natgillin/translations-raw huggingface dataset:
The most common adverse reactions following administration at usual doses are drowsiness, confusion, nausea, vomiting and constipation.
50 Najpogostejši neželeni učinki po običajnih odmerkih so zaspanost, zmedenost, slabost, bruhanje in zaprtje.
48 Respiratory depression As with all potent opioids some patients may experience respiratory depression with Fentanyl- ratiopharm, and patients must be observed for this effect.
Respiratorna depresija Fentanyl- ratiopharm lahko, tako kot drugi močni opioidi, povzroči respiratorno depresijo.
Patients with fever/ external heat Significant increases in body temperature can potentially increase fentanyl absorption rate.
51 Ob znatnem zvišanju telesne temperature se lahko poveča hitrost absorbcije fentanila.
49 Due to limited experience in children under 12 years of age, Fentanyl-ratiopharm should be used in this age group only after careful consideration has been given to the benefit versus risk ratio.
Pediatrični bolniki Zaradi omejenih izkušenj uporabe Fentanyl- ratiopharm pri otrocih mlajših od 12 let ne priporočamo, razen v primerih pazljivega ovrednotenja razmerja med koristmi in tveganji zdravljenja.
Itraconazole (a potent CYP3A4 inhibitor) at 200 mg/ day given orally for four days had no significant effect on the pharmacokinetics of intravenous fentanyl.
52 Peroralna uporaba itrakonazola (močnega zaviralca encima CYP3A4) v dnevnih odmerkih 200 mg in v trajanju 4 dni ni znatno vplivala na farmakokinetiko intravensko uporabljenega fentanila.
50 4.6 Pregnancy and lactation
Nosečnost in dojenje
respiratory depression, apnoea.
prsnega koša in mediastinalnega prostora dispneja, hipoventilacija respiratorna depresija, apneja 53
51 Very common: sweating, pruritus.
Bolezni kože in podkožja Zelo pogosti: potenje, pruritus Pogosti:
A starting dose of 0.4-2 mg naloxone hydrochloride i. v. is recommended for adults.
54 Priporočamo intravensko dajanje nalokson klorida v začetnem odmerku od 0, 4 do 2 mg (pri odraslih).
Pharmacokinetics in special groups Elderly and debilitated patients may have reduced clearance of fentanyl leading to prolonged terminal half life.
55 Farmakokinetika pri posebnih skupinah bolnikov Pri starejših in oslabelih bolnikih je očistek fentanila lahko zmanjšan; zdravilo ima zato daljšo razpolovno dobo.
53 Long-term carcinogenicity studies have not been performed.
Dolgoročnih študij kancerogenosti niso opravili.
High quantities of fentanyl remain in the transdermal patches even after use.
56 Visoke količine fentanila ostajajo v transdermalnih obližih tudi po uporabi.
55 LABELLING
57 OZNAČEVANJE
56 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
58 PODATKI NA ZUNANJI OVOJNINI
patches:]
59 [10 transdermalnih obližev:]
59 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
61 PODATKI NA NOTRANJI OVOJNINI
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
63 PODATKI NA ZUNANJI OVOJNINI
62 [10 transdermal patches:]
64 [10 transdermalnih obližev:]
64 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
66 PODATKI NA NOTRANJI OVOJNINI
SPECIAL STORAGE CONDITIONS 65 Do not store above 25 °C.
Shranjujte pri temperaturi do 25 °C.
66 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
68 PODATKI NA ZUNANJI OVOJNINI
patches:]
69 [10 transdermalnih obližev:]
69 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
71 PODATKI NA NOTRANJI OVOJNINI
70 9.
72 9.
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
73 PODATKI NA ZUNANJI OVOJNINI
patches:]
74 [10 transdermalnih obližev:]
73 10.
75 10.
74 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
76 PODATKI NA NOTRANJI OVOJNINI
76 PACKAGE LEAFLET
78 NAVODILO ZA UPORABO
WHAT Fentanyl-ratiopharm IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO FENTANYL- RATIOPHARM IN ZA KAJ GA UPORABLJAMO
BEFORE YOU USE Fentanyl-ratiopharm
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO FENTANYL - RATIOPHARM
Before starting to use Fentanyl-ratiopharm you should inform your doctor if you suffer from any of the below disorders, because the risk of side effects is higher and/ or your doctor may need to prescribe a lower dose of fentanyl.
Preden boste vzeli zdravilo Fentanyl- ratiopharm obvestite svojega zdravnika, če imate katero koli od spodaj navedenih bolezni.
- asthma, respiratory depression or any lung disease
Tveganje za pojav neželenih učinkov je večje in vam bo vaš zdravnik mogoče zmanjšal odmerek fentanila:
78
80
79 Please tell your doctor if you are taking MAO inhibitors (e. g. moclobemide against depression or selegiline against Parkinson’ s disease) or have taken them within the last 14 days.
81 Prosimo obvestite svojega zdravnika, če jemljete ali ste v zadnjih 14 dneh jemali zaviralce monoaminooksidaze (npr. moklobemid proti depresiji ali selegilin proti Parkinsonovi bolezni).
How to apply Fentanyl-ratiopharm
82 Kako uporabite obliž Fentanyl- ratiopharm
- Apply a new patch as described above but on another part of the skin.
Obliž lahko
At least 7 days should
namestite na isto mesto 7 dni po prejšnji namestitvi.
elapse before the same part is used again.
Če ste uporabili večji odmerek obližev Fentanyl- ratiopharm, kot bi smeli
81 Like all medicines, Fentanyl-ratiopharm can cause side effects, although not everybody gets them.
Kot vsa zdravila imajo lahko tudi obliži Fentanyl- ratiopharm neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
If you have been will become less develop).
84 Pri dolgotrajni uporabi obližev Fentanyl- ratiopharm se lahko zgodi, da bodo obliži Fentanyl - ratiopharm postali manj učinkoviti.
82 Do not use Fentanyl-ratiopharm after the expiry date which is stated on the package.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
3 89143 Blaubeuren Germany This medicinal product is authorised in the Member States of the EEA under the following names:
3 89143 Blaubeuren Nemčija
Austria Germany Spain France The Netherlands United Kingdom
< DE/ H/ 0740/ 01/ MR > Avstrija Nemčija Španija Francija Nizozemska Velika Britanija
83 This leaflet was last approved in {MM/ YYYY}.
Navodilo je bilo
86 Please tell your doctor if you are taking MAO inhibitors (e. g. moclobemide against depression or selegiline against Parkinson’ s disease) or have taken them within the last 14 days.
88 Prosimo obvestite svojega zdravnika, če jemljete ali ste v zadnjih 14 dneh jemali zaviralce monoaminooksidaze (npr. moklobemid proti depresiji ali selegilin proti Parkinsonovi bolezni).
How to apply Fentanyl-ratiopharm
89 Kako uporabite obliž Fentanyl- ratiopharm
88 Like all medicines, Fentanyl-ratiopharm can cause side effects, although not everybody gets them.
Kot vsa zdravila imajo lahko tudi obliži Fentanyl- ratiopharm neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
If you have been will become less develop).
91 Pri dolgotrajni uporabi obližev Fentanyl- ratiopharm se lahko zgodi, da bodo obliži Fentanyl - ratiopharm postali manj učinkoviti.
89 Do not use Fentanyl-ratiopharm after the expiry date which is stated on the package.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Austria Germany Spain France The Netherlands United Kingdom
< DE/ H/ 0740/ 02/ MR > Avstrija Nemčija Španija Francija Nizozemska Velika Britanija
90 This leaflet was last approved in {MM/ YYYY}.
Navodilo je bilo
INFORMATION FOR THE USER
93 NAVODILO ZA UPORABO
92
94
93 Please tell your doctor if you are taking MAO inhibitors (e. g. moclobemide against depression or selegiline against Parkinson’ s disease) or have taken them within the last 14 days.
95 Prosimo obvestite svojega zdravnika, če jemljete ali ste v zadnjih 14 dneh jemali zaviralce monoaminooksidaze (npr. moklobemid proti depresiji ali selegilin proti Parkinsonovi bolezni).
How to apply Fentanyl-ratiopharm
96 Kako uporabite obliž Fentanyl- ratiopharm
95 Like all medicines, Fentanyl-ratiopharm can cause side effects, although not everybody gets them.
Kot vsa zdravila imajo lahko tudi obliži Fentanyl- ratiopharm neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
If you have been will become less develop).
98 Pri dolgotrajni uporabi obližev Fentanyl- ratiopharm se lahko zgodi, da bodo obliži Fentanyl - ratiopharm postali manj učinkoviti.
96 Do not use Fentanyl-ratiopharm after the expiry date which is stated on the package.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Austria Germany Spain France The Netherlands United Kingdom
< DE/ H/ 0740/ 03/ MR > Avstrija Nemčija Španija Francija Nizozemska Velika Britanija
97 This leaflet was last approved in {MM/ YYYY}.
Navodilo je bilo
99
101
100 Please tell your doctor if you are taking MAO inhibitors (e. g. moclobemide against depression or selegiline against Parkinson’ s disease) or have taken them within the last 14 days.
102 Prosimo obvestite svojega zdravnika, če jemljete ali ste v zadnjih 14 dneh jemali zaviralce monoaminooksidaze (npr. moklobemid proti depresiji ali selegilin proti Parkinsonovi bolezni).
How to apply Fentanyl-ratiopharm
103 Kako uporabite obliž Fentanyl- ratiopharm
102 Like all medicines, Fentanyl-ratiopharm can cause side effects, although not everybody gets them.
Kot vsa zdravila imajo lahko tudi obliži Fentanyl- ratiopharm neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
If you have been will become less develop).
105 Pri dolgotrajni uporabi obližev Fentanyl- ratiopharm se lahko zgodi, da bodo obliži Fentanyl - ratiopharm postali manj učinkoviti.
103 Do not use Fentanyl-ratiopharm after the expiry date which is stated on the package.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Austria Germany Spain France The Netherlands United Kingdom
< DE/ H/ 0740/ 04/ MR > Avstrija Nemčija Španija Francija Nizozemska Velika Britanija
104 This leaflet was last approved in {MM/ YYYY}.
Navodilo je bilo
London, 23 October 2007 EMEA/ 331678/ 2007
London, 23. oktober 2007 EMEA/ 331678/ 2007
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Fentanyl-ratiopharm 25/ 50/ 75/ 100 µg/ h TTS and associated names
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29( 4) 1 ZA Fentanyl- ratiopharm 25/ 50/ 75/ 100 µg/ h TTS in z njim povezana imena
Fentanyl-ratiopharm 25/ 50/ 75/ 100 µg/ h TTS and associated names, is an opioid analgesic which is indicated in severe chronic pain which can be adequately managed only with opioid analgesics.
Fentanyl- ratiopharm 25/ 50/ 75/ 100 µg/ h TTS in z njim povezana imena so opioidni analgetiki, indicirani za hude kronične bolečine, ki jih je mogoče primerno blažiti le z opioidnimi analgetiki.
Ratiopharm GmbH submitted applications for mutual recognition of Fentanyl-ratiopharm 25/ 50/ 75/ 100 µg/ h TTS and associated names, transdermal patch on the basis of the marketing authorisation granted by Germany 04 April 2006.
Družba Ratiopharm GmbH je predložila vlogo za postopek medsebojnega priznavanja zdravila Fentanyl - ratiopharm 25/ 50/ 75/ 100 µg/ h TTS in z njim povezanih imen v obliki transdermalnega obliža na osnovi dovoljenja za promet z zdravilom, ki ga je Nemčija odobrila dne 4. aprila 2006.
During their July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Fentanyl- ratiopharm 25/ 50/ 75/ 100 µg/ h TTS and associated names, that the objections raised by France should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Med svojim zasedanjem julija 2007 je bil CHMP na podlagi vseh predloženih podatkov in znanstvene razprave v okviru Odbora mnenja, da je razmerje med koristmi in tveganji za zdravilo Fentanyl- ratiopharm 25/ 50/ 75/ 100 µg/ h TTS in z njim povezana imena ugodno, da ugovori, ki jih je imela Francija, ne bi smeli preprečiti izdaje dovoljenja za promet z zdravilom in da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo dopolniti.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, NAČINOV UPORABE ZDRAVILA IN IMETNIKOV DOVOLJENJA ZA PROMET V DRŽAVAH ČLANICAH Država članica
Intravenous use
intravensko
Solution for Injection in prefilled syringe
Raztopina za injiciranje v napolnjeni
Intravenous use
injekcijski brizgi
Solution for Injection in prefilled
Raztopina za injiciranje v napolnjeni
c/ Mendez Alvaro, 55 28045 Madrid ANNEX II
c / Mendez Alvaro, 55 28045 Madrid
syringe
DODATEK II
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA SCIENTIFIC CONCLUSIONS
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
Gadograf contains gadobutrol, a neutral macrocyclic gadolinium complex with contrast-enhancing properties, which is used for magnetic resonance imaging (MRI).
Ima lastnost izboljševanja kontrasta in se uporablja za magnetno- resonančno slikanje (MRI).
In renal pathologies, MRI techniques have become increasingly important, particularly in combination with a contrast agent that enables the assessment of different states of renal perfusion.
Ta kombinacija omogoča vrednotenje različnih stadijev perfuzije v ledvicah.
Following intravenous bolus injection of Gadograf, important information on hyper- or hypoperfusion of the organ and lesions can be obtained with MRI, which allow a better differentiation of pathological processes and the characterization of the renal mass as well as staging of renal neoplasms.
Ti podatki omogočajo boljšo diferenciacijo bolezenskih procesov, opredelitev mase v ledvicah ter razvrščanje ledvičnih neoplazem v stadije.
Gadograf consists of nonspecific, low-molecular-weight, extracellular gadolinium-chelates and is presented in the formulation l.0 mmol gadolinium/ ml and an osmolality of 1603 mosmol/ kg H2O at 37°C.
Na voljo je farmacevtska oblika z 1, 0 mmol gadolinija/ ml in osmolalnostjo 1603 mosmol/ kg H2O pri 37 °C.
Gadograf was the first paramagnetic contrast agent developed in a 1.0 molar solution thus requiring a smaller application volume in a higher dosage.
Gadograf je prvo paramagnetno kontrastno sredstvo s koncentracijo 1, 0 mol, kar omogoča manjši aplikacijski volumen pri višjih odmerkih.
Gadograf 1.0 mmol/ ml (INN gadobutrol) was approved for “ Contrast enhancement in cranial and spinal magnetic resonance imaging” (MRI) in Germany in January 2000 and subsequently in July 2001 in Spain via the mutual recognition procedure.
Gadograf 1, 0 mmol/ ml (INN gadobutrol) je bil januarja 2000 v Nemčiji odobren za „ izboljšanje kontrasta pri magnetnem resonančnem slikanju možganov in hrbtenice “, po postopku medsebojnega priznavanja pa nato julija 2001 v Španiji.
A label extension to the indication “ Contrast- enhanced Magnetic resonance angiography” (CE-MRA) followed in November 2003.
Razširitev označevanja na indikacijo „ izboljšanje kontrasta pri magnetno resonančni angiografiji “ (CE- MRA) je sledila novembra 2003.
In June 2005 a MR procedure started with Germany as the RMS for a Type II variation to add the indication of “ Contrast enhanced MRI of other body regions: liver, kidneys” and the following posology and method of administration/ dosage: “ CE-MRI of other body regions:
„ CE- MRI za druge dele telesa:
The recommended dose for adults is 0.1 mmol per kilogram body weight (mmol/ kg BW).
Priporočeni odmerek za odrasle je 0, 1 mmol na kilogram telesne mase (mmol/ kg TM).
This is equivalent to 0.1 ml/ kg BW of the 1.0 M solution”.
To je enakovredno 0, 1 ml/ kg TM 1, 0- M raztopine “.
The MRP procedure was finalised on Day 221 of the procedure on 09.05.2006 with approval of the proposed indication and inclusion of the liver and kidney imaging studies’ results under Section 5.1.
Postopek medsebojnega priznavanja je bil končan na 221. dan postopka, dne 9. maja 2006, z odobritvijo predlagane indikacije in vključitve rezultatov študij slikovnih preiskav jeter in ledvic v razdelek 5. 1.
After finalisation of the procedure the Spanish Agency for Medicines and Health Products initiated a referral for Arbitration under Article 36.1 of Directive 2001/ 83/ EC to the CHMP.
Po zaključku postopka je španska agencija za zdravila in medicinske proizvode pri Odboru za zdravila za uporabo v humani medicini (CHMP) uvedla napotitveni postopek za arbitražo po členu 36( 1) Direktive 2001/ 83/ ES.
1) The current indication does neither reflect the studied population in the two pivotal studies submitted for this variation of Gadograf nor the clinical context for which Gadograf has demonstrated to have the same diagnostic accuracy than its comparator.
1) Trenutna indikacija ne odraža niti preučevane populacije v dveh ključnih raziskavah, ki sta bili predloženi za variacijo dovoljenja za Gadograf, niti kliničnega konteksta, v katerem je bila za Gadograf dokazana enaka diagnostična natančnost kot za primerjalno zdravilo.
Moreover, the wording of the indication should also reflect the clinical context for which Gadograf has demonstrated to have the same diagnostic accuracy than its comparator, that is to correctly localise at least one malignant lesion of liver or kidney in an individual patient using combined pre- and post-contrast MR images. “ Contrast-enhanced magnetic resonance imaging (MRI) in patients with high suspicion or evidence of having a focal disease of liver or kidneys, obtained by other diagnostic tests or histopathology, to correctly localise malignant lesions of liver or kidney .”
Poleg tega mora besedilo indikacije odražati 3 tudi klinični kontekst, v katerem je bila za Gadograf dokazana enaka diagnostična natančnost kot za primerjalno zdravilo, kar pomeni pravilno lokalizacijo najmanj ene maligne lezije v jetrih ali ledvicah pri posameznem bolniku na osnovi kombiniranja kontrastiranih MRI slik pred in potem. “ Magnetno resonančno slikanje (MRI) z izboljšanim kontrastom za pravilno lokalizacijo malignih lezij v jetrih ali ledvicah pri bolnikih, pri katerih obstaja močan sum ali dokaz za fokalno bolezen jeter ali ledvic, pridobljen na osnovi drugih diagnostičnih ali histopatoloških preiskav. “
2) The requested indication cannot be approved for paediatric population aged less than 18 years since there is no data on the efficacy and safety of the use of Gadograf for contrast-enhancement MRI in this population in the submitted pivotal studies.
2) Zahtevane indikacije ni možno odobriti za otroke, mlajše od 18 let, saj v okviru predloženih ključnih raziskav niso bili zbrani podatki o učinkovitosti in varnosti uporabe zdravila Gadograf pri MRI z izboljšanim kontrastom v tej populaciji.
The MAH must include in section 4.2 the following sentence: “ Gadograf is not recommended for use in population below age 18 due to a lack of data on efficacy and safety .”
Imetnik dovoljenja za promet z zdravilom mora v poglavje 4. 2 vključiti naslednji stavek: “ Uporaba zdravila Gadograf se ne priporoča za uporabo pri populaciji mlajši od 18 let zaradi pomanjkanja podatkov o varnosti in učinkovitosti. “
The MAH is asked to provide information on the clinical utility of this product for the requested indication (directly or indirectly), according to the Points of Consider on the evaluation of diagnostic agents (CPMP/ EWP/ 1119/ 98).
3) Odbor je prosil imetnika dovoljenja za promet z zdravilom, da predloži podatke o klinični uporabnosti tega zdravila za želeno indikacijo (neposredno ali posredno) v skladu s Ključnimi vprašanji pri vrednotenju diagnostičnih sredstev (CPMP/ EWP/ 1119/ 98).
In the response the MAH acknowledges with reference to Question 1) that the patient population studied in the pivotal trials has some limitations in comparison to the overall anticipated patient population undergoing CE-MRI, but these limitations are the result of methodological requirements to adequately demonstrate the diagnostic efficacy of Gadograf-enhanced MRI in the pivotal studies.
V odgovoru se imetnik dovoljenja za promet z zdravilom glede prvega vprašanja strinja, da ima populacija, ki je bila preučena v ključnih raziskavah, nekaj omejitev v primerjavi s splošno populacijo, za katero se pričakuje uporaba CE- MRI, vendar te omejitve izvirajo iz metodoloških zahtev za zadosten dokaz diagnostične učinkovitosti uporabe zdravila Gadograf pri MRI.
With reference to Question 2) the MAH acknowledged that Gadograf has not been adequately studied for any of its approved indications (including the new indication “ contrast-enhanced MRI of liver and kidneys”) in patients aged less than 18 years.
Glede drugega vprašanja se imetnik dovoljenja za promet z zdravilom strinja, da pri otrocih, mlajših od 18 let, zdravilo Gadograf ni bilo zadostno preučeno za nobeno odobreno indikacijo (vključno z novo indikacijo „ MRI jeter in ledvic z izboljšanim kontrastom “).
Having considered the response provided by the MAH and assessed by the Rapporteurs, on 16 November 2006, the CHMP adopted a Request of Supplementary Information, in which the MAH was asked to further expand on the issue of clinical utility and to comment on a proposed wordings regarding the Indication in 4.1 and the Posology in 4.2 of the SPC.
CHMP je 16. novembra 2006 po preučitvi odgovorov, ki jih je predložil imetnik dovoljenja za promet z zdravilom in ki so jih nato preučili poročevalci, sprejel Zahtevek za dodatne informacije, v katerem imetnika dovoljenja za promet z zdravilom naproša, da dodatno obrazloži klinično uporabnost in komentira predlagano besedilo indikacije v poglavju 4. 1 in odmerjanja v poglavju 4. 2 Povzetka glavnih značilnosti zdravila (SPC).
Section 4.1 (Indication):
Poglavje 4. 1 (Indikacija):
“ Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesions to classify these lesions as benign or malignant”.
„ MRI jeter ali ledvic z izboljšanim kontrastom pri bolnikih, pri katerih obstaja močan sum ali dokaz za fokalne lezije, z namenom opredelitve benignosti ali malignosti teh lezij. “
Section 4.2 (Posology): “ Gadograf is not recommended for use in population below age 18 due to a lack of data on efficacy and safety .” 4.
Poglavje 4. 2 (Odmerjanje): “ Uporaba zdravila Gadograf se ne priporoča za uporabo pri populaciji mlajši od 18 let zaradi pomanjkanja podatkov o varnosti in učinkovitosti. “
Since the issue of clinical utility was satisfactorily addressed and the MAH agreed to the proposed wording, the CHMP is of the opinion that the data provided allow the conclusion that, on basis of the pivotal clinical studies comparing Gadograf-enhanced with Magnevist-enhanced MRI, diagnostic efficacy of Gadograf for the classification of focal liver or renal lesions as benign or malignant, as well as clinical safety of Gadograf has been adequately established.
4 Ker je bilo vprašanje klinične uporabnost zadovoljivo obravnavano in se imetnik dovoljenja za promet z zdravilom strinja s predlaganim besedilom, CHMP meni, da lahko na osnovi predloženih podatkov zaključi, da je ob upoštevanju ključnih kliničnih raziskav primerjave MRI, katerega kontrast je izboljšan z zdravilom Gadograf, in MRI, katerega kontrast je izboljšan z zdravilom Magnevist, zadostno dokazana diagnostična učinkovitost zdravila Gadograf za opredelitev benignosti ali malignosti fokalnih jetrnih ali ledvičnih lezij ter klinična varnost tega zdravila.
The MAH has updated SPC sections 4.1 and 4.2 in accordance with the requests of the CHMP.
Imetnik dovoljenja za promet z zdravilom je popravil poglavji 4. 1 in 4. 2 v Povzetku glavnih značilnosti zdravila skladno z zahtevami CHMP.
Whereas,
Ob upoštevanju, da
- the Committee considered the referral made under Article 36(1) of Directive 2001/ 83/ EC, as
- je Odbor upošteval napotitveni postopek v skladu s členom 36( 1) Direktive 2001/ 83/ ES, kot je bila
amended for Gadograf detailed in Annex I;
spremenjena, za zdravilo Gadograf in z njim povezana imena, ki so navedena v Dodatku I;
- the CHMP recommended that the following additional indication: “ Contrast enhanced
„ MRI jeter ali