natgillin/translations-raw huggingface dataset:
In order to avoid the injection of large volumes, one vial of Luveris can be reconstituted together with one or two ampoule(s)/ vial(s) of follitropin alfa, 37.5 IU, 75 IU or 150 IU, in 1 ml of solvent.
V izogib injiciranju velikega volumna, lahko eno vialo Luverisa rekonstituiramo skupaj z vsebino ene ali dveh ampul / vial s folitropinom alfa, 37, 5 i. e., 75 i. e. ali 150 i. e. v 1 ml vehikla.
SERONO EUROPE LIMITED, 56 Marsh Wall, London E14 9TP United Kingdom
SERONO EUROPE LIMITED, 56 Marsh Wall London E14 9TP Velika Britanija
Date of last renewal:
29. november 2000 Datum zadnjega podaljšanja dovoljenja za promet:
30th November 2005.
30. november 2005
7 ANNEX II
7 DODATEK II
1170 Aubonne Switzerland
1170 Aubonne Švica
Via delle Magnolie 15 I-70026 Modugno (Bari) Italy
Via delle Magnolie 15 I- 70026 Modugno (Bari) Italija
9 ANNEX III
9 DODATEK III
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGING LUVERIS 75 IU, VIALS
11 PODATKI NA ZUNANJI OVOJNINI LUVERIS 75 i. e., VIALE
Lutropin alfa
Luveris 75 i. e., prašek in vehikel za raztopino za injiciranje Lutropin alfa
Composition: one vial of powder contains: lutropin alfa 75 IU.
Sestava: ena viala s praškom vsebuje: lutropin alfa 75 i. e.
Other ingredients: polysorbate 20, sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, phosphoric acid, concentrated, sodium hydroxide, methionine and nitrogen.
Druge sestavine: polisorbat 20, saharoza, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat, koncentrirana fosforjeva( V) kislina, natrijev hidroksid, metionin in dušik.
1 ml water for injection.
1 ml vode za injekcije.
3 vials of powder for solution for injection / 3 ampoules of solvent.
1 viala s praškom za raztopino za injiciranje / 1 ampula z vehiklom 3 viale s praškom za raztopino za injiciranje / 3 ampule z vehiklom.
10 vials of powder for solution for injection / 10 ampoules of solvent.
10 vial s praškom za raztopino za injiciranje / 10 ampul z vehiklom.
1 vial of powder for solution for injection / 1 vial of solvent.
1 viala s praškom za raztopino za injiciranje / 1 viala z vehiklom.
3 vials of powder for solution for injection / 3 vials of solvent.
3 viale s praškom za raztopino za injiciranje / 3 viale z vehiklom.
10 vials of powder for solution for injection / 10 vials of solvent.
10 vial s praškom za raztopino za injiciranje / 10 vial z vehiklom.
Marketing authorisation holder:
Imetnik dovoljenja za promet:
SERONO EUROPE LIMITED, 56 Marsh Wall, London E14 9TP United Kingdom
SERONO EUROPE LIMITED 56 Marsh Wall London E14 9TP Velika Britanija
EU/ 1/ 00/ 155/ 001 (1vial/ 1 ampoule) EU/ 1/ 00/ 155/ 002 (3 vials/ 3 ampoules) EU/ 1/ 00/ 155/ 003 (10 vials/ 10 ampoules) EU/ 1/ 00/ 155/ 004 (1 vial/ 1 vial) EU/ 1/ 00/ 155/ 005 (3 vial/ 3 vials) EU/ 1/ 00/ 155/ 006 (10 vials/ 10 vials)
EU/ 1/ 00/ 155/ 001( 1 viala / 1 ampula) EU/ 1/ 00/ 155/ 002 (3 viale / 3 ampule) EU/ 1/ 00/ 155/ 003 (10 vial / 10 ampul) EU/ 1/ 00/ 155/ 004 (1 viala / 1 viala) EU/ 1/ 00/ 155/ 005 (3 viale / 3 viale) EU/ 1/ 00/ 155/ 006 (10 vial / 10 vial)
Batch Solvent Batch
Serija Serija vehikla
luveris 75 IU
luveris 75 i. e.
13 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LUVERIS 75 IU, VIALS
13 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH LUVERIS 75 I. E., VIALE
Luveris 75 IU
Luveris 75 i. e.
Lutropin alfa Subcutaneous use.
Prašek za raztopino za injiciranje Lutropin alfa Za subkutano uporabo.
14 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LUVERIS 75 IU, SOLVENT AMPOULES
14 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH LUVERIS 75 I. E., AMPULE Z VEHIKLOM
Water for injection Solvent for use with Luveris Injection.
Voda za injekcije Vehikel za uporabo z Luverisom Injekcija.
15 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LUVERIS 75 IU, SOLVENT VIALS
15 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH LUVERIS 75 I. E., VIALE Z VEHIKLOM
INFORMATION FOR THE USER Solvent in ampoules
17 NAVODILO ZA UPORABO Vehikel v ampulah
Luveris 75 IU, powder and solvent for solution for injection Lutropin alfa
Luveris 75 i. e., prašek in vehikel za raztopino za injiciranje Lutropin alfa
What Luveris is and what it is used for 2.
Kaj je zdravilo Luveris in za kaj ga uporabljamo 2.
Before you use Luveris 3.
Kaj morate vedeti, preden boste uporabili zdravilo Luveris 3.
How to use Luveris 4.
Kako uporabljati zdravilo Luveris 4.
How to store Luveris 6.
Shranjevanje zdravila Luveris 6.
WHAT LUVERIS IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO LUVERIS IN ZA KAJ GA UPORABLJAMO
Luveris is a medicine containing lutropin alfa, a recombinant luteinising hormone (LH) which is essentially similar to the hormone found naturally in humans, but is made by means of biotechnology.
Luveris je zdravilo, ki vsebuje lutropin alfa, rekombinantni humani folikel luteinizirajoči hormon (LH), ki je zelo podoben naravnemu hormonu pri ljudeh, vendar je izdelan s pomočjo biotehnologije.
It belongs to the family of hormones called gonadotrophins, which are involved in the normal control of reproduction.
Spada v družino hormonov, ki se imenujejo gonadotropini in predstavljajo sestavni del normalnega uravnavanja reprodukcije.
Luveris is recommended for the treatment of women who have been shown to produce very low levels of some of the hormones involved in the natural reproductive cycle.
Luveris se priporoča za zdravljenje žensk, za katere se je izkazalo, da tvorijo zelo majhne količine nekaterih hormonov, ki predstavljajo del naravnega reproduktivnega ciklusa.
The medicine is used together with another hormone called FSH (follicle stimulating hormone), to bring about the development of follicles, which are in the ovary, the structures maturing the eggs (ova).
Zdravilo se uporablja v kombinaciji z drugim hormonom, ki se imenuje FSH (folikle stimulirajoči hormon) za spodbujanje razvoja foliklov, ki se nahajajo v jajčniku, v strukturah, v katerih zorijo jajčeca (ova).
It is followed by treatment with a single dose of human chorionic gonadotrophin (hCG), which leads to the release of an egg from the follicle (ovulation).
Temu sledi zdravljenje z enim samim odmerkom humanega horionskega gonadotropina (hCG), ki privede do sprostitve jajčeca iz folikla (ovulacije).
BEFORE YOU USE LUVERIS
KAJ MORATE VEDETI PREDEN BOSTE UPORABILI ZDRAVILO LUVERIS
You and your partner's fertility should be evaluated before the treatment is started.
Pred pričetkom zdravljenja je treba oceniti vašo plodnost in plodnost vašega partnerja.
Do not take Luveris
Ne uporabljajte Luverisa
• If you are allergic (hypersensitive) to lutropin alfa or any of the other ingredients of Luveris. • If you have been diagnosed as having ovarian, uterine or breast cancer. • If you have had a brain tumour diagnosed. • If you have ovarian enlargement or cyst not due to polycystic ovarian disease. • If you have unexplained vaginal bleeding.
• Če ste alergični na (preobčutljivi za) lutropin alfa ali katerokoli sestavino zdravila Luveris. • Če so ugotovili, da imate rak jajčnika, maternice ali dojke. • Če so pri vas ugotovili možganski tumor. • Če imate povečanje jajčnika ali cisto, ki ni posledica policistične ovarijske bolezni. • Če imate nepojasnjene vaginalne krvavitve.
Take special care with Luveris
Bodite posebno pozorni pri uporabi Luverisa
This treatment increases your risk of developing a condition called ovarian hyperstimulation syndrome (OHSS) (see also section headed ‘ Possible side effects’).
To zdravljenje poveča tveganje za razvoj stanja, ki se imenuje sindrom hiperstimulacije jajčnikov (OHSS) (glejte tudi poglavje 'Možni neželeni učinki').
However, if the recommended dose and schedule of administration are adhered to, the occurrence of OHSS is uncommon.
Vendar pa je pojav OHSS redek, če upoštevate priporočeno odmerjanje ter shemo dajanja.
Luveris treatment seldom gives rise to significant OHSS unless the medicine used to induce final follicular maturation
Zdravljenje z Luverisom redko povzroči pomemben OHSS, razen če se daje tudi zdravilo za sprožitev končnega folikularnega zorenja (ki vsebuje hCG).
It is therefore prudent not to give hCG in cases where OHSS is developing and not to have sexual intercourse or use barrier methods for at least four days.
18 Zato je v primerih, ko se razvije OHSS, smiselno opustiti dajanje hCG in ne imeti spolnih odnosov ali pa uporabljati mehanska kontracepcijska sredstva najmanj štiri dni.
Your doctor is well aware of this condition and will inform you if necessary.
Vaš zdravnik je dobro seznanjen s tem stanjem in vas bo o tem tudi informiral, če bo potrebno.
This is the reason why he will organise careful monitoring of ovarian response, based on ultrasound and blood sampling before and during the course of treatment.
To je tudi razlog, zaradi katerega bo pred samim zdravljenjem, in tudi med njim, poskrbel za skrbno spremljanje ovarijskega odziva z ultrazvokom in jemanjem vzorcev krvi.
The medicine should not be used when a condition exists which would make a normal pregnancy impossible, such as malformation of sexual organs or benign tumours of the womb.
Zdravila ne smete uporabljati v primeru stanj, ki bi onemogočala normalno nosečnost, kot so malformacije spolnih organov ali benigni tumorji maternice.
Compared with natural conception, the incidence of multiple pregnancies (mainly twins) and births is increased in patients undergoing this type of treatment.
Pri bolnicah, ki se odločijo za tovrstno zdravljenje, je pogostnost večplodnih nosečnosti (v glavnem dvojčkov) in porodov, v primerjavi z naravno zanositvijo, povečana.
However, this can be minimised by using the recommended dose and schedule of administration.
Vendar pa jo ob upoštevanju priporočenega odmerka in režima dajanja lahko zmanjšamo na najmanjšo možno mero.
If you have had allergic reactions to similar medicines, please inform your doctor.
Če ste že imeli alergjiske reakcije na podobna zdravila, prosimo, da o tem obvestite svojega zdravnika.
Luveris should not be mixed with other medicinal products in the same injection, except for follitropin alfa.
Luverisa ne smete mešati z drugimi zdravili v isti injekcijski brizgi, razen s folitropinom alfa.
Studies have shown that these two medicines can be mixed and injected together, without either product being adversely affected.
Študije so pokazale, da ti dve zdravili lahko mešamo in injiciramo skupaj, ne da bi to negativno vplivalo na katero od zdravil.
You should not take Luveris if you are pregnant or breast-feeding.
Če ste noseči ali dojite, Luverisa ne smete uporabljati.
HOW TO USE LUVERIS
KAKO UPORABLJATI LUVERIS
Always take Luveris exactly as your doctor has told you.
Pri uporabi zdravila Luveris natančno upoštevajte zdravnikova navodila.
Luveris is usually taken every day for up to three weeks simultaneously with injections of FSH.
Luveris se običajno daje vsak dan, sočasno z injekcijami FSH- ja, do tri tedne.
The usual dose starts with 75 IU (1 vial) of Luveris together with 75 IU or 150 IU of FSH.
(1 viala) Luverisa, skupaj s 75 i. e. ali 150 i. e.
According to your response, your doctor may increase your dose of FSH by preferably 37.5-75 IU at 7-14-day intervals.
Glede na vaš odziv lahko vaš zdravnik poveča odmerek FSH- ja po možnosti za 37, 5 i. e. - 75 i. e., v 7 - 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 Luveris and FSH.
Ko je dosežen željeni odziv, se v 24- 48 urah po zadnji injekciji Luverisa in FSH- ja 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 ali dan, ki sledi dajanju hCG- ja.
If an excessive response is obtained, treatment should be stopped and hCG withheld (see section headed ‘ Possible Side Effects’).
Če pride do čezmernega odziva, je treba zdravljenje prekiniti in opustiti hCG (glejte poglavje z naslovom “ Možni neželeni učinki ”).
Luveris is intended for subcutaneous use which means it is given by injection under the skin.
Luveris je namenjen za subkutano uporabo, kar pomeni, da se ga injicira pod kožo.
19 If you administer Luveris to yourself, please carefully read the following instructions:
19
• Wash your hands.
- eno vialo Luverisa,
It is important that your hands and the items you use be as clean as possible.
- eno ampulo vehikla,
• Assemble everything you need.
- dve alkoholni blazinici,
- - - - - - -
- eno brizgo,
one vial of Luveris, one ampoule of solvent, two alcohol swabs, one syringe, one reconstitution needle for dissolving the powder in the solvent, a fine-bore needle for subcutaneous injection, a sharps container for safe disposal of glass and needles.
- eno iglo za rekonstitucijo za raztopljanje praška v vehiklu,
•
- fino iglo za podkožno injiciranje,
On the head of the solvent ampoule, you will see a small
- zaščitno posodo za varno odstranjevanje stekla in igel.
coloured dot.
• Odprite ampulo z vehiklom:
Directly below it is where the neck of the ampoule has been treated to make it
Na kapici ampule z vehiklom boste opazili majhno obarvano piko.
easier to break.
Direktno pod njo je vrat ampule, ki je obdelan tako, da ga je najlažje zlomiti.
• Draw up the solvent:
• Vehikel potegnite v brizgo:
Attach the reconstitution needle to the syringe, with the syringe in
Pritrdite iglo za rekonstitucijo na brizgo in z brizgo v v eni roki vzemite odprto ampulo ter vanjo vstavite iglo in potegnite iz nje ves vehikel.
up your syringe and slowly inject the solvent into the vial of Luveris.
Odstranite zaščitno kapico z viale z Luveris praškom vzemite brizgo in počasi injicirajte vehikel v vialo z Luverisom.
Turn the vial upside down and
• Ko se prašek raztopi (kar se občajno zgodi takoj), se prepričajte, da je nastala raztopina bistra in ne vsebuje delcev.
20 gently draw the solution back into the syringe.
Obrnite vialo navpično navzdol in previdno potegnite raztopino nazaj v brizgo.
You may also mix Luveris and follitropin alfa as an alternative to injecting each product separately.
Kot alternativo injiciranju vsakega zdravila posebej, lahko tudi pomešate Luveris in folitropin alfa.
After dissolving the Luveris powder, draw the solution back into the syringe and re-inject it into the container with the follitropin alfa powder.
Ko se prašek Luverisa raztopi, potegnite raztopino nazaj v brizgo in jo ponovno injicirajte v vsebnik s praškom folitropina alfa.
• Change the needle for the fine-bore needle and remove any air bubbles:
• Zamenjajte iglo s fino iglo za injiciranje in odstranite morebitne zračne mehurčke: če vidite 20 mehurčke zraka v brizgi, jo držite tako, da igla gleda navzgor in nežno krcajte brizgo, da se ves zrak zbere na vrhu.
If you see air bubbles
Nežno potiskajte bat, dokler zračni mehurčki ne izginejo.
in the syringe, hold the syringe with the needle pointing upwards and gently flick the syringe until all the air collects at the top.
•
• Immediately inject the solution:
Takoj vbrizgajte raztopino:
Your doctor or nurse will have already advised you where to inject (e.g. tummy, front of thigh).
Vaš zdravnik ali sestra sta vas že poučila, kje dati injekcijo
Wipe the chosen area with an alcohol swab.
(n. pr. v trebuh, sprednjo stran stegna).
skin together and insert the needle at a 45° to 90° angle using a dart-like motion.
Trdno stistnite kožo in z gibom, podobnim metu sulice, zabodite iglo pod kotom 45° do 90°.
Once you have finished your injection, immediately discard all needles and empty glass containers in the sharps container provided.
• Odstranite vse uporabljene predmete: ko ste zaključili z vbrizgavanjem, takoj odstranite vse igle in prazne steklene vsebnike v zaščitno posodo, ki je priložena.
The effects of an overdose of Luveris are unknown, nevertheless there is a possibility that ovarian hyperstimulation syndrome may occur, which is further described in ‘Possible side effects'.
Učinki prevelikega odmerka Luverisa niso poznani, vseeno pa je možen pojav sindroma ovarijske hiperstimulacije, kar je podrobno opisano v "Možni neželeni učinki".
However this will only occur if hCG is administered (see section headed ‘Take special care with Luveris’).
Vendar pa se le ta pojavi samo, če se daje hCG (glejte poglavje z naslovom ‘ Bodite posebno pozorni pri uporabi Luverisa ')
If you forget to take Luveris
Če ste pozabili vzeti Luveris
Like all medicines, Luveris can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Luveris neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The most frequent adverse events reported have been headache, abdominal pain, breast pain, nausea, somnolence (sleepiness) and ovarian cysts.
Najbolj pogosti neželeni dogodki, o katerih so poročali, so glavobol, bolečine v trebuhu, bolečine v prsih, slabost, somnolenca (zaspanost) in ovarijske ciste.
Local reactions at the injection site (pain, redness, itching, swelling and bruising) have been observed in some cases.
V nekaterih primerih so na mestu injiciranja opazili lokalne reakcije (bolečina, rdečica, srbenje, oteklina in modrica).
Treatment with FSH and LH followed by hCG can lead to a condition called ovarian hyperstimulation syndrome (OHSS) (see also section headed ‘Take Special Care with Luveris’).
Zdravljenje s FSH- jem in LH- jem, ki mu sledi še hCG, lahko privede do stanja, ki ga imenujemo sindrom hiperstimulacije jajčnikov (OHSS) (glejte tudi poglavje z naslovom “ Bodite posebno pozorni pri uporabi Luverisa ”).
This is when the ovaries over-react to the treatment, and large ovarian cysts develop.
To se zgodi, kadar se jajčniki preveč odzovejo na zdravljenje in se pri tem razvijejo velike ovarijske ciste.
First symptoms of OHSS are pain in the lower abdominal region, possibly in combination with nausea, vomiting and weight gain.
Prvi znaki OHSS so bolečina v spodnjem predelu trebuha, lahko v kombinaciji s slabostjo, bruhanjem in povečanjem telesne mase.
If you experience serious abdominal pain together with these symptoms, do not give any more injections, and speak to your doctor as soon as possible.
Če bi začutili močno bolečino v trebuhu, v povezavi z zgoraj naštetimi znaki, si popolnoma prenehajte
A careful examination will establish whether your ovaries have responded excessively to the treatment.
Natančen pregled bo pokazal, če so se vaši jajčniki pretirano odzvali na zdravljenje.
If so, your doctor may discontinue the FSH and LH, and abandon the treatment with hCG, to prevent the development of more severe OHSS.
Če se to potrdi, lahko vaš zdravnik prekine z dajanjem FSH- ja in LH- ja ter opusti zdravljenje s hCG- jem, da prepreči razvoj še hujše oblike OHSS.
Rarely abnormal blood clots in veins have been seen to occur with similar medicines, so this could possibly occur with Luveris / FSH / hCG therapy.
V redkih primerih so opazili pri uporabi podobnih zdravil pojav nenormalnih krvnih strdkov v žilah, zato bi se to lahko pojavilo tudi pri uporabi Luverisa / FSH- ja / hCG- ja.
Torsion of the ovary and bleeding into the abdomen have not been reported with Luveris, however, there have been rare cases reported following treatment with human menopausal gonadotrophin (hMG), a urine-derived medication also containing LH.
Pri zdravljenju z Luverisom ne poročajo o torziji jajčnika in krvavitvah v trebuh, obstajajo pa poročila o redkih primerih le- tega po zdravljenju s humanim menopavznim gonadotropinom (hMG- jem), ki je zdravilo urinskega izvora in vsebuje tudi LH.
Ectopic pregnancy (embryo implanted outside the womb) may occur especially in women with a history of prior tubal disease.
Pojavi se lahko tudi zunajmaternična nosečnost (zarodek vgnezden izven maternice), še posebej pri ženskah, ki so imele bolezni jajcevodov.
HOW TO STORE LUVERIS
SHRANJEVANJE ZDRAVILA LUVERIS
Do not use Luveris after the expiry date, which is stated on the vials after EXP.
Zdravila Luveris ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vialah poleg oznake EXP.
Do not use Luveris if you notice any visible signs of deterioration, such as discolouration of the powder or damage to the container.
Ne uporabljajte zdravila Luveris, če opazite vidne znake kvarjenja, kot so sprememba barve praška ali poškodovan vsebnik.
- The active substance is lutropin alfa 75 IU (International Units).
(internacionalne enote).
- The other ingredients are polysorbate 20, sucrose, sodium dihydrogen phosphate monohydrate,
- Pomožne snovi so polisorbat 20, saharoza, natrijev dihidrogenfosfat monohidrat, natrijev
disodium phosphate dihydrate, concentrated phosphoric acid, sodium hydroxide, methionine and nitrogen.
hidrogenfosfat dihidrat, koncentrirana fosforjeva( V) kislina, natrijev hidroksid, metionin in dušik.
- The solvent is water for injection.
Vehikel je voda za injekcije.
22 What Luveris looks like and contents of the pack
Izgled zdravila Luveris in vsebina pakiranja
Luveris is provided as a powder and solvent for solution for injection.
Luveris je na voljo kot prašek in vehikel za raztopino za injiciranje.
Each vial of powder contains 75 IU of lutropin alfa and each ampoule of solvent contains 1 ml of water for injection.
Vsaka viala s praškom vsebuje 75 i. e. lutropina alfa in vsaka ampula z vehiklom vsebuje 1 ml vode za injekcije.
Marketing Authorisation Holder
22 Imetnik dovoljenja za promet z zdravilom
Serono Europe Limited 56 Marsh Wall London E14 9TP United Kingdom
Serono Europe Limited 56 Marsh Wall London E14 9TP Velika Britanija.
Manufacturer
Izdelovalec zdravila
23 Deutschland Serono GmbH Alsfelder Straße 17 D-64289 Darmstadt Tel: +49-6151-6285-0
Deutschland Serono GmbH Alsfelder Straße 17 D- 64289 Darmstadt Tel: +49- 6151- 6285- 0
Ελλάδα Merck A.E.
23 Ελλάδα Merck A. E.
Lietuva Merck Serono Atstovybė C/o Ares Trading SA Baltic States Zamenhofo 11-3, LT-44287 Kaunas Tel: +370 37320603
24 Lietuva Merck Serono Atstovybė C/ o Ares Trading SA Baltic States Zamenhofo 11- 3, LT- 44287 Kaunas Tel: +370 37320603
INFORMATION FOR THE USER Solvent in vials
25 NAVODILO ZA UPORABO Vehikel v vialah
The medicine is used together with another hormone called FSH (follicle stimulating hormone), to bring about the development of follicles which are in the ovary, the structures maturing the eggs (ova).
Zdravilo se uporablja v kombinaciji z drugim hormonom, ki se imenuje FSH (folikle stimulirajoči hormon) za spodbujanje razvoja foliklov, ki se nahajajo v jajčniku, v strukturah, v katerih zorijo jajčeca (ova).
• If you are allergic (hypersensitive) to lutropin alfa or any of the other ingredients of Luveris. • If you have been diagnosed as having ovarian, uterine or breast cancer. • If you have had a brain tumour diagnosed. • If you have ovarian enlargement or cyst not due to polycystic ovarian disease. • If you have unexplained vaginal bleeding.
• če ste alergični na (preobčutljivi za) lutropin alfa ali katerokoli sestavino zdravil Luveris, • če so ugotovili, da imate rak jajčnika, maternice ali dojke, • če so pri vas ugotovili možganski tumor, • če imate povečanje jajčnika ali cisto, ki ni posledica policistične ovarijske bolezni, • če imate nepojasnjene vaginalne krvavitve.
This treatment increases your risk of developing a condition called ovarian hyperstimulation syndrome (OHSS) (see also section headed ‘Possible side effects’).
To zdravljenje poveča tveganje za razvoj stanja, ki se imenuje sindrom hiperstimulacije jajčnikov (OHSS) (glejte tudi poglavje 'Možni neželeni učinki').
It is therefore prudent not to give hCG in cases where OHSS is developing and not to have sexual intercourse or use barrier methods for at least four days.
26 Zato je v primerih, ko se razvije OHSS, smiselno opustiti dajanje hCG in ne imeti spolnih odnosov ali pa uporabljati mehanska kontracepcijska sredstva najmanj štiri dni.
If an excessive response is obtained, treatment should be stopped and hCG withheld (see section headed ‘Possible Side Effects’).
Če pride do čezmernega odziva, je treba zdravljenje prekiniti in opustiti hCG (glejte poglavje z naslovom “ Možni neželeni učinki “.
Luveris is intended for subcutaneous use which means it is given by injection under the skin.
Luveris je namenjen za subkutano uporabo, to je v obliki podkožne injekcije.
27 If you administer Luveris to yourself, please carefully read the following instructions:
27 je le mogoče.