natgillin/translations-raw huggingface dataset:
Adherence to recommended GONAL-f dosage, regimen of administration and careful monitoring of therapy will minimise the incidence of ovarian hyperstimulation and multiple pregnancy (see sections 4.2 and 4.8).
Upoštevanje priporočenega odmerjanja GONALA- f, režima uporabe in skrbno nadzorovanje zdravljenja zmanjšajo pogostnost hiperstimulacije jajčnikov in večplodnih nosečnosti na minimum (glejte poglavji 4. 2. in 4. 8).
86 Reproductive system neoplasms
Novotvorbe reprodukcijskega sistema
It is not yet established whether or not treatment with gonadotrophins increases the baseline risk of these tumours in infertile women.
Ni pa še ugotovljeno, ali zdravljenje z gonadotropini povečuje osnovno tveganje teh tumorjev pri neplodnih ženskah.
Congenital malformation
86 Prirojene malformacije
Semen analysis is recommended 4 to 6 months after the beginning of treatment as part of the assessment of the response.
Za ocenjevanje odziva se priporoča analiza semenske tekočine 4 do 6 mesecev od začetka zdravljenja.
Concomitant use of GONAL-f with other agents used to stimulate ovulation (e. g. hCG, clomiphene citrate) may potentiate the follicular response, whereas concurrent use of a GnRH agonist or antagonist to induce pituitary desensitisation may increase the dosage of GONAL-f needed to elicit an adequate ovarian response.
Sočasna uporaba GONALA- f z drugimi sredstvi, ki se uporabljajo za stimulacijo ovulacije (npr. hCG, klomifen citrat) lahko potencira folikularani odziv, medtem ko hkratna uporaba agonista ali antagonista GnRH za sprožitev desenzitizacije hipofize lahko poveča odmerek GONALA- f, ki je potreben za dosego ustreznega odziva jajčnikov.
There is no indication for use of GONAL-f during pregnancy.
Uporaba med nosečnostjo
During lactation, the secretion of prolactin can entail a poor prognosis to ovarian stimulation.
V obdobju dojenja lahko izločanja prolaktina prispeva k slabi prognozi za stimulacijo jajčnikov.
87 4.8 Undesirable effects
87 4. 8 Neželeni učinki
Uncommon (> 1/ 1,000 ,< 1/100) Rare (> 1/10 ,000, < 1/1,000)
Občasni (> 1/ 1000, < 1/ 100)
Very Common (> 1/ 10)
Redki (> 1/ 10000, < 1/ 1. 000)
The effects of an overdose of GONAL-f are unknown, nevertheless one could expect ovarian hyperstimulation syndrome to occur (see section 4.4).
88 hiperstimulacije jajčnikov (glejte poglavje 4. 4)
Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial half-life of around 2 hours and eliminated from the body with a terminal half-life of about one day.
5. 2 Farmakokinetične lastnosti
One-eighth of the follitropin alfa dose is excreted in the urine.
Ena osmina odmerka GONAL- f se izloči z urinom.
Following repeated administration, follitropin alfa accumulates 3-fold achieving a steady-state within 3-4 days.
Po večkratnem dajanju, doseže GONAL- f trikratno raven v plazmi in doseže stanje dinamičnega ravnotežja v 3 do 4 dneh.
In women whose endogenous gonadotrophin secretion is suppressed, follitropin alfa has nevertheless been shown to effectively stimulate follicular development and steroidogenesis, despite unmeasurable LH levels.
Pri ženskah z zavrtim izločanjem endogenega gonadotropina pa se je izkazalo, da GONAL- f učinkovito spodbuja razvoj foliklov in steroidogenezo, kljub nemerljivim ravnem LH.
Poloxamer 188 Sucrose Methionine Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate m-Cresol Phosphoric acid, concentrated
poloksamer 188, saharoza, metionin, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat, m- krezol,
89 Sodium hydroxide Water for Injections
89 fosforjeva( V) kislinafosforjeva( V) kislina, koncentrirana, natrijev hidroksid, voda za injekcije.
2 years Once opened, the product may be stored for a maximum of 28 days at or below 25°C.
Po odprtju se zdravilo lahko shranjuje največ 28 dni pri temperaturi do 25°C.
Within its shelf life, the product may be stored at or below 25°C for up to 3 months without being refrigerated again and must be discarded if it has not been used after 3 months.
V času roka uporabnosti, se lahko zdravilo shranjuje pri temperaturi do 25°C do 3 mesece brez ponovnega shranjevanja v hladilniku in se ga mora zavreči po 3 mesecih, če se ga ne uporabi.
For in-use storage conditions, see section 6.3.
Za pogoje shranjevanja po odprtju glejte poglavje 6. 3.
0.5 ml of solution for injection in 3 ml cartridge (Type I glass), with a plunger stopper (halobutyl rubber) and an aluminium crimp cap with a black rubber inlay.
0, 5 ml raztopine za injiciranje v 3 ml vložku (steklo Tipa I) z batnim zamaškom (halobutilna guma) in aluminijasto zgibano zaporko s črno gumijasto notranjo prevleko.
Pack of one pre-filled pen and 5 needles to be used with the pen for administration.
Škatlica z enim napolnjenim injekcijskim peresnikom in 5 injekcijskimi iglami za peresnik za dajanje zdravila.
GONAL-f 300 IU/ 0.5 ml (22 micrograms/ 0.5 ml) is not designed to allow the cartridge to be removed.
GONAL- f 300 i. e. / 0, 5 ml (22 mikrogramov/ 0, 5 ml) je oblikovan tako, da ne dopušča odstranitve vložka.
Discard used needles immediately after injection.
Uporabljene injekcijske igle zavrzite takoj po uporabi.
20 October 1995 Date of last renewal:
Datum zadnjega podaljšanja dovoljenja za promet:
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) solution for injection in a pre-filled pen.
GONAL - f 450 i. e. / 0, 75 ml (33 mikrogramov/ 0, 75 ml) raztopina za injiciranje v napolnjenem injekcijskem peresniku
Each cartridge delivers 450 IU (equivalent 33 micrograms) in 0.75 ml. * Follitropin alfa is recombinant human follicle stimulating hormone (FSH) produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
(enakovredno 33 mikrogramov) v 0, 75 ml. * Folitropin alfa je rekombinantni folikle stimulirajoči hormon (FSH) izdelan s tehnologijo rekombinantne DNK na celični liniji celic jajčnika kitajskega hrčka (CHO).
45 mg sucrose, 0.8325 mg disodium phosphate dihydrate, 0.3375 mg sodium dihydrogen phosphate monohydrate, 0.075 mg methionine, 2.25 mg m-cresol, 0.075 mg poloxamer 188.
45 mg saharoze, 0, 8325 mg natrijevega hidrogenfosfata dihidrata, 0, 33755 mg natrijevega dihidrogenfosfata monohidrata, 0, 075 mg metionina, 2, 25 mg m- krezola, 0, 075 mg poloksamera 188.
Solution for injection in a pre-filled pen.
Raztopina za injiciranje v napolnjenem injekcijskem peresniku..
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
Klinična ocena GONALA- f kaže, da njegovi dnevni odmerki, režim uporabe in postopki nadzorovanja zdravljenja ne bi smeli biti
However, when these doses were used in a clinical study comparing GONAL-f and urinary FSH, GONAL-f was more effective than urinary FSH in terms of a lower total dose and a shorter treatment period needed to achieve pre-ovulatory conditions.
92 drugačni od tistih, ki se trenutno uporabljajo za pripravke z urinarnim FSH.
Bioequivalence has been demonstrated between equivalent doses of the monodose presentation and the multidose presentation of GONAL-f.
Vendar pa, ko so te odmerke uporabili v primerjalni klinični raziskavi GONALA- f in urinarnega FSH, je bil GONAL- f bolj učinkovit od urinarnega v FSH v smislu nižjega skupnega odmerka in krajšega časa zdravljenja, potrebnega za dosego predovulacijskih pogojev.
In LH and FSH deficient women (hypogonadotrophic hypogonadism), the objective of GONAL-f therapy in association with lutropin alfa is to develop a single mature Graafian follicle from which the
Pri ženskah s pomankanjem LH in FSH (hipogonadotropni hipogonadizem), je cilj zdravljenja z GONALOM- f skupaj z lutropinom alfa razvoj enega samega zrelega Graafovega folikla, iz katerega se
92 oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG).
93 bo sprostilo jajčece po dajanju humanega horionskega gonadotropina (hCG).
93 Gonadotrophin therapy requires a certain time commitment by physicians and supportive health professionals, as well as the availability of appropriate monitoring facilities.
Zdravljenje z gonadotropinom zahteva od zdravnika in ostalega zdravstvenega osebja določen čas, kakor tudi razpoložljivost ustrezne opreme za nadzorovanje zdravljenja.
In women, safe and effective use of Gonal-f calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol levels, on a regular basis.
Pri ženskah je za varno in učinkovito uporabo GONALA- f potrebno redno nadzorovanje odziva jajčnikov z ultrazvokom ali še bolje z ultrazvokom v kombinaciji z merjenjem serumskih ravni estradiola.
There may be a degree of interpatient variability in response to FSH administration, with a poor response to FSH in some patients.
Razpon odziva na 94 zdravljenje z FSH se lahko med bolniki razlikuje, pri nekaterih bolnikih je odziv nas FSH zelo majhen.
Self-administration of Gonal-f should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
Sami si lahko dajejo GONAL- f samo bolniki, ki so dobro motivirani, ustrezno poučeni in imajo dostop do strokovnega nasveta.
Adherence to the recommended Gonal-f dosage and regimen of administration, and careful monitoring of therapy will minimise the incidence of such events.
Pogostnost takih dogodkov se zmanjša na minimum ob upoštevanju priporočenega odmerjanja in režima dajanja GONALA- f ter ob skrbnem nadzorovanju zdravljenja.
94 Excessive ovarian response to gonadotrophin treatment seldom gives rise to OHSS unless hCG is administered to trigger ovulation.
Pretiran odziv jajčnikov na zdravljenje z gonadotropini se le redko razvije v OHSS, razen če se uporabi hCG za sprožitev ovulacije.
95 There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment.
Pri ženskah, ki so se podvrgle režimu zdravljenja neplodnosti z več zdravili, so poročali o novotvorbah na jajčnikih in drugih delih reprodukcijskega sistema, tako benignih kot malignih.
It is not yet established whether or not treatment with gonadotrophins increases the baseline risk of these tumours in infertile women.
96 Ni pa še ugotovljeno, ali zdravljenje z gonadotropini povečuje osnovno tveganje teh tumorjev pri neplodnih ženskah.
4.8 Undesirable effects
97 4. 8 Neželeni učinki
96 Treatment in women Immune system disorders
Zdravljenje žensk Bolezni imunskega sistema
The effects of an overdose of GONAL-f are unknown, nevertheless one could expect ovarian hyperstimulation syndrome to occur (see section 4.4).
98 hiperstimulacije jajčnikov (glejte poglavje 4. 4)
97 Pharmacotherapeutic group: gonadotrophins, ATC code:
Farmakoterapevtska skupina: gonadotropini, Oznaka ATC:
Poloxamer 188 Sucrose Methionine Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate m-Cresol Phosphoric acid, concentrated Sodium hydroxide Water for Injections
poloksamer 188, saharoza, metionin, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat, m- krezol,
98 Not applicable.
Navedba smiselno ni potrebna.
Once opened, the product may be stored for a maximum of 28 days at or below 25°C.
Po odprtju se zdravilo lahko shranjuje največ 28 dni pri temperaturi do 25°C.
0.75 ml of solution for injection in 3 ml cartridge (Type I glass), with a plunger stopper (halobutyl rubber) and an aluminium crimp cap with a black rubber inlay.
0, 75 ml raztopine za injiciranje v 3 ml vložku (steklo Tipa I) z batnim zamaškom (halobutilna guma) in aluminijasto zgibano zaporko s črno gumijasto notranjo prevleko.
Pack of one pre-filled pen and 7 needles to be used with the pen for administration.
Škatlica z enim napolnjenim injekcijskim peresnikom in 7 injekcijskimi iglami za peresnik za dajanje zdravila.
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) is not designed to allow the cartridge to be removed.
GONAL- f 450 i. e. / 0, 75 ml (33 mikrogramov/ 0, 75 ml) je oblikovan tako, da ne dopušča odstranitve vložka.
GONAL-f 900 IU/ 1.5 ml (66 micrograms/ 1.5 ml) solution for injection in a pre-filled pen.
GONAL - f 900 i. e. / 1, 5 ml (66 mikrogramov/ 1, 5 ml) raztopina za injiciranje v napolnjenem injekcijskem peresniku
Each cartridge delivers 900 IU (equivalent 66 micrograms) in 1.5 ml. * Follitropin alfa is recombinant human follicle stimulating hormone (FSH) produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
(enakovredno 66 mikrogramov) v 1, 5 ml. * Folitropin alfa je rekombinantni folikle stimulirajoči hormon (FSH) izdelan s tehnologijo rekombinantne DNK na celični liniji celic jajčnika kitajskega hrčka (CHO).
90 mg sucrose, 1.665 mg disodium phosphate dihydrate, 0.675 mg sodium dihydrogen phosphate monohydrate, 0.15 mg methionine, 4.5 mg m-cresol, 0.15 mg poloxamer 188.
90 mg saharoze, 1, 665 mg natrijevega hidrogenfosfata dihidrata, 0, 675 mg natrijevega dihidrogenfosfata monohidrata, 0, 15 mg metionina, 4, 5 mg m- krezola, 0, 15 mg poloksamera 188.
The pH of the solution is 6.7 - 7.3.
pH raztopine je 6, 3 do 7, 3.
• Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT).
• Spodbujanje razvoja več foliklov pri bolnicah, pri katerih je potrebno izzvati superovulacijo v postopkih asistirane reprodukcije (ART), kot so in vitroin vitro oploditev (IVF), prenos gamete v jajcevod (GIFT) in prenos zigote v jajcevod (ZIFT).
Clinical assessment of GONAL-f indicates that its daily doses, regimens of administration and treatment
Vendar pa, ko so te
However, when these doses were used in a clinical study comparing GONAL-f and urinary FSH, GONAL-f was more effective than urinary FSH in terms of a lower total dose and a shorter treatment period needed to achieve pre-ovulatory conditions.
102 odmerke uporabili v primerjalni klinični raziskavi GONALA- f in urinarnega FSH, je bil GONAL- f bolj učinkovit od urinarnega v FSH v smislu nižjega skupnega odmerka in krajšega časa zdravljenja, potrebnega za dosego predovulacijskih pogojev.
101 In LH and FSH deficient women (hypogonadotrophic hypogonadism), the objective of GONAL-f therapy in association with lutropin alfa is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG).
Pri ženskah s pomankanjem LH in FSH (hipogonadotropni hipogonadizem), je cilj zdravljenja z GONALOM- f skupaj z lutropinom alfa razvoj enega samega zrelega Graafovega folikla, iz katerega se bo sprostilo jajčece po dajanju humanega horionskega gonadotropina (hCG).
Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
103 imajo nizko sekrecijo endogenega estrogena, se lahko zdravljenje začne kadarkoli.
102 GONAL-f is a potent gonadotrophic substance capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
GONAL- f je močna gonadotropna učinkovina, ki lahko povzroči blage do hude neželene reakcije in jo zato smejo uporabljati samo zdravniki, ki dobro poznajo težave neplodnosti in njihovo obvladovanje.
The lowest effective dose in relation to the treatment objective should be used in both men and women.
Pri obeh, moških in ženskah, se mora uporabiti najmanjši še učinkoviti odmerek glede na cilj 104 zdravljenja.
103 haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events.
Klinična ocena lahko razkrije hipovolemijo, hemokoncentracijo, elektrolitsko neravnovesje, ascites, hemoperitoneum, plevralni izliv, hidrotoraks, akutno respiratorno stisko, tromboembolične dogodke.
OHSS may progress rapidly (within 24 hours to several days) to become a serious medical event, therefore patients should be followed for at least two weeks after hCG administration.
Za zmanjšanje tveganja za OHSS ali večplodno nosečnost na minimum, se priporočajo ultrazvočni
To minimise the risk of OHSS or of multiple pregnancy, ultrasound scans as well as oestradiol measurements are recommended.
105 pregledi in merjenje estradiola.
Adherence to recommended GONAL-f dosage, regimen of administration and careful monitoring of therapy will minimise the incidence of ovarian hyperstimulation and multiple pregnancy (see sections 4.2 and 4.8).
Upoštevanje priporočenega odmerjanja GONALA- f, režima uporabe in skrbno nadzorovanje zdravljenja zmanjšajo pogostnost hiperstimulacije jajčnikov in večplodnih nosečnosti na minimum (glejte poglavje 4. 2. » Odmerjanje in način uporabe « in 4. 8 » Neželeni učinki «).
104 Reproductive system neoplasms
Novotvorbe reprodukcijskega sistema
Congenital malformation
106 Prirojene malformacije
Concomitant use of GONAL-f with other agents used to stimulate ovulation (e. g. hCG, clomiphene citrate) may potentiate the follicular response, whereas concurrent use of a GnRH agonist or antagonist to induce pituitary desensitisation may increase the dosage of Gonal-f needed to elicit an adequate ovarian response.
Sočasna uporaba GONALA- f z drugimi sredstvi, ki se uporabljajo za stimulacijo ovulacije (npr. hCG, klomifen citrat) lahko potencira folikularani odziv, medtem ko hkratna uporaba agonista ali antagonista GnRH za sprožitev desenzitizacije hipofize lahko poveča odmerek GONALA- f, ki je potreben za dosego ustreznega odziva jajčnikov.
No other clinically significant drug interaction has been reported during Gonal-f therapy.
Med zdravljenjem z GONALOM- f niso poročali o drugih klinično pomembnih interakcijah z zdravili.
4.8 Undesirable effects
107 4. 8 Neželeni učinki
105 Treatment in women Immune system disorders
Zdravljenje žensk Bolezni imunskega sistema
The effects of an overdose of GONAL-f are unknown, nevertheless one could expect ovarian hyperstimulation syndrome to occur (see section 4.4).
108 hiperstimulacije jajčnikov (glejte poglavje 4. 4)
106 Pharmacotherapeutic group: gonadotrophins, ATC code:
Farmakoterapevtska skupina: gonadotropini, Oznaka ATC:
Following repeated administration, follitropin alfa accumulates 3-fold achieving a steady-state within 3-4 days.
Po večkratnem dajanju, doseže GONAL- f trikratno raven v plazmi n doseže stanje dinamičnega ravnotežja v 3 do 4 dneh.
107 Not applicable.
Navedba smiselno ni potrebna.
Within its shelf life, the product may be stored at or below 25°C for up to 3 months without being refrigerated again and must be discarded if it has not been used after 3 months.
V času roka uporabnosti se lahko zdravilo shranjuje pri temperaturi do 25°C do 3 mesece brez ponovnega shranjevanja v hladilniku in se ga mora zavreči po 3 mesecih, če se ga ne uporabi.
1.5 ml of solution for injection in 3 ml cartridge (Type I glass), with a plunger stopper (halobutyl rubber) and an aluminium crimp cap with a black rubber inlay.
1, 5 ml raztopine za injiciranje v 3 ml vložku (steklo Tipa I) z batnim zamaškom (halobutilna guma) in aluminijasto zgibano zaporko s črno gumijasto notranjo prevleko.
Pack of one pre-filled pen and 14 needles to be used with the pen for administration.
Škatlica z enim napolnjenim injekcijskim peresnikom in 14 injekcijskimi iglami za peresnik za dajanje zdravila.
GONAL-f 900 IU/ 1.5 ml (66 micrograms/ 1.5 ml) is not designed to allow the cartridge to be removed.
GONAL- f 900 i. e. / 1, 5 ml (66 mikrogramov/ 1, 5 ml) je oblikovan tako, da ne dopušča odstranitve vložka.
108 ANNEX II
111 DODATEK II
Zone Industrielle de l’ Ouriettaz 1170 Aubonne SWITZERLAND
Zone Industrielle de l’ Ouriettaz 1170 Aubonne ŠVICA
C/ Batanes, 1 – 28760 Tres Cantos (Madrid) Spain
C/ Batanes 1 28770 Tres Cantos (Madrid) Španija
Merck Serono S. p. A., Via delle Magnolie 15, I-70026 Modugno (Bari) Italy
Merck Serono S. p. A., Via delle Magnolie 15, I- 70026 Modugno (Bari) Italija.
110 ANNEX III
113 DODATEK III
112 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1, 5, 10 AMPOULES AND 1, 5, 10 AMPOULES
115 PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z 1, 5, 10 AMPULAMI PRAŠKA IN 1, 5, 10 AMPULAMI VEHIKLA
Follitropin alfa
GONAL- f 75 i. e. prašek in vehikel za raztopino za injiciranje folitropin alfa
One ampoule of powder contains: follitropin alfa 75 IU.
75 i. e. folitropina alfa.
Other ingredients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid and sodium hydroxide.
Pomožne snovi: saharoza, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat, koncentrirana fosforjeva( V) kislina in natrijev hidroksid.
One ampoule of solvent contains:
Ena ampula z vehiklom vsebuje:
1 ml water for Injections.
1 ml vode za injekcije.
1 ampoule of powder for solution for injection.
1 ampula s praškom za raztopino za injiciranje.
1 ampoule of solvent.
1 ampula z vehiklom.
5 ampoules of powder for solution for injection.
5 ampul s praškom za raztopino za injiciranje.
5 ampoules of solvent.
5 ampul z vehiklom.
10 ampoules of powder for solution for injection.
10 ampul s praškom za raztopino za injiciranje.
10 ampoules of solvent.
10 ampul z vehiklom.
EU/ 1/ 95/ 001/ 001 1 ampoule of powder for solution for injection.
EU/ 1/ 95/ 001/ 001 1 ampula s praškom za raztopino za injiciranje.
EU/ 1/ 95/ 001/ 003 5 ampoules of powder for solution for injection.
EU/ 1/ 95/ 001/ 003 5 ampul s praškom za raztopino za injiciranje.
EU/ 1/ 95/ 001/ 004 10 ampoules of powder for solution for injection.
EU/ 1/ 95/ 001/ 004 10 ampul s praškom za raztopino za injiciranje.
Batch Solvent Batch
Serija Serija vehikel
gonal-f 75 iu
gonal- f 75 i. e.
114 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 75 IU AMPOULE LABEL
NALEPKA NA AMPULI
GONAL-f 75 IU powder for solution for injection Follitropin alfa Subcutaneous use.
GONAL- f 75 i. e prašek in vehikel za raztopino za injiciranje folitropin alfa Za subkutano uporabo.
75 IU/ amp.
75 i. e. / amp.
115 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT AMPOULE LABEL
118 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NALEPKA NA AMPULI Z VEHIKLOM
Water for Injections Solvent for use with GONAL-f
Voda za injekcije Vehikel za uporabo z GONAL- f
116 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1, 10 AMPOULES AND 1, 10 AMPOULES
119 PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z 1, 10 AMPULAMI PRAŠKA IN 1, 10 AMPULAMI VEHIKLA
Follitropin alfa
GONAL- f 150 i. e. prašek in vehikel za raztopino za injiciranje folitropin alfa
One ampoule of powder contains: follitropin alfa 150 IU.
150 i. e. folitropina alfa.
1 ml water for Injections
1 ml vode za injekcije.
EU/ 1/ 95/ 001/ 009 1 ampoule of powder for solution for injection.
EU/ 1/ 95/ 001/ 009 1 ampula s praškom za raztopino za injiciranje.
EU/ 1/ 95/ 001/ 012 10 ampoules of powder for solution for injection.
EU/ 1/ 95/ 001/ 012 10 ampul s praškom za raztopino za injiciranje.
GENERAL CLASSIFICATION FOR SUPPLY
NAČIN IZDAJANJA ZDRAVILA Izdaja zdravila je le na recept.
gonal-f 150 iu
gonal- f 150 i. e.
118 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 150 IU AMPOULE LABEL
NALEPKA NA AMPULI
GONAL-f 150 IU powder for solution for injection Follitropin alfa Subcutaneous use.
GONAL- f 150 i. e. prašek in vehikel za raztopino za injiciranje folitropin alfa Za subkutano uporabo.
150 IU/ amp.
150 i. e. / amp.
119 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT AMPOULE TEXT
122 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NALEPKA NA AMPULI Z VEHIKLOM
120 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL AND 1 VIAL
123 PODATKI NA ZUNANJI OVOJNINI ŠKATLA Z 1 VIALO PRAŠKA IN 1 VIALO VEHIKLA
GONAL-f 75 IU (5.5 micrograms) powder and solvent for solution for injection.
GONAL- f 75 i. e.
Follitropin alfa
(5, 5 mikrogramov) prašek in vehikel za raztopino za injiciranje folitropin alfa
One vial of powder contains 6 micrograms of follitropin alfa in order to deliver 5.5 micrograms, equivalent to 75 IU.
Ena viala s praškom vsebuje 6 mikrogramov folitropina alfa za zagotovitev odmerka 5, 5 mikrogramov, kar ustreza 75 i. e.