natgillin/translations-raw huggingface dataset:
FORTEKOR PLUS is a fixed combination product which should only be used in dogs which require both active substances to be administered concomitantly at this fixed dose.
FORTEKOR PLUS je kombinirano zdravilo, ki se sme uporabljati samo pri psih, ki potrebujejo sočasno zdravljenje z obema zdravilnima učinkovinama v takem odmerku.
In dogs with congestive heart failure benazepril hydrochloride reduces the blood pressure and volume load on the heart.
Pri psih s kongestivnim srčnim popuščanjem benazeprilijev klorid znižuje krvni tlak in volumensko obremenitev srca.
Levels of benazepril decline quickly as the drug is partially metabolised by liver enzymes to benazeprilat.
Ravni benazeprila upadajo hitro, ker jetrni encimi zdravilo delno presnovijo v benazeprilat.
In humans, the combination of ACE inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs) can lead to reduced anti-hypertensive efficacy or impaired kidney function.
Pri ljudeh lahko kombinacija zaviralcev angiotenzinske konvertaze (ACE) in nesteroidnih protivnetnih zdravil (NSAID) vodi do zmanjšane antihipertenzivne učinkovitosti ali do okvare delovanja ledvic.
Do not use during pregnancy or lactation.
Ne uporabite v obdobju brejosti ali laktacije.
As pimobendan is metabolised in the liver, the product should not be administered to dogs with severe hepatic insufficiency.
Ker se pimobendan presnavlja v jetrih, se zdravila ne sme dajati psom s hudo okvaro jeter.
The plasma elimination half-life of pimobendan when dosed with FORTEKOR PLUS tablets is 0.5 h, consistent with the high clearance of the compound.
Po odmerku tablet FORTEKOR PLUS je razpolovni čas izločanja pimobendana iz plazme 0,5 ure, kar je skladno z velikim očistkom učinkovine.
Do not use in case of hypersensitivity to pimobendan, to benazepril hydrochloride or to any ingredient of the tablets.
Ne uporabite v primeru preobčutljivosti na pimobendan, benazeprilijev klorid ali katero koli pomožno snov v tabletah.
Therapy should consist of intravenous infusion(s) of warm isotonic saline as required.
Terapija naj vključuje intravensko(e) infuzijo(e) tople fiziološke raztopine.
Interactions with other medicinal products and other forms of interaction: Inform the veterinary surgeon if the animal is taking, or has recently taken, any other medicines.
Obvestite veterinarja, če žival dobiva ali je pred kratkim dobivala katero koli drugo zdravilo.
FORTEKOR PLUS is a combination of 2 active substances: pimobendan and benazepril hydrochloride.
Farmakodinamične lastnosti FORTEKOR PLUS je kombinacija dveh zdravilnih učinkovin: pimobendana in benazeprilijevega klorida.
Pimobendan/Benazepril hydrochloride
Pimobendan/benazeprilijev klorid
Pimobendan, a benzimidazole-pyridazinone derivative, is a non-sympathomimetic, non-glycoside inotropic substance with potent vasodilating properties.
Pimobendan, derivat benzimidazol-piridazinona, je nesimpatikomimetična, neglikozidna inotropna učinkovina z močnimi vazodilatacijskimi lastnostmi.
The clearance of benazeprilat is not affected in dogs with impaired renal function; therefore no adjustment of the FORTEKOR PLUS dose is required in dogs with renal insufficiency.
Pri psih z okvarami delovanja ledvic ni težav pri očistku benazeprilata, zaradi česar odmerka zdravila FORTEKOR PLUS v primeru ledvične insuficience ni treba prilagajati.
Laboratory studies in rats with benazepril have shown foetotoxic effects (foetal urinary tract malformation) at maternally non-toxic doses.
Z laboratorijskimi študijami z benazeprilom na podganah so bili dokazani fetotoksični učinki (malformacije sečil ploda) pri odmerkih, ki niso bili toksični za mater.
Laboratory studies in rats and rabbits with pimobendan have not shown any effect on fertility.
Z laboratorijskimi študijami s pimobendanom na podganah in kuncih niso bili dokazani učinki na plodnost.
Silica, colloidal anhydrous Silicon dioxide anhydrous Sodium laurilsulfate Starch pregelatinised Succinic acid Sucrose
Silicijev dioksid, brezvodni Natrijev lavrilsulfat Škrob, predgelirani Jantarna kislina Saharoza
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Po uporabi si umijte roke.
Active substances:
Zdravilni učinkovini:
Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis.
Ne uporabite pri nezadostnem minutnem volumnu srca zaradi aortne ali pljučne stenoze.
Croscarmellose sodium Crospovidone
Natrijeva kroskarmeloza Krospovidon
Laboratory studies in rats and rabbits with pimobendan have shown foetotoxic effects at maternotoxic doses.
Z laboratorijskimi študijami s pimobendanom na podganah in kuncih so bili dokazani fetotoksični učinki pri uporabi odmerkov, toksičnih za mater.
Transient reversible hypotension (low blood pressure) may occur in accidental overdose.
V primeru nenamernega prevelikega odmerjanja se lahko pojavi prehodna reverzibilna hipotenzija (nizek krvni tlak).
Pimobendan is a non-sympathomimetic, non-glycoside inotropic substance with potent vasodilating properties.
Pimobendan je nesimpatikomimetična, neglikozidna inotropna učinkovina z močnimi vazodilatacijskimi lastnostmi.
Benazepril increased the time to worsening of heart failure, and the time to death, improved clinical condition, reduced cough and improved exercise tolerance in dogs with symptomatic congestive heart failure caused by valvular disease or dilated cardiomyopathy.
Pri psih s simptomatskim kongestivnim srčnim popuščanjem zaradi bolezni zaklopk ali dilatativne kardiomiopatije je benazepril podaljšal čas do poslabšanja srčnega popuščanja in čas do smrti, izboljšal splošno klinično stanje, zmanjšal kašelj ter izboljšal toleranco za telesno dejavnost.
A moderate positive chronotropic effect and vomiting may occur in rare cases.
Pimobendan V redkih primerih se lahko pojavita zmeren pozitivni kronotropni učinek in bruhanje, vendar sta ta učinka odvisna od odmerka in se lahko preprečita z zmanjšanjem le-tega.
Pimobendan
Kopovidon
The recommended dose range for FORTEKOR PLUS is 0.25-0.5 mg pimobendan per kg bodyweight and 0.5-1 mg benazepril hydrochloride per kg bodyweight divided into two daily doses.
Priporočen razpon odmerkov zdravila FORTEKOR PLUS je 0,25 - 0,5 mg pimobendana na kg telesne mase in 0,5 - 1 mg benazeprilijevega klorida na kg telesne mase.
Benazeprilat is an inhibitor of ACE, thus reducing the blood pressure and volume load on the heart in dogs with congestive heart failure.
Benazeprilat je zaviralec ACE in pri psih s kongestivnim srčnim popuščanjem znižuje krvni tlak in volumensko obremenitev srca.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each tablet contains
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI
Transient reversible hypotension may occur in accidental overdose.
V primeru nenamernega prevelikega odmerjanja se lahko pojavi prehodna reverzibilna hipotenzija.
It is therefore recommended to monitor plasma potassium levels when using FORTEKOR PLUS in combination with a potassium sparing diuretic because of the risk of hyperkalaemia.
Pri uporabi zdravila FORTEKOR PLUS v kombinaciji z diuretikom, ki zadržuje kalij, je priporočljivo spremljanje ravni kalija v plazmi zaradi tveganja za hiperkaliemijo.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
FORTEKOR PLUS 5 mg/10 mg tablets: 30 tablets or 60 tablets.
FORTEKOR PLUS 5 mg/10 mg tablete: 30 ali 60 tablet.
Benazepril hydrochloride is a prodrug which is hydrolysed in vivo to its active metabolite, benazeprilat.
Benazeprilijev klorid je predzdravilo, hidrolizirano in vivo v aktivni metabolit, benazeprilat.
FORTEKOR PLUS 1.25 mg/2.5 mg tablets: 30 tablets or 60 tablets.
FORTEKOR PLUS 1,25 mg/2,5 mg tablete: 30 ali 60 tablet.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each tablet contains 1.25 mg pimobendan and 2.5 mg benazepril hydrochloride.
Vsaka tableta vsebuje 1,25 mg pimobendana in 2,5 mg benazeprilijevega klorida.
5 mg/10 mg tablets: pack sizes of 30 or 60 tablets.
5 mg/10 mg tablete: velikosti pakiranj po 30 ali 60 tablet.
Benazepril hydrochloride is partially metabolised by liver enzymes to the active metabolite benazeprilat.
Jetrni encimi benazeprilijev klorid delno presnovijo v aktivni metabolit benazeprilat.
1.25 mg/2.5 mg tablets: pack sizes of 30 or 60 tablets.
1,25 mg/2,5 mg tablete: velikosti pakiranj po 30 ali 60 tablet.
The main active metabolite of pimobendan is eliminated with a plasma elimination half-life of 2.6 h. Pimobendan is excreted principally in the faeces and to a lesser extent in the urine.
Pimobendan se izloča večinoma z blatom in v manjši meri z urinom.
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
- redki (pojavijo se pri 1 do 10 živalih od 10000 živali)
Strength and number of tablets to be administered FORTEKOR PLUS 1.25 mg/2.5 mg tablets
Jakost in število odmerjenih tablet FORTEKOR PLUS 1,25 mg/2,5 mg tablete
Ask your veterinary surgeon or your pharmacist how to dispose of medicines no longer required.
Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem ali farmacevtom.
Special precautions for use in animals
POSEBNO(A) OPOZORILO(A) Posebni previdnostni ukrepi za uporabo pri živalih
NAME OF THE MARKETING AUTHORISATION HOLDER Elanco
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Elanco
Benazepril hydrochloride
Benazeprilijev klorid
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Elanco GmbHHeinz-Lohmann-Str. 4
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Elanco GmbH
NAME OF THE VETERINARY MEDICINAL PRODUCT FORTEKOR PLUS 1.25 mg/2.5 mg tablets for dogs FORTEKOR PLUS 5 mg/10 mg tablets for dogs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI FORTEKOR PLUS 1,25 mg/2,5 mg tablete za pse FORTEKOR PLUS 5 mg/10 mg tablete za pse
Your veterinary surgeon may therefore recommend the monitoring of plasma potassium concentrations when using FORTEKOR PLUS in combination with a potassium-sparing diuretic because of the risk of hyperkalaemia (high blood potassium).
Zaradi tveganja za hiperkaliemijo (visoko raven kalija v krvi) lahko veterinar pri uporabi zdravila FORTEKOR PLUS v kombinaciji z diuretikom, ki zadržuje kalij, priporoči spremljanje plazemskih koncentracij kalija.
Elanco GmbH
Imetnik dovoljenja za promet z zdravilom: Elanco GmbH
FORTEKOR PLUS 1.25 mg/2.5 mg tablets for dogs FORTEKOR PLUS 5 mg/10 mg tablets for dogs
NAVODILO ZA UPORABO FORTEKOR PLUS 1,25 mg/2,5 mg tablete za pse FORTEKOR PLUS 5 mg/10 mg tablete za pse
MINIMUM PARTICULARS TO APPEAR ON BLISTERS Blister
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU Pretisni omot
Artificial Special Dry Flavour Basic butylated methacrylate copolymer Copovidone
Bazični butilmetakrilat, kopolimer
Polysorbate 80
Celuloza, mikrokristalna Polisorbat 80
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
- zelo redki (pojavijo se pri manj kot 1 živali od 10000 živali, vključujoč posamezne primere) Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Elanco France S.A.S
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije
Overdose (symptoms, emergency procedures, antidotes):
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) V primeru prevelikega odmerjanja je treba psa zdraviti simptomatsko.
Use during pregnancy, lactation:
Uporaba v obdobju brejosti in laktacije
The plasma elimination half-life of benazepril hydrochloride and benazeprilat, when dosed with FORTEKOR PLUS tablets is 0.36 h and 8.36 h, respectively.
0,36 ure in benazeprilata 8,36 ure.
To be supplied only on veterinary prescription.
Zdravilo odstranite na okolju prijazen način.
If you have diabetes
• če imate sladkorno bolezen
The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Po potrebi bodo pristojni nacionalni organi v sodelovanju z državo članico naknadno posodobili povzetek glavnih značilnosti zdravila in navodilo za uporabo v skladu s postopki, določenimi v poglavju 4 pod naslovom III Direktive 2001/83/ES.
The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically.
Potrebo bolnika po lajšanju simptomov in njegov odziv na zdravljenje je treba redno preverjati.
If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides
• če imate angino pektoris, krvne strdke, visok krvni tlak, povišan holesterol ali povišane trigliceride
This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure.
Ta povzetek glavnih značilnosti in navodilo za uporabo sta izid napotitvenega postopka.
Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Potrjeno kongestivno srčno popuščanje (razred NYHA II-IV), ishemična bolezen srca, periferna arterijska bolezen in/ali možganskožilna bolezen.
Section 2 ‘What you need to know before you take <diclofenac containing medicinal product> [The wording below should be inserted in the relevant sections]
Poglavje 2 Kaj morate vedeti, preden boste vzeli zdravilo <ime zdravila, ki vsebuje diklofenak> [Spodnje besedilo je treba vključiti v ustrezna poglavja]
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use).
Možnost neželenih učinkov se lahko zmanjša z uporabo najnižjega učinkovitega odmerka za najkrajše možno trajanje zdravljenja za obvladovanje (lajšanje) simptomov (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi).
Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.
Bolnike s pomembnimi dejavniki tveganja za srčnožilne bolezni (npr. visok krvni tlak, hiperlipidemija, diabetes mellitus, kajenje) se lahko zdravi z diklofenakom le po skrbni presoji.
Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.
Možnost neželenih učinkov se lahko zmanjša z uporabo najnižjega učinkovitega odmerka za najkrajše možno trajanje zdravljenja.
As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Kardiovaskularno tveganje zaradi diklofenaka se lahko poveča s povečevanjem odmerka in s trajanjem izpostavljenosti zdravilu, zato mora biti zdravljenje čim krajše in z najmanjšim učinkovitim dnevnim odmerkom.
Section 4.8 Undesirable effects: [The wording below should be inserted in this section]
Poglavje 4.8 Neželeni učinki: [V to poglavje je treba vključiti spodnje besedilo]
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Dopolnitve, ki jih je treba vključiti v ustrezna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo
A. Summary of Product Characteristics Section 4.2 Posology and method of administration: [The wording below should be inserted in this section]
A. Povzetek glavnih značilnosti zdravila Poglavje 4.2 Odmerjanje in način uporabe: [V to poglavje je treba vključiti spodnje besedilo]
Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150mg daily) and in long term treatment.
Podatki iz kliničnih preizkušanj in epidemiološki podatki kažejo, da je uporaba diklofenaka (zlasti visokih odmerkov (150 mg na dan) in pri dolgotrajnem zdravljenju) povezana s povečanim tveganjem za pojav arterijskih trombotičnih dogodkov (npr. miokardnega infarkta ali možganske kapi) (glejte poglavji 4.3 Kontraindikacije in 4.4 Posebna opozorila in previdnostni ukrepi).
Do not use diclofenac if you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages if you have or have had problems with your blood circulation (peripheral arterial disease)
• če imate potrjeno srčno bolezen in/ali možganskožilno bolezen, npr. če ste doživeli srčni napad, možgansko kap, lažjo obliko kapi (tranzitorno ishemično atako - TIA) ali ste imeli zamašitev žil, ki vodijo do srca ali možganov, ali operativno odstranitev ali obvod zamašenega dela
Section 4.4 Special warnings and precautions for use: [The wording below should be inserted in this section]
Poglavje 4.4 Posebna opozorila in previdnostni ukrepi: [V to poglavje je treba vključiti spodnje besedilo]
Section 4.3 Contraindications: [The wording below should be inserted in this section]
Poglavje 4.3 Kontraindikacije: [V to poglavje je treba vključiti spodnje besedilo]
Make sure your doctor knows, before you are given diclofenac If you smoke
Pred uporabo diklofenaka morate zdravniku povedati
Strength Pharmaceutical
Farmacevtska oblika Pot uporabe Stična ovojnina
Protelos/Osseor has been authorised since September 2004.
Zdravilo Protelos/Osseor je odobreno od septembra 2004.
The full European Public Assessment Report for Protelos/Osseor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Protelos/Osseor je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The applicant presented data from one main study involving 1,683 patients with osteoarthritis of the knee.
Predlagatelj je predložil podatke iz ene glavne študije, v kateri je sodelovalo 1 683 bolnikov z osteoartritisom kolena.
The main measure of effectiveness was the effect in slowing the loss of cartilage from the joint as measured by X-rays after 3 years of treatment.
Glavno merilo učinkovitosti je bil učinek na upočasnitev izgube hrustanca v sklepu, izmerjen z rentgenskimi slikanji po 3 letih zdravljenja.
In addition, the Committee had some concerns about the way in which the loss of cartilage had been evaluated.
Poleg tega je imel odbor CHMP določene pomisleke glede načina ocenjevanja izgube hrustanca.
The CHMP noted that the size of the benefit seen in the study was small and the long-term benefit unclear, whereas the medicine had an established risk of serious side effects.
Odbor CHMP je izpostavil, da je bila korist, ki so jo opazili v študiji, majhna in da je dolgoročna korist nejasna, medtem ko je bilo v povezavi z zdravilom ugotovljeno tveganje za resne neželene učinke.
The applications were withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Vlogi so umaknili potem, ko je CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval sezname vprašanj.
After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Potem ko je CHMP ocenil odgovore družbe na zadnja vprašanja, so nekatera še vedno ostala nerešena.
It is currently used to treat severe osteoporosis (a disease that makes bones fragile) in post-menopausal women and men who have a high risk of fracture.
Trenutno se uporablja za zdravljenje hude osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi in moških z velikim tveganjem za zlome.
In this study, strontium ranelate 1 or 2 g was compared with placebo (a dummy treatment).
V njej so stroncijev ranelat v odmerku 1 ali 2 g primerjali s placebom (zdravilom brez zdravilne učinkovine).
Protelos and Osseor are identical medicines that contain the active substance strontium ranelate.
Protelos in Osseor sta identični zdravili, ki vsebujeta zdravilno učinkovino stroncijev ranelat.
How far into the evaluation were the applications when they were withdrawn?
Kako daleč je bil postopek ocenjevanja vlog ob njunem umiku?
In its letter notifying the Agency of the withdrawal of the applications, the company stated that the withdrawal was due to the fact that the data so far available were insufficient to address the CHMP's concerns.
Družba je v dopisu, s katerim agencijo obvešča o umiku vlog, navedla, da se je za umik odločila zaradi dejstva, da trenutno razpoložljivi podatki niso zadostni, da bi lahko odpravili pomisleke odbora CHMP.
They are available as sachets containing strontium ranelate (2 g) as granules to be made up into a suspension to be taken by mouth.
Na voljo sta v vrečkah, ki vsebujejo stroncijev ranelat (2 g) v obliki zrnc za pripravo suspenzije, ki se jemlje peroralno.
On 21 March 2014, Les Laboratoires Servier officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its applications to extend the indication of Protelos/Osseor to include the treatment of osteoarthritis of the knee and hip.
Družba Les Laboratoires Servier je dne 21. marca 2014 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogi za razširitev indikacije zdravila Protelos/Osseor na vključitev zdravljenja osteoartritisa kolena in kolka.
What were the reasons given by the company for withdrawing the applications?
Kakšni so bili razlogi družbe za umik vlog?
There are no consequences on the use of Protelos/Osseor in its authorised indications.
Umik nima nobenih posledic za uporabo zdravila Protelos/Osseor pri odobrenih indikacijah.
In osteoarthritis, the cartilage, a smooth layer that lines the joints and helps them to move easily, is gradually lost, and the bone underneath becomes damaged and exposed.
Pri osteoartritisu se hrustanec, tj. gladka plast, ki obdaja sklepe in jim omogoča lažje premikanje, postopno tanjša, zaradi česar se kost pod njim poškoduje in ni več zaščitena.
What did the company present to support its applications?
Katero dokumentacijo je družba predložila v podporo svojima vlogama?
Protelos/Osseor was also expected to be used to treat osteoarthritis (a long-term disease that damages joints and makes them stiff and painful) in the knee and hip.
Zdravilo Protelos/Osseor naj bi se uporabljalo tudi za zdravljenje osteoartritisa (dolgotrajne bolezni, ki poškoduje sklepe, tako da postanejo okoreli in boleči) kolena in kolka.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Protelos/Osseor could not have been approved for the treatment of osteoarthritis.
Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil CHMP, je odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Protelos/Osseor ni mogoče odobriti za zdravljenje osteoartritisa.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Protelos/Osseor in the treatment of osteoarthritis did not outweigh its risks.
Zato je CHMP v času umika menil, da koristi zdravila Protelos/Osseor pri zdravljenju osteoartritisa ne odtehtajo z njim povezanih tveganj.
The company informed the CHMP that there are no consequences for any ongoing clinical trials with Protelos/Osseor.
Družba je obvestila CHMP, da umik nima nobenih posledic za klinična preskušanja zdravila Protelos/Osseor, ki trenutno potekajo.
What is Protelos/Osseor?
Kaj je zdravilo Protelos/Osseor?
What is happening with Protelos/Osseor for the treatment of osteoporosis?
Kakšne so posledice za zdravilo Protelos/Osseor, indicirano za zdravljenje osteoporoze?