natgillin/translations-raw huggingface dataset:
B/Colorado/06/2017 - like strain (B/Colorado/06/2017, MEDI 293454)
B/Colorado/06/2017 - podoben sev (B/Colorado/06/2017, MEDI 293454)
Fluenz has demonstrated superiority in 3 active-controlled studies with injectable influenza vaccine.
Cepivo Fluenz je bilo v 3 aktivno kontroliranih študijah s cepivom gripe, ki se injicira, superiorno.
Fluenz Tetra should under no circumstances be injected.
Cepiva Fluenz Tetra se ne sme v nobenem primeru injicirati.
SINGLE-USE NASAL APPLICATOR
NOSNIK ZA ENKRATNO UPORABO
This vaccine is presented as a nasal spray suspension in a single-use nasal applicator (0.2 ml) in a pack size of 1 and 10.
Cepivo je v obliki pršila za nos, suspenzije, ki se nahaja v nosniku za enkratno uporabo (0,2 ml) v velikosti pakiranja 1 in 10.
..................................................................................................................per 0.2 ml dose
........................................................................................................na 0,2 ml odmerek
• if you are in close contact with someone with a severely weakened immune system
• če ste v tesnem stiku z nekom, ki ima hudo oslabljen imunski sistem (na primer bolnik s presajenim kostnim mozgom, ki mora biti izoliran).
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Fluenz efficacy
Učinkovitost cepiva Fluenz
A/Kansas/14/2017 (H3N2) - like strain (A/Kansas/14/2017, MEDI 308763)
A/Kansas/14/2017 (H3N2) - podoben sev (A/Kansas/14/2017, MEDI 308763)
Additional experience has occurred with marketed use of Fluenz.
V času trženja cepiva Fluenz so se pridobile dodatne izkušnje.
This vaccine complies with the WHO (World Health Organisation) recommendations (Northern Hemisphere) and EU decision for the 2019/2020 season.
Cepivo ustreza priporočilom Svetovne zdravstvene organizacije (severna polobla) in odločbi EU za sezono 2019/2020.
PACK SIZE OF 1 SINGLE-USE NASAL APPLICATOR PACK SIZE OF 1 SINGLE-USE NASAL APPLICATOR (IN A TRI-FOLD CARTON) PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS (IN TRAYS) PACK SIZE OF 10 SINGLE-USE NASAL APPLICATORS
VELIKOST PAKIRANJA 1 NOSNIKA ZA ENKRATNO UPORABO VELIKOST PAKIRANJA 1 NOSNIKA ZA ENKRATNO UPORABO (V KARTONU S TREMI PREGIBI)
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2019/2020 season.
Cepivo ustreza priporočilom SZO (Svetovne zdravstvene organizacije) (severna polobla) in odločbi EU za sezono 2019/2020.
PACK SIZE OF 5 SINGLE-USE NASAL APPLICATORS
VELIKOST PAKIRANJA 5 NOSNIKOV ZA ENKRATNO UPORABO
• nose bleed
• krvavitve iz nosu
Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal) 2019/2020 season
Fluenz Tetra pršilo za nos, suspenzija cepivo proti gripi (z živimi oslabljenimi virusi, nosno) sezona 2019/2020
Very rare reports of Guillain-Barré syndrome and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy) have also been observed in the post-marketing setting with Fluenz.
Po začetku trženja cepiva Fluenz so opazili zelo redka poročila o Guillain-Barréjevem sindromu in poslabšanju simptomov Leigh-sindroma (mitohondrijska encefalomiopatija).
Respiratory, thoracic and mediastinal disorders Very common: Nasal congestion/rhinorrhoea
Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo pogosti: zamašen nos/rinoreja Občasni: epistaksa
The suspension should be colourless to pale yellow, clear to opalescent.
Suspenzija mora biti brezbarvna do bledorumena in bistra do opalescentna.
If any of these apply, tell your doctor, nurse or pharmacist before vaccination.
Če karkoli od tega velja za vas, obvestite zdravnika, farmacevta ali medicinsko sestro pred cepljenjem.
Other possible side effects of Fluenz Tetra
Drugi možni neželeni učinki cepiva Fluenz Tetra
No clinically meaningful changes in immune responses to measles, mumps, varicella, orally-administered poliovirus or Fluenz have been observed.
Klinično pomembnih sprememb odziva imunskega sistema na cepivo proti ošpicam, mumpsu, noricam in na peroralno cepivo proti otroški paralizi ali cepivo Fluenz niso opazili.
• Refer to the Fluenz Tetra administration diagram (Figure 1) for step-by-step administration instructions.
• Za navodila za aplikacijo cepiva Fluenz Tetra po korakih glejte postopek aplikacije (slika 1).
The safety experience with trivalent Fluenz is relevant to the use of Fluenz Tetra because Fluenz Tetra (influenza vaccine-live attenuated, nasal) is identical to Fluenz with the only difference being the addition of a fourth strain (a second B strain) to Fluenz Tetra.
Izkušnje o varnosti s trivalentnim cepivom Fluenz so pomembne za uporabo cepiva Fluenz Tetra, saj je Fluenz Tetra (cepivo proti gripi - z živimi oslabljenimi virusi, nosno) identično cepivu Fluenz, pri čemer je edina razlika dodatek četrtega seva (drugi B sev) v cepivu Fluenz Tetra.
The patient can breathe normally while the vaccine is being administered - there is no need to actively inhale or sniff.
Oseba lahko med dajanjem cepiva normalno diha - ni potrebe za aktivno inhaliranje ali vdihavanje skozi nosnici.
You can breathe normally while you are given Fluenz Tetra.
Med prejemanjem cepiva Fluenz Tetra lahko normalno dihate.
Peak incidence of vaccine virus recovery occurred 2-3 days post-vaccination in Fluenz clinical studies.
V kliničnih študijah cepiva Fluenz je bila največja incidenca rekuperacije virusa iz cepiva 2 - 3 dni po cepljenju.
• The patient can breathe normally while the vaccine is being administered - there is no need to actively inhale or sniff.
• Oseba lahko med dajanjem cepiva normalno diha - ni potrebe za aktivno inhaliranje ali vdihavanje skozi nosnici.
This observation with trivalent Fluenz is relevant to the use of Fluenz Tetra because Fluenz Tetra (influenza vaccine-liveattenuated, nasal) is identical to Fluenz with the only difference being the addition of a fourth strain (a second B strain) to Fluenz Tetra.
Ta sprememba pri trivalentnem cepivu Fluenz je pomembna za uporabo cepiva Fluenz Tetra, saj je Fluenz Tetra (cepivo proti gripi - z živimi oslabljenimi virusi, nosno) identično cepivu Fluenz, pri čemer je edina razlika dodatek četrtega seva (drugi B sev) v cepivu Fluenz Tetra.
Non-clinical data reveal no special hazard for humans based on conventional non-clinical studies of repeated dose toxicity, reproduction and developmental toxicity, local tolerance and neurovirulence.
Predklinični podatki na osnovi običajnih študij predklinične varnosti, toksičnosti pri ponavljajočih se odmerkih, vpliva na sposobnost razmnoževanja in razvoja, lokalnega prenašanja in nevrovirulence ne kažejo posebnega tveganja za človeka.
Overdose with Fluenz Tetra is unlikely due to its presentation as a pre-filled sprayer.
Preveliko odmerjanje cepiva Fluenz Tetra zaradi njegove oblike v napolnjenem razpršilniku ni verjetno.
Immunocompromised
Imunska oslabelost
There was no evidence of significant maternal adverse outcomes in 138 pregnant women who had a record of receiving trivalent Fluenz in a US-based health insurance claims database.
Po podatkih ameriške baze odškodninskih zahtevkov zdravstvenega zavarovanja pri 138 nosečnicah, ki so prejemale trivalentno cepivo Fluenz, ni bilo dokazov o posebnih neželenih izidih nosečnosti za mater.
AV006 USA 15 to 71 M 1,259
ZDA 15 do 71 m 1.259
What Fluenz Tetra looks like and contents of the pack
Izgled cepiva Fluenz Tetra in vsebina pakiranja
Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal)
Fluenz Tetra pršilo za nos, suspenzija cepivo proti gripi (z živimi oslabljenimi virusi, nosno)
Talk to your doctor, nurse or pharmacist before vaccination:
Pred cepljenjem se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom:
Spray in other nostril Place the tip just inside the other nostril and with a single motion, depress plunger as rapidly as possible to deliver remaining vaccine.
Konico namestite nekoliko v drugo nosnico in z enkratnim pritiskom pritisnite na bat tako hitro, kot lahko, da vnesete preostanek cepiva.
Contains also: sucrose, dipotassium phosphate, potassium dihydrogen phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate, water for injections.
Vsebuje tudi: saharozo, kalijev hidrogenfosfat, kalijev dihidrogenfosfat, želatino (svinjsko, tipa A), argininijev klorid, natrijev glutamat monohidrat, vodo za injekcije.
Fluenz Tetra must not be injected.
Cepiva Fluenz Tetra se ne sme injicirati.
General disorders and administration site conditions Very common: Malaise
Splošne težave in spremembe na mestu aplikacije Zelo pogosti: slabost
- If you have any further questions, ask your doctor, nurse or pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Tell your doctor straight away or seek urgent medical care if you experience any of the effects above.
Če opazite kateri koli zgoraj naštet neželeni učinek, nemudoma obvestite zdravnika ali poiščite nujno medicinsko pomoč.
Figure 1 Fluenz Tetra Administration
Slika 1 Aplikacija cepiva Fluenz Tetra
The suspension is colourless to pale yellow, clear to slightly cloudy.
Suspenzija je brezbarvna do bledorumena, bistra do nekoliko motna.
The co-administration of trivalent Fluenz with the live attenuated vaccines: measles, mumps, rubella, varicella and orally-administered poliovirus has been studied.
Preučili so sočasno uporabo trivalentnega cepiva Fluenz z živimi oslabljenimi cepivi proti ošpicam, mumpsu, rdečkam, noricam in peroralnim cepivom proti otroški paralizi.
• After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter.
• Kmalu ali takoj po aplikaciji polovice odmerka v eno nosnico aplicirajte drugo polovico v drugo nosnico.
• Fluenz Tetra is administered as a divided dose in both nostrils.
• Cepivo Fluenz Tetra se aplicira kot razdeljen odmerek v obe nosnici.
Check expiry date Product must be used before date on applicator label.
Preverite rok uporabnosti Cepivo uporabite pred datumom na nalepki nosnika.
Improved Efficacy (95% CI) Matched strains
Izboljšana učinkovitost (95-% IZ) Ujemajoči se sevi
If you have any further questions on this vaccine, ask your doctor, nurse or pharmacist.
Če imate dodatna vprašanja o uporabi cepiva, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
For administration in the other nostril, pinch and remove the dose-divider clip from plunger.
Odstranite sponko za razdelitev odmerka Za vnos v drugo nosnico odščipnite in odstranite sponko za razdelitev odmerka z bata.
The other ingredients are sucrose, dipotassium phosphate, potassium dihydrogen phosphate, gelatin (porcine, Type A), arginine hydrochloride, monosodium glutamate monohydrate and water for injections.
Pomožne snovi so saharoza, kalijev hidrogenfosfat, kalijev dihidrogenfosfat, želatina (svinjska, tipa A), argininijev klorid, natrijev glutamat monohidrat in voda za injekcije.
You will not be given Fluenz Tetra:
Cepiva Fluenz Tetra ne boste prejeli
If any of these apply, tell your doctor, nurse or pharmacist.
Če karkoli od tega velja za vas, obvestite zdravnika, farmacevta ali medicinsko sestro.
Nasal spray, suspension 1 single-use nasal applicator (0.2 ml) 10 single-use nasal applicators (0.2 ml each)
1 nosnik za enkratno uporabo (0,2 ml) 10 nosnikov za enkratno uporabo (vsak po 0,2 ml)
- If any of the side effects gets serious, talk to your doctor, nurse or pharmacist.
- Če katerikoli neželeni učinek postane resen, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Dipotassium phosphate Potassium dihydrogen phosphate Gelatin (porcine, Type A) Arginine hydrochloride Monosodium glutamate monohydrate Water for injections
6.1 Seznam pomožnih snovi saharoza kalijev hidrogenfosfat kalijev dihidrogenfosfat želatina (svinjska, tip A) argininijev klorid natrijev glutamat monohidrat voda za injekcije
Do not inject Fluenz Tetra.
Cepiva Fluenz Tetra ne injicirajte.
No data exist regarding the safety of intranasal administration of Fluenz Tetra in children with unrepaired craniofacial malformations.
O intranazalnem dajanju cepiva Fluenz Tetra otrokom z nepopravljenimi kraniofacialnimi deformacijami ni podatkov.
Fluenz Tetra will be given as a spray in each nostril.
Cepivo Fluenz Tetra se daje v obliki pršila v vsako nosnico.
Fluenz Tetra is administered as a divided dose in both nostrils.
Cepivo Fluenz Tetra se daje kot razdeljen odmerek v obe nosnici.
Immunisation must be carried out by nasal administration.
Imunizacija se opravi z nazalno uporabo.
After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter.
Kmalu ali takoj po aplikaciji polovice odmerka v eno nosnico, dajte drugo polovico v drugo nosnico.
Fluenz Tetra immunogenicity
Imunogenost cepiva Fluenz Tetra
Improved Efficacy (95% CI) All strains regardless of match
Izboljšana učinkovitost (95-% IZ) Vsi sevi neodvisno od ujemanja
How to store Fluenz Tetra
Kako uporabljati cepivo Fluenz Tetra
Fluenz Tetra must only be used as a nasal spray.
Cepivo Fluenz Tetra se lahko uporablja le v obliki pršila za nos.
Remove dose-divider clip
Sponka za razdelitev odmerka
How Fluenz Tetra works
Kako učinkuje cepivo Fluenz Tetra
Efficacy (95% CI) Matched strains
Učinkovitost (95-% IZ) Ujemajoči se sevi
Efficacy (95% CI) All strains regardless of match
Učinkovitost (95-% IZ) Vsi sevi neodvisno od ujemanja
Fluenz Tetra is for nasal use only.
Cepivo Fluenz Tetra JE SAMO ZA NAZALNO UPORABO.
Fluenz Tetra IS FOR NASAL USE ONLY.
Cepivo Fluenz Tetra je samo za nazalno uporabo.
Medicinal products subject to medical prescription.
Predpisovanje in izdaja zdravil je le na recept.
Age Range
Starostni razpon
Skin and subcutaneous tissue disorders Uncommon: Rash
Bolezni kože in podkožja Občasni: izpuščaj
What Fluenz Tetra contains
Kaj vsebuje cepivo Fluenz Tetra
6 to 71 M 2,085 2002-2003
D153-P514 Evropa 6 do 71 m 2.085 2002 - 2003
- Keep this leaflet.
Napršite v drugo nosnico
The review was initiated on the basis of unresolved safety and efficacy concerns.
Pregled je bil sprožen zaradi nerešenih vprašanj glede varnosti in učinkovitosti.
Prozac and associated names
Prozac in z njim povezana imena
The final opinion was converted into a Decision by the European Commission on 21 August 2006.
Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 21. avgusta 2006.
International Non-Proprietary Name (INN): Fluoxetine
Mednarodno nelastniško ime (INN): Fluoksetin
London, 21 August 2006 EMEA/311654/2006
London, 21. avgusta 2006 EMEA/311654/2006
The referral procedure started on 26 May 2005.
Napotitveni postopek se je začel 26. maja 2005.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6(12) REFERRAL
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 6(12)
* Notes: The information given in this document and Annexes reflect only the CHMP Opinion dated 1 June 2006.
* Opombe: Informacije, podane v tem dokumentu in Dodatkih, odražajo samo mnenje CHMP z dne 1. junija 2006.
The Rapporteur and Co-Rapporteur appointed were: Dr Barbara van Zwieten-Boot and Dr Tomas Salmonson, respectively.
Za poročevalca je bila imenovana dr. Barbara van Zwieten-Boot in za soporočevalca dr. Tomas Salmonson.
Fluoxetine is a selective inhibitor of serotonin reuptake.
Fluoksetin je selektivni zaviralec ponovnega prevzema serotonina.
Written explanations were provided by the Marketing Authorisation Holders on 29 August 2005, 6 January 2006, 3 April 2006 and 11 May 2006.
Imetniki dovoljenj za promet z zdravilom so pisna pojasnila predložili 29. avgusta 2005, 6. januarja 2006, 3. aprila 2006 in 11. maja 2006.
Based on evaluation of the currently available data and the Rapporteurs' assessment reports, the CHMP considered that the benefits of Prozac are greater than its potential risks in this population and therefore adopted an opinion on 1 June 2006 recommending the following extension of the indication:
Na podlagi vrednotenja trenutno razpoložljivih podatkov in poročevalčevega poročila o oceni je CHMP menil, da so pri tej populaciji koristi zdravila Prozac večje od z njim povezanih morebitnih tveganj in je zato dne 1. junija 2006 sprejel mnenje, v katerem priporoča naslednjo razširitev indikacije:
On 2 May 2005, France referred the matter to the EMEA under Article 6(12) of Commission Regulation EC No 1084/2003.
Francija je dne 2. maja 2005 Evropski agenciji za zdravila (EMEA) predložila napotitev v skladu s členom 6(12) Uredbe Komisije (ES) št. 1084/2003.
Prozac is authorised in most EU Member States for the treatment of major depressive episodes, obsessive-compulsive disorder and bulimia nervosa in adults.
Prozac je odobren v večini držav članic EU za zdravljenje hudih epizod depresije, obsesivnokompulzivnih motenj in bulimije nervoze pri odraslih.
Children and adolescents aged 8 years and above: Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4-6 sessions.
Otroci in mladostniki stari 8 let in več: Zmerne do močno izražene hude epizode depresije, če se depresija ne odziva na psihološko zdravljenje po 4 do 6 seansah.
The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the amended product information in the Annex III and the conditions of the marketing authorisations in the Annex IV.
Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, skupaj s Povzetkom glavnih značilnosti zdravila v Dodatku III ter s Pogoji dovoljenja za promet z zdravilom v Dodatku IV.
The CHMP began an arbitration review for Prozac, following an application by the marketing authorisation holder to extend the indication to include the treatment of major depressive episodes in children and adolescents.
CHMP je začel arbitražni pregled zdravila Prozac po vlogi imetnika dovoljenja za promet z zdravilom za razširitev indikacije, da bi bilo vključeno tudi zdravljenje hudih epizod depresije pri otrocih in mladostnikih.
Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy.
Zdravljenje z antidepresivi je treba nuditi otroku ali mladi osebi z zmerno do hudo depresijo samo v kombinaciji s sočasnim psihološkim zdravljenjem.
Oral explanations were given by the Marketing Authorisation Holders on 26 April 2006.
Ustna pojasnila so podali 26. aprila 2006.
7 January 2016
7. januar 2016
The European Commission issued a decision on 7 January 2016.
Evropska komisija je sklep izdala 7. januarja 2016.
This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a veterinary medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Poland, Portugal, Slovakia, Spain and The Netherlands).
To je postopek, pri katerem ena od držav članic („referenčna država članica“, v tem primeru Združeno kraljestvo) oceni zdravilo za uporabo v veterinarski medicini glede tega, ali se zanj lahko izda dovoljenje za promet, ki bo veljavno v tej državi in drugih državah članicah („zadevnih državah članicah“, v tem primeru Avstriji, Belgiji, Češki republiki, na Danskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, Irskem, v Italiji, Luksemburgu, na Poljskem, Portugalskem, Slovaškem, v Španiji in na Nizozemskem).
However, the Member States were not able to reach an agreement and the Veterinary Medicines Directorate of the United Kingdom referred the matter to the CVMP for arbitration on 28 May 2015.
Vendar države članice niso uspele doseči soglasja, zato je direktorat za zdravila za uporabo v veterinarski medicini v Združenem kraljestvu 28. maja 2015 zadevo napotil na odbor CVMP v arbitražo.
In addition, Denmark raised a concern that the advice for prudent use in the product information is insufficient.
Poleg tega je Danska izrazila pomislek, da nasvet o preudarni uporabi v informacijah o zdravilu ne zadošča.
The grounds for the referral were concerns raised by Denmark that the marketing authorisation of Solamocta may present a potential serious risk to human and animal health.
Razlogi za napotitev so bili pomisleki Danske, da dovoljenje za promet z zdravilom Solamocta lahko pomeni morebitno resno tveganje za zdravje ljudi in živali.
Amoxicillin is a bactericidal antibiotic belonging to the semisynthetic penicillin group.
Amoksicilin je baktericidni antibiotik iz skupine polsintetskih penicilinov.
The CVMP also recommended that the product information for Solamocta be amended.
Priporočil je tudi, da se informacije o zdravilu Solamocta spremenijo.
The product is indicated for treatment of infections in chickens, turkeys and ducks caused by bacteria susceptible to amoxicillin.
Zdravilo je indicirano za zdravljenje okužb pri piščancih, puranih in racah, ki jih povzročajo bakterije, občutljive za amoksicilin.
Denmark considered that Solamocta is essentially different from the reference product Amoxinsol 100% w/w Powder for Oral Solution and that these differences could be sufficient to require a formal bioequivalence study.
Danska je menila, da se zdravilo Solamocta bistveno razlikuje od referenčnega zdravila Amoxinsol 100 % m/m prašek za peroralno raztopino in da lahko te razlike zadostujejo, da se zahteva izvedba uradne študije biološke enakovrednosti.
Thus the CVMP concluded that the concerns expressed by Denmark should not prevent the granting of marketing authorisations and recommended marketing authorisation be granted in the concerned Member States.
Tako je zaključil, da pomisleki, ki jih je izrazila Danska, ne bi smeli preprečiti izdaje dovoljenj za promet z zdravilom, in priporočil, da se v zadevnih državah članicah izda dovoljenje za promet z zdravilom.
On 4 November 2015, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the veterinary medicinal product Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys.
Evropska agencija za zdravila je 4. novembra 2015 zaključila arbitražni postopek po nesoglasju med državami članicami Evropske unije (EU) v zvezi z izdajo dovoljenja za promet z zdravilom za uporabo v veterinarski medicini Solamocta 697 mg/g prašek za uporabo v pitni vodi za piščance, race in purane.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that a satisfactory justification has been provided that the product, Solamocta, is eligible for a waiver from the requirement to demonstrate in vivo bioequivalence with the reference product in accordance with section 7.1.c) of the CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.2) and that the excipients will not impact the bioavailability or safety of this product compared to the reference product.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v odboru CVMP je ta zaključil, da je bila podana zadovoljiva utemeljitev, da je zdravilo Solamocta upravičeno do odstopanja od zahteve za dokaz biološke enakovrednosti in vivo z referenčnim zdravilom v skladu s točko 7.1.c) Smernic CVMP o izvajanju študij biološke enakovrednosti za zdravila za uporabo v veterinarski medicini (EMA/CVMP/016/00-Rev. 2) in da pomožne snovi ne bodo vplivale na biološko uporabnost ali varnost tega zdravila v primerjavi z referenčnim zdravilom.
Solamocta contains 800 mg amoxicillin trihydrate (equivalent to 697 mg amoxicillin) as an active substance per gram product.
Zdravilo Solamocta vsebuje 800 mg amoksicilin trihidrata (kar ustreza 697 mg amoksicilina) kot zdravilno učinkovino na gram zdravila.