natgillin/translations-raw huggingface dataset:
122 If you forget to use Fertavid
Če ste pozabili uporabiti zdravilo Fertavid
123 What Fertavid contains
Kaj vsebuje zdravilo Fertavid
• The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 75 IU in 0.5 ml aqueous solution per vial. • The other ingredients are sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections.
• Zdravilna učinkovina je folitropin beta, znan kot folikle stimulirajoči hormon (FSH).
The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
Viala vsebuje 75 i. e. zdravilne učinkovine v 0, 5 ml vodne raztopine. • Pomožne snovi so: saharoza, natrijev citrat, L- metionin in polisorbat 20 v vodi za injekcije. pH je uravnan z natrijevim hidroksidom in/ ali klorovodikovo kislino.
It is supplied in a glass vial.
Izgled zdravila Fertavid in vsebina pakiranja 119 Fertavid raztopina za injiciranje je bistra, brezbarvna raztopina.
INFORMATION FOR THE USER
120 NAVODILO ZA UPORABO
• if you have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus • if you are allergic (hypersensitive) to follitropin beta or any of the other ingredients of Fertavid • if you have heavy or irregular vaginal bleeding where the cause is not known • if you suffer from primary ovarian failure • if you have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD) • if you have malformations of the sexual organs which make a normal pregnancy impossible • if you have fibroids in the uterus which make a normal pregnancy impossible • if you suffer from primary testicular failure.
• če imate tumor jajčnikov, dojk, maternice, testisov, hipofize ali hipotalamusa • če ste alergični (preobčutljivi) na folitropin beta ali katerokoli sestavino zdravila Fertavid • če imate močne ali neredne nepojasnjene krvavitve iz nožnice • če imate primarno odpoved jajčnikov • če imate ciste na jajčnikih ali povečane jajčnike, ki niso povezani s policistično boleznijo jajčnikov (PCOD) • če imate malformacije spolnih organov, ki preprečujejo normalno nosečno • če imate fibrome maternice, ki preprečujejo normalno nosečnost • če imate primarno odpoved testisov.
125 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
121 Opozorite zdravnika, če ste bili v preteklosti alergični na neomicin in/ ali streptomicin (antibiotika).
126 Always use Fertavid exactly as your doctor has told you.
Pri uporabi zdravila Fertavid natančno upoštevajte zdravnikova navodila.
Your doctor will decide on the dose of Fertavid to be given.
Odmerjanje pri ženskah 122 Zdravnik vam bo določil odmerek zdravila Fertavid.
127 Step 2 - The injection site The best site for subcutaneous injection is in the abdomen around the navel (e) where there is a lot of loose skin and layers of fatty tissue.
123 Drugi korak – mesto injiciranja Najbolj primerno mesto za subkutano injekcijo je trebuh okoli popka (e), kjer je veliko ohlapne kože in maščobnega tkiva.
128 If you forget to use Fertavid
Če ste pozabili uporabiti zdravilo Fertavid
129 What Fertavid contains
Kaj vsebuje zdravilo Fertavid
• The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 100 IU in 0.5 ml aqueous solution per vial. • The other ingredients are sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections.
• Zdravilna učinkovina je folitropin beta, znan kot folikle stimulirajoči hormon (FSH).
The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
Viala vsebuje 100 i. e. zdravilne učinkovine v 0, 5 ml vodne raztopine. • Pomožne snovi so: saharoza, natrijev citrat, L- metionin in polisorbat 20 v vodi za injekcije. pH je uravnan z natrijevim hidroksidom in/ ali klorovodikovo kislino.
It is supplied in a glass vial.
Izgled zdravila Fertavid in vsebina pakiranja 125 Fertavid raztopina za injiciranje je bistra, brezbarvna raztopina.
INFORMATION FOR THE USER
126 NAVODILO ZA UPORABO
Fertavid 150 IU/ 0,5 ml solution for injection follitropin beta
Fertavid 150 i. e. / 0, 5 ml raztopina za injiciranje folitropin beta
131 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
127 Opozorite zdravnika, če ste bili v preteklosti alergični na neomicin in/ ali streptomicin (antibiotika).
132 Always use Fertavid exactly as your doctor has told you.
Pri uporabi zdravila Fertavid natančno upoštevajte zdravnikova navodila.
Your doctor will decide on the dose of Fertavid to be given.
Odmerjanje pri ženskah 128 Zdravnik vam bo določil odmerek zdravila Fertavid.
133 Step 2 - The injection site The best site for subcutaneous injection is in the abdomen around the navel (e) where there is a lot of loose skin and layers of fatty tissue.
129 Drugi korak – mesto injiciranja Najbolj primerno mesto za subkutano injekcijo je trebuh okoli popka (e), kjer je veliko ohlapne kože in maščobnega tkiva.
134 If you forget to use Fertavid
Če ste pozabili uporabiti zdravilo Fertavid
135 What Fertavid contains
Kaj vsebuje zdravilo Fertavid
• The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 150 IU in 0.5 ml aqueous solution per vial. • The other ingredients are sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections.
• Zdravilna učinkovina je folitropin beta, znan kot folikle stimulirajoči hormon (FSH).
The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
Viala vsebuje 150 i. e. zdravilne učinkovine v 0, 5 ml vodne raztopine. • Pomožne snovi so: saharoza, natrijev citrat, L- metionin in polisorbat 20 v vodi za injekcije. pH je uravnan z natrijevim hidroksidom in/ ali klorovodikovo kislino.
It is supplied in a glass vial.
Izgled zdravila Fertavid in vsebina pakiranja 131 Fertavid raztopina za injiciranje je bistra, brezbarvna raztopina.
INFORMATION FOR THE USER
132 NAVODILO ZA UPORABO
137 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
133 Opozorite zdravnika, če ste bili v preteklosti alergični na neomicin in/ ali streptomicin (antibiotika).
138 Always use Fertavid exactly as your doctor has told you.
Pri uporabi zdravila Fertavid natančno upoštevajte zdravnikova navodila.
Your doctor will decide on the dose of Fertavid to be given.
Odmerjanje pri ženskah 134 Zdravnik vam bo določil odmerek zdravila Fertavid.
139 Step 2 - The injection site The best site for subcutaneous injection is in the abdomen around the navel (e) where there is a lot of loose skin and layers of fatty tissue.
135 Drugi korak – mesto injiciranja Najbolj primerno mesto za subkutano injekcijo je trebuh okoli popka (e), kjer je veliko ohlapne kože in maščobnega tkiva.
140 If you forget to use Fertavid
Če ste pozabili uporabiti zdravilo Fertavid
141 What Fertavid contains
Kaj vsebuje zdravilo Fertavid
• The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 200 IU in 0.5 ml aqueous solution per vial. • The other ingredients are sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections.
• Zdravilna učinkovina je folitropin beta, znan kot folikle stimulirajoči hormon (FSH).
The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
Viala vsebuje 200 i. e. zdravilne učinkovine v 0, 5 ml vodne raztopine. • Pomožne snovi so: saharoza, natrijev citrat, L- metionin in polisorbat 20 v vodi za injekcije. pH je uravnan z natrijevim hidroksidom in/ ali klorovodikovo kislino.
It is supplied in a glass vial.
Izgled zdravila Fertavid in vsebina pakiranja 137 Fertavid raztopina za injiciranje je bistra, brezbarvna raztopina.
INFORMATION FOR THE USER
138 NAVODILO ZA UPORABO
Fertavid 150 IU/ 0.18 ml solution for injection contains a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ ml.
Fertavid 150 i. e. / 0, 18 ml raztopina za injiciranje vsebuje hormon, ki je poznan kot folikle stimulirajoči hormon (FSH), z jakostjo 833 i. e. / ml.
143 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
139 Opozorite zdravnika, če ste bili v preteklosti alergični na neomicin in/ ali streptomicin (antibiotika).
144 Always use Fertavid exactly as your doctor has told you.
Pri uporabi zdravila Fertavid natančno upoštevajte zdravnikova navodila.
Your doctor will decide on the dose of Fertavid to be given.
Odmerjanje pri ženskah 140 Zdravnik vam bo določil odmerek zdravila Fertavid.
The separate instructions for using the pen must be followed carefully.
Fertavid raztopino za injiciranje v vložkih smo razvili za uporabo s peresnikom Puregon Pen. Ločena navodila za uporabo peresnika morate natančno upoštevati.
Using the pen, injections just under the skin (in the abdominal wall, for example) can be given by you or your partner.
S peresnikom si lahko zdravilo injicirate tik pod kožo (npr. v trebušno steno), bodisi sami ali pa naj to stori vaš partner.
The very first injection of Fertavid should be given under medical supervision.
Prvo injekcijo zdravila Fertavid morate prejeti pod zdravniškim nadzorom.
Like all medicines, Fertavid can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Fertavid neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
145 Minor side effects include bruising, pain, redness, swelling and itching at the site of the injection.
Manjši neželeni učinki so odrgnina, bolečina, rdečica, oteklina in srbenje na mestu vboda.
This condition can become very serious, but the risk can be reduced by careful monitoring of follicle development during treatment.
To stanje lahko postane zelo resno, 141 vendar lahko tveganje zanj zmanjšamo s skrbnim spremljanjem razvoja foliklov med zdravljenjem.
Rarely, blood clots may occur without unwanted overstimulation of the ovaries (see also “ Take special care with Fertavid”).
Redkokdaj se krvni strdki pojavijo tudi brez prevelike stimulacije jajčnikov (glejte tudi odstavek “ Bodite posebno pozorni pri uporabi zdravila Fertavid ”)
Do not use Fertavid if you notice that the solution contains particles or is not clear.
Ne uporabljajte zdravila Fertavid, če ste opazili delce ali če raztopina ni bistra.
The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
• Zdravilna učinkovina je folitropin beta, hormon znan pod imenom folikle stimulirajoči hormon (FSH) z jakostjo 833 i. e. / ml vodne raztopine na vložek. • Pomožne snovi so: saharoza, natrijev citrat, L- metionin, polisorbat 20 in benzilalkohol v vodi za injekcije. pH je uravnan z natrijevim hidroksidom in/ ali klorovodikovo kislino.
It is supplied in a glass cartridge.
Izgled zdravila Fertavid in vsebina pakiranja 142 Fertavid raztopina za injiciranje je bistra, brezbarvna raztopina.
Marketing Authorisation Holder SP Europe, Rue de Stalle 73, B-1180 Bruxelles, Belgium.
Imetnik dovoljenja za promet z zdravilom SP Europe, Rue de Stalle 73, B- 1180 Bruselj, Belgija
Fertavid 300 IU/ 0.36 ml solution for injection contains a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ ml.
Fertavid 300 i. e. / 0, 36 ml raztopina za injiciranje vsebuje hormon, ki je poznan kot folikle stimulirajoči hormon (FSH), z jakostjo 833 i. e. / ml.
148 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
144 Opozorite zdravnika, če ste bili v preteklosti alergični na neomicin in/ ali streptomicin (antibiotika).
149 Always use Fertavid exactly as your doctor has told you.
Pri uporabi zdravila Fertavid natančno upoštevajte zdravnikova navodila.
Dosage in women
145 Odmerjanje pri ženskah
Your doctor will decide on the dose of Fertavid to be given.
Zdravnik vam bo določil odmerek zdravila Fertavid.
Fertavid solution for injection in cartridges has been developed for use in a pen injector called Puregon Pen.
Fertavid raztopino za injiciranje v vložkih smo razvili za uporabo s peresnikom Puregon pen.
The separate instructions for using the pen must be followed carefully.
Ločena navodila za uporabo peresnika morate natančno upoštevati.
150 Minor side effects include bruising, pain, redness, swelling and itching at the site of the injection.
Manjši neželeni učinki so odrgnina, bolečina, rdečica, oteklina in srbenje na mestu vboda.
A complication with FSH treatment is unwanted overstimulation of the ovaries.
Če ste ženska 146 Zaplet pri zdravljenju s FSH je neželena hiperstimulacija ovarijev.
What Fertavid looks like and contents of the pack
147 Izgled zdravila Fertavid in vsebina pakiranja
Fertavid solution for injection is a clear, colourless solution.
Fertavid raztopina za injiciranje je bistra, brezbarvna raztopina.
Fertavid 600 IU/ 0.72 ml solution for injection contains a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ ml.
Fertavid 600 i. e. / 0, 72 ml raztopina za injiciranje vsebuje hormon, ki je poznan kot folikle stimulirajoči hormon (FSH), z jakostjo 833 i. e. / ml.
• if you have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus • if you areallergic (hypersensitive) to follitropin beta or any of the other ingredients of Fertavid • if you have heavy or irregular vaginal bleeding where the cause is not known • if you suffer from primary ovarian failure • if you have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD) • if you have malformations of the sexual organs which make a normal pregnancy impossible • if you have fibroids in the uterus which make a normal pregnancy impossible • if you suffer from primary testicular failure.
• če imate tumor jajčnikov, dojk, maternice, testisov, hipofize ali hipotalamusa • če ste alergični (preobčutljivi) na folitropin beta ali katerokoli sestavino zdravila Fertavid • če imate močne ali neredne nepojasnjene krvavitve iz nožnice • če imate primarno odpoved jajčnikov • če imate ciste na jajčnikih ali povečane jajčnike, ki niso povezani s policistično boleznijo jajčnikov (PCOD) • če imate malformacije spolnih organov, ki preprečujejo normalno nosečnost • če imate fibrome maternice, ki preprečujejo normalno nosečnost • če imate primarno odpoved testisov.
153 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
149 Opozorite zdravnika, če ste bili v preteklosti alergični na neomicin in/ ali streptomicin (antibiotika).
154 Always use Fertavid exactly as your doctor has told you.
Pri uporabi zdravila Fertavid natančno upoštevajte zdravnikova navodila.
Your doctor will decide on the dose of Fertavid to be given.
Odmerjanje pri ženskah 150 Zdravnik vam bo določil odmerek zdravila Fertavid.
Fertavid solution for injection in cartridges has been developed for use in a pen injector called Puregon Pen.
Fertavid raztopino za injiciranje v vložkih smo ga razvili za uporabo s peresnikom Puregon Pen.
155 Minor side effects include bruising, pain, redness, swelling and itching at the site of the injection.
Manjši neželeni učinki so odrgnina, bolečina, rdečica, oteklina in srbenje na mestu vboda.
This condition can become very serious, but the risk can be reduced by careful monitoring of follicle development during treatment.
To stanje lahko postane zelo resno, 151 vendar lahko tveganje zanj zmanjšamo s skrbnim spremljanjem razvoja foliklov med zdravljenjem.
If any of the side effects gets serious, or if you notice any side efefcts not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
It is supplied in a glass cartridge.
Izgled zdravila Fertavid in vsebina pakiranja 152 Fertavid raztopina za injiciranje je bistra, brezbarvna raztopina.
Donot pass it on to others.
Njim bi lahko celo
Fertavid 900 IU/ 1.08 ml solution for injection contains a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ ml.
Fertavid 900 i. e. / 1, 08 ml raztopina za injiciranje vsebuje hormon, ki je poznan kot folikle stimulirajoči hormon (FSH), z jakostjo 833 i. e. / ml.
Take special care with Fertavid:
Bodite posebno pozorni pri uporabi zdravila Fertavid
158 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
154 Opozorite zdravnika, če ste bili v preteklosti alergični na neomicin in/ ali streptomicin (antibiotika).
159 Always use Fertavid exactly as your doctor has told you.
Pri uporabi zdravila Fertavid natančno upoštevajte zdravnikova navodila.
Your doctor will decide on the dose of Fertavid to be given.
Odmerjanje pri ženskah 155 Zdravnik vam bo določil odmerek zdravila Fertavid.
Fertavid solution for injection in cartridges has been developed for use in a pen injector called Puregon Pen.
Fertavid raztopino za injiciranje v vložkih smo razvili za uporabo s peresnikom Puregon Pen.
160 Minor side effects include bruising, pain, redness, swelling and itching at the site of the injection.
Manjši neželeni učinki so odrgnina, bolečina, rdečica, oteklina in srbenje na mestu vboda.
This condition can become very serious, but the risk can be reduced by careful monitoring of follicle development during treatment.
To stanje lahko postane zelo resno, 156 vendar lahko tveganje zanj zmanjšamo s skrbnim spremljanjem razvoja foliklov med zdravljenjem.
It is supplied in a glass cartridge.
Izgled zdravila Fertavid in vsebina pakiranja 157 Fertavid raztopina za injiciranje je bistra, brezbarvna raztopina.
Filgrastim Hexal is a ‘ biosimilar’ medicine.
Filgrastim Hexal je podobno biološko zdravilo.
This means that Filgrastim Hexal is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘ reference medicine’).
To pomeni, da je Filgrastim Hexal podobno biološkemu zdravilu, ki je že odobreno v Evropski uniji (EU) in vsebuje enako zdravilno učinkovino (imenovano tudi „ referenčno zdravilo “).
Filgrastim Hexal is used to stimulate the production of white blood cells in the following situations:  to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing);  to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a risk of long-term, severe neutropenia;  to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;  to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Zdravilo Filgrastim Hexal se uporablja za stimulacijo tvorbe belih krvničk v naslednjih primerih:  za zmanjšanje trajanja nevtropenije (nizke ravni nevtrofilcev, vrste belih krvničke) in pojava febrilne nevtropenije (nevtropenije s povišano telesno temperaturo) pri bolnikih, ki jih zdravijo s kemoterapijo (zdravljenje raka), ki je citotoksična (ubija celice);  za zmanjšanje trajanja nevtropenije pri bolnikih, ki prejemajo zdravljenje za uničenje celic kostnega mozga pred njegovo presaditvijo (kot npr. pri nekaterih bolnikih z levkemijo), pri katerih obstaja tveganje za dolgotrajno, hudo obliko nevtropenije;  za povišanje ravni nevtrofilcev in zmanjšanje tveganja okužb pri bolnikih z nevtropenijo z anamnezo hudih, ponavljajočih se okužb;  za zdravljenje trdovratne nevtropenije pri bolnikih z napredovalo okužbo z virusom humane imunske pomanjkljivosti (HIV), za zmanjšanje bakterijskih okužb, kadar ostale vrste zdravljenja niso primerne.
How it is given, the dose and the duration of treatment depend on why it is being used, the patient’ s body weight and the response to treatment.
Način dajanja zdravila, odmerek in trajanje zdravljenja so odvisni od vzroka za uporabo zdravila, bolnikove telesne mase in odziva ne zdravljenje.
Filgrastim Hexal is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Zdravilo Filgrastim Hexal se ponavadi daje v specializiranih centrih za zdravljenje, čeprav
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. si lahko bolniki, ki prejemajo injekcijo v podkožje in so bili ustrezno usposobljeni, cepivo vbrizgajo sami.
The active substance in Filgrastim Hexal, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Zdravilna učinkovina v zdravilu Filgrastim Hexal, filgrastim, je zelo podobna človeški beljakovini, imenovani granulocitne kolonije spodbujajoči faktor (G- CSF).
Filgrastim is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce filgrastim.
Filgrastim proizvajajo z metodo, znano kot „ tehnologija rekombinantne DNK “, pri kateri bakterija prejme gen (DNK), s katerim lahko tvori filgrastim.
The replacement acts in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
Nadomestilo deluje na enak način kot naravno tvorjeni G- CSF s spodbujanjem kostnega mozga k tvorjenju več belih krvničk.
The most common side effect with Filgrastim Hexal (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Najpogostejši neželeni učinki zdravila Filgrastim Hexal (opaženi pri več kot 1 bolniku od 10) so mišično- skeletne bolečine (bolečine v mišicah in kosteh).
For the full list of all side effects reported with Filgrastim Hexal, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Filgrastim Hexal, glejte navodilo za uporabo.
Filgrastim Hexal should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.
Zdravila Filgrastim Hexal se ne sme uporabljati pri osebah, ki utegnejo biti preobčutljive za (alergične na) filgrastim ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Filgrastim Hexal has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da je bilo v skladu z zahtevami Evropske unije dokazano, da ima zdravilo Filgrastim Hexal podoben profil kakovosti, varnosti in učinkovitosti kot zdravilo Neupogen.
Therefore, the CHMP’ s view was that, as for Neupogen, the benefit outweighs the identified risk.
Zaradi tega je CHMP menil, da so koristi zdravila Neupogen večje od z njim povezanih tveganj.
The Committee recommended that Filgrastim Hexal be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Filgrastim Hexal odobri dovoljenja za promet.
Other information about Filgrastim Hexal:
Druge informacije o zdravilu Filgrastim Hexal:
The European Commission granted a marketing authorisation valid throughout the EU for Filgrastim Hexal to Hexal AG on 06 February 2009.
Evropska komisija je dovoljenje za promet z zdravilom Filgrastim Hexal, veljavno po vsej Evropski uniji, odobrila družbi Hexal AG dne 06. februarja 2009.
The full EPAR for Filgrastim Hexal can be found here.
Celotno javno poročilo o oceni zdravila (EPAR) za zdravilo Filgrastim Hexal je na voljo tukaj.
Content
(koncentracija)
30 MU (60 MU/ ml)
30 ME (60 ME/ ml)
Pre-filled Syringe (glass)
Napolnjena injekcijska brizga (steklo)
30 MU(60 MU/ ml)
30 ME (60 ME/ ml)
48 MU (96 MU/ ml)
48 ME (96 ME/ ml)