FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of the veterinary medicinal product has not been established in lactating dogs and in pregnant and lactating cats.
Slovenian: Varnost zdravila ni raziskana pri psicah v obdobju laktacije in pri brejih mačkah in mačkah v obdobju laktacije.
English: 15 mg per kg bodyweight = 0.5 ml of gel per kg bodyweight
Slovenian: 15 mg /kg telesne mase = 0,5 ml gela/kg telesne mase
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Slovenian: Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi zahtevami.
English: 4.9 Posology and method of administration
Slovenian: 4.9 Odmerjanje in pot uporabe
English: This period depends on the breed.
Slovenian: Trajanje obdobja rasti je različno glede na pasmo.
English: CARTON BOX FOR 1 SYRINGE IBAFLIN 7.5% ORAL GEL / CARTON BOX FOR 5 SYRINGES IBAFLIN 7.5% ORAL GEL
Slovenian: ZLOŽENKA Z 1 BRIZGO IBAFLIN 7,5 % PERORALNEGA GELA / ZLOŽENKA S 5 BRIZGAMI IBAFLIN 7,5 % PERORALNEGA GELA
English: Do not use during the period of growth or in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures.
Slovenian: Zdravila ne uporabljajte v obdobju rasti ali v kombinaciji z nesteroidnimi protivnetnimi zdravili (NSAID) pri psih, ki imajo v anamnezi krče.
English: Oral use, 15 mg ibafloxacin/kg once daily.
Slovenian: Peroralno, 15 mg ibafloksacina/kg, 1-krat na dan
English: 150mg and 300mg tablets: 4 years 30mg and 900mg tablets: 3 years 6.4 Special precautions for storage Do not store above 25°C.
Slovenian: Tablete po 150 mg in 300 mg: 4 leta Tablete po 30 mg in 900 mg: 3 leta
English: B. PACKAGE INSERT
Slovenian: DODATEK II
English: The safety of the veterinary medicinal product has not been established during lactation.
Slovenian: Varnost zdravila ni raziskana med laktacijo.
English: Ibafloxacin is a broad spectrum bactericidal antibiotic from the quinolone group.
Slovenian: Ibafloksacin je širokospektralen, baktericidni antibiotik iz skupine kinolonov.
English: The syringe should be adjusted to the calculated dosage by setting the ring on the appropriate place on the plunger (steps of 0.5 ml for the 15 ml syringe).
Slovenian: Brizgo je treba nastaviti na izračunani odmerek s pomikom objemke na ustrezno mesto na batu (brizga s 15 ml - stopnje po 0,5 ml).
English: The safety of the veterinary medicinal product has not been established in pregnant cats and in lactating dogs and cats.
Slovenian: Varnost zdravila ni raziskana pri brejih mačkah ter pri psicah in mačkah v obdobju laktacije.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 3% oral gel for dogs and cats Ibaflin 7.5% oral gel for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ibaflin 3 %, peroralni gel za pse in mačke Ibaflin 7,5 %, peroralni gel za pse
English: Can be used during pregnancy in dogs.
Slovenian: Zdravilo se pri psih lahko uporablja v obdobju brejosti.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 3% oral gel for dogs and cats
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ibaflin 3 %, peroralni gel za pse in mačke
English: The syringe should be adjusted to the calculated dosage by setting the ring on the appropriate place on the plunger (steps of 0.5 ml for the 15 ml syringe and 1.0 ml for the 30 ml syringe).
Slovenian: Brizgo je treba nastaviti na izračunani odmerek s pomikom objemke na ustrezno mesto na batu (brizga s 15 ml - stopnje po 0,5 ml, brizga s 30 ml - stopnje po 1,0 ml).
English: and Salmonella spp.
Slovenian: in Salmonella spp., izolirane pri psih.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 3% oral gel
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ibaflin 3 %, peroralni gel
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 75 mg of ibafloxacin per ml of gel
Slovenian: KOLIČINA ZDRAVILNE UČINKOVINE 75 mg ibafloksacina v 1 ml gela
English: The main excretory routes are via urine and faeces.
Slovenian: Izloča se pretežno z urinom in blatom.
English: The syringe should be adjusted to the calculated dosage by setting the ring on the appropriate place on the plunger (steps of 1 ml for the 30 ml syringe).
Slovenian: Brizgo je treba nastaviti na izračunani odmerek s pomikom objemke na ustrezno mesto na batu (brizga s 30 ml - stopnje po 1,0 ml).
English: D. STATEMENT OF THE MRLs Not applicable
Slovenian: D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Ni smiselno.
English: The safety of the veterinary medicinal product has not been established in lactating dog.
Slovenian: Varnost zdravila ni raziskana pri psicah v obdobju laktacije.
English: 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.
Slovenian: Pri večini pasem je uporaba ibafloksacina kontraindicirana za pse, mlajše od 8 mesecev, pri zelo velikih pasmah pa za pse, mlajše od 18 mesecev.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 30 mg of ibafloxacin per ml of gel
Slovenian: KOLIČINA ZDRAVILNE UČINKOVINE 30 mg ibafloksacina v 1 ml gela
English: 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.
Slovenian: Pri večini pasem je uporaba ibafloksacina kontraindicirana za pse, mlajše od 8 mesecev in pri zelo velikih pasmah za pse, mlajše od 18 mesecev.
English: Pharmacotherapeutic group: antibacterial quinolone ATCvet code: QJ 01 MA 96
Slovenian: Farmakoterapevtska skupina: kinolonske protimikrobne učinkovine Oznaka ATCvet: QJ 01 MA 96 Ibafloksacin je širokospektralen, baktericidni antibiotik.
English: - Dermal infections (soft tissue infections - wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp, E. coli, Proteus spp.
Slovenian: - dermalne okužbe (okužbe mehkega tkiva - rane, abscesi), ki jih povzročajo občutljivi mikroorganizmi, kot so Staphylococcus spp., E. coli, Proteus spp.
English: Fluoroquinolones should not be used in combination with non-steroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures.
Slovenian: Fluorokinolonov ne smemo uporabljati v kombinaciji z nesteroidnimi protivnetnimi zdravili (NSAID) pri psih, ki imajo v anamnezi konvulzije.
English: Marketing Authorisation number(s) EU/2/00/022/09-12
Slovenian: Številka dovoljenja za promet EU/2/00/022/09-12
English: Quinolones should not be used in combination with nonsteroidal anti-inflammatory drugs (NSAID) in dogs with a history of seizures.
Slovenian: Kinolonov ne smemo uporabljati v kombinaciji z nesteroidnimi protivnetnimi zdravili (NSAID) pri psih, ki imajo v anamnezi konvulzije.
English: Ibaflin should only be used based on susceptibility testing.
Slovenian: Ibaflin smemo uporabljati samo na podlagi testiranja občutljivosti povzročitelja.
English: 0.5 ml of gel per kg body weight
Slovenian: 0,5 ml gela na kg telesne mase
English: The main excretory route is via urine and faeces.
Slovenian: Zdravilo se pretežno izloča z urinom in blatom.
English: 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.
Slovenian: 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.
English: Ibaflin gel should only be used based on susceptibility testing.
Slovenian: Ibaflin gel smemo uporabljati samo na podlagi testiranja občutljivosti povzročitelja.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Slovenian: NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA ( MRL)
English: Diarrhoea, soft faeces, vomiting, dullness, anorexia and salivation were observed with low frequency.
Slovenian: Driska, mehko blato, bruhanje, otopelost, anoreksija in slinjenje so redki.
English: Oral use, 15 mg ibafloxacin/kg bodyweight once daily.
Slovenian: Peroralno, 15 mg ibafloksacina/kg telesne mase, 1-krat na dan.
English: Acute, uncomplicated urinary tract infections, caused by susceptible strains of Staphylococci, Proteus spp., Enterobacter spp., E. coli and Klebsiella spp.
Slovenian: Akutne, nezapletene okužbe sečil, ki jih povzročajo občutljivi sevi stafilokokov, Proteus spp., Enterobacter spp., E. coli in Klebsiella spp.
English: - Upper respiratory tract infections caused by susceptible pathogens such as Staphylococcus spp., E. coli, Klebsiella spp.
Slovenian: - okužbe zgornjih dihalnih poti, ki jih povzročajo občutljivi mikroorganizmi, kot so Staphylococcus spp., E. coli, Klebsiella spp.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 7.5% oral gel for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ibaflin 7,5 %, peroralni gel za pse
English: Diarrhoea, soft faeces, vomiting, dullness and anorexia have been observed with low frequency.
Slovenian: Driska, mehko blato, bruhanje, otopelost in anoreksija se pojavljajo redko.
English: Acute, uncomplicated urinary tract infections, caused by susceptible strains such as Staphylococci, Proteus spp., Enterobacter spp., E. coli and Klebsiella spp.
Slovenian: Akutne, nezapletene okužbe sečil, ki jih povzročajo občutljivi sevi, kot so stafilokoki, Proteus spp., Enterobacter spp., E. coli in Klebsiella spp.
English: 30 mg of ibafloxacin per tablet 150 mg of ibafloxacin per tablet 300 mg of ibafloxacin per tablet 900 mg of ibafloxacin per tablet
Slovenian: 30 mg ibafloksacina v 1 tableti 150 mg ibafloksacina v 1 tableti 300 mg ibafloksacina v 1 tableti 900 mg ibafloksacina v 1 tableti
English: Marketing Authorisation number(s) EU/2/00/022/001-008
Slovenian: Številke dovoljenja za promet EU/2/00/022/001-008
English: Ibaflin gel should be used based on susceptibility testing.
Slovenian: Ibaflin gel uporabljamo na podlagi izvidov testiranja občutljivosti povzročitelja.
English: Ibaflin gel can be used during pregnancy in dogs.
Slovenian: Ibaflin gel lahko dajemo brejim psicam.
English: Yeast
Slovenian: Avstrija
English: RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Slovenian: POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
English: Sodium laurylsulphate Silica
Slovenian: 6.1 Seznam pomožnih snovi kvas škrob celuloza laktoza natrijev lavrilsulfat silicijev dioksid magnezijev stearat
English: PACKAGE INSERT FOR INCLUSION WITH THE 3% ORAL GEL SYRINGE PACKAGES
Slovenian: NAVODILO ZA UPORABO ZA BRIZGE S PERORALNIM GELOM 3 %
English: / Carton box containing 5 adjustable pre-filled multidose syringes, each containing 15 ml Ibaflin 3% oral gel.
Slovenian: 1 nastavljiva, napolnjena večodmerna brizga s 15 ml / Zloženka s 5 nastavljivimi, napolnjenimi, večodmernimi brizgami s 15 ml Ibaflin 3 % peroralnega gela
English: 15 mg per kg bodyweight = 0.5 ml of gel per kg bodyweight Read the package insert before use.
Slovenian: 0,5 ml gela/kg telesne mase) Pred uporabo preberite navodilo za uporabo.
English: Do not use in cats.
Slovenian: Ne uporabljajte pri psih s krči v anamnezi.
English: Intervet GesmbH.
Slovenian: Intervet International B.V.
English: Respiratory tract infections (upper tract) caused by susceptible strains of Staphylococci, E. coli, and Klebsiella spp.
Slovenian: Okužbe dihalnih poti (zgornjih dihal), ki jih povzročajo občutljivi sevi stafilokokov, E. coli in Klebsiella spp.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 7.5% oral gel
Slovenian: IME ZDRAVILA Z AUPORABO V VETERINARSKI MEDICINI Ibaflin 7,5 %, peroralni gel
English: THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN" Keep out of the reach and sight of children.
Slovenian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
English: Do not use in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures.
Slovenian: Zdravila ne uporabljajte v kombinaciji z nesteroidnimi protivnetnimi zdravili (NSAID) pri psih, ki imajo v anamnezi krče.
English: PACKAGE INSERT FOR INCLUSION WITH THE 7.5 % ORAL GEL SYRINGE PACKAGES
Slovenian: NAVODILO ZA UPORABO ZA BRIZGE S PERORALNIM GELOM 7,5 %
English: 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.
Slovenian: 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
English: 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.
Slovenian: 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
English: IBAFLIN 7.5% ORAL GEL ADJUSTABLE MULTIDOSE SYRINGE
Slovenian: NASTAVLJIVA VEČODMERNA BRIZGA IBAFLIN 7,5 % PERORALNEGA GELA
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/022/09
Slovenian: ŠTEVILKE DOVOLJENJA ZA PROMET EU/2/00/022/09
English: MARKETING AUTHORISATION NUMBER(S) EU/2/00/022/11
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/00/022/11
English: ROUTE(S) OF ADMINISTRATION Oral use, 15 mg per kg bodyweight once daily (i.e. 1 ml of gel per 5 kg body weight).
Slovenian: 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.
English: 15 mg per kg bodyweight = 1 ml of gel per 5 kg bodyweight Read the package insert before use.
Slovenian: 1 ml gela/5 kg telesne mase) Pred uporabo preberite navodilo za uporabo.
English: Name and address of the Manufacturing Authorisation Holder responsible for batch release
Slovenian: Ime in naslov imetnika dovoljenja za izdelavo zdravila, odgovornega za sprostitev serije Intervet GesmbH.
English: IBAFLIN 3% ORAL GEL ADJUSTABLE MULTIDOSE SYRINGE
Slovenian: NASTAVLJIVA VEČODMERNA BRIZGA IBAFLIN 3 %, PERORALNI GEL
English: 6.3 Shelf-life
Slovenian: 4.11 Karenca
English: ROUTE(S) OF ADMINISTRATION Oral use, 15 mg per kg bodyweight once daily (i.e. 0.5 ml of gel per kg body weight).
Slovenian: 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.
English: Carton box containing 1 adjustable pre-filled multidose syringe, containing 30 ml Ibaflin 7.5% oral gel.
Slovenian: 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
English: The gel should be administered at the time of feeding.
Slovenian: Gel dajemo ob času hranjenja.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use, 15 mg per kg bodyweight once daily.
Slovenian: NAČIN IN POTI UPORABE Peroralno, 15 mg/kg telesne mase, 1-krat na dan Pred uporabo preberite navodilo za uporabo.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Ibaflin contains:
Slovenian: Ena tableta Ibaflina vsebuje:
English: coli, Klebsiella spp.
Slovenian: Staphylococcus spp., E. coli, Klebsiella spp.
English: - Dermal infections (pyoderma - superficial and deep, wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp., E. coli and Proteus mirabilis.
Slovenian: - 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:
English: The frequency of these risks in children is not known.
Slovenian: Pogostnost teh tveganj pri otrocih ni znana.
English: Date of first authorisation: 18 August 2016
Slovenian: Datum prve odobritve: 18. avgust 2016
English: You should see green plastic.
Slovenian: Videti morate zeleno plastiko.
English: It requires 30-60 seconds to be effective.
Slovenian: Potrebno je 30-60 sekund, da to postane učinkovito.
English: No data available.
Slovenian: Podatkov ni na voljo.
English: You will receive appropriate training for you to do this.
Slovenian: V ta namen boste ustrezno usposobljeni.
English: 9) The injection lasts for a maximum of 10 seconds.
Slovenian: 9) Injiciranje traja največ 10 sekund.
English: 2132 WT Hoofddorp The Netherlands
Slovenian: 2132 WT Hoofddorp Nizozemska
English: This can lead to a loss of the medicine.
Slovenian: To lahko vodi do izgube zdravila.
English: SE-201 25 Malmo Sweden
Slovenian: SE-201 25 Malmo Švedska
English: Healthcare professionals and patients should be clearly instructed.
Slovenian: Zdravstveno osebje in bolniki morajo biti o tem jasno poučeni.
English: Use only once a week
Slovenian: Uporabite samo enkrat na teden.
English: Further tests may also be done during and after treatment.
Slovenian: Nadaljnje preiskave se lahko opravljajo tudi med zdravljenjem ali po njem.
English: This means that all the fluid has been injected.
Slovenian: To pomeni, da se je injicirala vsa tekočina.
English: This will send the medication under the skin.
Slovenian: Tako boste zdravilo dostavili pod kožo.
English: You can now let go of the skin fold.
Slovenian: Zdaj lahko kožno gubo spustite.
English: Do not use Nordimet during pregnancy or if you are trying to become pregnant.
Slovenian: Zdravila Nordimet ne uporabljajte med nosečnostjo ali če poskušate zanositi.
English: Depending on the individual activity of the disease and patient tolerability, the initial dose may be increased.
Slovenian: Glede na aktivnost bolezni pri posamezniku in toleranco bolnika se lahko začetni odmerek postopoma povečuje.
English: If clinically indicated, exclude tuberculosis and hepatitis.
Slovenian: Če je klinično indicirano, je treba izključiti tuberkulozo in hepatitis.
English: 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.
Slovenian: 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.
English: Approximately 50% of methotrexate is bound to serum proteins.
Slovenian: Približno 50 % metotreksata je vezanega na serumske beljakovine.
English: 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.
Slovenian: Ker pa se lahko hudi neželeni učinki pojavijo celo pri manjših odmerkih, mora zdravnik nujno redno spremljati bolnike v kratkih časovnih presledkih.
English: In some cases, the ability to drive vehicles and/or use machines may be impaired.
Slovenian: V nekaterih primerih je lahko sposobnost upravljanja vozil in/ali strojev zmanjšana.
English: 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).
Slovenian: 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).
English: Plasma peak concentrations are attained within 1-2 hours.
Slovenian: Najvišje plazemske koncentracije so dosežene po 1-2 urah.
English: 11) Remove the needle by pulling it out straight.
Slovenian: 11) Iglo odstranite tako, da jo potegnete naravnost ven.
English: In these cases use of methotrexate should be interrupted until the symptoms cease.
Slovenian: V takšnih primerih je treba uporabo metotreksata prekiniti, dokler simptomi ne izzvenijo.
English: The doctor will calculate the dose required from the child's body surface area (m2), and the dose is expressed as mg/m
Slovenian: Zdravnik bo izračunal potrebni odmerek glede na telesno površino otroka (m2), pri čemer je odmerek izražen v mg/m
English: It is important to tell your doctor that you are taking Nordimet.
Slovenian: Pomembno je, da zdravniku poveste, da jemljete zdravilo Nordimet.
English: It is not known if methotrexate is present in semen.
Slovenian: Ni znano, ali je metotreksat prisoten v semenski tekočini.
English: Teratogenic effects have been identified in four species (rats, mice, rabbits, cats).
Slovenian: Teratogene učinke so ugotovili pri štirih živalskih vrstah (podgane, miši, kunci, mačke).
English: You may see a small air bubble, this does not affect the injection and will not harm you.
Slovenian: Morda boste opazili majhen zračni mehurček, ki pa ne vpliva na injiciranje in ni škodljiv.
English: Average terminal half-life is 6-7 hours and demonstrates considerable variation (3-17 hours).
Slovenian: Končni razpolovni čas je povprečno 6-7 ur, vendar s precejšnjimi odstopanji (3-17 ur).
English: At the start of your treatment, Nordimet may be injected by medical staff.
Slovenian: Na začetku zdravljenja vam lahko zdravilo Nordimet injicira zdravstveno osebje.
English: However, your doctor may decide that you can learn how to inject Nordimet yourself.
Slovenian: Vendar se vaš zdravnik lahko odloči, da se naučite sami injicirati zdravilo Nordimet.
English: Particularly elderly patients should be examined for early signs of toxicity in short intervals.
Slovenian: Zlasti pri starejših ljudeh je treba v kratkih časovnih presledkih preverjati zgodnje znake toksičnosti.
English: You should be offered advice regarding the risk of harmful effects on the child through treatment.
Slovenian: Zdravnik vam mora svetovati glede tveganja za škodljive učinke na otroka med zdravljenjem.
English: The overall duration of treatment is decided by the doctor.
Slovenian: O skupnem trajanju zdravljenja odloča zdravnik.
English: For contraception advice for men, see section 4.6.
Slovenian: Za nasvet glede kontracepcije pri moških glejte poglavje 4.6.
English: Component of a multipack, can't be sold separately
Slovenian: Sestavni del skupnega pakiranja, ni za ločeno prodajo.
English: Do not take a double dose to make up for a forgotten dose, but continue taking the prescribed dose as normal.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek, temveč nadaljujte normalno z naslednjim odmerkom.
English: Before injecting yourself with Nordimet - Check the expiry date on the medicine.
Slovenian: Pred injiciranjem zdravila Nordimet - Preverite datum izteka roka uporabnosti zdravila.
English: Instructions on injecting yourself with Nordimet 1) Wash your hands thoroughly with soap and water.
Slovenian: Navodila za samostojno injiciranje zdravila Nordimet 1) Temeljito si umijte roke z vodo in milom.
English: Do not breast-feed during treatment because methotrexate passes into breast milk.
Slovenian: Med zdravljenjem ne dojite, ker metotreksat prehaja v materino mleko.
English: QPharma AB Agneslundsvagen 27 P.O.
Slovenian: QPharma AB Agneslundsvagen 27 P.O. Box 590