FrancophonIA/ELRC3.0 huggingface dataset:
English: Powder: glycine disodium hydrogen phosphate heptyhydrate sodium dihydrogen phosphate dihydrate
Croatian: glicin dinatrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat
English: Omnitrope 15 mg/1.5 ml in a cartridge for SurePal 15 is intended for multiple use.
Croatian: Omnitrope 15 mg/1,5 ml u ulošku za SurePal 15 je namijenjen za višekratnu upotrebu.
English: 0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day.
Croatian: 0,035 mg/kg tjelesne težine na dan ili 1,0 mg/m2 površine tijela na dan.
English: 0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 body surface area per day.
Croatian: 0,045-0,050 mg/kg tjelesne težine na dan ili 1,4 mg/m2 površine tijela na dan.
English: What Omnitrope 10 mg/1.5 ml contains
Croatian: Što Omnitrope 10 mg/1,5 ml sadrži
English: • Leukaemia (This has been reported in a small number of growth hormone deficiency patients,
Croatian: • leukemija (bila je prijavljena u malog broja bolesnika s nedostatkom hormona rasta, od kojih su neki bili liječeni somatropinom.
English: • Your doctor should examine your kidney function and your growth rate before starting somatropin.
Croatian: • Prije primjene somatropina liječnik mora ispitati bubrežnu funkciju i stopu rasta.
English: Musculoskeletal, Connective Tissue and Bone Disorders
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva artralgija*
English: A subcutaneous dose of 5 mg of Omnitrope 5 mg/1.5 ml solution for injection in healthy adults results in plasma Cmax and tmax values of 72 ± 28 µg/l and 4.0 ± 2.0 hours, respectively.
Croatian: Supkutana doza od 5 mg Omnitrope 5 mg/1,5 ml otopine za injekciju u zdravih odraslih osoba rezultira plazmatskim vrijednostima Cmax i tmax od 72 ± 28 µg/l, odnosno 4,0 ± 2,0 sata.
English: A subcutaneous dose of 5 mg of Omnitrope 15 mg/1.5 ml solution for injection in healthy adults results in plasma Cmax and tmax values of 52 ± 19 µg/l and 3.7 ± 1.2 hours, respectively.
Croatian: Supkutana doza od 5 mg Omnitrope 15 mg/1,5 ml otopine za injekciju u zdravih odraslih osoba rezultira plazmatskim vrijednostima Cmax i tmax od 52 ± 19 µg/l, odnosno 3,7 ± 1,2 sata.
English: Omnitrope 15 mg/1.5 ml solution for injection disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate sodium chloride poloxamer 188 phenol water for injections
Croatian: Omnitrope 15 mg/1,5 ml otopina za injekciju dinatrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat natrijev klorid poloksamer 188 fenol voda za injekcije
English: Common side effects (likely to occur in fewer than 1 in 10 patients) include:
Croatian: Česte nuspojave (vjerojatnost javljanja u manje od 1 na 10 bolesnika) obuhvaćaju:
English: Injecting Omnitrope
Croatian: Injiciranje Omnitropea
English: Omnitrope 5 mg/1.5 ml solution for injection disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate mannitol poloxamer 188 benzyl alcohol water for injections
Croatian: Omnitrope 5 mg/1,5 ml otopina za injekciju dinatrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat manitol poloksamer 188 benzilni alkohol voda za injekcije
English: Omnitrope 5 mg/1.5 ml solution for injection Each ml of solution contains 3.3 mg of somatropin* (corresponding to 10 IU) One cartridge contains 1.5 ml corresponding to 5 mg somatropin* (15 IU).
Croatian: Omnitrope 5 mg/1,5 ml otopina za injekciju Jedan ml otopine sadrži 3,3 mg somatropina* (što odgovara vrijednosti od 10 IU).
English: Paraesthesia* Carpal Tunnel Syndrome
Croatian: Poremećaji živčanog sustava parestezija* sindrom karpalnog tunela benigna intrakranijalna hipertenzija
English: Omnitrope 10 mg/1.5 ml solution for injection disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol water for injections
Croatian: Omnitrope 10 mg/1,5 ml otopina za injekciju dinatrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat glicin poloksamer 188 fenol voda za injekcije
English: It should only be administered with the Omnitrope Pen L, an injection device specifically developed for use with Omnitrope 5 mg/ml reconstituted solution for injection.
Croatian: Smije se primjenjivati samo pomoću brizgalice Omnitrope Pen L, medicinskog proizvoda posebno izrađenog za primjenu Omnitrope 5 mg/ml rekonstituirane otopine za injekciju.
English: A subcutaneous dose of 5 mg of Omnitrope 10 mg/1.5 ml solution for injection in healthy adults results in plasma Cmax and tmax values of 74 ± 22 µg/l and 3.9 ± 1.2 hours, respectively.
Croatian: Supkutana doza od 5 mg Omnitrope 10 mg/1,5 ml otopine za injekciju u zdravih odraslih osoba rezultira plazmatskim vrijednostima Cmax i tmax od 74 ± 22 µg/l, odnosno od 3,9 ± 1,2 sata.
English: What Omnitrope 15 mg/1.5 ml contains
Croatian: Što Omnitrope 15 mg/1,5 ml sadrži
English: Myalgia* Musculoskel etal stiffness*
Croatian: mialgija* mišićno-koštana ukočenost*
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS OMNITROPE VIAL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE OZNAKA NA ULOŠKU S OTAPALOM
English: Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, glycine, poloxamer 188, phenol, water for injections.
Croatian: Pomoćne tvari: dinatrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat dihidrat, glicin, poloksamer 188, fenol, voda za injekcije.
English: INFORMATION IN BRAILLE Omnitrope 15 mg/1.5 ml
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Omnitrope 15 mg/1,5 ml
English: Omnitrope 15 mg/1.5 ml solution for injection Each ml of solution contains 10 mg of somatropin* (corresponding to 30 IU) One cartridge contains 1.5 ml corresponding to 15 mg somatropin* (45 IU).
Croatian: Omnitrope 15 mg/1,5 ml otopina za injekciju Jedan ml otopine sadrži 10 mg somatropina* (što odgovara vrijednosti od 30 IU).
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 5 mg/ml powder and solvent for solution for injection Somatropin
Croatian: Omnitrope 5 mg/ml prašak i otapalo za otopinu za injekciju somatropin
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 1.3 mg/ml powder and solvent for solution for injection Somatropin
Croatian: Omnitrope 1,3 mg/ml prašak i otapalo za otopinu za injekciju somatropin
English: Omnitrope 5 mg/1.5 ml in a cartridge for SurePal 5 is intended for multiple use.
Croatian: Omnitrope 5 mg/1,5 ml u ulošku za SurePal 5 je namijenjen za višekratnu upotrebu.
English: What Omnitrope 5 mg/1.5 ml contains
Croatian: Što Omnitrope 5 mg/1,5 ml sadrži
English: Omnitrope 10 mg/1.5 ml solution for injection
Croatian: Omnitrope 10 mg/1,5 ml otopina za injekciju
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 5 mg/ml powder for solution for injection Somatropin
Croatian: NAZIV LIJEKA I PUT PRIMJENE LIJEKA Omnitrope 5 mg/ml prašak za otopinu za injekciju somatropin s.c.
English: It should only be administered with the Omnitrope Pen 5, an injection device specifically developed for use with Omnitrope 5 mg/1.5 ml solution for injection.
Croatian: Smije se primjenjivati samo pomoću brizgalice Omnitrope Pen 5, medicinskog proizvoda posebno izrađenog za primjenu Omnitrope 5 mg/1,5 ml otopine za injekciju.
English: INFORMATION IN BRAILLE Omnitrope 10 mg/1.5 ml
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Omnitrope 10 mg/1,5 ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 1.3 mg/ml powder for solution for injection Somatropin
Croatian: NAZIV LIJEKA I PUT PRIMJENE LIJEKA Omnitrope 1,3 mg/ml prašak za otopinu za injekciju somatropin s.c.
English: One cartridge contains 1.5 ml corresponding to 15 mg somatropin (45 IU).
Croatian: Jedan uložak sadrži 1,5 ml što odgovara količini od 15 mg somatropina (45 IU).
English: Other ingredients: disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, poloxamer 188, phenol, water for injections.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: dinatrijev hidrogenfosfat heptahidrat, natrijev dihidrogenfosfat dihidrat, natrijev klorid, poloksamer 188, fenol, voda za injekcije.
English: Children with chronic renal (kidney) insufficiency:
Croatian: Djeca s kroničnom insuficijencijom bubrega:
English: Uncommo n ≥ 1/1,000 to < 1/100
Croatian: Često ≥ 1/100 i
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial of 1.3 mg powder
Croatian: 1 bočica s 1,3 mg praška
English: - The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate mannitol poloxamer 188 benzyl alcohol water for injections
Croatian: Drugi sastojci su: dinatrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat manitol poloksamer 188 benzilni alkohol voda za injekcije
English: Growth disturbance in chronic renal insufficiency A dose of 0.045 - 0.050 mg/kg body weight per day (1.4 mg/m2 body surface area per day) is recommended.
Croatian: Preporučuje se doza od 0,045 - 0,050 mg/kg tjelesne težine na dan (1,4 mg/m2 tjelesne površine na dan).
English: Omnitrope 10 mg/1.5 ml solution for injection EU/1/06/332/007
Croatian: Omnitrope 10 mg/1,5 ml otopina za injekciju EU/1/06/332/007
English: The treatment should be discontinued at renal transplantation.
Croatian: U slučaju transplantacije bubrega liječenje se mora prekinuti.
English: One cartridge contains 1.5 ml corresponding to 5 mg somatropin (15 IU).
Croatian: Jedan uložak sadrži 1,5 ml što odgovara količini od 5 mg somatropina (15 IU).
English: Omnitrope 1.3 mg/ml powder and solvent for solution for injection
Croatian: Omnitrope 1,3 mg/ml prašak i otapalo za otopinu za injekciju
English: - The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate sodium chloride poloxamer 188 phenol water for injections
Croatian: Drugi sastojci su: dinatrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat natrijev klorid poloksamer 188 fenol voda za injekcije
English: Thyroid function
Croatian: Funkcija štitnjače
English: - The other ingredients are: disodium hydrogen phosphate heptahydrate sodium dihydrogen phosphate dihydrate glycine poloxamer 188 phenol water for injections
Croatian: Drugi sastojci su: dinatrijev hidrogenfosfat heptahidrat natrijev dihidrogenfosfat dihidrat glicin poloksamer 188 fenol voda za injekcije
English: INFORMATION IN BRAILLE Omnitrope 5 mg/1.5 ml
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Omnitrope 5 mg/1,5 ml
English: It should only be administered with SurePal 10, an injection device specifically developed for use with Omnitrope 10 mg/1.5 ml solution for injection.
Croatian: Smije se primjenjivati samo pomoću brizgalice SurePal 10, medicinskog proizvoda posebno izrađenog za primjenu Omnitrope 10 mg/1,5 ml otopine za injekciju.
English: Clinical trials in children with chronic renal insufficiency Table 3
Croatian: Klinička ispitivanja u djece s deficitom hormona rasta Tablica 1
English: Omnitrope 5 mg/ml powder and solvent for solution for injection
Croatian: Omnitrope 5 mg/ml prašak i otapalo za otopinu za injekciju
English: Metabolism and Nutrition Disorders
Croatian: Poremećaji metabolizma i prehrane dijabetes melitus tipa II
English: Omnitrope 1.3 mg/ml is supplied in a vial containing the active substance as a powder and the solvent filled in a vial for single use.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Omnitrope 1,3 mg/ml se isporučuje u bočici koja sadrži djelatnu tvar u obliku praška i s otapalom u bočici za jednokratnu upotrebu.
English: Use only with Omnitrope Pen L. Read package leaflet before use.
Croatian: Koristiti samo uz SurePal 5. Prije uporabe pročitajte Uputu o lijeku.
English: It should only be administered with SurePal 15, an injection device specifically developed for use with Omnitrope 15 mg/1.5 ml solution for injection.
Croatian: Smije se primjenjivati samo pomoću brizgalice SurePal 15, medicinskog proizvoda posebno izrađenog za primjenu Omnitrope 15 mg/1,5 ml otopine za injekciju.
English: Omnitrope 15 mg/1.5 ml solution for injection EU/1/06/332/010
Croatian: Omnitrope 15 mg/1,5 ml otopina za injekciju EU/1/06/332/010
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/016
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/332/016
English: Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/004
Croatian: Omnitrope 5 mg/1,5 ml otopina za injekciju EU/1/06/332/004
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/013
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/332/013
English: Omnitrope 5 mg/1.5 ml solution for injection EU/1/06/332/013
Croatian: Omnitrope 5 mg/1,5 ml otopina za injekciju EU/1/06/332/013
English: Powder in a vial (type I glass) with a stopper (fluor-resin laminated butyl rubber), a strip (aluminium) and a cap (violet polypropylene flip-off), and 1 ml of solvent in a vial (type I glass) with a stopper (fluor-resin laminated chlorobutyl elastomer), a strip (lacquered aluminium) and a cap (white polypropylene flip-off).
Croatian: (klorobutilni elastomer laminiran smolom fluora), dvoslojnica/strip (lakirani aluminij) i zatvarač (bijeli polipropilenski „flip-off“).
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/007
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/332/007
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/010
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/332/010
English: Prader-Willi syndrome, for improvement of growth and body composition in paediatric patients Generally a dose of 0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day is recommended.
Croatian: Djeca s Prader-Willijevim sindromom: 0,035 mg/kg tjelesne težine na dan ili 1,0 mg/m2 površine tijela na dan.
English: Therefore caution should be exercised when Omnitrope is administered to breast-feeding women.
Croatian: Stoga je prilikom primjene Omnitropea kod dojilja potreban oprez.
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 10 mg/1.5 ml solution for injection Somatropin
Croatian: Omnitrope 10 mg/1,5 ml otopina za injekciju somatropin
English: - SurePal, an injection device specifically developed for use with
Croatian: - SurePal, medicinski proizvod posebno izrađen za primjenu uz Omnitrope otopinu za injekciju (nije isporučeno u pakovanju;
English: It should only be administered with SurePal 5, an injection device specifically developed for use with Omnitrope 5 mg/1.5 ml solution for injection.
Croatian: Smije se primjenjivati samo pomoću brizgalice SurePal 5, medicinskog proizvoda posebno izrađenog za primjenu Omnitrope 5 mg/1,5 ml otopine za injekciju.
English: Paraesthesia
Croatian: Doziranje
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 15 mg/1.5 ml solution for injection Somatropin
Croatian: Omnitrope 15 mg/1,5 ml otopina za injekciju somatropin
English: Measuring the dose of Omnitrope to be injected - Take the sterile, disposable syringe of appropriate size (e.g. 1 ml syringe) and injection needle (e.g. 0.25 mm x 8 mm).
Croatian: štrcaljku od 1 ml) i iglu za injekcije (npr. 0,25 mm x 8 mm).
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/332/004
English: If you get any side effects, talk to your doctor or pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika ili medicinsku sestru.
English: The manufacturer's instructions with each pen must be followed for loading the cartridge, attaching the injection needle and for the administration.
Croatian: Prilikom umetanja uloška, pričvršćivanja injekcijske igle i primjene nužno je pridržavanje uputa proizvođača za svaku brizgalicu.
English: Fertility studies with Omnitrope have not been performed.
Croatian: Nisu provedena ispitivanja utjecaja Omnitropea na plodnost.
English: Each ml of solution contains 3.3 mg of somatropin (corresponding to 10 IU) One cartridge contains 5.0 mg (corresponding to 15 IU) of somatropin in 1.5 ml.
Croatian: Jedan uložak sadrži 10,0 mg (što odgovara vrijednosti od 30 IU) somatropina u 1,5 ml.
English: NAME OF THE MEDICINAL PRODUCT Omnitrope 5 mg/1.5 ml solution for injection Somatropin
Croatian: Omnitrope 5 mg/1,5 ml otopina za injekciju somatropin
English: Children with chronic renal (kidney) insufficiency
Croatian: Djeca s kroničnom insuficijencijom bubrega
English: MARKETING AUTHORISATION NUMBERS EU/1/06/332/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/332/002
English: Somatropin induces the retention of sodium, potassium and phosphorus.
Croatian: Somatropin potiče zadržavanje natrija,
English: To setup the pen dial the dose.
Croatian: Da biste podesili brizgalicu,
English: MARKETING AUTHORISATION NUMBER EU/1/06/332/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/332/001
English: Growth disturbance due to insufficient secretion of growth hormone in paediatric patients Generally a dose of 0.025 - 0.035 mg/kg body weight per day or 0.7 - 1.0 mg/m2 body surface area per day is recommended.
Croatian: Djeca s nedostatkom hormona rasta: 0,025-0,035 mg/kg tjelesne težine na dan ili 0,7-1,0 mg/m2 površine tijela na dan.
English: • If you have raised intracranial pressure (which causes symptoms, such as strong headache, visual disturbances or vomiting) you should inform your doctor about it.
Croatian: • povišen intrakranijalni tlak (koji uzrokuje simptome, kao što su jake glavobolje, poremećaji vida ili povraćanje) • bolovi u mišićima
English: Musculoskeletal , Connective Tissue and Bone Disorders
Croatian: Poremećaji mišićno koštanog sustava i vezivnog tkiva artralgija* mialgija*
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 10 mg/1.5 ml Injection
Croatian: NAZIV LIJEKA I PUT PRIMJENE LIJEKA Omnitrope 10 mg/1,5 ml injekcija somatropin s.c.
English: 8°C in the original package.
Croatian: utvrđena je stabilnost u primjeni do 24 sata pri 2 °C-8 °C u originalnom pakiranju.
English: Omnitrope 10 mg/1.5 ml solution for injection is for use in SurePal 10 only.
Croatian: Omnitrope 10 mg/1,5 ml otopine za injekciju postiže se poluvijek od 3 sata.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 15 mg/1.5 ml Injection
Croatian: NAZIV LIJEKA I PUT PRIMJENE LIJEKA Omnitrope 15 mg/1,5 ml injekcija somatropin s.c.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Omnitrope 5 mg/1.5 ml Injection
Croatian: NAZIV LIJEKA I PUT PRIMJENE LIJEKA Omnitrope 5 mg/1,5 ml injekcija somatropin s.c.
English: After the needle is in, remove the hand used to pinch the skin and use it to hold the syringe barrel.
Croatian: otpustite nabor kože između prstiju i tom rukom primite tijelo štrcaljke.
English: Whereas
Croatian: Kakvoća
English: Particularly the endpoint of main interest which is pain.
Croatian: Posebice krajnju točku od glavnog interesa, odnosno bol.
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC,
Croatian: • Odbor je razmotrio arbitražni postupak u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ.
English: The difference in median VAS score was 8 mm at day 3-4 and 4.6mm at day 7-8.
Croatian: Razlika u srednjoj vrijednosti VAS-a iznosila je 8 mm za 3. i 4. dan te 4,6 mm za 7. i 8. dan.
English: An effect was seen on the critical secondary endpoint of spontaneous pain visual analogue scale (VAS).
Croatian: Primijećen je učinak na kritičnu sekundarnu krajnju točku vizualne analogne ljestvice vizualne boli (VAS).
English: The product information remains as per the final version achieved during the Coordination group procedure as mentioned in Annex III of the CHMP opinion.
Croatian: Informacije o lijeku ostaju u skladu sa završnom verzijom donesenom tijekom postupka Koordinacijske grupe kako je navedeno u Prilogu III. mišljenja CHMP-a.
English: • The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as a potential serious risk to public health.
Croatian: • Odbor je razmotrio ukupne podatke koje je podnositelj zahtjeva dostavio imajući u vidu primjedbe navedene kao potencijalne ozbiljne rizike po javno zdravlje.
English: The study was designed and powered to demonstrate superiority with a significant level of 5% one-sided, but the current requirement is now that a significance level of 2.5% one-sided, which the study could not reach.
Croatian: Ispitivanje je osmišljeno i pokrenuto da bi se pokazala nadmoćnost uz razinu značajnosti od 5 % za jednostrano ispitivanje, ali trenutačni zahtjev jest razina značajnosti od 2,5 % za jednostrano ispitivanje, a taj zahtjev ispitivanje nije ispunilo.
English: However, this study cannot be considered to provide confirmatory evidence on efficacy of Spraygel as the primary endpoint is not validated and statistical analysis does not meet regulatory requirements.
Croatian: No, ovo ispitivanje ne pruža nepobitne dokaze o učinkovitosti lijeka Spraygel jer primarna krajnja točka nije potvrđena, a statistička analiza ne ispunjava regulatorne zahtjeve.
English: The qualitative comparison is based on composition, degree of ionization and complete solubility of active substance.
Croatian: Usporedba kakvoće temelji se na sastavu, stupnju ionizacije i potpunoj topivosti djelatne tvari.
English: MIKA Pharma GmbH requested that the marketing authorisation for Diclofenac Sodium Spray Gel 4% granted by the UK in 2001, and subsequently granted by Austria, Estonia, Hungary, Ireland, Latvia, Lithuania and Slovenia, be also recognised in Germany, Italy and Spain as part of a “second wave” Mutual recognition procedure (MRP).
Croatian: Tvrtka MIKA Pharma GmbH zatražila je da odobrenje za puštanje lijeka u promet za Diclofenac Sodium Spray Gel 4 % koje je izdala Ujedinjena Kraljevina (UK) 2001., a nakon toga i Austrija, Estonija, Mađarska, Irska, Latvija, Litva i Slovenija, bude priznato i u Njemačkoj, Italiji i Španjolskoj u „drugom valu” postupka o uzajamnom prepoznavanju (MRP).
English: Clinical Pharmacology
Croatian: Klinička farmakologija
English: The application subject to this referral therefore concerns a repeat-use mutual recognition procedure (UK-H-0563-001-E-002) for Diclofenac sodium 4% cutaneous spray, solution (PL 18017/0006) with UK as RMS and which involves Italy, Spain, Germany as Concerned Member States.
Croatian: Predmet prijave ovog upućivanja stoga se odnosi na ponovljenu upotrebu postupka uzajamnog prepoznavanja (UK-H-0563-001-E-002) za lijek Diclofenac sodium 4% za kožnu primjenu (PL 18017/0006), pri čemu je UK referentna država članica, a postupak uključuje Italiju, Španjolsku i Njemačku kao predmetne države članice.
English: However, the systemic exposure is low enough that the adverse event profile seen with oral or other systemically administered NSAIDs is not problematic.
Croatian: No, sustavna je izloženost dovoljno niska da profil nuspojava koji je primijećen u NSAID-ova za oralnu ili drugu sustavnu primjenu nije problematičan.
English: • The Committee was of the view that the totality of data submitted justified the efficacy of the applied medicinal product as well as the bridging to the literature, in particular to existing data on topical diclofenac formulations including Voltarol Emulgel formulations.
Croatian: • Odbor smatra da svi podneseni podatci opravdavaju učinkovitost primijenjenog lijeka, kao i upućivanje na literaturu, posebno u pogledu formulacija diklofenaka za lokalnu primjenu, uključujući formulacije Voltarol Emulgel.
English: The plasma and tissue pharmacokinetic (PK) data of SprayGel in healthy volunteers, and patients with acute inflammation, are compared to those of Voltaren Sodium Gel and Voltaren Emulgel.
Croatian: Farmakokinetički podatci za plazmu i tkivo za SprayGel u zdravih dobrovoljaca i bolesnika s akutnom upalom uspoređeni su s podatcima bolesnika koji su primali Voltaren Sodium Gel i Voltaren Emulgel.
English: Numerically, the exposure of Spraygel is lower than Emulgel and its impact on efficacy cannot be ascertained accurately.
Croatian: Brojčana izloženost lijeka Spraygel niža je od izloženosti lijeka Emulgel te se njegov učinak na učinkovitost ne može sigurno procijeniti.