natgillin/translations-raw huggingface dataset:
Arterial thromboembolic events (ATEs) were reported in approximately 4 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 6 % in the pemetrexed and cisplatin alone arm) and mainly present as stroke and myocardial infarction.
O arterijskih trombemboličnih dogodkih so poročali pri približno 4 % bolnikov, zdravljenih z necitumumabom v kombinaciji s pemetreksedom in cisplatinom (v primerjavi s 6 % v skupini s pemetreksedom in cisplatinom) in so večinoma predstavljali kap in miokardni infarkt.
The pharmacokinetics of gemcitabine/cisplatin were not affected when co-administered with necitumumab and the pharmacokinetics of necitumumab were not affected when co-administered with gemcitabine/cisplatin.
Na farmakokinetiko gemcitabina/cisplatina sočasno dajanje necitumumaba ni vplivalo.
No formal studies have been conducted to evaluate the effect of renal impairment on the PK of necitumumab.
Formalne študije, ki bi ocenjevale učinek ledvične okvare na farmakokinetiko necitumumaba, niso bile opravljene.
No formal studies have been conducted to evaluate the effect of hepatic impairment on the PK of necitumumab.
Formalne študije, ki bi ocenjevale učinek okvare jeter na farmakokinetiko necitumumaba, niso bile opravljene.
The physician educational material package should also contain: o The Summary of Product Characteristics o Patient Information Leaflet
Paket izobraževalnega gradiva za zdravnike mora vsebovati tudi:
America, Europe, and Australia vs. South America, South Africa, and India vs. Eastern Asia])
c Stratificirano z randomizacijskimi stratumi (ocena stanja zmogljivosti po ECOG [0-1 v primerjavi z 2] in geografsko regijo [Severna Amerika, Evropa in Avstralija v primerjavi z Južno Ameriko, Južno Afriko in Indijo v primerjavi z Vzhodno Azijo])
In a phase 2 clinical trial investigating necitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone (106 versus 55 patients, 2:1 randomisation) as the first-line therapy in patients with Stage IV metastatic squamous NSCLC, a higher rate of death, including death due to infection, was observed for the necitumumab plus paclitaxel/carboplatin arm during the first 4 months (see also section 4.4), with a later trend towards improved survival after 4 months.
vključno s smrtjo zaradi okužb v skupini z necitumumabom v kombinaciji s paklitakselom in karboplatinom v prvih štirih mesecih (glejte tudi poglavje 4.4), s kasnejšim trendom v smeri izboljšanja preživetja po štirih mesecih.
For IV use after dilution.
Za intravensko uporabo po redčenju.
Blood clots in the veins
OVOJNINAH OZNAKA NA VIALI
Progression free survival Number of events (n) Median - months (95 % CI) Hazard ratio (95 % CI) b, c Two-sided log-rank p-value c a Abbreviations: CI = confidence interval b Hazard ratio is expressed as treatment/control and estimated from Cox model c Stratified by the randomization strata (ECOG PS [0-1 vs. 2], and geographic region [North
Dvostranska p vrednost testa log-rankc a Okrajšave: IZ = interval zaupanja b Razmerje tveganja je izraženo kot zdravljenje/kontrola in ocenjeno s pomočjo Coxovega modela.
Severe VTEs were reported in approximately 6 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 4 % in the pemetrexed and cisplatin alone arm).
O hudih venskih trombemboličnih dogodkih so poročali pri približno 6 % bolnikov, zdravljenih z necitumumabom v kombinaciji s pemetreksedom in cisplatinom (v primerjavi s 4 % v skupini s pemetreksedom in cisplatinom).
Severe ATEs were reported in approximately 3 % of patients treated with necitumumab in combination with pemetrexed and cisplatin (versus 4 % in the pemetrexed and cisplatin alone arm).
O hudih arterijskih trombemboličnih dogodkih so poročali pri približno 3 % bolnikov, zdravljenih z necitumumabom v kombinaciji s pemetreksedom in cisplatinom (v primerjavi s 4 % v skupini s pemetreksedom in cisplatinom).
Handling instructions Portrazza 800 mg concentrate for solution for infusion necitumumab
Navodilo za uporabo Portrazza 800 mg koncentrat za raztopino za infundiranje necitumumab
Portrazza 800 mg concentrate for solution for infusion necitumumab
Portrazza 800 mg koncentrat za raztopino za infundiranje necitumumab
Eye disorders
- vnetje očesa (konjunktivitis)
Alcobendas
ZDRAVILA
Severe ATEs were reported in 3 % of patients.
O hudih arterijskih trombemboličnih dogodkih so poročali pri približno 3 % bolnikov.
No animal studies have been specifically conducted to evaluate the effect of necitumumab on reproduction and foetal development; however, based on its mechanism of action and animal models where EGFR expression is disrupted, necitumumab may cause foetal harm or developmental anomalies.
Kljub temu pa na podlagi mehanizma delovanja necitumumaba in živalskih modelov z moteno izraženostjo EGFR
Venous thromboembolic events (VTE) and arterial thromboembolic events (ATE), including fatal cases, were observed with necitumumab in combination with gemcitabine and cisplatin (see also section 4.8).
so opazili pri zdravljenju z necitumumabom v kombinaciji z gemcitabinom in cisplatinom (glejte tudi poglavje 4.8).
Common Headache Common Dysgeusia
Pogosti disfagija
Women of childbearing potential/contraception in females Based on its mechanism of action and animal models where EGFR expression is disrupted, necitumumab may cause foetal harm or developmental anomalies.
Na podlagi mehanizma delovanja necitumumaba in živalskih modelov z moteno izraženostjo EGFR
To administer using empty intravenous infusion containers Aseptically transfer 50 mL of necitumumab medicine into an empty intravenous container and add 200 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection to the container to bring the total volume to 250 mL.
Če uporabljate prazne vsebnike za intravensko infuzijo: Aseptično prenesite 50 ml necitumumaba v prazen vsebnik za intravensko infuzijo in dodajte v vsebnik 200 ml sterilnega natrijevega klorida 9 mg/ml (0,9%) raztopine za injiciranje, tako da bo za skupna končna prostornina v vsebniku znašala 250 ml. Vsebnik nežno obrnite, da zagotovite zadostno mešanje.
To administer using empty intravenous infusion containers Aseptically transfer 50 mL of necitumumab medicinal product into an empty intravenous container and add 200 mL of sodium chloride 9 mg/mL (0.9 %) solution for injection to the container to bring the total volume to 250 mL.
Če uporabljate prazne vsebnike za intravensko infuzijo Aseptično prenesite 50 ml necitumumaba v prazen vsebnik za intravensko infuzijo in dodajte v vsebnik 200 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje, tako da bo za skupna končna prostornina v vsebniku znašala 250 ml. Vsebnik nežno obrnite, da zagotovite zadostno mešanje.
Gastrointestinal disorders
Trihomegalija trepalnic
In vivo studies in cell line-derived xenograft models of human cancer, including non-small cell lung carcinoma, demonstrate that necitumumab has antitumor activity both in monotherapy and in combination with gemcitabine and cisplatin.
da ima necitumumab protitumorsko delovanje tako v monoterapiji kot v kombinaciji z gemcitabinom in cisplatinom.
To administer using pre-filled intravenous infusion containers Aseptically remove 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection from the prefilled 250 mL container and transfer 50 mL of necitumumab medicine into the container to bring the final volume in the container back to 250 mL.
Aseptično odvzemite 50 ml natrijev klorid 9 mg/ml (0,9%) raztopine za injiciranje iz napolnjenega 250-mililitrskega vsebnika in prenesite 50 ml necitumumaba v vsebnik, tako da bo za skupna končna prostornina v vsebniku znova znašala 250 ml. Vsebnik nežno obrnite, da zagotovite zadostno mešanje.
Sodium restricted diet
Zelo pogosti zmanjšana telesna masa
How you are given Portrazza 4.
Shranjevanje zdravila Portrazza 6.
Common Urinary tract infection
Pogosti okužba sečil
Hypomagnesaemiac
Zelo pogosti hipofosfatemijac
Grade ≥ 3
PRILOGA III
Following improvement to Grade ≤ 2, resume at reduced dose of 400 mg.
≤ 2 nadaljujte z zmanjšanim odmerkom 400 mg. • Če se simptomi pri odmerku 600 mg še en cikel ne poslabšajo,
Ελλάδα
Po redčenju
11 January 2019
11. januar 2019
Hetero Europe S.L.
Podjetje Hetero Europe S.L.
The European Commission issued an EU-wide legally binding decision on 11 January 2019.
Evropska komisija je 11. januarja 2019 izdala pravno zavezujoč sklep za vse države članice EU.
The review of Paclitaxel Hetero was initiated at the request of Portugal under Article 29 of Directive 2001/83/EC.
Pregled zdravila Paxlitaxel Heterose je začel na zahtevo Portugalske v skladu s členom 29 Direktive 2001/83/ES.
However, the Member States were not able to reach an agreement and the Portuguese agency referred the matter to EMA for arbitration on 2 November 2017.
Ker pa države članice niso dosegle soglasja, je portugalska regulativna agencija za zdravila 2. novembra 2017 zadevo napotila na agencijo EMA v arbitražo.
It blocks the ability of cancer cells to break down their internal ‘skeleton' that allows them to divide and multiply.
Deluje tako, da zavira sposobnost rakavih celic za razgradnjo njihovega notranjega „ogrodja“, ki jim omogoča, da se delijo in množijo.
In particular, the company did not provide direct comparative data with the reference medicine, which is normally required for medicines formulated in micelles.
Podjetje zlasti ni predložilo neposrednih primerjalnih podatkov z referenčnim zdravilom, kar se običajno zahteva pri zdravilih v obliki micel.
On 18 October 2018, the European Medicines Agency (EMA) completed a review of Paclitaxel Hetero following a disagreement among EU Member States regarding its authorisation.
Evropska agencija za zdravila (EMA) je 18. oktobra 2018 zaključila pregled zdravila Paclitaxel Hetero po nesoglasju med državami članicami EU v zvezi z izdajo dovoljenja za promet z njim.
It was to be available as a concentrate for solution for infusion (6 mg/ml) for the treatment of breast cancer, cancer of the ovaries, non-small cell lung cancer and Kaposi's sarcoma (a cancer of the blood vessels) in patients with acquired immune deficiency syndrome (AIDS).
Na voljo naj bi bilo v obliki koncentrata za raztopino za infundiranje (6 mg/ml) za zdravljenje raka dojk, raka jajčnikov, nedrobnoceličnega raka pljuč in Kaposijevega sarkoma (raka krvnih žil) pri bolnikih s pridobljenim sindromom imunske pomanjkljivosti (aidsom).
Viladecans (Barcelona) submitted Paclitaxel Hetero to the Portuguese medicines agency for a decentralised procedure.
Viladecans (Barcelona) je vlogo za zdravilo Paclitaxel Hetero predložilo portugalski regulativni agenciji za zdravila v decentralizirani postopek.
The Agency concluded that the benefits of Paclitaxel Hetero do not outweigh its risks, and the marketing authorisation cannot be granted in Portugal or in other Member States of the EU (Germany, the Netherlands and the UK).
Agencija je zaključila, da koristi zdravila Paclitaxel Hetero ne odtehtajo njegovih tveganj in da dovoljenja za promet na Portugalskem in v drugih državah članicah EU (v Nemčiji, na Nizozemskem in v Združenem kraljestvu) ni mogoče izdati.
Instead, it submitted indirect comparative data and a study which compared blood levels of paclitaxel in Paclitaxel Hetero with those of another generic paclitaxel medicine, which was not considered sufficient by the Netherlands.
Namesto tega je predložilo posredne primerjalne podatke in študijo, v kateri je primerjalo ravni paklitaksela v krvi, ki jih povzroči zdravilo Paclitaxel Hetero, z ravnmi, ki jih povzroči drugo generično zdravilo s paklitakselom, to pa po mnenju Nizozemske ne zadošča.
The grounds for the referral were concerns raised by the Netherlands that the data submitted to support the application were not sufficient to show that Paclitaxel Hetero is ‘bioequivalent' to Taxol.
Razlog za napotitev so bili pomisleki Nizozemske, da podatki, predloženi v podporo vlogi, ne zadoščajo kot dokaz, da je zdravilo Paclitaxel Hetero „bioekvivalentno“ zdravilu Taxol.
Paclitaxel belongs to the group of cancer medicines known as the ‘taxanes'.
Paklitaksel spada v skupino zdravil za zdravljenje raka, imenovanih „taksani“.
This is a procedure where one Member State (the ‘reference Member State', in this instance Portugal) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States where the company has applied for a marketing authorisation (the ‘concerned Member States', in this instance Germany, the Netherlands and the UK).
To je postopek, pri katerem ena država članica („referenčna država članica“, v tem primeru Portugalska) oceni zdravilo z namenom odobritve dovoljenja za promet z njim, ki bo veljavno v tej državi in v drugih državah članicah, v
Based on the evaluation of the currently available data, the Agency concluded that they were not sufficient to show that Paclitaxel Hetero is ‘bioequivalent' to Taxol and that their active substances behave in the same way in the body.
Na podlagi vrednotenja trenutno razpoložljivih podatkov je agencija zaključila, da ti ne zadoščajo kot dokaz, da je zdravilo Paclitaxel Hetero bioekvivalentno zdravilu Taxol in da se njuni učinkovini v telesu obnašata enako.
Why was Paclitaxel Hetero reviewed?
Zakaj je bilo zdravilo Paclitaxel Hetero pregledano?
The paclitaxel in Paclitaxel Hetero and in Taxol is contained in tiny particles called micelles, to help it dissolve in the solution.
Učinkovina paklitaksel v zdravilih Paclitaxel Hetero in Taxol je vključena v majhne delce, imenovane micele, ki pripomorejo k boljšemu raztapljanju v raztopini.
Paclitaxel Hetero was developed as a generic medicine.
Zdravilo Paclitaxel Hetero je bilo razvito kot „generično zdravilo“.
This means that Paclitaxel Hetero was developed to contain the same active substance and work in the same way as a ‘reference medicine' already authorised in EU called Taxol.
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Taxol.
Paclitaxel Hetero is a medicine that contains the active substance paclitaxel.
Paclitaxel Hetero je zdravilo, ki vsebuje učinkovino paklitaksel.
The Agency therefore concluded that the benefits of Paclitaxel Hetero do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member States.
Agencija je zaključila, da koristi zdravila Paclitaxel Hetero ne odtehtajo z njim povezanih tveganj, in priporočila, da se dovoljenje za promet z zdravilom v zadevnih državah članicah ne izda.
What is Paclitaxel Hetero?
Kaj je zdravilo Paclitaxel Hetero?
EMA/712446/2018 Rev.1
(paklitaksel, 6 mg/ml koncentrat za raztopino za infundiranje) EMA/712446/2018 Rev.1
This may take between 30 to 60 minutes.
To lahko traja od 30 do 60 minut.
Via del Murillo Km 2.800 04013 Sermoneta Latina, Italy <{tel}> <{fax}> <{e-mail}>
Via del Murillo Km 2.800 04013 Sermoneta Latina, Italija <{tel.}> <{faks}>
• water for injections or,
• vode za injekcije ali
Blood pressure usually normalizes within a few hours after cessation of the infusion.
Krvni tlak se po navadi normalizira v nekaj urah po prenehanju infuzije.
• high blood pressure • low blood pressure
• visok krvni tlak • nizek krvni tlak
All steps of preparation must be carried out under Laminar Air Flow conditions.
Vse korake priprave je treba opraviti v sistemu z laminarnim pretokom zraka.
The safety profile between paediatric patients and adults is expected to be similar.
Pričakuje se, da sta varnostna profila pediatričnih bolnikov in odraslih enaka.
<Date of first authorisation: {DD month YYYY}> <Date of latest renewal: {DD month YYYY}>
<Datum prve odobritve: <{DD. mesec LLLL}> <Datum zadnjega podaljšanja: <{DD. mesec LLLL}>
Exact measuring must be ensured for withdrawal.
Za odvzem je treba zagotoviti natančno merjenje.
However, if this does occur your doctor will treat any symptoms that follow.
Če bi kljub temu prišlo do tega, bo zdravnik zdravil morebitne simptome, ki bi sledili.
Bleeding has been reported.
Poročali so o krvavitvah.
The doctor may sometimes prescribe a different dose particularly if you are receiving, or have received, other treatments for your cancer or if you have kidney problems.
Zdravnik lahko včasih predpiše drugačen odmerek, še zlasti, če prejemate ali ste prejemali druga zdravila za zdravljenje raka ali če imate težave z ledvicami.
The mean volumes of distribution at steady state range from 18 to 29 liters .
Srednji volumen porazdelitve v stanju dinamičnega ravnovesja je od 18 do 29 litrov.
The stock solution should be used as soon as possible (see section 6.3).
Osnovno raztopino je treba uporabiti takoj, ko je mogoče (glejte poglavje 6.3).
The safety and efficacy of ETOPOPHOS and associated names below 18 years of age have not been established.
Varnost in učinkovitost zdravila ETOPOPHOS in povezana imena pri otrocih, mlajših od 18 let, še nista bili dokazani.
It will be given as a slow infusion into a vein.
Prejeli ga boste v obliki počasne infuzije v veno.
If spikes are used they should be equipped with particle filters or other measures should be taken (e.g. inline-filters) to ensure that only particle free solutions are administered.
Ob uporabi prebodnih igel morajo biti te opremljene s filtri za delce ali pa je treba uporabiti druge ukrepe (npr. linijske filtre) za zagotovitev, da dajemo samo raztopine brez delcev.
• changes in skin colour (pigmentation)
• spremembe barve kože (pigmentacija) • zaprtje
Care should be taken to avoid extravasation.
Paziti je treba, da ne pride do ekstravazacije.
The stock solution should be used as soon as possible.
Osnovno raztopino je treba uporabiti takoj, ko je mogoče.
Tell your doctor or nurse immediately if you get any of the following symptoms: swelling of your tongue or throat, breathing difficulties, fast heartbeat, flushing of the skin or a rash.
Takoj obvestite zdravnika ali medicinsko sestro, če se pri vas pojavijo naslednji simptomi: otekanje jezika ali grla, težave z dihanjem, hiter srčni utrip, vročinski oblivi ali izpuščaj.
Reversible alopecia, sometimes progressing to total baldness, was observed in up to 44% of patients treated with etoposide phosphate.
O reverzibilni alopeciji, ki je včasih napredovala do popolne plešavosti, so poročali pri do 44 % bolnikov, ki so se zdravili z etopozid fosfatom.
The stock solution should be withdrawn under aseptic conditions according to the physician's prescription and transferred to the infusion bottles and/or syringes for the individual patients.
Osnovno raztopino je treba odvzeti v aseptičnih pogojih po navodilih zdravnika in jo prenesti v infuzijske stekleničke in/ali brizge za posamezne bolnike.
Hypotension usually responds to cessation of infusion of etoposide phosphate and/or other supportive therapy as appropriate.
Hipotenzija se po navadi odzove na prenehanje infundiranja etopozid fosfata in/ali drugo podporno zdravljenje, kot je ustrezno.
These adverse reactions are presented by system organ class and frequency, which is defined by the following categories: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1, 000, <1/100), rare (≥1/10, 000, <1/1,000), not known (cannot be estimated from the available data).
Kategorije pogostnosti so opredeljene z naslednjim dogovorom: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Facial flushing was reported in 2% of patients and skin rashes in 3%.
O vročinskih oblivih so poročali pri 2 % bolnikov, o kožnih izpuščajih pa pri 3 % bolnikov.
• damage to the liver (hepatotoxicity)
• poškodbe jeter (hepatotoksičnost)
If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.
Če opazite kakršno koli obarvanost ali delce, je treba rekonstituirano raztopino zavreči.
The predominant macromolecular effect of etoposide seems to be the rupture of the double strand by an interaction with DNAtopoisomerase II or by the formation of free radicals.
Ključno delovanje etopozida na makromolekule je povzročanje zlomov DNA vijačnice z interakcijo z DNA topoizomerazo II ali s formiranjem prostih radikalov.
In clinical studies in which ETOPOPHOS and associated names was administered as a single agent at a total dose of ≥450 mg/m2 the most frequent adverse reactions of any severity were leucopenia (91%), neutropenia (88%), anaemia (72%) thrombocytopenia (23%), asthenia (39%), nausea and/or vomiting (37%), alopecia (33%) and chills and/or fever (24%).
V kliničnih študijah, kjer so dajali zdravilo ETOPOPHOS in povezana imena v monoterapiji v skupnem odmerku ≥ 450 mg/m2, so bili najpogostejši neželeni učinki katere koli resnosti levkopenija (91 %), nevtropenija (88 %), anemija (72 %) trombocitopenija (23 %), astenija (39 %), navzea in/ali bruhanje (37 %), alopecija (33 %) in mrzlica in/ali vročina (24
Solutions should be prepared under aseptic conditions.
Raztopine je treba pripraviti v aseptičnih pogojih.
Apnoea with spontaneous resumption of breathing following cessation of infusion have also been reported.
Poročali so tudi o apneji s spontano ponovno vzpostavitvijo dihanja po prekinitvi infundiranja.
• tumour lysis syndrome (complications of substances released from treated cancer cells entering the blood)
• sindrom tumorske lize (zapleti ob sproščanju snovi iz zdravljenih rakavih celic v krvni obtok)
Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake Uporabno do/EXP.
Before use the content of each vial must be reconstituted with 5 ml or 10 ml of:
Pred uporabo je treba vsebino vsake viale rekonstituirati s 5 ml ali z 10 ml:
Effect of etoposide phosphate on the pharmacokinetics of other drugs
Učinek etopozid fosfata na farmakokinetiko drugih zdravil
ETOPOPHOS and associated names SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION.
Zdravila ETOPOPHOS in povezana imena SE NE SME DAJATI V HITRI INTRAVENSKI INJEKCIJI.
Given its mechanism of action, etoposide phosphate should be considered a possible carcinogen in humans.
Glede na mehanizem delovanja lahko sklepamo, da je etopozid fosfat potencialno karcinogen za človeka.
Both male and female patients who are considering having a child after having treatment with ETOPOPHOS and associated names should discuss this with their doctor or nurse.
Bolniki in bolnice, ki razmišljajo o spočetju otroka po zdravljenju z zdravilom ETOPOPHOS in povezana imena, naj se o tem posvetujejo z zdravnikom ali medicinsko sestro.
Infections and infestations common infection
Infekcijske in parazitske bolezni pogosti okužba
If clinically significant hypertension occurs in patients receiving etoposide phosphate, appropriate supportive therapy should be initiated.
Če se pri bolnikih, ki prejemajo etopozid fosfat, pojavi klinično pomembna hipertenzija, je potrebno uvesti ustrezno podporno zdravljenje.
The role that concentration or rate of infusion plays in the development of anaphylactic reactions is uncertain.
Vloga koncentracije ali hitrosti infundiranja pri nastanku reakcij anafilaktičnega tipa ni povsem jasna.
• reactions at the site of infusion
• reakcije na mestu infundiranja
Given the possibility of extravasation, it is recommended to closely monitor the infusion site for possible infiltration during drug administration.
Zaradi možnosti za ekstravazacijo je treba mesto infundiranja med dajanjem zdravila natančno kontrolirati glede infiltracije.
ETOPOPHOS and associated names should not be physically mixed with any other drug.
Zdravila ETOPOPHOS in povezana imena se ne sme fizično mešati z drugimi zdravili.
The exact reason why you have been prescribed ETOPOPHOS and associated names is best discussed with your doctor.
O natančnem razlogu, zakaj so vam predpisali zdravilo ETOPOPHOS in povezana imena, se pogovorite s svojim zdravnikom.
Bacterial infections should be brought under control before treatment with ETOPOPHOS and associated names.
Bakterijske okužbe morajo biti pod nadzorom pred pričetkom zdravljenja z zdravilom ETOPOPHOS in povezana imena.