natgillin/translations-raw huggingface dataset:
 Do not shake the pre-filled syringe. 
X Napolnjene injekcijske brizge ne stresajte.
Breast-feeding 
pegfilgrastima
1 tablet bottle (glass) + syringe (plastic) 
3 tablete steklenica (steklo) + brizga (plastika)
• if you are under 18 years of age 
• če ste mlajši od 18 let.
The text was valid at that time. 
Besedilo je bilo takrat veljavno.
It may take up to four weeks to reach optimal effect. 
Za doseganje optimalnega učinka je lahko potrebno do 4 tedne.
This should be considered when analysing laboratory data. 
To je treba upoštevati pri analizi laboratorijskih podatkov.
There was no difference in mortality. 
Pri umrljivosti ni bilo razlik.
You should lie down on your back with your feet higher than your head. 
Ulezite se na tla, stopala pa postavite višje kot glavo.
In conclusion essential similarity has been sufficiently demonstrated. 
Bistvena podobnost je bila na koncu zadostno dokazana.
2-18, 61118 Bad Vilbel Germany 
2-18, 61118 Bad Vilbel Nemčija
The clinical relevance of these findings is still unknown. 
Klinični pomen teh ugotovitev še ni znan.
Studies on morbidity and mortality have not yet been terminated. 
Študije obolevnosti in umrljivosti še niso končane.
The foodinteraction study was not performed according to the CHMP guidelines. 
Raziskava o medsebojnem delovanju s hrano ni bila izvedena v skladu s smernicami CHMP.
Elderly: Same dosage recommendations as for adults. 
Starejši bolniki: Isto priporočilo za odmerjanje kot za odrasle.
Paediatric patients: There are not sufficient data to recommend the use in children and adolescents. 
Pediatrični bolniki: Ni zadosti podatkov, da bi priporočili uporabo pri otrocih in mladostnikih.
You should tell your doctor immediately and see your doctor as soon as possible. 
Takoj obvestite zdravnika in ga čim prej obiščite.
Volume of distribution: 1 litre/kg. 
Volumen porazdelitve: 1 l/kg.
The directions should be given on the label. 
Navodila morajo biti napisana na nalepki.
Since 2002 more than 44,000,000 generic tablets of this formulation have been supplied to the market and that thousands of subjects have been switched from the originator product to the generic product. 
Od leta 2002 je bilo na trg danih več kot 44.000.000 generičnih tablet tega pripravka in tisoče uporabnikov je originatorjevo zdravilo zamenjalo z generičnim izdelkom.
Provide symptomatic treatment as needed. 
Po potrebi nudite simptomatsko zdravljenje.
Frequencies are defined as very common (≥1/10); common (>1/100 to <1/10); uncommon (>1/1000 to <1/100); rare (>1/10 000 to <1/1000); very rare (<1/10 
Pogostost je opredeljena kot zelo pogosti (≥ 1/10), pogosti (> 1/100 do < 1/10), občasni (> 1/1000 do < 1/100), redki (> 1/10.000 do < 1/1000), zelo redki (< 1/10.000).
Furthermore, they had 25% higher risk of developing clinically significant cardiovascular disorders. 
Poleg tega je bilo pri njih tveganje za razvoj klinično pomembnih srčno-žilnih bolezni večje za 25 %.
ATC code: C02CA04 
Oznaka ATC: C02CA04
The company made additionally a commitment for post-marketing surveillance. 
Podjetje pa se je tudi zavezalo, da bo izvajalo postmarketinški nadzor.
Possibly hypoglycaemia, hypokalaemia. 
Možna hipoglikemija, hipokaliemija.
Distribution: Approximately 98% of doxazosin is protein-bound in plasma. 
Porazdelitev: Približno 98 % doksazosina se veže na beljakovine v plazmi.
Clearance of doxazosin is 1.3 ml/min/kg. 
Očistek doksazosina je 1,3 ml/min/kg.
Trough levels at 24 hours are, however, similar for both formulations. 
Po 24 urah so koncentracije pred naslednjim odmerkom pri obeh formulacijah podobne.
The tablets should be swallowed whole with a sufficient amount of liquid. 
Tablete je treba pogoltniti cele z zadostno količino tekočine.
If you feel dizzy or light-headed, do not drive or operate machinery. 
Če se vam vrti v glavi ali ste omotični, ne vozite ali upravljajte strojev.
This helps to lower raised blood pressure, and reduce the risk of heart disease. 
Tako se zniža krvni tlak in zmanjša tveganje za nastanek srčne bolezni.
Any additional doubts regarding essential similarity are overcome by a commitment for post-marketing surveillance of the applicant. 
Kakršnekoli dodatne dvome v zvezi z bistveno podobnostjo bo razrešila vlagateljeva zavezanost k postmarketinškemu nadzoru.
Abnormally short transport time through the gastrointestinal tract could lead to incomplete absorption. 
Nenormalno kratek čas prehoda skozi prebavila lahko povzroči nepopolno absorpcijo.
This makes it difficult to pass urine. 
Zaradi tega je uriniranje oteženo.
Be especially careful when you take your first dose, if your dose is increased, or if you are starting to take your medicine again after not having taking it for some time. 
Bodite posebej pozorni, kadar vzamete prvi odmerek, če vam odmerek povečajo ali če začnete jemati zdravilo znova, po daljšem premoru.
After you have been told to stop taking your tablets, return any unused tablets to your pharmacist for safe disposal. 
Če vam naročijo, da prenehate jemati tablete, neporabljene tablete vrnite farmacevtu za varno odstranjevanje.
Your doctor may increase your dose to the maximum recommended dose of two tablets each day. 
Zdravnik vam lahko odmerek poveča na največji priporočeni odmerek, dve tableti dnevno.
- It is unlikely that the potential differences observed between the reference product and the generic versions influence the information in the Summary of Product Characteristics (SPC), 
- Ni verjetno, da bi morebitne razlike, opažene med referenčnim zdravilom in generičnimi izdelki, vplivale na informacije v Povzetku glavnih značilnosti zdravila (SPC),
Blister (PVC/PVDC/aluminium) 
Pretisni omot (PVC/PVDC/aluminij).
Titanium dioxide (E171) 
Titanov dioksid (E 171)
The adverse reactions considered at least possibly related to treatment are listed below by body system organ class and absolute frequency. 
Neželeni učinki, za katere menijo, da so vsaj morda povezani z zdravljenjem, so navedeni spodaj po organskih sistemih in absolutni pogostosti pojavljanja.
There are no adequate data from the use of doxazosin in pregnant women. 
Ni zadostnih podatkov o uporabi doksazosina pri nosečnicah.
The usual dose is one tablet (4 mg) each day. 
Običajni odmerek je ena tableta (4 mg) vsak dan.
Do not take a double dose to make up for a forgotten tablet. 
Ne vzemite dvojnega odmerka, če ste pozabili vzeti tableto.
• if you have suffered acute heart disease such as heart failure 
• če imate akutno srčno bolezen, kot je srčna odpoved;
The test product has shown consistent single dose performance across the studies and sufficient reassurance has been provided that the steady state results submitted are representative of other batches. 
Testni izdelek je pokazal konsistentne učinke pri enkratnem odmerjanju v vseh raziskavah, zagotovljena pa je bila zadostna gotovost, da so predloženi rezultati o stalnem stanju reprezentativni tudi za druge serije.
The observed differences in Tmax are modest and the Cmax of the test tablet is not higher than the innovator tablet. 
Opažene razlike v Tmax so zmerne in Cmax testnih tablet ni višji kot v inovativnem zdravilu.
- The SPC, labelling and package leaflet proposed by the applicant has been assessed based on the documentation submitted, the scientific discussion within the Committee and the new wording proposed in the updated Guideline on SPC dated October 2005 and the latest QRD template, 
- Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo, kot jih je predlagal vlagatelj, so bili ovrednoteni na podlagi predložene dokumentacije, znanstvene razprave znotraj Odbora in novega besedila, predlaganega v posodobljenih smernicah o SPC iz oktobra 2005 ter zadnje predloge QRD,
Your medicine is available in PVC/PVDC/aluminium blister packs containing 28 tablets [10, 20, 30, 50, 56, 60, 90, 98, 100, 140 (10x14) tablets]. 
Zdravilo je na voljo v pretisnih omotih iz PVC/PVDC/aluminija, ki vsebujejo 28 tablet [10, 20, 30, 50, 56, 60, 90, 98, 100, 140 (10 x 14) tablet].
With once daily dosing, clinically significant reductions in blood pressure are present throughout the day and at 24-hours post dose. 
Pri odmerjanju enkrat dnevno je klinično pomembno znižanje krvnega tlaka prisotno ves dan in 24 ur po odmerku.
Simply take the next day's tablet when it is due. 
Tableto preprosto vzemite naslednji dan ob načrtovanem času.
After the Commission Decision, the Member State competent authorities will update the product information as required. 
Pristojne oblasti držav članic bodo informacije o zdravilu posodobile v skladu z zahtevami, ko bo podana odločba Komisije.
Only keep the tablets if your doctor tells you to. 
Tablete obdržite samo, če vam je to naročil zdravnik.
even if their symptoms are the same as yours. 
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
Doxazosin has a vasodilating effect through selective and competitive blocking of postsynaptic alpha-1-receptors. 
Doksazosin učinkuje vazodilatatorno s selektivnim in kompetitivnim blokiranjem postsinaptičnih alfa-1 receptorjev.
CHMP was of the opinion that the bioequivalence was sufficiently established after single dose administration in two different bioequivalence studies (study 463/04 and 1995/04-05) and after multiple dose administration (study5208/02-3) according to the CHMP guidelines. 
CHMP je menil, da je bila bioekvivalenca po uporabi enega odmerka zadostno dokazana v dveh različnih bioekvivalenčnih raziskavah (raziskavi 463/04 in 1995/04-05) in po uporabi večkratnega odmerka (raziskava 5208/02-3) v skladu s smernicami CHMP.
The clinical safety during lactation has not been established, consequently use in nursing mothers is not recommended. 
Klinične varnosti med dojenjem niso ugotovili, zato uporaba pri doječih materah ni priporočena.
The results are difficult to interpret due to various reasons such as differences in effect on systolic blood pressure and discontinuation of diuretics in the doxazosin-treated group prior to commencement of the treatment. 
Rezultate je težko pojasnjevati zaradi več dejavnikov, kot so razlike v učinku na sistolični krvni tlak in prekinitev zdravljenja z diuretiki v skupini bolnikov, ki so prejemali doksazosin pred začetkom zdravljenja.
Doxazosin is primarily metabolised by O-demethylation and hydroxylation. 
Doksazosin se presnavlja predvsem z O-demetilacijo in hidroksilacijo.
6 FURTHER INFORMATION 
16 DODATNE INFORMACIJE
Therefore, sildenafil doses above 25 mg should not be taken within 4 hours of taking an alpha-blocker (see section 4.4). 
Zato se odmerki sildenafila, večjih od 25 mg, ne smejo jemati 4 ure pred jemanjem alfa-blokatorja ali 4 ure po njem (glejte poglavje 4.4).
The active ingredient in your tablets, doxazosin, belongs to a group of medicines known as alpha-1 antagonists. 
Zdravilna učinkovina v tabletah, doksazosin, spada v skupino zdravil, znanih kot alfa-1 antagonisti.
• if you know that you are sensitive to quinazolines (e.g. prazosin, terazosin) which is the chemical family of medicines to which doxazosin belongs 
• če veste, da ste občutljivi za kinazoline (npr. prazosin, terazosin), kemijsko skupino zdravil, v katero spada doksazosin;
It is unlikely that these differences will result in clinically relevant adverse events. 
Ni pričakovati, da bi posledica teh razlik lahko bili klinično pomembni neželeni učinki.
If you take too many tablets, the most likely symptoms of overdose would be a feeling of lightheadedness or dizziness due to a fall in blood pressure. 
Če vzamete preveč tablet, sta najverjetnejša simptoma prevelikega odmerjanja občutek omotice ali vrtoglavice, zaradi znižanja krvnega tlaka.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 
12.2 Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Biotransformation: 
Biološka transformacija:
Psychiatric disorders: Nervousness. 
Psihiatrične motnje: živčnost.
Non-steroidal antirheumatics or estrogens may reduce the antihypertensive effect of doxazosin. 
Nesteroidni antirevmatiki ali estrogeni lahko zmanjšajo antihipertenzivni učinek doksazosina.
• if you have ever suffered an allergic reaction (e.g. itching, reddening of the skin or difficulty breathing) to the active ingredient, doxazosin, or any of the other ingredients listed above 
• če ste kdaj imeli alergijsko reakcijo (npr. srbenje, rdečico kože ali težave pri dihanju) na zdravilno učinkovino doksazosin ali katero koli zgoraj navedeno sestavino zdravila;
There is limited data on the effect of overdoses. 
Podatki o učinkih prevelikega odmerjanja so omejeni.
However, results of this study indicated that when administered with food no clinical significant differences exist between both products. 
Rezultati te raziskave pa so nakazali, da ni pomembnih kliničnih razlik med obema zdraviloma, če se jemljeta s hrano.
The CHMP is of the opinion the product does not differ significantly from the originator in terms of efficacy and safety. 
CHMP je mnenja, da se zdravilo, kar se tiče učinkovitosti in varnosti, ne razlikuje pomembno od originatorjevega zdravila.
In cases of hypotension: lower the head position, provide intravenous fluids and if needed vasopressors (for instance noradrenaline or ephedrine). 
V primeru hipotenzije: znižajte položaj glave, intravensko dovajajte tekočino in po potrebi vazopresorje (na primer noradrenalin ali efedrin).
Before surgery and anaesthesia (even at the dentist), you should tell the doctor or dentist that you are taking Doxastad 4 mg prolonged release tablets and associated names . 
Pred kirurškim posegom in anestezijo (tudi pri zobozdravniku) morate zdravniku ali zobozdravniku povedati, da jemljete zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena.
As for other antihypertensives, including alpha-blocking agents, the patient should be monitored on initiation of therapy to minimise the potential risk for postural effects. 
Kot pri drugih antihipertenzivih, vključno z alfa-blokatorji, je treba na začetku zdravljenja bolnika opazovati, da bi zmanjšali morebitno tveganje posturalnih učinkov.
Take as directed by your doctor. 
Jemljite po zdravnikovih navodilih.
Up to now there were no adverse events potentially related to a faster release of doxazosin reported. 
Do sedaj niso poročali o neželenih učinkih, ki bi bili morebiti povezani s hitrejšim sproščanjem doksazosina.
10 Prolonged-release tablets 20 Prolonged-release tablets 28 Prolonged-release tablets 30 Prolonged-release tablets 50 Prolonged-release tablets 56 Prolonged-release tablets 60 Prolonged-release tablets 90 Prolonged-release tablets 98 Prolonged-release tablets 100 Prolonged-release tablets 140 Prolonged-release tablets 
10 tablet s podaljšanim sproščanjem 20 tablet s podaljšanim sproščanjem 28 tablet s podaljšanim sproščanjem 30 tablet s podaljšanim sproščanjem 50 tablet s podaljšanim sproščanjem 56 tablet s podaljšanim sproščanjem 60 tablet s podaljšanim sproščanjem 90 tablet s podaljšanim sproščanjem 98 tablet s podaljšanim sproščanjem 100 tablet s podaljšanim sproščanjem 140 tablet s podaljšanim sproščanjem
The plasma elimination is biphasic with the terminal elimination half-life being 22 hours and hence this provides the basic for once daily dosing. 
Izločanje iz plazme je dvofazno, končni razpolovni čas izločanja je 22 ur, kar omogoča odmerjanje enkrat dnevno.
Sympathomimetics may reduce the antihypertensive effect of doxazosin; doxazosin may reduce blood pressure and vascular reactions to dopamine, ephedrine, epinephrine, metaraminol, methoxamine and phenylephrine. 
Simpatikomimetiki lahko zmanjšajo antihipertenzivni učinek doksazosina, doksazosin lahko zniža krvni tlak in reakcije ožilja na dopamin, efedrin, epinefrin, metaraminol, metoksamin in fenilefrin.
Interim analysis of the study “Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial” (ALLHAT) shows that patients with hypertension and at least one other clinical risk factor for coronary heart disease treated with doxazosin are exposed to a doubled risk for chronic heart failure compared to patients treated with chlortalidone. 
Vmesna analiza študije "Preskušanje antihipertenzivnega zdravljenja in zdravljenja za nižanje ravni lipidov za preprečevanje srčne kapi" ("Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial" - ALLHAT) je pokazala, da so bolniki s hipertenzijo in vsaj še enim kliničnim dejavnikom tveganja izpostavljeni dvakrat večjemu tveganju za nastanek kronične srčne odpovedi kot bolniki, ki jih zdravijo s klortalidonom.
Rare cases of syncope (faint) in association with orthostatic hypotension (low blood presssure as a result of getting up from a sitting or lying position) have been observed. 
Opazili so redke primere sinkope (omedlevice) v povezavi z ortostatsko hipotenzijo (nizek krvni tlak, ki je posledica vstajanja iz sedečega ali ležečega položaja.
These medicines work by widening your blood vessels making it easier for your heart to pump blood through them. 
Ta zdravila delujejo tako, da razširijo krvne žile, kar srcu olajša črpanje krvi skoznje.
Tel: 0034 93 4738889 Fax: 0034 93 4737495 
Tel: 0034 93 4738889 Faks: 0034 93 4737495
Nausea, vomiting. 
Navzea, bruhanje.
Although no teratogenic effects were noted in animal studies, Doxastad 4 mg prolonged release tablets and associated names should not be used during pregnancy unless clearly needed. 
Čeprav v študijah na živalih niso opazili teratogenih učinkov, zdravila Doxastad 4 mg tablete s podaljšanim sproščanjem in povezana imena ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
Reproductive system and breast disorders: Priapism and impotence. 
Motnje reprodukcije in dojk: priapizem in impotenca.
Patients should be closely monitored in the initial phase of the treatment due to the risk of postural adverse events. 
Na začetku zdravljenja je treba bolnike pozorno spremljati, ker obstaja tveganje posturalnih neželenih učinkov.
In a clinical study of 12 subjects with moderate hepatic impairment, single dose administration of doxazosin resulted in an increase of AUC of 43% and a decrease in oral clearance of approximately 30%. 
V klinični študiji pri 12 bolnikih z zmerno jetrno okvaro je uporaba enega odmerka doksazosina povzročila povečanje vrednosti AUC za 43 % in zmanjšanje peroralnega očistka za približno 30 %.
Recommended dose is 4 mg once daily. 
Priporočeni odmerek je 4 mg enkrat dnevno.
Your pharmacist may also be able to help if you are not sure. 
Če niste prepričani, vam lahko pomaga tudi farmacevt.
Doxazosin may influence the plasma renin activity and urinary excretion of vanillylmandelic acid. 
Doksazosin lahko vpliva na aktivnost renina v plazmi in izločanje vanililmandljeve kisline z urinom.
This is the pharmacological basis for clinical use of doxazosin in treatment for benign prostatic hyperplasia. 
To je farmakološka osnova klinične uporabe doksazosina pri zdravljenju benigne hiperplazije prostate.
This condition causes enlargement of the prostate gland, which is just underneath the bladder in men. 
Ta bolezen povzroča povečanje prostate, ki leži pod mehurjem pri moških.
Essential hypertension. 
Esencialna hipertenzija.
Since no clinical experience from patients with severe hepatic insufficiency exists, use in these patients is not recommended (see section 4.4). 
Kliničnih izkušenj pri bolnikih s hudo jetrno okvaro ni, zato se uporaba pri teh bolnikih ne priporoča (glejte poglavje 4.4).
Ventricle emptying and charcoal if required. 
Praznjenje prekata in po potrebi aktivno oglje.
• if you have or have had any form of obstruction of the digestive tract 
• če imate ali ste imeli kakršno koli obliko zapore prebavil;
Since doxazosin is strongly bound to proteins dialysis is not indicated. 
Doksazosin se močno veže na beljakovine, zato dializa ni indicirana.
Therefore, this SPC, labelling and package leaflet may not necessarily represent the current text. 
Zaradi tega je možno, da ta Povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo ne predstavljajo trenutno veljavnega besedila.
Effect and safety studies (with a total of 1,317 patients treated with doxazosin) have only been performed in patients with a baseline of ≥ 12 on the International Prostate Symptom Score and a maximum urinary flow of <15 ml/sec. 
Študije učinkovitosti in varnosti (pri kateri je sodelovalo 1317 bolnikov, ki so jih zdravili z doksazosinom) so opravili samo na bolnikih z izhodiščnim rezultatom ≥ 12 na mednarodni lestvici prostatičnih simptomov in največjim pretokom urina < 15 ml/s.
Note: This SPC, labelling and package leaflet is the version that was annexed to the Commission Decision on this Article 29 referral for doxazosin mesilate containing medicinal products. 
Opomba: Ta Povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo so bili priloženi k odločbi Komisije v zvezi z napotitvenim postopkom, ki je bil sprožen v skladu z členom 29, za zdravila, ki vsebujejo doksazosinmezilat.
4 CLINICAL PARTICULARS 
4 KLINIČNI PODATKI
Hypertension: 
Hipertenzija:
- The scope of the referral was to agree whether Doxastad 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food with concern regarding the adequate sensitivity of to detect a difference between products, 
- Namen napotitve je bil doseči soglasje o tem, ali se zdravilo Doxastad 4 mg tablete s podaljšanim sproščanjem, kar se tiče profila sproščanja, pomembno razlikuje od originatorjevega zdravila, in ali je možnost pojavov neželenih učinkov, kot so omotica in hipotenzija, morebiti povečana; nadalje ali so bile razlike v rezultatih iz študij 5208 in 1995 testnih serij pri enkratnem odmerjanju pomembne, ter končno ali se je vlagatelj oddaljil od smernic pri oblikovanju bioekvivalenčnih raziskav, zlasti kar se tiče učinka, ki bi ga lahko imela hrana na ustrezno občutljivost za zaznavanje razlik med zdraviloma.
Doxazosin is extensively metabolised with <5% excreted as unchanged product. 
V veliki meri se doksazosin presnavlja, v nespremenjeni obliki se ga izloči < 5 %.
The patient should not chew, divide or crush the tablet. 
Bolnik tablete ne sme žvečiti, prelomiti ali zdrobiti.
Blocking alpha-1-adrenoreceptors through doxazosin reduces the tonus of the smooth muscle in the prostatic part of the urethra which facilitates the urinary flow. 
Blokiranje alfa-1-adrenoreceptorjev z doksazosinom zmanjšuje tonus gladkih mišic v prostatičnem delu uretre, kar olajša pretok urina.
Concomitant intake of food results in a somewhat higher degree of absorption, AUC is 14% higher and Cmax 23% higher compared with intake when fasting. 
Vrednost AUC je za 14 % večja, vrednost Cmax pa je za 23 % večja v primerjavi z jemanjem na tešče.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA(OV) GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO, KI JIH JE PREDSTAVILA EMEA
Treatment with doxazosin immediate release tablets has been shown to result in regression of left ventricular hypertrophy. 
Pokazali so, da zdravljenje s tabletami doksazosina s takojšnjim sproščanjem povzroča regresijo hipertrofije levega prekata.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, NAČINOV UPORABE ZDRAVILA, VLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Tel: 0049 6101 603301 Fax: 0049 6101 603151 
Tel: 0049 6101 603301 Faks: 0049 6101 603151