natgillin/translations-raw huggingface dataset:
Mannitol Methionine Poloxamer 188 Diluted phosphoric acid Sodium hydroxide Water for injections
manitol metionin poloksamer 188 razredčena fosforjeva kislina natrijev hidroksid voda za injekcije
After opening, the product should be used immediately.
Po odprtju morate zdravilo takoj uporabiti.
However, the in-use stability has been demonstrated for 24 hours at +2° to 8° C.
Vendar pa je bila dokazana stabilnost pripravljene raztopine 24 ur pri +2 °C do 8° C.
0.5 ml of solution in a pre-filled syringe (type I glass) with a plunger stopper (halobutyl rubber) and plunger (plastic), and with a needle for injection (stainless) – pack of 1.
0, 5 ml raztopine v napolnjeni injekcijski brizgi (steklo Tip I) z batnim zamaškom (halobutilna guma) in batom (plastičnim) ter injekcijsko iglo (nerjavečo) - pakiranje po 1.
Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom
SERONO EUROPE LIMITED, 56 Marsh Wall London E14 9TP Velika Britanija
MANUFACTUREROF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
OVITRELLE 250 MICROGRAMS, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION, SOLVENT IN AMPOULES
OVITRELLE 250 MIKROGRAMOV, PRAŠEK IN VEHIKEL ZA RAZTOPINO ZA INJICIRANJE, VEHIKEL V AMPULAH
Choriogonadotropin alfa.
Ovitrelle 250 mikrogramov prašek in vehikel za raztopino za injiciranje Horiogonadotropin alfa.
Composition: one vial delivers:
Sestava: ena viala zagotovi odmerek:
Choriogonadotropin alfa 250 micrograms (6500 IU).
250 mikrogramov (6500 i. e.) horiogonadotropina alfa
Other ingredients:
Druge sestavine: saharoza, fosforjeva kislina, natrijev hidroksid.
Sucrose, phosphoric acid, sodium hydroxide.
Ena ampula z vehiklom vsebuje:
One ampoule of solvent contains:1 ml water for injections.
1 ml vode za injekcije.
1 ampoule of solvent.
1 viala s praškom za raztopino za injiciranje 1 ampula z vehiklom.
2 vials of powder for solution for injection 2 ampoules of solvent
2 ampuli z vehiklom.
10 vials of powder for solution for injection 10 ampoules of solvent
10 ampul z vehiklom.
Do not store above 25oC.
Shranjujte pri temperaturi do 25° C.
Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom
SERONO EUROPE LIMITED 56, Marsh Wall London E14 9TP Velika Britanija
OVITRELLE 250 MICROGRAMS, POWDER AND SOLVENT FOR SOLUTION FOR INJECTION, SOLVENT IN VIALS
OVITRELLE 250 MIKROGRAMOV, PRAŠEK IN VEHIKEL ZA RAZTOPINO ZA INJICIRANJE, VEHIKEL V VIALAH
Sucrose, phosphoric acid, sodium hydroxide.
Ena viala z vehiklom vsebuje:
One vial of solvent contains:1 ml water for injections.
1 ml vode za injekcije.
1 vial of solvent.
1 viala s praškom za raztopino za injiciranje 1 viala z vehiklom.
2 vials of powder for solution for injection 2 vials of solvent
2 viali z vehiklom.
10 vials of powder for solution for injection 10 vials of solvent
10 vial z vehiklom.
Do not store above 25oC.
Shranjujte pri temperaturi do 25°C.
1 vial of powder/ 1 vial of solvent 2 vials of powder/ 2 vials of solvent 10 vials of powder/ 10 vials of solvent
1 viala s praškom / 1 viala z vehiklom 2 viali s praškom / 2 viali z vehiklom 10 vial s praškom/ 10 vial z vehiklom
OVITRELLE 250 MICROGRAMS, SOLUTION FOR INJECTION
OVITRELLE 250 MIKROGRAMOV, RAZTOPINA ZA INJICIRANJE
Ovitrelle 250 micrograms/ 0.5 ml solution for injection in a pre-filled syringe.
Ovitrelle 250 mikrogramov/ 0, 5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi.
Choriogonadotropin alfa.
Horiogonadotropin alfa.
One pre-filled syringe contains:
Ena napolnjena injekcijska brizga vsebuje:
250 micrograms (6500 IU) of Choriogonadotropin alfa
250 mikrogramov (6500 i. e.) horiogonadotropina alfa
Mannitol, methionine, poloxamer 188, diluted phosphoric acid, sodium hydroxide, water for injections.
Druge sestavine: manitol, metionin, poloksamer 188, razredčena fosforjeva kislina, natrijev hidroksid, voda za injekcije.
1 pre-filled syringe with 0.5 ml solution for injection
1 napolnjena injekcijska brizga z 0, 5 ml raztopine za injiciranje
Store in a refrigerator.
Shranjujte pri temperaturi med 2°C in 8°C (v hladilniku).
May be stored at or below + 25° C for up to 30 days without being refrigerated again during this period and must be discarded if not used during these 30 days.
Zdravilo lahko shranjujete pri temperaturi do +25 °C do 30 dni, brez ponovnega shranjevanja v hladilniku v tem času, in ga morate zavreči, če ga ne uporabite v teh 30 dneh.
Any unused solution or waste material should be disposed of in accordance with local requirements
Neuporabljeno raztopino ali odpadni material zavrzite v skladu z lokalnimi predpisi.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
IME IN NASLOV IMETNIKA ZA PROMET Z ZDRAVILOM
OVITRELLE 250 MICROGRAMS s, POWDER
OVITRELLE 250 MIKROGRAMOV, PRAŠEK
Ovitrelle 250 micrograms powder for injection
Ovitrelle 250 mikrogramov prašek za raztopino za injiciranje
OVITRELLE 250 MICROGRAMS s, SOLVENT VIALS AND AMPOULES
OVITRELLE 250 MIKROGRAMOV, VIALE IN AMPULE Z VEHIKLOM
OVITRELLE 250 MICROGRAMS s, PRE-FILLED SYRINGE
OVITRELLE 250 MIKROGRAMOV, NAPOLNJENA INJEKCIJSKA BRIZGA
Ovitrelle 250 micrograms/ 0.5 ml solution for injection in a pre-filled syringe Choriogonadotropin alfa Subcutaneous use.
Ovitrelle 250 mikrogramov/ 0, 5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Horiogonadotropin alfa Za subkutano uporabo.
Ampoule)
27 NAVODILO ZA UPORABO (Vsebnik z vehiklom: ampula)
Choriogonadotropin alfa.
Ovitrelle 250 mikrogramov prašek in vehikel za raztopino za injiciranje Horiogonadotropin alfa
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Če katerikoli neželen učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni
What Ovitrelle is and what it is used for 2.
Kaj je zdravilo Ovitrelle in za kaj ga uporabljamo 2.
Before you use Ovitrelle 3.
Kaj morate vedeti, preden boste uporabili zdravilo Ovitrelle 3.
How to use Ovitrelle 4.
Kako uporabljati zdravilo Ovitrelle 4.
How to store Ovitrelle 6.
Shranjevanje zdravila Ovitrelle 6.
WHAT OVITRELLE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO OVITRELLE IN ZA KAJ GA UPORABLJAMO?
Ovitrelle is a medicinal product containing choriogonadotropin alfa, which is very similar to chorionic gonadotrophin found naturally in humans, but it is made in laboratories by special recombinant DNA techniques.
Ovitrelle je zdravilo, ki vsebuje horiogonadotropin alfa, ki je zelo podoben naravnemu človeškemu horionskemu gonadotropinu, le da je izdelan v laboratorijih s posebno tehnologijo rekombinantne DNK.
It belongs to the family of hormones called gonadotrophins, which are involved in the normal control of reproduction.
Spada v skupino hormonov, imenovanih gonadotropini, ki sodelujejo pri normalnem nadzoru reprodukcije.
Ovitrelle is used in women undergoing assisted reproductive techniques such as in vitro fertilisation (IVF).
Ovitrelle se uporablja pri ženskah, ki so v postopku asistirane reprodukcije, kot je npr. oploditev in vitro (IVF).
Other medicines are given first to bring about the growth and development of several follicles, to produce eggs.
V teh postopkih najprej dajemo druga zdravila, da se doseže rast in razvoj več foliklov za tvorbo jajčec.
Ovitrelle is then used to ripen (mature) these follicles.
Ovitrelle nato uporabimo, da ti folikli dozorijo.
Ovitrelle is also used in women who do not produce eggs (a condition called anovulation) or who produce too few eggs (oligo-ovulation).
Ovitrelle uporabljamo tudi pri ženskah, pri katerih jajčeca ne nastajajo (to stanje imenujemo anovulacija) ali jih nastaja premalo (oligoovulacija).
It is given to bring about the release of eggs (ovulation), after other medicines have been used to develop the follicles.
Uporabljamo ga za dosego sprostitve jajčeca (ovulacijo), in sicer potem, ko so bila uporabljena druga zdravila za razvoj foliklov.
BEFORE YOU USE OVITRELLE
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO OVITRELLE
You and your partner's fertility should be evaluated before the treatment is started.
Pred začetkom zdravljenja morata s partnerjem opraviti preiskave plodnosti.
Do not take Ovitrelle:
Ne uporabljajte zdravila Ovitrelle
- If you are pregnant or breast-feeding
- če ste noseči ali dojite
- If you have ovarian enlargement or one or more large ovarian cysts
- če imate povečan jajčnik ali eno ali več velikih cist na jajčniku
- if you have unexplained vaginal bleeding
- če imate nepojasnjeno krvavitev iz nožnice
- if you have been diagnosed as having ovarian, uterine or breast cancer
- če so vam odkrili raka na jajčniku, maternici ali dojki
- if you had a tumour of the hypothalamus or pituitary gland
- če ste imeli tumor hipotalamusa ali žleze hipofize
- If you suffer from severe inflammation of the veins or blood clotting in the veins (active
- če imate hudo vnetje ven ali krvne strdke v venah (aktivno trombembolično bolezen)
thrombo-embolic disorders)
- če ste alergični na (preobčutljivi za) horiogonadotropin ali katerokoli sestavino zdravila
- if you are allergic (hypersensitive) to choriogonadotropin, or any of the ingredients of Ovitrelle
Ovitrelle,
- if you have any condition which would make a normal pregnancy impossible (e. g. absent uterus,
- če imate katerokoli stanje, ki onemogoča normalno nosečnost (npr. nimate maternice, imate
ovaries which have not developed properly, fibroids) or you have been through menopause
nepravilno razvita jajčnika, miome), ali ste že po menopavzi
- if you had an extrauterine pregnancy within the last 3 months
- če ste imeli v zadnjih 3 mesecih zunajmaternično nosečnost.
28 Take special care with Ovitrelle:
28 Bodite posebno pozorni pri uporabi zdravila Ovitrelle:
Treatment with Ovitrelle may increase your risk of developing a condition called ovarian hyperstimulation syndrome (OHSS) (see also ‘ Possible side effects’).
Zdravljenje z Ovitrelle lahko poveča tveganje za razvoj stanja, ki se imenuje sindrom hiperstimulacije jajčnikov (OHSS) (glejte tudi "Možni neželeni učinki").
This is when the ovaries over- react to the treatment and develop too many follicles.
Ta nastane, če se jajčnika pretirano odzoveta na zdravljenje in razvijeta preveč foliklov.
The most common symptom is abdominal pain.
Najpogostejši znak je bolečina v trebuhu.
If you have significant abdominal pain or discomfort, do not take the injection, and speak to your doctor or nurse as soon as possible.
Če imate v trebuhu močne bolečine ali nelagodje, ne uporabite injekcije in se čim prej pogovorite s svojim zdravnikom ali medicinsko sestro.
You should not have intercourse for at least 4 days, or otherwise you should use a barrier method for contraception.
Spolnih odnosov ne smete imeti najmanj 4 dni, ali pa morate uporabljati mehansko kontracepcijsko zaščito.
Compared with natural conception, the frequency of multiple pregnancies and births is increased in patients receiving this treatment.
Večplodne nosečnosti in rojstva so pri bolnicah, ki prejemajo to zdravljenje, pogostejši kot pri ženskah, ki naravno zanosijo.
The majority of these are twins.
Večinoma gre za dvojčke.
In assisted conception techniques, the number of babies is related to the number of embryos replaced.
Pri postopkih asistirane oploditve je število otrok povezano s številom prenesenih zarodkov.
Your risk of OHSS or multiple pregnancy is reduced if the usual dose of Ovitrelle is used, and you are monitored closely throughout your treatment cycle (e. g. blood tests for estradiol levels and ultrasound).
Vaše tveganje za sindrom hiperstimulacije jajčnikov ali večplodno nosečnost se zmanjša, če uporabljate običajni odmerek Ovitrelle in vas celotni ciklus zdravljenja skrbno nadzirajo (npr. z določevanjem ravni estradiola v krvi in ultrazvokom).
You should not take Ovitrelle if you are pregnant or breast-feeding.
Če ste noseči ali dojite, zdravila Ovitrelle ne smete uporabljati.
HOW TO USE OVITRELLE
KAKO UPORABLJATI ZDRAVILO OVITRELLE
Always take Ovitrelle exactly as your doctor has told you.
Pri uporabi zdravila Ovitrelle natančno upoštevajte zdravnikova navodila.
The usual dose of Ovitrelle is 1 vial (250 micrograms) given as a single injection.
Običajen odmerek zdravila Ovitrelle je 1 viala (250 mikrogramov) in se ga daje v obliki enkratne injekcije.
Ovitrelle is intended for subcutaneous use, that means given by injection under the skin.
Ovitrelle je namenjen za subkutano uporabo, kar pomeni, da se ga injicira pod kožo.
Sometimes the injection will be given to you by a doctor or nurse, or you or your partner may be trained to give the injection at home.
V nekaterih primerih daje injekcijo vaš zdravnik ali medicinska sestra ali pa lahko naučijo vas ali vašega partnerja, kako dajati injekcijo doma.
If you administer Ovitrelle to yourself, please carefully read the following instructions:
Če si boste Ovitrelle dajali sami, vas prosimo, da natančno preberete naslednja navodila:
It is important that your hands and the items you use be as clean as possible.
Pomembno je, da so vaše roke in predmeti, ki jih boste uporabljali, kolikor je mogoče čisti.
Please note that alcohol swabs, syringes and needles are not contained in the package.
Prosimo upoštevajte, da alkoholni tamponi, injekcijske brizge in igle niso priloženi v pakiranju.
two alcohol swabs, one solvent ampoule, one vial containing the medicinal product one syringe, one big needle for reconstitution, a fine-bore needle for subcutaneous injection.
dva alkoholna tampona, ampulo z vehiklom, vialo z zdravilom, injekcijsko brizgo, veliko iglo za pripravo, tanko iglo za podkožno injiciranje.
Opening the ampoule of solvent:
Odpiranje ampule z vehiklom:
On the head of the solvent ampoule, you will see a small coloured dot.
Na glavi ampule z vehiklom boste opazili majhno obarvano piko.
Directly below it is where the neck of the ampoule has been treated to make it easier to break.
Tik pod njo je mesto, na katerem je vrat ampule obdelan tako, da se lažje prelomi.
Gently flick the top section of the ampoule so that any fluid in the neck of the ampoule drops into the bottom chamber.
Rahlo frcnite v zgornji del ampule, da bo tekočina, ki je morda v vratu ampule, stekla v spodnji del.
Now press the ampoule firmly over the neck, and break the ampoule away from the coloured dot.
Zdaj ampulo močno pritisnite nad vratom in jo odlomite proč od obarvane pike.
Carefully place the open ampoule upright on the work-surface.
Odprto ampulo pazljivo pokonci položite na delovno površino.
Drawing up the solvent:
Izvlek vehikla:
Attach the needle for reconstitution to the syringe, with the syringe in one hand, pick up the open ampoule, insert the needle and draw up all of the solvent.
Držite brizgo v eni roki in vzemite odprto ampulo, vstavite vanjo iglo in iz nje potegnite ves vehikel.
Carefully set the syringe down on the work- surface, taking care not to touch the needle.
Pazljivo odložite brizgo na delovno površino in pri tem pazite, da se ne dotaknete igle.
Preparation of the injection solution:
Priprava raztopine za injiciranje:
Remove the protective cap from the Ovitrelle powder vial, pick up your syringe and slowly inject the solvent into the vial of Ovitrelle.
Odstranite zaščitni pokrovček z viale s praškom Ovitrelle, vzemite brizgo in vehikel počasi vbrizgajte v vialo z Ovitrelle.
Swirl gently.
Narahlo zavrtinčite.
The powder should dissolve into a clear solution immediately.
Prašek se mora takoj raztopiti v bistro raztopino.
Turn the vial upside down, gently draw the solution back into the syringe.
Obrnite vialo na glavo in raztopino pazljivo potegnite nazaj v brizgo.
Change the needle for the fine-bore needle and remove any air bubbles:
Zamenjajte iglo s tanko iglo in odstranite morebitne zračne mehurčke:
If you see air bubbles in the syringe, hold the syringe with the needle pointing upwards and gently flick the syringe until all the air collects at the top.
Če v brizgi vidite zračne mehurčke, primite brizgo (z iglo obrnjeno navzgor) in jo rahlo frcajte, dokler se zrak ne zbere na vrhu.
Gently push the plunger until the air bubbles are gone.
Počasi potiskajte bat, dokler zračni mehurčki ne izginejo.
30 Immediately inject the solution:
30 Raztopino takoj injicirajte.
Your doctor or nurse will have already advised you where to inject (e. g. tummy, front of thigh).
Zdravnik ali medicinska sestra sta vas že poučila kam si dati injekcijo (npr. v trebuh, sprednji del stegna).
Wipe the chosen area with an alcohol swab.
Obrišite izbrano mesto z alkoholnim tamponom.
Firmly pinch the skin together and insert the needle at a 45° to 90° angle using a dart-like motion.
Kožo trdno stisnite skupaj in iglo zabodite pod kotom 45 °do 90° z gibom, podobnim metu sulice.
Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.
Nato iglo takoj izvlecite in kožo očistite z alkoholnim tamponom s krožnimi gibi.
Once you have finished your injection, immediately discard all needles and empty glass containers in a sharps container.
Ko injiciranje končate, obe igli in prazna steklena vsebnika takoj vrzite v posodo za ostre odpadke.
If you take more Ovitrelle than you should:
Če ste uporabili večji odmerek zdravila Ovitrelle, kot bi smeli
If too much Ovitrelle is used, there is a possibility that ovarian hyperstimulation syndrome may occur, which is further described under ‘ Take special care with Ovitrelle’ and ‘ Possible side effects'.
Če uporabite preveč Ovitrelle, se lahko pojavi sindrom hiperstimulacije jajčnikov, ki je podrobno opisan v poglavju z naslovom "Bodite posebno pozorni pri uporabi zdravila Ovitrelle" in "Možni neželeni učinki".
You should consult your doctor if symptoms of this syndrome occur.
Če se pojavijo znaki tega sindroma, se morate posvetovati z zdravnikom.
If you forget to take Ovitrelle:
Če ste pozabili uporabiti zdravilo Ovitrelle
You should contact your doctor.
Posvetovati se morate z zdravnikom.
Like all medicines, Ovitrelle can cause side effects, although not everybody gets them..
Kot vsa zdravila, ima lahko tudi zdravilo Ovitrelle neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The majority of side effects seen to date have been mild or moderate.
Večina doslej opaženih neželenih učinkov je bila blagih ali zmernih.
The most frequent side effects reported have been tiredness, pain and local reactions at the site of injection.
Najpogosteje opisani neželeni učinki so utrujenost, bolečina in lokalne reakcije na mestu injiciranja.
Ovarian hyperstimulation syndrome has been observed in approximately 4% of the patients in clinical studies; most of these cases were mild or moderate in nature.
V kliničnih raziskavah so sindrom hiperstimulacije jajčnikov opazili pri približno 4% bolnic; večinoma je bil blage ali zmerne narave.
Blood in the peritoneal cavity, respiratory difficulties are possible complications of ovarian hyperstimulation syndrome.
Možna zapleta sindroma hiperstimulacije jajčnikov sta kri v peritonealni votlini in težave z dihanjem.
This syndrome is characterized by large ovarian cysts.
Za ta sindrom so značilne velike ciste na jajčniku.
Should the above mentioned symptoms occur, a careful medical examination is indicated as soon as possible.
Prvi znaki hiperstimulacije jajčnikov so bolečine v spodnjem predelu trebuha, lahko v povezavi s slabostjo, bruhanjem in večanjem telesne teže. Če se pojavijo zgoraj navedeni znaki, je v najkrajšem možnem času potreben natančen zdravniški pregled.
Common side effects reported include abdominal pain, nausea and vomiting, headache, injection site inflammation and reaction, dizziness.
Pogosti neželeni učinki o katerih so poročali so bolečina v trebuhu, slabost in bruhanje, glavobol, vnetje in reakcija na mestu injiciranja, omotica.
Diarrhoea, depression, irritability, restlessness and breast pain have also been reported in some cases and are considered uncommon.
O driski, depresiji, razdražljivosti, nemiru in bolečih dojkah so prav tako poročali v nekaterih primerih in štejejo za občasne neželene učinke..
Extrauterine pregnancy, ovarian torsion (a condition affecting the ovaries) and other complications may arise from the assisted conception techniques your doctor may use.
Pri postopkih asistirane oploditve, ki jih lahko uporabi vaš zdravnik, se lahko pojavijo zunajmaternična nosečnost, zasuk (torzija) jajčnika (stanje, ki prizadene jajčnik) in drugi zapleti.
Isolated cases of mild allergic reactions to Ovitrelle (rash) have been reported.
V posamičnih primerih so poročali o blagi alergijski reakciji (izpuščaj) na Ovitrelle.
HOW TO STORE OVITRELLE
SHRANJEVANJE ZDRAVILA OVITRELLE
31 Do not use after the expiry date which is stated on the label after EXP.
31 Zdravila Ovitrelle ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki viale poleg oznake EXP.
Once the medicine is reconstituted (made up with the solvent), it should be used immediately.
Ko je zdravilo pripravljeno (raztopljeno z vehiklom), ga morate takoj uporabiti.
Do not use Ovitrelle if you notice any visible signs of deterioration.
Ne uporabljajte zdravila Ovitrelle, če opazite vidne znake kvarjenja.
Any unused solution should be discarded.
Neuporabljeno raztopino morate zavreči.
The active substance is choriogonadotropin alfa, each vial contains 285 micrograms.
Zdravilna učinkovina je horiogonadotropin alfa, vsaka viala vsebuje 285 mikrogramov.
After reconstitution 250 micrograms, which is the equivalent of 6500 IU, is delivered because some choriogonadotropin alfa will be left in the vial, in the syringe and in the needle.
Uporabna količina po pripravi je 250 mikrogramov, kar ustreza 6. 500 i. e., ker nekaj horiogonadotropina alfa ostane v viali, injekcijski brizgi in igli.
The other ingredients are sucrose, phosphoric acid, and sodium hydroxide.
Pomožne snovi so saharoza, fosforjeva kislina in natrijev hidroksid.
Ovitrelle is provided as a powder and solvent for solution for injection.
Ovitrelle je v obliki praška in vehikla za raztopino za injiciranje.
It is available in packs containing 1, 2, or 10 vials of powder containing the active substance which are accompanied by the corresponding number of solvent containers.
Na voljo je v pakiranjih z 1, 2 ali 10 vialami praška z zdravilno učinkovino in priloženim ustreznim številom vsebnikov z vehiklom.
Each vial of powder contains 285 micrograms of choriogonadotropin alfa and each container of solvent contains 1 ml of water for injections.
Vsaka viala s praškom vsebuje 285 mikrogramov horiogonadotropina alfa in vsak vsebnik z vehiklom vsebuje 1 ml vode za injekcije.
When one vial is reconstituted with 1 ml of solvent you will receive a dose of 250 micrograms.
Ko vialo rekonstituiramo z 1 ml vehikla, je dobljeni odmerek 250 mikrogramov.
Serono Europe Limited, 56 Marsh Wall, London E14 9TP, United Kingdom
Serono Europe Limited, 56 Marsh Wall, London E14 9TP, Velika Britanija.
Merck Serono S. p. A., Via delle Magnolie 15, I-70026 Modugno (Bari), Italy
Merck Serono S. p. A., Via delle Magnolie 15, I- 70026 Modugno (Bari), Italija.
For any information about this medicine e, please contact the local representative of the Marketing Authorisation Holder.
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Vial)
34 NAVODILO ZA UPORABO (Vsebnik z vehiklom: viala)
- if you are allergic (hypersensitive) to choriogonadotropin, or any of the ingredients of Ovitrelle.
Ovitrelle,
35 Take special care with Ovitrelle:
35 Bodite posebno pozorni pri uporabi zdravila Ovitrelle
The usual dose of Ovitrelle is 1 vial (250 micrograms) given as a single injection.
Običajni odmerek zdravila Ovitrelle je 1 viala (250 mikrogramov) in se ga daje v obliki enkratne injekcije.
Please note that alcohol, swabs, syringes and needles are not contained in the package.
Prosimo upoštevajte, da alkoholni tamponi, injekcijskebrizge in igle niso priloženi v pakiranju.
two alcohol swabs, one solvent vial, one vial containing the medicinal product one syringe, one big needle for reconstitution, a fine-bore needle for subcutaneous injection.
dva alkoholna tampona, vialo z vehiklom, vialo z zdravilom, injekcijsko brizgo, veliko iglo za pripravo, tanko iglo za podkožno injiciranje.
Remove the protective cap from the solvent vial.
Odstranite zaščitni pokrovček z viale z vehiklom.