natgillin/translations-raw huggingface dataset:
• Clean the chosen skin area with an alcohol swab using a circular motion.
• Kožo na mestu injiciranja očistite z alkoholno blazinico s krožnimi gibi.
• Inject the solution by pushing gently on the plunger.
• Raztopino injicirajte tako, da nežno pritiskate na bat.
You and your partner's fertility should be evaluated before the treatment is started by a doctor experienced in treating fertility problems.
Kaj morate vedeti, preden boste uporabili zdravilo Pergoveris Pred začetkom zdravljenja mora vašo plodnost in plodnost vašega partnerja oceniti zdravnik z izkušnjami pri zdravljenju motenj plodnosti.
Renal and hepatic impairment
Ledvične in jetrne poškodbe
INFORMATION IN BRAILLE pergoveris (300 iu + 150 iu)/0.48 ml pen
PODATKI V BRAILLOVI PISAVI pergoveris (300 i.e. + 150 i.e.)/0,48 ml peresnik
EU/1/07/396/002 3 vials of powder for solution for injection.
EU/1/07/396/002 3 viale s praškom za raztopino za injiciranje 3 viale z vehiklom
This is to help you get pregnant.
To vam pomaga pri zanositvi.
Important information about the Pergoveris pre-filled pen How to use your Pergoveris pre-filled pen treatment diary Gathering your supplies
Pomembne informacije o zdravilu Pergoveris napolnjen injekcijski peresnik Kako uporabljati dnevnik zdravljenja z zdravilom Pergoveris napolnjen injekcijski peresnik
Important information about the Pergoveris pre-filled pen
Pomembne informacije o zdravilu Pergoveris napolnjen injekcijski peresnik
By replacing the missing hormones, Pergoveris allows women with low levels of FSH and LH to develop a follicle.
Zdravilo Pergoveris ženski z nizkimi ravnmi FSH in LH nadomesti manjkajoče hormone, za razvoj folikla.
EU/1/07/396/003 10 vials of powder for solution for injection.
EU/1/07/396/003 10 vial s praškom za raztopino za injiciranje 10 vial z vehiklom
Warning: Please read these instructions for use before using your Pergoveris pre-filled pen.
Opozorilo: Pred uporabo zdravila Pergoveris napolnjen injekcijski peresnik preberite ta navodila za uporabo.
1 multidose pre-filled pen of 0.48 mL solution 5 injection needles
1 večodmerni napolnjen injekcijski peresnik z 0,48 ml raztopine 5 injekcijskih igel
• Sucrose, arginine monohydrochloride, poloxamer 188, methionine, phenol, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate and water for injections.
• Saharoza, argininijev monoklorid, poloksamer 188, metionin, fenol, natrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat monohidrat in voda za injekcije.
Reusing a pen It is NOT required to check for a droplet of liquid.
NI potrebe po preverjanju kapljice tekočine.
INFORMATION IN BRAILLE pergoveris (900 iu + 450 iu)/1.44 ml pen
PODATKI V BRAILLOVI PISAVI pergoveris (900 i.e. + 450 i.e.)/1,44 ml peresnik
• tumours of the hypothalamus and pituitary gland
• s tumorji hipotalamusa in hipofize;
• Pergoveris is presented as a powder and solvent for solution for injection.
• Zdravilo Pergoveris je v obliki praška in vehikla za raztopino za injiciranje.
Gathering your supplies
Priprava potrebščin
• Swirl gently without removing the syringe.
• Ne da bi odstranili brizgo, nežno zavrtinčite.
Prepare your needle.
Pripravite injekcijsko iglo.
• The dose number shown in the Dose Feedback
• Številka, prikazana v okencu za prikaz odmerka,
• Slowly push the needle into the skin entirely
• Počasi zabodite celo iglo v kožo (sl. 9).
Fig. 5
Sl. 5
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 900 IU r-hFSH- 450 IU r-hLH/1.44 mL
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 900 i.e. r-hFSH- 450 i.e. r-hLH/1,44 mL
In clinical trials the efficacy of the combination of follitropin alfa and lutropin alfa has been demonstrated in women with hypogonadotropic hypogonadism.
V kliničnih preskušanjih z ženskami s hipogonadotropnim hipogonadizmom so potrdili učinkovitost kombinacije folitropina alfa in lutropina alfa.
• 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.