natgillin/translations-raw huggingface dataset:
You do not need to be hospitalised to receive MEPACT.
Za uporabo zdravila MEPACT ni potrebna hospitalizacija.
You must not use MEPACT with high doses of NSAIDs.
Zdravila MEPACT ne smete uporabljati, če jemljete velike odmerke nesteroidnih protivnetnih zdravil.
These are typically mild to moderate and transient and can usually be treated by your doctor, e.g. with paracetamol for fever.
Ti neželeni učinki so običajno blagi do zmerni in prehodni, zdravnik pa jih običajno lahko uspešno zdravi, npr. paracetamol za zvišano telesno temperaturo.
In vivo administration of mifamurtide resulted in the inhibition of tumour growth in mouse and rat models of lung metastasis, skin and liver cancer, and fibrosarcoma.
In vivo je uporaba mifamurtida zavrla rast tumorja pri miših in podganah s pljučnimi metastazami, kožnim rakom in rakom jeter ter fibrosarkomom.
The patient experienced shaking, chills, fever, nausea, vomiting, uncontrollable coughing, shortness of breath, cyanotic lips, dizziness, weakness, hypotension, tachycardia, hypertension and hypothermia leading to study discontinuation.
Pri bolniku so poročali o tresenju, mrzlici, zvišani telesni temperaturi, navzei, bruhanju, nenadzorovanem kašlju, težkem dihanju, cianozi ustnic, omotici, oslabelosti, hipotenziji, tahikardiji, hipertenziji in hipotermiji.
You should take your temperature as you may have a fever.
Izmerite si telesno temperaturo, saj bi le-ta lahko bila povišana.
The no-adverse-effect level for mifamurtide in animals corresponds roughly to the 2 mg/m2 recommend dose for humans.
Koncentracija mifamurtida, ki pri živalih ne povzroči neželenih učinkov, ustreza približno priporočenemu odmerku za človeka (2 mg/m2).
MEPACT contains sodium
Zdravilo MEPACT vsebuje natrij
The freeze-dried powder has to be reconstituted into a liquid suspension, filtered using the filter provided and further diluted before use.
Liofiliziran prašek je treba pred uporabo pripraviti v obliko tekoče suspenzije, filtrirati s priloženim filtrom in nato še nadalje razredčiti.
General disorders and administration site conditions The majority of patients experience chills (89%), fever (85%) and fatigue (53%).
Pri večini bolnikov se je pojavila mrzlica (89%), zvišana telesna temperatura (85%) in utrujenost (53%).
White to off-white homogeneous cake or powder.
Bel ali skoraj bel homogen zbit ali prost prašek.
Mean half-lives of total and free MTP-PE in moderate hepatic impairment were 3.21 hours and 3.15 hours, respectively.
Pri zmerni okvari jeter je srednji razpolovni čas skupnega MTP-PE znašal 3,21 ure, prostega MTP-PE pa 3,15 ure.
Powder for concentrate for dispersion for infusion Pack of 1 vial of powder, 1 sterile filter
FARMACEVTSKA OBLIKA IN VSEBINA Prašek za koncentrat za disperzijo za infundiranje Škatla z 1 vialo s praškom in 1 sterilnim filtrom
The bag should be gently swirled to mix the solution.
Vrečko nežno zavrtite, da se raztopina premeša.
Cancer pain
Bolečina zaradi raka
The filter should be removed from the blister pack, and the cap removed from the filter spike.
Vzemite filter iz pretisnega omota in odstranite zamašek s filtrske konice.
It is recommended to separate the times of administration of MEPACT and doxorubicin or other medicines if used in the same chemotherapy treatment regimen.
Zdravilo MEPACT in doksorubicin ali druga zdravila, ki se uporabljajo v istem režimu zdravljenja s kemoterapijo, je priporočljivo uporabljati ob različnih časih.
MEPACT must be reconstituted, filtered using the filter provided and further diluted using aseptic technique, prior to administration.
Pred uporabo je zdravilo MEPACT treba rekonstituirati, filtrirati z uporabo priloženega filtra in nato dodatno razredčiti z aseptično tehniko.
You may experience more severe side effects, including fever, chills, fatigue, nausea, vomiting, headache and high blood pressure or low blood pressure.
Če ste uporabili večji odmerek zdravila MEPACT, kot bi smeli Pojavijo se lahko hujši neželeni učinki, vključno z zvišanjem telesne temperature, mrzlico, utrujenostjo, slabostjo, bruhanjem, glavobolom in visokim krvnim tlakom ali nizkim krvnim tlakom.
The pharmacokinetics of a single 4 mg dose of mifamurtide following a 1 hour intravenous infusion were evaluated in adult volunteers with mild (n = 9) or moderate (n = 8) renal impairment and in age-, sex-, and weight-matched healthy adults with normal renal function (n = 16).
Farmakokinetiko enkratnega 4 mg odmerka mifamurtida po 1 urnem intravenskem infundiranju so vrednotili pri odraslih prostovoljcih z blago (n = 9) ali zmerno (n = 8) okvaro ledvic in pri po starosti, spolu in telesni masi primerljivih zdravih odraslih osebah z normalnim delovanjem ledvic (n = 16).
The sodium chloride 9 mg/mL (0.9%) solution for injection is added to the vial by slow, firm depression of the syringe plunger.
Raztopino natrijevega klorida 9 mg/ml (0,9%) za injiciranje dodajte v vialo, tako da počasi in trdno pritiskate bat brizge.
The pharmacokinetics of a single 4 mg dose of mifamurtide following a 1 hour intravenous infusion were evaluated in adult volunteers with mild (Child-Pugh class A; n = 9) or moderate (Child-Pugh class B; n = 8) hepatic impairment and in age, sex-, and weight-matched healthy adults with normal hepatic function (n = 19).
Farmakokinetiko enkratnega 4 mg odmerka mifamurtida po 1 urnem intravenskem infundiranju so vrednotili pri odraslih prostovoljcih z blago (Child-Pugh razred A, n = 9) ali zmerno (Child-Pugh razred B, n = 8) okvaro jeter in pri po starosti, spolu in telesni masi primerljivih zdravih odraslih osebah z normalnim delovanjem jeter (n = 19).
Treatment with MEPACT can often cause stomach problems such as nausea, vomiting and loss of appetite when used with chemotherapy.
Pri uporabi zdravila MEPACT skupaj s kemoterapijo se pogosto lahko pojavijo prebavne težave, kot so siljenje na bruhanje, bruhanje in izguba apetita.
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