natgillin/translations-raw huggingface dataset:
A commonly used regimen commences at 75-150 IU FSH daily and is increased preferably by 37.5 or 75 IU at 7 or preferably 14 day intervals if necessary, to obtain an adequate, but not excessive, response.
FSH na dan, in se ga, če je potrebno povečuje za 37, 5 ali 75 i. e. v 7 ali po možnosti 14 dnevnih intervalih, za doseganje zadostnega, a ne pretiranega odziva.
23 Women with anovulation resulting from severe LH and FSH deficiency:
Ženske z anovulacijo zaradi hudega pomanjkanja 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 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
GONAL-f should be given as a course of daily injections simultaneously with lutropin alfa.
GONAL- f se mora dajati kot zaporedje vsakodnevnih injekcij sočasno z lutropinom alfa.
If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5-75 IU increments.
Če se presodi, da je povečanje odmerka FSH primerno, se mora odmerek prilagajati po možnosti v 7 - 14 dnevnih intervalih in po možnosti s porastom za 37, 5 do 75 i. e.
and in women: • ovarian enlargement or cyst not due to polycystic ovarian disease • gynaecological haemorrhages of unknown aetiology • ovarian, uterine or mammary carcinoma
GONAL- f se ne sme uporabljati v primeru: • preobčutljivosti za zdravilno učinkovino folitropin alfa, FSH ali katerokoli pomožno snov • tumorjev hipotalamusa in hipofize ter pri ženskah z: • povečanjem jajčnika ali ciste, ki ni nastalo zaradi ovarijske policistične bolezni • ginekološko krvavitvijo neznane etiologije • rakom na jajčniku, maternici ali dojkah
GONAL-f should 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.:
In women: • primary ovarian failure • malformations of sexual organs incompatible with pregnancy • fibroid tumours of the uterus incompatible with pregnancy
Pri ženskah: • primarna odpoved jajčnikov • malformacije spolnih organov, ki niso združljive z nosečnostjo • fibroidni tumorji maternice, ki niso združljivi z nosečnostjo Pri moških: • primarna insuficienca testisov
24 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
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 24 zdravljenje z FSH se lahko med bolniki razlikuje, pri nekaterih bolnikih je odziv nas FSH zelo majhen.
No direct comparison of GONAL-f/ LH versus human menopausal gonadotrophin (hMG) has been performed.
Direktna primerjava med GONALOM– f/ LH s humanim menopavzalnim gonadotropinom (hMG) ni bila izvedena.
Very rarely, severe OHSS may be complicated by pulmonary embolism, ischemic stroke and myocardial infarction.
Klinična ocena lahko razkrije hipovolemijo, hemokoncentracijo, elektrolitsko neravnovesje, ascites, hemoperitoneum, plevralni izliv, hidrotoraks, akutno respiratorno stisko, tromboembolične dogodke Pri hudem OHSS je zelo redko lahko zaplet pljučni embolizem, ishemični cerebrovaskularni insult in miokardni infarkt.
To minimise the risk of OHSS or of multiple pregnancy, ultrasound scans as well as oestradiol measurements are recommended.
25 Za zmanjšanje tveganja za OHSS ali večplodno nosečnost na minimum, se priporočajo ultrazvočni pregledi in merjenje estradiola.
26 Reproductive system neoplasms
Novotvorbe reprodukcijskega sistema
Congenital malformation
26 Prirojene malformacije
No teratogenic risk has been reported, following controlled ovarian hyperstimulation, in clinical use with gonadotrophins.
V klinični uporabi gonadotropinov, ni poročil o tveganju teratogenosti po kontrolirani ovarijski hiperstimulaciji.
In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant hFSH.
V primeru izpostavljenosti zdravilu v času nosečnosti, ni zadostnih kliničnih podatkov, da bi lahko izključili teratogeni učinek rekombinantnega hFSH.
4.8 Undesirable effects
27 4. 8 Neželeni učinki
27 Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
The effects of an overdose of GONAL-f are unknown, nevertheless one could expect ovarian hyperstimulation syndrome to occur, which is further described in section 4.4.
28 hiperstimulacije jajčnikov, ki je podrobno opisan v poglavju 4. 4.
Non-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity and genotoxicity additional to that already stated in other sections of this SPC..
Predklinični podatki na osnovi običajnih študij toksičnosti in genotoksičnosti pri enkratnih in ponavljajočih se odmerkih, ne kažejo posebnega tveganja za človeka, razen že omenjenega v drugih poglavjih Povzetka glavnih značilnosti zdravila.
Sucrose Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Methionine Polysorbate 20 Phosphoric acid, concentrated Sodium hydroxide
Prašek: saharoza, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat, metionin, polisorbat 20,
29 Solvent:
29 fosforjeva( V) kislina, koncentrirana, natrijev hidroksid.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v 6. 6.
GONAL-f is presented as a powder and solvent for injection.
GONAL- f je v obliki praška in vehikla za raztopino za injiciranje.
The powder is presented in 3 ml vials (Type I glass), with stopper (bromobutyl rubber) and aluminium flip-off cap.
Prašek je pakiran v 3 ml viale (steklo Tipa I) z zamaškom (iz bromobutilne gume) in aluminijsko kapico, ki se odtrga na poteg.
The solvent for reconstitution is presented in either 2 or 3 ml vials (Type I glass) with stopper (teflon-coated rubber) or in 1 ml pre-filled syringes (Type I glass) with a rubber stopper.
Vehikel za rekonstitucijo je pakiran v 2 ali 3 ml viale (steklo Tipa I) z zamaškom (iz s teflonom prevlečene gume) ali v 1 ml napolnjene injekcijske brizge (steklo Tipa I) z gumijastim zamaškom.
The product is supplied in packs of 1 vials with the corresponding number of solvent vials or packs of 1, 5 or 10 vials with the corresponding number of solvent pre-filled syringes.
Zdravilo je na voljo v škatlicah z 1 vialo s praškom in ustreznim številom vial z vehiklom ali v škatlicah z 1, 5 ali 10 vial s praškom in ustreznim številom napolnjenih injekcijskih brizg z vehiklom.
In this case lutropin alfa should be reconstituted first and then used to reconstitute GONAL-f powder.
GONAL- f se lahko sočasno pripravi z lutropinom alfa in sočasno injicira kot eno samo injekcijo. V tem primeru morate najprej pripraviti raztopino lutropina alfa in jo nato uporabiti za rekonstitucijo praška GONAL- f.
20 October 1995.
20. oktober 1995.
19 October 2005.
19. oktober 2005.
GONAL-f 150 IU (11 micrograms) powder and solvent for solution for injection.
(11 mikrogramov) prašek in vehikel za raztopino za injiciranje
One vial contains 12 micrograms follitropin alfa, recombinant human follicle stimulating hormone (FSH) in order to deliver 11 micrograms, equivalent to 150 IU.
Ena viala vsebuje 12 mikrogramov folitropina alfa, rekombinantnega folikle stimulirajočega hormona (FSH) za zagotovitev odmerka 11 mikrogramov, kar ustreza 150 i. e.
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.
32 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.
Women with anovulation resulting from severe LH and FSH deficiency:
Ženske z anovulacijo zaradi hudega pomanjkanja LH in FSH:
33 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).
33 bo sprostilo jajčece po dajanju humanega horionskega gonadotropina (hCG).
Men with hypogonadotrophic hypogonadism:
Moški s hipogonadotropnim hipogonadizmom:
and in women: • ovarian enlargement or cyst not due to polycystic ovarian disease • gynaecological haemorrhages of unknown aetiology • ovarian, uterine or mammary carcinoma
ter pri ženskah z: • povečanjem jajčnika ali ciste, ki ni nastalo zaradi ovarijske policistične bolezni • ginekološko krvavitvijo neznane etiologije • rakom na jajčniku, maternici ali dojkah
In women: • primary ovarian failure • malformations of sexual organs incompatible with pregnancy • fibroid tumours of the uterus incompatible with pregnancy
Pri ženskah: • primarna odpoved jajčnikov • malformacije spolnih organov, ki niso združljive z nosečnostjo • fibroidni tumorji maternice, ki niso združljivi z nosečnostjo
34 In men: • primary testicular insufficiency
Pri moških: • primarna insuficienca testisov
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 34 bolje z ultrazvokom v kombinaciji z merjenjem serumskih ravni estradiola.
35 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.
V hudih primerih OHSS lahko opazimo naslednjo simptomatiko: bolečine v trebuhu, povečanje trebuha, hudo povečanje jajčnikov, pridobivanje telesne teže, dispneo, oligurijo in gastrointestinalne znake vključno s slabostjo, bruhanjem in drisko.
Clinical evaluation may reveal hypovolaemia, 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.
36 Ectopic pregnancy
Zunajmaternična nosečnost
It is not yet established whether or not treatment with gonadotrophins increases the baseline risk of these tumors in infertile women.
Ni pa še ugotovljeno, ali zdravljenje z gonadotropini povečuje osnovno tveganje teh tumorjev pri
37 No studies on the effects on the ability to drive and use machines have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
4.8 Undesirable effects
37 4. 8 Neželeni učinki
Acne
Zdravljenje moških
Reproductive system and breast disorders
Bolezni kože in podkožja Motnje reprodukcije in dojk
38 The effects of an overdose of GONAL-f are unknown, nevertheless one could expect ovarian hyperstimulation syndrome to occur, which is further described in section 4.4.
Učinki prevelikega odmerka GONALA- f niso znani, vendar pa lahko pričakujemo pojav sindroma hiperstimulacije jajčnikov, ki je podrobno opisan v poglavju 4. 4.
39 Methionine Polysorbate 20 Phosphoric acid, concentrated Sodium hydroxide
Prašek: saharoza, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat, metionin, polisorbat 20, fosforjeva( V) kislina, koncentrirana, natrijev hidroksid.
Water for Injections
39 Vehikel: voda za injekcije
The powder is presented in 3 ml vials (Type I glass) with stopper (bromobutyl rubber) and aluminium flip-off cap.
Prašek je pakiran v 3 ml viale (steklo Tipa I) z zamaškom (iz bromobutilne gume) in aluminijsko kapico, ki se odtrga na poteg.
The solvent for reconstitution is presented in 1 ml pre-filled syringes (Type I glass) with a rubber stopper.
Vehikel za rekonstitucijo je pakiran v 1 ml napolnjene injekcijske brizge (steklo Tipa I) z gumijastim zamaškom.
The product is supplied in packs of 1 vial with 1 solvent pre-filled syringe.
Zdravilo je na voljo v škatlicah z 1 vialo s praškom in 1 napolnjeno injekcijsko brizgo z vehiklom.
In this case lutropin alfa should be reconstituted first and then used to reconstitute GONAL-f powder.
V tem primeru se mora najprej pripraviti raztopino lutropina alfa in jo nato uporabiti za rekonstitucijo praška GONAL- f.
GONAL-f 37.5 IU (2.8 micrograms) powder and solvent for solution for injection.
(2, 8 mikrogramov) prašek in vehikel za raztopino za injiciranje
One vial contains 3 micrograms follitropin alfa, recombinant human follicle stimulating hormone (FSH) in order to deliver 2.8 micrograms, equivalent to 37.5 IU.
Ena viala vsebuje 3 mikrograme folitropina alfa, rekombinantnega folikle stimulirajočega hormona (FSH) za zagotovitev odmerka 2, 8 mikrogramov, kar ustreza 37, 5 i. e.
The reconstituted solution contains 37.5 IU/ ml.
Pripravljena raztopina vsebuje 37, 5 i. e. / ml.
• 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). • GONAL-f in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency.
• 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).
GONAL-f is intended for subcutaneous administration.
Tik pred uporabo se mora prašek rekonstituirati s priloženim vehiklom.
The powder should be reconstituted immediately prior to use with the solvent provided.
Da se izognemo injiciranju velikih volumnov, se lahko GONAL- f 37, 5 i. e.
In order to avoid the injection of large volumes, GONAL-f 37.5 IU (2.8 micrograms) may be dissolved in 1 ml of solvent and combined with GONAL-f 75 IU (5.5 micrograms) and/ or GONAL-f 150 IU (11 micrograms).
(11 mikrogramov).
Up to three vials of product may be dissolved in 1 ml of solvent.
Vsebino do treh vial zdravila se lahko raztopi v 1 ml vehikla.
42 The dosage recommendations given for GONAL-f are those in use for urinary FSH.
42 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 preparations.
Klinična ocena GONALA- f kaže, 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.
43 Women with anovulation resulting from severe LH and FSH deficiency:
Ženske z anovulacijo zaradi hudega pomanjkanja 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 oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG).
43 GONALOM- f skupaj z lutropinom alfa razvoj enega samega zrelega Graafovega folikla, iz katerega se bo sprostilo jajčece po dajanju humanega horionskega gonadotropina (hCG).
GONAL-f must not be used in: • hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients • case of tumours of the hypothalamus and pituitary gland and in women: • ovarian enlargement or cyst not due to polycystic ovarian disease • gynaecological haemorrhages of unknown aetiology • ovarian, uterine or mammary carcinoma
GONAL- f se ne sme uporabljati v primeru: • preobčutljivosti za zdravilno učinkovino folitropin alfa, FSH ali katerokoli pomožno snov • tumorjev hipotalamusa in hipofize
GONAL-f should not be used when an effective response cannot be obtained, such as:
ter pri ženskah z: • povečanjem jajčnika ali ciste, ki ni nastalo zaradi ovarijske policistične bolezni • ginekološko krvavitvijo neznane etiologije • rakom na jajčniku, maternici ali dojkah
In men: • primary testicular insufficiency
Pri moških: • primarna insuficienca testisov
44 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
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 44 učinkovito uporabo GONALA- f potrebno redno nadzorovanje odziva jajčnikov z ultrazvokom ali še bolje z ultrazvokom v kombinaciji z merjenjem serumskih ravni estradiola.
45 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.
Therefore in cases of ovarian hyperstimulation it is prudent to withhold hCG and advise the patient to refrain from coitus or to use barrier methods for at least 4 days.
Zato je v primeru hiperstimulacije jajčnikov smiselno opustiti
46 Reproductive system neoplasms
46 na jajčnikih in drugih delih reprodukcijskega sistema, tako benignih kot malignih.
47 4.8 Undesirable effects
47 4. 8 Neželeni učinki
Sucrose Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Methionine Polysorbate 20 Phosphoric acid, concentrated
Prašek: saharoza, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat, metionin, polisorbat 20, fosforjeva( V) kislina, koncentrirana, natrijev hidroksid.
49 Sodium hydroxide
49 Vehikel: voda za injekcije
GONAL-f 1050 IU/ 1.75 ml (77 micrograms/ 1.75 ml) powder and solvent for solution for injection.
GONAL - f 1050 i. e. / 1, 75 ml (77 mikrogramov/ 1, 75 ml) prašek in vehikel za raztopino za injiciranje
One multidose vial contains 87 micrograms follitropin alfa, recombinant human follicle stimulating hormone (FSH) in order to deliver 77 micrograms, equivalent to 1050 IU.
Ena večodmerna viala vsebuje 87 mikrogramov folitropina alfa, rekombinantnega folikle stimulirajočega hormona (FSH) za zagotovitev odmerka 77 mikrogramov, kar ustreza 1050 i. e.
30 mg sucrose, 1.11 mg disodium phosphate dihydrate, 0.45 mg sodium dihydrogen phosphate monohydrate
30 mg saharoze, 1, 11 mg natrijevega hidrogenfosfata dihidrata, 0, 45 mg natrijevega dihidrogenfosfata monohidrata.
Powder and solvent for solution for injection in a pre-filled syringe.
Prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi.
The pH of the reconstituted solution is 6.5 – 7.5.
pH rekonstituirane raztopine je 6, 5 do 7, 5.
The powder should be reconstituted prior to the first use with the solvent provided.
Pred prvo uporabo se mora prašek rekonstituirati s priloženim vehiklom.
GONAL-f 1050 IU/ 1.75 ml (77 micrograms/ 1.75 ml) preparation must not be reconstituted with any other GONAL-f container.
Pripravka GONAL- f 1050 i. e. / 1, 75 ml (77 mikrogramov/ 1, 75 ml) se ne sme rekonstituirati z nobenim drugim vsebnikom GONALA- f.
52 The dosage recommendations given for GONAL-f are those in use for urinary FSH.
52 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.
Bioekvivalentnost je dokazana za enake odmerke enoodmerne oblike in večodmerne oblike GONALA- f.
53 Women with anovulation resulting from severe LH and FSH deficiency:
Ženske z anovulacijo zaradi hudega pomanjkanja LH in FSH:
54 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
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 54 zdravljenje z FSH se lahko med bolniki razlikuje, pri nekaterih bolnikih je odziv nas FSH zelo majhen.
During training of the patient for self- administration, special attention should be given to specific instructions for the use of the multidose presentation.
Pri poučevanju bolnikov o samoinjiciranju, se mora posvetiti posebno pozornost specifičnim navodilom za uporabo večodmerne oblike zdravila.
As GONAL-f multidose is intended for several injections, clear instructions should be provided to the patients to avoid misuse of the multidose presentation.
Ker je GONAL- f v večodmerni obliki in je namenjen dajanju več injekcij, mora dobiti bolnik jasna navodila za uporabo, v izogib napačni uporabi večodmerne oblike zdravila.
Due to a local reactivity to benzyl alcohol, the same site of injection should not be used on consecutive days.
Zaradi lokalne odzivnosti na benzilni alkohol, se ne sme uporabiti istega mesta injiciranja dva dni zaporedoma.
55 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.
V hudih primerih OHSS lahko opazimo naslednjo simptomatiko: bolečine v trebuhu, povečanje trebuha, hudo povečanje jajčnikov, pridobivanje telesne teže, dispneo, oligurijo in gastrointestinalne znake vključno s slabostjo, bruhanjem in drisko.
Excessive ovarian response to gonadotrophin treatment seldom gives rise to OHSS unless hCG is administered to trigger ovulation.
55 Pretiran odziv jajčnikov na zdravljenje z gonadotropini se le redko razvije v OHSS, razen če se uporabi hCG za sprožitev ovulacije.
56 Pregnancy wastage
Izguba nosečnosti
Reproductive system neoplasms
56 Novotvorbe reprodukcijskega sistema
GONAL-f should not be administered as mixture with other medicinal products in the same injection.
GONALA- f se ne sme dajati v obliki mešanice z drugimi zdravili v isti injekcijski brizgi.
57 Use during lactation
Uporaba med dojenjem
4.8 Undesirable effects
57 4. 8 Neželeni učinki
58 Treatment in men Skin and subcutaneous tissue disorders
Splošne težave in spremembe na mestu aplikacije
59 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.
Sucrose Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Phosphoric acid, concentrated Sodium hydroxide
Prašek: saharoza, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat,
Solvent:
59 fosforjeva( V) kislina, koncentrirana, natrijev hidroksid.
Water for Injections Benzyl alcohol
Vehikel: voda za injekcije, benzilalkohol.
The reconstituted solution is stable for 28 days.
Rekonstituirana raztopina je stabilna 28 dni.
Prior to reconstitution, do not store above 25°C.
Pred rekonstitucijo shranjujte pri temperaturi do 25°C.
After reconstitution, do not store above 25ºC.
Po rekonstituciji shranjujte pri temperaturi do 25°C.