FrancophonIA/ELRC3.0 huggingface dataset:
English: In animal studies repeated dosing of gadobutrol only at maternally toxic dose levels (8 to 17 times the diagnostic dose) caused retardation of the embryonal development and embryolethality but no teratogenicity.
Slovenian: V študijah na živalih je ponavljajoče dajanje gadobutrola le v maternalno toksičnih odmerkih (8 do 17-kratni diagnostični odmerek) upočasnilo embrionalni razvoj in povzročiloembrioletalnost, ni pa imelo teratogenih učinkov.
English: Gadograf may cause local pain lasting up to several minutes if it is injected beside the vein.
Slovenian: Zdravilo Gadograf povzroči več minut trajajočo lokalno bolečino, če se injicira poleg vene.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Therefore, the possibility that Gadograf may cause torsade de pointes arrhythmias in an individual patient can not be excluded.
Slovenian: Torej možnosti, da zdravilo Gadograf lahko pri posameznih bolnikih povzroči aritmije torsade de pointes, ni mogoče izključiti.
English: What GADOGRAF looks like and contents of the pack
Slovenian: Izgled zdravila GADOGRAF in vsebina pakiranja
English: Gadograf is not recommended for use in population below age 18 due to a lack of data on efficacy and safety.
Slovenian: Uporaba zdravila Gadograf se ne priporoča za uporabo pri populaciji mlajši od 18 let zaradi pomanjkanja podatkov o varnosti in učinkovitosti.
English: • Adults
Slovenian: • Odmerjanje • Odrasli
English: Due to potential effects of Gadograf on cardiac repolarization in cases of overdose, disturbances of cardiac rhythm may be possible.
Slovenian: Ker Gadograf lahko vplivana repolarizacijo srca, so v primeru prevelikega odmerjanjaq možne motnje srčnega ritma.
English: Gadograf should only be administered by physicians experienced in the field of clinical MRI practice.
Slovenian: Zdravilo Gadograf sme dajati samo zdravnik z izkušnjami na področju klinične uporabe MRI.
English: The contrast-enhancing effect is mediated by gadobutrol, the nonionic complex consisting of gadolinium(III) and the macrocyclic ligand dihydroxy-hydroxymethylpropyl-tetraazacyclododecane-triacetic acid (butrol).
Slovenian: Povečanje kontrasta povzroči gadobutrol, neionski kompleks, sestavljen iz gadolinija (III) in makrocikličnega liganda dihidroksi-hidroksimetilpropil-tetraazaciklododekan-triocetne kisline (butrola).
English: Further to the approval Spain raised a major objection related to the wording of the indication as Spain considered that the approved indication neither reflected 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.
Slovenian: Kljub odobritvi je Španija predložila pomemben ugovor glede besedila indikacije, saj Španija meni, da odobrena 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.
English: The CHMP has recommended the variation (extension of indication) of the Marketing Authorisation in accordance with the Summary of Product Characteristics set out in Annex III for Gadograf (see Annex I).
Slovenian: CHMP je za Gadograf in z njim povezana imena (glejte Dodatek I) priporočil variacijo (razširitev indikacije) dovoljenja za promet z zdravilom v skladu s Povzetkom glavnih značilnosti zdravila, opredeljenim v Dodatku III.
English: Take special care with GADOGRAF - if you suffer or have suffered from allergy (e.g. hay fever, hives) or asthma - if you had a previous reaction to contrast media - if you have a very poor kidney function - if you have a serious disease of the heart and blood vessels - if you suffer from low potassium levels - if you, or someone in your family, has ever had problems with the electrical rhythm of the heart (long
Slovenian: Bodite posebno pozorni pri uporabi zdravila GADOGRAF - če imate ali ste imeli alergijo (na primer seneni nahod ali koprivnico) ali astmo; - če ste v preteklosti imeli reakcije na kontrastna sredstva; - če imate oslabele ledvice; - če imate resno bolezen srca ali krvnih žil; - če imate nizko raven kalija; - če ste vi ali kdo v vaši družini imeli težave z električnim ritmom srca (sindrom dolgega intervala QT); - če ste kadar koli po jemanju zdravil imeli spremembe srčnega ritma ali hitrosti utripa; - če imate bolezni možganov z epileptičnimi napadi, ki izvirajo iz drugih bolezni živčevja.
English: On paravascular injection Gadograf may cause tissue pain lasting up to several minutes.
Slovenian: Pri paravaskularnem injiciranju lahko zdravilo Gadograf povzroči več minut trajajočo bolečino v tkivu.
English: Max-Dohrn-Strasse 10 D-10589 Berlin
Slovenian: D-10589 Berlin
English: 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.
Slovenian: 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.
English: Do not use GADOGRAF - if you are allergic (hypersensitive) to gadobutrol or any of the other ingredients of
Slovenian: Ne uporabljajte zdravila GADOGRAF - če ste alergični na (preobčutljivi za) gadobutrol ali katerokoli sestavino zdravila Gadograf (glejte "Kaj vsebuje zdravilo Gadograf").
English: 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.
Slovenian: 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.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature.
Slovenian: Dokazano je bilo, da je raztopina pri sobni temperaturi stabilna 24 ur.
English: Gadograf is injected by a doctor via a small needle into a vein.
Slovenian: Zdravilo Gadograf zdravnik injicira z majhno iglo v veno.
English: Delayed anaphylactoid reactions (after hours to days) have been observed rarely (see section 4.4).
Slovenian: Redko so opazili pozne anafilaktoidne reakcije (po več urah ali dneh) (glejte poglavje 4.4).
English: 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.
Slovenian: 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“).
English: Osmolality at 37°C: 1603 mOsm/kg H2O Viscosity at 37°C: 4.96 mPa·s
Slovenian: Osmolalnost pri 37 °C: 1603 mOsm/kg H2O
English: Important information about some of the ingredients of GADOGRAF This medicinal product contains less than 1 mmol sodium (23 mg) per dose (based on the average amount given to a 70 kg person), i.e. essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek (na podlagi povprečne količine, ki se daje osebi, ki tehta 70 kg), kar v bistvu pomeni "brez natrija".
English: 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.”
Slovenian: 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.“
English: In case of an overdose, Gadograf can be removed from the body by extracorporeal dialysis.
Slovenian: Pri prevelikem odmerjanju se lahko zdravilo Gadograf odstrani iz telesa z zunajtelesno dializo.
English: Cardiovascular safety pharmacology studies as well as clinical phase I studies gave indication for a potential of Gadograf to block cardiac potassium channels and an effect on cardiac repolarization when administered in doses 3 to 8fold higher than normally administered to patients.
Slovenian: Farmakološke študije kardiovaskularne varnosti in klinične študije I. faze so pokazale, da lahko zdravilo Gadograf pri odmerkih, ki so 3- do 8-krat večji od odmerkov, ki se po navadi uporabljajo pri bolnikih, zavre kalijeve kanale v srcu in vpliva na repolarizacijo srca.
English: HOW TO USE GADOGRAF
Slovenian: KAKO UPORABLJATI ZDRAVILO GADOGRAF
English: Do not use Gadograf after the expiry date which is stated on the label after EXP.
Slovenian: Zdravila Gadograf ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: After opening of the infusion bottle under aseptic conditions Gadograf remains stable for at least 8 hours at room temperature.
Slovenian: Naslednja izjava velja za uporabo infuzijske steklenice, ki vsebuje 65 ml: Po odprtju infuzijske steklenice v aseptičnih pogojih ostane zdravilo Gadograf stabilno vsaj 8 ur pri sobni temperaturi.
English: 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.”
Slovenian: 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.“
English: Imaging of >1 field of view (FOV): 15 ml for body weight below 75 kg; 20 ml for body weight of 75 kg and higher (corresponding to 0.2-0.3 mmol/kg BW).
Slovenian: Slikanje > 1 vidnega polja (VP): 15 ml za telesno maso pod 75 kg; 20 ml za telesno maso 75 kg ali več (kar ustreza 0,2-0,3 mmol/kg TM).
English: Gadograf is a contrast medium for magnetic resonance imaging (MRI) of the brain, spine, vessels, liver and kidneys.
Slovenian: KAJ JE ZDRAVILO GADOGRAF IN ZA KAJ GA UPORABLJAMO Zdravilo Gadograf je kontrastno sredstvo za magnetnoresonančno slikanje (MRI - magnetic resonance imaging) možganov, hrbtenjače, žil, jeter in ledvic.
English: Gadograf should not be prepared until immediately before use.
Slovenian: Zdravilo Gadograf smete pripraviti tik pred uporabo.
English: A total amount of 0.3 millilitres Gadograf per kg body weight may be administered at maximum.
Slovenian: Največ se lahko uporabi skupno 0,3 mililitre zdravila Gadograf na kg telesne mase.
English: Delayed allergy-like reactions, hours to several days after the administration of Gadograf, have been observed in rare cases.
Slovenian: V redkih primerih so v več urah do več dneh po uporabi zdravila Gadograf opazili zapoznele reakcije, podobne alergijam.
English: In patients with an allergic disposition the decision to use Gadograf must be made after particularly careful evaluation of the risk-benefit ratio.
Slovenian: Pri bolnikih, ki so nagnjeni k alergijskim reakcijam, je treba pred uporabo zdravila Gadograf posebno pozorno oceniti razmerje tveganja in koristi.
English: Gadograf will be administered immediately before your MRI examination.
Slovenian: Zdravilo Gadograf vam bodo dali neposredno pred preiskavo MRS.
English: Since contrast medium elimination is delayed in patients with severely impaired renal function, the benefits must be weighed very carefully against the risks in such cases.
Slovenian: Pri bolnikih s hudo ledvično okvaro je izločanje kontrastnega sredstva upočasnjeno, zato je treba v takih primerih pozorno pretehtati razmerja koristi in tveganja.
English: - The other ingredients are calcobutrol sodium, trometamol, hydrochloric acid and water for injections
Slovenian: - Pomožne snovi so natrijev kalkobutrol, trometamol, klorovodikova kislina in voda za injekcije.
English: The increase of sensitivity from precontrast to combined pre and postcontrast MRI for Gadograf-treated patients was 33% in the liver study (patient-based analysis) and 18% in the kidney study (patient-based analysis as well as lesion-based analysis).
Slovenian: Povečanje občutljivosti od predkontrastnega do kombiniranega pred- in pokontrastnega slikanja z magnetno resonanco je bila pri bolnikih, ki so prejemali zdravilo Gadograf, 33 % v študiji na jetrih (analiza na temelju števila bolnikov) in 18 % v študiji na ledvicah (analiza na temelju števila bolnikov in analiza na temelju števila lezij).
English: In its response the MAH addressed the issue of clinical utility by comparing Gadograf-enhanced with Magnevist-enhanced MRI and underlined the diagnostic efficacy of Gadograf.
Slovenian: V svojem odgovoru je imetnik dovoljenja za promet z zdravilom odgovoril na vprašanje o klinični uporabnost s primerjavo MRI, katerega kontrast je izboljšan z zdravilom Gadograf, in MRI, katerega kontrast je izboljšan z zdravilom Magnevist.
English: What GADOGRAF contains
Slovenian: Kaj vsebuje zdravilo GADOGRAF
English: METHOD AND ROUTE OF ADMINISTRATION Intravenous use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA intravenska uporaba
English: Gadograf should not be drawn up into the syringe from the vial until immediately before use.
Slovenian: Zdravilo Gadograf smete povleči iz viale v injekcijsko brizgo šele tik pred uporabo.
English: In a pivotal phase III kidney study average sensitivity was 91% (patient-based analysis) and 85% (lesionbased analysis) for classification of malignant and benign renal lesions.
Slovenian: V ključni študiji III. faze na ledvicah je bila pri razvrstitvi malignih in benignih ledvičnih lezij povprečna občutljivost 91 % (analiza na temelju števila bolnikov) in 85 % (analiza na temelju števila lezij).
English: In a pivotal phase III liver study average sensitivity in combined pre and postcontrast MRI for Gadograftreated patients was 79% and specificity was 81% for lesion detection and classification of suspected malignant liver lesions (patientbased analysis).
Slovenian: V ključni študiji III. faze na jetrih je bila povprečna občutljivost pri kombiniranem pred- in pokontrastnem slikanju z magnetno resonanco pri bolnikih, pri katerih so uporabili zdravilo Gadograf, za detekcijo lezij in razvrstitev jetrnih lezij, pri katerih so sumili, da so maligne, 79 %, specifičnost pa 81 % (analiza na temelju števila bolnikov).
English: Gadograf not used in one examination must be discarded.
Slovenian: Zdravilo Gadograf, ki ga pri pregledu ne porabite, morate zavreči.
English: The usual safety requirements for magnetic resonance imaging, especially the exclusion of ferromagnetic materials, also apply when using Gadograf.
Slovenian: Pri uporabi zdravila Gadograf je potrebno upoštevati običajne previdnostne ukrepe za magnetnoresonančno slikanje zlasti izključitev feromagnetnih snovi.
English: Breast-feeding should be stopped for at least 24 hours following Gadograf administration.
Slovenian: Dojiti ne smete najmanj 24 ur po uporabi zdravila Gadograf.
English: - The active substance is gadobutrol 604.72 mg corresponding to 1 mmol/ml
Slovenian: - Zdravilna učinkovina je 604,72 mg gadobutrola, kar ustreza 1 mmol/ml.
English: 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.
Slovenian: Na voljo je farmacevtska oblika z 1,0 mmol gadolinija/ml in osmolalnostjo 1603 mosmol/kg H2O pri 37 °C.
English: 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.
Slovenian: Po intravenski bolusni injekciji sredstva Gadograf lahko z MRI pridobimo pomembne podatke o hiper- in hipoperfuziji organa ter lezijah.
English: Each ml contains 604.72 mg of gadobutrol (equivalent to 1.0 mmol gadobutrol containing 157.25 mg gadolinium).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsak ml vsebuje 604,72 mg gadobutrola (kar ustreza 1,0 mmol gadobutrola, ki vsebuje 157,25 mg gadolinija).
English: In healthy persons renal clearance of gadobutrol is 1.1 to 1.7 ml min kg and thus comparable to the renal clearance of inulin, pointing to the fact that gadobutrol is eliminated primarily by glomerular filtration.
Slovenian: , torej je primerljiv ledvičnemu očistku inulina, kar kaže, da se gadobutrol v prvi vrsti izloča z glomerulalno filtracijo.
English: - the CHMP recommended that the following additional indication: “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.” can be granted for Gadograf.
Slovenian: CHMP priporoča, da se za zdravilo Gadograf odobri naslednja dodatna indikacija: „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.“
English: Gadograf should not be used in case of severe discoloration, the occurrence of particulate matter or a defective container.
Slovenian: Če je zdravilo Gadograf močno razbarvano, vsebuje delce ali ima poškodovan vsebnik, se ne sme uporabiti.
English: Gadograf contains gadobutrol, a neutral macrocyclic gadolinium complex with contrast-enhancing properties, which is used for magnetic resonance imaging (MRI).
Slovenian: Zdravilo Gadograf vsebuje gadobutrol, ki je nevtralen makrociklični gadolinijev kompleks.
English: Short-lasting mild to moderate feelings of coldness, warmth or pain at the injection site have been uncommonly observed during or after the injection of Gadograf.
Slovenian: Med injiciranjem zdravila Gadograf ali po njem so občasno opazili kratkotrajne blage do zmerne občutke mraza, toplote ali bolečine na mestu injiciranja.
English: HOW TO STORE GADOGRAF
Slovenian: Shranjevanje zdravila GADOGRAF
English: Headache, Dizziness, Paresthesia, Dysgeusia
Slovenian: Bolezni živčevja glavobol, vrtoglavica, parestezija, disgevzija parosmija izguba zavesti, konvulzije
English: Gadograf is a clear, colourless to pale yellow solution.
Slovenian: Zdravilo Gadograf je prozorna, brezbarvna do svetlo rumena raztopina.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Gadograf 1.0 mmol/ml solution for injection
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Gadograf 1,0 mmol/ml raztopina za injiciranje.
English: Solution for injection in prefilled syringe
Slovenian: Raztopina za injiciranje v napolnjeni injekcijski brizgi intravensko
English: What GADOGRAF is and what it is used for Before you are given GADOGRAF How to use GADOGRAF Possible side effects
Slovenian: KAJ MORATE VEDETI, PREDEN VAM BODO DALI ZDRAVILO GADOGRAF
English: - Allergy-like reactions may occur after use of Gadograf.
Slovenian: - Po uporabi zdravila Gadgraf se lahko pojavijo reakcije, podobne alergijam.
English: NAME OF THE MEDICINAL PRODUCT Gadograf 1.0 mmol/ml solution for injection
Slovenian: IME ZDRAVILA Gadograf 1,0 mmol/ml raztopina za injiciranje
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Gadograf 1.0 mmol/ml solution for injection in prefilled syringes Gadobutrol
Slovenian: IME ZDRAVILA IN POT UPORABE Gadograf 1,0 mmol/ml raztopina za injiciranje v napolnjenih injekcijskih brizgah.
English: Solution for Injection in prefilled syringe
Slovenian: Raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: NAME OF THE MEDICINAL PRODUCT Gadograf 1.0 mmol/ml solution for injection Gadobutrol
Slovenian: NAVODILO ZA UPORABO Gadograf 1,0 mmol/ml raztopina za injiciranje gadobutrol
English: Gadograf (see “What Gadograf contains”).
Slovenian: Ne uporabljajte zdravila GADOGRAF - alergični na (preobčutljivi za) gadobutrol ali katerokoli sestavino zdravila Gadograf (glejte "Kaj vsebuje zdravilo Gadograf").
English: NAME OF THE MEDICINAL PRODUCT Gadograf 1.0 mmol/ml solution for injection in prefilled syringes Gadobutrol
Slovenian: NAVODILO ZA UPORABO Gadograf 1,0 mmol/ml raztopina za injiciranje napolnjena injekcijska brizga gadobutrol
English: EU Number Invented name Strength Pharmaceutical form Route of administration
Slovenian: Številka EU Zaščiteno ime Jakost Farmacevtska oblika
English: One test kit contains: - 1 sealed sachet containing 1
Slovenian: Set vsebuje: - vrečko, ki vsebuje eno tableto
English: 100 mg Soluble tablet oral use
Slovenian: 100 mg tableta za peroralno raztopino peroralno uporabo vrečko Ena tableta v večkomponentnem preskusnem kompletu
English: Pylobactell tablet - 6 glass tubes with caps and bar code labels - 3 additional bar code labels - 30 ml mixing and administration vial.
Slovenian: - šest steklenih epruvet z zaporkami in etiketami s črtnimi kodami.
English: Pharmaceutical Form Route of Administration Packaging
Slovenian: Farmacevtska Oblika
English: Further information on Rheumocam can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Rheumocam so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Rheumocam received a marketing authorisation valid throughout the EU on 10 January 2008.
Slovenian: Zdravilo Rheumocam je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 10. januarja 2008.
English: Rheumocam (meloxicam)
Slovenian: Rheumocam (meloksikam)
English: What are the benefits and risks of Rheumocam?
Slovenian: Kakšne so koristi in tveganja zdravila Rheumocam?
English: An overview of Rheumocam and why it is authorised in the EU
Slovenian: Pregled zdravila Rheumocam in zakaj je odobreno v EU
English: Rheumocam is an anti-inflammatory medicine used in cattle, pigs, horses, dogs and cats.
Slovenian: Rheumocam je protivnetno zdravilo, ki se uporablja za zdravljenje govedi, prašičev, konjev, psov in mačk.
English: Why is Rheumocam authorised in the EU?
Slovenian: Zakaj je zdravilo Rheumocam odobreno v EU?