natgillin/translations-raw huggingface dataset:
Hypersensitivity including flushing, rash, hypotension, oedema/angioedema, urticaria, dyspnoea Common
Zelo pogosti preobčutljivost, vključno z vročinskimi oblivi, izpuščajem, hipotenzijo, edemi/angioedemom, urtikarijo, dispnejo
Before initiating therapy bilirubin, hepatic transaminases and coagulation parameters (e.g. partial thromboplastin time [PTT], prothrombin time [PT], antithrombin III and fibrinogen) should be determined.
Pred uvedbo zdravljenja je treba določiti bilirubin, jetrne transaminaze in koagulacijske parametre (npr. parcialni tromboplastinski čas [PTČ], protrombinski čas [PČ], antitrombin III in fibrinogen).
• severe inflammation of the pancreas (acute pancreatitis),
• hudo vnetje trebušne slinavke (akutni pankreatitis),
Asparaginase must not be administered as a bolus dose.
Asparaginaze ni dovoljeno dajati v obliki bolusnega odmerka.
• destruction of liver cells (liver cell necrosis)
• zlatenica, • odmrtje (nekroza) jetrnih celic,
• Medicines which may suppress bone marrow function as these effects may be enhanced by concomitant use of asparaginase.
• Zdravila, ki lahko zavrejo delovanje kostnega mozga, ker lahko sočasna uporaba asparaginaze zveča te učinke.
• If you get any side effects, talk to your doctor or nurse.
• Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali medicinsko sestro.
In rare cases, a reversible posterior leukoencephalopathy syndrome (RPLS) has been observed during therapy with asparaginase-containing regimens.
V redkih primerih so med zdravljenjem s terapevtskimi shemami, ki vsebujejo asparaginazo, ugotavljali sindrom reverzibilne posteriorne levkoencefalopatije (RPLS).
It is usually given with other anti-cancer medicines.
Navadno se daje skupaj z drugimi zdravili z delovanjem na novotvorbe.
Hepatic steatosis
Neznana steatoza jeter
Similarly to adults, the recommended dose in children and adolescents aged 1 - 18 years is 5,000 U per m² BSA given every third day.
Uporaba pri otrocih in mladostnikih Podobno kot pri odraslih je priporočeni odmerek pri otrocih in mladostnikih, starih 1-18 let, 5.000 E
If you get any side effects, talk to your doctor or nurse.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali medicinsko sestro.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Spectrila 10,000 U powder for concentrate for solution for infusion Asparaginase
IME ZDRAVILA IN POT(I) UPORABE Spectrila 10.000 e. prašek za koncentrat za raztopino za infundiranje asparaginaza
• Reversible posterior leukoencephalopathy syndrome (a condition characterised by headache,
• sindrom reverzibilne posteriorne levkoencefalopatije (bolezensko stanje, za katerega so značilni glavobol, zmedenost, epileptični napadi in okvara vida),
Diarrhoea, nausea, vomiting, abdominal pain Common
Zelo pogosti driska, navzea, bruhanje, bolečine v trebuhu
Anaphylactic shock
Redki anafilaktični šok
The following life-threatening situations could arise during treatment with Spectrila:
Med zdravljenjem z zdravilom Spectrila lahko nastanejo naslednji smrtno nevarni zapleti:
Sinus vein thrombosis can occur.
Lahko se pojavi tromboza venskih sinusov.
The active substance is asparaginase.
• Zdravilna učinkovina je asparaginaza.
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM medac Gesellschaft für klinische Spezialpräparate mbH
Because of a higher frequency of comorbidities such as liver and/or renal impairment, patients > 55 years of age usually tolerate asparaginase treatment worse than paediatric patients.
55 let, navadno slabše prenašajo zdravljenje z asparaginazo kot pediatrični bolniki.
Headaches
Dojenje
Name and address of the manufacturer of the biological active substance Wacker Biotech GmbH
Ime in naslov izdelovalca biološke zdravilne učinkovine
After administration of asparaginase, close monitoring of bilirubin, hepatic transaminases, of blood/urinary glucose, coagulation parameters (PTT, PT, antithrombin III, fibrinogen, and D-dimer), amylase, lipase, triglycerides, and cholesterol is recommended.
Po uporabi asparaginaze je priporočljivo skrbno spremljanje bilirubina, jetrnih transaminaz, glukoze v krvi in urinu, koagulacijskih parametrov (PTČ, PČ, antitrombin III, fibrinogen in D-dimer), amilaze,
4 years
Neodprte viale 4 leta
• pain (back pain, joint pain, stomach ache)
• bolečine (v križu, sklepih, trebuhu).
• high blood levels of ammonia (hyperammonaemia)
• visoka raven amoniaka v krvi (hiperamonemija), • glavobol.
Hypoglycaemia mostly without clinical symptoms has been commonly observed in patients treated with asparaginase.
Pri bolnikih, zdravljenih z asparaginazo, so pogosto opazili hipoglikemijo, navadno brez kliničnih simptomov.
Therefore, caution should be exercised in patients receiving other medicines metabolised by the liver.
ki prejemajo druga zdravila, ki jih presnavljajo jetra.
No anti-asparaginase antibodies were detected in any of the 12 infants < 1 year of age during treatment with Spectrila (study MC-ASP.6/INF).
Pri nobenem od 12 dojenčkov, mlajših od 1 leta, niso med zdravljenjem z zdravilom Spectrila zaznali antiasparaginaznih protiteles (študija MC-ASP.6/INF).
• high blood levels of uric acid (hyperuricaemia)
• visoka raven sečne kisline v krvi (hiperurikemija),
Renal impairment No dose adjustment is necessary in patients with renal impairment.
Okvara ledvic Pri bolnikih z okvaro ledvic prilagajanje odmerjanja ni potrebno.
The calculated quantity of asparaginase is dissolved further in 50 to 250 ml of sodium chloride 9 mg/ml (0.9 %) solution for infusion.
50-250 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje.
A method other than oral contraceptives should be used in women of childbearing potential.
Ženske v rodni dobi morajo uporabljati drugo metodo, ne peroralnih kontraceptivov.
What Spectrila looks like and contents of the pack Spectrila is provided as a powder for concentrate for solution for infusion.
Zdravilo Spectrila je na voljo kot prašek za koncentrat za raztopino za infundiranje.
Fax: +49 4103 8006-100
Tel.: +49 4103 8006-0 Faks: +49 4103 8006-100 E-pošta: contact@medac.de
After reconstitution, one ml contains 2,500 units of asparaginase.
Po rekonstituciji vsebuje en ml 2,500 enot asparaginaze.
NAME OF THE MEDICINAL PRODUCT Spectrila 10,000 U powder for concentrate for solution for infusion Asparaginase
IME ZDRAVILA Spectrila 10.000 e. prašek za koncentrat za raztopino za infundiranje
Spectrila 10,000 U powder for concentrate for solution for infusion Asparaginase
Spectrila 10.000 e. prašek za koncentrat za raztopino za infundiranje asparaginaza
Blood clotting disorders may require you to receive fresh plasma or a certain type of protein (antithrombin III) in order to reduce the risk of bleeding or formation of blood clots (thrombosis).
(antitrombin III), da se bo zmanjšalo tveganje krvavitve ali nastanka krvnih strdkov (tromboza).
Disseminated intravascular coagulation (DIC), anaemia, leukopenia, thrombocytopenia
fibrinogena in D-dimera), amilaze, lipaze, trigliceridov in holesterola.
• allergic reactions including serious allergic reaction (anaphylactic shock), flushing, rash, low blood pressure, swelling of face and throat, hives, shortness of breath,
izpuščaj, nizek krvni tlak, otekanje obraza in žrela, koprivnico, kratko sapo,
Due to the inhibition of protein synthesis (decreased synthesis of factors II, V, VII, VIII, and IX, proteins C and S, antithrombin III [AT III]) caused by asparaginase, coagulation disorders can occur which can manifest either as thrombosis, disseminated intravascular coagulation (DIC), or bleeding.
in S, antitrombina III [AT III]), ki jo povzroči asparaginaza, se lahko pojavijo motnje koagulacije, ki se pokažejo kot tromboza, diseminirana intravaskularna koagulacija (DIK) ali krvavitev.
Dyslipidemia
Bolezni živčevja
PHARMACEUTICAL FORM Powder for concentrate for solution for infusion.
FARMACEVTSKA OBLIKA prašek za koncentrat za raztopino za infundiranje bel prašek
Not evaluable / not known
MRD pozitivna ni mogoče oceniti/ni znano razlika (95 % CI
How to store Spectrila
Shranjevanje zdravila Spectrila
After administration of any asparaginase preparation, close monitoring of bilirubin, hepatic transaminases, blood/urinary glucose, coagulation parameters (e.g. PTT, PT, antithrombin III, fibrinogen and D-dimer), amylase, lipase, triglycerides and cholesterol is recommended.
Po dajanju katerega koli zdravila z asparaginazo je priporočljivo skrbno spremljanje bilirubina, jetrnih transaminaz, glukoze v krvi/urinu, koagulacijskih parametrov (npr. PTČ, PČ, antitrombina III,
• feeling sick (nausea), being sick (vomiting), stomach ache or watery stools (diarrhoea)
• slabost s siljenjem na bruhanje (navzea), bruhanje, bolečine v trebuhu ali redko blato (driska),
A method other than oral contraceptives should be used in women of childbearing potential (see section 4.4).Men should use effective contraceptive measures and be advised to not father a child while receiving asparaginase.
Moški morajo uporabljati učinkovite kontracepcijske ukrepe in jim je treba svetovati, naj ne spočnejo otroka, ko prejemajo asparaginazo.
Common side effects (may affect up to 1 in 10 people):
Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov):
6.1 List of excipients
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi saharoza
Antineoplastic agents
Aktivnost asparaginaze
Spectrila
Zdravilo Spectrila
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 10,000 units of asparaginase.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 10.000 enot asparaginaze.
The calculated quantity of asparaginase is dissolved further in 50 to 250 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection.
Izračunano količino asparaginaze še nadalje raztopite v 50 do 250 ml raztopine natrijevega klorida
Reference asparaginase
Referenčna asparaginaza
medac GmbH Theaterstr.
Theaterstr.
• anaphylaxis,
• anafilaksija,
For EpiPen/Nepipe and associated names
Za EpiPen/Nepipe in povezana imena
Sometimes a single dose of adrenaline may not be sufficient to completely reverse the effects of a serious allergic reaction.
Včasih en odmerek adrenalina ne zadostuje za popolno odpravo znakov in simptomov resne alergijske reakcije.
The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Pristojni organi držav članic bodo kasneje, v povezavi z referenčno državo članico, posodobili Informacije o zdravilu, kot je primerno, v skladu s postopki, ki jih določa Poglavje 4, Naslov III Direktive 2001/83/ES.
Section 6 - Contents of the pack and other information
Poglavje 6 - Vsebina pakiranja in dodatne informacije
All patients who are prescribed [Invented name] should be thoroughly instructed to understand the indications for the use and the correct method of administration (see section 6.6).
Vsem bolnikom, ki se jim predpiše zdravilo [ime zdravila], je treba podati podrobne informacije in poskrbeti, da razumejo indikacije za uporabo in pravilen način uporabe zdravila (glejte poglavje 6.6).
If your symptoms have not improved or have deteriorated within 5-15 minutes after the first injection, either you or the person with you should give a second injection.
Če se vaši simptomi v 5-15 minutah po prvi injekciji ne izboljšajo ali pa se poslabšajo, si morate sami ali pa vam mora nekdo drug injicirati še en odmerek zdravila [ime zdravila].
In the absence of clinical improvement or if deterioration occurs, a second injection with an additional [Invented name] may be administered 5-15 minutes after the first injection.
Če se klinični znaki ne izboljšajo ali če pride do poslabšanja, se lahko 5-15 minut po prvi injekciji da druga injekcija z dodatnim odmerkom zdravila [ime zdravila].
It is recommended that your family members, carers or teachers are also instructed in the correct use of [Invented name].
Priporočljivo je, da se tudi vaši družinski člani, skrbniki ali učitelji seznanijo z informacijami o pravilni uporabi zdravila [ime zdravila].
It is strongly advised also to educate the patient's immediate associates (e.g. parents, caregivers, teachers) for the correct usage of the [Invented name] in case support is needed in the emergency situation.
Zelo priporočljivo je tudi, da se s temi informacijami seznanijo tudi bližnje osebe bolnika (npr. starši, skrbniki, učitelji), da se zagotovi pravilna uporaba zdravila [ime zdravila] v primeru, da bolnik potrebuje pomoč v življenjsko nevarni situaciji.
For this reason you should carry more than one [Invented name] with you at all times.
Zato morate vedno imeti pri sebi več kot en peresnik zdravila [ime zdravila].
[The MAH(s) should submit improved diagram in the instructions for use by increasing the size and ensuring that it clearly shows that the injection should be in the antero-lateral aspect of the thigh]
[Imetnik dovoljenja za promet mora v Navodilo za uporabo priložiti izboljšano in povečano sliko, iz katere je jasno razvidno, da je treba zdravilo injicirati v anterolateralni del stegna.]
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Spremembe ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo
This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure.
Ustrezna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo so rezultat napotitvenega postopka.
Section 4.4 - Special warnings and precautions for use [The section should be amended to reflect the following wording]
Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi [To poglavje je potrebno spremeniti, tako da odraža naslednje besedilo.]
Section 3 - How to use [Invented name]
B. Navodila za uporabo Poglavje 3 - Kako uporabljati zdravilo [ime zdravila]
Section 3 - How to use [Invented name] [The section should be amended to reflect the following wording]
Poglavje 3 - Kako uporabljati zdravilo [ime zdravila] [To poglavje je potrebno spremeniti, tako da odraža naslednje besedilo.]
Section 6.5 - Nature and contents of container [The section should be amended to reflect the exposed needle length of the device(s)] [To be completed nationally]
Poglavje 6.5 - Vrsta ovojnine in vsebina [To poglavje je potrebno spremeniti, tako da je razvidna izpostavljena dolžina igle.]
Section 4.2 - Posology and method of administration [The section should be amended to reflect the following wording]
Poglavje 4.2 - Odmerjanje in način uporabe [To poglavje je potrebno spremeniti, tako da odraža naslednje besedilo.]
What [Invented name] looks like and contents of the pack [The section should be amended to reflect the exposed needle length of the device(s)] [To be completed nationally]
Izgled zdravila [ime zdravila] in vsebina pakiranja [To poglavje je potrebno spremeniti, tako da je razvidna izpostavljena dolžina igle.]
The European Commission issued a decision on this opinion on 26/6/17.
Evropska komisija je sklep o tem mnenju izdala dne 26/6/17.
Etopophos is marketed in the following EU member States: France, Germany, Sweden and the United Kingdom.
Zdravilo Etopophos se trži v naslednjih državah članicah EU: v Franciji, Nemčiji, na Švedskem in v Združenem kraljestvu.
The company that markets these medicines is Bristol-Myers Squibb.
Ta zdravila trži farmacevtska družba Bristol-Myers Squibb.
It is also available in the EU under the trade name Etopofos.
V EU je na voljo tudi pod trgovskim imenom Etopofos.
• testicular cancer, including cancer that is resistant to treatment or has come back;
• raka mod, vključno z rakom, ki je odporen proti zdravljenju ali pa se je ponovil;
On 21 April 2017, the European Medicines Agency completed a review of Etopophos.
Evropska agencija za zdravila je 21. aprila 2017 zaključila pregled zdravila Etopophos.
Etopophos is given as a slow intravenous infusion.
Zdravilo Etopophos se daje s počasno intravensko infuzijo.
Why was Etopophos reviewed?
Zakaj je bilo zdravilo Etopophos pregledano?
Etopophos is authorised in the EU via national procedures.
Zdravilo Etopophos je bilo v EU odobreno po nacionalnih postopkih.
• Hodgkin's and non-Hodgkin's lymphoma;
• Hodgkinovega in ne-Hodgkinovega limfoma;
Other sections of the SmPC harmonised include section 4.4 (special warnings and precautions), section 4.6 (fertility, pregnancy and lactation) and section 4.8 (undesirable effects).
Druga usklajena poglavja povzetka glavnih značilnosti zdravila zadevajo poglavje 4.4 (posebna opozorila in previdnostni ukrepi), poglavje 4.6 (plodnost, nosečnost in dojenje,) ter poglavje 4.8 (neželeni učinki).
• high-risk gestational trophoblastic neoplasia as first- and second-line treatments;
• visoko tvegane gestacijske trofoblastne neoplazije, kot zdravljenje prve in druge izbire;
What is Etopophos?
Kaj je zdravilo Etopophos?
This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Zato je med državami članicami prišlo do razlik v načinu uporabe zdravila, kot je razvidno iz razlik v povzetkih glavnih značilnosti zdravila, označevanju in navodilih za uporabo v državah, v katerih se zdravilo trži.
The recommended dose for adults is 50 to 100 mg per m2 of body surface area for 5 days in a row or 100 to 120 mg/m2 on days 1, 3 and 5.
Priporočeni odmerek za odrasle je od 50 do 100 mg na m2 telesne površine pet zaporednih dni ali od 100 do 120 mg/m2 1., 3. in 5. dan. Cikel zdravljenja je mogoče ponoviti, vendar ne prej kot 21 dni po začetku prvega cikla.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Etopophos and associated names in the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba uskladiti podatke o predpisovanju zdravila Etopophos in povezanih imen v Evropski uniji (EU).
The CHMP recommended that Etopophos should be used in combination with other cancer treatments to treat the following cancers:
Odbor CHMP je priporočil, naj se zdravilo Etopophos uporablja v kombinaciji z drugimi zdravili proti raku za zdravljenje naslednjih vrst raka:
Etopophos is a cancer medicine used to treat: testicular cancer, lung cancer, ovarian cancer, gestational trophoblastic neoplasia (a rare tumour of the womb that occurs during pregnancy) and cancers of the blood (Hodgkin's and non-Hodgkin's lymphoma and acute myeloid leukaemia).
Zdravilo Etopophos je zdravilo proti raku, ki se uporablja za zdravljenje raka mod, pljučnega raka, raka jajčnikov, gestacijske trofoblastne neoplazije (redkega tumorja maternice, ki nastane med nosečnostjo) ter krvnih rakov (Hodgkinovega in ne-Hodgkinovega limfoma in akutne mieloične levkemije).
In addition, the CHMP recommended Etopophos for treating epithelial ovarian cancer that is resistant to treatments with platinum-containing medicines, with no specification that it should be used in combination with other medicines.
Poleg tega je odbor CHMP priporočil uporabo zdravila Etopophos za zdravljenje epitelijskega raka jajčnikov, odpornega proti zdravljenju z zdravili, ki vsebujejo platino, pri čemer ni podrobno navedel, da ga je treba uporabljati v kombinaciji z drugimi zdravili.
• acute myeloid leukaemia;
• akutne mieloične levkemije;
For blood cancers (Hodgkin's and non-Hodgkin's lymphoma and acute myeloid leukaemia), Etopophos is recommended for both adults and children, while its other uses are for adults only.
Zdravilo Etopophos je pri krvnih rakih (Hodgkinovem in ne-Hodgkinovem limfomu ter akutni mieloični levkemiji) priporočeno za odrasle in otroke, drugačne vrste uporabe pa so namenjene samo odraslim.
The areas of the SmPC harmonised include:
Usklajena področja povzetkov glavnih značilnosti zdravila so:
Etopophos contains the active substance etoposide (as etoposide phosphate) and is available as a powder to be made into a solution for infusion into a vein.
Zdravilo Etopophos vsebuje zdravilno učinkovino etopozid (v obliki etopozid fosfata) in je na voljo v obliki praška za pripravo raztopine za infundiranje v veno.
Etopophos should not be administered during vaccination with yellow fever or other live vaccines in patients with weakened immune systems and should not be given to breast-feeding women.
Pri bolnikih z oslabljenim imunskim sistemom se zdravilo Etopophos ne sme dajati med cepljenjem proti rumeni mrzlici ali z drugimi živimi cepivi, prav tako se ne sme dajati ženskam, ki dojijo.
On 14 October 2015, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Etopophos in the EU.
Da bi uskladili dovoljenja za promet z zdravilom Etopophos v EU, je Evropska komisija 14. oktobra 2015 napotila zadevo na odbor CHMP.
Etopophos was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopekzdravila za uporabo v humani medicini (CMDh) je ugotovila, da je za zdravilo Etopophos potrebno usklajevanje.
EMA/251789/2017 Rev. 1
Vprašanja in odgovori v zvezi z zdravilom Etopophos in povezanimi imeni (etopozid, 100 in 1 000 mg, prašek za raztopino za infundiranje) EMA/251789/2017 Rev. 1
Moxifloxacin Moxifloxacin "Teva"
Moksifloksacin Moxifloxacin "Teva"
ANNEX I LIST OF THE PRODUCT NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND ICELAND
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH IN ISLANDIJI
3641 RT Mijdrecht Nederland
3641 RT Mijdrecht Nizozemska
BayHealth - Comercialização de Produtos Farmacêuticos Unipessoal, Lda.
Portugalska BayHealth - Comercialização de Produtos Farmacêuticos Unipessoal, Lda.
Bravničarjeva 13 1000 Ljubljana Slovenia
Bravničarjeva 13 1000 Ljubljana Slovenija
4745-457 S. Mamede do Coronado Portugal
4745-457 S. Mamede do Coronado Portugalska
Netherlands Bayer BV Energieweg 1
Nizozemska Bayer BV Energieweg 1
Hungary Bayer Hungária Kft Alkotás ut.50
Madžarska Bayer Hungária Kft Alkotás ut.50
Berkshire RG14 1JA United Kingdom
Berkshire RG14 1JA Velika Britanija
RECORDATI ESPAÑA, SL Carretera De Zeneta, 149 30588 Beniel (Murcia) Spain
RECORDATI ESPAÑA, SL Carretera De Zeneta, 149 30588 Beniel (Murcia) Španija
Via M. Civitali, 1 20148 Milano Italy
Via M. Civitali, 1 20148 Milano Italija
BAYER SANTE 13, rue Jean Jaures 92807 PUTEAUX CEDEX France
BAYER SANTE 13, rue Jean Jaures 92807 PUTEAUX CEDEX Francija
15125 Maroussi - Athens Greece
15125 Maroussi - Athens Grčija
151 25 Marousi - Athens Greece
151 25 Marousi - Athens Grčija
Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austria
Bayer Austria GmbH Herbststraße 6-10 1160 Wien Avstrija
BN22 9AG East Sussex United Kingdom
Teva UK Limited Brampton Road BN22 9AG East Sussex Velika Britanija
Moxifloxacin Avelox
Moksifloksacin Avelox
Belgium Therabel Pharma S.A. Rue Egide Van Ophem 108 1180 Bruxelles
Therabel Pharma S.A. Rue Egide Van Ophem 108 1180 Bruxelles Belgija
À Av. da Siderurgia Nacional P.O.
Portugalska Bialfar - Produtos À Av. da Siderurgia Nacional P.O. Box 56
Moxifloxacin Proflox
Moksifloksacin Proflox
Belgium Bayer s.a.-n.v. Avenue Louise 143 Louizalaan B-1050 Bruxelles Belgium
Avenue Louise 143 Louizalaan B-1050 Bruxelles Belgija
Moxifloxacin Infekt
Moksifloksacin Infekt
Film-coated tablet
Filmsko obložena tableta Peroralna uporaba
2800 Kongens Lyngby Denmark
Teva Denmark A/S, Parallelvej 10, 2800 Kongens Lyngby Danska
Bayer Vital GmbH 51368 Leverkusen Germany
Bayer Vital GmbH 51368 Leverkusen Nemčija
Bayer Health Care AG 51368 Leverkusen Germany
Bayer Health Care AG 51368 Leverkusen Nemčija
Avalox 400 mg Filmtabletten 400 mg Film-coated tablet
Avalox 400 mg Filmtabletten 400 mg Filmsko obložena tableta Peroralna uporaba
Bayer AG 51368 Leverkusen Germany
Bayer AG 51368 Leverkusen Nemčija