natgillin/translations-raw huggingface dataset:
Common (more than 1 but less than 10 animals in 100 animals), Uncommon (more than 1 but less than 10 animals in 1,000 animals), Rare (more than 1 but less than 10 animals in 10,000 animals), Very rare (less than 1 animal in 10,000 animals, including isolated reports).
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pri več kot 1 živali od 10 živali med enim ciklom zdravljenja) - pogosti (pri več kot 1 a manj kot 10 živali od 100 živali) - občasni (pri več kot 1 a manj kot 10 živali od 1.000 živali) - redki (pri več kot 1 a manj kot 10 živali od 10.000 živali) - zelo redki (pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Leishmania infantum Excreted Secreted Proteins (ESP) at least 100 µg Adjuvant:
Leishmania infantum ekskrecijko-sekrecijski proteini (Excreted Secreted Proteins - ESP) najmanj 100 µg Dodatek:
EXP: {month/year} Use immediately after reconstitution.
Exp : {mesec/leto} Zdravilo porabite takoj po rekonstituciji.
Primary vaccination course: - First dose from 6 months of age, - Second dose 3 weeks later, - Third dose 3 weeks after the 2
Osnovno cepljenje: - prvi odmerek od starosti 6 mesecev, - drugi odmerek 3 tedne kasneje, - tretji odmerek 3 tedne po drugem odmerku.
Purified extract of Quillaja saponaria (QA-21): 60 µg
Prečiščeni ekstrakt Quillaja saponaria (QA-21): 60 µg
Lyophilisate: beige freeze-dried fraction Solvent: colourless liquid
Liofilizat: liofilizirana frakcija bež barve Vehikel: brezbarvna tekočina
Duration of immunity: 1 year after the last (re-)vaccination.
Trajanje imunosti: 1 leto po zadnjem cepljenju oz. ponovnem cepljenju.
Shelf life after first opening the immediate packaging: use immediately after reconstitution.
Rok uporabnosti po prvem odpiranju stične ovojnine: uporabite takoj po rekonstituciji.
Purified extract of Quillaja saponaria (QA-21) Trometamol
Prečiščeni ekstrakt Quillaja saponaria (QA-21) Trometamol
For the active immunization of Leishmania negative dogs from 6 months of age to reduce the risk to develop an active infection and clinical disease after contact with Leishmania infantum.
Za aktivno imunizacijo na Leishmanio negativnih psov, starejših od 6 mesece,, za zmanjšanje tveganja okužbe in kliničnih znakov bolezni, po stiku s parazitom Leishmania infantum.
After reconstitution of the lyophilisate with the solvent, shake gently and administer immediately one dose of 1 ml subcutaneously according to the following vaccination schedule: Primary vaccination course: - First dose from 6 months of age, - Second dose 3 weeks later, - Third dose 3 weeks after the 2
Subkutana uporaba.Po rekonstituciji liofilizata z vehiklom rahlo pretresite in dajte takoj subkutano en odmerek po 1 ml, v skladu s sledečimi programom cepljenja: Osnovno cepljenje: - prvi odmerek od starosti 6 mesecev, - drugi odmerek 3 tedne kasneje, - tretji odmerek 3 tedne po drugem odmerku.
darprocedure@virbac.com
dar@virbac.com
In rare cases anorexia and emesis have been reported.
V redkih primerih poročajo o anoreksiji in bruhanju.
Therefore, the use is not recommended during pregnancy and lactation.
Zato uporaba med brejostjo in laktacijo ni priporočljiva.
Each dose of 1 ml vaccine contains: L. infantum Proteins (ESP) ≥ 100 µg
Vsak odmerek po 1 ml cepiva vsebuje : Leishmania infantum proteini (ESP) ≥ 100 µg
L. infantum Proteins (ESP) ≥ 100 µg
L. infantum proteini (ESP) ≥ 100 µg
Box of 10 vials of lyophilisate and 10 vials of solvent Box of 15 vials of lyophilisate and 15 vials of solvent Box of 25 vials of lyophilisate and 25 vials of solvent Box of 30 vials of lyophilisate and 30 vials of solvent Box of 50 vials of lyophilisate and 50 vials of solvent
Škatla s 10 vialami liofilizata in 10 vialami vehikla Škatla z 15 vialami liofilizata in 15 vialami vehikla Škatla z 25 vialami liofilizata in 25 vialami vehikla Škatla z 30 vialami liofilizata in 30 vialami vehikla Škatla z 50 vialami liofilizata in 50 vialami vehikla
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJE DOVOLJENJA ZA PROMET
Injection of the vaccine to dogs already infected by Leishmania infantum did not show any specific adverse reactions other than those described in section 4.6.
Dajanje cepiva psom, ki so že okuženi s parazitom Leishmania infantum, ni pokazalo neželenih učinkov, razen tistih, ki so navedeni v poglavju 4.6.
De-worming of infested dogs prior to vaccination is recommended.
Pred cepljenjem priporočamo dehelmintizacijo okuženih psov.
Solvent: Sodium chloride solution 9 mg/ml (0.9%)
Vehikel: Raztopina natrijevega klorida 9 mg/ml (0.9%) 1 ml
After reconstitution of the lyophilisate with the solvent, shake gently and administer immediately one dose of 1 ml subcutaneously according to the vaccination schedule.
Po rekonstituciji liofilizata z vehiklom rahlo pretresite in dajte takoj subkutano en odmerek po 1 ml, v skladu s sledečimi programom.
Annual re-vaccination: - One booster injection of a single dose should be given 1 year after the third injection and annually thereafter.
Letno ponovno cepljenje: - Krepitvena injekcija-en odmerek 1 leto po tretjem odmerku in nato enkrat letno.
CaniLeish lyophilisate and solvent for suspension for injection for dogs
CaniLeish liofilizat in vehihel za suspenzijo za injiciranje za pse.
Each dose of 1 ml vaccine contains:
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsak odmerek po 1 ml cepiva vsebuje:
Injection of the vaccine to dogs already infected by Leishmania infantum did not show any specific adverse reactions other than those described in section 6.
Dajanje cepiva psom, ki so že okuženi s parazitom Leishmania infantum, ni pokazalo neželenih učinkov, razen tistih, ki so navedeni v poglavju 6.
Sodium chloride 9 mg/ml (0.9%)
9 mg/ml (0.9%) natrijevega klorida.
Tel. 0033/4.92.08.73.00
Tel. 0033/4.92.08.73.00 Faks.
The detection of Leishmania infection using a rapid serological diagnostic test is recommended prior to vaccination.
Pred cepljenjem je priporočljivo izvesti hiter serološki diagnostični test za ugotavljanje okuženosti z Leishmanio.
A symptomatic treatment should be rapidly implemented and clinical monitoring should be maintained until symptoms resolve.
Potrebno je hitro simptomatsko zdravljenje in treba je vzdrževati klinični nadzor, dokler dokler simptomi niso odpravljeni.
In case of anaphylactic reaction appropriate symptomatic treatment should be administered and clinical monitoring should be maintained until symptoms resolve.
V primeru anafilaktične reakcije je treba uvesti primerno simptomatsko zdravljenje in klinični nadzor je treba vzdrževati, dokler simptomi niso odpravljeni.
BATCH NUMBER
SERIJSKA ŠTEVILKA
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
BESEDILO »ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM«
Name and address of the manufacturer of the biological active substance
Ime in naslov izdelovalcabiološke zdravilne učinkovine)
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJE, ČE STA RAZLIČNA Imetnik dovoljenja za promet z zdravilom in izdelovalec:
4.5 Special precautions for use
4.5 Posebni previdnosti ukrepi
Active substance:
Zdravilne učinkovine:
1 dose
1 odmerkom
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca) zdravila, odgovornega za sprostitev serije
Transient antibodies against Leishmania detected by immunofluorescence antibody test (IFAT) may appear after vaccination.
Po cepljenju se lahko razvijejo prehodna protitelesa proti Leshmania, ki jih odkrije imunofluorescenčni test za ugotavljanje protiteles (IFAT).
Type I glass vial containing 1 dose of lyophilisate and type I glass vial containing 1 ml of solvent, both closed with a butyl elastomer closure and sealed with an aluminium cap.
Viala iz stekla tipa I z 1 odmerkom liofilizata in viala iz stekla tipa I z 1 ml vehikla, zaprti z z zamaškom iz butilelastomera in zapečateni z aluminijastim pokrovčkom.
1 dose.
1 odmerkom.
Lyophilisate and solvent for suspension for injection.
Liofilizat in vehikel -suspenzija za injiciranje.
30 doses.
30 odmerkov.
Efficacy data have shown that a vaccinated dog has 3.6 times less risk to develop an active infection and 4 times less risk to develop a clinical disease than a non-vaccinated dog, on dogs submitted to multiple natural parasite exposure in zones with high infection pressure.
Podatki o učinkovitosti pri psih, ki so bili izpostavljeni številnim naravnim parazitom na območjih, kjer je okuženost zelo razširjena, kažejo, da imajo cepljeni psi 3-krat manj možnosti, da bi se okužili in 4krat manj možnosti, da bi razvili bolezen, kot necepljeni psi..
CaniLeish solvent
CaniLeish vehikel
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI OPADNIH SNOVI, ČE OBSTAJAJO
• a T-cell lymphoproliferation with the secretion of interferon gamma cytokine,
• proliferacijaT limfocitov z izločanjem interferon- gama citokinov
25 doses.
25 odmerkov.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROSTITEV SERIJE
10 doses.
10 odmerkov.
PACKAGE SIZE
VELIKOST OVOJNINE
3 doses.
3 odmerkov.
Box of 3 vials of lyophilisate and 3 vials of solvent Box of 5 vials of lyophilisate and 5 vials of solvent
Škatla s 3 vialami liofilizata in 2 vialami z vehikla Škatla s 5 vialami liofilizata in 5 vialami z vehikla
The frequency of adverse reactions is defined using the following convention: Very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment),
Pogostost škodljivih reakcij definiramo tako, da uporabimo naslednji dogovor: - Zelo običajna (več kot 1 od 10 živali kaže znake škodljivih reakcij med potekom enega postopka zdravljenja), - Običajna (več kot 1, toda manj kot 10 živali od 100), - Nepogosta (več kot 1, toda manj kot 10 živali od 1000), - Redka (več kot 1, toda manj kot 10 živali od 10.000), - Zelo redka (manj kot 1 žival od 10.000, vključno z ločenimi poročili)
50 doses.
50 odmerkov.
EU/2/11/121/001-009
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/11/121/001-009
Box of 1 vial of lyophilisate and 1 vial of solvent Box of 1 vial of lyophilisate, 1 vial of solvent, 1 syringe and 1 needle.
Škatla z 1 vialo liofilizata in 1 vialo z vehikla Škatla z 1 vialo liofilizata, 1 vialo z vehikla, 1 vbrizgo in 1 iglo.
15 doses.
15 odmerkov.
Plastic box containing 1 vial of 1 dose of lyophilisate, 1 vial of 1 ml of solvent, 1 syringe and 1 needle.
Plastična škatla z 1 vialo z 1 dozo liofilizata, 1 vialo z 1 ml topila, 1 brizgo in 1 iglo.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC(IZDELOVALCI) BIOLOŠKE AKTIVNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
5 doses.
5 odmerkov.
METHOD AND ROUTE OF ADMINISTRATION
NAČIN IN POT(IT) UPORABE
Ask your veterinary surgeon how to dispose of medicines no longer required.
Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem ali farmacevtom.
4.1 Target species
KLINIČNI PODATKI 4.1 Ciljne živalske vrste Psi.
Plastic box containing 3 vials of 1 dose of lyophilisate and 3 vials of 1 ml of solvent.
Plastična škatla s 3 vialami z 1 dozo liofilizata in 3 vialami z 1 ml topila.
Plastic box containing 30 vials of 1 dose of lyophilisate and 30 vials of 1 ml of solvent.
Plastična škatla s 30 vialami z 1 dozo liofilizata in 30 vialami z 1 ml topila.
Plastic box containing 1 vial of 1 dose of lyophilisate and 1 vial of 1 ml of solvent.
Plastična škatla z 1 vialo z 1 odmerkom liofilizata in 1 vialo z 1 ml vehikla.
Plastic box containing 25 vials of 1 dose of lyophilisate and 25 vials of 1 ml of solvent.
Plastična škatla s 25 vialami z 1 dozo liofilizata in 25 vialami z 1 ml topila.
Sucrose
KARENCA
Plastic box containing 10 vials of 1 dose of lyophilisate and 10 vials of 1 ml of solvent.
Plastična škatla z 10 vialami z 1 odmerkom liofilizata in 10 vialami z 1 ml vehikla.
Fax.
Subkutana .
Plastic box containing 15 vials of 1 dose of lyophilisate and 15 vials of 1 ml of solvent.
Plastična škatla s 15 vialami z 1 dozo liofilizata in 15 vialami z 1 ml topila.
Plastic box containing 5 vials of 1 dose of lyophilisate and 5 vials of 1 ml of solvent.
Plastična škatla s 5 vialami z 1 dozo liofilizata in 5 vialami z 1 ml topila.
Plastic box containing 50 vials of 1 dose of lyophilisate and 50 vials of 1 ml of solvent.
Plastična škatla s 50 vialami z 1 odmerkom liofilizata in 50 vialami z 1 ml vehikla.
No adverse reactions other than those mentioned in section 6 were observed after the administration of a double-dose of the vaccine.
Po dajanju dvojnega odmerka cepiva niso opazili neželenih učinkov, razen tistih, navedenih v poglavju
Interactions with other medicinal products
POT(I) UPORABE ZDRAVILA
London, 20 November 2008 Doc.
London, 20. november 2008 Sklic dok.
Ref. EMEA/586612/2008
EMEA/650811/2008
The antibiotics were given for up to 14 days.
Bolniki so antibiotike prejemali do 14 dni.
International non-proprietary name (INN): telavancin
Mednarodno nelastniško ime (INN): telavancin
The main measure of effectiveness was the number of patients whose infection had been cured after the end of treatment.
Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bila okužba po koncu zdravljenja ozdravljena.
The studies were carried out at sites where infection with MRSA is common.
Študiji sta bili izvedeni na lokacijah, kjer je okužba z MRSA pogosta.
The effects of Vibativ were first tested in experimental models before being studied in humans.
Učinki zdravila Vibativ so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The Committee was also concerned that Vibativ may cause ‘QTc prolongation' (an alteration of the electrical activity of the heart).
Odbor je bil zaskrbljen tudi glede tega, da bi lahko Vibativ povzročil „podaljšanje intervala QTc“ (spremembo električne aktivnosti srca).
Together, the cell wall and membrane form a barrier between the bacterial cell contents and the external environment.
Celična stena in membrana skupaj tvorita pregrado med vsebino bakterijske celice in zunanjim okoljem.
The CHMP also had concerns regarding the production of the medicine, its stability and the possible presence of impurities.
CHMP je imel zadržke tudi glede proizvodnje zdravila, njegove stabilnosti in možne prisotnosti nečistoč.
These include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Te vključujejo Staphylococcus aureus (vključno s tistimi oblikami, ki so odporne na meticilin, poznane kot „MRSA“) in Streptococcus pyogenes.
Questions and answers on the withdrawal of the marketing application for Vibativ
Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Vibativ
‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
„Zapletena“ pomeni, da je okužbo težko zdraviti, ker se je razširila globoko v podkožno tkivo, ali da je morda potrebno zdravljenje s kirurškim posegom ali pa ima bolnik še druge zdravstvene težave, ki lahko vplivajo na odziv na zdravljenje.
What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Vibativ?
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Vibativ?
By disrupting this barrier, telavancin is expected to kill the bacteria that are causing the infection.
Z oviranjem delovanja te pregrade naj bi telavancin uničil bakterije, ki povzročajo okužbo.
Vibativ was compared with vancomycin (another antibiotic) in two main studies involving a total of 2,079 adults with complicated skin and soft tissue infections due to Gram-positive bacteria.
Zdravilo Vibativ so primerjali z vankomicinom (drugim antibiotikom) v dveh glavnih študijah, ki sta vključevali skupno 2 079 odraslih z zapletenimi okužbami kože in mehkega tkiva zaradi grampozitivnih bakterij.
On 20 October 2008, Astellas Pharma Europe B. V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vibativ, for the treatment of complicated skin and soft tissue infections in adults.
Družba Astellas Pharma Europe B. V. je dne 20. oktobra 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Vibativ, namenjenim zdravljenju zapletenih okužb kože in mehkega tkiva pri odraslih.
The active substance in Vibativ, telavancin, is an antibiotic that belongs to the group ‘glycopeptides'.
Zdravilna učinkovina v zdravilu Vibativ, telavancin, je antibiotik, ki spada v skupino „glikopeptidov“.
The company informed the CHMP that there are currently no clinical trials or compassionate use programmes ongoing with Vibativ.
Družba je obvestila CHMP, da trenutno ne potekajo nobena klinična preskušanja ali programi sočutne uporabe zdravila Vibativ.
Hence, the CHMP recommended that Vibativ be refused marketing authorisation.
CHMP je zato priporočil zavrnitev dovoljenja za promet z zdravilom Vibativ.
It is expected to work in two ways, both by stopping the bacteria making their cell walls and by disrupting their cell membranes.
Deloval naj bi na dva načina, in sicer s preprečevanjem izgradnje celične stene bakterije in z oviranjem delovanja njihove celične membrane.
The CHMP was concerned that there was no additional benefit of Vibativ over vancomycin, and could cause more kidney damage than vancomycin.
CHMP je bil zaskrbljen, ker zdravilo Vibativ nima dodatnih koristi v primerjavi z vankomicinom in lahko povzroči večjo poškodbo ledvic kot vankomicin.
Vibativ was to be used only when the infection was known or thought to be caused by types of bacteria that are classified as ‘Gram-positive'.
Zdravilo Vibativ bi se naj uporabljalo samo v primeru, ko vemo ali menimo, da okužbo povzročajo vrste bakterij, ki spadajo med „grampozitivne“ bakterije.
Based on the review of the data and the company's responses to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Vibativ could not have been approved for the treatment of complicated skin and soft tissue infections in adults.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da se zdravila Vibativ ne more odobriti za zdravljenje zapletenih okužb kože in mehkega tkiva pri odraslih.
What is Vibativ?
Kaj je zdravilo Vibativ?
What was Vibativ expected to be used for?
Za kaj naj bi se zdravilo Vibativ uporabljalo?
The application was at day 201 when the company withdrew.
Družba je vlogo umaknila na 201. dan postopka.
Vibativ was expected to be used to treat adults with complicated infections of the skin and the ‘soft tissues' below the skin.
Zdravilo Vibativ naj bi se uporabljalo za zdravljenje odraslih z zapletenimi okužbami kože in „mehkega tkiva“, ki se nahaja pod kožo.
How is Vibativ expected to work?
Kako naj bi zdravilo Vibativ delovalo?
Vibativ is a powder to be made up into a solution for infusion (drip into a vein).
Zdravilo Vibativ je prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
It contains the active substance telavancin.
Vsebuje zdravilno učinkovino telavancin.
At that point in time, the CHMP was of the opinion that the benefits of Vibativ in the treatment of complicated skin and soft tissue infections in adults did not outweigh its risks.
CHMP je bil mnenja, da koristi zdravila Vibativ pri zdravljenju zapletenih okužb kože in mehkega tkiva pri odraslih ne odtehtajo z njim povezanih tveganj.
Once the company has supplied responses to the questions, the CHMP reviews them and may, before
Ko družba predloži odgovore na vprašanja, jih CHMP pregleda in lahko pred izdajo svojega mnenja na 180. dan postopka zastavi morebitna druga vprašanja.
• The Committee considered (Co-)Rapporteur's assessment report;
• odbor je upošteval poročilo o oceni (so-)poročevalca;
Annex II Scientific conclusions
Priloga II Znanstveni zaključki
This minor difference in concentration (5.93%) is expected to be reduced even more by the available saliva in the mouth.
Ta manjša razlika v koncentraciji (5,93 %) naj bi se zaradi razpoložljive sline v ustih še zmanjšala.
This justification was accepted by the CHMP.
Odbor CHMP je to obrazložitev sprejel.
Grounds for the CHMP opinion
Podlaga za mnenje odbora CHMP
The benefit-risk balance of the applied medicinal product is considered positive.
Razmerje med tveganji in koristmi predlaganega zdravila velja za pozitivno.
• The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as potential serious risk to public health and the questions asked by the CHMP;
• odbor je proučil vse podatke, ki jih je predložil predlagatelj v odziv na zadržke glede morebitnih resnih tveganj za javno zdravje in vprašanja, ki mu jih je odbor zastavil;
First, the lower amount of cyclodextrins is preferable from a safety point of view.
Prvič, manjša količina ciklodekstrinov je s stališča varnosti boljša.
The product information remains as per the final version achieved during the Coordination group procedure as mentioned in Annex III of the CHMP opinion.
Informacije o zdravilu ostajajo take, kot so v končni različici, pripravljeni v postopku skupine za usklajevanje, kakor je navedeno v Prilogi III k mnenju odbora CHMP.
• The Committee was of the view that the submitted in-vitro studies and bibliographical data demonstrate sufficiently the safety and efficacy of the medicinal product.
• odbor je menil, da predložene študije in vitro in bibliografski podatki zadovoljivo dokazujejo varnost in učinkovitost zdravila,
The CHMP also considered that the different amount of cyclodextrins is not of concern.
Odbor CHMP je menil tudi, da razlika v količini ciklodekstrinov ni zaskrbljujoča.
However, there are some quantitative and qualitative differences among the products which concern:
Kljub temu je med zdraviloma nekaj količinskih in kakovostnih razlik, ki se nanašajo na:
The applicant has requested a waiver of the need to conduct clinical studies.
Predlagatelj je zaprosil za izvzetje iz obveznosti izvedbe kliničnih študij.
The drug inhibits the synthesis of prostaglandins by mixed inhibition of the enzymes COX-1/COX-2 with some selectivity towards COX-1.
Zdravilo zavira sintezo prostaglandinov z mešanim zaviranjem encimov COX-1/COX-2, z določeno selektivnostjo do COX-1.
Therefore, this difference in concentration is considered insignificant and clinically irrelevant, taking into consideration that eventually the same dose is administered locally.
Zato ta razlika v koncentraciji velja za nepomembno in klinično brezpredmetno, ob upoštevanju, da je lokalno uporabljen praktično enak odmerek.
The removal of one of the flavours from the formulation had been discussed as a factor that could potentially affect the saliva secretion resulting in an unequal contribution to the local action.
O odstranitvi ene od arom iz formulacije so razpravljali kot o dejavniku, ki bi lahko vplival na izločanje sline, to pa bi privedlo do neenakomernega prispevka k lokalnemu delovanju.