FrancophonIA/ELRC3.0 huggingface dataset:
English: <No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to {Active substance} is negligible.>
Slovenian: <Učinkov na dojene novorojence/otroke se ne pričakuje, ker je sistemska izpostavljenost doječih mater {zdravilna učinkovina} zanemarljiva.>
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja.
English: <{Active substance}/metabolites are excreted in human milk, but at therapeutic doses of {Invented name} no effects on the breastfed newborns/infants are anticipated.>
Slovenian: <{Zdravina učinkovina}/presnovki se izločajo v materino mleko, vendar se pri terapevtskih odmerkih zdravila {Lastniško ime} ne pričakuje učinkov na dojene novorojence/otroke.>
English: {Invented name} should not be used <during pregnancy><during {trimester} of pregnancy> unless the clinical condition of the woman requires treatment with {Active substance}.
Slovenian: Zdravila {Lastniško ime} ne smete uporabljati <pri nosečnicah><med {trimester} nosečnosti>, razen če klinično stanje nosečnice zahteva zdravljenje z {zdravilna učinkovina}.
English: <{Active substance}/metabolites are excreted in human milk to such an extent that effects on the breastfed newborns/infants are likely.>
Slovenian: <{Zdravilna učinkovina}/presnovki se v materino mleko izločajo v tolikšnem obsegu, da je možen učinek na dojene novorojence/otroke.>
English: [1] <{Active substance}/metabolites are excreted in human milk and effects have been shown in breastfed newborns/infants of treated women.>
Slovenian: [1] <{Zdravilna učinkovina}/presnovki se izločajo v materino mleko in povzročajo učinke pri dojenih novorojencih/otrocih zdravljenih žensk.>
English: <{Active substance}/metabolites are not excreted in human milk.>
Slovenian: <{Zdravilna učinkovina}/presnovki se ne izločajo v materino mleko.>
English: [2] <Based on human experience [specify] {Active substance} is suggested / suspected to cause congenital malformations [specify] when administered during pregnancy.
Slovenian: [2] <Na podlagi izkušenj pri ljudeh [specify] se domneva/sumi, da {zdravilna učinkovina} povzroča kongenitalne malformacije [specify], če jo jemljejo nosečnice.
English: [2] <It is unknown whether {Active substance}/metabolites are excreted in human milk.>
Slovenian: [2] <Ni znano, ali se {zdravilna učinkovina}/presnovki izločajo v materino mleko.>
English: {Invented name} is not recommended <during pregnancy><during {trimester} of pregnancy> and in women of childbearing potential not using contraception.>
Slovenian: Zdravila {Lastniško ime} ne uporabljajte <pri nosečnicah><med {trimester} nosečnosti> in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.>
English: [3] <Based on human experience [specify] {Active substance} is suggested / suspected to cause congenital malformations [specify] when administered during pregnancy.
Slovenian: [3] <Na podlagi izkušenj pri ljudeh [specify] se domneva/sumi, da {zdravilna učinkovina} povzroča kongenitalne malformacije [specify], če jo jemljejo nosečnice.
English: <{Active substance}/metabolites have not been identified in plasma of breastfed newborns/infants of treated mothers.>
Slovenian: <{Zdravilna učinkovina}/presnovkov niso ugotovili v plazmi dojenih novorojencev/otrok zdravljenih mater.>
English: [5] <There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of {Active substance} in pregnant women.
Slovenian: [5] <Podatkov o uporabi {zdravilna učinkovina} pri nosečnicah ni oziroma so omejeni (manj kot 300 izpostavljenih nosečnosti).
English: <There is insufficient information on the excretion of {Active substance}/metabolites in animal milk.>
Slovenian: < Ni dovolj podatkov o izločanju {zdravilne učinkovine}/presnovkov v živalsko mleko.>
English: <{Active substance}/metabolites have been identified in breastfed newborns/infants of treated women.
Slovenian: <{Zdravilna učinkovina}/presnovke so ugotovili pri dojenih novorojencih/otrocih zdravljenih žensk.
English: [8] <A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no malformative nor feto/ neonatal toxicity of {Active substance}.>
Slovenian: [8] <Večje število podatkov o uporabi {zdravilna učinkovina} pri nosečnicah (več kot 1000 izpostavljenih nosečnosti) ne kaže na <njeno> <njegovo> malformacijsko ali feto/neonatalno toksičnost.>
English: [4] <There are no or limited amount of data from the use of {Active substance} in pregnant women.
Slovenian: [4] <Podatkov o uporabi {zdravilna učinkovina} pri nosečnicah ni oziroma so omejeni.
English: <Physico-chemical data suggest excretion of {Active substance}/metabolites in human milk.>
Slovenian: <Na podlagi fizikalno-kemijskih podatkov se predvideva izločanje {zdravilna učinkovina}/presnovkov v materino mleko.>
English: [Version 07-200810-2009]
Slovenian: (glejte poglavje 5.3).
English: <Breast-feeding should be discontinued during treatment with {Invented name}.>
Slovenian: <Med zdravljenjem z zdravilom {Lastniško ime} je treba prenehati z dojenjem.>
English: [6] <A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of {Active substance}.
Slovenian: [6] <Manjše število podatkov o uporabi {zdravilna učinkovina} pri nosečnicah (med 300 in 1000 izpostavljenih nosečnosti) ne kaže na <njeno><njegovo> malformacijsko ali feto/neonatalno toksičnost.
English: [7] <A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of {Active substance}.>
Slovenian: [7] <Manjše število podatkov o uporabi {zdravilna učinkovina} pri nosečnicah (med 300 in 1000 izpostavljenih nosečnosti) ne kaže na <njeno><njegovo> malformacijsko ali feto/neonatalno toksičnost.
English: The use of {invented name} may be considered <during pregnancy><during {trimester} of pregnancy>, if necessary.
Slovenian: Če je potrebno, se lahko pretehta možnost uporabe zdravila {Lastniško ime} <med nosečnostjo><med {trimester} nosečnosti>.
English: As a precautionary measure, it is preferable to avoid the use of {Invented name} <during pregnancy> <during {trimester} of pregnancy>.
Slovenian: Iz previdnostnih razlogov se je med <nosečnostjo><med {trimester} nosečnosti> uporabi zdravila {Lastniško ime} bolje izogibati.>
English: {Invented name} can be used <during pregnancy><during {trimester} of pregnancy> if clinically needed.
Slovenian: Če je klinično potrebno, se zdravilo {Lastniško ime} lahko uporablja <med nosečnostjo><med {trimester} nosečnosti>.
English: [3] <No effects of {Active substance} have been shown in breastfed newborns/infants of treated mothers.>
Slovenian: [3] <Pri dojenih novorojencih/otrocih zdravljenih žensk ni bilo ugotovljenih učinkov {zdravilna učinkovina}.>
English: This summary was last updated in 04-2011.
Slovenian: Ta povzetek je bil nazadnje posodobljen 04-2011.
English: The recommended dose of Adrovance is one tablet once a week.
Slovenian: Priporočeni odmerek zdravila Adrovance je ena tableta enkrat tedensko.
English: It is intended for long-term use.
Slovenian: Zdravilo je namenjeno dolgotrajni uporabi.
English: This authorisation was based on the authorisation granted to Fosavance in 2005 (‘informed consent').
Slovenian: To dovoljenje temelji na dovoljenju, ki je bilo leta 2005 odobreno za zdravilo Fosavance (s „privolitvijo po soglasju“).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Adrovance to Merck Sharp & Dohme Ltd. on 4 January 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Adrovance, veljavno po vsej Evropski uniji, odobrila družbi Merck Sharp & Dohme Ltd. dne 4. januarja 2007.
English: The full EPAR for Adrovance can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Adrovance je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The main measure of effectiveness was the reduction in the number of patients with low vitamin D levels after 15 weeks.
Slovenian: Glavno merilo učinkovitosti je bilo zmanjšanje števila bolnikov z nizko ravnjo vitamina D po 15 tednih zdravljenja.
English: For more information about treatment with Adrovance, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Adrovance preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: Gradually, the bones become thin and fragile, and more likely to break.
Slovenian: Kosti se tako postopoma redčijo ter postajajo krhkejše in posledično bolj lomljive.
English: The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink or other medicines (including antacids, calcium supplements and vitamins).
Slovenian: Bolnik mora tableto zaužiti s polnim kozarcem vode (vendar ne mineralne), in sicer najmanj 30 minut pred zaužitjem hrane, pijače ali drugih zdravil (vključno z antacidi, dodatki kalcija in vitamini).
English: Alendronic acid is a bisphosphonate that has been used in osteoporosis since the mid-1990s.
Slovenian: Alendronska kislina je difosfonat, ki se pri zdravljenju osteoporoze uporablja od sredine devetdesetih let prejšnjega stoletja.
English: This is a summary of the European public assessment report (EPAR) for Adrovance.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Adrovance.
English: What benefit has Adrovance shown during the studies?
Slovenian: Kakšne koristi je zdravilo Adrovance izkazalo med študijami?
English: The tablet should be swallowed whole and not crushed, chewed or allowed to dissolve in the mouth.
Slovenian: Bolnik mora tableto pogoltniti celo in je ne sme zdrobiti, žvečiti ali raztopiti v ustih.
English: Other information about Adrovance
Slovenian: Druge informacije o zdravilu Adrovance
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adrovance.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Adrovance, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in Adrovance.
Slovenian: Ker bolniki z osteoporozo z izpostavljanjem sončni svetlobi morda ne dobijo dovolj vitamina D3, je ta vključen v zdravilo Adrovance.
English: Vitamin D3, along with other forms of vitamin D, is required for calcium absorption and normal bone formation.
Slovenian: Vitamin D3 je skupaj z drugimi vrstami vitamina D potreben za absorpcijo kalcija in normalno tvorbo kostne mase.
English: Vitamin D3 is a nutrient that is found in some foods, but also made in the skin through exposure to natural sunlight.
Slovenian: Vitamin D3 je hranilna snov, ki jo najdemo v nekaterih vrstah hrane, z izpostavljanjem naravni sončni svetlobi pa nastaja tudi v koži.
English: The most common side effects with Adrovance are headache, abdominal pain (stomach ache), dyspepsia (heartburn), constipation, diarrhoea, flatulence (gas), oesophageal (gullet) ulcers, dysphagia (difficulty swallowing), abdominal distension (swollen tummy), acid regurgitation and musculoskeletal pain (pain in the muscles, bones and joints).
Slovenian: Najpogostejši neželeni učinki zdravila Adrovance so glavobol, bolečine v trebuhu, dispepsija (zgaga), zaprtje, driska, flatulenca (vetrovi), razjede požiralnika, disfagija (težave pri požiranju), napihnjen trebuh, refluks kisline in mišično-skeletne bolečine (bolečine v mišicah, kosteh in sklepih).
English: It slows the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Slovenian: Upočasni delovanje osteoklastov, celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
English: Because alendronic acid and vitamin D3 are already used separately in authorised medicines in the European Union (EU), the company presented data obtained in earlier studies and from the published literature from women who had been through the menopause and who were taking alendronic acid and vitamin D as separate tablets.
Slovenian: Ker se alendronska kislina in vitamin D3 ločeno že uporabljata v zdravilih, odobrenih v EU, je družba predložila podatke iz starejših študij ter iz objavljene literature o ženskah, ki so že prestale menopavzo in so jemale alendronsko kislino in vitamin D kot ločeni tableti.
English: The CHMP decided that Adrovance's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Adrovance večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: It must not be used in patients who have abnormalities of the oesophagus, who have hypocalcaemia (low calcium levels), or who cannot stand or sit upright for at least 30 minutes.
Slovenian: Ne smejo ga uporabljati bolniki z nepravilnostmi v požiralniku, bolniki s hipokalciemijo (nizkimi ravnmi kalcija) ali bolniki, ki ne morejo stati ali sedeti vzravnano vsaj 30 minut.
English: What is the risk associated with Adrovance?
Slovenian: Kakšna tveganja so povezana z zdravilom Adrovance?
English: Adrovance alendronic acid / colecalciferol
Slovenian: Adrovance alendronska kislina in holekalciferol
English: The information presented by the company from earlier studies and the published literature showed that the dose of alendronic acid included in Adrovance was the same as the dose needed to prevent bone loss.
Slovenian: Podatki iz starejših študij in objavljene literature, ki jih je predstavila družba, so pokazali, da je odmerek alendronske kisline v zdravilu Adrovance enak odmerku, ki je potreben za preprečevanje izgube kostne mase.
English: Adrovance should not be used in people who may be hypersensitive (allergic) to alendronic acid, vitamin D3 or any of the other ingredients.
Slovenian: Zdravila Adrovance ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) alendronsko kislino, vitamin D3 ali katero koli drugo sestavino zdravila.
English: It is available as white tablets (capsule-shaped: 70 mg alendronic acid and 2,800 international units [IU] colecalciferol; rectangular: 70 mg alendronic acid and 5,600 IU colecalciferol).
Slovenian: Na voljo je kot bele tablete (v obliki kapsule: 70 mg alendronske kisline in 2 800 mednarodnih enot [i.e.] holekalciferola; pravokotne oblike: 70 mg alendronske kisline in 5 600 i.e. holekalciferola).
English: For the full list of all side effects reported with Adrovance, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Adrovance, glejte navodilo za uporabo.
English: To avoid irritation of the oesophagus (gullet), the patient should not lie down until after their first food of the day, which should be at least 30 minutes after taking the tablet.
Slovenian: Da bi preprečili draženje požiralnika (cevke, ki vodi od ust do želodca), bolnik ne sme leči, dokler ne zaužije prvega dnevnega obroka hrane, kar pa ne sme biti prej kot 30 minut po zaužitju tablete.
English: Why has Adrovance been approved?
Slovenian: Zakaj je bilo zdravilo Adrovance odobreno?
English: This study was extended in 652 patients for a further 24 weeks to compare the effects on continuing with Adrovance 70 mg/2,800 IU on its own or adding another 2,800 IU vitamin D3 (equivalent to using Adrovance 70 mg/5,600 IU).
Slovenian: Ta študija je bila pri 652 bolnikih podaljšana za nadaljnjih 24 tednov, da bi primerjali učinke nadaljevanja zdravljenja samo z zdravilom Adrovance 70 mg/2 800 i.e. z učinki dodajanja 2 800 i.e. vitamina D3 (kar je enakovredno uporabi zdravila Adrovance 70 mg/5 600 i.e.).
English: Patients received either Adrovance 70 mg/2,800 IU or alendronic acid only once a week.
Slovenian: Bolniki so enkrat tedensko prejemali bodisi zdravilo Adrovance 70 mg/2 800 i.e. bodisi le alendronsko kislino.
English: To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also carried out a study in 717 patients with osteoporosis, including 682 women who had been through the menopause, to show Adrovance's ability to increase vitamin D levels.
Slovenian: V podporo uporabi kombinacije alendronske kisline in vitamina D3 v isti tableti in za pridobitev dokazov, da zdravilo Adrovance lahko poveča ravni vitamina D, je družba izvedla študijo s 717 bolniki z osteoporozo, ki je vključevala 682 žensk, ki so že prestale menopavzo.
English: Adrovance is a medicine that contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Slovenian: Adrovance je zdravilo, ki vsebuje dve zdravilni učinkovini: alendronsko kislino in holekalciferol (vitamin D3).
English: Patients should also take calcium supplements if they are not getting enough calcium from their diet. For more information, see the package leaflet.
Slovenian: Bolniki morajo jemati tudi dodatke kalcija, če njegov vnos s prehrano ni zadosten.
English: In the extension study, similar numbers of patients taking Adrovance 70 mg/2,800 IU and Adrovance 70 mg/5,600 IU had low vitamin D levels (below 6%), but the patients taking Adrovance 70 mg/5,600 IU had greater increases in vitamin D levels over the 24 weeks of the study.
Slovenian: V podaljšani študiji je bilo število bolnikov z nizkimi ravnmi vitamina D (pod 6 %) v skupini bolnikov, ki so jemali zdravilo Adrovance 70 mg/2 800 i.e., podobno številu bolnikov v skupini, ki je prejemala zdravilo Adrovance 70 mg/5 600 i.e., vendar pa so se pri bolnikih, ki so jemali zdravilo Adrovance 70 mg/5 600 i.e., v 24 tednih študije ravni vitamina D bolj povečale.
English: What is Adrovance used for?
Slovenian: Za kaj se zdravilo Adrovance uporablja?
English: Adrovance contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Slovenian: Zdravilo Adrovance vsebuje dve zdravilni učinkovini: alendronsko kislino in holekalciferol (vitamin D3).
English: How has Adrovance been studied?
Slovenian: Kako je bilo zdravilo Adrovance raziskano?
English: Adrovance (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of low vitamin D levels.
Slovenian: Zdravilo Adrovance (ki vsebuje 2 800 ali 5 600 i.e. holekalciferola) se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi, pri katerih obstaja tveganje za pomanjkanje vitamina D. Zdravilo Adrovance 70 mg/5 600 i.e. se uporablja pri bolnikih, ki ne jemljejo dodatkov vitamina D. Zdravilo Adrovance zmanjšuje tveganje za zlome kosti v hrbtenici in kolkih.
English: How does Adrovance work?
Slovenian: Kako zdravilo Adrovance deluje?
English: How is Adrovance used?
Slovenian: Kako se zdravilo Adrovance uporablja?
English: After 15 weeks, fewer patients had low vitamin D levels when they took Adrovance 70 mg/2,800 IU (11%) than when they took alendronic acid only (32%).
Slovenian: Dodatne študije so pokazale, da lahko vključitev vitamina D3 in alendronske kisline v isto tableto poveča ravni vitamina D. Po 15 tednih zdravljenja je bil delež bolnikov z nizko ravnjo vitamina D med bolniki, zdravljenimi z zdravilom Adrovance 70 mg/2 800 i.e., nižji (11 %) kot pri tistih, ki so prejemali le alendronsko kislino (32 %).
English: What is Adrovance?
Slovenian: Kaj je zdravilo Adrovance?
English: Vial 2 years.
Slovenian: Viala 2 leti.
English: Most ISRs lasted for one to two days.
Slovenian: Večina ISR je trajala en dan do dva dni.
English: • tuberculosis or you have been in close contact with someone who has had tuberculosis;
Slovenian: • tuberkulozo ali ste bili v tesnem stiku z nekom, ki je imel/ima tuberkulozo;
English: The steady state appeared to be reached by 6 weeks.
Slovenian: Zdi se, da je bilo stanje ravnovesja doseženo v 6 tednih.
English: These will be monitored by your doctor.
Slovenian: Te bo spremljal vaš zdravnik.
English: Combinations not recommended
Slovenian: Kombinacije, ki jih ne priporočajo
English: Part A of the trial was initiated in the winter months, while Part B was predominantly performed in the summer months.
Slovenian: Del A preskušanja se je začel v zimskih mesecih, del B pa je bil pretežno opravljen v poletnih mesecih.
English: The next dose should be injected at the next regularly scheduled time.
Slovenian: Naslednji odmerek si injicirajte ob naslednjem redno načrtovanem času.
English: The patients should be included in the Registry until both following conditions are met: 5 years recruitment period and 200 patients included.
Slovenian: Bolniki morajo biti vključeni v register dokler ne bosta izpolnjena oba naslednja pogoja: 5-letno obdobje vključevanja in 200 vključenih bolnikov.
English: Figure 13a (Adults)
Slovenian: Slika 13a (odrasli)
English: Proceed with the injection as described in Step 6 below.
Slovenian: Nadaljujte z injiciranjem, kot je opisano spodaj v koraku 6.
English: If you feel a spinning sensation, do not drive or operate any tools or machines until you are feeling normal again.
Slovenian: Če začutite vrtoglavico, ne vozite in ne upravljajte kakšnih orodij ali strojev, dokler se ne počutite spet normalno.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 October 2009
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 23. oktober 2009 Datum zadnjega podaljšanja:
English: • The possibility to include patients in the registry study to facilitate the collection of long term efficacy and safety data;
Slovenian: • o možnosti vključitve bolnikov v študijo registra, s čimer bo olajšano zbiranje dolgoročnih podatkov o varnosti in učinkovitosti;
English: Let the alcohol air dry completely.
Slovenian: Počakajte, da se alkohol popolnoma posuši.
English: Your doctor may need to perform some tests and adjust the dose of such medicines.
Slovenian: Vaš zdravnik bo moral mogoče opraviti nekatere preiskave in prilagoditi odmerek takih zdravil.
English: The physician information should contain the following key messages:
Slovenian: Izobraževalno gradivo mora vsebovati naslednja ključna sporočila:
English: The maximum amount of product that can be safely administered has not been determined.
Slovenian: Največje količine zdravila, ki jo lahko varno uporabimo, niso določili.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Slovenian: Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v spodaj navedenem časovnem okviru izvesti naslednje ukrepe:
English: Active, severe infections (see section 4.4).
Slovenian: Aktivne, težke okužbe (glejte poglavje 4.4).
English: In particular, you should tell your doctor if you are using any of the below medicines:
Slovenian: Zdravniku še zlasti povejte, če uporabljate katero koli izmed spodaj navedenih zdravil:
English: Animal studies were conducted to assess reproductive toxicity.
Slovenian: Študije na živalih so opravili, da bi ocenili toksičnost za razmnoževanje.
English: None of these patients had serious infections associated with the neutropenia.
Slovenian: Nobeden od teh bolnikov ni imel resnih okužb, povezanih z nevtropenijo.
English: In both cases your doctor will calculate the corresponding volume to inject.
Slovenian: V obeh primerih bo vaš zdravnik izračunal ustrezni volumen, ki ga je treba injicirati.