natgillin/translations-raw huggingface dataset:
You should use effective contraception if you are being treated with MEPACT. 
Če se zdravite z zdravilom MEPACT, morate uporabljati učinkovito kontracepcijo.
A healthy adult volunteer accidentally received a single dose of 6.96 mg mifamurtide and experienced a reversible treatment-related event of orthostatic hypotension. 
Zdrav odrasel prostovoljec je pomotoma prejel mifamurtid v enkratnem odmerku 6,96 mg.
Significant enhancement of disease-free survival was also demonstrated in the treatment of dog osteosarcoma and hemangiosarcoma with mifamurtide as adjuvant therapy. 
Dokazano je bilo tudi, da je adjuvantno zdravljenje z mifamurtidom bistveno izboljšalo preživetje brez ponovitve bolezni pri zdravljenju osteosarkoma in hemangiosarkoma pri psih.
The filter luer connector cap should not be removed at this time. 
Pokrovčka s filtrskega luer nastavka še ne smete odstraniti.
Each mL reconstituted suspension contains 0.08 mg mifamurtide. 
En ml rekonstituirane suspenzije vsebuje 0,08 mg mifamurtida.
The lyophilised powder should be allowed to reach a temperature between approximately 20 C-25 °C prior to reconstitution, filtering using the filter provided and dilution. 
Liofiliziran prašek mora pred rekonstitucijo, filtriranjem s priloženim filtrom in razredčitvijo doseči temperaturo okoli 20 C - 25 °C.
As no pharmacokinetic data of mifamurtide is available in patients with severe renal or hepatic impairment, caution when administering mifamurtide to these patients is recommended. 
Pri bolnikih s hudo okvaro ledvic ali jeter podatki o farmakokinetiki mifamurtida niso na voljo, zato je pri teh bolnikih treba mifamurtid uporabljati previdno.
Volume to withdraw = [12.5 x calculated dose (mg)] mL 
Volumen suspenzije, ki ga morate izvleči za določen odmerek, se izračuna na naslednji način: Volumen, ki ga je treba izvleči = [12,5 x izračunani odmerek (mg)] ml V pomoč vam bo naslednja preglednica skladnosti: Odmerek
A higher percentage of objective and subjective hearing loss was observed overall in patients who received MEPACT and chemotherapy (12% and 4%, respectively) in the phase III study (see section 5.1 for a description of the study) compared to those patients that received only chemotherapy (7% and 1%). 
V študiji III. faze (za opis študije glejte poglavje 5.1) so pri bolnikih, ki so se zdravili z zdravilom MEPACT in s kemoterapijo zabeležili višji odstotek objektivne in subjektivne izgube sluha (12% oz. 4%) kot pri bolnikih, ki so se zdravili samo s kemoterapijo (7% oz. 1%).
Adverse reactions 
Vnetni odziv
It should be used with caution in patients with a history of autoimmune, inflammatory or other collagen diseases. 
Pri bolnikih, ki so imeli avtoimunske, vnetne ali druge kolagenske bolezni, ga je treba uporabljati previdno.
MEPACT 4 mg powder for concentrate for dispersion for infusion mifamurtide 
MEPACT 4 mg prašek za koncentrat za disperzijo za infundiranje mifamurtid
Each vial should be reconstituted with 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection. 
Eno vialo je treba rekonstituirati s 50 ml raztopine natrijevega klorida 9 mg/ml (0,9%) za injiciranje.
The site of the sodium chloride 9 mg/mL (0.9%) solution for injection bag where the needle is going to be inserted should be swabbed with an alcohol pad. 
Mesto, kjer boste vrečko z raztopino natrijevega klorida 9 mg/ml (0,9%) za injiciranje prebodli z iglo, morate obrisati z alkoholno blazinico.
Mild-moderate tachycardia (50%), hypertension (26%) and hypotension (29%) were very commonly reported in uncontrolled studies of mifamurtide. 
V nenadzorovanih študijah mifamurtida so zelo pogosto poročali o blagi do zmerni tahikardiji (50%), hipertenziji (26%) in hipotenziji (29%).
In a phase I study, there was one report of severe allergic reaction occurring after the first infusion of mifamurtide at 6 mg/m dose level. 
Bolezni imunskega sistema V študiji I. faze so po prvem infundiranju mifamurtida v odmerku 6 mg/m2 poročali o enem primeru hude alergijske reakcije.
Excipients: Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC), 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS) 
Pomožni snovi: 1-palmitoil-2-oleoil-sn-glicero-3-fosfoholin (POPC), 1,2-dioleoil-sn-glicero-3-fosfo-L-serin mononatrijeva sol (OOPS)
It is recommended to separate the administration times of mifamurtide and doxorubicin or other lipophilic medicinal products if used in the same chemotherapy regimen. 
Če se mifamurtid in doksorubicin ali druga lipofilna zdravila uporabljajo v istem režimu kemoterapije, je priporočljivo, da se jih aplicira ob različnih časih.
- The other ingredients are 1-Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) and 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS). 
- Pomožni snovi sta 1-palmitoil-2-oleoil-sn-glicero-3-fosfoholin (POPC) in 1,2-dioleoil-sn-glicero-3-fosfo-L-serin mononatrijeva sol (OOPS).
Skin and subcutaneous disorders Hyperhidrosis (11%) was very common in patients receiving mifamurtide in uncontrolled studies. 
Bolezni kože in podkožja Pri bolnikih, ki so prejemali mifamurtid v nenadzorovanih študijah, je bila zelo pogosta hiperhidroza
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
The syringe should then be removed from the filter and a new needle placed on the suspension-filled syringe. 
Brizgo s suspenzijo morate nato odstraniti iz filtra in nanjo namestiti novo iglo.
1-Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS) 
1-palmitoil-2-oleoil-sn-glicero-3-fosfoholin (POPC) 1,2-dioleoil-sn-glicero-3-fosfo-L-serin mononatrijeva sol (OOPS) 6.2 Inkompatibilnosti
Pleural effusion, Exacerbated dyspnoea, Productive cough, Haemoptysis, Wheezing, Epistaxis, Exertional dyspnoea, Sinus congestion, Nasal congestion, Pharyngolaryngeal pain 
Plevralni izliv, Poslabšanje dispneje, Produktivni kašelj, Hemoptiza, piskajoče dihanje, Krvavitev iz nosu, Dispneja med naporom, Sinusna kongestija, Nazalna kongestija, Bolečina v žrelu in grlu
Peripheral oedema, Oedema, Mucosal inflammation, Infusion site erythema, Infusion site reaction, Catheter site pain, Chest discomfort, Feeling cold 
Periferni edem, Edem, Vnetje sluznice, Rdečina na mestu aplikacije, Reakcija na mestu aplikacije, Bolečina na mestu vstavljenega katetra, Nelagodje v prsnem košu, Občutek mraza
Muscle spasms, Neck pain, Groin pain, Bone pain, Shoulder pain, Chest wall pain, Musculoskeletal stiffness 
Mišični krči, Bolečina v vratu, Bolečina v dimljah, Bolečina v kosteh, Bolečina v ramenih, Bolečina v prsni steni, Mišično-skeletna okorelost
Phlebitis, Flushing, Pallor 
Flebitis, pordevanje, Bledica
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). 
Podatkov o uporabi mifamurtida pri nosečnicah ni. Ni dovolj študij na živalih o vplivu zdravila na sposobnost razmnoževanja (glejte poglavje 5.3).
MEPACT 4 mg powder for concentrate for dispersion for infusion 
IME ZDRAVILA MEPACT 4 mg prašek za koncentrat za disperzijo za infundiranje
Dyspnoea, Tachypnoea, Cough 
Zelo pogosti Dispneja, Tahipneja, Kašelj Pogosti
Each vial contains 4 mg mifamurtide*. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 4 mg mifamurtida*.
The most frequent adverse reactions are chills, pyrexia, fatigue, nausea, tachycardia and headache. 
Najpogostejši neželeni učinki so mrzlica, zvišana telesna temperatura, utrujenost, navzea, tahikardija in glavobol.
Hypertension, Hypotension 
Zelo pogosti Hipertenzija, Hipotenzija Pogosti
Powder for concentrate for dispersion for infusion 
FARMACEVTSKA OBLIKA Prašek za koncentrat za disperzijo za infundiranje.
Using the needle and syringe, 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection should be withdrawn from the bag. 
Z iglo in brizgo iz vrečke izvlecite 50 ml raztopine natrijevega klorida 9 mg/ml (0,9%) za injiciranje.
If you are breast-feeding, you should discuss with your doctor. 
Če ste negotovi, se posvetujte s svojim zdravnikom.
The 100 mL sodium chloride 9 mg/mL (0.9%) solution for injection bag, needle and syringe should be unpacked (not provided in the pack). 
Pripravite vrečko s 100 ml raztopine natrijevega klorida 9 mg/ml (0,9%) za injiciranje ter iglo in brizgo (niso priložene).
Immune system disorders 
Neželeni učinki Organski sistem
After reconstitution, each mL suspension in the vial contains 0.08 mg mifamurtide. 
Po rekonstituciji en ml suspenzije v viali vsebuje 0,08 mg mifamurtida.
Post-procedural pain 
Bolečina po posegu
*fully synthetic analogue of a component of Mycobacterium sp. cell wall. 
*povsem sintetični analog sestavine celične stene Mycobacterium sp. Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Therefore, the SmPC of mifamurtide should be updated with the inclusion of pericardial effusion as an ADR in section 4.8 under SOC Cardiac disorders. 
Zato je povzetek glavnih značilnosti zdravila za mifamurtid treba posodobiti tako, da se perikardialni izliv vključi med neželene učinke v poglavju 4.8 pod organski sistem srčne bolezni, z oznako »neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)«.
Metabolism and nutritional disorders Anorexia (21%) was very commonly reported in phase I and II studies of mifamurtide 
faze mifamurtida so zelo pogosto poročali o anoreksiji (21%).
GENERAL CLASSIFICATION FOR SUPPLY 
Kategorija pogostnosti
Powder for concentrate for dispersion for infusion 4 mg mifamurtide 
FARMACEVTSKA OBLIKA IN VSEBINA Prašek za koncentrat za disperzijo za infundiranje 4 mg mifamurtida
MEPACT is administered by intravenous infusion over a period of 1 hour. 
-Zdravilo MEPACT se aplicira v obliki enourne intravenske infuzije.
Patient identification, time and date should be added to the label on the bag containing the reconstituted, filtered and diluted liposomal suspension. 
Na nalepko na vrečki, ki vsebuje rekonstituirano, filtrirano in razredčeno liposomsko suspenzijo, napišite bolnikove identifikacijske podatke, čas in datum.
After reconstitution, each mL of suspension contains 0.08 mg of mifamurtide. 
Po rekonstituciji en ml suspenzije vsebuje 0,08 mg mifamurtida.
Fever, Chills, Fatigue, Hypothermia, Pain, Malaise, Asthenia, Chest pain 
Zelo pogosti Zvišana telesna temperatura, Mrzlica, Utrujenost, Hipotermija, Bolečina, Splošno slabo počutje, Astenija, Bolečina v prsnem košu
You should be more closely monitored while receiving MEPACT treatment. 
V takšnih primerih je med zdravljenjem z zdravilom MEPACT potreben skrben zdravniški nadzor.
Upper abdominal pain, Dyspepsia, Abdominal distension, Lower abdominal pain 
Bolečina v zgornjem predelu trebuha, Dispepsija, Občutek polnosti v trebuhu, Bolečina v spodnjem predelu trebuha
Respiratory distress 
Dihalna stiska
Blurred vision 
Zamegljen vid
Reproductive system and breast disorders 
Motnje reprodukcije in dojk Pogosti
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA
Myalgia, Arthralgia, Back pain, Pain in extremity 
Zelo pogosti Mialgija, Artralgija, Bolečina v hrbtu, Bolečina v okončinah
ANNEX II 
V študiji II.
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja Zelo pogosti Hiperhidroza Pogosti
Vomiting, Diarrhoea, Constipation, Abdominal pain, Nausea 
Zelo pogosti Bruhanje, Driska, Zaprtost, Bolečina v trebuhu, Navzea
Doctors and patients must be aware of this possibility. 
Zdravniki in bolniki se morajo zavedati te možnosti.
It has also been studied as part of assisted reproductive techniques in 470 women. 
Proučevali so ga tudi kot del postopkov asistirane reprodukcije pri 470 ženskah.
In some women, the ovaries can over-respond to stimulation. 
Pri nekaterih ženskah se lahko jajčniki čezmerno odzovejo na stimulacijo.
The European Commission granted a marketing authorisation valid throughout the European Union for GONAL-f to Merck Serono Europe Ltd. on 20 October 1995. 
Evropska komisija je dovoljenje za promet z zdravilom GONAL-f, veljavno po vsej Evropski uniji, odobrila družbi Merck Serono Europe Ltd dne 20. oktobra 1995.
After the first injection, the patient or their partner may give the injections themselves, if they are well motivated, have been trained and have access to expert advice. 
Po prvem injiciranju si lahko bolnik sam ali s pomočjo partnerja injicira zdravilo, če sta dovolj motivirana, če sta bila za to ustrezno usposobljena in če imata na voljo strokovno svetovanje.
In men, the studies looked at the number of men who started to produce sperm within the first 18 months of treatment. 
Pri moških je bilo v študijah pomembno število moških, pri katerih je v prvih 18 mesecih zdravljenja začela nastajati sperma.
GONAL-f follitropin alfa 
GONAL-f folitropin alfa
The dose of GONAL-f and how often it is given depend on why it is being used and on the patient's response to treatment. 
Odmerek zdravila GONAL-f in kako pogosto se daje sta odvisna od razloga za uporabo in od bolnikovega odziva na zdravljenje.
In the studies of women, the main measures of effectiveness were the number of eggs collected, the number of women who released eggs and the number of follicles produced in the ovaries (small sacs that hold the eggs). 
V študijah pri ženskah je bilo glavno merilo število zbranih jajčec, število žensk, pri katerih so se jajčeca sprostila in število foliklov, proizvedenih v jajčnikih (majhne vrečice, ki držijo jajčeca).
Because these conditions are rare, GONAL-f was not compared with any other treatments in these studies, and the low number of patients in the studies was considered to be acceptable. 
Ker je ta bolezen redka, zdravila GONAL-f v teh študijah niso primerjali z nobenim drugim zdravilom, majhno število bolnikov, ki je sodelovalo v študiji, pa se je zdelo sprejemljivo.
Previously, the FSH used in medicines was extracted from urine. 
V preteklosti so FSH, uporabljen v zdravilih, pridobili iz urina.
It must not be used when it would not be possible for the patient to have an effective response, such as in patients whose ovaries or testicles do not work or in women who should not get pregnant for medical reasons. 
Ne sme se uporabljati, kadar se bolnik ne more učinkovito odzvati na zdravljenje, kot so bolniki, katerih jajčniki ali moda ne delujejo ali pri ženskah, ki ne smejo zanositi iz zdravstvenih razlogov.
Treatment with GONAL-f should be carried out by a doctor who has experience in the treatment of fertility problems. 
Zdravljenje z zdravilom GONAL-f mora izvajati zdravnik, ki ima izkušnje pri zdravljenju težav s plodnostjo.
GONAL-f is given by injection under the skin once a day. 
Zdravilo GONAL-f se daj z injekcijo pod kožo enkrat na dan.
For more information about treatment with GONAL-f, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom GONAL-f preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
The most common side effects with GONAL-f (seen in more than 1 patient in 10) are reactions at the injection site (pain, redness, bruising, swelling or irritation). 
Najpogostejši neželeni učinki zdravila GONAL-f (opaženi pri več kot 1 bolniku od 10) so reakcije na mestu injiciranja (bolečina, rdečina, modrice, oteklina ali razdraženost).
• adult women (aged 18 years or over) who do not produce eggs and do not respond to treatment with clomiphene citrate (another medicine that stimulates the ovaries to produce eggs); 
• pri odraslih ženskah (starejših od 18 let), ki ne proizvajajo jajčec in se ne odzivajo na zdravljenje s klomifen citratom (drugim zdravilom, ki spodbuja jajčnike, da proizvajajo jajčeca);
Other information about GONAL-f: 
Druge informacije o zdravilu GONAL-f:
This document is a summary of the European public assessment report (EPAR) for GONAL-f. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo GONAL-f.
• adult men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease). 
• pri odraslih moških, ki imajo hipogonadotropni hipogonadizem (redko bolezen pomanjkanja hormona).
This is called ‘ovarian hyperstimulation syndrome'. 
To imenujemo sindrom hiperstimulacije jajčnikov.
If the powder is being used, it should be mixed with the solvent provided just before use. 
Če se uporablja prašek, ga je treba tik pred dajanjem zmešati s priloženim vehiklom.
The CHMP decided that GONAL-f's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila GONAL-f večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
It is available as a solution for injection in a prefilled pen and as a powder and solvent that are made up into a solution for injection. 
Na voljo je v obliki raztopine za injiciranje v napolnjenem peresniku ter kot prašek in vehikel, ki se zmešata v raztopino za injiciranje.
GONAL-f should not be used in people who may be hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients. 
Zdravila GONAL-f ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) folitropin alfa, FSH ali katero koli drugo sestavino zdravila.
What benefit has GONAL-f shown during the studies? 
Kakšne koristi je zdravilo GONAL-f izkazalo med študijami?
GONAL-f, in combination with LH, has also been studied in 38 women with severe LH and FSH deficiency, and in combination with hCG in 19 men with hypogonadotrophic hypogonadism. 
Zdravilo GONAL-f so v kombinaciji z LH proučevali tudi pri 38 ženskah s hudim pomanjkanjem LH in FSH ter v kombinaciji s hCG pri 19 moških s hipogonadotropnim hipogonadizmom.
GONAL-f has been studied in 222 women who do not produce eggs or respond to clomiphene citrate. 
Zdravilo GONAL-f je bilo proučevano pri 222 ženskah, ki ne proizvajajo jajčec ali se ne odzivajo na klomifen citrat.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for GONAL-f. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo GONAL-f, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe
It must not be used in patients with tumours of the pituitary gland or hypothalamus, or cancer of the breast, womb or ovary. 
Ne sme se uporabljati pri bolnikih s tumorji hipofize ali hipotalamusa ali rakom na prsih, maternici ali jajčnikih.
GONAL-f is given to stimulate the ovaries to produce more than one egg at a time; 
Zdravilo GONAL-f se daje za spodbujanje jajčnikov k izdelavi več kot enega jajčeca naenkrat;
GONAL-f is used to treat the following groups: 
Zdravilo GONAL-f se uporablja pri naslednjih skupinah bolnikov:
• adult women with severe deficiency (very low levels) of luteinising hormone (LH) and follicle stimulating hormone (FSH). 
• pri odraslih ženskah s hudim pomanjkanjem (zelo nizkimi ravnmi) luteinizirajočega hormona (LH) in folikle stimulirajočega hormona (FSH).
• adult women who are undergoing assisted reproductive techniques (fertility treatment) such as in-vitro fertilisation. 
• pri odraslih ženskah, ki se zdravijo s postopki asistirane reprodukcije, kot je in vitro oploditev (zdravljenje neplodnosti).
In these studies, GONAL-f was compared with human FSH that had been extracted from urine. 
V teh študijah so zdravilo GONAL-f primerjali s FSH, ki je bil izločen iz urina.
The active substance in GONAL-f, follitropin alfa, is a copy of the natural hormone FSH. 
Zdravilna učinkovina zdravila GONAL-f, folitropin alfa, je kopija naravnega hormona FSH.
In the body, FSH controls reproductive function: in women, it stimulates the production of eggs; and in men, it stimulates the production of sperm in the testicles. 
Hormon FSH v telesu nadzoruje funkcijo reprodukcije: pri ženskah spodbuja nastajanje jajčec, pri moških pa nastajanje semenčic v modih.
What is the risk associated with GONAL-f? 
Kakšna tveganja so povezana z zdravilom GONAL-f?
GONAL-f is used together with human chorionic gonadotrophin (hCG) to stimulate sperm production. 
Zdravilo GONAL-f se uporablja skupaj s humanim horionskim gonadotropinom (hCG) za spodbujanje nastanka sperme.
GONAL-f is a medicine that contains the active substance follitropin alfa. 
GONAL-f je zdravilo, ki vsebuje zdravilno učinkovino folitropin alfa.
For the full list of all side effects reported with GONAL-f, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila GONAL-f, glejte navodilo za uporabo.
GONAL-f was effective in triggering egg development in women with severe LH and FSH deficiency. 
Zdravilo GONAL-f je bilo učinkovito tudi pri sprožitvi nastajanja jajčec pri ženskah s hudim pomanjkanjem LH/FSH.
In the study in men, GONAL-f, used in combination with hCG, was effective in stimulating sperm production, with 63% of the men starting to produce sperm. 
V študiji pri moških je bilo zdravilo GONAL-f v kombinaciji s hCG pri 63 % moških učinkovito pri spodbujanju nastajanja sperme.
GONAL-f was also as effective as human FSH at stimulating the ovaries during assisted reproductive techniques. 
Zdravilo GONAL-f je bilo enako učinkovito kot humani FSH pri spodbujanju jajčnikov med postopki asistirane reprodukcije.
Why has GONAL-f been approved? 
Zakaj je bilo zdravilo GONAL-f odobreno?
In women, GONAL-f must not be used when there is enlargement of an ovary or a cyst that is caused by something other than polycystic ovarian disease, or when there is unexplained bleeding from the vagina. 
Pri ženskah se ne sme uporabljati ob povečanih jajčnikih ali prisotnosti cist, ki niso posledica policističnega obolenja jajčnikov, ali pri nepojasnjenem krvavenju iz nožnice.
GONAL-f is given together with a medicine containing LH to stimulate the eggs to mature in the ovaries; 
Zdravilo GONAL-f se daje skupaj z zdravili, ki vsebujejo LH, kar spodbudi jajčeca, da dozorijo v jajčnikih;
In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10. 
Pri več kot 1 ženski od 10 je bilo opaziti tudi nastanek ovarijskih cist (vrečic s tekočino v jajčnikih) in glavobol.
The full EPAR for GONAL-f can be found here. 
Celotno javno poročilo o oceni zdravila (EPAR) za zdravilo GONAL-f je na voljo tukaj.
What is GONAL-f used for? 
Za kaj se zdravilo GONAL-f uporablja?
What is GONAL-f? 
Kaj je zdravilo GONAL-f?
The follitropin alfa in GONAL-f is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human FSH. 
Folitropin alfa v zdravilu GONAL-f je izdelan z metodo, imenovano „tehnologija rekombinantne DNK“.
GONAL-f was as effective as human FSH in women who did not produce eggs or respond to clomiphene citrate: 84% of the women receiving GONAL-f produced eggs, compared with 91% of those receiving human FSH. 
Jajčeca so začela nastajati pri 84 % žensk, ki so prejemale zdravilo GONAL-f, v primerjavi z 91 % tistih, ki so prejemale humani FSH.
How has GONAL-f been studied? 
Kako je bilo zdravilo GONAL-f raziskano?
How is GONAL-f used? 
Kako se zdravilo GONAL-f uporablja?
How does GONAL-f work? 
Kako zdravilo GONAL-f deluje?
The dose is adjusted to give the best control. 
Odmerek se prilagodi tako, da se doseže najboljši možni nadzor.
It is available as round tablets (blue: 0.5 mg; yellow: 1 mg; peach: 2 mg). 
Na voljo je v obliki okroglih tablet (modre barve: 0,5 mg; rumene barve: 1 mg; breskove barve: 2 mg).
Repaglinide Teva repaglinide EPAR summary for the public 
Repaglinid Teva repaglinid Povzetek EPAR za javnost
Repaglinide Teva is taken before meals, normally up to 15 minutes before each main meal. 
Zdravilo Repaglinid Teva se jemlje pred obroki, ponavadi največ 15 minut pred vsakim glavnim obrokom.
This means that Repaglinide Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called NovoNorm. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu NovoNorm.