natgillin/translations-raw huggingface dataset:
More patients experienced at least one grade 3 or 4 adverse event in the 2-year treatment arm (20.4 %) compared with the 1-year treatment arm (16.3 %).
Več bolnikov je doživelo najmanj en neželeni dogodek stopnje 3 ali 4 v skupini z dvoletnim zdravljenjem (20,4 %) v primerjavi s skupino z enoletnim zdravljenjem (16,3 %).
The recommended dose for Herceptin subcutaneous formulation is 600 mg irrespective of the patient's body weight.
Priporočeni odmerek zdravila Herceptin v subkutani obliki je 600 mg ne glede na bolnikovo telesno maso.
• Tumour lysis syndrome (a group of metabolic complications occurring after cancer treatment characterized by high blood levels of potassium and phosphate, and low blood levels of calcium).
· Sindrom razpada tumorja (skupina presnovnih zapletov, ki se pojavijo po zdravljenju raka, za katero so značilne visoke vrednosti kalija in fosfata ter nizke vrednosti kalcija v krvi).
Do not use this medicine if you notice any particulate matter or discoloration prior to administration.
Ne uporabljajte tega zdravila, če pred njegovim dajanjem opazite kakršne koli delce ali obarvanje.
Paclitaxel2 N=77
paklitaksel2 n = 77
• followed by adequate storage of the prepared solution for intravenous infusion to ensure maintenance of the aseptic conditions
· Po pripravi je treba pripravljeno raztopino za intravensko infundiranje ustrezno shraniti, da je zagotovljeno vzdrževanje aseptičnih pogojev.
Should an infusion reaction occur the infusion should be discontinued or the rate of infusion slowed and the patient should be monitored until resolution of all observed symptoms (see section 4.2).
Če se pojavi infuzijska reakcija, je potrebno infundiranje zdravila Herceptin prekiniti ali upočasniti njegovo hitrost in bolnika nadzorovati, dokler vsi simptomi ne izzvenijo (glejte poglavje 4.2).
After transfer of the solution to the syringe, it is recommended to replace the transfer needle by a syringe closing cap to avoid drying of the solution in the needle and not compromise the quality of the medicinal product.
Po prehodu raztopine v injekcijsko brizgo je priporočljivo na iglo za prenos namestiti zaporko, da bi preprečili izsušitev raztopine in da ne bi ogrozili kakovosti zdravila.
In rare cases, these reactions were associated with a clinical course culminating in a fatal outcome.
V redkih primerih so imele te reakcije klinični potek, ki je privedel do smrtnega izida.
For early breast cancer, metastatic breast cancer and metastatic gastric cancer, Herceptin is given every 3 weeks.
Pri zgodnji obliki raka dojk, metastatskem raku dojk in metastatskem raku želodca se zdravilo Herceptin daje vsake 3 tedne.
The main test method used to determine HER2 positivity in the pivotal trial of docetaxel, with or without Herceptin, was immunohistochemistry.
Glavna testna metoda, ki so jo uporabili za določitev pozitivnosti HER2 v ključnem preskušanju docetaksela skupaj z zdravilom Herceptin ali brez njega, je bila imunohistokemija.
• The active substance is trastuzumab.
· Učinkovina je trastuzumab.
If the initial loading dose was well tolerated, the subsequent doses can be administered as a 30-minute infusion.
Če je bolnik uvajalni odmerek dobro prenašal, lahko nadaljnje odmerke dajemo kot 30-minutne infuzije.
In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of Herceptin, or longer if a continuous decrease of LVEF is observed.
Pri bolnikih, ki prejemajo kemoterapijo z antraciklini, je priporočljivo nadaljnje spremljanje, ki ga je treba izvajati letno do 5 let po zadnjem dajanju zdravila Herceptin ali dlje, če iztisni delež levega prekata (LVEF) stalno pada.
Recombinant human hyaluronidase (rHuPH20) L-histidine
rekombinantna humana hialuronidaza (rHuPH20) L-histidin
1 Blood pressure decreased
1znižanje krvnega tlaka
Your doctor will advise you of the risks and benefits of taking Herceptin during pregnancy.
Zdravnik vam bo svetoval glede tveganja in koristi uporabe zdravila Herceptin v času nosečnosti.
Herceptin subcutaneous formulation contains recombinant human hyaluronidase (rHuPH20), an enzyme used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously.
Subkutana oblika zdravila Herceptin vsebuje humano hialuronidazo (rHuPH20), encim, ki se uporablja za povečanje disperzije in absorpcije sočasno dajanih subkutanih zdravil.
For the other parameters the improvements seen for the combination were for overall response (16.5 % versus 6.7 %); clinical benefit rate (42.7 % versus 27.9 %); time to progression (4.8 months versus 2.4 months).
Pri drugih parametrih so bila izboljšanja pri kombinaciji vidna pri celokupnem odgovoru (16,5 % v primerjavi s 6,7 %), deležu klinične koristi (42,7 % v primerjavi s 27,9 %) in času do napredovanja bolezni (4,8 meseca v primerjavi z
Your doctor may consider switching your Herceptin intravenous treatment to Herceptin subcutaneous treatment (and vice versa) if considered appropriate for you.
Zdravnik bo morda razmislil o prehodu z zdravljenja z intravensko obliko zdravila Herceptin na zdravljenje s podkožno obliko zdravila Herceptin (in obratno), če bo smatral, da je to za vas primerno.
It is important to check the product labels to ensure that the correct formulation (intravenous or subcutaneous fixed dose) is being administered to the patient, as prescribed.
Pomembno je preveriti ovojnino zdravila in zagotoviti, da bolnik prejme pravilno obliko (intravensko ali subkutano s fiksnim odmerkom), kot mu je bila predpisana.
• You should use effective contraception during treatment with Herceptin and for at least 7 months after treatment has ended.
· Med zdravljenjem z zdravilom Herceptin in vsaj še 7 mesecev po zaključku zdravljenja morate uporabljati učinkovito kontracepcijo.
In addition, comparison of two years of Herceptin treatment versus one year of Herceptin treatment was performed.
Poleg tega so izvedli primerjavo dvoletnega zdravljenja z zdravilom Herceptin z enoletnim zdravljenjem z zdravilom Herceptin.
Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in Section 4.4.
Podrobnosti o dejavnostih za zmanjšanje tveganja v skladu z evropskim načrtom za obvladovanje tveganja (RMP) so navedene v poglavju 4.4.
After aseptic dilution in polyvinylchloride, polyethylene or polypropylene bags containing sodium chloride 9 mg/mL (0.9 %) solution for injection, chemical and physical stability of Herceptin has been demonstrated for up to 30 days at 2 oC - 8oC, and 24 hours at temperatures not exceeding 30°C.
Po aseptičnem redčenju v polivinilkloridnih, polietilenskih ali polipropilenskih vrečkah, ki vsebujejo raztopino 9 mg/ml (0,9 %) natrijevega klorida za injiciranje, je kemijska in fizikalna stabilnost zdravila Herceptin dokazana do 30 dni pri temperaturi 2 °C-8 °C in 24 ur pri temperaturah, ki ne presežejo 30 °C.
On very rare occasions, patients have experienced the onset of infusion symptoms and pulmonary symptoms more than six hours after the start of the Herceptin infusion.
V zelo redkih primerih so se infuzijski in pljučni simptomi pojavili več kot šest ur po začetku infuzije zdravila Herceptin.
No. patients with event p=0.0555 * defined as absence of any invasive cancer both in the breast and axillary nodes
p = 0,0555 * Definiran kot odsotnost kakršnega koli invazivnega raka v dojkah in aksilarnih bezgavkah IZ = interval zaupanja
The rate of serious infections (most of which were identified because of in-patient hospitalisation or prolongation of existing hospitalisation) was 4.4 % in the Herceptin intravenous formulation arm and 8.1 % in the Herceptin subcutaneous formulation arm.
Odstotek resnih okužb (večino so odkrili zaradi hospitalizacije bolnika ali podaljšanja obstoječe hospitalizacije) je bil 4,4 % v skupini z intravensko obliko zdravila Herceptin in 8,1 % v skupini s subkutano obliko.
Overall survival (death) - No. patients with event - No. patients without event
Celokupno preživetje (smrt) - št. bolnikov z dogodkom - št. bolnikov brez dogodka
The final results of study BO22227 at a median follow-up exceeding 70 months were also consistent with the known safety profile for Herceptin IV and Herceptin SC, and no new safety signals were observed.
Končni rezultati študije BO22227 pri mediani spremljanja, ki je presegla 70 mesecev, so bili v skladu z znanima varnostnima profiloma za intravensko in subkutano obliko zdravila Herceptin; novih varnostnih signalov niso opazili.
Most of the patients (79 %) who developed cardiac dysfunction in these trials experienced an improvement after receiving standard treatment for CHF.
Pri večini bolnikov (79 %), pri katerih so se pojavile motnje v delovanju srca v teh preskušanjih, je prišlo do izboljšanja po standardnem zdravljenju za kongestivno srčno popuščanje.
The rate of asymptomatic cardiac dysfunction was increased in the 2-year treatment arm (8.1 % versus 4.6 % in the 1-year treatment arm).
Delež asimptomatskih motenj v delovanju srca je bil večji v skupini z dvoletnim zdravljenjem (8,1 % v primerjavi s 4,6 % v skupini z enoletnim zdravljenjem).
The interval between consecutive Herceptin subcutaneous formulation administrations should not be less than three weeks.
Interval med zaporednima odmerkoma zdravila Herceptin v subkutani obliki ne sme biti krajši od treh tednov.
• increased muscle tone or tension (hypertonia)
· povečan mišični tonus ali napetost
Herceptin is for single-use only.
Zdravilo Herceptin je le za enkratno uporabo.
The safety of continuation or resumption of Herceptin in patients who experience cardiac dysfunction has not been prospectively studied.
Varnosti nadaljevanja ali ponovnega dajanja zdravila Herceptin pri bolnikih, pri katerih se je pojavila motnja v delovanju srca, niso proučevali prospektivno.
The frequency of progression in the liver was significantly reduced in patients treated with the combination of Herceptin and paclitaxel, compared to paclitaxel alone (21.8 % versus 45.7 %; p=0.004).
Pogostnost napredovanja v jetrih je bila signifikantno zmanjšana pri bolnikih, zdravljenih s kombinacijo zdravila Herceptin in paklitaksela, v primerjavi s samim paklitakselom (21,8 % v primerjavi s 45,7 %; p = 0,004).
Always keep this medicine in the closed original pack at a temperature of 2ºC - 8 ºC in a refrigerator.
Zdravilo shranjujte v dobro zaprti originalni ovojnini pri temperaturi 2 °C-8 °C, v hladilniku.
• If you are pregnant, think you may be pregnant or are planning to have a baby, you must tell your doctor, pharmacist or nurse before taking this medicine.
Nosečnost · Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden boste prejeli to zdravilo.
If you develop any signs of heart failure (inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Herceptin treatment.
Če bodo pri vas nastopili kakršni koli znaki srčnega popuščanja (to je, da vaše srce ne črpa krvi v zadostni meri), bo zdravnik delovanje vašega srca preveril pogosteje (vsakih šest do osem tednov); lahko prejmete zdravila proti srčnemu popuščanju ali pa boste morda morali prenehati z zdravljenjem z zdravilom Herceptin.
Portsmouth, NH 03801 USA
Lonza Portsmouth 101 International Dr. Portsmouth, NH 03801 ZDA
Trastuzumab may persist in the circulation for up to 7 months after stopping Herceptin treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Trastuzumab je lahko po prenehanju zdravljenja z zdravilom Herceptin v krvnem obtoku prisoten do 7 mesecev glede na populacijsko farmakokinetično analizo vseh razpoložljivih podatkov (glejte poglavje 5.2).
No long-term animal studies have been performed to establish the carcinogenic potential of Herceptin, or to determine its effects on fertility in males.
Za ugotovitev kancerogenega potenciala zdravila Herceptin ali učinkov na plodnost pri moških niso opravili nobenih dolgotrajnih študij na živalih.
Severe adverse events (defined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE grade ≥3) version 3.0) were equally distributed between both Herceptin formulations (52.3 % versus 53.5 % in the intravenous formulation versus subcutaneous formulation respectively).
Resni neželeni učinki (opredeljeni s kriteriji National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE stopnje ≥ 3), različica 3.0) so bili enakomerno porazdeljeni med obe obliki zdravila Herceptin (52,3 % pri intravenski obliki v primerjavi s 53,5 % pri subkutani obliki).
Post-hoc exploratory analysis with DFS and symptomatic cardiac events Long term follow-up**
Post-hoc explorativna analiza z dogodki preživetja brez bolezni in simptomatskimi srčnimi dogodki Dolgoročno spremljanje**
Studies of HER2-positivity rates in gastric cancer (GC) using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) have shown that there is a broad variation of HER2-positivity ranging from 6.8 % to 34.0 % for IHC and 7.1 % to 42.6 % for FISH.
Študije stopnje HER2-pozitivnosti pri raku želodca s pomočjo imunohistokemije (IHC) in fluorescenčne hibridizacije in situ (FISH) ali kromogene hibridizacije in situ (CISH) so pokazale veliko variabilnost HER2-pozitivnosti - od 6,8 % do 34,0 % za metodo IHC in 7,1 % do 42,6 % za metodo FISH.
(≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare
pogosti (³ 1/100 do < 1/10), občasni (³ 1/1000 do < 1/100), redki (³ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznano (ni mogoče oceniti iz razpoložljivih podatkov).
A single dose study in rabbits and a 13-week repeat dose toxicity study in Cynomolgus monkeys were conducted.
Opravili so študijo z enim odmerkom pri zajcih in 13-tedensko študijo toksičnosti z večkratnim odmerjanjem pri opicah Cynomolgus.
• You have metastatic gastric cancer with high levels of HER2, when it is in combination with the other cancer medicines capecitabine or 5-flououracil and cisplatin.
· imate metastatskega raka želodca, pri katerem so izražene velike količine HER2, v kombinaciji z drugimi zdravili za zdravljenje raka, kapecitabinom ali 5-fluorouracilom in cisplatinom.
The median Tmax following subcutaneous administration was approximately 3 days, with high interindividual variability (range 1-14 days).
Mediani tmax je bil po subkutanem dajanju približno 3 dni, variabilnost med posamezniki je bila velika
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Posodobljen RMP je treba predložiti: · na zahtevo Evropske agencije za zdravila; · ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
tender, or hard.
ima modrice, je nežna ali trda.
• blood infection.
· okužba krvi
The median duration of follow-up in the Herceptin arm was 3.8 years.
Mediana spremljanja v skupini, ki je prejemala zdravilo Herceptin, je bila 3,8 leta.
Other side effects can occur at any time during treatment with Herceptin, not just related to an infusion.
Drugi neželeni učinki se lahko pojavijo kadar koli med zdravljenjem z zdravilom Herceptin in niso povezani le z infuzijo.
The efficacy of Herceptin in combination with paclitaxel in patients who did not receive prior adjuvant anthracyclines has not been studied.
Učinkovitost zdravila Herceptin v kombinaciji s paklitakselom pri bolnikih, ki niso prejeli predhodne kemoterapije z antraciklinom, ni bila proučevana.
Study JP19959 was a substudy of BO18255 (ToGA) performed in male and female Japanese patients with advanced gastric cancer to study the pharmacokinetics of capecitabine and cisplatin when used with or without Herceptin.
Študija JP19959 je bila podštudija BO18255 (ToGA) pri japonskih bolnikih in bolnicah z napredovalim rakom želodca, v kateri so proučevali farmakokinetiko kapecitabina in cisplatina z zdravilomHerceptin ali brez njega.
No loading dose is required.
Uvajalni odmerek ni potreben.
50 %, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks.
50 %, zdravljenje prekinemo in ponovno opravimo meritev LVEF v približno treh tednih.
Once transferred from the vial to the syringe the medicinal product is physically and chemically stable for 28 days at 2°C - 8°C and for 6 hours (cumulative time in the vial and the syringe) at ambient temperature (max. 30°C) in diffused daylight.
Potem ko zdravilo preide iz viale v injekcijsko brizgo, je fizikalno in kemično stabilno28 dni pri temperaturi od 2 °C do 8 °C in 6 ur (skupni čas v viali in injekcijski brizgi) pri sobni temperaturi (največ 30 °C) v razpršeni dnevni svetlobi.
Single doses of up to 960 mg of Herceptin subcutaneous formulation have been administered with no reported untoward effects.
4.9 Preveliko odmerjanje Enkratne odmerke subkutane oblike zdravila Herceptin do 960 mg so dajali brez poročil o neželenih učinkih.
Trastuzumab washout period was assessed following subcutaneous administration using the population PK model.
Obdobje izpiranja trastuzumaba je bilo ocenjeno po subkutani aplikaciji zdravila s pomočjo populacijskega farmakokinetičnega modela.
If a pregnant woman is treated with Herceptin, or if a patient becomes pregnant while receiving Herceptin or within 7 months following the last dose of Herceptin, close monitoring by a multidisciplinary team is desirable.
Če se noseča ženska zdravi z zdravilom Herceptin ali če bolnica zanosi med zdravljenjem z zdravilom Herceptin ali v obdobju 7 mesecev po prejemu zadnjega odmerka zdravila Herceptin, je zaželeno, da jo skrbno spremlja multidisciplinarna ekipa.
(see section 6.2).
(glejte poglavje 4.4).
In the pivotal trial of docetaxel (100 mg/m2 infused over 1 hour) with or without Herceptin, 60 % of the patients had received prior anthracycline-based adjuvant chemotherapy.
(100 mg/m2, infudirano v 1 uri) z zdravilom Herceptin ali brez njega je 60 % bolnikov predhodno prejelo adjuvantno kemoterapijo na osnovi antraciklinov.
Body weight and serum alanine aminotransferase (SGPT/ALT) showed a statistically significant influence on PK, however, simulations demonstrated that no dose adjustments are required in EBC patients.
Telesna masa in serumska alanin-aminotransferaza (SGPT/ALT) sta imeli statistično pomemben vpliv na farmakokinetiko, vendar so simulacije pokazale, da prilagajanje odmerkov pri bolnikih z zgodnjim rakom dojk ni potrebno.
IHC is recommended as the first testing modality and in cases where HER2 gene amplification status is also required, either a silver-enhanced in situ hybridization (SISH) or a FISH technique must be applied.
Kot prva metoda je priporočena imunohistokemijska metoda, v primerih, ko pa je potreben tudi status amplifikacije gena HER2, pa je treba uporabiti tehniko hibridizacije in situ s srebrom (SISH) ali FISH.
An absolute benefit of 13 percentage points in favour of the Herceptin arm was estimated in terms of 3-year event-free survival rate (65 % versus.
Absolutna korist 13 odstotnih točk v prid skupini, ki je prejemala zdravilo Herceptin, je bila ocenjena v smislu 3-letnega preživetja brez bolezni (65 % proti 52 %).
If the patient has missed a dose of Herceptin by more than one week, a re-loading dose of Herceptin should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg) as soon as possible.
Če je bolnik izpustil odmerek zdravila Herceptin za več kot en teden, mu je treba čim prej ponovno dati uvajalni odmerek zdravila Herceptin v približno 90 minutah (tedenski režim: 4 mg/kg; 3-tedenski režim: 8 mg/kg).
The majority of patients with cardiac symptoms and evidence of a clinical benefit of Herceptin treatment continued on therapy without additional clinical cardiac events.
Pri večini bolnikov s srčnimi simptomi in znaki klinične koristi zdravljenja z zdravilom Herceptin je nadaljevanje zdravljenja z njim potekalo brez dodatnih kliničnih zapletov v delovanju srca.
Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in (section 4.4) Warnings and Precautions.
Podrobnosti o dejavnostih za zmanjšanje tveganja v skladu z evropskim načrtom za obvladovanje tveganja (RMP) so navedene v poglavju Posebna opozorila in previdnostni ukrepi (poglavje 4.4).
In addition, treatment of lower body weight patients with Herceptin subcutaneous fixed dose in adjuvant EBC was not associated with increased safety risk, adverse events and serious adverse events, compared to the higher body weight patients.
Poleg tega adjuvantno zdravljenje bolnikov z zgodnjim rakom dojk s fiksnim odmerkom subkutane oblike zdravila Herceptin in manjšo telesno maso ni bilo povezano z večjim tveganjem za varnost, večjim številom neželenih učinkov in resnih neželenih učinkov v primerjavi z bolniki z večjo telesno maso.
In a method comparison study (study D008548) a high degree of concordance (>95 %) was observed for SISH and FISH techniques for the detection of HER2 gene amplification in gastric cancer patients.
V študiji za primerjavo metod (študija D008548) so med tehnikama SISH in FISH za ugotavljanje amplifikacije gena HER2 pri bolnikih z rakom želodca ugotovili visoko stopnjo ujemanja (> 95 %).
- capecitabine - 1000 mg/m2 orally twice daily for 14 days every 3 weeks for 6 cycles
kapecitabin - 1000 mg/m2 peroralno dvakrat na dan 14 dni vsake 3 tedne, skupaj 6 ciklov
* Observed with combination therapy following anthracyclines and combined with taxanes
* Opaženo pri kombinirani uporabi po antraciklinih in sočasno s taksani.
Other side effects can occur at any time during treatment with Herceptin.
Drugi neželeni učinki se lahko pojavijo kadar koli med zdravljenjem z zdravilom Herceptin.
Table 6 Efficacy Results from Study BO16348
Rezultati učinkovitosti študije BO16348
Cysts and polyps)
(vključno s cistami in polipi)
Some of these symptoms can be serious and some patients have died (see the section “Warnings and precautions”).
Nekateri od teh simptomov so lahko resni in opisani so primeri smrti (glejte poglavje Opozorila in previdnostni ukrepi).
• performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products.
· Pripravo mora izvesti usposobljeno osebje v aseptičnih pogojih v skladu s pravili dobre prakse,
(95 % CI)
(95-% IZ)
In patients receiving Herceptin after completion of adjuvant chemotherapy, the risk of cardiac dysfunction was associated with a higher cumulative dose of anthracycline given prior to initiation of Herceptin and a body mass index (BMI) >25 kg/m2.
Pri bolnikih, ki so prejemali zdravilo Herceptin po zaključku adjuvantne kemoterapije, je bilo tveganje za pojav motnje v delovanju srca povezano z višjim kumulativnim odmerkom antraciklina, ki so ga dajali pred uvedbo zdravila Herceptin in visokim indeksom telesne mase (body mass index - BMI) > 25 kg/m2.
Serious reactions to intravenous Herceptin have been treated successfully with supportive therapy such as oxygen, beta-agonists, and corticosteroids.
Resne reakcije po intravensko dajanem zdravilu Herceptin so uspešno zdravili s podpornim zdravljenjem, kot so kisik, beta agonisti in kortikosteroidi.
A volume overage of 4 % ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Štiri odstoten presežek volumna omogoča, da na nalepki naveden odmerek 150 mg res odvzamemo iz viale.
METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use only.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Le za subkutano uporabo.
Description of selected adverse reactions with the subcutaneous formulation
Opis izbranih neželenih učinkov pri subkutani obliki