natgillin/translations-raw huggingface dataset:
Patients who achieve a complete or partial response to induction treatment with Gazyvaro in combination with chemotherapy (CHOP or CVP or bendamustine) should continue to receive Gazyvaro 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first). 
Bolesnici koji ostvare potpun ili djelomičan odgovor na uvodno liječenje lijekom Gazyvaro u kombinaciji s kemoterapijom (protokolom CHOP ili CVP ili bendamustinom) trebaju nastaviti primati terapiju održavanja samo lijekom Gazyvaro u dozi od 1000 mg jedanput svaka 2 mjeseca tijekom 2 godine ili do progresije bolesti (što god nastupi ranije).
Table 5 Follicular lymphoma: Standard infusion rate in the absence of IRRs /hypersensitivity and recommendations in case an IRR occurred with previous infusion 
Tablica 5 Folikularni limfom: Standardna brzina infuzije u odsustvu reakcija na infuziju/preosjetljivosti i preporuke u slučaju da je tijekom prethodne infuzije nastupila reakcija na infuziju
Patients with follicular lymphoma who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen 
Bolesnici s folikularnim limfomom koji nisu odgovorili na liječenje rituksimabom ili protokolom koji sadrži rituksimab, ili su doživjeli progresiju tijekom ili do 6 mjeseci nakon takvog liječenja
# Patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen 
#Bolesnici s FL-om koji nisu odgovorili na liječenje rituksimabom ili protokolom koji sadrži rituksimab, ili su doživjeli progresiju tijekom ili do 6 mjeseci nakon takvog liječenja
The incidence of thrombocytopenia was higher in the Gazyvaro plus chlorambucil arm compared to the rituximab plus chlorambucil arm (16% vs. 7%) especially during the first cycle. 
Incidencija trombocitopenije bila je viša u skupini liječenoj lijekom Gazyvaro i klorambucilom (16%)
If the patient experienced an IRR of Grade 2 or higher during the previous infusion administer at 50 mg/hr. 
Ako se tijekom prethodne infuzije razvila reakcija na infuziju 2. ili višeg stupnja, ovu treba primijeniti brzinom od 50 mg/h.
● a hole in the stomach or intestines (gastrointestinal perforation, especially in cases where the cancer affects the gastrointestinal tubes) 
Manje često (mogu se javiti u do 1 na 100 osoba) · probušenje stijenke želuca ili crijeva (gastrointestinalna perforacija, osobito u slučajevima u kojima rak zahvaća probavnu cijev)
Premedication to reduce the risk of IRRs is outlined in Table 1 (see also section 4.4). 
Profilaksa i premedikacija za reakcije na infuziju Premedikacija radi smanjenja rizika od reakcija na infuziju opisana je u Tablici 1 (vidjeti i dio 4.4).
Your doctor may decide to stop treatment with Gazyvaro if you have a severe infusion related reaction. 
Ako dobijete jaku reakciju na infuziju, liječnik može odlučiti prekinuti liječenje lijekom Gazyvaro.
You may be more likely to get an infection during and after treatment with Gazyvaro. 
Tijekom i nakon liječenja lijekom Gazyvaro može postojati veća vjerojatnost da dobijete infekciju.
Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany 
D-79639 Grenzach-Wyhlen
Progressive multifocal leukoencephalopathy PML has been reported in patients treated with Gazyvaro (see section 4.4). 
U bolesnika liječenih lijekom Gazyvaro prijavljen je PML (vidjeti dio 4.4).
Dose delays should be considered in case of severe or life-threatening neutropenia. 
U slučaju teške i po život opasne neutropenije dolazi u obzir odgoda primjene doze.
Parenteral medicinal products should be inspected visually for particulates and discolouration prior to administration. 
Lijekove za parenteralnu primjenu potrebno je prije primjene vizualno pregledati kako bi se utvrdila moguća prisutnost čestica ili promjena boje.
Fatal haemorrhagic events have also been reported in Cycle 1 in patients treated with Gazyvaro. 
U bolesnika liječenih lijekom Gazyvaro su u 1. ciklusu prijavljeni i događaji smrtonosnih krvarenja.
Eye disorders Common 
Poremećaji oka često očna hiperemija
Premedication 
Primjena
If no IRR occurred during the previous infusion, administer at 50 mg/hr. 
Ako se tijekom prethodne infuzije nije razvila reakcija na infuziju, ovu infuziju treba primijeniti brzinom od 50 mg/h.
NAME OF THE MEDICINAL PRODUCT Gazyvaro 1,000 mg concentrate for solution for infusion obinutuzumab 
Gazyvaro 1000 mg koncentrat za otopinu za infuziju obinutuzumab
Cycles 2-6 or 2-8 - this will be just one dose of Gazyvaro in the 28 or 21 days depending on which other cancer medicines are given together with Gazyvaro: · Day 1 - full dose (1,000 mg). 
Od 2. do 6. ciklusa ili od 2. do 8. ciklusa - primjenjuje se samo jedna doza lijeka Gazyvaro u razdoblju od 28 ili 21 dana, ovisno o tome koji se drugi lijekovi za liječenje raka primjenjuju zajedno s lijekom
The incidence of IRRs was higher in the Gazyvaro plus chlorambucil arm compared to the rituximab plus chlorambucil arm. 
Kronična limfocitna leukemija Incidencija reakcija na infuziju bila je veća u skupini liječenoj lijekom Gazyvaro i klorambucilom nego u skupini liječenoj rituksimabom i klorambucilom.
Key Endpoints 
Ključne mjere ishoda
Oral herpes, rhinitis, pharyngitis, lung infection, influenza nasopharyngitis 
često oralni herpes, rinitis, faringitis,
Primary Endpoint in FL population IRC-assessed PFS (PFS-IRC) Number (%) of patients with event Median time to event (months, 95% CI) 
PFS prema ocjeni neovisnog ocjenjivačkog povjerenstva Broj (%) bolesnika s događajem
Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with anti-CD20 antibodies including Gazyvaro (see section 4.8). 
U bolesnika liječenih anti-CD20 protutijelima, uključujući lijek Gazyvaro, može doći do reaktivacije virusa hepatitisa B (HBV), što u nekim slučajevima može rezultirati fulminantnim hepatitisom,
Clear, colourless to slightly brownish liquid. 
Bistra, bezbojna do smećkasta tekućina.
Dose of Gazyvaro to be administered 
Doza lijeka Gazyvaro za primjenu
Nervous system disorders Very common 
Poremećaji živčanog sustava vrlo često glavobolja manje često glavobolja
Cough§ 
I DOHVATA
Patients with renal impairment (CrCl < 50 mL/min) are more at risk of neutropenia (see section 4.8). 
Rizik od neutropenije veći je u bolesnika s oštećenjem funkcije bubrega (CrCl < 50 ml/min) (vidjeti dio 4.8).
Table 2 Dose of Gazyvaro to be administered during 6 treatment cycles each of 28 days duration for patients with CLL 
Tablica 2 Doza lijeka Gazyvaro koju je potrebno primijeniti u bolesnika s KLL-om tijekom
Urinary tract infection, pneumonia, lung infection, upper respiratory tract infection, sinusitis, herpes zoster 
Infekcije i infestacije vrlo često infekcija gornjih dišnih putova, sinusitis
No dose adjustment is required in patients with mild to moderate renal impairment (creatinine clearance [CrCl] 30-89 mL/min) (see section 5.2). 
(klirens kreatinina [CrCl] 30-89 ml/min) (vidjeti dio 5.2).
The incidence of infection was 38% in the Gazyvaro plus chlorambucil arm and 37% in the rituximab plus chlorambucil arm (with Grade 3-5 events reported in 12% and 14%, respectively and fatal events reported in < 1% in both treatment arms). 
(događaji 3.-5. stupnja prijavljeni su u 12% bolesnika liječenih lijekom Gazyvaro i klorambucilom i u 14% bolesnika koji su primali rituksimab i klorambucil, a incidencija smrtnih slučajeva u obje je liječene skupine bila manja od 1%).
Patients with renal impairment (CrCl < 50 mL/min) and patients with both Cumulative Illness Rating Scale (CIRS) > 6 and CrCl < 70 mL/min are more at risk of IRRs, including severe IRRs (see section 4.8). 
Cumulative Illness Rating Scale, CIRS) iznosio > 6, a CrCl bio < 70 ml/min (vidjeti dio 4.8).
HR (95% CI) p-value (Log-Rank test, stratified*) Secondary Endpoints Investigator-assessed PFS (PFS-INV) Number (%) of patients with event Median time to event (months, 95% CI) HR (95% CI) p-value (Log-Rank test, stratified*) 
Medijan vremena do događaja (mjeseci, 95% CI) HR (95% CI) p-vrijednost (log-rang test, stratificiran*) Najbolji ukupan odgovor (prema ocjeni neovisnog ocjenjivačkog povjerenstva)§ Broj bolesnika uključenih u analizu
and the number of prior therapies (≤ 2 versus > 2). 
Uvodno liječenje (u kombinaciji s bendamustinom2)
Patients with previously untreated follicular lymphoma 
Bolesnici s prethodno neliječenim folikularnim limfomom Uvodno liječenje (u kombinaciji s kemoterapijom2)
Figure 3 Kaplan-Meier curve of investigator assessed PFS from Stage 2 in patients with CLL (Study BO21004/CLL11) 
Slika 3 Kaplan-Meierova krivulja PFS-a u stadiju 2 prema ocjeni ispitivača u bolesnika s KLL-om (ispitivanje BO21004/CLL11)
Figure 2 Kaplan-Meier curve of OS from Stage 1a in patients with CLL (Study BO21004/CLL11) 
Slika 2 Kaplan-Meierova krivulja OS-a u stadiju 1a u bolesnika s KLL-om (ispitivanje BO21004/CLL11)
In a 26-week cynomolgus monkey study, hypersensitivity reactions were noted and attributed to the foreign recognition of the humanised antibody in cynomolgus monkeys (0.7-6 times the clinical exposure based on Cmax and AUC at steady state after weekly administration of 5, 25, and 50 mg/kg). 
(izloženost 0,7-6 puta veća od kliničke izloženosti na temelju Cmax i AUC-a u stanju dinamičke ravnoteže nakon primjene tjednih doza od 5, 25 i 50 mg/kg).
Figure 4 Kaplan-Meier curve of OS from Stage 2 in patients with CLL (Study BO21004/CLL11) 
Slika 4 Kaplan-Meierova krivulja OS-a u stadiju 2 u bolesnika s KLL-om (ispitivanje BO21004/CLL11)
Oral analgesic/anti-pyretic2 At least 30 minutes before Gazyvaro infusion 
Intravenski kortikosteroid1,4 Završiti primjenu najmanje 1 sat prije infuzije lijeka Gazyvaro
Tumour lysis syndrome, hyperuricaemia, hypokalaemia 
Poremećaji metabolizma i prehrane često sindrom lize tumora, hiperuricemija, hipokalijemija sindrom lize tumora, hipokalijemija manje često hiperuricemija
Patients with renal impairment (CrCl < 50 mL/min) are more at risk of thrombocytopenia (see section 4.8). 
Rizik od trombocitopenije veći je u bolesnika s oštećenjem funkcije bubrega (CrCl < 50 ml/min) (vidjeti dio 4.8).
Figure 1 Kaplan-Meier curve of Investigator assessed PFS from Stage 1a in patients with CLL (Study BO21004/CLL11) 
Slika 1 Kaplan-Meierova krivulja PFS-a u stadiju 1a prema ocjeni ispitivača u bolesnika s KLL-om (ispitivanje BO21004/CLL11)
No renal toxicity with a causal relationship to obinutuzumab has been observed in humans. 
U ljudi nije primijećena toksičnost za bubrege koja bi bila posljedica primjene obinutuzumaba.
Prophylaxis and premedication for infusion related reactions (IRRs) 
Profilaksa i premedikacija za reakcije na infuziju Premedikacija radi smanjenja rizika od reakcija na infuziju opisana je u Tablici 1.
No formal pharmacokinetic study has been conducted in patients with hepatic impairment. 
U bolesnika s oštećenjem funkcije jetre nisu provedena formalna farmakokinetička ispitivanja.
The demographic data and baseline characteristics of the patient population were well balanced between the treatment arms; median age was 59 years, 81% were Caucasian, 53% were female, 79% had a FLIPI score of ≥ 2 and 7% had Stage II (bulky), 35% had Stage III and 57% had Stage IV disease, 44% had bulky disease (> 7 cm), 34% had at least one B-symptom at baseline and 97% had an ECOG performance status of 0-1 at baseline. 
44% imalo je veliku tumorsku masu (> 7 cm), 34% bolesnika imalo je najmanje jedan B-simptom na početku ispitivanja, a njih 97% imalo je početni funkcionalni ECOG status 0 - 1.
Immunogenicity 
Trombocitopenija
In the majority of patients, Gazyvaro was given intravenously as a 1,000 mg initial dose administered on Day 1, Day 8 and Day 15 of the first treatment cycle. 
Većina je bolesnika Gazyvaro primila intravenski u početnoj dozi od 1000 mg primijenjenoj 1. dan,
Patients (CLL) with both CIRS > 6 and CrCl < 70 mL/min are more at risk of infections, including severe infections (see section 4.8). 
rezultat > 6 i CrCl < 70 ml/min (vidjeti dio 4.8).
Patients who are considered to be at risk of TLS (e.g. patients with a high tumour burden and/or a high circulating lymphocyte count [> 25 x 109/L] and/or renal impairment [CrCl < 70 mL/min]) should receive prophylaxis. 
Bolesnici s velikim tumorskim opterećenjem i/ili velikim brojem cirkulirajućih limfocita (> 25 x 109/l) i/ili oštećenjem bubrežne funkcije (klirens kreatinina [CrCl] <70 ml/min) smatraju se rizičnima za razvoj sindroma lize tumora i stoga bi trebali primiti profilaksu.
No post-baseline HAHA (Human Anti-Human Antibody) were observed in patients with iNHL treated in study GAO4753g/GADOLIN. 
U bolesnika s iNHL-om liječenih u ispitivanju GAO4753g/GADOLIN nisu pronađena humana antihumana protutijela (engl. human anti-human antibodies, HAHA) nakon početka liječenja.
Nasal congestion, rhinorrhoea, oropharyngeal pain 
nazofaringitis infekcija mokraćnih putova, pneumonija, plućna infekcija,
Talk to your doctor or nurse before you are given Gazyvaro if: · you have an infection, or have had an infection in the past which lasted a long time or keeps coming back · you have ever taken, or been given, medicines which affect your immune system (such as chemotherapy or immunosuppressants) · you are taking medicines for high blood pressure or medicines used to thin your blood - your doctor might need to alter how you take these · you have ever had heart problems · you have ever had brain problems (such as memory problems, difficulty moving or feeling sensations in your body, eyesight problems) · you have ever had breathing problems or lung problems · you have ever had “hepatitis B” - a type of liver disease · you are due to have a vaccine or you know you may need to have one in the near future. 
· ako uzimate lijekove za liječenje visokog krvnog tlaka ili lijekove koji se koriste za razrjeđivanje krvi - liječnik će možda morati promijeniti način na koji ih uzimate · ako ste ikada imali srčane tegobe
Hypersensitivity reactions with immediate (e.g. anaphylaxis) and delayed onset (e.g. serum sickness) have been reported in patients treated with Gazyvaro. 
(npr. anafilaksija) i one s odgođenim nastupom (npr. serumska bolest).
· Tell your doctor or nurse straight away if you have memory loss, trouble speaking, difficulty walking or problems with your eyesight. 
· Odmah obavijestite svog liječnika ili medicinsku sestru ako primijetite gubitak pamćenja,
Musculoskeletal chest pain, pain in extremity, bone pain 
mišićno-koštana bol u prsištu, bol u kostima
Squamous cell carcinoma of skin Squamous cell carcinoma of skin Blood and lymphatic system disorders Very common 
Poremećaji krvi i limfnog sustava vrlo često neutropenija§, trombocitopenija, anemija, leukopenija neutropenija, trombocitopenija često bol u limfnom čvoru anemija, leukopenija
IRC: Independent Review Committee; PFS: progression-free survival; HR: Hazard Ratio; CI: Confidence Intervals, NR = Not Reached # Patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen *Stratification factors for analysis were refractory type (rituximab monotherapy vs. rituximab + chemotherapy) and prior therapies (≤ 2 vs > 2). 
Bolesnici s FL-om koji nisu odgovorili na liječenje rituksimabom ili protokolom koji sadrži rituksimab, ili su doživjeli progresiju tijekom ili do 6 mjeseci nakon takvog liječenja *Stratifikacijski čimbenici za analizu bili su refraktornost (refraktorni na monoterapiju rituksimabom naspram refraktornih na rituksimab + kemoterapiju) i prethodne terapije (≤ 2 naspram > 2).
GAO4753g/GADOLIN) that occurred at a higher incidence (difference of ≥ 2%) compared to the relevant comparator arm in at least one pivotal study in: · Patients with CLL receiving Gazyvaro plus chlorambucil compared with chlorambucil alone or rituximab plus chlorambucil (study BO21004/CLL11) · Patients with previously untreated iNHL receiving Gazyvaro plus chemotherapy (bendamustine, CHOP, CVP) followed by Gazyvaro maintenance in patients achieving a response, compared to rituximab plus chemotherapy followed by rituximab maintenance in patients achieving a response (study BO21223/GALLIUM) · Patients with iNHL who had no response to or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen receiving Gazyvaro plus bendamustine, followed by Gazyvaro maintenance in some patients, compared to bendamustine alone (study GAO4753g/GADOLIN) The incidences presented in Table 6 (all grades and Grades 3-5) are the highest incidence of that ADR reported from any of the three studies. 
(bendamustin, CHOP, CVP), nakon čega je u bolesnika koji su ostvarili odgovor uslijedila terapija održavanja lijekom Gazyvaro, nego u bolesnika liječenih rituksimabom plus kemoterapijom, nakon čega je u bolesnika koji su ostvarili odgovor uslijedila terapija održavanja rituksimabom (ispitivanje BO21223/GALLIUM)
Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. 
indiciran za liječenje bolesnika s FL-om koji nisu odgovorili na liječenje rituksimabom ili protokolom koji sadrži rituksimab, ili su doživjeli progresiju tijekom ili do 6 mjeseci nakon takvog liječenja.
These include: · fever · cough · chest pain · fatigue · painful rash · sore throat · burning pain when passing urine · feeling weak or generally unwell 
· žareću bol pri mokrenju · slabost ili opće loše osjećanje
Common 
ND
Water for injections 
· vrućica · plućna infekcija
The subgroups evaluated included IPI, FLIPI, Bulky Disease, B Symptoms at baseline, Ann Arbor Stage and ECOG at baseline. 
Prognostic Index, IPI), indeksu FLIPI, velikoj tumorskoj masi, B-simptomima na početku ispitivanja,
Molecular remission at end of treatmentd No. of patients included in the analysis MRD negativee (%) 
Stabilna bolest (%) Trajanje odgovora (prema ocjeni neovisnog ocjenjivačkog povjerenstva) Broj bolesnika uključenih u analizu Broj (%) bolesnika s događajem
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Common 
Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) često planocelularni karcinom kože planocelularni karcinom kože
Most frequently reported: · nausea · fatigue · dizziness · headache · diarrhoea · fever, flushing or chills · vomiting · shortness of breath · low or high blood pressure · heart beating very fast · chest discomfort 
Poremećaji probavnog sustava vrlo često proljev, konstipacija često dispepsija, kolitis, hemoroidi proljev, kolitis manje često konstipacija, hemoroidi
Haemorrhagic events and Grade 3-5 haemorrhagic events occurred in 12% and 5% of patients, respectively. 
Događaji krvarenja javili su se u 12% bolesnika, a događaji krvarenja 3. - 5. stupnja u 5% bolesnika.
Metabolism and nutrition disorders Common 
Trombocitopenija i događaji krvarenja
Median was not reached at time of analysis # not adjusted for multiplicity **Assessed as per modified Cheson 2007 criteria ‡ End of Induction = end of induction phase, does not include monotherapy maintenance 
**Ocijenjeno prema modificiranim Chesonovim kriterijima iz 2007.
Inhalation Powder, Hard Capsule 
Prašak inhalata, tvrda kapsula
Novartis Poland Sp. Z O. O. 
Novartis Poland Sp. Z O.
Pressurised Inhalation, Suspension 
Stlačeni inhalat, suspenzija
Smithkline Beecham Farma S.A. 
Španjolska Smithkline Beecham Farma S.A.
Ucb Pharma Gmbh (Monheim De) 
Njemačka Ucb Pharma Gmbh (Monheim De)
Astrazeneca Farmacéutica Spain, S.A. 
Španjolska Astrazeneca Farmacéutica Spain, S.A.
Netherlands Chiesi Pharmaceuticals B.V. 
Nizozemska Chiesi Pharmaceuticals B.V.
Janssen-Cilag Gmbh 
Njemačka Janssen-Cilag Gmbh
Clenil Compositum Beclometasone Dipropionate 0.8mg/2 Ml, Salbutamol Sulfate 1.928mg/2 Ml 
Clenil Compositum Beklometazon dipropionat 0,8 mg/2 Ml, salbutamol sulfat 1,928 mg/2 Ml
Flunisolide 25mg Bottle, Salbutamol 10mg Bottle 
Flunisolid 25 mg boca, salbutamol 10 mg boca
Netherlands Astrazeneca Bv 
Nizozemska Astrazeneca Bv
Medochemie Romania S.R.L. 
Rumunjska Medochemie Romania S.R.L.
Budesonide 200µg Capsule 
Budezonid 200 µg kapsula
Salmeterol/Flutikazonpropio nat Diskus Glaxosmithkline 
Salmeterol/Flutikazonpro pionat Diskus Glaxosmithkline
Allen Farmaceutica, S.A. 
Španjolska Allen Farmaceutica, S.A.
Formoterol Fumarate Dihydrate 1,08 Mg, Beclometasone Dipropionate 18 Mg 
Formoterol fumarat dihidrat 1,08 Mg, beklometazon dipropionat 18 Mg
Astrazeneca France 
Francuska Astrazeneca France
Budesonide 0,92 Mg 
Budezonid 0,92 Mg
Fluticasone Propionate 2mg/2ml 
Flutikazon propionat 2 mg/2 ml
Mylan Dura Gmbh 
Njemačka Mylan Dura Gmbh
Ratiopharm Gmbh 
Njemačka Ratiopharm Gmbh
Belgium Cipla Europe Nv 
Cipla Europe
Budezonid Lek-Am Budesonide 400µg Inhalation 
Budezonid Lek-Am Budezonid 400 µg inhalat
S.C. Sandoz S.R.L. 
Rumunjska S.C. Sandoz S.R.L.
Luxembourg Elpen Pharmaceutical Co. Inc. 
Luksemburg Elpen Pharmaceutical Co.
Budezonid Lek-Am Budesonide 200µg Inhalation 
Budezonid Lek-Am Budezonid 200 µg inhalat
Budesonide 0.8mg Capsule 
Cyclocaps Budesonid Budezonid 0,8 mg kapsula
Chiesi España, S.A. 
Španjolska Chiesi España, S.A.
Clenil Compositum Beclometasone Dipropionate 50µg Actuation, Salbutamol Sulfate 120µg Actuation 
Clenil Compositum Beklometazon dipropionat 50 µg po aktuaciji, salbutamol sulfat 120 µg po aktuaciji
Fluticasone Propionate 125µg Capsule Inhalation Powder, Hard Capsule 
Flutikazon propionat 125 µg kapsula Prašak inhalata, tvrda kapsula
Almirall, S.A. 
Španjolska Almirall, S.A.
Budesonide 1mg Ampoule 
Budezonid 1 mg ampula
Netherlands Glaxosmithkline B.V. 
Nizozemska Glaxosmithkline B.V.
Salbutamol Sulfate 0.602mg Vial, Flunisolide 0.5mg Vial 
Salbutamol sulfat 0,602 mg bočica, flunisolid 0,5 mg bočica
Beclometasone Dipropionate 250µg/59.2 Mg 
Beklometazon dipropionat 250 µg/59,2 Mg
Fluticasone Propionate 0.05mg/2ml 
Flutikazon propionat 0,05 mg/2 ml
Laboratorio Tau, S.A. 
Španjolska Laboratorio Tau, S.A.
Budosenide 320mcg, Formoterol Fumarate Dihydrate 9mcg 
Budezonid 320 mcg, formoterol fumarat dihidrat 9 mcg
Fluticasone Propionate 500 Microgram, Salmeterol Xinafoate 50 Microgram 
Flutikazon propionat 500 mikrograma, salmeterol ksinafoat 50 mikrograma
Chiesi S.A. 
Francuska Chiesi S.A.
Beclometasone Dipropionate 50µg/50 µl 
Beklometazon dipropionat 50 µg/50 µl
Budosenide 160mcg, Formoterol Fumarate Dihydrate 4.5mcg 
Budezonid 160 mcg, formoterol fumarat dihidrat 4,5 mcg
Fluticasone Propionate 250mgg 
Flutikazon propionat 250 mgg
Budesonide 0.2mg/0.05ml 
Budezonid 0,2 mg/0,05 ml
Fluticasone Propionate 0,5 Mg, Salmeterol Xinafoate 0,073 Mg 
Flutikazon propionat 0,5 Mg, salmeterol ksinafoat 0,073 Mg
Belgium Orion Corporation 
Španjolska Orion Corporation
Fluticasone Propionate 0,25 Mg, Salmeterol Xinafoate 0,073 Mg 
Flutikazon propionat 0,25 Mg, salmeterol ksinafoat 0,073 Mg
Budesonide 0.25mg Ampoule 
Budezonid 0,25 mg ampula
Laboratoire Glaxosmithkline S.A.S. 
Francuska Laboratoire Glaxosmithkline S.A.S.
Fluticasone Propionate 250µg Dose, Salmeterol 50µg Dose, Lactose Monohydrate 24.677mg Dose 
Flutikazon propionat doza od 250 µg, salmeterol doza od 50 µg, laktoza monohidrat doza od 24,677 mg
Teva Gmbh 
Njemačka Teva Gmbh
Budesonide 0,2 Mg 
Budezonid 0,2 Mg
Fluticasone Propionate 500µg Dose, Salmeterol 50µg Dose, Lactose Monohydrate 24.677mg Dose 
Flutikazon propionat doza od 500 µg, salmeterol doza od 50 µg, laktoza monohidrat doza od 24,677 mg
Astrazeneca Gmbh 
Njemačka Astrazeneca Gmbh
Abz-Pharma Gmbh 
Njemačka Abz-Pharma Gmbh
Netherlands Elpen Pharmaceutical Co. Inc. 
Nizozemska Elpen Pharmaceutical Co.
Pb Pharma Gmbh 
Njemačka Pb Pharma Gmbh
Beclometasone Dipropionate 100g/10ml 
Beklometazon dipropionat 100 g/10 ml
Budesonide 400µg 
Budezonid 400 µg
Chiesi Gmbh 
Njemačka Chiesi Gmbh
Beclometasone Dipropionate 100µg/50 µl 
Beklometazon dipropionat 100 µg/50 µl
Budesonide, Micronised 0.4mg Actuation 
Budezonid, mikronizirani 0,4 mg po aktuaciji
Cyclocaps Beclometason Beclometasone Dipropionate 400µg Units 
Cyclocaps Beclometason Beklometazon dipropionat 400 µg jedinice