natgillin/translations-raw huggingface dataset:
Non-gBRCAmut cohort niraparib (N = 138)
(n = 203) in ne-gBRCAmut (n = 350).
Haematologic adverse reactions (thrombocytopenia, anaemia, neutropenia) have been reported in patients treated with Zejula.
Pri bolnicah, zdravljenih z zdravilom Zejula, so poročali o hematoloških neželenih učinkih (trombocitopeniji, anemiji, nevtropeniji).
• Stomach pain
• bolečina v trebuhu,
Hypertension, including hypertensive crisis, has been reported with Zejula therapy.
Pri zdravljenju z zdravilom Zejula so poročali o hipertenziji, vključno s hipertenzivno krizo.
Hypertension, including hypertensive crisis, has been reported with the use of Zejula.
Pri uporabi zdravila Zejula so poročali o hipertenziji, vključno s hipertenzivno krizo.
Headache, dizziness, dysgeusia
Zelo pogosti glavobol, omotičnost, disgevzija
Inhibition of renal uptake transporters (OAT1, OAT3, and OCT2) Neither niraparib nor M1 inhibits organic anion transporter 1 (OAT1), 3 (OAT3), and organic cation transporter 2 (OCT2).
Zaviranje prenašalcev ledvičnega privzema (OAT1, OAT3 in OCT2) Niraparib in M1 ne zavirata organskega anionskega prenašalca 1 (OAT1), 3 (OAT3) in organskega kationskega prenašalca 2 (OCT2).
The safety and efficacy of niraparib as maintenance therapy was studied in a Phase 3 randomised, double-blind, placebo-controlled international trial (ENGOT-OV16 / NOVA) in patients with relapsed predominantly high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who were platinum sensitive, defined by complete response (CR) or partial response (PR) for more than six months to their penultimate (next to last) platinum-based therapy.
jajcevoda ali primarnega peritonealnega raka visoke stopnje, ki je bil občutljiv na platino, kar je bilo opredeljeno kot popoln odziv (PO) ali delni odziv (DO) na njihovo predzadnje zdravljenje na osnovi platine, ki je trajal več kot šest mesecev.
• Indigestion
• omotičnost,
No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit (e.g. itraconazole, ritonavir, and clarithromycin) or induce CYP enzymes (e.g. rifampin, carbamazepine, and phenytoin).
Pri sočasnem dajanju zdravila Zejula z zdravili, za katera je znano, da zavirajo (npr. itrakonazol, ritonavir in klaritromicin) ali spodbujajo
Your doctor may recommend a lower dose if you experience side effects (such as nausea, tiredness, abnormal bleeding/bruising, anaemia).
Če se pri vas pojavijo neželeni učinki (kot so siljenje na bruhanje (navzea), utrujenost, nenormalna krvavitev/modrice, anemija), bo zdravnik morda priporočil manjši odmerek.
Niraparib as a substrate of CYPs (CYP1A2 and CYP3A4) Niraparib is a substrate of carboxylesterases (CEs) and UDP-glucuronosyltransferases (UGTs) in vivo.
Niraparib je in vivo substrat karboksilesteraz (CE, carboxylesterases) in UDP-glukuronoziltransferaz (UGT).
Low blood-cell counts
Nizka števila krvnih celic
Tachycardia
CTCAE
Capsule content Magnesium stearate
Občasni fotosenzitivnost, izpuščaj
What Zejula is and what it is used for What you need to know before you take Zejula How to take Zejula
Kaj morate vedeti, preden boste vzeli zdravilo Zejula
There are limited clinical data in patients aged 75 or over.
75 let, so omejeni.
In patients with baseline platelet count less than 180 × 109/L, thrombocytopenia of any grade and Grade 3/4 occurred in 76 % and 45 % of the patients, respectively.
Pri bolnicah z izhodiščnim številom trombocitov manj kot 180 × 109/l se je trombocitopenija katere koli stopnje oziroma 3. ali
Gamma-glutamyl transferase increased * Frequencies are based on percent of patients using all-causality adverse events.
* Pogostnosti temeljijo na odstotku bolnic ob upoštevanju neželenih dogodkov vseh vzrokov.
Estimated Survival Function
- Navodilo shranite.
Very common
Pogosti dispneja
Urinary tract infection, bronchitis
Infekcijske in parazitske bolezni Zelo pogosti okužba sečil Pogosti bronhitis, konjunktivitis
Name and address of the manufacturer(s) responsible for batch release Manufacturing Packaging Farmaca (MPF) B.V. Appelhof 13
Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij
A.
IZ)
How to store Zejula
Shranjevanje zdravila Zejula
Back pain, arthralgia, myalgia
Zelo pogosti bolečina v hrbtu, artralgija Pogosti mialgija
Lactose
stomatitis
Lactose monohydrate
Pogosti hipertenzija
The median duration of anaemia of any grade was 63 days, and 8 days for Grade 3/4 events.
Mediani čas trajanja anemije katere koli stopnje je bil 63 dni, dogodkov
Reproductive toxicology
Toksikologija vpliva na sposobnost razmnoževanja
Nervous system disorders
• prebavne motnje,
Neither niraparib nor M1 is a substrate of organic anion transport polypeptide 1B1 (OATP1B1), 1B3 (OATP1B3), or organic cation transporter 1 (OCT1).
Niraparib kot substrat jetrnih privzemnih prenašalcev (OATP1B1, OATP1B3 in OCT1) Niraparib in M1 nista substrata organskega anionskega prenašalnega polipeptida 1B1 (OATP1B1), 1B3 (OATP1B3) ali organskega kationskega prenašalca 1 (OCT1).
• Abdominal bloating
• siljenje na bruhanje,
Ελλάδα
• izpuščaj,
10 June 2016
10. junij 2016
The European Commission issued a decision on 10 June 2016.
Evropska komisija je sklep izdala 10. junija 2016.
The company requested the authorisation to be recognised in Bulgaria, Croatia, France, Germany, Ireland, Italy, the Netherlands, Poland, Portugal, Romania, Slovenia, Spain and the United Kingdom (the ‘concerned Member States').
Želela je priznanje dovoljenja za promet v Bolgariji, na Hrvaškem, v Franciji, Nemčiji, na Irskem, v Italiji, na Nizozemskem, Poljskem, Portugalskem, v Romuniji, Sloveniji, Španiji in Združenem kraljestvu („zadevne države članice“).
However, the Member States could not reach an agreement and the Belgian Federal Agency for Medicines and Health Products referred the matter to the CVMP for arbitration on 29 September 2015.
Vendar države članice niso mogle doseči soglasja, zato je belgijska zvezna agencija za zdravila in zdravstvene izdelke 29. septembra 2015 zadevo napotila na odbor CVMP v arbitražo.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that subject to the conduct of additional studies and the implementation of further measures specified in a Risk Management Plan the marketing authorisation for CattleMarker IBR Inactivated should be granted in all concerned Member States.
Na osnovi vrednotenja trenutno razpoložljivih podatkov in znanstvene razprave znotraj odbora je odbor CVMP zaključil, da se pod pogojem, da bodo opravljene dodatne študije in izvedeni nadaljnji ukrepi, opredeljeni v načrtu za obvladovanje tveganj, dovoljenje za promet s cepivom CattleMarker IBR Inactivated izda v vseh zadevnih državah članicah.
On 17 March 2016, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine CattleMarker IBR Inactivated emulsion for injection for cattle (thereafter called CattleMarker IBR Inactivated).
Evropska agencija za zdravila je 17. marca 2016 zaključila postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede izdaje dovoljenja za promet s cepivom CattleMarker IBR Inactivated emulzija za injiciranje za govedo (v nadaljnjem besedilu: CattleMarker IBR Inactivated).
Why was CattleMarker IBR Inactivated reviewed?
Zakaj je bilo cepivo CattleMarker IBR Inactivated pregledano?
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, subject to conditions relating to risk mitigation and surveillance measures, the marketing authorisation granted in Belgium for CattleMarker IBR Inactivated can be recognised in other Member States of the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da se pod pogoji glede ukrepov za zmanjšanje tveganja in nadzornih ukrepov dovoljenje za promet z zdravilom, izdano v Belgiji za cepivo CattleMarker IBR Inactivated, lahko prizna v drugih državah članicah EU.
What is CattleMarker IBR Inactivated?
Kaj je cepivo CattleMarker IBR Inactivated?
Zoetis Belgium SA submitted an application for CattleMarker IBR Inactivated for mutual recognition on the basis of the initial authorisation granted by Belgium.
Družba Zoetis Belgium SA je predložila vlogo za medsebojno priznavanje cepiva CattleMarker IBR Inactivated na podlagi začetne odobritve, izdane v Belgiji.
The potential risk of recurrence of Bovine Neonatal Pancytopenia linked to the use of this vaccine in pregnant cows had been addressed by Zoetis; however Germany considered that the proposed handling of the risks was inadequate and that a large scale post authorisation study should be initiated by Zoetis.
Družba Zoetis je obravnavala možno tveganje za ponovitev pancitopenije novorojenega goveda v povezavi z uporabo tega cepiva pri brejih kravah, vendar pa je bilo po mnenju Nemčije predlagano obvladovanje tveganja neustrezno in bi morala družba Zoetis začeti obsežno študijo o varnosti zdravila po pridobitvi dovoljenja za promet.
The grounds for the referral were concerns raised by Germany regarding the immunological safety of CattleMarker IBR Inactivated, as the composition and manufacture of this product are similar to PregSure BVD, a vaccine from Zoetis which has been shown to induce a long-lasting allogeneic antibody response that has been associated with Bovine Neonatal Pancytopenia, a neonatal alloimmune disease, in the progeny of vaccinated dams.
Podlaga za napotitev so bili pomisleki, ki jih je izrazila Nemčija glede imunološke varnosti cepiva CattleMarker IBR Inactivated, ker sta sestava in izdelava tega cepiva podobni kot pri cepivu PregSure BVD družbe Zoetis, za katerega je bilo dokazano, da pri potomcih cepljenih samic sproža dolgotrajen alogenski odziv protiteles, povezan s pancitopenijo novorojenega goveda, ki je aloimunska bolezen novorojenega goveda.
Questions and answers on CattleMarker IBR Inactivated emulsion for injection for cattle (inactivated gE Bovine Herpes Virus type 1 (BoHv-1), strain Difivac) EMA/290855/2016
Vprašanja in odgovori o cepivu CattleMarker IBR Inactivated emulzija za injiciranje za govedo (inaktiviran gE goveji herpes virus tipa 1 (BoHV-1), sev Difivac) EMA/290855/2016
CattleMarker IBR Inactivated is produced on the same bovine cell line and is adjuvanted with the same highly potent adjuvant as PregSure BVD.
Cepivo CattleMarker IBR Inactivated se proizvaja na enaki celični liniji goveda kot cepivo PregSure BVD in dodan mu je enak zelo močan adjuvans.
The product is indicated for active immunisation of seronegative cattle from 2 weeks of age to reduce the clinical signs (pyrexia and depression) of IBR and the duration of virus shedding caused by BoHV-1 infection.
Cepivo je indicirano za aktivno imunizacijo seronegativnega goveda, starejšega od dveh tednov, za zmanjšanje kliničnih znakov (pireksija in depresija) infekcioznega bovinega rinotraheitisa in skrajšanje trajanja izločanja virusa, ki ga povzroča okužba z virusom BoHV-1.
CattleMarker IBR Inactivated is an inactivated infectious bovine rhinotracheitis (IBR) vaccine which contains inactivated glycoprotein E (gE) negative bovine herpes virus 1 (BoHV-1), strain Difivac.
CattleMarker IBR Inactivated je inaktivirano cepivo proti infekcioznemu bovinemu rinotraheitisu (IBR), ki vsebuje inaktiviran glikoprotein E (gE)-negativen goveji herpes virus tipa 1 (BoHV-1), sev Difivac.
Active immunisation of female cattle from 6 months of age is also indicated to reduce the clinical signs (pyrexia and duration of dyspnoea) of IBR and virus shedding caused by BoHV-1 infection and to reduce the incidence of abortions associated with BoHV-1 infections as demonstrated during the second trimester of gestation following challenge.
Indicirano je tudi za aktivno imunizacijo goveda ženskega spola, starejšega od šest mesecev, zaradi zmanjšanja kliničnih znakov (pireksija in trajanje dispneje) infekcioznega bovinega rinotraheitisa in skrajšanja trajanja izločanja virusa, ki ga povzroča okužba z virusom BoHV-1, ter zmanjšanja pojavov zvrgavanja, povezanih z okužbami z virusom BoHV-1, kot je bilo dokazano v drugem trimesečju brejosti po provokaciji.
Questions and answers on CattleMarker IBR Inactivated emulsion for injection for cattle (inactivated gE Bovine Herpes Virus type 1 (BoHv-1), strain Difivac)
Vprašanja in odgovori o cepivu CattleMarker IBR Inactivated emulzija za injiciranje za govedo (inaktiviran gE goveji herpes virus tipa 1 (BoHV-1), sev Difivac)
Strength Pharmaceutical Form
ime jakost farmacevtska oblika pot uporabe ovojnina
Invented name
EMA številka Izmišljeno ime
These reactions can sometimes be serious.
Včasih so lahko te reakcije resne.
• 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 uporabljate, kolikor je le mogoče čisti.
Tell your doctor straight away if:
Takoj povejte zdravniku, če:
You may need it again.
Morda jo boste ponovno potrebovali.
The larger the dose, the longer it will take to inject.
Večji ko je odmerek, dlje traja injiciranje.
For immediate and single use following first opening and reconstitution.
Za takojšnjo in enkratno uporabo po prvem odprtju in rekonstituciji.
Follow the procedure exactly, as it may differ from your past experience.
Postopek natančno upoštevajte, saj se morda razlikuje od tistega, ki ga poznate iz preteklosti.
Need to increase the dose (%)
Potreba po povečanju odmerka (%)
Not provided in the pack:
Ni priloženo v pakiranju:
Complete a partial injection (only when needed).
Dokončajte z delno injekcijo (le po potrebi)
E - 28760 Tres Cantos (Madrid) Spain
E - 28760 Tres Cantos (Madrid) Španija
This usually takes about 10 days but can take any time between 5 and 20 days.
To običajno traja približno 10 dni, vendar je razpon kadarkoli med 5 in 20 dni.
EXP Shelf-life after first use: 28 days
EXP Rok uporabnosti po prvi uporabi: 28 dni
Put it aside for later use.
Shranite ga za kasnejšo uporabo.
Your doctor will decide how much medicine you will take and how often.
Vaš zdravnik bo določil, koliko zdravila boste uporabili in kako pogosto.
Wash your hands and find a clean area
Umijte si roke in poiščite čisto površino
It most often occurs after hormonal treatment has been discontinued and reaches its maximum at about seven to ten days following treatment.
Najpogosteje se pojavi po prekinitvi hormonskega zdravljenja in doseže maksimum približno sedem do deset dni po zdravljenju.
• A good place is a clean table or kitchen surface.
• Primerna površina je čista miza ali kuhinjska površina.
See the “Instructions for Use”.
Glejte „Navodilo za uporabo“.
Due to a local reactivity to benzyl alcohol, the same site of injection should not be used on consecutive days.
Zaradi lokalnih reakcij na benzilalkohol se isto mesto injiciranja ne sme uporabiti več dni zaporedoma.
Gonadotropins are involved in reproduction and fertility.
Gonadotropini sodelujejo pri razmnoževanju in plodnosti.
• malformations of sexual organs incompatible with pregnancy
• malformacije spolnih organov, ki niso združljive z nosečnostjo
Volume to be injected (mL)
Volumen, ki ga je treba injicirati (ml)
A treatment diary is included on the last page.
Dnevnik zdravljenja je vključen na zadnji strani.
Do not touch the needle and do not allow the needle to touch any surface.
Igle se ne dotikajte in pazite, da se tudi igla ne dotakne nobene površine.
• Record the treatment day number (1), date (2) and time (3) of your injection.
• Za datum zdravljenja zabeležite številko (1), datum (2) in čas (3) injekcije.
The next injection should be done at the same time the next day.
Naslednjo injekcijo je treba aplicirati naslednji dan, ob istem času.
Do not inject directly into a vein.
Ne injicirajte direktno v žilo.
Any unused solution must be discarded not later than 28 days after first opening.
Vso neuporabljeno raztopino morate zavreči najkasneje 28 dni po prvem odprtju.
•Wash your hands with soap and water.
•Umijte si roke z milom in vodo.
An example of a treatment diary:
Primer dnevnika zdravljenja:
• Before starting the preparation, please read these instructions the whole way through first.
• Preden začnete s pripravo, najprej v celoti preberite spodnja navodila.
• Slowly push the needle into the skin entirely (1).
• Počasi zabodite celo iglo v kožo (1).
The following definitions apply to the frequency terminology used hereafter: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
V nadaljevanju se uporabljajo naslednje navedbe pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
Warning: Do not attach the needle too tightly; the needle could be difficult to remove after the injection.
Opozorilo: Igle ne pritrdite preveč tesno; morda jo bo po injiciranju težko odstraniti.
Studies have shown that these two medicines can be mixed and injected together, without either product being adversely affected.
Študije so pokazale, da se ti dve zdravili lahko mešata in injicirata skupaj, ker to ne vpliva na nobeno od teh dveh zdravil.
• Carefully remove and discard the green inner shield.
• Previdno odstranite in zavrzite notranji zeleni ščitnik.
OHSS may progress rapidly (within 24 hours) or over several days to become a serious medical event.
OHSS se lahko razvije hitro (v 24 urah) ali v nekaj dneh v resen zdravstven zaplet.
• GONAL-f is usually given every day.
• Zdravilo GONAL-f se običajno daje vsak dan.
• Give yourself the injection at the same time each day.
• Injekcijso si dajte vsak dan ob istem času.
Set the dose that was prescribed by your doctor (in the example shown in the figure, it is 50 IU).
Nastavite odmerek, ki vam ga je predpisal zdravnik (v prikazanem primeru na sliki je 50 i.e.).
A sticker will be added to allow the patient to write the day of first use.
Dodana bo nalepka, da bo lahko bolnik zapisal datum prve uporabe.
In case of the above events your doctor may recommend that you stop treatment.
V zgoraj naštetih primerih vam bo zdravnik lahko priporočil prekinitev zdravljenja.
Treatment Day Number
Številka dneva zdravljenja
If you do not have periods you can start using the medicine on any convenient day.
Če nimate menstruacij, lahko začnete zdravilo uporabljati katerikoli dan, kot vam ustreza.
Data on a limited number of exposed pregnancies (less than 300 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of follitropin alfa.
Podatki omejenega števila izpostavljenih nosečnosti (manj kot 300 izidov nosečnosti) ne kažejo na malformacijsko ali feto/neonatalno toksičnost folitropina alfa.
•Find a clean area and aflat surface.
•Najdite čisti prostor in ravno površino.
Do not use GONAL-f if any of the above applies to you.
Ne uporabljajte zdravila GONAL-f, če kar koli od zgoraj naštetega velja za vas.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 October 1995.
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 20. oktober 1995 Datum zadnjega podaljšanja: 20. oktober 2010
• if you are allergic to Follicle Stimulating Hormone or any of the other ingredients of this medicine listed in section 6.
• če ste alergični na folikle stimulirajoči hormon ali katero koli sestavino tega zdravila, navedeno v poglavju 6.
Get a new needle.
Vzemite novo iglo.
If you are developing OHSS your doctor may not give you any hCG in this treatment cycle and you may be told not to have sex or to use a barrier contraceptive method for at least four days.
Če se razvije OHSS, vam zdravnik ne sme dati hCG v tem ciklusu zdravljenja in morda vam bo povedal, da ne smete imeti spolnih odnosov ali da morate uporabljati mehanska kontracepcijska sredstva najmanj štiri dni.
• When the pen is empty, ask your pharmacist how to dispose of it.
• Ko je injekcijski peresnik prazen, vprašajte vašega farmacevta, kako ga zavreči.
If you are not ovulating, having no periods and have been diagnosed with very low levels of FSH and LH hormones
Če nimate ovulacije, nimate menstruacije in imate diagnozo zelo nizkih ravni hormonov FSH in LH
After the powder has dissolved (which usually occurs immediately), check that the resulting solution is clear and does not contain any particles.
Ko se prašek raztopi (običajno takoj), se prepričajte, da je raztopina bistra in ne vsebuje delcev.
This could cause chest pain, breathlessness, stroke or heart attack (see also in section 2. under “Blood clotting problems”).
Povzročijo lahko bolečino v prsih, zasoplost, kap ali srčni napad (glejte tudi "Težave s strjevanjem krvi" v poglavju 2).
• your skin becomes fragile and easily blistered, especially skin that has been frequently in the sun, and/or
• postane vaša koža krhka in se hitro tvorijo mehurji, zlasti na tistih delih, ki so pogosto izpostavljeni soncu in/ali
You can reduce the risk of multiple pregnancy by using the right dose of GONAL-f at the right times.
Tveganje večplodne nosečnosti lahko zmanjšate tako, da ob pravem času uporabite pravi odmerek zdravila GONAL-f.
Proceed to Section 5: Setting the dose prescribed by your doctor.
Nadaljujte na poglavje 5: Nastavitev odmerka, ki ga je predpisal zdravnik.
In menstruating women treatment should commence within the first 7 days of the menstrual cycle.
Pri ženskah, ki imajo menstruacijo, se mora zdravljenje začeti v prvih 7 dneh menstrualnega ciklusa.
Prescribed Dose
Predpisani odmerek
If you forget to use GONAL-f, do not take a double dose to make up for a forgotten dose.
Če ste pozabili uporabiti zdravilo GONAL-f, ne vzemite dvojnega odmerka, da bi nadomestili izpuščeni odmerek.
Total dose of FSH required (number of FSH 75 IU ampoules)
Skupni odmerek potrebnega FSH (število ampul FSH 75 i.e.)
Clinical assessment of GONAL-f indicates that its daily doses, regimens of administration, and treatment monitoring procedures should not be different from those currently used for urinary FSH-containing medicinal products.
Klinična ocena zdravila GONAL-f kaže, da njegovi dnevni odmerki, režim uporabe in postopki nadzorovanja zdravljenja ne bi smeli biti drugačni od tistih, ki se trenutno uporabljajo za zdravila z urinarnim FSH.
GONAL-f must not be used when an effective response cannot be obtained, such as:
Zdravila GONAL-f ne smete uporabljati, kadar ni mogoče doseči učinkovitega odziva, kot je npr.:
It is not expected that this medicine will affect your ability to drive and use machines.
Ne pričakuje se, da bi zdravilo vplivalo na sposobnost vožnje ali upravljanja strojev.
Warning: Check that the Dose Feedback Window displays your complete prescribed dose before you move on to the next step.
Opozorilo: Preverite, ali prikazuje okno za prikaz odmerka celotni predpisani odmerek, preden preidete na naslednji korak.
• if you have a tumour in your hypothalamus or pituitary gland (both are parts of the brain).
• če imate tumor hipotalamusa ali hipofize (oboje je del možganov)
• Remove the syringe from the vial and throw it away (put the protective cap to avoid injuries).
• Brizgo odstranite iz viale in jo zavrzite (znova nataknite zaščitno zaporko, da preprečite poškodbe).
• This vial contains several doses of GONAL-f. You will have to keep it several days and only draw the prescribed dose every day.
• Viala vsebuje več odmerkov zdravila GONAL-f. Hraniti jo morate več dni in vsak dan odvzeti samo predpisani odmerek.
• Your dose of GONAL-f may be increased every 7 or every 14 days by 37.5 to 75 IU, until you get the desired response.
• Vaš odmerek zdravila GONAL-f se lahko poveča vsakih 7 ali 14 dni za 37,5 do 75 i.e., dokler ne boste dosegli želenega odziva.
Men with hypogonadotrophic hypogonadism
Moški s hipogonadotropnim hipogonadizmom
• hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1