natgillin/translations-raw huggingface dataset:
The primary container is a polyethylene naphthalate amber coloured bottle containing 240 ml or 960 ml of Pulmotil AC, with a polypropylene screw top and polyethylene/aluminium/polyethylene terephthalate seal.
Primarni vsebnik je plastenka iz polietilennaftalata jantarne barve, ki vsebuje 240 ml ali 960 ml zdravila Pulmotil AC s polipropilenskim navojnim pokrovčkom in zaporko iz polietilena/aluminija/polietilentereftalata.
Phosphoric acid (for pH adjustment) Purified water
6.1 Seznam pomožnih snovi dinatrijev edetat propilgalat fosforjeva kislina (za uravnavo pH) prečiščena voda
Severely ill individuals tend to drink less and may need simultaneous treatment, preferably by parenteral medication.
Vsebuje dinatrijev edetat; ne injicirajte Hudo bolne živali ponavadi pijejo manj, zato bodo morda potrebovale sočasno zdravljenje, zaželeno s parenteralnimi zdravili.
WITHDRAWAL PERIOD
Rok uporabnosti
Pigs: 14 days Chickens: 12 days Turkeys: 19 days Calves: 42 days
Prašiči: 14 dni Kokoši: 12 dni Purani: 19 dni Teleta: 42 dni
Czech Republic Eli Lilly Regional Operation Ges.m.b.H.
Češka republika Eli Lilly Regional Operation Ges.m.b.H.
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND LABELLING
PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN OZNAČEVANJA
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
For oral use in drinking water or milk replacer.
Za peroralno uporabo v pitni vodi ali nadomestku mleka.
Do not use within 14 days of onset of the laying.
Ne uporabite v obdobju 14 dni pred začetkom obdobja nesnosti.
The CVMP has assessed five dose determination studies provided by the Marketing Authorisation Holders.
CVMP je ocenil pet študij določitve odmerka, ki so jih predložili imetniki dovoljenja za promet z zdravilom.
For animal treatment only.
Samo za živali.
One 240 ml bottle and 960 ml bottle of Pulmotil AC are sufficient to medicate in milk replacer respectively 12 to 20 and 48 to 80 veal calves each of 40 kg bodyweight depending on the duration of treatment.
Ena plastenka z 240 ml zdravila Pulmotil AC zadostuje za pripravo nadomestka mleka z zdravilom za 12 do 20 klavnih telet s telesno maso 40 kg, ena plastenka z 960 ml zdravila Pulmotil AC pa zadostuje za pripravo nadomestka mleka z zdravilom za 48 do 80 klavnih telet s telesno maso 40 kg, odvisno od trajanja zdravljenja.
the CVMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics is set out in Annex III Pulmotil AC and associated names.
CHMP je priporočil dopolnitev dovoljenj za promet z zdravilom Pulmotic AC, katerih povzetek glavnih značilnosti zdravila in označevanja so navedeni v Dodatku III.
One 240 ml bottle of Pulmotil AC is sufficient to medicate 300 litres of drinking water for pigs or 800 litres of drinking water for chickens or turkeys.
Ena plastenka z 240 ml zdravila Pulmotil AC zadostuje za pripravo 300 litrov pitne vode, ki se ji primeša zdravilo, za prašiče ali 800 litrov pitne vode, ki se ji primeša zdravilo, za kokoši ali purane.
Once opened, use within 3 months Once reconstituted, use within 24 hours
Odprto zdravilo uporabite v 3 mesecih Pripravljeno zdravilo uporabite v 24 urah.
Chickens and Turkeys (except hens producing eggs for human consumption): To be included in the drinking water at a daily dose of 15-20 mg/kg bodyweight in chickens and 10-27 mg/kg bodyweight in turkeys for 3 days, which may achieved by the inclusion of 75 mg tilmicosin per litre (30 ml Pulmotil AC per 100 litres).
Kokoši in purani (razen za kokoši, katerih jajca so namenjena prehrani ljudi): Zdravilo se zmeša s pitno vodo, da se zagotovi dnevni odmerek 15-20 mg/kg telesne mase za kokoši in 10-27 mg/kg telesne mase za purane v obdobju 3 dni, kar je mogoče doseči z dodajanjem 75 mg tilmikozina na liter (30 ml zdravila Pulmotil AC na 100 litrov).
The CVMP has assessed a dose determination studies and four clinical study reports in turkeys
CVMP je ocenil eno študijo določitve odmerka in štiri poročila o klinični študiji pri puranih.
Not authorised for use in laying birds producing eggs for human consumption.
Ni dovoljena uporaba pri pticah v obdobju nesnosti, katerih jajca so namenjena za prehrano ljudi.
The CVMP recommends that further changes to the SPC proposed by the Marketing Authorisation Holders are made:
CVMP priporoča, da se v povzetek glavnih značilnosti zdravila vnesejo naslednje spremembe, ki so jih predlagali imetniki dovoljenja za promet:
The CVMP has assessed three dose determination studies provided by the Marketing Authorisation Holders.
CVMP je ocenil tri študije določitve odmerka, ki so jih predložili imetniki dovoljenja za promet z zdravilom.
The highest mean tilmicosin concentration detected for lung tissues was 2.19 µg/g at 6 days; for air sac tissue it was 4.18 µg/g at 2 days and in the plasma it was 0.172 µg/g at 3 days.
Najvišja zaznana povprečna koncentracija tilmikozina v pljučnem tkivu je bila 2,19 µg/g 6. dan, v tkivu pljučnih mešičkov 4,18 µg/g 2. dan, v plazmi pa 0,172 µg/g 3. dan.
In order to obtain a correct dosage the concentration of tilmicosin should be adjusted accordingly.
Koncentracijo tilmikozina morate prilagoditi tako, da dosežete pravilni odmerek.
- Propyl galate and disodium edentate should be included in Quantitative and Quantitative composition; - The Phamaceutical Form should be: Concentrate for Oral Solution for use in drinking water or milk replacer'; - Contraindications: include a new statement in relation to the hypersensitivity to tilmicosin; - Modified the special precautions to be taken by the person administering the veterinary medicinal product to animals; - The follow statements should be included: Not authorised for use in laying birds producing eggs for human consumption.
- propilgalat in dinatrijev edentat se vključita v poglavje Kakovostna in količinska sestava; - farmacevtska oblika mora biti: koncentrat za peroralno raztopino za uporabo v pitni vodi ali nadomestku mleka; - kontraindikacije: vključitev nove izjave v zvezi s preobčutljivostjo za tilmikozin; - popravek poglavja Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo; - vključita se naslednji izjavi: Ni dovoljena uporaba pri pticah v obdobju nesnosti, katerih jajca so namenjena prehrani ljudi.
TARGET SPECIES
CILJNE ŽIVALSKE VRSTE
- Propyl galate and disodium edentate are relevant to be listed in the quantitative and quantitative composition; - The phamaceutical form appears to be “concentrate for oral solution for use in drinking water or milk replacer”; - Contraindications should include a statement in relation to the hypersensitivity to tilmicosin; - The special precautions to be taken by the person administering the veterinary medicinal product to animals need modification; - The follow statements should be included: Not authorised for use in laying birds producing eggs for human consumption.
- propilgalat in dinatrijev edentat sta pomembna, da se vključita v poglavje Kakovostna in količinska sestava; - farmacevtska oblika je „koncentrat za peroralno raztopino za uporabo v pitni vodi ali mleku“; - kontraindikacije morajo vsebovati izjavo v zvezi s preobčutljivostjo za tilmikozin; - poglavje Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo, je treba popraviti; - vključita se naslednji izjavi: Ni dovoljena uporaba pri pticah v obdobju nesnosti, katerih jajca so namenjena prehrani ljudi.
Not for use in lactating animals.
Ne uporabite pri živalih v laktaciji.
Excipients: Propyl gallate, Disodium edetate.
Pomožne snovi: propilgalat, dinatrijev edetat
Macrolides, such as tilmicosin, may also cause hypersensitivity (allergy) following injection, inhalation, ingestion or contact with skin or eye. Hypersensitivity to tilmicosin may lead to cross reactions to other macrolides and vice versa.
Makrolidi, kot je tilmikozin, lahko tudi povzročijo preobčutljivost (alergijo) po injiciranju, vdihavanju, zaužitju ali pri stiku s kožo ali očmi.
To be supplied only on veterinary prescription.
Na veterinarski recept.
- To avoid exposure during preparation of the medicated drinking water, wear overalls, safety glasses, and impervious gloves.
- Da preprečite izpostavitev med mešanjem pitne vode z zdravilom, oblecite delovno obleko,
Pigs - 14 days Chickens - 12 days Turkeys - 19 days Calves - 42 days
Prašiči - 14 dni Kokoši - 12 dni Purani - 19 dni Teleta - 42 dni
Calves: To be included in milk replacer only, at a dose of 12.5 mg/kg bodyweight and given twice daily for 3-5 consecutive days, which may be achieved by the inclusion of 1 ml of product every 20 kg bodyweight.
Teleta: Zdravilo se lahko doda le nadomestku mleka z odmerkom 12,5 mg/kg telesne mase, ki se daje dvakrat dnevno v obdobju 3-5 zaporednih dni, kar je možno doseči z dodajanjem 1 ml zdravila na vsakih 20 kg telesne mase.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER {For national implementation}
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM {Izpolni država članica}
Efficacy in chickens (except hens producing eggs for human consumption)
Učinkovitost pri piščancih (razen za kokoši v obdobju nesnosti, katerih jajca so namenjena za prehrano ljudi)
In the event of accidental skin contact, wash thoroughly with soap and water.
primeru nenamernega stika s kožo temeljito sperite z milom in vodo.
6.5 Nature and composition of immediate packaging
6.5 Vrsta ovojnine in vsebina
Pigs: To be included in the drinking water to provide a daily dose of 15-20 mg/kg bodyweight for 5 days, which may be achieved by the inclusion of 200 mg tilmicosin per litre (80 ml Pulmotil AC per 100 litres).
Prašiči: Zdravilo se zmeša s pitno vodo, da se zagotovi dnevni odmerek 15-20 mg/kg telesne mase v obdobju 5 dni, kar je mogoče doseči z dodajanjem 200 mg tilmikozina na liter (80 ml zdravila Pulmotil AC na 100 litrov).
Chickens (except hens producing eggs for human consumption) Pigs
Kokoši (razen kokoši, katerih jajca so namenjena za prehrano ljudi) Prašiči
In case of accidental ingestion seek medical advice immediately and show the label to the physician.
V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite nalepko na zunanji ovojnini.
EXPIRY DATE EXP
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP
Propyl gallate
Pot uporabe
Do not use within 14 days of onset of the laying
Ne uporabljajte v obdobju 14 dni pred začetkom obdobja nesnosti.
4.11 Withdrawal period(s)
4.11 Karenca(e)
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
Do not use 14 days of onset of the laying; - The pharmacodynamic properties have been reworded; - The self life of the veterinary medicinal product as packaged for sale should be 2 years; - The description of the nature and composition of immediate packaging has been harmonized.
; - opis farmakodinamičnih lastnosti se preoblikuje; - rok uporabnosti zdravila v pakiranju za prodajo mora biti 2 leti; - opis narave in sestave stične ovojnine se je uskladil.
48 hours after the start of treatment, the tilmicosin concentrations in lung and alveolar tissue were 2.3 µg/g and 3.29 µg/g respectively.
Po 48 urah od začetka zdravljenja je bila koncentracija tilmikozina v pljučnem tkivu 2,3 µg/g, v alveolarnem tkivu pa 3,29 µg/g.
Active substance:
Ob upoštevanju naslednjega:
Calves: As early as 6 hours after oral administration of 25 mg tilmicosin/kg body weight/day in milk replacer, an average active substance concentration of 3.1 µg/g was detected in lung tissue.
Teleta: Že po 6 urah po peroralnem dajanju 25 mg tilmikozina/kg telesne mase/dan v nadomestek mleka je bila povprečna koncentracija zdravilne učinkovine v pljučih 3,1 µg/g.
CVMP accepts that a claim for efficacy at a dose of 15-20 mg/kg bodyweight for 5 days, which may be achieved by the inclusion of 200 mg tilmicosin per litre for treatment and prevention of respiratory disease in pig herds, associated with Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae and other organisms susceptible to tilmicosin has been demonstrated.
CVMP se strinja, da je bila dokazana trditev o učinkovitosti pri odmerku 15-20 mg/kg telesne mase v obdobju 5 dni, kar je mogoče doseči z vključitvijo 200 mg tilmikozina na liter, za zdravljenje in preprečevanje bolezni dihal, ki so povezane z Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae in drugimi za tilmikozin občutljivimi organizmi, v čredah prašičev.
The CVMP accepts that a claim for efficacy at a dose of 12.5 mg/kg bodyweight (twice a day) for 5 days for the treatment and prevention of bovine respiratory disease, associated with Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis, M. dispar has been demonstrated.
CVMP se strinja, da je bila dokazana trditev o učinkovitosti pri odmerku 12,5 mg/kg telesne mase (dvakrat dnevno) v obdobju 5 dni za zdravljenje in preprečevanje bolezni dihal, ki so povezane z Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis in M. dispar, pri govedu.
Special precautions for use in animals
Posebni previdnostni ukrepi za uporabo pri živalih Samo za peroralno uporabo.
Chickens (except hens producing eggs for human consumption) Turkeys
Kokoši (razen za kokoši, katerih jajca so namenjena prehrani ljudi) Purani
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Polyethylene naphthalate amber coloured bottle with a polypropylene screw top and polyethylene/aluminium/polyethylene terephthalate seal.
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Plastenka iz polietilennaftalata jantarne barve s polipropilenskim navojnim pokrovčkom in zaporko iz polietilena/aluminija/polietilentereftalata.
Turkeys: After oral administration of 75 mg tilmicosin/l drinking water, the average active substance concentrations detected in lung tissue, air sac tissue and plasma 5 days after the start of treatment were 1.89 µg/ml, 3.71 µg/ml and 0.02 µg/g respectively.
Purani: Po 5 dneh od začetka peroralnega dajanja 75 mg tilmikozina na liter pitne vode je bila povprečna koncentracija zdravilne učinkovine v pljučnem tkivu 1,89 µg/ml, v tkivu pljučnih mešičkov 3,71 µg/ml in v plazmi 0,02 µg/g.
No symptoms of overdose, with exception of a slight decrease in the milk consumption, have been seen in calves given twice daily doses 5 times the maximum recommended dose or for twice the maximum recommended duration of treatment.
Pri teletih, ki so dvakrat dnevno prejemala petkratnik največjega priporočenega odmerka ali dvakrat dlje od največjega priporočenega trajanja zdravljenja, niso opazili simptomov prevelikega odmerjanja, razen majhnega zmanjšanja vnosa mleka.
4.2 Indications for use, specifying the target species Pigs: For the treatment and prevention of respiratory disease in pig herds, associated with Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae and other organisms susceptible to tilmicosin.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Prašiči: zdravljenje in preprečevanje bolezni dihal, ki jih v prašičjih čredah povzročajo Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae in drugi organizmi, ki so občutljivi za tilmikozin.
Pigs: After oral administration of 200 mg tilmicosin/l drinking water, the average active substance concentrations detected in lung tissue, alveolar macrophages and bronchial epithelium 5 days after the start of treatment were 1.44 µg/ml, 3.8 µg/ml and 7.4 µg/g respectively.
Prašiči: Po 5 dneh od začetka peroralnega dajanja 200 mg tilmikozina na liter pitne vode je bila povprečna koncentracija zdravilne učinkovine v pljučih 1,44 µg/ml, v alveolarnih makrofagih 3,8 µg/ml in v bronhialnem epitelu 7,4 µg/g.
4.7 Use during pregnancy, lactation or lay
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Varnost tilmikozina pri vzrejnih živalih ni bila ugotovljena.
Tilmicosin is a semi-synthetic antibiotic of the macrolide group and is believed to affect protein synthesis.
Tilmikozin je polsintetični antibiotik iz skupine makrolidov.
Calves: For the treatment and prevention of bovine respiratory disease, associated with Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis, M. dispar and other organisms susceptible to tilmicosin.
Teleta: Zdravljenje in preprečevanje bolezni dihal, ki jih pri govedu povzročajo Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis, M. dispar in drugi organizmi, ki so občutljivi za tilmikozin.
Pigs: For the treatment and prevention of respiratory disease in pig herds, associated with Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae and other organisms susceptible to tilmicosin.
Prašiči: Zdravljenje in preprečevanje bolezni dihal, ki jih v prašičjih čredah povzročajo Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae in drugi organizmi, ki so občutljivi za tilmikozin.
Poultry: As early as 6 hours after oral administration of 75 mg tilmicosin/l drinking water, the average active substance concentrations detected in lung and alveolar tissue were 0.63 µg/g and 0.30 µg/g respectively.
Perutnina: Že po 6 urah po peroralnem dajanju 75 mg tilmikozina na liter pitne vode je bila povprečna koncentracija zdravilne učinkovine v pljučih 0,63 µg/g, v alveolarnem tkivu pa 0,30 µg/g.
The CVMP accepts that a claim for efficacy at a dose of 10-27 mg/kg body weight for 3 days for the treatment and prevention of respiratory disease in turkey flocks, associated with Mycoplasma gallisepticum and M. synoviae, has been demonstrated.
CVMP se strinja, da je bila dokazana trditev o učinkovitosti pri odmerku 10-27 mg/kg telesne mase v obdobju 3 dni za zdravljenje in preprečevanje bolezni dihal, ki so povezane z Mycoplasma gallisepticum in M. synoviae, v jatah puranov.
No symptoms of overdose have been seen in chickens given drinking water containing levels of tilmicosin up to 375 mg/litre (equivalent to 75-100 mg/kg bodyweight or 5 times the recommended dose) for 5 days; daily treatment with 75 mg/litre (equivalent to the maximum recommended dose) for 10 days resulted in a reduction in faecal consistency.
Pri kokoših, ki so 5 dni dobivale pitno vodo s tilmikozinom do 375 mg/liter (enakovredno 75-100 mg/kg telesne mase ali 5-kratniku priporočenega odmerka), niso opazili simptomov prevelikega odmerjanja.
The CVMP accepts that a claim for efficacy at a dose of 15-20 mg/kg bodyweight for 3 days for the treatment and prevention of respiratory disease in chicken flocks, associated with Mycoplasma gallisepticum and M. synoviae has been demonstrated.
CVMP se strinja, da je bila dokazana trditev o učinkovitosti pri odmerku 15-20 mg/kg telesne mase v obdobju 3 dni za zdravljenje in preprečevanje bolezni dihal, ki so povezane z Mycoplasma gallisepticum in M. synoviae, v jatah piščancev.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Posebni previdnostni ukrepi, ki naj jih upošteva oseba, ki daje zdravilo živali - Tilmikozin lahko povzroči draženje.
PULMOTIL AC Oral solution Tilmicosin 250mg/ml
Pulmotil AC oral solution peroralna raztopina tilmikozin 250 mg/ml govedo (teleta) prašiči kokoši purani
No symptoms of overdose have been seen in turkeys given drinking water containing levels of tilmicosin up to 375 mg/litre (equivalent to 50-135 mg/kg bodyweight or 5 times the recommended dose) for 3 days; daily treatment with 75 mg/litre (equivalent to the maximum recommended dose) for 6 days also produced no symptoms of overdose.
Pri puranih, ki so 3 dni dobivali pitno vodo s tilmikozinom, do 375 mg/liter (enakovredno 50135 mg/kg telesne mase ali 5-kratniku priporočenega odmerka), niso opazili simptomov prevelikega odmerjanja.
Chickens: For the treatment and prevention of respiratory disease in chicken flocks, associated with Mycoplasma gallisepticum and M. synoviae.
Kokoši: Zdravljenje in preprečevanje bolezni dihal, ki jih v jatah kokoši povzročajo Mycoplasma gallisepticum in M. synoviae.
Tilmicosin (as phosphate) 250 mg/ml Excipients:
Zdravilna učinkovina: tilmikozin (v obliki fosfata) 250 mg/ml Pomožne snovi: propilgalat dinatrijev edetat
MARKETING AUTHORISATION HOLDER {For national implementation}
IMETNIK DOVOLJENJA ZA PROMET {Izpolni država članica}
Cattle (calves) Pigs for fattening Chickens
peroralna raztopina tilmikozin 250 mg/ml kokoši (vzreja za zakol) prašiči teleta
Turkeys: For the treatment and prevention of respiratory disease in turkey flocks, associated with Mycoplasma gallisepticum and M. synoviae.
Purani: zdravljenje in preprečevanje bolezni dihal, ki jih v jatah puranov povzročajo Mycoplasma gallisepticum in M. synoviae.
Basingstoke
KARENCA
4.4 Special warnings for each target species
4.4 Posebna opozorila za vsako ciljno živalsko vrsto Pomembno: Preden daste živali zdravilo, ga je treba razredčiti.
Pulmotil AC Oral Solution Tilmicosin 250mg/ml
Pulmotil AC peroralna raztopina tilmikozin 250 mg/ml prašiči kokoši (vzreja za zakol) teleta
These measures will help protect the environment.
Takšni ukrepi pomagajo varovati okolje.
3 years.
3 leta.
The mechanism of this effect is unclear.
Mehanizem tega učinka ni jasen.
Interactions studies have only been performed in adults.
Študije medsebojnega delovanja so izvedli le pri odraslih.
However, animal studies to evaluate this specific risk have not been conducted.
Študije na živalih za oceno tega specifičnega tveganja ni bilo.
Fertility was not reduced.
Plodnost se ni zmanjšala.
The expiry date refers to the last day of that month.
Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
- if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
- če ste kdaj imeli tuberkulozo ali če ste bili v tesnem stiku s kom, ki je imel ali ima tuberkulozo.
• every two weeks during the first six months of treatment, and
• vsaka dva tedna v prvih 6 mesecih zdravljenja in
Classification of expected frequencies:
Razvrstitev po pričakovani pogostnosti:
No special requirements for disposal.
Ni posebnih zahtev za odstranjevanje.
After this, most patients need a dose of:
Potem potrebuje večina bolnikov odmerek:
Folate supplementation was optional and only used in 10% of patients.
Dodajanje folata je bilo fakultativno in uporabljeno le pri 10 % bolnikov.
It is considered essential that monitoring recommendations are strictly adhered to.
Strogo upoštevanje priporočil za nadziranje je ključnega pomena.
These data do not allow an effective and safe dose recommendation.
Ti podatki ne dopuščajo priporočil o učinkovitem in varnem odmerku.
Before starting treatment, all patients should be evaluated for active and inactive (“latent”) tuberculosis, as per local recommendations.
Pred začetkom zdravljenja je treba vse bolnike oceniti glede aktivne in neaktivne ("latentne") tuberkuloze v skladu z lokalnimi priporočili.
If possible, take your tablets or the box with you to show the doctor.
Če je mogoče, vzemite tablete ali škatlico s seboj, da jih boste pokazali zdravniku.
There is no preferential uptake in erythrocytes.
Prioritetnega privzema v eritrocite ni.
Excretion data from the 14C study indicated that at least about 82 to 95% of the dose is absorbed.
Podatki o ekskreciji iz študije 14C so pokazali, da se absorbira vsaj 82 do 95 % odmerka.
• Additional risk minimisation measures
• Dodatni ukrepi za zmanjševanje tveganj
Procreation (recommendations for men)
Zaploditev otroka (priporočila za moške)
For more information on these, please read section 4 (Possible side effects).
Za več informacij o tem, prosimo preberite poglavje 4 (Možni neželeni učinki).
There is no indication that these effects are of clinical relevance.
Ni znakov, da bi bili ti učinki klinično pomembni.
Your doctor may perform tests to see if you have tuberculosis.
Zdravnik lahko opravi preiskave, da bi ugotovil, ali imate tuberkulozo.
Waiting period
Čakalno obdobje
Duration of a complete washout is usually 11 days.
Popolno izpiranje ponavadi traja 11 dni.
A complete washout is essential in such cases.
V teh primerih je nujno popolno izpiranje.
Most of the cases occurred within the first 6 months of treatment.
Večina primerov se je pojavila v prvih 6 mesecih zdravljenja.