICATION FOR SUPPLY
Slovenian: 3.Priprava potrebščin
English: Solvent: 3 mL vials (Type I glass) with a Teflon coated rubber stopper and aluminium flip-off cap. 1 vial of solvent contains 1 mL of water for injections.
Slovenian: Vehikel: 3 ml viale (steklo Tipa I) z gumijastim zamaškom prevlečenim s Teflonom in aluminijasto snemljivo zaporko.
English: Each Pergoveris (450 IU + 225 IU)/0.72 mL pre-filled pen contains 0.72 mL of solution for injection and can deliver three doses of Pergoveris 150 IU/75 IU.
Slovenian: Eno zdravilo Pergoveris (450 i.e. + 225 i.e.)/0,72 ml napolnjen injekcijski peresnik vsebuje 0,72 ml raztopine za injiciranje in lahko zagotovi tri odmerke zdravila Pergoveris 150 i.e./75 i.e.. Pakiranje z 1 zdravilom Pergoveris (450 i.e. + 225 i.e.)/0,72 ml napolnjen injekcijski peresnik in 7 injekcijskih igel.
English: Powder: white to off-white lyophilised pellet.
Slovenian: FARMACEVTSKA OBLIKA prašek in vehikel za raztopino za injiciranje Prašek: bele do sivo bele liofilizirane pelete Vehikel: bistra brezbarvna raztopina
English: Units) of follitropin alfa and 450 IU of lutropin alfa in 1.44 mL and can deliver six doses of Pergoveris 150 IU/75 IU.
Slovenian: • En napolnjen injekcijski peresnik zdravila (900 i.e. + 450 i.e.)/1,44 ml vsebuje 900 i.e. folitropina alfa in 450 i.e. lutropina alfa v 1,44 ml in zagotavlja šest odmerkov zdravila Pergoveris 150 i.e./75 i.e..
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) One vial contains 150 IU (equivalent to 11 micrograms) of follitropin alfa (r-hFSH) and 75 IU (equivalent to 3 micrograms) of lutropin alfa (r-hLH).
Slovenian: Ena viala vsebuje 150 i.e. (kar ustreza 11 mikrogramom) folitropina alfa (r-hFSH) in 75 i.e. (kar ustreza 3 mikrogramom) lutropina alfa (r-hLH).
English: Amount Set to Inject
Slovenian: Količina, ki jo nastavite za injiciranje
English: What Pergoveris is used for
Slovenian: Za kaj uporabljamo zdravilo Pergoveris
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) Each pre-filled pen contains 300 IU (equivalent to 22 micrograms) of follitropin alfa (r-hFSH) and 150 IU (equivalent to 6 micrograms) of lutropin alfa (r-hLH) in 0.48 mL.
Slovenian: En napolnjen injekcijski peresnik vsebuje 300 i.e. (kar ustreza 22 mikrogramom) folitropina alfa (r-hFSH) in 150 i.e. (kar ustreza 6 mikrogramom) lutropina alfa (r-hLH) v 0,48 ml.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each multidose pre-filled pen contains 450 IU (equivalent to 33 micrograms) of follitropin alfa* (r-hFSH) and 225 IU (equivalent to 9 micrograms) of lutropin alfa* (r-hLH) in 0.72 mL solution.
Slovenian: En večodmerni napolnjen injekcijski peresnik vsebuje 450 i.e. (kar ustreza 33 mikrogramom) folitropina alfa* (r-hFSH) in 225 i.e. (kar ustreza 9 mikrogramom) lutropina alfa* (r-hLH) v 0,72 ml raztopine.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Pergoveris.
Slovenian: Pred začetkom uporabe zdravila Pergoveris se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Units) of follitropin alfa and 225 IU of lutropin alfa in 0.72 mL and can deliver three doses of Pergoveris 150 IU/75 IU.
Slovenian: • En napolnjen injekcijski peresnik zdravila Pergoveris (450 i.e. + 225 i.e.)/0,72 ml vsebuje 450 i.e. folitropina alfa in 225 i.e. lutropina alfa v 0,72 ml in zagotavlja tri odmerke zdravila Pergoveris 150 i.e./75 i.e..
English: • Pergoveris (900 IU + 450 IU)/1.44 mL is supplied in packs of 1 multidose pre-filled pen and
Slovenian: • Zdravilo Pergoveris (900 i.e. + 450 i.e.)/1,44 ml je na voljo v pakiranju z 1 večodmernim napolnjenim injekcijskim peresnikom in 14 injekcijskimi iglami za enkratno uporabo.
English: Fig.7
Slovenian: Sl. 7
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Sodium hydroxide (for pH adjustment) Phosphoric acid, concentrated (for pH adjustment) Water for injections
Slovenian: Prašek saharoza polisorbat 20 metionin natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat monohidrat fosforjeva kislina, koncentrirana (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each multidose pre-filled pen contains 900 IU (equivalent to 66 micrograms) of follitropin alfa* (r-hFSH) and 450 IU (equivalent to 18 micrograms) of lutropin alfa* (r-hLH) in 1.44 mL solution.
Slovenian: En večodmerni napolnjen injekcijski peresnik vsebuje 900 i.e. (kar ustreza 66 mikrogramom) folitropina alfa* (r-hFSH) in 450 i.e.(kar ustreza 18 mikrogramom) lutropina alfa* (r-hLH) v 1,44 ml raztopine.
English: N/A
Slovenian: Alkoholn e
English: Caution: Never store the pen with the needle still attached.
Slovenian: Peresnika nikoli ne shranite z nameščeno injekcijsko iglo.
English: • Pergoveris (300 IU +150 IU)/0.48 mL is supplied in packs of 1 multidose pre-filled pen and
Slovenian: • Zdravilo Pergoveris (300 i.e. + 150 i.e.)/0,48 ml je na voljo v pakiranju z 1 večodmernim napolnjenim injekcijskim peresnikom in 5 injekcijskimi iglami za enkratno uporabo.
English: • Pergoveris (450 IU + 225 IU)/0.72 mL is supplied in packs of 1 multidose pre-filled pen and
Slovenian: • Zdravilo Pergoveris (450 i.e. + 225 i.e.)/0,72 ml je na voljo v pakiranju z 1 večodmernim napolnjenim injekcijskim peresnikom in 7 injekcijskimi iglami za enkratno uporabo.
English: Units) of follitropin alfa and 150 IU of lutropin alfa in 0.48 mL and can deliver two doses of Pergoveris 150 IU/75 IU.
Slovenian: • En napolnjen injekcijski peresnik zdravila Pergoveris (300 i.e. + 150 i.e.)/0,48 ml vsebuje 300 i.e. folitropina alfa in 150 i.e. lutropina alfa v 0,48 ml in zagotavlja dva odmerka zdravila 150 i.e./75 i.e..
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each multidose pre-filled pen contains 300 IU (equivalent to 22 micrograms) of follitropin alfa* (r-hFSH) and 150 IU (equivalent to 6 micrograms) of lutropin alfa* (r-hLH) in 0.48 mL solution.
Slovenian: En večodmerni napolnjen injekcijski peresnik vsebuje 300 i.e. (kar ustreza 22 mikrogramom) folitropina alfa* (r-hFSH) in 150 i.e. (kar ustreza 6 mikrogramom) lutropina alfa* (r-hLH) v 0,48 ml raztopine.
English: Get a new needle.
Slovenian: Uporabite nov peresnik
English: Pergoveris pre-filled pen
Slovenian: Zdravilo Pergoveris napolnjen injekcijski peresnik
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/005
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/396/005
English: • Recap the pen.
Slovenian: • Peresnik ponovno zaprite s pokrovčkom.
English: NAME OF THE MEDICINAL PRODUCT Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa
Slovenian: Pergoveris (450 i.e.+ 225 i.e.)/0,72 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin alfa/lutropin alfa
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/396/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/006
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/396/006
English: Read the leaflet for the shelf life of the reconstituted medicine.
Slovenian: Rok trajanja rekonstituiranega zdravila je naveden v navodilu za uporabo.
English: Storing the Pergoveris pre-filled pen.
Slovenian: Shranjevanje zdravila Pergoveris napolnjen injekcijski peresnik.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PERGOVERIS (450 IU + 225 IU)/0.72 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
Slovenian: PERGOVERIS (450 i.e. + 225 i.e.)/0,72 ML RAZTOPINA ZA INJICIRANJE V NAPOLNJENEM INJEKCIJSKEM PERESNIKU
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PERGOVERIS (900 IU + 450 IU)/1.44 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
Slovenian: PERGOVERIS (900 i.e. + 450 i.e.)/1,44 ML RAZTOPINA ZA INJICIRANJE V NAPOLNJENEM INJEKCIJSKEM PERESNIKU
English: 14 disposable injection needles.
Slovenian: Notranji ščitnik injekcijske igle
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PERGOVERIS (300 IU + 150 IU)/0.48 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
Slovenian: PERGOVERIS (300 i.e. + 150 i.e.)/0,48 ML RAZTOPINA ZA INJICIRANJE V NAPOLNJENEM INJEKCIJSKEM PERESNIKU
English: Ovarian cysts
Slovenian: LOT vehikla
English: • abdominal or pelvic pain
Slovenian: • bolečine v trebuhu ali medenici
English: Powder: 3 mL vials (Type I glass) with a stopper (bromobutyl rubber) and aluminium flip-off cap. 1 vial contains 11 micrograms r-hFSH and 3 micrograms r-hLH.
Slovenian: Ena viala vsebuje 11 mikrogramov r-hFSH in 3 mikrograme r-hLH.
English: 5 disposable injection needles.
Slovenian: Zunanji pokrovček injekcijske
English: Contents of the pack and other information What Pergoveris contains
Slovenian: Druga zdravila in zdravilo Pergoveris
English: Dose Feedback Window
Slovenian: Okno za prikaz odmerka
English: • Remove the outer needle cap by pulling it gently.
Slovenian: • Zunanji pokrovček injekcijske igle odstranite z rahlim potegom.
English: Testing during and after the transition period
Slovenian: Testiranje v prehodnem obdobju in po njem
English: • If there is a need for further recalls or other measures, national authorities will inform you of what action to take.
Slovenian: • Če bodo potrebni nadaljnji odpoklici ali drugi ukrepi, vas bodo nacionalni organi obvestili o potrebnem ukrepanju.
English: • If you have any questions about your medicine or any medicine you have taken in the past, speak to your doctor or pharmacist.
Slovenian: • Če imate kakršna koli vprašanja o svojem zdravilu ali zdravilu, ki ste ga jemali v preteklosti, se pogovorite z zdravnikom ali farmacevtom.
English: You can also contact your national medicines authority.
Slovenian: Obrnete se lahko tudi na nacionalni organ za zdravila.
English: An assessment report with further details about the review has been published on EMA's website.
Slovenian: Poročilo o oceni z dodatnimi podrobnostmi o pregledu je objavljeno na spletni strani agencije EMA.
English: 2 International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance: M7(R1)
Slovenian: 2 Navodilo Mednarodnega sveta za usklajevanje tehničnih zahtev za zdravila za uporabo v humani medicini (ICH): M7(R1).
English: The review estimated the highest possible cancer risk with these impurities.
Slovenian: Pri pregledu so ocenjevali največje možno tveganje za raka zaradi teh nečistot.
English: Following tests, some medicines have been recalled from pharmacies and are no longer used in the EU.
Slovenian: Po testiranjih so nekatera zdravila odpoklicali iz lekarn in se v EU ne uporabljajo več.
English: The review of valsartan medicines was triggered by the European Commission on 5 July 2018 under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled zdravil, ki vsebujejo valsartan, je 5. julija 2018 v skladu s členom 31 Direktive 2001/83/ES sprožila Evropska komisija.
English: The estimates have been extrapolated from animal studies and are very low compared with the lifetime risk of cancer in the EU (1 in 2).
Slovenian: Ocene, ki so jih ekstrapolirali na podlagi študij na živalih, so v primerjavi s tveganjem za raka v celotni življenjski dobi v EU zelo nizke (1 od 2).
English: The CHMP opinion was forwarded to the European Commission, which issued final legally binding decisions for the medicines concerned between 2 April and 17 April 2019 that are applicable in all EU Member States.
Slovenian: Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je med 2. in 17. aprilom 2019 izdala končne pravno zavezujoče sklepe za zadevna zdravila, ki veljajo v vseh državah članicah EU.
English: Candesartan (32 mg) Irbesartan (300 mg) Losartan (150 mg) Olmesartan (40 mg) Valsartan (320 mg)
Slovenian: Kandesartan (32 mg) Irbesartan (300 mg) Losartan (150 mg) Olmesartan (40 mg) Valsartan (320 mg)
English: EMA's recommendations for NDMA and NDEA were sent to the European Commission, which issued a legally binding decisions.
Slovenian: Priporočila agencije EMA za NDMA in NDEA so bila poslana Evropski komisiji, ki je izdala pravno zavezujoči sklep.
English: These medicines are used to treat patients with hypertension (high blood pressure) and those with certain heart or kidney diseases.
Slovenian: Ta zdravila se uporabljajo za zdravljenje bolnikov s hipertenzijo (visokim krvnim tlakom) in bolnikov z določenimi boleznimi srca ali ledvic.
English: The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Slovenian: Pregled je opravil Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA, odgovoren za vprašanja glede zdravil za uporabo v humani medicini, ki je sprejel tudi mnenje agencije.
English: • Manufacturers must now review their manufacturing processes to avoid the presence of nitrosamines.
Slovenian: • Proizvajalci morajo pregledati svoje proizvodne postopke in tako preprečiti prisotnost nitrozaminov.
English: Companies must now take measures to avoid the presence of these impurities and carry out rigorous testing of their products.
Slovenian: Zdaj morajo podjetja ukrepati in preprečiti prisotnost teh nečistot ter izvesti strogo testiranje svojih zdravil.
English: Products containing either impurity above these limits or products containing both nitrosamines at whatever level will not be allowed in the EU.
Slovenian: Zdravila, ki vsebujejo eno ali drugo nečistoto nad temi mejami, ali zdravila, ki vsebujejo oba nitrozamina v kakršni koli količini, v EU ne bodo dovoljena.
English: Other medicines of the class which do not have this ring, such as azilsartan, eprosartan and telmisartan, were not included in the review.
Slovenian: Druga zdravila istega razreda, ki ne vsebujejo tega obroča, kot so azilsartan, eprosartan in telmisartan, niso bila vključena v pregled.
English: Investigation continuing
Slovenian: Nadaljnje proučevanje
English: The limits are based on the maximum daily intake for each impurity derived from animal studies: 96.0 nanograms for NDMA and 26.5 nanograms for NDEA.
Slovenian: Meje temeljijo na največjem dnevnem vnosu posamezne nečistote, pridobljenem iz študij na živalih: 96,0 nanograma za NDMA in 26,5 nanograma za NDEA.
English: Authorities in the EU will also consider the lessons that can be learned from this review to improve the way impurities in medicines are identified and handled.
Slovenian: Organi v EU bodo proučili tudi nova spoznanja iz tega pregleda, da bi lahko lažje ugotovili in obravnavali nečistote v zdravilih.
English: Active substance (max daily dose)
Slovenian: Učinkovina (največji dnevni odmerek)
English: NDEA in these medicines could lead to 8 extra cases in 100,000 patients taking the medicine at the highest dose every day for 4 years.1
Slovenian: NDEA v teh zdravilih bi pri 100 000 bolnikih, ki bi štiri leta vsak dan jemali zdravilo v največjem odmerku, povzročil osem dodatnih primerov1.
English: For the vast majority of sartan medicines, impurities were either not found or were present at very low levels.
Slovenian: Pri veliki večini zdravil, ki vsebujejo sartane, nečistot niso našli ali pa so bile prisotne v zelo majhnih količinah.