natgillin/translations-raw huggingface dataset:
For the majority of breeds the use of ibafloxacin is contra-indicated in dogs less than 8 months of age and in giant breeds less than 18 months. 
Pri večini pasem je uporaba ibafloksacina kontraindicirana za pse, mlajše od 8 mesecev, pri zelo velikih pasmah pa za pse, mlajše od 18 mesecev.
QUANTITY OF THE ACTIVE SUBSTANCE(S) 30 mg of ibafloxacin per ml of gel 
KOLIČINA ZDRAVILNE UČINKOVINE 30 mg ibafloksacina v 1 ml gela
For the majority of breeds, the use of ibafloxacin is contra-indicated in dogs less than 8 months of age and in giant breeds less than 18 months old. 
Pri večini pasem je uporaba ibafloksacina kontraindicirana za pse, mlajše od 8 mesecev in pri zelo velikih pasmah za pse, mlajše od 18 mesecev.
Pharmacotherapeutic group: antibacterial quinolone ATCvet code: QJ 01 MA 96 
Farmakoterapevtska skupina: kinolonske protimikrobne učinkovine Oznaka ATCvet: QJ 01 MA 96 Ibafloksacin je širokospektralen, baktericidni antibiotik.
- Dermal infections (soft tissue infections - wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp, E. coli, Proteus spp. 
- dermalne okužbe (okužbe mehkega tkiva - rane, abscesi), ki jih povzročajo občutljivi mikroorganizmi, kot so Staphylococcus spp., E. coli, Proteus spp.
Fluoroquinolones should not be used in combination with non-steroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures. 
Fluorokinolonov ne smemo uporabljati v kombinaciji z nesteroidnimi protivnetnimi zdravili (NSAID) pri psih, ki imajo v anamnezi konvulzije.
Marketing Authorisation number(s) EU/2/00/022/09-12 
Številka dovoljenja za promet EU/2/00/022/09-12
Quinolones should not be used in combination with nonsteroidal anti-inflammatory drugs (NSAID) in dogs with a history of seizures. 
Kinolonov ne smemo uporabljati v kombinaciji z nesteroidnimi protivnetnimi zdravili (NSAID) pri psih, ki imajo v anamnezi konvulzije.
Ibaflin should only be used based on susceptibility testing. 
Ibaflin smemo uporabljati samo na podlagi testiranja občutljivosti povzročitelja.
0.5 ml of gel per kg body weight 
0,5 ml gela na kg telesne mase
The main excretory route is via urine and faeces. 
Zdravilo se pretežno izloča z urinom in blatom.
Ibaflin gel is indicated in dogs for the treatment of the following conditions: - Dermal infections (pyoderma - superficial and deep, wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp., E. coli and Proteus mirabilis Ibaflin gel is indicated in cats for treatment of the following conditions: - Dermal infections (soft tissue infections - wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp., E. coli, Proteus spp. 
INDIKACIJE Ibaflin gel je pri psih indiciran za zdravljenje naslednjih bolezenskih stanj: - dermalne okužbe (pioderma - površinska in globoka, rane, abscesi), ki jih povzročajo občutljivi mikroorganizmi, kot so Staphylococcus spp., E. coli in Proteus mirabilis Ibaflin gel je pri mačkah indiciran za zdravljenje naslednjih bolezenskih stanj: - dermalne okužbe (okužbe mehkega tkiva - rane, abscesi), ki jih povzročajo občutljivi mikroorganizmi, kot so Staphylococcus spp., E. coli, Proteus spp.
Ibaflin gel should only be used based on susceptibility testing. 
Ibaflin gel smemo uporabljati samo na podlagi testiranja občutljivosti povzročitelja.
QUANTITY OF THE ACTIVE SUBSTANCE(S) 
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA ( MRL)
Diarrhoea, soft faeces, vomiting, dullness, anorexia and salivation were observed with low frequency. 
Driska, mehko blato, bruhanje, otopelost, anoreksija in slinjenje so redki.
Oral use, 15 mg ibafloxacin/kg bodyweight once daily. 
Peroralno, 15 mg ibafloksacina/kg telesne mase, 1-krat na dan.
Acute, uncomplicated urinary tract infections, caused by susceptible strains of Staphylococci, Proteus spp., Enterobacter spp., E. coli and Klebsiella spp. 
Akutne, nezapletene okužbe sečil, ki jih povzročajo občutljivi sevi stafilokokov, Proteus spp., Enterobacter spp., E. coli in Klebsiella spp.
- Upper respiratory tract infections caused by susceptible pathogens such as Staphylococcus spp., E. coli, Klebsiella spp. 
- okužbe zgornjih dihalnih poti, ki jih povzročajo občutljivi mikroorganizmi, kot so Staphylococcus spp., E. coli, Klebsiella spp.
NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 7.5% oral gel for dogs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ibaflin 7,5 %, peroralni gel za pse
Diarrhoea, soft faeces, vomiting, dullness and anorexia have been observed with low frequency. 
Driska, mehko blato, bruhanje, otopelost in anoreksija se pojavljajo redko.
Acute, uncomplicated urinary tract infections, caused by susceptible strains such as Staphylococci, Proteus spp., Enterobacter spp., E. coli and Klebsiella spp. 
Akutne, nezapletene okužbe sečil, ki jih povzročajo občutljivi sevi, kot so stafilokoki, Proteus spp., Enterobacter spp., E. coli in Klebsiella spp.
30 mg of ibafloxacin per tablet 150 mg of ibafloxacin per tablet 300 mg of ibafloxacin per tablet 900 mg of ibafloxacin per tablet 
30 mg ibafloksacina v 1 tableti 150 mg ibafloksacina v 1 tableti 300 mg ibafloksacina v 1 tableti 900 mg ibafloksacina v 1 tableti
Marketing Authorisation number(s) EU/2/00/022/001-008 
Številke dovoljenja za promet EU/2/00/022/001-008
Ibaflin gel should be used based on susceptibility testing. 
Ibaflin gel uporabljamo na podlagi izvidov testiranja občutljivosti povzročitelja.
Ibaflin gel can be used during pregnancy in dogs. 
Ibaflin gel lahko dajemo brejim psicam.
Yeast 
Avstrija
RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. 
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
Sodium laurylsulphate Silica 
6.1 Seznam pomožnih snovi kvas škrob celuloza laktoza natrijev lavrilsulfat silicijev dioksid magnezijev stearat
PACKAGE INSERT FOR INCLUSION WITH THE 3% ORAL GEL SYRINGE PACKAGES 
NAVODILO ZA UPORABO ZA BRIZGE S PERORALNIM GELOM 3 %
/ Carton box containing 5 adjustable pre-filled multidose syringes, each containing 15 ml Ibaflin 3% oral gel. 
1 nastavljiva, napolnjena večodmerna brizga s 15 ml / Zloženka s 5 nastavljivimi, napolnjenimi, večodmernimi brizgami s 15 ml Ibaflin 3 % peroralnega gela
15 mg per kg bodyweight = 0.5 ml of gel per kg bodyweight Read the package insert before use. 
0,5 ml gela/kg telesne mase) Pred uporabo preberite navodilo za uporabo.
Do not use in cats. 
Ne uporabljajte pri psih s krči v anamnezi.
Respiratory tract infections (upper tract) caused by susceptible strains of Staphylococci, E. coli, and Klebsiella spp. 
Okužbe dihalnih poti (zgornjih dihal), ki jih povzročajo občutljivi sevi stafilokokov, E. coli in Klebsiella spp.
NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 7.5% oral gel 
IME ZDRAVILA Z AUPORABO V VETERINARSKI MEDICINI Ibaflin 7,5 %, peroralni gel
THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN" Keep out of the reach and sight of children. 
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
Do not use in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures. 
Zdravila ne uporabljajte v kombinaciji z nesteroidnimi protivnetnimi zdravili (NSAID) pri psih, ki imajo v anamnezi krče.
PACKAGE INSERT FOR INCLUSION WITH THE 7.5 % ORAL GEL SYRINGE PACKAGES 
NAVODILO ZA UPORABO ZA BRIZGE S PERORALNIM GELOM 7,5 %
INDICATIONS Ibaflin gel is indicated in dogs for the treatment of the following conditions: - Dermal infections (pyoderma - superficial and deep, wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp., E. coli and Proteus mirabilis. 
INDIKACIJE Ibaflin gel je pri psih indiciran za zdravljenje naslednjih bolezenskih stanj: - dermalne okužbe (pioderma - površinska in globoka, rane, abscesi), ki jih povzročajo občutljivi mikroorganizmi, kot so Staphylococcus spp., E. coli in Proteus mirabilis
Ibaflin is indicated for the treatment of the following conditions in dogs: Dermal infections (pyoderma - superficial and deep, wounds, abscesses) caused by susceptible strains of Staphylococci, E. coli, and Proteus mirabilis. 
Ibaflin je pri psih indiciran za zdravljenje naslednjih bolezenskih stanj: Dermalne okužbe (pioderma - površinska in globoka, rane, abscesi), ki jih povzročajo občutljivi sevi stafilokokov, E. coli in Proteus mirabilis
IBAFLIN 7.5% ORAL GEL ADJUSTABLE MULTIDOSE SYRINGE 
NASTAVLJIVA VEČODMERNA BRIZGA IBAFLIN 7,5 % PERORALNEGA GELA
MARKETING AUTHORISATION NUMBER(S) EU/2/00/022/09 
ŠTEVILKE DOVOLJENJA ZA PROMET EU/2/00/022/09
MARKETING AUTHORISATION NUMBER(S) EU/2/00/022/11 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/00/022/11
ROUTE(S) OF ADMINISTRATION Oral use, 15 mg per kg bodyweight once daily (i.e. 1 ml of gel per 5 kg body weight). 
NAČIN IN POT(I) UPORABE Peroralno, 15 mg/kg telesne mase, 1-krat na dan 15 mg/kg telesne mase = 1 ml gela/5 kg telesne mase Pred uporabo preberite navodilo za uporabo.
15 mg per kg bodyweight = 1 ml of gel per 5 kg bodyweight Read the package insert before use. 
1 ml gela/5 kg telesne mase) Pred uporabo preberite navodilo za uporabo.
Name and address of the Manufacturing Authorisation Holder responsible for batch release 
Ime in naslov imetnika dovoljenja za izdelavo zdravila, odgovornega za sprostitev serije Intervet GesmbH.
IBAFLIN 3% ORAL GEL ADJUSTABLE MULTIDOSE SYRINGE 
NASTAVLJIVA VEČODMERNA BRIZGA IBAFLIN 3 %, PERORALNI GEL
6.3 Shelf-life 
4.11 Karenca
ROUTE(S) OF ADMINISTRATION Oral use, 15 mg per kg bodyweight once daily (i.e. 0.5 ml of gel per kg body weight). 
NAČIN IN POTI UPORABE Peroralno, 15 mg/kg telesne mase, 1-krat na dan 15 mg/kg telesne mase = 0,5 ml gela/kg telesne mase Pred uporabo preberite navodilo za uporabo.
Carton box containing 1 adjustable pre-filled multidose syringe, containing 30 ml Ibaflin 7.5% oral gel. 
Zloženka z 1 nastavljivo, napolnjeno, večodmerno brizgo s 30 ml Ibaflin 7,5 % peroralnega gela / Zloženka s 5 nastavljivimi, napolnjenimi, večodmernimi brizgami s 30 ml Ibaflin 7,5 % peroralnega gela
The gel should be administered at the time of feeding. 
Gel dajemo ob času hranjenja.
METHOD AND ROUTE(S) OF ADMINISTRATION Oral use, 15 mg per kg bodyweight once daily. 
NAČIN IN POTI UPORABE Peroralno, 15 mg/kg telesne mase, 1-krat na dan Pred uporabo preberite navodilo za uporabo.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Ibaflin contains: 
Ena tableta Ibaflina vsebuje:
coli, Klebsiella spp. 
Staphylococcus spp., E. coli, Klebsiella spp.
- Dermal infections (pyoderma - superficial and deep, wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp., E. coli and Proteus mirabilis. 
- dermalne okužbe (pioderma - površinska in globoka, rane, abscesi), ki jih povzročajo občutljivi mikroorganizmi, kot so Staphylococcus spp., E. coli in Proteus mirabilis Ibaflin gel je pri mačkah indiciran za zdravljenje naslednjih bolezenskih stanj:
The frequency of these risks in children is not known. 
Pogostnost teh tveganj pri otrocih ni znana.
Date of first authorisation: 18 August 2016 
Datum prve odobritve: 18. avgust 2016
You should see green plastic. 
Videti morate zeleno plastiko.
It requires 30-60 seconds to be effective. 
Potrebno je 30-60 sekund, da to postane učinkovito.
No data available. 
Podatkov ni na voljo.
You will receive appropriate training for you to do this. 
V ta namen boste ustrezno usposobljeni.
9) The injection lasts for a maximum of 10 seconds. 
9) Injiciranje traja največ 10 sekund.
This can lead to a loss of the medicine. 
To lahko vodi do izgube zdravila.
Healthcare professionals and patients should be clearly instructed. 
Zdravstveno osebje in bolniki morajo biti o tem jasno poučeni.
Use only once a week 
Uporabite samo enkrat na teden.
Further tests may also be done during and after treatment. 
Nadaljnje preiskave se lahko opravljajo tudi med zdravljenjem ali po njem.
This means that all the fluid has been injected. 
To pomeni, da se je injicirala vsa tekočina.
This will send the medication under the skin. 
Tako boste zdravilo dostavili pod kožo.
You can now let go of the skin fold. 
Zdaj lahko kožno gubo spustite.
Do not use Nordimet during pregnancy or if you are trying to become pregnant. 
Zdravila Nordimet ne uporabljajte med nosečnostjo ali če poskušate zanositi.
Depending on the individual activity of the disease and patient tolerability, the initial dose may be increased. 
Glede na aktivnost bolezni pri posamezniku in toleranco bolnika se lahko začetni odmerek postopoma povečuje.
If clinically indicated, exclude tuberculosis and hepatitis. 
Če je klinično indicirano, je treba izključiti tuberkulozo in hepatitis.
The tests below must be conducted every week during the first two weeks, then every two weeks for the next month; afterwards, depending on leukocyte count and stability of the patient, at least once monthly during the next six months and at least every three months thereafter. 
Spodaj navedene teste je potrebno opraviti vsak teden v prvih dveh tednih, nato v naslednjem mesecu vsaka dva tedna; nato glede na število belih krvničk in stabilnost bolnika v naslednjih šestih mesecih vsaj enkrat mesečno in nato vsaj enkrat na tri mesece.
Approximately 50% of methotrexate is bound to serum proteins. 
Približno 50 % metotreksata je vezanega na serumske beljakovine.
However, as severe undesirable effects can occur even at lower doses, it is indispensable that patients are monitored regularly by the doctor at short intervals. 
Ker pa se lahko hudi neželeni učinki pojavijo celo pri manjših odmerkih, mora zdravnik nujno redno spremljati bolnike v kratkih časovnih presledkih.
In some cases, the ability to drive vehicles and/or use machines may be impaired. 
V nekaterih primerih je lahko sposobnost upravljanja vozil in/ali strojev zmanjšana.
Frequencies are defined using the following convention: very common (≥ 1/10) common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). 
Neželeni učinki so razvrščeni po pogostnosti v skladu 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), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Plasma peak concentrations are attained within 1-2 hours. 
Najvišje plazemske koncentracije so dosežene po 1-2 urah.
11) Remove the needle by pulling it out straight. 
11) Iglo odstranite tako, da jo potegnete naravnost ven.
In these cases use of methotrexate should be interrupted until the symptoms cease. 
V takšnih primerih je treba uporabo metotreksata prekiniti, dokler simptomi ne izzvenijo.
The doctor will calculate the dose required from the child's body surface area (m2), and the dose is expressed as mg/m 
Zdravnik bo izračunal potrebni odmerek glede na telesno površino otroka (m2), pri čemer je odmerek izražen v mg/m
It is important to tell your doctor that you are taking Nordimet. 
Pomembno je, da zdravniku poveste, da jemljete zdravilo Nordimet.
It is not known if methotrexate is present in semen. 
Ni znano, ali je metotreksat prisoten v semenski tekočini.
Teratogenic effects have been identified in four species (rats, mice, rabbits, cats). 
Teratogene učinke so ugotovili pri štirih živalskih vrstah (podgane, miši, kunci, mačke).
You may see a small air bubble, this does not affect the injection and will not harm you. 
Morda boste opazili majhen zračni mehurček, ki pa ne vpliva na injiciranje in ni škodljiv.
Average terminal half-life is 6-7 hours and demonstrates considerable variation (3-17 hours). 
Končni razpolovni čas je povprečno 6-7 ur, vendar s precejšnjimi odstopanji (3-17 ur).
At the start of your treatment, Nordimet may be injected by medical staff. 
Na začetku zdravljenja vam lahko zdravilo Nordimet injicira zdravstveno osebje.
However, your doctor may decide that you can learn how to inject Nordimet yourself. 
Vendar se vaš zdravnik lahko odloči, da se naučite sami injicirati zdravilo Nordimet.
Particularly elderly patients should be examined for early signs of toxicity in short intervals. 
Zlasti pri starejših ljudeh je treba v kratkih časovnih presledkih preverjati zgodnje znake toksičnosti.
You should be offered advice regarding the risk of harmful effects on the child through treatment. 
Zdravnik vam mora svetovati glede tveganja za škodljive učinke na otroka med zdravljenjem.
The overall duration of treatment is decided by the doctor. 
O skupnem trajanju zdravljenja odloča zdravnik.
For contraception advice for men, see section 4.6. 
Za nasvet glede kontracepcije pri moških glejte poglavje 4.6.
Component of a multipack, can't be sold separately 
Sestavni del skupnega pakiranja, ni za ločeno prodajo.
Do not take a double dose to make up for a forgotten dose, but continue taking the prescribed dose as normal. 
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek, temveč nadaljujte normalno z naslednjim odmerkom.
Before injecting yourself with Nordimet - Check the expiry date on the medicine. 
Pred injiciranjem zdravila Nordimet - Preverite datum izteka roka uporabnosti zdravila.
Instructions on injecting yourself with Nordimet 1) Wash your hands thoroughly with soap and water. 
Navodila za samostojno injiciranje zdravila Nordimet 1) Temeljito si umijte roke z vodo in milom.
Do not breast-feed during treatment because methotrexate passes into breast milk. 
Med zdravljenjem ne dojite, ker metotreksat prehaja v materino mleko.
2) Sit or lie in a relaxed, comfortable position. 
2) Udobno sedite ali lezite.
This means that the medicine may cause genetic mutation. 
To pomeni, da lahko povzroči genske mutacije.
If you feel tired or dizzy, you should not drive or use machines. 
Če čutite utrujenost ali omotico, ne upravljajte vozil in/ali strojev.
Parenteral administration is limited to subcutaneous injection. 
Parenteralna uporaba je omejena na subkutano injiciranje.
Due to the risk of severe or even fatal toxic reactions, patients should be thoroughly informed by the doctor about the risks (including early signs and symptoms of toxicity) and recommended safety measures. 
Zaradi možnosti pojava hudih ali celo smrtno nevarnih toksičnih reakcij mora biti bolnik v celoti seznanjen z možnimi tveganji zdravljenja (vključno z zgodnjimi znaki in simptomi toksičnosti) ter s priporočenimi varnostnimi ukrepi.
A blood test will be taken to check for possible reduction of white blood cells (agranulocytosis). 
Opravil bo krvne preiskave, da bi preveril morebitno znižanje števila belih krvnih celic (agranulocitoza).
Note: the safety system allowing release of the safety shield, can only be activated when the syringe has been emptied by pressing the plunger all the way down. 
Opomba: varnostni sistem, ki dopušča odstranitev varnostnega ščitnika, se lahko aktivira samo ko je brizga izpraznjena, tako da bat potisnete do konca navzdol.
Increased monitoring frequency should also be considered when increasing the dose. 
O večji pogostnosti spremljanja je treba razmisliti tudi ob povečanju odmerka.
If serum creatinine is increased, the dose should be reduced. 
Če je serumski kreatinin povišan, je treba odmerek zdravila zmanjšati.
An overactive immune system has been linked to inflammatory diseases. 
Čezmerno aktiven imunski sistem povezujemo z vnetnimi boleznimi.
The solution is to be visually inspected prior to use. 
Raztopino je treba pred uporabo vizualno preveriti.
Approx. 5-20% of methotrexate and 1-5% of 7hydroxymethotrexate are eliminated via the bile. 
Približno 5-20 % metotreksata in 1-5 % 7-hidroksimetotreksata se izloči z žolčem.
Pulmonary diseases induced by methotrexate were not always completely reversible. 
Z metotreksatom povzročene pljučne bolezni niso bile vedno povsem reverzibilne.
If the results of any of these tests are abnormal, treatment will only be resumed when all readings are back to normal. 
Če so rezultati katere koli od teh preiskav neobičajni, bo zdravljenje prekinjeno, dokler ne bodo vrednosti zopet normalne.
Nordimet contains the active substance methotrexate which works by: - reducing inflammation or swelling, and - reducing the activity of the immune system (the body's own defense mechanism). 
Zdravilo Nordimet vsebuje učinkovino metotreksat, ki deluje tako, da: - zmanjšuje vnetje ali otekanje in - zmanjšuje aktivnost imunskega sistema (lastni obrambni mehanizem telesa).
Do not use this medicine if you notice that the solution is not clear and contains particles. 
Ne uporabljajte zdravila Nordimet, če opazite, da raztopina ni bistra in vsebuje delce.
Methotrexate may be genotoxic. 
Metotreksat je lahko genotoksičen.
Also, make sure you drink plenty of liquids during treatment with Nordimet because dehydration (reduction in body water) can increase the toxicity of Nordimet. 
Bodite tudi pozorni, da med zdravljenjem z zdravilom Nordimet zaužijete dovolj tekočine, saj lahko dehidracija (zmanjšanje deleža vode v telesu) poveča toksičnost zdravila Nordimet.
B-1420 Braine-l'Alleud Belgium 
B-1420 Braine-L'Alleud Belgija
The appearance and degree of severity of undesirable effects depends on the dosage level and the frequency of administration. 
Pojavnost in stopnja resnosti neželenih učinkov sta odvisni od velikosti odmerka in pogostnosti uporabe zdravila.
What you need to know before you use Nordimet 
Kaj morate vedeti, preden boste uporabili zdravilo Nordimet
8) Apply downward pressure on the pen on to your skin until you hear and feel a “click”. 
8) Pritiskajte peresnik na kožo, dokler ne zaslišite in začutite »klik«.
In case of contamination, the affected parts are to be rinsed immediately with plenty of water (see section 6.6). 
V primeru kontaminacije je treba prizadeto območje takoj sprati z obilo vode (glejte poglavje 6.6).
The safety and efficacy of Nordimet in children < 3 years of age have not been established (see section 4.4). 
Varnost in učinkovitost zdravila Nordimet pri otrocih, mlajših od 3 let, nista bili dokazani (glejte poglavje 4.4).
4) Precaution: DO NOT lift the product by the plunger or needle cover. 
4) Opozorilo: NE dvignite zdravila s pokrovom bata ali igle.
Further research is needed to establish whether serial liver chemistry tests or propeptide of type III collagen can detect hepatotoxicity sufficiently. 
Potrebne so nadaljnje raziskave, da bi ugotovili, ali lahko z rednimi serijskimi kemijskimi jetrnimi testi ali z določanjem propeptida kolagena tipa III v zadostni meri odkrijemo hepatotoksičnost.
The dose for elderly patients should be lowered due to age-related reduced liver and kidney function. 
Odmerek pri starejših ljudeh mora biti manjši zaradi zmanjšane ledvične in jetrne funkcije, povezane s starostjo.
Such abnormalities should return to normal within two weeks; after which, treatment may be resumed at the discretion of the doctor. 
Take bolezenske spremembe naj bi se normalizirale v dveh tednih, potem pa se lahko zdravnik po lastni presoji odloči za ponovno uvedbo zdravljenja.
Patients must be instructed to report all signs and symptoms suggestive of infection. 
Bolnikom je treba svetovati, naj poročajo o vseh znakih in simptomih, ki bi lahko kazali na okužbo.
A mutagenic effect is suspected in humans. 
Pri ljudeh obstaja sum na mutageni učinek.
This is to make sure that the needle stays clean. 
Tako bo igla ostala čista.
Clear, yellow solution with a pH of 8.0-9.0 and an osmolality of approximately 300 mOsm/kg. 
Bistra, rumena raztopina z vrednostjo pH 8,0-9,0 in osmolalnostjo približno 300 mOsm/kg.
Do not press on the plunger before injecting yourself to get rid of air bubbles. 
Ne pritiskajte na bat pred injiciranjem, da bi se znebili zračnih mehurčkov.
What Nordimet is and what it is used for 
Kaj je zdravilo Nordimet in za kaj ga uporabljamo
Children, adolescents and the elderly being treated with Nordimet should be kept under close medical surveillance to identify possible side effects as early as possible. 
Otroci, mladostniki in starejši ljudje, zdravljeni z zdravilom Nordimet, morajo biti pod temeljitim zdravstvenim nadzorom, da se morebitni neželeni učinki prepoznajo čim bolj zgodaj.
Use only once a week on …………………………………………………………….. (include weekday of use in full) 
Uporabite samo enkrat na teden v …………………………………………………………….. (napišite dan v tednu s celo besedo)