natgillin/translations-raw huggingface dataset:
Two doses of Versican Plus Pi/L4R 3-4 weeks apart from 8-9 weeks of age. 
Dvije doze Versican Plus Pi/L4R u razmaku od 3 - 4 tjedna nakon navršenih 8 - 9 tjedana starosti.
Dose and route of administration: 
Doza i put primjene:
Aseptically reconstitute the lyophilisate with the suspension. 
Aseptički rekonstituirati liofilizat sa suspenzijom.
Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress. 
Imunokompetencija životinje može biti ugrožena zbog raznih čimbenika uključujući loše zdravstveno stanje, gojno stanje,
Rabies virus 
Virus bjesnoće
CLINICAL PARTICULARS 4.1 Target species Dogs 
KLINIČKE POJEDINOSTI 4.1 Ciljne vrste životinja
L. interrogans serovar Canicola 
L. interrogans, serotip Canicola
Bioveta, a.s., 
Bioveta, a.s., Komenského 212,
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 
U slučaju da se nehotice samoinjicira, odmah potražiti pomoć liječnika i pokazati mu uputu o VMP ili etiketu.
The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, and rabies virus. 
Cjepivo je namijenjeno aktivnoj imunizaciji zdrave štenadi i zdravih pasa protiv bolesti koje uzrokuje pseći virus parainfluence, Leptospira interrogans, serotip Australis, serovar Bratislava, Leptospirakirschneri , serotip Canicola, serovar Canicola, Leptospira interrogans, serotip Grippotyphosa, serovar Grippotyphosa, Leptospira interrogans, serotip Icterohaemorrhagiae, serovar Icterohaemorrhagiae i virusa bjesnoće.
Aluminium hydroxide 
Aluminijev hidroksid
Suspension: pink colour with fine sediment. 
Suspenzija: ružičaste boje sa sitnim talogom.
Canine parainfluenza virus Type 2 
Pseći parainfluenca virus tip 2
A single dose of Versican Plus Pi/L4R should be given every 3 years. 
Jednu dozu Versican Plus Pi/L4R treba primijeniti svake tri godine.
Plastic box containing 25 vials (1 dose) of lyophilisate and 25 vials (1 ml) of suspension. 
Plastična kutija sadržava 25 bočica (1 doza) liofilizata i 25 bočica (1 ml) suspenzije.
Plastic box containing 50 vials (1 dose) of lyophilisate and 50 vials (1 ml) of suspension. 
Plastična kutija sadržava 50 bočica (1 doza) liofilizata i 50 bočica (1 ml) suspenzije.
Reconstituted vaccine: pink/red, or yellowish colour with slight opalescence. 
Rekonstituirano cjepivo: ružičasto/crvene ili žućkaste boje s blagom opalescencijom.
− to prevent mortality, clinical signs and infection caused by rabies virus. 
− sprječavanje smrtnosti, kliničkih znakova i infekcija uzrokovanih virusom bjesnoće.
At least one year following the primary vaccination course for canine parainfluenza virus and Leptospira components. 
Najmanje godinu dana nakon osnovnog cijepljenja za pseći parainfluenca virus i Leptospira komponente.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
Some animals may also not show titres > 0.5 IU/ml after the primary vaccination. 
Isto tako, neke životinje nisu proizvele titar antitijela > 0,5 IU/ml nakon primarnog cijepljenja jednom dozom.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis. 
Odluku o primjeni ovog cjepiva prije, odnosno poslije primjene bilo kojeg drugog veterinarsko-medicinskog proizvoda treba donositi veterinar, od slučaja do slučaja.
The live attenuated virus vaccine strain CPiV may be shed by vaccinated animals following vaccination. 
Živo atenuirano virusno cjepivo soj CPiV može se izlučivati nakon cijepljenja.
Primary vaccination scheme: 
Osnovno cijepljenje (primovakcinacija):
Therefore a single dose of compatible vaccine Versican Plus Pi/L4 can be used annually as required. 
Stoga se pojedinačna doza kompatibilnog cjepiva Versican Plus Pi/L4 može primjenjivati godišnje, prema potrebi.
Clinical signs of immune-mediated diseases, such as haemolytic anaemia, thrombocytopenia or polyarthritis have been reported in very rare cases. 
U vrlo rijetkim slučajevima zabilježeni su klinički znakovi imunološki posredovanih bolesti, poput hemolitičke anemije, trombocitopenije ili poliartritisa.
Suspension (inactivated): 
Sus pe nzija(inaktivirana):
Type 1 glass vial containing 1 ml of suspension closed with a chlorobutyl rubber stopper and aluminium cap. 
I sadržavaju 1 ml suspenzije zatvorene brombutilnim gumenim čepom i aluminijskom kapicom.
Onset of immunity: - 2 weeks after a single vaccination from 12 weeks of age for rabies, - 3 weeks after completion of the primary course for CPiV and - 4 weeks after the completion of primary course for Leptospira components. 
- 2 tjedna nakon jednog cijepljenja, od 12. tjedana starosti za bjesnoću, - 3 tjedna nakon završetka osnovnog cijepljenja za CPiV i - 4 tjedna nakon završetka osnovnog cijepljenja za Leptospira komponente.
In this case the second vaccination with Versican Plus Pi/L4R should not be given before 12 weeks. 
tom slučaju sljedeće cijepljenje s Versican Plus Pi/L4R ne smije se dati prije navršenih 12 tjedana starosti.
L. kirschneri serovar Grippotyphosa 
L. kirschneri, serotip Grippotyphosa
Minimum Maximum Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 10 
Pseći parainfluenca virus tip 2, soj CPiV-2-Bio 15
The efficacy of the rabies fraction is proven after a single dose from 12 weeks of age in laboratory studies. 
U laboratorijskim istraživanjima, učinkovitost komponente za bjesnoću dokazana je nakon primjene jedne doze, u starosti od 12 tjedana.
Annual re-vaccination is required for canine parainfluenza and Leptospira components. 
Godišnje docjepljivanje potrebno je za parainfluencu i Leptospira komponente.
Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088 
Leptospira interrogans, serotip Australis, serovar Bratislava, soj MSLB 1088
Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091 
Leptospira kirschneri, serotip Grippotyphosa, serovar Grippotyphosa, soj MSLB 1091
Potassium chloride 
Kalijev klorid
Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae strain MSLB 1089 
Leptospira interrogans, serotip Icterohaemorrhagiae, serovar Icterohaemorrhagiae, soj MSLB 1089
Annual re-vaccination is required for canine parainfluenza virus and Leptospira components. 
Godišnje docjepljivanje potrebno je za pseći parainfluenca virus i Leptospira komponente.
Suspension (inactivated): L. interrogans serovar Icterohaemorrhagiae 
L. interrogans, serotip Icterohaemorrhagiae
Leptospira interrogans serogroup Canicola serovar Canicola, strain MSLB 1090 
Leptospira interrogans, serotip Canicola, serovar Canicola, soj MSLB 1090
Potassium dihydrogen phosphate 
Kalijev dihidrogen fosfat Dinatrijev fosfat dodekahidrat Voda za injekcije
− to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus, 
− sprječavanje kliničkih znakova (iscjedak iz nosa i očiju) i smanjivanje izlučivanja virusa,
STATEMENT OF ACTIVE SUBSTANCES Each dose of 1 ml contains: 
Svaka doza od 1 ml sadržava:
Manufacturer responsible for batch release: 
Nositelj odobrenja za proizvodnju odgovoran za puštanje serije u promet:
ALR titre ≥ 1:51 
ALR titar ≥ 1:51
ALR titre ≥ 1:40 
ALR titar ≥ 1:40
PACKAGE LEAFLET: Versican Plus Pi/L4R lyophilisate and suspension for suspension for injection for dogs 
Versican Plus Pi/L4R liofilizat i suspenzija za suspenziju za injekciju za pse
Re-vaccination scheme: 
Docjepljivanje (revakcinacija):
No other adverse effects other than those mentioned under section 6 (Adverse reactions) have been observed after administration of a 10-fold overdose of the vaccine. 
Nakon primjene deseterostruke propisane doze nisu zapažene druge nuspojave osim onih navedenih u odjeljku 6. (Nuspojave).
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 
6.6 Posebne mjere opreza prilikom odlaganja neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
ALR** titre ≥ 1:40 
ALR** titar ≥ 1:40
− to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, 
L. interrogans, serotip Canicola, serovar Canicola i L. interrogans, serotip Icterohaemorrhagiae, serovar Icterohaemorrhagiae,
6.5 Nature and composition of immediate packaging Type I glass vial containing 1 dose of lyophilisate closed with a bromobutyl rubber stopper and aluminium cap. 
I sadržavaju 1 dozu liofilizata zatvorene brombutilnim gumenim čepom i aluminijskom kapicom.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1 ml contains: 
KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Svaka doza od 1 ml sadržava:
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4R lyophilisate for dogs 
Versican Plus Pi/L4R liofilizat za pse
ROUTE(S) OF ADMINISTRATION 
NAČIN I PUT(EVI) PRIMJENE
− to prevent clinical signs, infection and urinary excretion caused by L. interrogans serogroup Australis serovar Bratislava, 
− sprječavanje kliničkih znakova, infekcije i izlučivanja mokraćom, uzrokovanih s L. interrogans ,
STATEMENT OF THE MRLs Not applicable. 
IZVJEŠĆE O MRL
ALR** titre ≥ 1:51 
ALR** titar ≥ 1:51
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4R suspension for dogs 
Versican Plus Pi/L4R suspenzija za pse
VIAL (1 ML SUSPENSION) 
BOČICA (1 ML SUSPENZIJE) NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 103.1 TCID50* 105.1 TCID50 Suspension (inactivated): 
Pseći parainfluenca virus, tip 2, soj CPiV-2 Bio 15
Lyophilisate: Trometamol Edetic Acid Sucrose Dextran 70 
EDTA - etilendiamintetraoctena kiselina Saharoza
− to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa and 
L.kirschneri , serotip Grippotyphosa, serovar Grippotyphosa i
Contact your doctor immediately if: 
Odmah se javite svojem liječniku ako:
Take care not to block the air vents. 
Pazite da ne blokirate ispust za zrak.
Date of first authorisation: 19th November 2014 Date of latest renewal: 
Datum prvog odobrenja: 19. studeni 2014 Datum posljednje obnove:
Special populations: Elderly patients (≥65 years old) 
Posebne populacije: Stariji bolesnici (≥65 godina)
Lactose is a type of sugar found in milk. 
Laktoza je vrsta šećera koji se nalazi u mlijeku.
Every time you need to take an inhalation, follow the instructions below. 
Svaki puta kada trebate inhalirati, postupite u skladu s dolje navedenim uputama.
After opening the foil wrap: 6 months. 
3 godine Nakon otvaranja folije: 6 mjeseci
Median FEV1 at inclusion in the trials was 36% of predicted normal. 
Pri uključivanju u ispitivanja, medijan FEV1 bio je 36% od predviđene normale.
These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately. 
Ti znakovi mogu značiti da astma ili KOPB kod Vas nisu adekvatno kontrolirani i da Vam je možda odmah potrebno drukčije ili dodatno liječenje.
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti u svakoga.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updatespublished on the European medicines web-portal. 
Zahtjevi za podnošenje periodičkih izvješća o neškodljisvosti za ovaj lijek usklađeni su s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim naknadnim izmjenama objavljenim na europskom internetskom portalu za lijekove.
There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies. 
Postoje neki pokazatelji povećanog rizika od pneumonije s povećanjem doze steroida, ali to se nije uvjerljivo dokazalo u svim ispitivanjima.
Adults (18 years and older) 
Odrasli (s 18 godina i više)
• An increase in the amount of sugar (glucose) in your blood. 
• Povišena razina šećera (glukoze) u krvi.
Contact your doctor immediately as you may need to have your treatment changed. 
Odmah se javite svojem liječniku jer Vam može biti potrebna promjena liječenja.
• Disturbance of the heart's electrical system (prolongation of the QTc-interval). 
• Poremećaj električnog sustava srca (produljenje QTc-intervala)
Frequencies are defined as: very common (1/10), common (1/100, <1/10), uncommon (1/1,000, < 1/100), rare (1/10,000, < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). 
Učestalost je definirana kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
The mechanisms of action of the two substances respectively are discussed below. 
O mehanizmima djelovanja dviju djelatnih tvari je više rečeno u dolje navedenom tekstu.
• Increased cough or increased breathing difficulties 
• pojačan kašalj ili otežano disanje
Sudden and progressive deterioration in control of asthma or COPD is potentially life-threatening and the patient should undergo urgent medical assessment. 
Iznenadno i progresivno pogoršanje kontrole astme ili KOPB-a potencijalno je opasno po život te bolesnik mora pristupiti hitnoj medicinskoj procjeni.
Remove your inhaler from your mouth. 
6. Izvadite inhalator iz usta.
It is important that you take your dose as advised by your doctor. 
Važno je da svoju dozu uzimate prema naputku Vašeg liječnika.
A separate rapid-acting bronchodilator should be considered for such prophylactic use. 
Mora se razmotriti korištenje zasebnog brzodjelujućeg bronhodilatatora kod takve profilaktičke uporabe.
If patients find the treatment ineffective, or exceed the highest recommended dose of Budesonide/Formoterol Teva, medical attention must be sought (see section 4.2). 
Ako bolesnici smatraju liječenje neučinkovitim ili prekorače najvišu preporučenu dozu lijeka Budezonid/Formoterol Teva, moraju zatražiti liječničku pomoć (vidjeti dio 4.2).
Symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. 
Simptomatsko liječenje bolesnika s teškom KOPB (FEV1 < 50% od predviđene normale) i anamnezom ponavljanih egzacerbacija, koji imaju značajne simptome unatoč redovnoj terapiji bronhodilatatorima dugog djelovanja.
Headache, tremor Dizziness Taste disturbances 
Glavobolja, tremor Omaglica Poremećaji okusa
What Budesonide/Formoterol Teva is and what it is used for 
Što je Budezonid/Formoterol Teva i za što se koristi
Aggression, psychomotor hyperactivity, anxiety, sleep disorders 
Agresivnost, psihomotorna hiperaktivnost, anksioznost, poremećaji spavanja
You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine (listed in section 6). 
ste alergični na budezonid, formoterolfumarat dihidrat, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
In spite of this, a small increase in cortisol suppression was seen after administration of fixed-dose combination compared to the monoproducts. 
Usprkos tome, primijećeno je malo povećanje supresije kortizola nakon primjene kombinacije fiksne doze u usporedbi s monokomponentama.
How to take an inhalation 
Kako inhalirati
• Your breathing is getting worse or you often wake up at night with breathlessness and wheezing. 
• se pogorša Vaše disanje ili se noću često budite zbog nedostatka ili zviždanja u plućima.
Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations. 
Liječnici moraju pozorno pratiti mogući razvoj pneumonije u bolesnika s KOPB-om s obzirom da se kliničke manifestacije tih infekcija podudaraju sa simptomima egzacerbacije KOPB-a.
A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur. 
Na općenito insuficijentan glukokortikosteroidni učinak mora se posumnjati ako se, u rijetkim slučajevima, pojave simptomi poput umora, glavobolje, mučnine i povraćanja.
COPD is a long-term lung disease of the airways in the lungs, which is often caused by cigarette smoking. 
KOPB je dugotrajna bolest dišnih puteva u plućima, koja je često uzrokovana pušenjem cigareta.
If you have been taking steroid tablets for your asthma or COPD, your doctor may reduce the number of tablets that you take, once you start to use Budesonide/Formoterol Teva. 
Ako ste uzimali tablete steroida za astmu ili KOPB, Vaš liječnik može smanjiti broj tableta koje uzimate nakon što počnete koristiti Budezonid/Formoterol Teva.
Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD. 
Čimbenici rizika za pneumoniju u bolesnika s KOPB-om uključuju aktivne pušače, stariju dob, niski indeks tjelesne mase (BMI) i teški oblik KOPB-a.
• Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. 
• Inhalirani kortikosteroidi mogu utjecati na normalno stvaranje steroidnih hormona u Vašem tijelu, posebice ako dulje vrijeme primjenjujete visoke doze.
• Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow) or hives together with difficulties to breathe (angioedema) and/or sudden feeling of faintness. 
• Oticanje lica, posebice oko usta (jezik i/ili grlo i/ili otežano gutanje) ili koprivnjača u kombinaciji s otežanim disanjem (angioedem) i/ili iznenadni osjećaj nesvjestice.
Important information about your asthma or COPD symptoms 
Važne informacije o simptomima astme ili KOPB-a
Place the mouthpiece between your teeth. 
4. Stavite nastavak za usta između zuba.
(budesonide/formoterol fumarate dihydrate) 
(budezonid/ formoterolfumarat dihidrat)
• Sudden acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm'). 
• Iznenadno akutno zviždanje u plućima i/ili nedostatak zraka neposredno nakon primjene inhalatora (također se naziva 'paradoksalni bronhospazam').
Contains 1 inhaler. 
Sadrži 1 inhalator.
Use of your ‘reliever inhaler' should not exceed 8 inhalations (puffs) in any 24 hours and you should not use your ‘reliever inhaler' more often than every 4 hours. 
“Inhalator za brzo ublažavanje simptoma” ne smije se koristiti za više od 8 inhalacija (potisaka) u 24 sata i češće od svaka 4 sata.
For changes in lung-function parameters, such as FEV1, budesonide/formoterol was not superior to treatment with formoterol alone. 
Za promjene parametara plućne funkcije poput FEV1, liječenje kombinacijom budezonida/formoterola nije bilo superiornije od liječenja samo formoterolom.
There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products. 
Ne postoje uvjerljivi klinički dokazi o razlikama u veličini rizika za pneumoniju između pojedinih inhalacijskih kortikosteroida unutar te skupine.
Hold your breath for 10 seconds or as long as you comfortably can. 6. 
Zadržite dah 10 sekundi ili koliko god možete izdržati.
Recommended doses: 
Preporučene doze:
Before using your Budesonide/Formoterol Teva for the first time, you need to prepare it for use as follows: 
Prije prve primjene inhalatora Budezonid/Formoterol Teva, trebate ga pripremiti za primjenu na sljedeći način:
Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD). 
Liječnik Vam je propisao ovaj lijek za liječenje astme ili kronične opstruktivne plućne bolesti (KOPB).
- The other ingredient is lactose monohydrate (see section 2 under ‘Budesonide/Formoterol Teva contains lactose') 
- Drugi sastojak je laktoza hidrat (pogledajte dio 2 pod „Budezonid/Formoterol Teva sadrži laktozu”)
When ketoconazole was administered 12 hours after budesonide the concentration was on average increased only three-fold showing that separation of the administration times can reduce the increase in plasma levels. 
Kad je ketokonazol bio primjenjen 12 sati nakon budezonida, koncentracija se povećala u prosjeku za samo tri puta, pokazujući da odvajanje vremena primjene može smanjiti povećanje razina u plazmi.
Do not use Budesonide/Formoterol Teva to treat these asthma symptoms. 
Nemojte koristiti Budezonid/Formoterol Teva za liječenje tih simptoma astme.
Pharmacodynamic interactions β adrenergic blockers can weaken or inhibit the effect of formoterol. 
Beta-adrenergički blokatori mogu oslabiti ili inhibirati učinak formoterola.
Budesonide/Formoterol Teva 320 mcg/9 mcg 
Budezonid/Formoterol Teva 320 mcg/9 mcg
The mean number of exacerbations per year (as defined above) was significantly reduced with budesonide/formoterol as compared with treatment with formoterol alone or placebo (mean rate 1.4 compared with 1.8-1.9 in the placebo/formoterol group). 
Srednja vrijednost broja egzacerbacija godišnje (prema gornjoj definiciji) bila je značajno smanjena pri liječenju kombinacijom budezonida/formoterola u usporedbi s liječenjem samo formoterolom ili placebom (srednja vrijednost stope 1,4 u usporedbi s 1,8-1,9 u skupini placebo/formoterol).
The mean PIFR achieved by patients with asthma or COPD was over 60L/min, a flow rate at which both devices studied are known to deliver comparable amounts of drug to the lungs. 
Srednja vrijednost PIFR postignuta u bolesnika s astmom ili KOPB-om bila je viša od 60 l/min, a to je brzina protoka pri kojoj je za oba ispitivana inhalatora poznato da su dostavljene usporedive količne lijeka u pluća.
Cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles Angina pectoris. 
Srčane aritmije, npr. fibrilacija atrija, supraventrikularna tahikardija, ekstrasistole Angina pektoris.
If these effects occur, they are usually mild and usually disappear as you continue to use Budesonide/Formoterol Teva. 
Ako se ti učinci pojave, obično su blagi i nestanu kad nastavite s primjenom lijeka Budezonid/Formoterol Teva.
• Medicines for allergies or antihistamines (such as terfenadine). 
• lijekove za alergije ili antihistaminike poput terfenadina.
• Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting β2 adrenoceptor agonists' or ‘bronchodilators'. 
• Formoterolfumarat dihidrat pripada skupini lijekova pod nazivom „dugodjelujući agonisti beta2adrenoceptora” ili „bronhodilatatori”.
Hypokalaemia Hyperglycaemia 
Hipokalemija Hiperglikemija
Recommended dose: 
Preporučena doza:
You should speak to your doctor if you are concerned as to whether you should continue to use Budesonide/Formoterol Teva. 
Trebate razgovarati sa svojim liječnikom ako Vas brine trebate li nastaviti s uzimanjem inhalatora Budezonid/Formoterol Teva.