natgillin/translations-raw huggingface dataset:
• The powder is a white to off-white lyophilised pellet in a glass vial with a bromobutyl rubber stopper containing 150 IU (equivalent to 11 micrograms) of follitropin alfa and 75 IU 
• Prašek so bele do sivo bele liofilizirane pelete v stekleni viali z bromobutilnim gumijastim zamaškom, ki vsebuje 150 i.e. (kar ustreza 11 mikrogramom) folitropina alfa in 75 i.e. (kar ustreza 3 mikrogramom) lutropina alfa.
4 Press the dose setting knob as far as it will go. A tiny drop of liquid will appear at the tip of the needle (Fig. 7). 
Na konici injekcijske igle se prikaže majhna kapljica tekočine (sl. 7).
Caution: Do not release the dose knob until you remove the needle from the skin. 
Opozorilo: Ne izpustite gumba za nastavitev odmerka,
• Hold the Pergoveris pre-filled pen with the needle pointing upward. 
• Držite zdravilo Pergoveris napolnjen injekcijski peresnik z injekcijsko iglo navzgor.
Choose an injection site in the area your doctor or nurse has told you to use for the injection. 
Izberite mesto, kamor boste dali injekcijo na predelu, ki vam ga je svetoval zdravnik ali medicinska sestra.
EU/1/07/396/001 1 vial of powder for solution for injection. 
EU/1/07/396/001 1 viala s praškom za raztopino za injiciranje 1 viala z vehiklom
• One vial contains 150 IU (equivalent to 11 micrograms) of follitropin alfa and 75 IU (equivalent to 3 micrograms) of lutropin alfa. 
• Ena viala vsebuje 150 i.e. (kar ustreza 11 mikrogramom) folitropina alfa in 75 i.e. (kar ustreza 3 mikrogramom) lutropina alfa.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 450 IU r-hFSH-225 IU r-hLH/0.72 mL 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 450 i.e. r-hFSH-225 i.e. r-hLH/0,72 ml
3 Tap the reservoir holder gently (Fig. 6). 
3 Nežno krcajte po prostoru za tekočino (sl. 6).
There have been reports of tumours in the ovaries and other sex organs, both benign and malignant, in women who have undergone multiple regimens for infertility treatment. 
Pri ženskah, ki so se bile v postopku zdravljenja neplodnosti z več zdravili, so poročali o tumorjih na jajčniku in drugih spolnih organih, tako benignih kot malignih.
What Pergoveris contains The active substances are follitropin alfa and lutropin alfa. 
Kaj vsebuje zdravilo Pergoveris Učinkovini sta folitropin alfa in lutropin alfa.
After the injection, dispose of the used needle safely. 
Po injiciranju iglo varno zavzite.
• When needed, inject youself using a second pen, dialing your remaining dose written in the 
• Po potrebi uporabite za injiciranje drugi injekcijski peresnik in izberite preostali odmerek, zabeležen v poglavju "Količina, ki jo nastavite za drugo injiciranje" (stolpec 8).
What Pergoveris is 
Kaj je zdravilo Pergoveris
NAME OF THE MEDICINAL PRODUCT Pergoveris 150 IU/75 IU powder and solvent for solution for injection 
IME ZDRAVILA Pergoveris 150 i.e./75 i.e. prašek in vehikel za raztopino za injiciranje
Powder: disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, methionine, polysorbate 20, sucrose, sodium hydroxide (for pH adjustment) and concentrated phosphoric acid (for pH adjustment). 
Prašek: natrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat monohidrat, metionin, polisorbat 20, saharoza, natrijev hidroksid (za uravnavanje pH) in koncentrirana fosforjeva(V) kislina (za uravnavanje pH).
Pergoveris pre-filled pen treatment diary 
Dnevnik zdravljenja z zdravilom Pergoveris napolnjen injekcijski peresnik
(Getting your Pergoveris pre-filled pen ready for injection) with a second pen. 
do konca poglavja 5 (Priprava zdravila Pergoveris napolnjen injekcijski peresnik na injiciranje) z drugim peresnikom.
Fig. 6 
Sl. 6
INFORMATION IN BRAILLE pergoveris 150 iu/75 iu 
PODATKI V BRAILLOVI PISAVI pergoveris 150 i.e./75 i.e.
Select your Pergoveris pre-filled pen. 
Izberite zdravilo Pergoveris napolnjen injekcijski peresnik.
INFORMATION IN BRAILLE pergoveris (450 iu + 225 iu)/0.72 ml pen 17. 
PODATKI V BRAILLOVI PISAVI pergoveris (450 i.e. + 225 i.e.)/0,72 ml peresnik
• feeling sick or vomiting 
• slabost ali bruhanje
How Pergoveris works 
Kako deluje zdravilo Pergoveris
Fig.8 
Sl. 8
Pergoveris 150 IU/75 IU powder and solvent for solution for injection Follitropin alfa/Lutropin alfa 
Pergoveris 150 i.e./75 i.e. prašek in vehikel za raztopino za injiciranje folitropin alfa/lutropin alfa
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). 
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).
seconds to ensure you inject the full dose (Fig. 10). 
• Gumb za odmerek držite navzdol vsaj 5 sekund, da injicirate celotni odmerek (sl. 10).
There is no relevant indication for the use of Pergoveris in the elderly population. 
Zdravilo Pergoveris ni namenjeno za uporabo pri starejših bolnikih.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 300 IU r-hFSH-150 IU r-hLH/0.48 mL 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 300 i.e. r-hFSH-150 i.e. r-hLH/0,48 ml
if "0", injection complete if not "0", need second injection Injectthisamount..........usingnewpen 
če je "0", je injiciranje končano če ni"0",je potrebna druga injekcija.
Exacerbation or aggravation of asthma Gastrointestinal disorders Common: 
ponovni izbruhi ali poslabšanje astme
Batch 
Bat
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. 
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.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris (450 IU + 225 IU)/0.72 mL injection Follitropin alfa/Lutropin alfa 
IME ZDRAVILA IN POT(I) UPORABE Pergoveris (450 i.e. + 225 i.e.)/0,72 ml injekcija folitropin alfa/lutropin alfa subkutana uporaba
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris (300 IU + 150 IU)/0.48 mL injection Follitropin alfa/Lutropin alfa 
IME ZDRAVILA IN POT(I) UPORABE Pergoveris (300 i.e. + 150 i.e.)/0,48 ml injekcija folitropin alfa/lutropin alfa subkutana uporaba
Pergoveris (300 IU + 150 IU)/0.48 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa 
Pergoveris (300 i.e. + 150 i.e.)/0,48 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin alfa/lutropin alfa
How to store Pergoveris 
Shranjevanje zdravila Pergoveris
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 150 IU r-hFSH/75 IU r-hLH 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 150 i.e.r-hFSH/75 i.e.r-hLH
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. 
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
Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa 
Pergoveris (900 i.e. + 450 i.e.)/1,44 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin alfa/lutropin alfa
How to store Pergoveris Keep this medicine out of the sight and reach of children. 
Shranjevanje zdravila Pergoveris Zdravilo shranjujte nedosegljivo otrokom!
Subcutaneous use. 
"enkratno uporabo".
• Contains 0.48 mL of Pergoveris solution • Contains 300 IU follitropin alfa and 150 IU lutropin alfa. 
• Vsebuje 300 i.e. folitropina alfa in 150 i.e. lutropina alfa.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris (900 IU + 450 IU)/1.44 mL injection Follitropin alfa/Lutropin alfa 
IME ZDRAVILA IN POT(I) UPORABE Pergoveris (900 i.e. + 450 i.e.)/1,44 ml injekcija folitropin alfa/lutropin alfa subkutana uporaba
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. 
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.
Check for a droplet of liquid at the tip of the needle. 
Preverite, ali na konici injekcijske igle iztekajo kapljice tekočine.
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. 
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.
12/06 19:00 450IU + 225 IU 
Št. 3 12/06 19:00
NAME OF THE MEDICINAL PRODUCT Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in pre-filled pen 
IME ZDRAVILA Pergoveris (900 i.e. + 450 i.e.)/1,44 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
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. 
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.
Setting the dose prescribed by your doctor 6.1. 
Nastavitev odmerka, ki ga je predpisal zdravnik.
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. 
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.
Pen Volume 
Volumen peresnika
Immune system disorders 
Priprava raztopine
Fig. 3 
Sl. 3
12/06 19:00 450IU + 225 IU 225IU/ 112.5IU 225 
225 i.e./ 112,5i.e.
NAME OF THE MEDICINAL PRODUCT Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in pre-filled pen 
IME ZDRAVILA Pergoveris (450 i.e. + 225 i.e.)/0,72 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa 
Pergoveris (450 i.e. + 225 i.e.)/0,72 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin alfa/lutropin alfa
• Check that the Dose Feedback Window shows 
Okno za prikaz odmerka*
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris 150 IU/75 IU powder for solution for injection Follitropin alfa/Lutropin alfa 
IME ZDRAVILA IN POT(I) UPORABE Pergoveris 150 i.e./75 i.e. prašek za raztopino za injiciranje folitropin alfa/lutropin alfa s.c.
NAME OF THE MEDICINAL PRODUCT Pergoveris (300 IU + 150 IU)/0.48 mL solution for injection in pre-filled pen 
IME ZDRAVILA Pergoveris (300 i.e. + 150 i.e.)/0,48 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku
How to use your Pergoveris pre-filled pen treatment diary A treatment diary is included on the last page. 
Kako uporabljati dnevnik zdravljenja z zdravilom Pergoveris napolnjen injekcijski peresnik
GENERAL CLASSIFICATION FOR SUPPLY 
3.Priprava potrebščin
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. 
Vehikel: 3 ml viale (steklo Tipa I) z gumijastim zamaškom prevlečenim s Teflonom in aluminijasto snemljivo zaporko.
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. 
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.
Powder: white to off-white lyophilised pellet. 
FARMACEVTSKA OBLIKA prašek in vehikel za raztopino za injiciranje Prašek: bele do sivo bele liofilizirane pelete Vehikel: bistra brezbarvna raztopina
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. 
• 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..
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). 
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).
Amount Set to Inject 
Količina, ki jo nastavite za injiciranje
What Pergoveris is used for 
Za kaj uporabljamo zdravilo Pergoveris
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. 
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.
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. 
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.
Warnings and precautions Talk to your doctor, pharmacist or nurse before using Pergoveris. 
Pred začetkom uporabe zdravila Pergoveris se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
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. 
• 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..
• Pergoveris (900 IU + 450 IU)/1.44 mL is supplied in packs of 1 multidose pre-filled pen and 
• 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.
Fig.7 
Sl. 7
Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Sodium hydroxide (for pH adjustment) Phosphoric acid, concentrated (for pH adjustment) Water for injections 
Prašek saharoza polisorbat 20 metionin natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat monohidrat fosforjeva kislina, koncentrirana (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH)
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. 
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.
N/A 
Alkoholn e
Caution: Never store the pen with the needle still attached. 
Peresnika nikoli ne shranite z nameščeno injekcijsko iglo.
• Pergoveris (300 IU +150 IU)/0.48 mL is supplied in packs of 1 multidose pre-filled pen and 
• 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.
• Pergoveris (450 IU + 225 IU)/0.72 mL is supplied in packs of 1 multidose pre-filled pen and 
• 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.
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. 
• 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..
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. 
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.
Get a new needle. 
Uporabite nov peresnik
Pergoveris pre-filled pen 
Zdravilo Pergoveris napolnjen injekcijski peresnik
MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/005 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/396/005
• Recap the pen. 
• Peresnik ponovno zaprite s pokrovčkom.
NAME OF THE MEDICINAL PRODUCT Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa 
Pergoveris (450 i.e.+ 225 i.e.)/0,72 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin alfa/lutropin alfa
MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/004 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/396/004
MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/006 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/07/396/006
Read the leaflet for the shelf life of the reconstituted medicine. 
Rok trajanja rekonstituiranega zdravila je naveden v navodilu za uporabo.
Storing the Pergoveris pre-filled pen. 
Shranjevanje zdravila Pergoveris napolnjen injekcijski peresnik.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PERGOVERIS (450 IU + 225 IU)/0.72 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN 
PERGOVERIS (450 i.e. + 225 i.e.)/0,72 ML RAZTOPINA ZA INJICIRANJE V NAPOLNJENEM INJEKCIJSKEM PERESNIKU
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PERGOVERIS (900 IU + 450 IU)/1.44 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN 
PERGOVERIS (900 i.e. + 450 i.e.)/1,44 ML RAZTOPINA ZA INJICIRANJE V NAPOLNJENEM INJEKCIJSKEM PERESNIKU
14 disposable injection needles. 
Notranji ščitnik injekcijske igle
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PERGOVERIS (300 IU + 150 IU)/0.48 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN 
PERGOVERIS (300 i.e. + 150 i.e.)/0,48 ML RAZTOPINA ZA INJICIRANJE V NAPOLNJENEM INJEKCIJSKEM PERESNIKU
Ovarian cysts 
LOT vehikla
• abdominal or pelvic pain 
• bolečine v trebuhu ali medenici
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. 
Ena viala vsebuje 11 mikrogramov r-hFSH in 3 mikrograme r-hLH.
5 disposable injection needles. 
Zunanji pokrovček injekcijske
Contents of the pack and other information What Pergoveris contains 
Druga zdravila in zdravilo Pergoveris
Dose Feedback Window 
Okno za prikaz odmerka
• Remove the outer needle cap by pulling it gently. 
• Zunanji pokrovček injekcijske igle odstranite z rahlim potegom.
Testing during and after the transition period 
Testiranje v prehodnem obdobju in po njem
• If there is a need for further recalls or other measures, national authorities will inform you of what action to take. 
• Če bodo potrebni nadaljnji odpoklici ali drugi ukrepi, vas bodo nacionalni organi obvestili o potrebnem ukrepanju.
• If you have any questions about your medicine or any medicine you have taken in the past, speak to your doctor or pharmacist. 
• Če imate kakršna koli vprašanja o svojem zdravilu ali zdravilu, ki ste ga jemali v preteklosti, se pogovorite z zdravnikom ali farmacevtom.
You can also contact your national medicines authority. 
Obrnete se lahko tudi na nacionalni organ za zdravila.
An assessment report with further details about the review has been published on EMA's website. 
Poročilo o oceni z dodatnimi podrobnostmi o pregledu je objavljeno na spletni strani agencije EMA.
2 International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance: M7(R1) 
2 Navodilo Mednarodnega sveta za usklajevanje tehničnih zahtev za zdravila za uporabo v humani medicini (ICH): M7(R1).
The review estimated the highest possible cancer risk with these impurities. 
Pri pregledu so ocenjevali največje možno tveganje za raka zaradi teh nečistot.
Following tests, some medicines have been recalled from pharmacies and are no longer used in the EU. 
Po testiranjih so nekatera zdravila odpoklicali iz lekarn in se v EU ne uporabljajo več.
The review of valsartan medicines was triggered by the European Commission on 5 July 2018 under Article 31 of Directive 2001/83/EC. 
Pregled zdravil, ki vsebujejo valsartan, je 5. julija 2018 v skladu s členom 31 Direktive 2001/83/ES sprožila Evropska komisija.
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). 
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).
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. 
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.
Candesartan (32 mg) Irbesartan (300 mg) Losartan (150 mg) Olmesartan (40 mg) Valsartan (320 mg) 
Kandesartan (32 mg) Irbesartan (300 mg) Losartan (150 mg) Olmesartan (40 mg) Valsartan (320 mg)
EMA's recommendations for NDMA and NDEA were sent to the European Commission, which issued a legally binding decisions. 
Priporočila agencije EMA za NDMA in NDEA so bila poslana Evropski komisiji, ki je izdala pravno zavezujoči sklep.
These medicines are used to treat patients with hypertension (high blood pressure) and those with certain heart or kidney diseases. 
Ta zdravila se uporabljajo za zdravljenje bolnikov s hipertenzijo (visokim krvnim tlakom) in bolnikov z določenimi boleznimi srca ali ledvic.
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. 
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.
• Manufacturers must now review their manufacturing processes to avoid the presence of nitrosamines. 
• Proizvajalci morajo pregledati svoje proizvodne postopke in tako preprečiti prisotnost nitrozaminov.
Companies must now take measures to avoid the presence of these impurities and carry out rigorous testing of their products. 
Zdaj morajo podjetja ukrepati in preprečiti prisotnost teh nečistot ter izvesti strogo testiranje svojih zdravil.
Products containing either impurity above these limits or products containing both nitrosamines at whatever level will not be allowed in the EU. 
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.
Other medicines of the class which do not have this ring, such as azilsartan, eprosartan and telmisartan, were not included in the review. 
Druga zdravila istega razreda, ki ne vsebujejo tega obroča, kot so azilsartan, eprosartan in telmisartan, niso bila vključena v pregled.