natgillin/translations-raw huggingface dataset:
Mothers receiving nitisinone should not breast-feed (see section 4.6 and 5.3).
12 Matere, ki jemljejo nitizinon, ne smejo dojiti (glejte poglavji 4. 6 in 5. 3).
Studies in animals have shown reproductive toxicity (see sections 5.3).
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5. 3).
Skin and subcutaneous tissue disorders Uncommon: pruritus, exfoliative dermatitis, erythematous rash
Bolezni kože in podkožja Občasne: eksfoliativni dermatitis, kožni izpuščaji, pruritus
Effects on overall survival When compared to data for historical controls, it can be seen that treatment with nitisinone together with dietary restriction results in a better survival probability in all HT-1 phenotypes.
14 Učinek na preživetje Pri primerjavi podatkov o pojavnosti bolezni v preteklosti je mogoče opaziti, da se zdravljenje z nitizinonom, ki poteka hkrati z zdravljenjem z dieto, pri vseh fenotipih HT- 1, odraža v večji verjetnosti za preživetje.
Apoteket AB Produktion & Laboratorier Prismavägen 2 SE-141 75 Kungens Kurva Sweden
Apoteket AB Produktion & Laboratorier Primasvagen 2 SE- 141 75 Kungens Kurva Švedska
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile.
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednji program študij, katerih rezultati služijo kot osnova za vsakoletno ponovno oceno razmerja koristi/ tveganj.
Area1 Clinical
Področje1
Description The company should establish a Post Marketing Surveillance Program (PMS) for the use of nitisinone in the treatment of Hypertyrosinaemia type 1, including liver, renal, haematological, neurological and ophthalmic status.
Podjetje mora oblikovati program postmarketinškega nadzora (PMS – » Post Marketing Surveillance Program «) za uporabo nitizonina pri zdravljenju hipertirozinemije vrste 1, vključno s statusom jeter in ledvic ter hematološkim, nevrološkim in oftalmološkim statusom.
The PMS protocol has been developed and provided to the CHMP.
Protokol PMS je bil razvit in posredovan Odboru za lastniška zdravila za humano uporabo
All relevant data gathered from this program will be summarized and included in the PSUR.
Pridobljeni podatki bodo vključeni v PSUR po običajnem razporedu
Due date2 Available data will be provided in the PSUR according to the normal reporting schedule.
Vsi ustrezni podatki, pridobljeni v tem programu, bodo povzeti in vključeni v periodično poročilo o varnosti (PSUR – Periodic Safety Data Report).
Quality, Non-clinical, Clinical, Pharmacovigilance 2.
Področja: kakovost, neklinično, klinično, farmakovigilanca 2.
Due date for the follow-up measure or for the first interim report if a precise date cannot be committed to.
Rok za nadaljnje raziskave ali prvo vmesno poročilo, če ni mogoče postaviti natančnega roka za končne rezultate.
18 ANNEX III
18 DODATEK III
OUTER PACKAGING/ CARTON
ZUNANJA OVOJNINA/ ŠKATLA
Orfadin 2 mg hard capsules Nitisinone
Orfadin 2 mg trde kapsule nitizinon
Each capsule contains 2 mg nitisinone
Vsaka kapsula vsebuje 2 mg nitizinona.
Swedish Orphan International AB Drottninggatan 98, SE-111 60 Stockholm, Sweden
21 Swedish Orphan International AB Drottninggatan 98, SE- 111 60 Stockholm, Sweden
22 PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS
22 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
IMMEDIATE PACKAGING/ BOTTLE LABEL
STIČNA OVOJNINA/ NALEPKA NA STEKLENIČKI
Orfadin 2 mg hard capsules Nitisinone Oral use
Orfadin 2 mg trde kapsule nitizinon Peroralna uporaba
EXP {MM/ YYYY)
EXP {MM/ LLLL}
Orfadin capsules can be stored for a single period of 3 months at a temperature not above 25°C, after which the product must be discarded.
Kapsule Orfadin lahko shranjujete 3 mesece pri temperaturi do 25 °C, potem je treba zdravilo zavreči.
Date removed from refrigerator: _______________
Datum odvzema zdravila iz hladilnika: _______________
Orfadin 5 mg hard capsules Nitisinone
Orfadin 5 mg trde kapsule nitizinon
Each capsule contains 5 mg nitisinone
Vsaka kapsula vsebuje 5 mg nitizinona.
EXP{MM/ YYYY}
EXP {MM/ LLLL}
25 PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS
25 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Orfadin 5 mg hard capsules Nitisinone Oral use
Orfadin 5 mg trde kapsule nitizinon Peroralna uporaba
EXP {MM/ YYYY
EXP {MM/ LLLL}
Orfadin 10 mg hard capsules Nitisinone
Orfadin 10 mg trde kapsule nitizinon
Each capsule contains 10 mg nitisinone
Vsaka kapsula vsebuje 10 mg nitizinona.
28 PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS
28 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Orfadin 10 mg hard capsules Nitisinone Oral use
Orfadin 10 mg trde kapsule nitizinon Peroralna uporaba
Orfadin 2 mg hard capsules Orfadin 5 mg hard capsules Orfadin 10 mg hard capsules nitisinone
Orfadin 2 mg trde kapsule Orfadin 5 mg trde kapsule Orfadin 10 mg trde kapsule nitizinon
What Orfadin is and what it is used for 2.
Kaj je zdravilo Orfadin in za kaj ga uporabljamo 2.
Before you take Orfadin 3.
Kaj morate vedeti, preden boste vzeli zdravilo Orfadin 3.
How to take Orfadin 4.
Kako jemati zdravilo Orfadin 4.
Possible side effects 5 How to store Orfadin 6.
Možni neželeni učinki 5 Shranjevanje zdravila Orfadin 6.
WHAT ORFADIN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ORFADIN IN ZA KAJ GA UPORABLJAMO
Orfadin is used for treatment of a disease called hereditary tyrosinemia type I.
Zdravilo Orfadin se uporablja za zdravljenje dedne tirozinemije tipa 1.
In this disease the body is unable to completely break down the amino acid tyrosine.
Pri tej bolezni telo ni sposobno popolnoma razgraditi aminokisline tirozin.
Harmful substances will be formed and accumulate in the body.
V telesu pride do nastanka in kopičenja škodljivih snovi.
Orfadin blocks the breakdown of tyrosine and by doing so the harmful substances are not formed.
Zdravilo Orfadin zaustavi razgraditev tirozina in tako prepreči nastanek škodljivih snovi.
However, tyrosine will remain in the body and therefore a special diet (with low tyrosine and phenylalanine content) must be followed when taking Orfadin.
Kljub temu tirozin ostane v telesu, zato je pri jemanju zdravila Orfadin bolniku treba predpisati posebno dieto (z nizko vsebnostjo tirozina in fenilanina).
BEFORE YOU TAKE ORFADIN
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO ORFADIN
- if you are allergic (hypersensitive) to nitisinone or any of the other ingredients of Orfadin.
Ne jemljite zdravila Orfadin: – če ste alergični na (preobčutljivi za) nitizinon ali katerokoli sestavino zdravila Orfadin.
Take special care with Orfadin:
Bodite posebno pozorni pri jemanju zdravila Orfadin: − če ste opazili, da imate rdeče oči ali katerekoli druge znake na očeh.
- if you get red eyes or any other signs of effects on the eyes.
Nemudoma obiščite svojega zdravnika, da vam pregleda oči.
Eye problems could be a sign of inadequate dietary control.
Težave z očmi so lahko znak neustrezne diete.
Your liver will be checked at regular intervals as the disease affects the liver.
Ker bolezen prizadene jetra, vam bodo v intervalih opravili redne preglede jeter.
Pregnancy The safety of Orfadin has not been studied in pregnant women.
Nosečnost Študije o varnosti Orfadina pri nosečnicah niso bile izvedene.
Please contact your doctor if you plan to become pregnant.
Če nameravate zanositi, se posvetujte s svojim zdravnikom.
If you become pregnant you should contact your doctor immediately.
Če zanosite, nemudoma obvestite zdravnika.
31 Breast-feeding The safety of Orfadin has not been studied in breast-feeding women and therefore you should not breast-feed while taking Orfadin.
31 Dojenje Študije o varnosti Orfadina pri ženskah, ki dojijo, niso bile izvedene, zato med jemanjem kapsul Orfadin ne smete dojiti.
HOW TO TAKE ORFADIN
KAKO JEMATI ZDRAVILO ORFADIN
Always take Orfadin exactly as your doctor has told you.
Pri jemanju zdravila Orfadin natančno upoštevajte zdravnikova navodila.
The usual total daily dose is 1 mg/ kg body weight divided in morning and evening administrations.
Običajni celotni dnevni odmerek je 1 mg/ kg telesne mase, ki se razdeli v jutranji in večerni odmerek.
If you have problems with swallowing the capsules, they may be opened and the powder suspended into a small amount of water or formula diet just before intake.
Če imate težave s požiranjem kapsul, jih lahko odprete, prašek pa stresete v malo vode ali v predpisano dieto tik pred zaužitjem.
If you have the impression that Orfadin is not working properly, talk to your doctor.
Če menite, da je učinek zdravila Orfadin premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
Do not change the dose or stop the treatment without talking to your doctor.
Ne spreminjajte odmerka ali prekinjajte zdravljenja, ne da bi se prej posvetovali s svojim zdravnikom.
If you take more Orfadin than you should:
Če ste vzeli večji odmerek zdravila Orfadin, kot bi smeli:
If you have taken more than you should, contact your doctor or pharmacist.
Če ste vzeli prevelik odmerek, se posvetujte s svojim zdravnikom ali farmacevtom.
If you forget to take Orfadin:
Če ste pozabili vzeti zdravilo Orfadin:
Like all medicines, Orfadin can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Orfadin neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The most common (more than 1 out of 100 patients and less than 1 out of 10 patients) side effects are: different eye symptoms (inflammation of the conjunctiva, opacity in the cornea, inflammation in the cornea, sensitivity to light, eye pain), reduced number of platelets and white blood cells, shortage of certain white blood cells (granulocytopenia).
Najbolj pogosti (pri več kot 1 od 100 bolnikov in manj kot 1 od 10 bolnikov) neželeni učinki so: različni očesni simptomi (vnetje očesne veznice, motnjava roženice, vnetje roženice, občutljivost za svetlobo, bolečine v očeh), zmanjšano število trombocitov in belih krvnih celic, pomanjkanje nekaterih belih krvnih celic (granulocitopenija).
Uncommon (more than 1 out of 1,000 patients and less than 1 out of 100 patients) side effects are: inflammation of the eyelid, increased number of white blood cells, itching, skin inflammation (exfoliative dermatitis), rash.
Občasni (pri več kot 1 od 1. 000 bolnikov in manj kot 1 od 100 bolnikov) neželeni učinki so: vnetje vek, povečano število belih krvnih celic, srbečica, vnetje kože (eksfoliativni dermatitis), izpuščaji.
If you notice any side effects relating to the eyes, you should contact your doctor immediately for an eye examination.
Če opazite katerekoli neželene učinke povezane z očmi, nemudoma obiščite svojega zdravnika, da vam pregleda oči.
HOW TO STORE ORFADIN
SHRANJEVANJE ZDRAVILA ORFADIN
Do not use Orfadin after the expiry date which is stated on the bottle and the carton after “ EXP”.
Zdravila Orfadin ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na steklenici in škatli poleg oznake » EXP «.
32 Orfadin capsules can be removed from the refrigerator for one single period of maximum 3 months and stored at a temperature not above 25°C, after which the product must be discarded.
32 Kapsule Orfadin lahko shranjujete zunaj hladilnika največ 3 mesece in pri temperaturi do 25 °C, potem jih morate zavreči.
Do not forget to mark the date on the bottle, when removed from the refrigerator.
Ne pozabite na steklenički označiti datuma, ko ste zdravilo vzeli iz hladilnika.
What Orfadin contains The active substance is nitisinone.
Kaj vsebuje zdravilo Orfadin Zdravilna učinkovina je nitizinon.
Each capsule contains 2 mg, 5 mg or 10 mg nitisinone.
Vsaka kapsula vsebuje 2 mg, 5 mg ali 10 mg nitizinona.
Capsule content: pregelatinised starch (from maize) Capsule shell: gelatine and titanium dioxide (E 171) Printing ink: iron oxide (E 172), shellac and propylene glycol
Druge sestavine Vsebina kapsule: predgeliran koruzni škrob Zunanjost kapsule: želatina in titanov dioksid (E 171) Vtis: železov oksid (E 172), šelak in propilenglikol
What Orfadin looks like and contents of the pack Orfadin capsules are white, opaque, hard gelatin capsules, imprinted with “ NTBC” and the strength “ 2 mg”, “ 5 mg” or “ 10 mg”, in black.
Izgled zdravila Orfadin in vsebina pakiranja Kapsule Orfadin so trde želatinske kapsule motno bele barve, vtisnjen imajo napis » NTBC « in jakost » 2 mg «, » 5 mg « ali » 10 mg « v črni barvi.
The capsules are packaged in plastic bottles with child resistant closures.
Kapsule so pakirane v plastičnih stekleničkah z za otroke varno zaporko.
Each bottle contains 60 capsules.
Vsaka steklenička vsebuje 60 kapsul.
Marketing Authorisation Holder SWEDISH ORPHAN INTERNATIONAL AB Drottninggatan 98 SE-111 60 Stockholm Sweden
Imetnik dovoljenja za promet z zdravilom SWEDISH ORPHAN INTERNATIONAL AB Drottninggatan 98 SE- 111 60 Stockholm Švedska
Manufacturer Apoteket AB Produktion & Laboratorier Prismavägen 2 SE-141 75 Kungens Kurva Sweden
Izdelovalec Apoteket AB Produktion & Laboratorier Prismavägen 2 SE- 141 75 Kungens Kurva Švedska
Orgalutran is a pre-filled syringe containing a solution for injection.
Orgalutran je predhodno napolnjena injekcijska brizga, ki vsebuje raztopino za injiciranje.
Each syringe of Orgalutran contains 0.25 mg of the active substance ganirelix in 0.5 ml.
Vsaka brizga zdravila Orgalutran vsebuje 0, 25 mg zdravilne učinkovine ganireliks v 0, 5 ml raztopine.
Orgalutran is given to women having fertility treatment whose ovaries are being stimulated to produce more eggs (ovarian stimulation).
Zdravilo Orgalutran se daje ženskam, ki se zdravijo zaradi težav s plodnostjo, pri čemer njihove jajčnike spodbujajo, da tvorijo več jajčec (ovarijska stimulacija).
It is used to prevent premature ovulation (early release of eggs from the ovary, before induction of the ovulation).
Zdravilo se uporablja za preprečevanje prezgodnje ovulacije (zgodnje sprostitve jajčec iz jajčnikov pred sprožitvijo ovulacije).
Orgalutran can only be obtained with a prescription.
Zdravilo Orgalutran se dobi samo na recept.
Orgalutran is given as 0.25 mg once daily.
Orgalutran se daje v odmerku 0, 25 mg enkrat dnevno.
Treatment should start on day 6 of ovarian stimulation, this is 6 days after the start of FSH (follicle stimulating hormone) administration.
6 dni po začetku jemanja FSH (hormona, ki stimulira folikle).
Daily treatment with Orgalutran should be continued up to the day that there are enough large follicles (small sacs that hold the eggs).
Z vsakodnevnim dajanjem zdravila Orgalutran je treba nadaljevati vse do dneva, ko nastane dovolj velikih foliklov (majhnih vrečic, v katerih se nahajajo jajčeca).
Orgalutran is given by subcutaneous (under the skin) injection, preferably into the upper leg.
Orgalutran se injicira subkutano (pod kožo), najbolje v stegno.
The patient or her partner may carry out the injections of Orgalutran themselves, if they have been trained and have access to expert advice.
Zdravilo Orgalutran lahko injicira tudi bolnica sama ali njen partner, če sta bila za to ustrezno usposobljena in imata na voljo strokovno svetovanje.
For further information on how to use Orgalutran, see the Package Leaflet.
Podrobnejše informacije o uporabi zdravila Orgalutran so na voljo v Navodilih za uporabo.
The active substance in Orgalutran, ganirelix, blocks the effects of a natural hormone, called gonadotrophin-releasing hormone (GnRH).
Zdravilna učinkovina zdravila Orgalutran, ganireliks, zavira učinke naravnega hormona, imenovanega gonadotropin sproščajoč hormon (GnRH).
GnRH controls the secretion of another hormone, called luteinising hormone (LH), which causes the release of the egg (ovulation) during the menstrual cycle.
GnRH uravnava izločanje drugega hormona, imenovanega luteinizirajoči hormon (LH), ki povzroči sproščanje jajčec (ovulacijo) med menstrualnim ciklom.
During fertility treatment, ovarian stimulation is normally used to make the ovaries produce more than one egg.
Med zdravljenjem težav s plodnostjo se običajno uporablja spodbujanje jajčnikov z namenom spodbuditi jajčnike k tvorbi več kot enega jajčeca.
A few days later, a hormone such as hCG (human Chorionic Gonadotrophin) is given to trigger ovulation, and the eggs are then harvested and used in techniques such as in-vitro fertilisation.
Zatem se jajčeca odvzamejo in uporabijo v postopkih, kot je in- vitro oploditev.
Orgalutran, by blocking the effect of GnRH, stops the production of LH, and therefore prevents premature ovulation, which is the release by the ovaries of eggs that may be immature and not suitable for fertilisation.
Zdravilo Orgalutran z blokiranjem učinka GnRH ustavi tvorbo LH in posledično prepreči prezgodnjo ovulacijo, to je sprostitev jajčec iz jajčnikov, ki bi lahko bila nezrela in neprimerna za oploditev.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Orgalutran been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Orgalutran raziskano?
The effectiveness of Orgalutran as a treatment to prevent premature ovulation was studied in 1,335 women who were included in three main studies.
Učinkovitost zdravila Orgalutran pri preprečevanju prezgodnje ovulacije so raziskali pri 1335 ženskah, ki so sodelovale v treh glavnih raziskavah.
Orgalutran was compared with buserelin, leuprorelin, and triptorelin (these medicines are GnRH agonists: they act on the secretion of LH by stimulating the production of GnRH to such an extent that the body stops making LH).
Zdravilo Orgalutran so primerjali z buserelinom, leuprorelinom in triptorelinom (ta zdravila so agonisti GnRH: učinkujejo na izločanje luteinizirajočega hormona tako, da spodbujajo tvorbo GnRH do te mere, da telo preneha izdelovati luteinizirajoči hormon).
The main measures of effectiveness were the number of eggs that could be harvested and the ongoing pregnancy rate.
Glavno merilo učinkovitosti je bilo število jajčec, ki so jih lahko odvzeli in stopnja temu sledečih zanositev.
What benefit has Orgalutran shown during the studies?
Kakšne koristi je zdravilo Orgalutran izkazalo med raziskavami?
After treatment with Orgalutran, the number of eggs that could be harvested was between 7.9 and 11.6, and the ongoing pregnancy rate per attempt was between 20.3% and 31%.
Po zdravljenju z zdravilom Orgalutran je število jajčec, ki so jih lahko odvzeli, znašalo med 7, 9 in 11, 6, stopnja zanositev na vsak poskus pa je bila med 20, 3% in 31%.
The values for the comparator treatments were slightly higher (buserelin:
V primerjalnih zdravljenjih so bile vrednosti nekoliko višje (buserelin:
9.7 and 25.7%, leuprorelin:
9, 7 in 25, 7%, leuprorelin:
14.1 and 36.4%, triptorelin:
14, 1 in 36, 4%, triptorelin:
8.6 and 35.1%).
8, 6 in 35, 1%).
Orgalutran may cause a skin reaction at the injection site, mainly redness with or without swelling (seen in 12% of the patients in the studies).
Zdravilo Orgalutran lahko povzroči kožno reakcijo na mestu injiciranja, predvsem pordelost z oteklino ali brez nje (opaženo pri 12% bolnic, vključenih v raziskave).
The other side effects (seen in less than 1 patient in 100) are nausea (feeling sick), headache and malaise (feeling unwell).
Ostali neželeni učinki (opaženi pri manj kot 1 od 100 bolnic) so slabost, glavobol in občutek bolehnosti (slabo počutje).
Orgalutran should not be used in people who may be hypersensitive (allergic) to ganirelix, to any of the other ingredients of Orgalutran, to GnRH or to GnRH agonists.
Zdravila Orgalutran ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) ganireliks ali katerokoli drugo sestavino zdravila Orgalutran, na GnRH ali agoniste GnRH.
It should not be used by women who are pregnant or breast-feeding, and in women with moderate or severe kidney or liver disease.
Ne smejo ga prejemati ženske, ki so noseče ali dojijo, ter ženske z zmernimi ali hudimi obolenji jeter ali ledvic.
For the full list of restrictions, please see the Package Leaflet.
Celoten seznam omejitev najdete v Navodilih za uporabo.
Sometimes, the ovaries can over- respond to treatment (ovarian hyperstimulation syndrome), and both doctors and patients must be aware of this possibility.
Jajčniki se lahko včasih čezmerno odzovejo na zdravljenje (sindrom hiperstimulacije jajčnikov), zato morajo biti zdravniki in bolnice pozorni na možnost nastanka tega pojava.
The Committee for Medicinal products for Human Use (CHMP) considered that Orgaluran had shown its effectiveness, and that the tendency towards lower results compared with the GnRH agonists was acceptable.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da je zdravilo Orgalutran izkazalo svojo učinkovitost in da so njegovi nižji rezultati v primerjavi z agonisti GnRH sprejemljivi.
They decided that Orgalutran’ s benefits are greater than its risks for the prevention of premature luteinising hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction techniques.
Odbor je zato odločil, da so koristi zdravila Orgalutran pri preprečevanju prezgodnjih vrhov sproščanja luteinizirajočega hormona pri ženskah, ki prejemajo nadzorovano hiperstimulacijo jajčnikov pri postopkih oploditve z biomedicinsko pomočjo, večje od z njim povezanih tveganj.
They recommended that Orgalutran be given marketing authorisation.
Zato je za zdravilo Orgalutran priporočil odobritev dovoljenja za promet z zdravilom.
The European Commission granted a marketing authorisation valid throughout the European Union, for Orgalutran to N. V.
Evropska komisija je dovoljenje za promet z zdravilom Orgalutran, veljavno po vsej Evropski uniji, odobrila družbi N. V.
Organon on 17 May 2000.
Organon dne 17. maja 2000.
The marketing authorisation was renewed on 17 May 2005.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 17. maja 2005.
The full EPAR for Orgalutran is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Orgalutran je na voljo tukaj.
Solution for injection Subcutaneous use
Raztopina za injiciranje
Pre-filled syringe (glass)
Subkutana uporaba
0,5 ml (0.5 mg/ ml)
napolnjena injekcijska 0, 5 ml (0, 5 mg / ml) brizga (steklo)
Orgalutran 0.25 mg/ 0.5 ml solution for injection
Orgalutran 0, 25 mg/ 0, 5 ml raztopina za injiciranje
Each pre-filled syringe contains 0.25 mg of ganirelix in 0.5 ml aqueous solution.
Vsaka napolnjena injekcijska brizga vsebuje 0, 25 mg ganireliksa v 0, 5 ml vodne raztopine.
The active substance ganirelix (INN) is a synthetic decapeptide with high antagonistic activity to the naturally occurring gonadotrophin releasing hormone (GnRH).
Zdravilna učinkovina ganireliks (INN) je sintetični dekapeptid z močnim antagonističnim delovanjem proti naravnemu gonadotropin sproščujočemu hormonu (GnRH).
The amino acids at positions 1, 2, 3, 6, 8 and 10 of the natural GnRH decapeptide have been substituted resulting in N-Ac-D-Nal(2)1, D- -pClPhe2, D-Pal(3)3, D-hArg(Et2)6, L-hArg(Et2)8, D-Ala10]-GnRH with a molecular weight of 1570.4.
Aminokisline na mestih 1, 2, 3, 6, 8 in 10 naravnega dekapeptida gonadotropin sproščujočega hormona so zamenjane tako, da nastane [N- Ac- D - Nal( 2) 1, D- pCIPhe2, D- Pal( 3) 3, D- hArg (Et2) 6, L- hArg( Et2) 8, D- Ala10] - GnRH, z molekulsko maso 1570, 4.
Clear and colourless aqueous solution.
Bistra in brezbarvna vodna raztopina.
The prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).
Preprečevanje prezgodnjih vrhov sproščanja luteinizirajočega hormona (LH) pri ženskah, ki prejemajo nadzorovano hiperstimulacijo jajčnikov (COH - controlled ovarian hyperstimulation) pri postopkih oploditve z biomedicinsko pomočjo (ART - assisted reproduction techniques).
In clinical trials Orgalutran was used with recombinant human follicle stimulating hormone (FSH).
V kliničnih preskušanjih so zdravilo Orgalutran uporabljali skupaj z rekombinantnim folikle stimulirajočim hormonom (FSH).