natgillin/translations-raw huggingface dataset:
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
Pomožne snovi, navedene v poglavju 6.1 SPC, tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
ATCvet code: QI10AX. 
oznaka ATC vet: QI10AX
Duration of immunity is approximately 3 months after vaccination (demonstrated under laboratory conditions at a water temperature of 12 ±2 °C). 
Imunost traja približno 3 mesece po cepljenju (dokazano pod laboratorijskimi pogoji pri temperaturi vode 12 ±2 °C).
Do not use in clinically diseased groups of fish. 
Ne uporabljajte pri klinično obolelih jatah rib.
Needle injuries at the site of injection are common following administration of the vaccine which can persist in up to 5% of fish for at least 90 days, and can be seen both macroscopically and microscopically. 
Poškodbe zaradi igle na mestu injiciranja so po dajanju cepiva pogoste in lahko pri 5 % rib trajajo najmanj 90 dni, vidne pa so lahko tako makroskopsko kot mikroskopsko.
CLYNAV stimulates active immunity against salmonid alphavirus subtype 3 (SAV3). 
CLYNAV spodbudi aktivno imunost proti salmonidnemu alfavirusu podtipa 3 (SAV3).
For the active immunisation of Atlantic salmon to reduce impaired daily weight gain, and reduce mortality, and cardiac, pancreatic and skeletal muscle lesions caused by pancreas disease following infection with salmonid alphavirus subtype 3 (SAV3). 
Za aktivno imunizacijo atlantskega lososa z namenom izboljšanja oslabljenega dnevnega prirasta teže ter zmanjšanja smrtnosti in lezij na srcu, trebušni slinavki in skeletnih mišicah, ki jih povzroča bolezen trebušne slinavke po okužbi s salmonidnim alfavirusom podtipa 3 (SAV3).
Connect the other end of the transfer tubing set to the vaccine injection equipment (gun). 
Drugi del kompleta cevja za prenos povežite na opremo za injiciranje zdravila (puška).
Transient changes in swimming behaviour, pigmentation and inappetence are very common and can be observed for up to 2, 7 and 9 days, respectively. 
Prehodne spremembe v načinu plavanja, pigmentaciji in neješčnost so zelo pogoste in jih je mogoče opaziti do 2, 7 oz. 9 dni.
Onset of immunity occurs within 399 degree days (mean water temperature in °C multiplied by number of holding days) following vaccination. 
Imunost nastopi v 399 dnevnih stopinjah (povprečna temperatura vode v °C, pomnožena s številom dni v bazenu) po cepljenju.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports). 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pri več kot 1 živali od 10 živali v teku enega zdravljenja) - pogosti (pri več kot 1, toda manj kot 10 živalih od 100 živali) - občasni (pri več kot 1, toda manj kot 10 živalih od 1000 živali) - redki (pri več kot 1, toda manj kot 10 živalih od 10.000 živali) - zelo redki (pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
Interactions with other medicinal products and other forms of interaction No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
Shake product gently before use. 
Zdravilo pred uporabo nežno pretresite.
Special warnings for the target species Do not use in clinically diseased groups of fish. 
Posebna opozorila za vsako živalsko vrsto Ne uporabljajte pri klinično obolelih jatah rib.
Name and address of the manufacturer of the biological active substance Elanco Canada Ltd 
Ime in naslov izdelovalca biološke zdravilne učinkovine Elanco Canada Limited
Based on a 25 g fish weight a standard 0.5 mm diameter 3mm depth needle is recommended to be used routinely. 
Na osnovi rib s težo 25 g je pri redni uporabi priporočeno uporabiti standardno iglo s premerom 0,5 mm za vbode globine 3 mm.
Consideration should be made for the weight of the fish before the final selection is made. 
Končno izbiro igle je treba sprejeti ob upoštevanju teže ribe.
CLYNAV contains a supercoiled DNA plasmid which expresses proteins of salmon alphavirus which induces a protective immune response in vaccinated Atlantic salmon. 
CLYNAV vsebuje dodatno zvito plazmidno DNK , ki izraža beljakovine salmonidnega alfavirusa, kar inducira zaščitni imunski odziv pri cepljenem atlantskem lososu.
Potassium dihydrogen phosphate Disodium hydrogen phosphate heptahydrate Sodium chloride 
6.1 Seznam pomožnih snovi kalijev klorid kalijev dihidrogenfosfat heptahidrat natrijevega hidrogenfosfata dinatrijev hidrogenfosfat heptahidrat natrijev klorid prečiščena voda
Anaesthetise the fish to immobilise them, and administer 0.05 ml of the vaccine by intramuscular injection in the area immediately anterior and lateral to the dorsal fin in the epaxial muscle. 
Anestezirajte ribo za imobilizacijo in ji dajte 0,05 ml cepiva z intramuskularno injekcijo na mesto, ki je neposredno anteriorno in lateralno glede na hrbtno plavut in epaksialno mišico.
Manufacturer responsible for batch release: Lohmann Animal Health GmbH Heinz-Lohmann-Straβe 4, 27472 Cuxhaven 
Izdelovalec, odgovoren za sproščanje serij: Lohmann Animal Health GmbH Heinz-Lohmann-Straβe 4, 27472 Cuxhaven
A minimum body weight of 25 g is recommended at vaccination. 
Priporočena telesna teža ob cepljenju je najmanj 25 g.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with any other veterinary medicinal products. 
Zaradi pomanjkanja študij kompatibilnosti tega zdravila za uporabo v veterinarski medicini ne smemo mešati z drugimi zdravili za uporabo v veterinarski medicini.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX 
PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA
Transfer tubing kit instructions: using the spiked end, screw the transfer tubing set onto the fill port of the ethyl vinyl acetate (EVA) bag with a ¼ turn in order to secure the line in place. 
Navodila za uporabo kompleta cevja za prenos: komplet cevja za prenos privijte s konico na vhod za polnjenje na vrečki iz etilvinilacetata (EVA) ter obrnite za ¼ obrata, da bo linija fiksirana.
Pharmacotherapeutic group: Immunologicals for Atlantic salmon. 
Farmakoterapevtska skupina: imunološka zdravila za atlantskega lososa.
TARGET SPECIES Atlantic salmon (Salmo salar). 
CILJNE ŽIVALSKE VRSTE Atlantski losos (Salmo salar)
4.11 Withdrawal period(s) Zero degree days. 
4.11 Karenca Nič dnevnih stopinj.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.05 ml dose contains: 
En 0,05-mililitrski odmerek vsebuje:
Do not mix with any other veterinary medicinal products prior to or during administration. 
Pred ali med dajanjem ne mešajte z drugimi zdravili za uporabo v veterinarski medicini.
Personal protective equipment, for example, appropriate protective gloves, should be worn when handling the veterinary product. 
Pri ravnanju z zdravilom nosite osebno zaščitno opremo, kot so npr. ustrezne zaščitne rokavice.
Do not use in broodstock. 
Ne uporabljajte pri plemenski jati.
Position the needle at 90° in the epaxial muscle, central to the dorsal fin and above the mid-line. 
Iglo vbodite pravokotno v epaksialno mišico, centralno na hrbtno plavut in nad vzdolžno osjo.
SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 °C - 8 °C). 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniki (2 °C-8 °C).
WITHDRAWAL PERIOD Zero degree days. 
Nič dnevnih stopinj.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs 
DODATEK II A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
SPECIAL WARNING(S), IF NECESSARY 
KARENCA Karenca: nič dnevnih stopinj POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A)
METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use. 
NAČIN IN POT(I) UPORABE Intramuskularna injekcija Pred uporabo preberite navodilo za uporabo.
NAME OF THE VETERINARY MEDICINAL PRODUCT CLYNAV solution for injection for Atlantic salmon 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI CLYNAV raztopina za injiciranje za atlantskega lososa
250 ml sterile, flexible, ethyl vinyl acetate (EVA) bags with a locking snap down port. A sterile and individually packaged transfer tube set is included in the final product packaging. 
250-mililitrsko sterilno, prožna vrečka iz etilvinilacetata (EVA) z odprtino s potisnim poklopcem.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
EXPIRY DATE EXP {month/year} Once opened use within 10 hours. 
Odprto zdravilo uporabite v 10 urah.
No effects other than those described in section 6 have been observed following the administration of an overdose. 
Preveliko odmerjanje Po dajanju prevelikega odmerka niso opazili nobenih drugih učinkov, kot tistih opisanih v poglavju
A clear, colourless, particulate-free solution. 
FARMACEVTSKA OBLIKA Raztopina za injiciranje Bistra, brezbarvna raztopina brez delcev
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP. Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti.
Active substance: pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins: 5.1 - 9.4 μg. 
Zdravilna učinkovina: plazmidno kodirane DNK pUK-SPDV-poly2#1 beljakovine virusa bolezni trebušne slinavke pri lososu: 5,1-9,4 μg.
QUANTITY OF THE ACTIVE SUBSTANCE(S) Each 0.05 ml dose contains: pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins: 5.1 - 9.4 μg. 
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) En 0,05-mililitrski odmerek vsebuje: plazmidno kodirane DNK pUK-SPDV-poly2#1 beljakovine virusa bolezni trebušne slinavke pri lososu: 5,1-9,4 μg.
PACKAGE LEAFLET FOR: CLYNAV solution for injection for Atlantic salmon 
NAVODILO ZA UPORABO CLYNAV raztopina za injiciranje za atlantskega lososa
Name and address of the manufacturer responsible for batch release 
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije Lohmann Animal Health GmbH
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 0.05 ml dose contains: pUK-SPDV-poly2#1 DNA plasmid coding for salmon pancreas disease virus proteins: 5.1 - 9.4 μg. 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI CLYNAV raztopina za injiciranje za atlantskega lososa NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI En 0,05-mililitrski odmerek vsebuje: plazmidno kodirane DNK pUK-SPDV-poly2#1 beljakovine virusa bolezni trebušne slinavke pri lososu: 5,1-9,4 μg.
Disposal: read package leaflet. 
ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO Odstranjevanje: preberite navodilo za uporabo.
MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS EVA (250 ml) 
FARMACEVTSKA OBLIKA Raztopina za injiciranje VELIKOST PAKIRANJA 250 ml CILJNE ŽIVALSKE VRSTE Atlantski losos (Salmo salar) INDIKACIJA(E)
¾ It is important that you finish the course of treatment even if you begin to feel better after a few days. 
Pomembno je, da zaključite zdravljenje, tudi če se čez nekaj dni počutite bolje.
Advice/medical education 
Nasvet/zdravstveno izobraževanje
However, these proposals were not in line with the bioequivalence data. 
Kljub temu pa ti predlogi niso bili v skladu s podatki o biološki enakovrednosti.
It is important to inform your doctor about your medicine. 
Pomembno je obvestiti vašega zdravnika o vašemu zdravilu.
Do not chew the tablets because they do not taste nice. 
Tablet ne žvečite, ker niso dobrega okusa.
B - 1050 Bruxelles-Brussel Belgium 
B - 1050 Bruxelles-Brussel Belgija
Consequently, to preserve the efficacy of this drug: 
Za ohranitev učinkovitosti tega zdravila je potrebno:
Food and Dairy Products 
Hrana in mlečni izdelki
It has a long history of known safety and efficacy in adults, children and adolescents. 
Ima dolgo zgodovino znane učinkovitosti in varnosti uporabe pri odraslih, otrocih in mladostnikih.
Such a use is supported by publications and clinical experience. 
Takšna uporaba je podprta z objavami in kliničnimi izkušnjami.
Do not pour water into the suspension! 
Ne vlijte vode v suspenzijo!
The absolute bioavailability is approximately 70-80%. 
Absolutna biološka uporabnost je približno 70 do 80 %.
+ Resistance rate ≥ 50% in one or more EU countries 
+ stopnja odpornosti ≥ 50 % v eni ali več državah Evropske unije
This phenomenon is called resistance: some antibiotic treatments become ineffective. 
Ta pojav se imenuje rezistenca; nekatera antibiotična zdravljenja postanejo neučinkovita.
2794-003 Carnaxide Portugal 
2794-003 Carnaxide Portugalska
However, this indication was not considered acceptable for the IV ciprofloxacin formulation. 
Vendar pa ta indikacija ni bila sprejemljiva za formulacijo IV ciprofloksacina.
Tell your doctor if you are planning to get pregnant. 
Posvetujte se z zdravnikom, če načrtujete nosečnost.
{Name and Address} <{tel}> <{fax}> <{e-mail}> 
{Ime in naslov} <{tel}> <{fax}> <{e-mail}>
The CHMP agreed to simplify the wording for other indications and adapt them to the current epidemiological concerns. 
CHMP se je strinjal s poenostavitvijo besedila za druge indikacije in njihovo prilagoditvijo trenutnim epidemiološkim zahtevam.
The response document included a review of clinical data (published data, medical research reports) and microbiological data. 
V odgovor vključena dokumentacija je vključevala pregled kliničnih podatkov (objavljeni podatki, poročila medicinskih raziskav) in mikrobiološke podatke.
No new safety concerns arose from these data. 
Na osnovi teh podatkov ni bilo nobenih novih zadržkov.
Despite antibiotics, some bacteria may survive or grow. 
Kljub antibiotičnemu zdravljenju lahko nekaj bakterij preživi ali zraste.
If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered. 
Če po treh dneh zdravljenja ni kliničnega izboljšanja, je treba o zdravljenju ponovno razmisliti.
Other specific severe infections 
Druge specifične hude okužbe
4 - Never give your antibiotic to another person; maybe it is not adapted to her/his illness. 
Nikoli dati antibiotika drugi osebi; morda ni primeren za njeno bolezen.
In a study in children Cmax and AUC were not age-dependent (above one year of age). 
V študijah pri otrocih Cmax in AUC nista bili odvisni od starosti (nad prvim letom starosti).
A drink of water may be taken afterwards. 
Nato lahko popijete vodo.
However, if it is almost time for your next dose, do not take the missed dose and continue as usual. 
Če je že skoraj čas za vaš naslednji odmerek, ne vzemite pozabljeni odmerek, ampak nadaljujte kot običajno.
Therefore, the CHMP requested that an appropriate restriction of the indication be made. 
Tako je CHMP zahteval, da se pri tej indikaciji sprejme ustrezna omejitev.
In daylight conditions complete efficacy is guaranteed for a period of three days. 
Pri dnevni svetlobi je njena učinkovitost zagotovljena 3 dni.
¾ If you take more than the prescribed dose, get medical help immediately. 
Če ste vzeli večji odmerek kot je predpisan, takoj poiščite zdravniško pomoč.
If your doctor has prescribed antibiotics, you need them precisely for your current illness. 
Če vam je zdravnik predpisal antibiotike, jih uporabite le za vašo sedanjo bolezen.
3 - Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness. 
Ne uporabljati antibiotika ponovno brez zdravnikovega nasveta, tudi če bi želeli zdraviti podobno bolezen.
The duration of treatment depends on the severity of the illness and on the clinical and bacteriological course. 
Trajanje zdravljenja je odvisno od resnosti bolezni ter kliničnega in bakteriološkega poteka.
28 days up to 3 months 
28 dni do 3 mesecev
Your doctor will give you each dose by slow infusion through a vein into your bloodstream. 
Zdravnik vam bo dal vsak odmerek s počasnim infundiranjem skozi veno v krvni obtok.
A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). 
Potrebno bo opraviti preiskavo krvi, da bi preverili morebitno zmanjšanje števila belih krvnih celic (agranulocitoza).
1 - Use antibiotics only when prescribed. 
Uporabljati antibiotike samo kadar so predpisani.
In summary, the CHMP considers that both indications (curative treatment and prophylaxis) were acceptable. 
CHMP je tako menil, da sta obe indikaciji (zdravljenje in profilaksa) sprejemljivi.
Frequency not known (cannot be estimated from available data) 
Pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov)
For children, the infusion duration is 60 minutes. 
Pri otrocih traja infundiranje 60 minut.
Serum concentrations increase proportionately with doses up to 1000 mg. 
Serumske koncentracije naraščajo sorazmerno z odmerkom do 1000 mg.
Interaction with tests 
Interakcije s testi
Misuse of antibiotics increases resistance. 
Napačna uporaba antibiotikov zvečuje odpornost.
Antibiotics are used to cure bacterial infections. 
Antibiotiki se uporabljajo za zdravljenje bakterijskih okužb.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. 
Študije na živalih ne kažejo direktnih ali indirektnih škodljivih učinkov glede vpliva na sposobnost razmnoževanja.
Viale Certosa 130 I-20156 Milan Italy 
Viale Certosa 130 I-20156 Milan Italija
You might also develop resistance to the antibiotic. 
Prav tako se lahko razvije odpornost na antibiotik.
Then tear the sachet open as indicated and take the contents directly. 
Nato se vrečico odpre kot je prikazano in zaužije vsebina.
Bayer Santé 13, rue Jean Jaurès 92807 Puteaux Cedex France 
Bayer Santé 13, rue Jean Jaurès 92807 Puteaux Cedex Francija
A statement in section 5.1 referring to this indication was also recommended as follows: 
V zvezi s to indikacijo je bila priporočena tudi vključitev naslednje izjave v poglavje 5.1:
They are ineffective against viral infections. 
Ne učinkujejo proti virusnim okužbam.
The Applicant/MAH provided reports summarizing the results of a literature search from 2001 to 2006, including animal model and clinical articles. 
Predlagatelj/imetnik dovoljenja za promet z zdravilom je predložil poročilo s povzetkom rezultatov iz literature od leta 2001 do leta 2006, vključno z modelom pri živalih in kliničnimi članki.
Patients should be kept well hydrated. 
Bolniki morajo biti primerno hidrirani.
As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. 
Nasvet izvedenca je nujno potreben, kjer je lokalna razširjenost odpornosti tolikšna, da je koristnost uporabe učinkovine pri vsaj nekaterih vrstah okužb dvomljiva.
All in-vitro mechanisms of resistance are commonly observed in clinical isolates. 
Vsi in vitro mehanizmi odpornosti so običajno opazni pri kliničnih izolatih.
The following sections of the Product Information were addressed during this harmonisation procedure. 
V postopku uskladitve so bila obravnavana naslednja poglavja iz informacij o zdravilu.
The reconstituted suspension is stable for no more than about 14 days even when stored in a refrigerator. 
Pripravljena suspenzija je stabilna 14 dni, tudi če jo shranjujete v hladilniku.
Some neurological adverse events can occur. 
Pojavijo se lahko nekateri nevrološki neželeni učinki.
This should be taken into account in patients with diabetes mellitus. 
To je treba upoštevati pri sladkornih bolnikih.
The rate of resistance to methicillin is around 20 to 50% among all staphylococcal species and is usually higher in nosocomial isolates. 
Stopnja odpornosti do meticilina je približno 20 do 50 % med vsemi stafilokoki in je običajno višja pri nozokomialnih izolatih.
Do try to take the suspension at around the same time every day. 
Jemljite suspenzijo vsak dan ob približno istem času.
However, for infections such as malignant external otitis (MEO), the scenario is different. 
Kljub temu pa so scenariji pri okužbah, kot je na primer maligni zunanji otitis (MEO), drugačni.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any that you obtained without a prescription. 
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta.
Preparing and taking the suspension 
Priprava in jemanje suspenzije
The serum elimination half-life in subjects with normal renal function is approximately 4-7 hours. 
Razpolovni čas izločanja v serum je pri ljudeh z normalnim ledvičnim delovanjem približno 4 do 7 ur.
Treatment of Shigellosis: 
Zdravljenje šigeloze:
The restriction does not apply to antacids belonging to the class of H2 receptor blockers. 
Omejitev ne velja za zdravila iz skupine zaviralcev receptorjev H2.
In rare cases, depression or psychosis can progress to selfendangering behaviour. 
V zelo redkih primerih lahko depresija ali psihoza napredujeta do samomorilskih nagnjenj.
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee, 
- da so bili povzetki glavnih značilnosti zdravila, označevanj in navodil za uporabo, ki so jih predlagali imetniki dovoljenj za promet z zdravilom, ovrednoteni na podlagi predložene dokumentacije in strokovne razprave v Odboru,
Be sure to complete your course of treatment. 
Zanesljivo zaključite celotno zdravljenje.
{Name and address} <{tel}> <{fax}> <{e-mail}> 
<{fax}> <{e-mail}>
The CHMP initially proposed to put this information in section 4.4 under the subheading “Children and adolescents”. 
Odbor za zdravila za uporabo v humani medicini je najprej predlagal vključitev teh podatkov v poglavje 4.4 v podpoglavje „Otroci in mladostniki“.
Do not chew the granules present in the suspension, simply swallow them. 
Ne žvečite zrnc, ki so v suspenziji, ampak jih pogoltnite.
However, the CHMP considered that the particular context of anthrax (i.e.bioterrorism) required deviation from the usual requirement of clinical data and the benefit assessment. 
CHMP je kljub temu upošteval, da specifični kontekst antraksa (to je bioterorizem) zahteva odmik od običajnih zahtev glede kliničnih podatkov in ocene koristnosti.
Hepatobiliary system 
Hepatobiliarni sistem
The applicant/MAH submitted 11 studies (8 published clinical studies and 3 medical study reports) in which treatment duration for ciprofloxacin ranged from 2 and 476 days. 
Predlagatelj/imetnik dovoljenja za promet z zdravilom je predložil 11 študij (8 objavljenih kliničnih študij in 3 poročila o medicinskih študijah), v katerih je zdravljenje s ciprofloksacinom potekalo od 2 do 476 dni.
• have ever had kidney problems because your treatment may need to be adjusted 
− ste kdaj imeli težave z ledvicami, ker bi bilo lahko treba vaše zdravljenje prilagoditi
These reactions are more frequent if the infusion time is 30 minutes or less. 
Reakcije so bolj pogoste, če se ciprofloksacin infundira 30 minut ali manj.
Occasionally the suspension may contain yellow-orange droplets and globular particles. 
Včasih lahko suspenzija vsebuje rumeno-oranžne kapljice in kroglaste delce.