natgillin/translations-raw huggingface dataset:
The powder is presented in 3 ml vials (Type I glass), with rubber stopper (bromobutyl rubber) and aluminium flip-off cap.
Prašek je pakiran v 3 ml viale (steklo Tipa I) z gumijastim zamaškom (bromobutilna guma) in aluminijsko kapico, ki se odtrga na poteg.
The solvent for reconstitution is presented in 2 ml pre-filled syringes (Type I glass) with a rubber stopper.
Vehikel za rekonstitucijo je na voljo v 2 ml napolnjenih injekcijskih brizgah (steklo Tipa I) z gumijastim zamaškom.
The product is supplied as a pack of 1 vial of powder with 1 pre-filled syringe of solvent for reconstitution and 15 disposable syringes for administration graduated in FSH units.
Zdravilo je na voljo v škatlicah, ki vsebujejo 1 vialo s praškom, 1 napolnjeno injekcijsko brizgo z vehiklom za rekonstitucijo in 15 injekcijskih brizg za dajanje zdravila za enkratno uporabo, ki so graduirane v FSH enotah.
GONAL-f 1050 IU/ 1.75 ml (77 micrograms/ 1.75 ml) must be reconstituted with the 2 ml solvent provided before use.
GONAL - f 1050 i. e. / 1, 75 ml (77 mikrogramov/ 1, 75 ml) se mora pred uporabo rekonstituirati z 2 ml priloženega vehikla.
GONAL-f 1050 IU/ 1.75 ml (77 micrograms/ 1.75 ml) preparation must not be reconstituted with any other GONAL-f containers.
GONAL - f 1050 i. e. / 1, 75 ml (77 mikrogramov/ 1, 75 ml) se ne sme rekonstituirati z nobenim drugim vsebnikom GONALA- f.
The solvent pre-filled syringe provided should be used for reconstitution only and then disposed of in accordance with local requirements.
Priložen vehikel v napolnjeni injekcijski brizgi se sme uporabljati samo za rekonstitucijo in brizgo je nato treba zavreči v skladu z lokalnimi zahtevami.
A set of administration syringes graduated in FSH units is supplied in the GONAL-f Multidose box.
Škatlica z Gonalom - f za večkratno odmerjanje vsebuje komplet injekcijskih brizg za dajanje zdravila, ki so graduirane v FSH enotah.
Alternatively, a 1 ml syringe, graduated in ml, with pre-fixed needle for subcutaneous administration could be used.
Alternativno se lahko uporabi 1 ml injekcijsko brizgo, graduirano v mililitrih, z že pritrjeno injekcijsko iglo za subkutano injiciranje.
Each ml of reconstituted solution contains 600 IU r-hFSH.
Vsak mililiter pripravljene raztopine vsebuje 600 i. e. r- hFSH.
The following table states the volume to be administered to deliver the prescribed dose:
Naslednja tabela navaja injekcijske volumne, ki so potrebni za zagotavljanje predpisanega odmerka:
Individual reconstituted vials should be for single patient use only.
Posamično rekonstituirane viale sme uporabljati samo en bolnik.
The next injection should be done at the same time the next day.
Naslednjo injekcijo si mora dati naslednji dan ob istem času.
The reconstituted solution should not be administered if it contains particles or is not clear.
Pripravljene raztopine se ne sme uporabiti, če vsebuje delce ali ni bistra.
MARKETING AUTHORISATION NUMBER
ŠTEVILKA (ŠTEVILKA) DOVOLJENJA (DOVOLJENJ) ZA PROMET
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) powder and solvent for solution for injection.
GONAL - f 450 i. e. / 0, 75 ml (33 mikrogramov/ 0, 75 ml) prašek in vehikel za raztopino za injiciranje
One multidose vial contains 44 micrograms follitropin alfa, recombinant human follicle stimulating hormone (FSH) in order to deliver 33 micrograms, equivalent to 450 IU.
Ena večodmerna viala vsebuje 44 mikrogramov folitropina alfa, rekombinantnega folikle stimulirajočega hormona (FSH) za zagotovitev odmerka 33 mikrogramov, kar ustreza 450 i. e.
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) preparation must not be reconstituted with any other GONAL-f containers.
Pripravka GONAL- f 450 i. e. / 0, 75 ml (33 mikrogramov/ 0, 75 ml) se ne sme rekonstituirati z nobenim drugim vsebnikom GONALA- f.
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 preparations.
62 da njegovi dnevni odmerki, režim uporabe in postopki nadzorovanja zdravljenja ne bi smeli biti drugačni od tistih, ki se trenutno uporabljajo za pripravke z urinarnim FSH.
The object of GONAL-f therapy is to develop a single mature Graafian follicle from which the ovum will be liberated after the administration of hCG.
ilj zdravljenja z GONALOM- f je razvoj enega samega dozorelega Graafovega folikla, iz katerega se bo sprostilo jajčece po dajanju hCG- ja.
Women with anovulation resulting from severe LH and FSH deficiency:
63 Ženske z anovulacijo zaradi hudega pomanjkanja LH in FSH:
63 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).
64 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
Gonadotrophin therapy requires a certain time commitment by physicians and supportive health professionals, as well as the availability of appropriate monitoring facilities.
64 Zdravljenje z gonadotropinom zahteva od zdravnika in ostalega zdravstvenega osebja določen čas, kakor tudi razpoložljivost ustrezne opreme za nadzorovanje zdravljenja.
65 Ovarian Hyperstimulation Syndrome (OHSS)
Sindrom hiperstimulacije jajčnikov (OHSS)
The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea.
65 trebuha, hudo povečanje jajčnikov, pridobivanje telesne teže, dispneo, oligurijo in gastrointestinalne znake vključno s slabostjo, bruhanjem in drisko.
The patients should be advised of the potential risk of multiple births before starting treatment.
Izguba nosečnosti zaradi spontanega splava ali abortusa je pri bolnicah, ki so se podvrgle stimulaciji folikularne rasti za indukcijo ovarijev ali tehnik asistirane reprodukcije, višja kot pri normalni populaciji.
66 Pregnancy wastage
66 Zunajmaternična nosečnost
67 Use during lactation
Uporaba med dojenjem
4.7 Effects on ability to drive and use machines
67 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
68 Treatment in men Skin and subcutaneous tissue disorders
Splošne težave in spremembe na mestu aplikacije
Gynaecomastia Varicocele
akne vinekomastija varikokela
4.9 Overdose
68 4. 9 Preveliko odmerjanje
69 In rabbits, the formulation reconstituted with 0.9% benzyl alcohol and 0.9% benzyl alcohol alone, both resulted in a slight haemorrhage and subacute inflammation after single subcutaneous injection or mild inflammatory and degenerative changes after single intramuscular injection respectively.
Pri zajcih sta, tako pripravek rekonstituiran z 0, 9% benzilalkoholom kot sam 0, 9% benzilalkohol, povzročila rahlo krvavitev in subakutno vnetje po enkratni subkutani injekciji oziroma blago vnetje in degenerativne spremembe po enkratni intramuskularni injekciji.
After reconstitution, do not store above 25°C.
Po rekonstituciji shranjujte pri temperaturi do 25°C.
The solvent for reconstitution is presented in 1 ml pre-filled syringes (Type I glass) with a rubber stopper.
Vehikel za rekonstitucijo je na voljo v 1 ml napolnjenih injekcijskih brizgah (steklo Tipa I) z gumijastim zamaškom.
The Administration syringes made of polypropylene with a stainless steel pre-fixed needle are also provided.
Priložene so tudi polipropilenske injekcijske brizge za dajanje zdravila s pritrjeno injekcijsko iglo iz nerjavečega jekla.
The product is supplied as a pack of 1 vial of powder with 1 pre-filled syringe of solvent for reconstitution and 6 disposable syringes for administration graduated in FSH units.
Zdravilo je na voljo v škatlicah, ki vsebujejo 1 vialo s praškom, 1 napolnjeno injekcijsko brizgo z vehiklom za rekonstitucijo in 6 injekcijskih brizg za dajanje zdravila za enkratno uporabo, ki so graduirane v FSH enotah.
70 6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) must be reconstituted with the 1 ml solvent provided before use.
GONAL - f 450 i. e. / 0, 75 ml (33 mikrogramov/ 0, 75 ml) se mora pred uporabo rekonstituirati z 1 ml priloženega vehikla.
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) preparation must not be reconstituted with any other GONAL-f containers.
GONAL - f 450 i. e. / 0, 75 ml (33 mikrogramov/ 0, 75 ml) se ne sme rekonstituirati z nobenim drugim vsebnikom GONALA- f.
The following table states the volume to be administered to deliver the prescribed dose:
70 Naslednja tabela navaja injekcijske volumne, ki so potrebni za zagotavljanje predpisanega odmerka:
GONAL-f 300 IU/ 0.50 ml (22 micrograms/ 0.50 ml) powder and solvent for solution for injection.
GONAL - f 300 i. e. / 0, 50 ml (22 mikrogramov/ 0, 50 ml) prašek in vehikel za raztopino za injiciranje
One multidose vial contains 33 micrograms follitropin alfa, recombinant human follicle stimulating hormone (FSH) in order to deliver 22 micrograms, equivalent to 300 IU.
Ena večodmerna viala vsebuje 33 mikrogramov folitropina alfa, rekombinantnega folikle stimulirajočega hormona (FSH) za zagotovitev odmerka 22 mikrogramov, kar ustreza 300 i. e.
GONAL-f 300 IU/ 0.50 ml (22 micrograms/ 0.50 ml) preparation must not be reconstituted with any other GONAL-f containers.
Pripravka GONAL- f 300 i. e. / 0, 50 ml (22 mikrogramov/ 0, 50 ml) se ne sme rekonstituirati z nobenim drugim vsebnikom GONALA- f.
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 preparations.
72 da njegovi dnevni odmerki, režim uporabe in postopki nadzorovanja zdravljenja ne bi smeli biti drugačni od tistih, ki se trenutno uporabljajo za pripravke z urinarnim FSH.
73 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).
73 GONALOM- f skupaj z lutropinom alfa razvoj enega samega zrelega Graafovega folikla, iz katerega se bo sprostilo jajčece po dajanju humanega horionskega gonadotropina (hCG).
74 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.
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 74 učinkovito uporabo GONALA- f potrebno redno nadzorovanje odziva jajčnikov z ultrazvokom ali še bolje z ultrazvokom v kombinaciji z merjenjem serumskih ravni estradiola.
OHSS is a syndrome that can manifest itself with increasing degrees of severity.
Sindrom hiperstimulacije jajčnikov je zdravstveno stanje, ki se razlikuje od nekompliciranega povečanja jajčnikov.
It comprises marked ovarian enlargement, high
OHSS je sindrom, ki se lahko izrazi z naraščajočo stopnjo resnosti.
75 serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities.
Obsega izrazito povečanje jajčnikov, visoko raven spolnih steroidnih hormonov in povečano prepustnost žil, kar lahko rezultira v nabiranju tekočine v trebušni votlini, plevralni votlini in redko v osrčniku.
The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea.
Klinična ocena lahko razkrije hipovolemijo,
Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events.
75 hemokoncentracijo, elektrolitsko neravnovesje, ascites, hemoperitoneum, plevralni izliv, hidrotoraks, akutno respiratorno stisko, tromboembolične dogodke.
76 Ectopic pregnancy
76 to ali pride do zanositve spontano ali z zdravljenjem neplodnosti.
77 4.7 Effects on ability to drive and use machines
77 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
Uncommon (> 1/ 1,000, < 1/ 100)
Občasni (> 1/ 1. 000, < 1/ 100)
Severe OHSS (see section 4.4)
hud OHSS (glejte poglavje 4. 4)
Rare (> 1/ 10,000, < 1/ 1,000)
Redki (> 1/ 10. 000, < 1/ 1. 000)
Ovarian torsion, a complication of OHSS
zasuk (torzija) jajčnika, zaplet OHSS
78 Treatment in men Skin and subcutaneous tissue disorders
Zdravljenje moških
4.9 Overdose
78 4. 9 Preveliko odmerjanje
79 In rabbits, the formulation reconstituted with 0.9% benzyl alcohol and 0.9% benzyl alcohol alone, both resulted in a slight haemorrhage and subacute inflammation after single subcutaneous injection or mild inflammatory and degenerative changes after single intramuscular injection respectively.
Pri zajcih sta, tako pripravek rekonstituiran z 0, 9% benzilalkoholom kot sam 0, 9% benzilalkohol, povzročila rahlo krvavitev in subakutno vnetje po enkratni subkutani injekciji oziroma blago vnetje in degenerativne spremembe po enkratni intramuskularni injekciji.
Given in high doses (≥ 5 IU/ kg/ day) follitropin alfa caused a decrease in the number of viable foetuses without being a teratogen, and dystocia similar to that observed with urinary hMG.
V visokih odmerkih (≥ 5 i. e. / kg/ dan) je folitropin alfa povzročil zmanjšanje števila živih zarodkov, brez teratogenega učinka in distocijo, podobno tisti, opaženi pri urinarnem hMG.
The product is supplied as a pack of 1 vial of powder with 1 pre-filled syringe of solvent for reconstitution and 4 disposable syringes for administration graduated in FSH units.
Zdravilo je na voljo v škatlicah, ki vsebujejo 1 vialo s praškom, 1 napolnjeno injekcijsko brizgo z vehiklom za rekonstitucijo in 4injekcijske brizge za dajanje zdravila za enkratno uporabo, ki so graduirane v FSH enotah.
80 6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje
GONAL-f 300 IU/ 0.50 ml (22 micrograms/ 0.50 ml) must be reconstituted with the 0.75 ml solvent provided before use.
GONAL - f 300 i. e. / 0, 50 ml (22 mikrogramov/ 0, 50 ml) se mora pred uporabo rekonstituirati z 0, 75 ml priloženega vehikla.
GONAL-f 300 IU/ 0.50 ml (22 micrograms/ 0.50 ml) preparation must not be reconstituted with any other GONAL-f containers.
GONAL - f 300 i. e. / 0, 50 ml (22 mikrogramov/ 0, 50 ml) se ne sme rekonstituirati z nobenim drugim vsebnikom GONALA- f.
The following table states the volume to be administered to deliver the prescribed dose:
80 Naslednja tabela navaja injekcijske volumne, ki so potrebni za zagotavljanje predpisanega odmerka:
Dose (IU) 75 150 225 300
Odmerek (i. e.)
Volume to
Volumen, ki ga je treba injicirati (ml)
GONAL-f 300 IU/ 0.5 ml (22 micrograms/ 0.5 ml) solution for injection in a pre-filled pen.
GONAL - f 300 i. e. / 0, 5 ml (22 mikrogramov/ 0, 5 ml) raztopina za injiciranje v napolnjenem injekcijskem peresniku
Follitropin alfa*, 600 IU/ ml (equivalent to 44 micrograms/ ml).
Folitropin alfa *, 600 i. e. / ml (enakovredno 44 mikrogramov/ ml).
Each cartridge delivers 300 IU (equivalent 22 micrograms) in 0.5 ml. * Follitropin alfa is recombinant human follicle stimulating hormone (FSH) produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
(enakovredno 22 mikrogramov) v 0, 5 ml. * Folitropin alfa je rekombinantni folikle stimulirajoči hormon (FSH) izdelan s tehnologijo rekombinantne DNK na celični liniji celic jajčnika kitajskega hrčka (CHO).
30 mg sucrose, 0.555 mg disodium phosphate dihydrate, 0.225 mg sodium dihydrogen phosphate monohydrate, 0.05 mg methionine, 1.5 mg m-cresol, 0.05 mg poloxamer 188.
30 mg saharoze, 0, 555 mg natrijevega hidrogenfosfata dihidrata, 0, 225 mg natrijevega dihidrogenfosfata monohidrata, 0, 05 mg metionina, 1, 5 mg m- krezola, 0, 05 mg poloksamera 188.
Clear colourless solution.
Bistra brezbarvna raztopina.
The pH of the solution is 6.7 - 7.3.
pH raztopine je 6, 7 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 vitro oploditev (IVF), prenos gamete v jajcevod (GIFT) in prenos zigote v jajcevod (ZIFT).
The dosage recommendations given for GONAL-f are those in use for urinary FSH.
Priporočeno odmerjanje za GONAL- f je enako kot za urinarni FSH.
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
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.
82 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.
When an optimal response is obtained, a single injection of 250 micrograms r-hCG or 5 000 IU up to 10 000 IU hCG should be administered 24-48 hours after the last GONAL-f injection.
Ko je dosežen optimalen odziv, se mora dati eno samo injekcijo 5000 i. e. do 10 000 i. e. hCG- ja, 24 do 48 ur po zadnji injekciji GONALA- f.
Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilisation or other assisted reproductive technologies:
Ženske v postopku stimulacije ovarijev za doseganje razvoja več foliklov pred in vitro oploditvijo ali drugimi tehnikami asistirane reprodukcije:
A single injection of 250 micrograms r-hCG or 5 000 IU up to 10 000 IU hCG is administered 24-48 hours after the last GONAL-f injection to induce final follicular maturation.
Ena sama injekcija 250 mikrogramov r- hCG ali 5000 i. e. do 10 000 i. e. hCG se injicira 24 do 48 ur po zadnji injekciji GONALA- f, za sprožitev končnega zorenja foliklov.
Down-regulation with a gonadotrophin-releasing hormone (GnRH) agonist or antagonist is now commonly used in order to suppress the endogenous LH surge and to control tonic levels of LH.
Negativna povratna regulacija z agonistom ali antagonistom gonadotropin sproščajočega hormona (GnRH) se danes že običajno uporablja za zaviranje porasta endogenega LH in za kontroliranje toničnih ravni LH.
Women with anovulation resulting from severe LH and FSH deficiency:
Ženske z anovulacijo zaradi hudega pomankanja LH in FSH:
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 bo sprostilo jajčece po dajanju humanega horionskega gonadotropina (hCG).
83 oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG).
83 imajo nizko sekrecijo endogenega estrogena, se lahko zdravljenje začne kadarkoli.
When an optimal response is obtained, a single injection of 250 micrograms r-hCG or 5 000 IU up to 10 000 IU hCG should be administered 24-48 hours after the last GONAL-f and lutropin alfa injections.
Ko je dosežen optimalen odziv, se injicira ena sama injekcija 250 mikrogramov r- hCG ali 5000 i. e. do 10 000 i. e. hCG - ja, 24 do 48 ur po zadnji injekciji GONALA- f in lutropina alfa.
• Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients • Tumours of the hypothalamus and pituitary gland
• preobčutljivost za zdravilno učinkovino folitropin alfa, FSH ali katerokoli pomožno snov • tumorji hipotalamusa in hipofize
In women: • ovarian enlargement or cyst not due to polycystic ovarian disease • gynaecological haemorrhages of unknown aetiology • ovarian, uterine or mammary carcinoma
Pri ženskah: • povečanje jajčnika ali ciste, ki ni nastalo zaradi ovarijske policistične bolezni • ginekološka krvavitev neznane etiologije • rak na jajčniku, maternici ali dojkah
Must not be used when an effective response cannot be obtained, such as:
GONAL – f se ne sme uporabljati, kadar ni mogoče doseči učinkovitega odziva, kot je npr.:
84 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.
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 84 zdravljenja.
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.
During training of the patient for self- administration, special attention should be given to specific instructions for the use of the prefilled pen.
Pri šolanju bolnikov o samoinjiciranju, se mora posvetiti posebno pozornost uporabi napolnjenih injekcijskih peresnikov.
Patients undergoing stimulation of follicular growth, whether as treatment for anovulatory infertility or for ART procedures, may experience ovarian enlargement or develop hyperstimulation.
Pri bolnicah v postopku stimulacije folikularne rasti bodisi v okviru zdravljenja anovulacijske neplodnosti ali postopkov ART, se lahko povečajo jajčniki ali se razvije hiperstimulacija.
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.
For accurate interpretation of the indices of follicle development and maturation, the physician should be experienced in the interpretation of the relevant tests.
Akutno interpretacijo kazalcev folikelskega razvoja in dozorevanja lahko izvede le zdravnik, ki ima izkušnje na področju interpretacije relevantnih testov.
Comparison with historical data suggests that the ovulation rate obtained with GONAL-f/ LH is similar to that obtained with hMG.
Primerjava dosedanjih podatkov nakazuje, da je delež ovulacij doseženih z GONALOM- f/ LH podoben tistemu, ki ga lahko dosežemo s hMG.
85 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.
To minimise the risk of OHSS or of multiple pregnancy, ultrasound scans as well as oestradiol measurements are recommended.
85 Za zmanjšanje tveganja za OHSS ali večplodno nosečnost na minimum, se priporočajo ultrazvočni pregledi in merjenje estradiola.