natgillin/translations-raw huggingface dataset:
To minimise the risk of OHSS or of multiple pregnancy (see below), ultrasound scans as well as oestradiol measurements are recommended.
Za zmanjšanje tveganja OHSS ali večplodne nosečnost (glejte spodaj), se priporočajo ultrazvočni pregledi in merjenje estradiola.
In anovulation the risk of OHSS is increased by a serum oestradiol level > 900 pg/ ml (3,300 pmol/ l) and by the presence of more than 3 follicles of 14 mm or more in diameter.
Pri anovulaciji se tveganje za OHSS poveča s serumsko koncentracijo estradiola > 900 pg/ ml (3300 pmol/ l) in s prisotnostjo več kot 3 foliklov, s premerom 14 mm ali več.
Adherence to recommended Pergoveris and FSH dosage and regimen of administration and careful monitoring of therapy will minimise the incidence of ovarian hyperstimulation and multiple pregnancy (see below).
Upoštevanje priporočenega odmerjanja zdravila Pergoveris in FSH, režima dajanja in skrbno nadzorovanje zdravljenja, zmanjšajo pogostnost hiperstimulacije jajčnikov in večplodnih nosečnosti na minimum (glejte spodaj).
The patient should be hospitalised and specific therapy for OHSS started.
Če se pojavi hud OHSS, se mora ukiniti zdravljenje z gonadotropini, v kolikor še traja. Bolnico se mora sprejeti v bolnišnico in začeti s specifičnim zdravljenjem OHSS.
In patients undergoing induction of ovulation, the incidence of multiple pregnancies and births is increased compared with natural conception.
Pri bolnicah v postopku indukcije ovulacije, je pogostnost večplodnih nosečnosti v primerjavi z naravno zanositvijo, povečana.
The incidence of pregnancy wastage by miscarriage or abortion is higher in patients undergoing stimulation of follicular growth for ovulation induction than in the normal population.
Pogostnost izgube nosečnosti zaradi spontanega splava ali abortusa je pri bolnicah, ki so v postopku stimulacije folikularne rasti za indukcijo ovulacije, večja kot pri normalni populaciji.
When risk of OHSS or multiple pregnancies is assumed, treatment discontinuation should be considered.
V primeru domneve tveganja OHSS ali večplodnih nosečnosti, je treba razmisliti o prekinitvi zdravljenja.
There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple drug 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.
5 In women with generally recognised risk factors for thrombo-embolic events, such as personal or family history, treatment with gonadotrophins may further increase the risk.
Pri ženskah s splošno znanimi dejavniki tveganja za tromboembolične dogodke, kot so osebna ali družinska anamneza, lahko zdravljenje z gonadotropini še poveča tveganje.
It should be noted however, that pregnancy itself also carries an increased risk of thrombo-embolic events.
Vendar pa je treba omeniti, da tudi nosečnost sama prinaša povečano tveganje za tromboembolične dogodke.
Pergoveris should not be administered as a mixture with other medicinal products, in the same injection, except follitropin alfa.
Pergoveris se ne sme dajati v obliki mešanice z drugimi zdravili v isti injekcijski brizgi, razen s folitropina alfa.
Pergoveris should not be used during pregnancy or lactation.
Zdravila Pergoveris se ne sme uporabljati v času nosečnosti ali dojenja.
Very Common (≥ 1/ 10) Common (≥ 1/ 100 to < 1/ 10)
Zelo pogosti (≥1/ 10) Pogosti (≥1/ 100 in < 1/ 10)
Headache Somnolence
Somnolenca.
Very rare (< 1/ 10,000)
Zelo redki (< 1/ 10, 000)
Exacerbation or worsening of asthma
Izbruh ali poslabšanje astme.
Common (≥ 1/ 100 to < 1/ 10)
Pogosti (≥1/ 100 in < 1/ 10)
Abdominal pain and gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal cramps and bloating
Bolečina v trebuhu in gastrointestinalni znaki, kot so slabost, bruhanje, driska, trebušni krči in napihnjenost.
Thromboembolism, usually associated with severe ovarian hyperstimulation syndrome (OHSS)
Tromboembolizem, običajno povezan s hudim sindromom hiperstimulacije jajčnikov (OHSS)
Very Common (≥ 1/ 10)
Zelo pogosti (≥1/ 10)
Mild systemic allergic reactions (e. g. mild forms of erythema, rash, facial swelling, urticaria, oedema, difficulty breathing).
Blage sistemske alergijske reakcije (npr. blage oblike eritema, izpuščaj, otekanje obraza, urtikarija, edem, težave z dihanjem).
Serious cases of allergic reactions, including anaphylactic reactions, have also been reported.
Poročali so tudi o resnih primerih alergijskih reakcij, vključno z anafilaktičnim šokom.
6 Reproductive system and breast disorders
Motnje reprodukcije in dojk
Very Common (≥ 1/ 10)
Zelo pogosti (≥1/ 10) Pogosti (≥1/ 100 in < 1/ 10)
Ovarian cysts
Ovarijske ciste.
Breast pain, pelvic pain, mild to moderate OHSS
Bolečine v prsih, bolečine v medenici, blag do zmeren OHSS
Uncommon (≥ 1/ 1,000 to < 1/ 100)
Občasni (≥1/ 1, 000 in < 1/ 100)
Severe OHSS
Hud OHSS
Rare (≥ 1/ 10,000 to < 1/ 1,000)
Redki (≥1/ 10, 000 in < 1/ 1, 000)
Ovarian torsion, a complication of OHSS
Zasuk jajčnika, zaplet OHSS
Nevertheless one could expect ovarian hyperstimulation syndrome to occur, which is further described in section 4.4.
Vendar pa lahko pričakujemo pojav sindroma hiperstimulacije jajčnikov, ki je podrobno opisan v poglavju 4. 4.
Pharmacotherapeutic group:
Farmakoterapevtska skupina: gonadotropini, Oznaka ATC:
Gonadotrophins, ATC code:
G03GA05 / ATC:
G03GA05 / G03GA07.
G03GA07
Pergoveris is a preparation of follicle stimulating hormone and luteinising hormone produced by genetically engineered Chinese Hamster Ovary (CHO) cells.
Pergoveris je pripravek s folikle stimulirajočim hormonom in luteinizirajočim hormonom, ki sta pridobljena z genetsko spremenjenimi celicami jajčnika kitajskega hrčka (CHO).
In the stimulation of follicular development in anovulatory women deficient in LH and FSH, the primary effect resulting from administration of lutropin alfa is an increase in oestradiol secretion by the follicles, the growth of which is stimulated by FSH.
Pri ženskah brez ovulacije s pomankanjem LH in FSH, je primarni učinek dajanja lutropina alfa povečanje izločanja estradiola iz foliklov, katerih rast je spodbujena z FSH.
In one clinical study of women with hypogonadotrophic hypogonadism and an endogenous serum LH concentration below 1.2 IU/ L the appropriate dose of r-hLH (lutropin alfa) was investigated.
V eni klinični študiji z ženskami s hipogonadotropnim hipogonadizmom in endogeno koncentracijo LH manjšo od 1, 2 i. e. / l, so proučevali ustrezen odmerek r- hLH (lutropina alfa).
A dose of 75 IU r-hLH daily (in combination with 150 IU follitropin alfa (r-hFSH)) resulted in adequate follicular development and oestrogen production.
Z dnevnim odmerkom 75 i. e. r- hLH (v kombinaciji s 150 i. e. folitropina alfa (r- hFSH)) so dosegli primeren razvoj foliklov in izločanje estrogena.
A dose of 25 IU r-hLH daily (in combination with 150 IU follitropin alfa) resulted in insufficient follicular development.
Z dnevnim odmerkom 25 i. e. r- hLH (v kombinaciji s 150 i. e. folitropina alfa), je bil dosežen razvoj foliklov nezadosten.
Follitropin alfa and lutropin alfa have shown the same pharmacokinetic profile as follitropin alfa and lutropin alfa separately.
Folitropina alfa in lutropina alfa kažeta enak farmakokinetični profil, kot folitropin alfa in lutropin alfa vsak posebej.
Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial half-life of around 2 hours and eliminated from the body with a terminal half-life of about one day.
Po intravenskem dajanju, se folitropina alfa porazdeli v zunajcelični prostor z začetnim razpolovnim časom približno 2 uri in izloči iz telesa s končnim razpolovnim časom približno en dan.
The steady state volume of distribution and total clearance are 10 l and 0.6 l/ h, respectively.
Volumen porazdelitve v stanju dinamičnega ravnovesja je 10 l in celokupni očistek je 0, 6 l/ h.
One-eighth of the follitropin alfa dose is excreted in the urine.
Ena osmina odmerka folitropina alfa se izloči z urinom.
Following subcutaneous administration, the absolute bioavailability is about 70%.
Po subkutani aplikaciji je absolutna biološka uporabnost 70%.
In women
Po večkratnem dajanju, se folitropina alfa trikratno kopiči in doseže stanje dinamičnega ravnovesja v 3 do 4 dneh.
7 whose endogenous gonadotrophin secretion is suppressed, follitropin alfa has nevertheless been shown to effectively stimulate follicular development and steroidogenesis, despite unmeasurable LH levels.
Pri ženskah z zavrtim izločanjem endogenih gonadotropinov, je folitropina alfa vseeno učinkovito spodbujal razvoj foliklov in steroidogenezo, kljub nemerljivim ravnem LH.
Following intravenous administration, lutropin alfa is rapidly distributed with an initial half-life of approximately one hour and eliminated from the body with a terminal half-life of about 10-12 hours.
Po intravenskem dajanju se lutropina alfa hitro porazdeli z začetnim razpolovnim časom približno 1 uro in se izloči iz telesa s končnim razpolovnim časom približno 10– 12 ur.
The steady state volume of distribution is around 10-14 l.
Volumen porazdelitve v stanju dinamičnega ravnovesja je približno 10- 14 l.
Lutropin alfa shows linear pharmacokinetics, as assessed by AUC which is directly proportional to the dose administered.
Lutropina alfa kaže linearne farmakokinetične lastnosti, kot so ocenili z AUC, ki je direktno sorazmerna danemu odmerku.
The lutropin alfa pharmacokinetics following single and repeated administration of lutropin alfa are comparable and the accumulation ratio of lutropin alfa is minimal.
Farmakokinetika lutropina po enkratnem in večkratnem dajanju lutropina alfa je primerljiva in stopnja akulmulacije lutropina alfa je minimalna.
There is no pharmacokinetic interaction with follitropin alfa when administered simultaneously.
Pri sočasnem dajanju s folitropina alfa ni farmakokinetičnih interakcij.
Sucrose Polysorbate 20 Methionine Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Phosphoric acid, concentrated for pH adjustment Sodium hydroxide for pH adjustment
saharoza polisorbat 20 metionin natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat monohidrat fosforjeva kislina, koncentrirana, za uravnavanje pH natrijev hidroksid za uravnavanje pH Vehikel:
Water for Injections
Voda za injekcije.
3 ml vials (Type I glass) with a stopper (bromobutyl rubber) and aluminium flip-off cap.
3 ml viale (steklo Tipa I) z zamaškom (bromobutilna guma) in aluminijsko kapico, ki se odtrga na poteg.
1 vial contains 11 micrograms r-hFSH and 3 micrograms r-hLH.
Ena viala vsebuje 11 mikrogramov r- hFSH in 3 mikrograme r- hLH.
3 ml vials (Type I glass) with a Teflon coated rubber stopper and aluminium flip-off cap.
Vehikel: 3 ml viale (steklo Tipa I) z gumijastim zamaškom prevlečenim s Teflonom in aluminijsko kapico, ki se odtrga na poteg.
The medicinal product is supplied in pack sizes of 1, 3 and 10 vials with the corresponding number of 1, 3 and 10 vials of solvent.
Zdravilo je na voljo v velikostih pakiranja po 1, 3 in 10 vial z ustreznim številom 1, 3 in 10 vial vehikla.
Pergoveris must be reconstituted with the solvent before use.
Pergoveris morate pred uporabo rekonstituirati z vehiklom.
Pergoveris may be mixed with follitropin alfa and co-administered as a single injection.
Pergoveris lahko mešate s folitropina alfa in ga dajete sočasno kot eno samo injekcijo.
Serono Europe Limited 56 Marsh Wall London E14 9TP United Kingdom
Serono Europe Limited 56 Marsh Wall London E14 9TP Velika Britanija 8.
Name and address of the manufacturer of the biological active substances
POSEBNE ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM A.
Zone Industrielle de l’ Ouriettaz 1170 Aubonne Switzerland
Zone Industrielle de l’ Ouriettaz 1170 Aubonne Švica
C/ Batanes 1 28760 Tres Cantos (Madrid) Spain
C / Batanes 1 28760 Tres Cantos (Madrid) Španija
The Marketing Authorisation Holder must ensure that the system of pharmacovigilance is in place and functioning prior to placing the product on the market.
Imetnik dovoljenja za promet mora zagotoviti vzpostavitev in delovanje sistema za farmakovigilanco pred dajanjem zdravila na trg.
11 ANNEX III
DODATEK III
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1, 3, 10 VIALS OF POWDER AND SOLVENT
OZNAČEVANJE PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z 1, 3, 10 VIALAMI PRAŠKA IN VEHIKLA
Follitropin alfa/ lutropin alfa
Pergoveris 150 i. e. / 75 i. e. prašek in vehikel za raztopino za injiciranje Folitropina alfa/ lutropina alfa
Other ingredients: disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, methionine, polysorbate 20.
Pomožne snovi: natrijev hidrogenfosfat dihidrat, natrijeve dihidrogenfosfat monohidrat, metionin, polisorbat 20.
Sucrose:
Saharoza:
See leaflet before use.
Pred uporabo preberite priloženo navodilo.
1 vial of powder (11 µg r-hFSH and 3 µg r-hLH).
1 viala s praškom (11 µg r- hFSH in 3 µg r- hLH).
3 vials of solvent.
3 viale s praškom 3 viale z vehiklom.
10 vials of solvent.
10 vial s praškom 10 vial z vehiklom.
EXP (powder) EXP (solvent)
EXP (prašek) EXP (vehikel)
Any unused product or waste material should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predisi.
3 vials of powder for solution for injection.
3 viale s praškom za raztopino za injiciranje.
Batch Solvent Batch
Serija vehikel:
pergoveris
PODATKI V BRAILLOVI PISAVI
16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PERGOVERIS 150 IU/ 75 IU VIAL LABEL
NALEPKA NA VIALI
Pergoveris 150 IU/ 75 IU powder for solution for injection Follitropin alfa/ Lutropin alfa Subcutaneous use
Pergoveris 150 i. e. / 75 i. e. prašek in vehikel za raztopino za injiciranje Folitropina alfa/ lutropina alfa Za subkutano uporabo.
150 IU r-hFSH-75 IU r-hLH
150 i. e. r- hFSH - 75 i. e. r- hLH
17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL
DRUGI PODATKI PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH VIALA Z VEHIKLOM
Solvent for Pergoveris Water for injections
Vehikel za Pergoveris Voda za injekcije
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 Folitropina alfa/ Lutropina alfa
What Pergoveris is and what it is used for 2.
Kaj je zdravilo Pergoveris in za kaj ga uporabljamo 2.
Before you use Pergoveris 3.
Kaj morate vedeti, preden boste uporabili zdravilo Pergoveris 3.
How to use Pergoveris 4.
Kako uporabljati zdravilo Pergoveris 4.
How to store Pergoveris 6.
Shranjevanje zdravila Pergoveris 6.
WHAT PERGOVERIS IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO PERGOVERIS IN ZA KAJ GA UPORABLJAMO
Pergoveris belongs to the family of hormones called gonadotrophins, which are involved in the normal control of reproduction.
Pergoveris spada v skupino hormonov, ki se imenujejo gonadotropini in sodelujejo pri normalnem nadzoru reprodukcije.
Pergoveris is a medicine containing follitropin alfa and lutropin alfa, which is made in laboratories by special recombinant DNA techniques.
Pergoveris je zdravilo, ki vsebuje folitropina alfa in lutropina alfa, ki sta izdelana v laboratorijih s posebno tehnologijo rekombinantne DNA.
The medicine should only be used under the strict supervision of a physician.
Zdravilo se sme uporabljati samo pod strogim nadzorom zdravnika.
In women who are not ovulating due to very low production of the fertility hormones (FSH and LH) by their pituitary gland, Pergoveris is used to cause ovulation.
Pri ženskah, ki nimajo ovulacije zaradi zelo majhnega izločanja fertilnih hormonov (FSH in LH) iz hipofize, se za sprožitev ovulacije uporablja Pergoveris.
BEFORE YOU USE PERGOVERIS
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO PERGOVERIS
• if you are allergic (hypersensitive) to follicle stimulating hormone, luteinising hormone or any of the other ingredients of Pergoveris, • if you have tumours of the hypothalamus and pituitary gland, • if you have ovarian enlargement or cyst not due to polycystic ovarian disease, • if you have gynaecological bleeding of unknown cause, • if you have ovarian, uterine or breast cancer.
• če ste alergični na (preobčutljivi za) folikle stimulirajoči hormon, folikle luteinizirajoči hormon ali katerokoli sestavino zdravila Pergoveris, • če imate tumor hipotalamusa in hipofize, • če imate povečanje jajčnika ali cisto, ki ni posledica policistične ovarijske bolezni, • če imate nepojasnjeno vaginalno krvavitev • če imate imate rak jajčnika, maternice ali dojke.
The medicine must not be used when a condition exists which would make a normal pregnancy impossible, such as:
Zdravila ne smete uporabljati v primeru stanj, ki bi onemogočala normalno nosečnost, kot so:
• premature menopause, 20 • malformation of sexual organs, • specific tumours of the womb.
• prezgodnja menopavza, • malformacije spolnih organov, • določeni tumorji maternice.
Take special care with Pergoveris
Bodite posebno pozorni pri uporabi zdravila Pergoveris
Inform you doctor if you have porphyria or a family history of porphyria (a disorder that may be passed on from parents to children).
Obvestite zdravnika, če imate porfirijo ali jo je imel kdo v vaši družini (bolezen, ki se prenaša od staršev na otroke).
The use of certain medications may trigger an attack of the illness.
Uporaba določenih zdravil lahko sproži napad bolezni.
Tell your doctor if you notice the following:
Obvestite zdravnika, če opazite naslednje:
• your skin becoming fragile and easily blistered (especially areas that are frequently exposed to sunlight) • and/ or you have stomach or limb pain.
• vaša koža postaja krhka in podvržena tvorbi mehurjev (zlasti na tistih delih, ki so pogosto izpostavljeni soncu) • in/ ali imate bolečine v trebuhu ali v okončinah.
Your doctor who may recommend that you stop treatment.
Zdravnik lahko priporoči prekinitev zdravljenja.
This can lead to the so called ovarian hyperstimulation syndrome (OHSS) (see 4.
To zdravljenje spodbuja jajčnike, včasih do pretirane rasti foliklov, kar je lahko povezano s tveganjem čezmernega povečanja jajčnika. To lahko privede do tako imenovanega sindroma hiperstimulacije jajčnikov (OHSS) (glejte 4.
However, if you are not ovulating and the recommended dose and schedule of administration are adhered to, the occurrence of severe OHSS is uncommon (likely to occur in fewer than 1 in 100 patients).
Vendar pa je pojav hudega OHSS redek (verjetnost pojava je manj kot pri 1 od 100 bolnic), če ne ovulirate in upoštevate priporočeno odmerjanje ter shemo dajanja.
Pergoveris treatment seldom gives rise to significant OHSS unless the medicine used to induce final follicular maturation (containing human chorionic gonadotrophin - hCG) is administered.
Zdravljenje z zdravilom Pergoveris redko povzroči pomemben OHSS, razen če se uporabi zdravilo za sprožitev končnega folikularnega zorenja (ki vsebuje humani horionski gonadotropin - hCG).
It is therefore prudent to withhold administration of hCG in cases where OHSS is developing (see 4.
Zato je v primerih, ko se razvije OHSS, smiselno opustiti dajanje hCG (glejte 4.
Possible side effects) and not to have sexual intercourse or use barrier methods for at least four days.
Možni neželeni učinki) in ne imeti spolnih odnosov ali pa uporabljati mehanska kontracepcijska sredstva najmanj štiri dni.
In patients undergoing induction of ovulation, the incidence of multiple pregnancies and births is increased compared with natural conception.
Pri bolnicah, ki so v postopku sprožitve ovulacije, je pogostnost večplodnih nosečnosti in porodov povečana, v primerjavi s tistimi z naravno zanositvijo.
However, this can be minimised by using the recommended dose and schedule of administration.
Vendar pa se to lahko zmanjša na minimum z uporabo priporočenega odmerka in sheme dajanja.
To minimise the risk of OHSS or of multiple pregnancy, ultrasound scans as well as oestradiol measurements are recommended.
Za zmanjšanje tveganja pojava OHSS ali večplodnih nosečnosti na najmanjšo možno mero, se priporočajo pregledi z ultrazvokom in merjenje estradiola.
Women with a history of tubal disease are at risk of pregnancy where the embryo is implanted outside the womb (ectopic pregnancy), whether the pregnancy is obtained by spontaneous conception or with fertility treatments.
Pri ženskah, ki so imele bolezni jajcevodov, obstaja tveganje nosečnosti, kjer se zarodek vgnezdi zunaj maternice (zunajmaternične nosečnosti), ne glede ali so zanosile spontano ali s pomočjo zdravljenja.
There have been reports of tumors to the ovary and other reproductive organs, both benign and malignant, in women who have undergone multiple drug 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 reprodukcijskih organih, tako benignih kot malignih.
There have been isolated reports of non-serious allergic reactions to Pergoveris.
Obstajajo posamična poročila o neogrožajočih alergijskih reakcijah na Pergoveris.
If you had this type of reaction to similar medicines, inform your doctor.
Če ste že imeli takšno reakcijo na podobna zdravila, obvestite o tem svojega zdravnika.
Pergoveris should not be administered as a mixture with other medicinal products in the same injection, except for follitropin alfa, if prescribed by your doctor.
Zdravila Pergoveris se ne sme dajati v obliki mešanice z drugimi zdravili v isti injekcijski brizgi, razen s folitropina alfa, če tako predpiše zdravnik.
21 Pregnancy and breast-feeding
Nosečnost in dojenje
Pergoveris is not indicated if you are pregnant or are breast-feeding.
Pergoveris ni indiciran, če ste noseči ali če dojite.
No studies on the effects on the ability to drive and use machines have been performed.
Vpliv na sposobnost upravljanja vozil in strojev
Important information about some of the ingredients of Pergoveris
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli Pomembne informacije o nekaterih sestavinah zdravila Pergoveris
Pergoveris contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially “ sodium-free”.
Pergoveris vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar pomeni, da je v bistvu brez natrija.
HOW TO USE PERGOVERIS
KAKO UPORABLJATI ZDRAVILO PERGOVERIS
Always use Pergoveris exactly as your doctor has told you.
Pri uporabi zdravila Pergoveris natančno upoštevajte zdravnikova navodila.
Pergoveris is intended for subcutaneous use, that means it is given by injection just under the skin.
Pergoveris je namenjen za subkutano uporabo, kar pomeni, da se ga injicira tik pod kožo.
It is for single use only.
Vsaka viala je samo za enkratno uporabo.
The usual dose is one vial of Pergoveris used every day for up to three weeks.
Običajen odmerek je ena viala zdravila Pergoveris vsak dan, do tri tedne.
According to your response, your doctor may increase your dose of follitropin alfa by preferably 37.5-75 IU at 7 to 14- day intervals.
Glede na vaš odziv, lahko zdravnik poveča odmerek folitropina alfa, po možnosti za 37, 5 i. e – 75 i. e. v 7 do 14 dnevnih časovnih razmakih.
When the desired response has been obtained, a single injection of hCG is given 24-48 hours after the last injections of Pergoveris.
Ko je dosežen željeni odziv, se v 24- 48 urah po zadnji injekciji zdravila Pergoveris, injicira ena sama injekcija hCG- ja.
You are recommended to have sexual intercourse on the day of, and the day following administration of the hCG.
Priporočamo vam, da imate spolni odnos na isti dan in na dan, ki sledi dajanju hCG - ja.
If an excessive response is obtained, treatment should be stopped and hCG withheld (see 4.
Če pride do čezmernega odziva, je treba zdravljenje prekiniti in opustiti hCG (glejte 4.
For the following cycle, your doctor will prescribe follitropin alfa at a lower dose than that of the previous cycle.
Za naslednji ciklus vam bo zdravnik predpisal manjši odmerek folitropina alfa kot v predhodnem ciklusu.
If you administer Pergoveris to yourself, please carefully read the following instructions:
Če si sami dajete Pergoveris, vas prosimo, da natančno preberete naslednja navodila: