natgillin/translations-raw huggingface dataset:
Consult your veterinarian before using the veterinary medicinal product on sick or debilitated cats.
Pred uporabo zdravila pri bolanih ali izčrpanih mačkah se posvetujte s svojim veterinarjem.
ProMeris for Large Cats (> 4 kg)* *Due to limited space on the packaging, the abbreviations "S" and "L", which represent "small" and "large", respectively, are used on the blister foil and applicator pipettes.
(> 4 kg)* * Zaradi omejenega prostora na ovojnini sta na foliji in merilnih kapalkah uporabljeni oznaki: S (za majhne mačke) in L (za velike mačke).
The veterinary medicinal product is packaged in individual-dose transparent plastic pipettes overpacked in an aluminium foil package.
Zdravilo je pakirano v prozorne plastične merilne kapalke z enkratnim odmerkom, ki so ovite v ovitek iz aluminijaste folije.
Special precautions for storage Do not store above 25°C
POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte pri temperaturi nad 25 ºC
Wyeth Lederle Italia S.p.A. 18, Via Franco Gorgone 95121 Catania Italy
18, Via Franco Gorgone 95121 Catania Italija
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris S
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris S
Cats over 8 weeks of age.
Mačke, starejše od 8 tednov.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Dosage:
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
WASTE MATERIALS, IF ANY
ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
Each strength of the veterinary medicinal product is available in boxes with 1 and in boxes with 2 blister cards of 3 pipettes.
Vsaka jakost zdravila je na voljo v škatlah z 1 in v škatlah z 2 blistroma s po 3 merilnimi kapalkami.
Marketing authorisation holder Pfizer Limited
Imetnik dovoljenja za promet Pfizer Limited
For animal treatment only - to be supplied only on veterinary prescription.
Samo za živali - na veterinarski recept.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 160 mg
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 160 mg
The top of the tip will fold back against the pipette.
Vrh konice se bo upognil proti merilni kapalki.
Active substance: 320 mg metaflumizone
Zdravilna učinkovina: 320 mg metaflumizona
ProMeris for Small Cats (≤ 4 kg)
ProMeris za majhne mačke (≤ 4 kg)
In rare cases, transient irritation may occur at the site of the product application.
V redkih primerih se lahko pojavi prehodna iritacija na mestu nanosa zdravila.
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris L
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris L
ProMeris for Small Cats ProMeris for Large Cats
ProMeris za majhne mačke ProMeris za velike mačke
Active substance: 160 mg metaflumizone
Zdravilna učinkovina: 160 mg metaflumizona
Care should be taken to ensure that the content of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.
Poskrbite, da vsebina pipete ali nanešen odmerek ne pride v stik z očmi ali usti zdravljene živali in/ali drugih živali.
Method of administration:
Način dajanja:
Each ml contains 200 mg metaflumizone.
1 ml vsebuje 200 mg metaflumizona.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA
Carefully dispose of used pipettes immediately after use.
Takoj po uporabi prazno merilno kapalko previdno odstranite.
D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
D. DRUGI POGOJI IN ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA
Not applicable.
Ni smiselno
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS , IF ANY
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
Do not store above 25 °C.Do not use after the expiry date stated on the carton after “EXP”.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po “EXP”.
TARGET SPECIES For cats over 8 weeks of age.
CILJNE ŽIVALSKE VRSTE Za mačke, starejše od 8 tednov.
4.9 Amounts to be administered and administration route Dosage:
4.9 Odmerjanje in pot uporabe Odmerki:
The application of the veterinary medicinal product may produce a local, temporary oily appearance and clumping or spiking of the fur at the application site.
Nanos zdravila lahko lokalno povzroči začasen masten izgled, vozlanje in zlepljanje dlake na mestu nanosa.
The solvent in ProMeris may stain certain materials including leather, fabrics, plastics and finished surfaces.
Topilo v zdravilu Promeris lahko pusti madeže na nekaterih materialih, vključno z usnjem, tkaninami,
In sick or debilitated animals, use only according to the benefit/risk assessment by the responsible veterinarian.
Pri bolnih ali izčrpanih živalih uporabite le v skladu z oceno razmerja koristi/tveganja odgovornega veterinarja.
After topical administration at a single site on the cat's neck at the base of the skull, metaflumizone is rapidly distributed throughout the surface of the skin.
Po topikalnem nanosu na eno mesto vratu na zatilje glave mačke se metaflumizon hitro razporedi po površini kože.
Remove the pipette from the package.
Odstranite merilno kapalko iz ovojnine.
In case of accidental spillage onto skin, wash off immediately with soap and water.
Če zdravilo pride v stik s kožo, jo takoj dobro sperite z milom in vodo.
Apply the content of the pipette to a single spot on the skin of the cat's neck at the base of the skull.
Nanesite vsebino merilne kapalke na eno mesto kože vratu na zatilju glave mačke.
In sick or debilitated animals use only according to the benefit/risk assessment.
Pri bolnih ali izčrpanih živalih uporabite zdravilo le v skladu z oceno razmerja koristi/tveganja.
Pharmacotherapeutic group: ATC Vet Code QP 53AX25
Farmakoterapevtska skupina: Oznaka ATC vet QP 53AX25 Metaflumizon je ektoparazitik, ki po sestavi spada v skupino semikarbazonov.
BATCH NUMBER Lot {number}
ŠTEVILKA SERIJE LOT {številka}
BATCH NUMBER LOT {number}
ŠTEVILKA SERIJE Lot {številka}
It is important to apply the dose to an area where the animal cannot lick it off. Do not allow animals to groom each other following treatment.
Odmerek nanesite na mesto, kjer ga žival ne more polizati.
MARKETING AUTHORISATION NUMBER(S) EU/2/06/064/001 - 1 blister card of 3 pipettes of 0.80 ml EU/2/06/064/002 - 2 blister cards of 3 pipettes of 0.80 ml
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/064/001 - 1 blister s 3 merilnimi kapalkamipo 0,80 ml EU/2/06/064/002 - 2 blistra s 3 merilnimi kapalkami po 0,80 ml
4.2 Indications for use, specifying the target species Treatment and prevention of flea infestations (Ctenocephalides canis and C. felis) in cats.
INDIKACIJA(E) Zdravljenje in preprečevanje bolhavosti (Ctenocephalides canis in C. felis) pri mačkah.
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
DRUGI POGOJI IN ZAHTEVE KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 0.80 ml pipette delivers:
Vsaka 0,80 ml pipeta vsebuje:
NAME OF THE MARKETING AUTHORISATION HOLDER PFIZER
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM PFIZER
The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Zdravilo se lahko uporablja za zdravljenje in preprečevanje alergijskih dermatitisov zaradi bolhavosti (FAD) pri mačkah.
METHOD AND ROUTE(S) OF ADMINISTRATION For cutaneous use only.
NAČIN IN POT(I) UPORABE
The following table defines the size of pipette to be used according to the weight of the cat.
Sledeča tabela prikazuje ustrezno velikost merilne kapalke glede na telesno maso mačke.
PHARMACEUTICAL FORM Spot-on solution A clear, yellow to amber solution
FARMACEVTSKA OBLIKA Kožni nanos, raztopina Bistra, rumena do jantarna raztopina.
The following table defines the size of pipette to be used according to the weight of the cat
Sledeča tabela prikazuje ustrezno velikost merilne kapalke glede na telesno maso mačke
If the veterinary medicinal product accidentally gets into eyes, flush the eyes thoroughly with water.
Če zdravilo pride v stik z očmi, jih dobro sperite z veliko količino čiste vode.
TARGET SPECIES Cats above 8 weeks of age.
CILJNE ŽIVALSKE VRSTE Mačke, starejše od 8 tednov.
Correct application will minimise licking of the application site.
Pravilen nanos zmanjša možnost lizanja mesta nanosa.
This is normal and will generally resolve within 1 - 4 days after administration.
Opazen je lahko tudi suh ostanek, ki se razgradi v 1 - 4 dneh po dajanju.
Part the fur on the cat's neck at the base of the skull until the skin is visible.
Razprite dlako na vratu na zatilju glave, dokler ni vidna koža.
MARKETING AUTHORISATION NUMBER(S) EU/2/06/064/003 - 1 blister card of 3 pipettes of 1.60 ml EU/2/06/064/004 - 2 blister cards of 3 pipettes of 1.60 ml
EU/2/06/064/003 - 1 blister s 3 merilnimi kapalkami po 1,60 ml EU/2/06/064/004 - 2 blistra s 3 merilnimi kapalkami po 1,60 ml
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca(izdelovalcev) zdravila, odgovornega (odgovornih) za sprostitev serije
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box for 1 blister card -Carton box for 2 blister cards
PODATKI NA ZUNANJI OVOJNINI Kartonasta škatla z 1 blistrom - Kartonasta škatla z 2 blistroma
The veterinary medicinal product will prevent flea infestation for up to 6 weeks following a single administration depending on the level of environmental rechallenge.
Zdravilo po enkratnem dajanju ščiti pred bolhami do 6 tednov, odvisno od ponovne infestacije iz okolja.
Do not administer to kittens under 8 weeks of age.
KONTRAINDIKACIJE Ne dajajte mačkam, mlajšim od 8 tednov.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Active Substance
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI
Box of 1 or 2 blister card of 3 x 0.80 ml pipettes Box of 1 or 2 blister card of 3 x 1.60 ml pipettes
Škatla z 1 ali 2 blistroma s 3 x 0,80 ml merilnimi kapalkami Škatla z 1 ali 2 blistroma s 3 x 1,60 ml merilnimi kapalkami
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each 1.60 ml pipette delivers:
Vsaka 1,60 ml pipeta vsebuje:
4.6 Adverse reactions (frequency* and seriousness)
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
ProMeris for Small Cats (≤ 4 kg)*
ProMeris za majhne mačke (≤ 4 kg)* ProMeris za velike mačke
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris 320 mg Spot-on for large cats {> 4 kg}
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris 320 mg kožni nanos za velike mačke {> 4 kg}
Box of 1 blister card of 3 x 0.80 ml pipettes Box of 2 blister cards of 3 x 0.80 ml pipettes
VELIKOST PAKIRANJA Škatla z 1 blistrom s 3 x 0,80 ml merilnimi kapalkami Škatla z 2 blistroma s 3 x 0,80 ml merilnimi kapalkami
Box of 1 blister card of 3 x 1.60 ml pipettes Box of 2 blister cards of 3 x 1.60 ml pipettes
VELIKOST PAKIRANJA Škatla z 1 blistrom s 3 x 1,60 ml merilnimi kapalkami Škatla z 2 blistroma s 3 x 1,60 ml merilnimi kapalkami
C. STATEMENT OF THE MRLs Not applicable
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
INDICATION(S) For the treatment and prevention of infestations by fleas.
Za zdravljenje in preprečevanje bolhavosti.
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris 160 mg Spot-on for small cats ProMeris 320 mg Spot-on for large cats
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris 160 mg kožni nanos za majhne mačke ProMeris 320 mg kožni nanos za velike mačke
STATEMENT OF THE MRLs
( MRL)
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box for 1 blister card
PODATKI NA ZUNANJI OVOJNINI Kartonasta škatla z 1 blistrom Kartonasta škatla z 2 blistroma
For use only under the supervision of a veterinary surgeon.
NASVET O PRAVILNI UPORABI ZDRAVILA Uporabljajte samo pod nadzorom veterinarja
4.7 Use during pregnancy, lactation or lay
Uporaba v obdobju brejosti, laktacije ali nesnosti Lahko se uporablja v obdobju brejosti in laktacije.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROSTITEV SERIJE
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children.
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris 160 mg Spot-on for small cats {< 4 kg}
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI ProMeris 160 mg kožni nanos za majhne mačke {≤ 4 kg}
Allow the application site to dry before permitting contact with such materials.
plastiko in lakiranimi površinami, zato zagotovite, da se mesto nanosa posuši, preden pride v stik s takimi površinami.
PACKAGE LEAFLET ProMeris Spot-on for cats
NAVODILO ZA UPORABO ProMeris kožni nanos za mačke
Hypersalivation may occur if the animal licks the application site immediately after treatment.
NEŽELENI UČINKI* Če žival takoj po nanosu liže mesto nanosa, se lahko pojavi pretirano slinjenje.
Place the tip of the pipette on the skin and squeeze the pipette to empty the entire contents.
Merilno kapalko stisnite, dokler popolnoma ne izpraznite njene vsebine.
It is supplied in units of 3 pipettes per cardboard card and one or two cards per cardboard box.
V enem blistru so 3 merilne kapalke, v eni škatli sta 1 ali 2 blistra.
Avoid contact with the eyes of the cat and avoid oral ingestion by the animal.
Preprečite, da bi zdravilo prišlo v stik z očmi mačke, ali da bi ga žival pojedla..
CONTRAINDICATIONS
Posebna opozorila
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription.
B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom
Pfizer Limited Ramsgate Road Sandwich
PHARMACEUTICAL FORM Spot-on solution
FARMACEVTSKA OBLIKA Kožni nanos, raztopina
MINIMUM PARTICULARS TO APPEAR ON PIPETTES for small cats
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the CHMP concludes that:
Odbor CHMP zato v skladu s členoma 31 in 32 Direktive 2001/83/ES zaključuje naslednje:
In view of the elements described above, BfArM considered that there was a need to take action at EU level.
Glede na navedeno je inštitut BfArM ocenil, da je treba ukrepati na ravni EU.
Conclusions
Zaključki
Three bioequivalence trials, two performed in 2013 and one performed in 2014, were inspected.
Pregledana so bila tri preskušanja bioekvivalence, dve, opravljeni leta 2013, in eno, opravljeno leta 2014.
• The Committee reviewed all available data and information provided by the MAHs/applicants, as well as information provided by Alkem Laboratories;
• Odbor je pregledal vse razpoložljive podatke in informacije, ki so jih zagotovili imetniki dovoljenj za promet z zdravilom/predlagatelji, ter informacije, ki jih je predložila družba Alkem Laboratories;
The findings of the above mentioned inspection cast doubts on the reliability of the data of bioequivalence studies conducted between 2013 and 2014 at the site inspected.
Izsledki navedenega inšpekcijskega pregleda vzbujajo dvome o zanesljivosti podatkov iz študij bioekvivalence, opravljenih leta 2013 in 2014 na pregledani lokaciji.
It has been highlighted that all the CAPAs agreed after the BfArM/IGZ inspection have been either implemented (for critical observations) or committed to (for other observations).
Poudarjeno je bilo, da so bili vsi dogovorjeni korektivni in preventivni ukrepi po inšpekcijskem pregledu inštituta BfArM/inšpektorata IGZ bodisi izvedeni (za kritične napake) bodisi je bila zanje prevzeta obveznost izvedbe (za druge napake).
There was one general quality management system implemented at the site which included a quality assurance unit which was responsible for the clinical and the bioanalytical parts of the trial and which reported to the CEO of the facility.
Na lokaciji se je izvajal en splošni sistem vodenja kakovosti, ki je vključeval enoto za zagotavljanje kakovosti, odgovorno za klinični in bioanalitski del preskušanja, ki je poročala izvršnemu direktorju obrata.
The conditions imposed to lift the suspension of the marketing authorisation are set out in section 4 of this report.
Pogoji za preklic začasnega umika dovoljenja za promet z zdravilom so navedeni v razdelku 4 tega poročila.
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC for marketing authorisations and marketing authorisation applications for medicinal products for which the clinical and/or bioanalytical parts of the bioequivalence studies were performed at Alkem Laboratories Limited during the period between March 2013 and March 2015;
• Odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za dovoljenja za promet z zdravilom in vloge za pridobitev dovoljenja za promet z zdravilom za zdravila, za katera so bili klinični in/ali bioanalitski deli študij bioekvivalence opravljeni v družbi Alkem Laboratories Limited v obdobju med marcem 2013 in marcem 2015;
The Federal Institute of Drugs and Medical Devices (BfArM), Germany, and the Health Care Inspectorate (IGZ), Ministry of Health of the Netherlands performed a joint GCP inspection from 9 - 12 March 2015 at Alkem Laboratories Limited, Department of Bioequivalence, C-17/7, MIDC Industrial Estate, Taloja, Dist. Raigad - 410 208, India (Inspection references: BfArM: 2015 03 D / 2015_05_D, NL: VGR-1005124).
Nemški zvezni inštitut za zdravila in medicinske pripomočke (BfArM) in nizozemski zdravstveni inšpektorat pri ministrstvu za zdravje (IGZ) sta med 9. in 12. marcem 2015 opravila skupni inšpekcijski pregled dobre klinične prakse v družbi Alkem Laboratories Limited, Oddelek za bioekvivalenco, C-17/7, MIDC Industrial Estate, Taloja, Dist. Raigad - 410 208, Indija (referenca inšpekcijskega pregleda: BfArM: 2015 03 D / 2015_05_D, NL: VGR-1005124).
Intentional misrepresentation of data happened at the site in two different trials performed in 2013 and 2014.
Na tej lokaciji je pri dveh različnih preskušanjih, opravljenih leta 2013 in 2014, prišlo do namernega izkrivljanja podatkov.
On 8 March 2016 the BfArM initiated a referral under Article 31 of Directive 2001/83/EC, and asked the CHMP to assess the potential impact of the above findings on the benefit-risk balance of marketing authorisation applications and medicinal products authorised on the basis of relevant trials performed at the inspected site between March 2013-March 2015, and issue a recommendation on whether the marketing authorisations should be maintained, varied, suspended or revoked.
Inštitut BfArM je 8. marca 2016 sprožil napotitev v skladu s členom 31 Direktive 2001/83/ES in odbor CHMP zaprosil, naj oceni morebiten vpliv zgornjih izsledkov na razmerje med tveganji in koristmi vlog za pridobitev dovoljenja za promet z zdravilom in zdravil, odobrenih na podlagi ustreznih preskušanj, izvedenih na lokaciji, kjer je bil opravljen inšpekcijski pregled, med marcem 2013 in marcem 2015, in izda priporočilo o tem, ali je treba zadevna dovoljenja za promet z zdravilom ohraniti, spremeniti, začasno umakniti ali ukiniti.
The CHMP considered these data, however a conclusion on bioequivalence cannot be drawn from a simple comparison of dissolution profiles.
Odbor CHMP je upošteval te podatke, vendar iz enostavne primerjave profilov raztapljanja ni mogoče sprejeti zaključka o bioekvivalenci.
However, the CHMP is of the opinion that the absence of the identification of any pharmacovigilance signals does not provide sufficient reassurance because it is not established that the pharmacovigilance activities may be designed to detect such a signal.
da farmakovigilančni signali niso bili ugotovljeni, ne zagotavlja zadostne gotovosti, saj ni ugotovljeno, da so farmakovigilančne dejavnosti zasnovane na način, ki omogoča zaznavanje tovrstnih signalov.
The condition for the lifting of the suspension of the Marketing Authorisations, as applicable, is set out in Annex III.
Pogoj za preklic začasnega umika dovoljenj za promet z zdravilom, kot je ustrezno, je določen v Prilogi III.
As the quality management system covered all parts of the trial and a failure of the system in particular in relation to the ECGs monitoring was detected and acknowledged by the site, this system was considered by BfArM to be insufficient and severe failures in other areas of the trial could not be excluded even if not detected.
Ker je sistem vodenja kakovosti zajemal vse dele preskušanja, na lokaciji pa so odkrili in priznali odpoved sistema predvsem v povezavi s spremljanjem EKG, je inštitut BfArM ocenil, da je ta sistem nezadosten in torej ni mogoče izključiti hudih napak na drugih področjih preskušanja, tudi če niso bile odkrite.
Although Alkem agreed to the CAPAs and committed to implement them following the joint GCP inspection in March 2015, the fact that a second inspection in March 2016 by the MHRA identified critical/major findings during the period of concern further demonstrates that the quality management system in place during the period concerned by the procedure was suboptimal.
Čeprav se je družba Alkem strinjala s korektivnimi in preventivni ukrepi in se po skupnem inšpekcijskem pregledu dobre klinične prakse marca 2015 zavezala k njihovi izvedbi, dejstvo, da so z drugim inšpekcijskim pregledom, ki ga je marca 2016 opravila agencija MHRA, v zadevnem obdobju ugotovili kritične/večje napake, nadalje dokazuje, da sistem vodenja kakovosti, vzpostavljen na lokaciji v obdobju, na katerega se nanaša postopek, ni bil optimalen.
Marketing authorisation holders (MAHs) have argued that pharmacovigilance data collected on their medicinal products have not indicated any problems which could be attributed to non-bioequivalence, such as reduced efficacy or worsened safety and tolerability.
Več imetnikov dovoljenj za promet z zdravili je trdilo, da farmakovigilančni podatki, zbrani za njihova zdravila, niso pokazali nobenih težav, ki bi jih lahko pripisali odsotnosti bioekvivalence, kot so zmanjšana učinkovitost ali slabša varnost ali prenašanje.
In view of the inspection findings and the conclusion that there was a failure of the overall quality management system in place at the site, even of the ECG data for this particular study has no abnormalities, severe failures in other parts of the trial could not be excluded and all the data generated by the site during the period from March 2013 to March 2015 cannot be relied upon.
Glede na izsledke inšpekcijskega pregleda in zaključek, da je odpovedal celoten sistem vodenja kakovosti, vzpostavljen na lokaciji, tudi v primeru, da podatki o EKG pri tej študiji niso vključevali nepravilnosti, ni mogoče izključiti hudih napak v drugih delih preskušanja, zato se ni mogoče zanesti na nobene podatke, pridobljene na lokaciji v obdobju med marcem 2013 in marcem 2015.
A later MHRA inspection (March 2016) has also resulted in one critical and 2 major observations, for which CAPAs have already been agreed with the inspectors.
S poznejšim inšpekcijskim pregledom, ki ga je opravila agencija MHRA (marca 2016), so prav tako našli eno kritično in dve večji napaki.
Having assessed the alternative study, the CHMP considered that it supports bioequivalence of these medicinal products to the reference medicinal product Zinnat.
Po oceni alternativne študije je odbor CHMP menil, da podpira bioekvivalenco omenjenih zdravil z referenčnim zdravilom Zinnat.
The MAH also submitted an expert report with a reassessment of the original bioequivalence study performed by Alkem, concluding that no abnormalities were observed with the ECG data.
Imetnik dovoljenja za promet z zdravilom je predložil tudi strokovno poročilo, ki je vsebovalo ponovno oceno prvotne bioekvivalenčne študije, ki jo je opravila družba Alkem, v kateri so zaključili, da pri podatkih o EKG ni bilo nobenih nepravilnosti.
• The Committee concluded that the particulars supporting the marketing authorisation/marketing authorisation application are incorrect and that the benefit-risk balance is considered not favourable for:
• Odbor je zaključil, da podatki, ki podpirajo dovoljenje za promet z zdravilom/vlogo za pridobitev dovoljenja za promet z zdravilom, niso ustrezni in da razmerje med tveganji in koristmi ni ugodno za:
The CHMP therefore recommends the suspension of the marketing authorisation for Riluzole Alkem.
Odbor CHMP zato priporoča začasni umik dovoljenja za promet z zdravilom Riluzole Alkem.