natgillin/translations-raw huggingface dataset:
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Parsabiv 2.5 mg solution for injection etelcalcetide 
IME ZDRAVILA IN POT(I) UPORABE Parsabiv 2,5 mg raztopina za injiciranje etelkalcetid i.v.
The threshold for seizures may be lowered by significant reductions in serum calcium levels. 
Bistveno znižanje koncentracije kalcija v serumu lahko zniža prag za konvulzije.
Each vial contains 5 mg of etelcalcetide (as hydrochloride) in 1 mL of solution. 
Parsabiv 5 mg raztopina za injiciranje Ena viala vsebuje 5 mg etelkalcetida (v obliki klorida) v 1 ml raztopine.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 10 mg of etelcalcetide (as hydrochloride). 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 10 mg etelkalcetida (v obliki klorida).
NAME OF THE MEDICINAL PRODUCT Parsabiv 10 mg solution for injection etelcalcetide 
Parsabiv 10 mg raztopina za injiciranje etelkalcetid
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Parsabiv 10 mg solution for injection etelcalcetide 
IME ZDRAVILA IN POT(I) UPORABE Parsabiv 10 mg raztopina za injiciranje etelkalcetid i.v.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Parsabiv 5 mg solution for injection etelcalcetide 
IME ZDRAVILA IN POT(I) UPORABE Parsabiv 5 mg raztopina za injiciranje etelkalcetid i.v.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 5 mg of etelcalcetide (as hydrochloride). 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 5 mg etelkalcetida (v obliki klorida).
NAME OF THE MEDICINAL PRODUCT Parsabiv 5 mg solution for injection etelcalcetide 
Parsabiv 5 mg raztopina za injiciranje etelkalcetid
NAME OF THE MEDICINAL PRODUCT Parsabiv 2.5 mg solution for injection etelcalcetide 
Parsabiv 2,5 mg raztopina za injiciranje etelkalcetid
Each vial contains 2.5 mg of etelcalcetide (as hydrochloride) in 0.5 mL of solution. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Parsabiv 2,5 mg raztopina za injiciranje Ena viala vsebuje 2,5 mg etelkalcetida (v obliki klorida) v 0,5 ml raztopine.
Reductions in serum calcium associated with tremoring, 
Ob klinični ravni izpostavljenosti so opažali znižanje kalcija v serumu s spremljajočim tremorjem, konvulzijami in s stresom povezanimi spremembami.
Single use only 
Način uporabe
Very common 
Pogosti mialgija
*PFU: plaque forming units 
*PFU: enote, ki tvorijo plak
Parenteral use 
parenteralna uporaba
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states 
Dodatek I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
GLAXOSMITHKLINE (GSK) SRL - ROMANIA Costache Negri Street, No. 1-5 
Romunija GLAXOSMITHKLINE (GSK) SRL - ROMANIA Costache Negri Street, No. 1-5
1495-131 Algés Portugal 
1495-131 Algés
United Kingdom Sanofi Pasteur MSD Limited Mallards Reach 
Velika Britanija Sanofi Pasteur MSD Limited Mallards Reach
United Kingdom SmithKline Beecham plc 980 Great West Road 
Velika Britanija SmithKline Beecham plc 980 Great West Road
The Netherlands GlaxoSmithKline B.V Huis ter Heideweg 62 
Nizozemska GlaxoSmithKline B.V Huis ter Heideweg 62
Laboratoire GlaxoSmithKline 100 route de Versailles 78163 Marly-le-Roi Cedex France 
GlaxoSmithKline 100 route de Versailles 78163 Marly-le-Roi Cedex France
GSK d.o.o Cvetkova ulica 29 1000 Ljubljana Slovenia 
Slovenija GSK d.o.o Cvetkova ulica 29
Subcutaneous use , Intramascular use 
subkutalna uporaba, intramuskularna uporaba
Priorix-Tetra injectieflacon/amp ul, poeder en oplosmiddel voor oplossing voor injectie 
Priorix-Tetra injectieflacon/ampul, poeder en oplosmiddel voor oplossing voor injectie parenteralna uporaba
PRIORIX TETRA one dose (0.5 ml) contains: 
Po pripravi cepiva 1 odmerek (0,5 ml) vsebuje:
Priorix-Tetra, poeder en oplosmiddel in voorgevulde spuit voor oplossing voor injectie 
Priorix-Tetra, poeder en oplosmiddel in voorgevulde spuit voor oplossing voor injectie parenteralna uporaba
Mumps virus Jeryl Lynn strain (live, attenuated) - 5 x 10 
Virus mumpsa, sev Jeryl Lynn (živ, oslabljen) - 5 x 103.0 CCID50
Measles virus Schwartz strain (live, attenuated) - not less than 10 
Virus ošpic, sev Schwartz (živ, oslabljen) - ne manj kot 103
Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) - not less than 10 
Živ, oslabljen virus mumpsa (RIT 4385, pridobljen iz seva Jeryl Lynn) - ne manj kot
one dose (0.5 ml) contains: Mumps virus (Strain Jeryl Lynn - B level) - not less than 20 x 10 TCID50 
Virus mumpsa (sev Jeryl Lynn - nivo B)ne manj kot 20 x 10
Live attenuated varicella-zoster virus (Oka strain) 103.3 PFU* 
Živ, oslabljen virus varicella-zoster (sev Oka) 103.3 PFU
Varivax one dose (0.5 ml) contains: varicella virus (zoster vivo) - 1350 PFU* 
1 odmerek (0,5 ml) vsebuje: Virus noric (zoster, živ) - 1350 PFU*
Powder for suspension for injection 
Prašek za razopino za injeciranje
strain, derived from Jeryl Lynn strain)not less than 103.7 CCID50 
Virus mumpsa (sev Jeryl Lynn) - ne manj kot 5 x 103.7 CCID50
one dose (0.5 ml) contains: not less than 103.0 CCID50 of the measles virus Enders-Edmonston strain not less than 5 x 103.0 CCID50 of the mumps virus (Jeryl Lynn strain) not less than 103.0 CCID50 of the rubella virus strain 
1 odmerek (0,5 ml) vsebuje: virus ošpic Edmonston 749D (živ, oslabljen)103.0 CCID50Virus mumpsa Jeryl Lynn (živ, oslabljen) - 5 x 103.0 CCID50Virus rdečk Wistar RA 27/3 (živ, oslabljen) - 103.0 CCID50
Mumps virus URABE AM-9 strain (live, attenuated) not less than 5 x 10 
Virus mumpsa, sev URABE AM-9 (živ, oslabljen) - ne manj kot 5 x 103.0 CCID50
Varicella Virus OKA/Merck Strain - not less than 1350 PFU* 
Virus noric, sev OKA/Merck - ne manj kot 1350 PFU*
Priorix-Tetra powder and solvent for solution for injection in prefilled syringe 
Priorix-Tetra powder and solvent for solution for injection in pre-filled syringe
Measles, mumps, rubella and varicella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA) 
Cepivo proti ošpicam, mumpsu, rdečkam in noricam (živo) z dovoljenjem za promet v Evropski uniji Država članica (EU/EEA)
Varicella virus OKA/Merck strain (live, attenuated) not less than 1350 PFU* 
Virus noric (sev Oka / Merck) (živ, oslabljen) - ne manj kot 1350 PFU*
Czech Republic GlaxoSmithKline Biologicals S.A. 
Češka republika GlaxoSmithKline Biologicals S.A.
one dose (0.5 ml) contains: Live attenuated varicella virus (Oka/Merck strain) not less than 1350 PFU* 
1 odmerek (0,5 ml) vsebuje: Virus noric (Oka / Merck): ne manj kot 1350 PFU*
Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103.0 CCID50 Live attenuated varicella virus (Oka strain)not less than 103.3 PFU* 
Virus ošpic - ne manj kot 103.0 CCID50 Virus mumpsa - ne manj kot 103.7 CCID50 Virus rdečk - ne manj kot 103.0 CCID50 Virus noric - ne manj kot 103.3 PFU*
Live attenuated measles virus (Schwarz strain) -not less than 103.0 CCID50 
Virus ošpic (živ, oslabljen) - ne manj kot 103.0 CCID50
RUBEATEN BERNA Rubella virus live (Strain Wistar RA 27/3) - not less than 10 
RUBEATEN BERNA Virus rdečk živ (sev RA 27/3) - ne manj kot 103.0 CCID50
Measles, mumps and rubella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA) 
Cepivo proti ošpicam, mumpsu in rdečkam (živo) z dovoljenjem za promet v Evropski uniji Država članica (EU/EEA)
one dose (0.5 ml) contains: Live, attenuated Varicella virus (OKA/Merck strain) not less than 1350 PFU* 
1 odmerek (0,5 ml) vsebuje: Živ, oslabljen virus noric (sev Oka / Merck), ki ni manj od 1350 PFU*
Varivax one dose (0.5 ml) contains: Varicella virus (Oka/Merck strain) ≥ 1350 PFU* 
1 odmerek (0,5 ml) vsebuje: Virus noric (sev Oka / Merck) 1350 PFU*
Varicella virus, live attenuated, Oka/Merck strain ≥ 1350 PFU* 
Živ, oslabljen virus noric,sev Oka / Merck ≥ 1350 PFU*
Priorix injection one dose (0.5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 10 
Priorix injection 1 odmerek (0,5 ml) vsebuje: Živ, oslabljen virus ošpic (sev Schwarz) - ne manj kot 103.0 CCID50
Live attenuated varicella virus (OKA strain) - not less than 103.3 PFU* 
Živ, oslabljen virus varicella zoster (Oka sev) - ne manj kot 103.3 PFU*
Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103.0 CCID50 
Živ, oslabljen virus rdečk (sev Wistar RA 27/3) - ne manj kot 103.0 CCID50
Measles vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA) 
Cepiva proti ošpicam (živo) z dovoljenjem za promet v Evropski uniji Država članica(EU/EEA)
Priorix-Tetra lag one dose (0.5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 10 
Priorix-Tetra lag 1 odmerek (0,5 ml) vsebuje: Živ, oslabljen virus ošpic (sev Schwarz) - ne manj kot 103.0 CCID50
one dose (0,5 ml) contains: Live attenuated varicella-zoster virus (OKa strain) - not less than 103.3 PFU* 
1 odmerek (0,5 ml) vsebuje: Živ, oslabljen virus varicella zoster (sev Oka) - ne manj kot 103.3 PFU*
one dose (0,5 ml) contains : Live attenuated varicella-zoster virus (Oka strain) - not less than 103.3 PFU* 
1 odmerek (0,5 ml) vsebuje: živ, oslabljen virus varicella zoster (sev Oka) - ne manj kot 103.3 PFU*
Live attenuated varicella virus (Oka strain)not less than 103.3 PFU* 
Živ, oslabljen virus varicella zoster(sev OKA): ne manj kot 103.3 PFU*
Rubella virus Wistar RA 27/3 strain (live, attenuated) - 10 
Virus rdečk sev Wistar RA 27/3 (živ, oslabljen) - 103.0 CCID50
Belgium GlaxoSmithKline Biologicals S.A. 
Romunija GlaxoSmithKline Biologicals S.A.
Varicella virus strain Oka/Merck (live, attenuated) ≥1350 PFU* 
Virus noric sev Oka / Merck (živ, oslabljen) ≥ 1350 PFU*
Rubella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA) 
Cepivo proti noricam (živo) z dovoljenjem za promet v Evropski uniji Država članica(EU/EEA)
PRIORIX TETRA one dose (0.5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 10 
PRIORIX TETRA 1 odmerek (0,5 ml) vsebuje: Živ, oslabljen virus ošpic (sev Schwarz) - ne manj kot 103.0 CCID50
Varicella virus Oka/Merck strain (live, attenuated)≥1350 PFU* 
Virus noric sev Oka / Merck (živ, oslabljen) ≥ 1350 PFU *
PRIORIX-TETRA one dose (0.5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 10 
PRIORIX-TETRA 1 odmerek (0,5 ml) vsebuje: Živ, oslabljen virus ošpic (sev Schwarz) - ne manj kot 103.0 CCID50
Varivax one dose (0.5 ml) contains: not less than 1350 PFU* of the live attenuated varicella virus (OKA.Merck strain) 
1 odmerek (0,5 ml) vsebuje: Ne manj kot 2 x 103.0 PFU* virusa varicellazoster
Varicella virus Oka/Merck strain (live, attenuated) 1350 PFU* 
Virus noric sev Oka / Merck (živ, oslabljen) 1350 PFU*
Powder and solvent for solution for injection, suspension 
Prašek in vehikel za raztopino za injiciranje, suspenzija
CCID50 of the measles virus Enders-Edmonston strain, not less than 12500 CCID50 of the mumps virus (Jeryl Lynn strain); and not less than 10 CCID50of the Wistar RA 27/3 rubella virus strains 
Virus mumpsa - ne manj kot 12500 CCID50 in Virus rdečk - ne manj kot 103.0CCID50
Measles and rubella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA) 
Cepivo proti ošpicam in rdečkam (živo) z dovoljenjem za promet v Evropski uniji Država članica (EU/EEA)
What measures are being taken to ensure the safe and effective use of Granpidam? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Granpidam?
It is not intended to provide practical advice on how to use Granpidam. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The full EPAR for Granpidam can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Granpidam je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This was considered acceptable since Revatio and Viagra have the same composition and are made in the same way by the same manufacturer. 
To je bilo sprejemljivo, saj imata zdravili Revatio in Viagra enako sestavo in ju na enak način izdeluje isti izdelovalec.
This is a summary of the European public assessment report (EPAR) for Granpidam. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Granpidam.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Granpidam was considered to be comparable to Revatio. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Granpidam primerljivo z zdravilom Revatio.
This means that Granpidam is similar to a ‘reference medicine' already authorised in the European Union (EU) called Revatio. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Revatio.
Because Granpidam is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Granpidam generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
In adults, it is used in patients with class II (slight limitation of physical activity) or class III (marked limitation of physical activity) PAH. 
Pri odraslih se uporablja pri bolnikih s PAH razreda II (blaga omejitev telesne aktivnosti) ali razreda III (izrazita omejitev telesne aktivnosti).
Granpidam is available as tablets (20 mg). 
Zdravilo Granpidam je na voljo v obliki tablet (20 mg).
Because the effectiveness and safety of sildenafil in PAH is already well established, studies in people have been limited to tests to determine that it is bioequivalent to another authorised sildenafilcontaining tablet. 
Ker sta učinkovitost in varnost sildenafila pri PAH že dobro raziskani, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je zdravilo biološko enakovredno drugi odobreni tableti, ki vsebuje sildenafil.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom dose would be 10 mg three times a day but Granpidam can only be used when a 20-mg dose is to be given. 
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom priporočeni odmerek 10 mg trikrat na dan, vendar se sme zdravilo Granpidam uporabljati le, kadar se dajejo odmerki po 20 mg. Za manjše odmerke je treba uporabiti druga zdravila, ki vsebujejo sildenafil.
In this case Granpidam was not compared with the reference product Revatio, but with Viagra. 
V tem primeru zdravila Granpidam niso primerjali z referenčnim zdravilom Revatio, pač pa z zdravilom Viagra.
Other information about Granpidam 
Druge informacije o zdravilu Granpidam
The active substance in Granpidam, sildenafil, belongs to a group of medicines called ‘phosphodiesterase-type-5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme. 
Zdravilna učinkovina v zdravilu Granpidam, sildenafil, spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5 (PDE5), kar pomeni, da zavira encim PDE5.
In children weighing less than 20 kg the maximum recommended 
Pri otrocih, ki tehtajo manj kot 20 kg, bi bil največji
Granpidam is a medicine used to treat adults and children from 1 year of age with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries in the lungs). 
Zdravilo Granpidam se uporablja za zdravljenje odraslih in otrok, starejših od enega leta, s pljučno arterijsko hipertenzijo (PAH, nenormalno visok krvni tlak v pljučnih arterijah).
What are the benefits and risks of Granpidam? 
Kakšne so koristi in tveganja, povezani z zdravilom Granpidam?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Granpidam have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo tega zdravila upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
When it is blocked, a substance called ‘cyclic guanine monophosphate' (cGMP) cannot be broken down, so that it remains in the vessels where it causes relaxation and widening of the blood vessels. 
Kadar je zavrt, se snov, imenovana ciklični gvanozinmonofosfat (cGMP), ne more razgrajevati in ostaja v žilah, kjer povzroča sproščanje in razširitev krvnih žil.
The Committee recommended that Granpidam be approved for use in the EU. 
Priporočil je, da se zdravilo Granpidam odobri za uporabo v EU.
For more information about treatment with Granpidam, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Granpidam preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Granpidam can only be obtained with a prescription and treatment should be started and monitored by a doctor who has experience in the treatment of PAH. 
Predpisovanje in izdaja zdravila Granpidam je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik z izkušnjami z zdravljenjem PAH.
In patients with PAH, sildenafil widens the blood vessels of the lungs, which lowers the blood pressure and improves symptoms. 
Pri bolnikih s PAH sildenafil širi krvne žile v pljučih in tako znižuje krvni tlak in izboljšuje simptome.
In adults, Granpidam is taken at a dose of 20 mg three times a day. 
Pri odraslih se zdravilo Granpidam jemlje v odmerku 20 mg trikrat na dan.
For practical information about using Granpidam, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Granpidam naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Why is Granpidam approved? 
Zakaj je bilo zdravilo Granpidam odobreno?
What is Granpidam and what is it used for? 
Kaj je zdravilo Granpidam in za kaj se uporablja?
Lower doses of Granpidam may be needed in patients taking some medicines that affect the way Granpidam is broken down in the body. 
Pri bolnikih, ki jemljejo nekatera zdravila, ki vplivajo na presnovo zdravila Granpidam v telesu, so morda potrebni manjši odmerki.
Granpidam contains the active substance sildenafil. 
Zdravilo Granpidam vsebuje zdravilno učinkovino sildenafil.
In children aged 1 to 17 years, the recommended dose is 20 mg three times a day in those over 20 kg. Higher doses should not be used. 
Pri otrocih, starih od 1 do 17 let, ki tehtajo več kot 20 kg, je priporočeni odmerek 20 mg trikrat na dan.
PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs. 
PAH je izčrpavajoča bolezen, pri kateri pride do hudega zoženja krvnih žil v pljučih.
How has Granpidam been studied? 
Kako je bilo zdravilo Granpidam raziskano?
How is Granpidam used? 
Kako se zdravilo Granpidam uporablja?
Therefore, the CHMP's view was that, as for Revatio, the benefit of Granpidam outweighs the identified risk. 
Zato je menil, da njegove koristi enako kot pri zdravilu Revatio odtehtajo znana tveganja.
Date of first authorisation: 17 May 2000 Date of last renewal: 10 May 2010 
Datum prve odobritve: 17. maj 2000 Datum zadnjega podaljšanja: 10. maj 2010
The relevance of these data for humans is unknown. 
Pomen teh podatkov za ljudi ni znan.
• At the request of the European Medicines Agency: 
• na zahtevo Evropske agencije za zdravila;
No teratogenic effects were observed. 
Teratogenih učinkov niso opažali.
Special care should be taken in women with signs and symptoms of active allergic conditions. 
Posebna previdnost je potrebna pri ženskah z znaki in simptomi aktivnih alergijskih stanj.
If you administer the injections yourself or have it done by your partner, follow the instructions below carefully. 
Če si injekcije dajete sami ali vam jih daje vaš partner, se natančno držite spodnjih navodil.
Do not use this medicine after the expiry date which is stated on the carton and on the label after ‘EXP'. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki poleg oznake "EXP".
However, based on the small number of patients treated so far, an effect cannot be excluded. 
Kljub temu pa na podlagi majhnega števila doslej zdravljenih bolnic ne moremo izključiti določenega vpliva telesne mase.
N.V. Organon, Kloosterstraat 6 Postbus 20 
Organon Kloosterstraat 6 Postbus 20
In clinical studies, luteal phase support was given according to study centres' practice or according to the clinical protocol. 
V kliničnih študijah so dajali podporo lutealne faze glede na prakso raziskovalnega centra ali glede na klinični protokol.
1, D-pClPhe 
1, D-pCIPhe
The local reactions generally disappear within 4 hours after administration. 
Lokalne reakcije so v splošnem izginile v 4 urah po aplikaciji.
Excretion occurs via faeces (approximately 75 %) and urine (approximately 22 %). 
Zdravilo se izloča z blatom (približno 75 %) in urinom (približno 22 %).
5340 BH Oss, The Netherlands. 
5340 BH Oss Nizozemska
It is not known whether ganirelix is excreted in breast milk. 
Ni znano, ali se ganireliks izloča v materino mleko.
Gonadotrophins play an important role in human fertility and reproduction. 
Gonadotropini igrajo pomembno vlogo v zvezi s plodnostjo in reprodukcijo pri ljudeh.
Your doctor will decide, depending on the severity, if additional monitoring is required during treatment. 
Glede na jakost alergije se bo zdravnik odločil, ali bo med zdravljenjem potrebno dodatno spremljanje.
Follicles are small round sacs that contain the egg cells. 
Folikli so majhne okrogle vrečke, ki vsebujejo jajčne celice.
The chance of having a side effect is described by the following categories: 
Pogostnost neželenih učinkov je opisana z naslednjimi kategorijami:
The frequency of hypersensitivity reactions (very rare, < 1/10,000) has been deduced from post-marketing surveillance. 
Pogostnost preobčutljivostnih reakcij (zelo redke, < 1/10.000) so ugotovili iz postmarketinških izkušenj.
The major circulating component in plasma is ganirelix. 
Glavna komponenta, ki kroži v plazmi, je ganireliks.
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) 
Aminokisline na mestih 1, 2, 3, 6, 8 in 10 naravnega dekapeptida GnRH so zamenjane tako, da nastane N-Ac-D-Nal(2)
Ganirelix is also the main compound found in urine. 
Ganireliks je tudi glavna spojina, ki se pojavi v urinu.
As a result a rapid, profound, reversible suppression of endogenous gonadotrophins occurs, without initial stimulation as induced by GnRH agonists. 
Posledica tega je hitro, temeljito in reverzibilno zaviranje endogenih gonadotropinov brez začetne stimulacije, ki jo povzročajo agonisti GnRH.
If you have an active allergic condition, please tell your doctor. 
Če imate aktivno alergijo, obvestite zdravnika.
There are no adequate data from the use of ganirelix in pregnant women. 
Ni zadostnih podatkov o uporabi ganireliksa pri nosečnicah.
If you realise that you forgot a dose, administer it as soon as possible. 
Če ugotovite, da ste pozabili posamezen odmerek, si ga injicirajte čim prej.
Start again with a new syringe. 
Postopek ponovite z novo brizgo.
If you are more than 6 hours late (so the time between two injections is longer than 30 hours) administer the dose as soon as possible and contact your doctor for further advice. 
Če ste zamudili več kot 6 ur (tako da je časovni razmik med dvema odmerkoma več kot 30 ur), si čim prej injicirajte odmerek in se posvetujte z zdravnikom.
The bioavailability of Orgalutran following subcutaneous administration is approximately 91 %. 
Biološka uporabnost zdravila Orgalutran po subkutanem dajanju je približno 91 %.
The possibility of interactions with commonly used medicinal products, including histamine liberating medicinal products, cannot be excluded. 
Možnosti za pojav interakcij s pogosto uporabljenimi zdravili, vključno s tistimi zdravili, ki sproščajo histamin, ni mogoče izključiti.