natgillin/translations-raw huggingface dataset:
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE
4.7 Use during pregnancy, lactation or lay
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Če opazite kakršne koli resne stranske učinke ali tudi tiste, ki niso navedeni v tem navodilu za uporabo ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
0.1 mg. Colourless suspension.
0,1 mg Brezbarvna suspenzija
Can be used during pregnancy.
Lahko se uporablja v obdobju brejosti.
Colourless suspension.
Brezbarvna suspenzija.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni stranu Evropske agencije za zdravila (http://www.ema.europa.eu/ ).
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je smiselno
(*) In case of high level of maternally derived antibodies, first vaccination is recommended at 9 weeks of age.
(*) V primeru visokega titra maternalnih protiteles se prvo cepljenje priporoča pri starosti 9 tednov.
Store in a refrigerator (2 °C - 8 °C).
Shranjujte v hladilniku (2 °C - 8 °C).
Do not mix with any other veterinary medicinal product except those mentioned in section 4.8.
Ne mešajte z nobenim drugim zdravilom razen s tistimi, ki so navedeni v poglavju 4.8.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil za uporabo v veterinarski medicini, je treba odstraniti v skladu z lokalnimi zahtevami.
A small transient swelling at the site of injection (≤ 4 cm), which can occasionally be firm and painful on palpation, has been observed very commonly in clinical studies.
Majhno prehodno oteklino na mestu injiciranja (≤ 4 cm), ki je včasih lahko trda in boleča na otip, so v kliničnih študijah opazili zelo pogosto.
0.1 mg. For the full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Date of last renewal: 13/03/2017.
Datum pridobitve dovoljenja za promet: 16/ 07/ 2012 Datum zadnjega podaljšanja: 13/03/2017
Name and address of the manufacturer of the biological active substances
Ime in naslov proizvajalca bioloških učinkovin
SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Pred uporabo preberite navodilo za uporabo.
SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Shranjujte v hladilniku.
Overdose (symptoms, emergency procedures, antidotes):
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi)
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above.
Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini razen z zgoraj omenjenimi.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
Revaccination: Dogs should be re-vaccinated annually with one dose (1 ml) of vaccine.
Revakcinacija: Pse ponovno cepimo vsako leto z enim odmerkom (1 ml) cepiva.
A mild and transient increase in body temperature (≤ 1 °C) has been observed very commonly in clinical studies for a few days after vaccination, with some pups showing less activity and/or a reduced appetite.
Rahlo in prehodno povišanje telesne temperature (≤ 1°C), ki je trajalo nekaj dni po cepljenju, so zelo pogosto opazili v kliničnih študijah , nekateri mladiči so bili manj aktivni in/ali so imeli zmanjšan apetit.
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Tega zdravila za uporabo v veterinarski medicini ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
In case of ocular irritation seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru draženja oči se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
Shelf life of the veterinary medicinal product as packaged for sale: 21 months.
Rok uporabnosti zdravila v pakiranju za prodajo: 21 mesecev
Type I glass vial of 1 ml (1 dose) or 10 ml (10 doses) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Steklena viala tipa I po 1 ml (1 odmerek) ali 10 ml (10 odmerkov), zaprta z zamaškom iz halogenobutilne gume in zatesnjena z aluminijasto zaporko s šifro.
SPECIAL STORAGE PRECAUTIONS
POSEBNA NAVODILA ZA SHRANJEVANJE
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Zato se za uporabo tega cepiva pred ali po uporabi katerega koli drugega zdravila odločamo od primera od primera.
Shelf life after first opening the immediate container: 10 hours.
Rok uporabnosti po prvem odpiranju stičnega vsebnika: 10 ur
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
- občasni (pri več kot 1, toda manj kot 10 živalih od 1.000 zdravljenih živali) - redki (pri več kot 1 toda manj kot 10 živalih od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primere).
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
Vaccination scheme: Basic vaccination: The first vaccination can be administered from 6 to 9(*) weeks of age and the second vaccination from 10 to 13 weeks of age.
Osnovno cepljenje: Prvič lahko cepimo pri starosti od 6 do 9(*) tednov, drugič pa pri starosti od 10 do 13 tednov.
In very rare cases, clinical signs of immune-mediated haemolytic anaemia, immune-mediated thrombocytopenia, or immune-mediated polyarthritis have been reported.
V zelo redkih primerih so poročali o kliničnih znakih imunsko pogojene hemolitične anemije, imunsko pogojene trombocitopenije ali imunsko pogojenega poliartritisa.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
MANUFACTURER'S BATCH NUMBER Lot {number}
IZDELOVALČEVA ŠTEVILKA SERIJE
Not applicable.
Ni smiselno.
When mixed with these Nobivac vaccines, the demonstrated safety and efficacy claims for Nobivac L4 are no different from those described for Nobivac L4 alone.
Kadar se cepivo meša s temi cepivi Nobivac, se podatki o varnosti in učinkovitosti za Nobivac L4 ne razlikujejo od tistih, ki so opisani za samo cepivo Nobivac L4.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, ki nastanejo pri uporabi teh zdravil
C. STATEMENT OF THE MRLs Not applicable.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Ni smiselno.
Read the package leaflet before use.
Pred uporabo preberite navodilo za uporabo.
IMMUNOLOGICAL PROPERTIES
IMUNOLOŠKE LASTNOSTI
When mixed with Nobivac vaccines containing canine parainfluenza virus at annual revaccination, it has been established that there is no interference with the anamnestic response induced by the injectable canine parainfluenza virus component.
Kadar se to cepivo meša s cepivi Nobivac, ki vsebujejo virus pasje parainfluence, pri letni revakcinaciji, je bilo ugotovljeno, da to ne vpliva na anamnestični odziv, ki ga sproži injicirana komponenta virusa pasje parainfluence.
Shelf life after reconstitution of Nobivac vaccines according to directions: 45 mins.
Rok uporabnosti po rekonstituciji cepiva Nobivac v skladu z navodili: 45 minut
The mixed vaccines should be at room temperature (15°C - 25°C) before they are administered by subcutaneous injection.
Mešana cepiva naj bodo pri sobni temperaturi (15°C - 25°C), preden jih damo subkutano.
Before use, ensure that the vaccine is at room temperature (15°C - 25°C).
Subkutano dajanje Pred uporabo zagotovite, da je cepivo na sobni temperaturi (15°C - 25°C).
Pack sizes:
Velikosti pakiranj:
Incompatibilities: Do not mix with any other veterinary medicinal products except the above mentioned vaccines.
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini razen z zgoraj navedenimi cepivi.
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET
Special warnings for each target species: Vaccinate healthy animals only.
4.4 Posebna opozorila za vsako ciljno živalsko vrsto Cepite samo zdrave živali.
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
BESEDILO “SAMO ZA ŽIVALI” Samo za živali
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains:
Vsak odmerek po 1 ml vsebuje:
For example, local swelling, which can be up to 5 cm in diameter and which may take over 5 weeks to completely disappear, may be observed at the site of injection.
Na primer, na mestu injiciranja lahko opazite lokalno oteklino do 5 cm premera, ki lahko popolnoma izgine po več kot 5 tednih.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with vaccines of the Nobivac series containing Bordetella bronchiseptica and/or parainfluenza virus components for intranasal administration.
Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko daje isti dan toda ne mešano s cepivi serije Nobivac za intranazalno dajanje, ki vsebujejo bakterijo Bordetella bronchiseptica in/ali virus parainfluence.
4.2 Indications for use, specifying the target species
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
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 PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA RAZLIČNA
Cardboard box with 1 vial of 10 ml (10 doses).
Kartonska škatla z 1 vialo po10 ml (10 odmerkov).
To stimulate active immunity in dogs against L. interrogans serogroup Canicola serovar Canicola, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, and L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang.
Za stimulacijo aktivne imunosti pri psih proti serološkim skupinam L. interrogans Canicola serovar Canicola, L. interrogans Icterohaemorrhagiae serovar Copenhageni, L. interrogans Australis serovar Bratislava in L. kirschneri Grippotyphosa serovar Bananal/Lianguang.
The product information of the relevant Nobivac vaccines should be consulted before administration of the mixed product.
Pred dajanjem mešanega cepiva je treba preučiti navodila ustreznih cepiv Nobivac.
Plastic box with 5, 10, 25 or 50 vials of 1 ml Cardboard box with 1 vial of 10 ml
Plastična škatla s 5, 10, 25 ali 50 vialami po 1 ml Kartonska škatla z 1 vialo po10 ml
Sodium chloride Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi tiomersal natrijev klorid kalijev klorid dinatrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
Once broached, use within 10 hours.
Načeto/odprto zdravilo uporabite v 10 urah.
- L. interrogans serogroup Australis serovar Bratislava (strain As-05-073)
- serološka skupina L. interrogans Australis serovar Bratislava (sev As-05-073)
PHARMACEUTICAL FORM Suspension for injection.
Suspenzija za injiciranje.
- L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
- serološka skupina L. kirschneri Grippotyphosa serovar Dadas (sev Gr-01-005)
4.1 Target species
KLINIČNI PODATKI 4.1 Ciljne živalske vrste
Inactivated Leptospira strains: - L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000)
Serološka skupina L. interrogans Canicola serovar Portland-vere (sev Ca-12-000)
PACKAGE LEAFLET: Nobivac L4 suspension for injection for dogs
Nobivac L4 suspenzija za injiciranje za pse
- L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001)
- serološka skupina L. interrogans Icterohaemorrhagiae serovar Copenhageni (sev Ic-02-001)
Pharmacotherapeutic group: Immunologicals for Canidae, inactivated bacterial vaccines.
Farmakoterapevtska skupina: Imunološko zdravilo za pse (Canidae), inaktivirano bakterijsko cepivo Oznaka ATC vet QI07AB01.
METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
NAČIN IN POT(I) UPORABE
For simultaneous use, 1 dose of a Nobivac vaccine containing canine distemper virus, canine adenovirus type 2, canine parvovirus and/or canine parainfluenza virus components should be reconstituted with 1 dose (1 ml) of Nobivac L4.
Za sočasno dajanje je treba 1 odmerek cepiva Nobivac, ki vsebuje virus pasje kuge, pasji adenovirus tipa 2, pasji parvovirus in/ali virus pasje parainfluence, rekonstituirati z 1 odmerkom (1 ml) cepiva Nobivac L4.
Vial of 1 ml or 10 ml
Viala po 1 ml in 10 ml
4.5 Special precautions for use
4.5 Posebni previdnostni ukrepi Posebni previdnostni ukrepi za uporabo pri živalih
PHARMACEUTICAL FORM Suspension for injection
Suspenzija za injiciranje
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC BIOLOŠKIH UČINKOVIN IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac L4 suspension for injection for dogs
NAVODILO ZA UPORABO Nobivac L4 suspenzija za injiciranje za pse
Administer two vaccinations of 1 dose (1 ml) of vaccine with an interval of 4 weeks to dogs from 6 weeks of age onwards.
Pse od 6 tednov starosti dalje cepite dvakrat s po 1 odmerkom (1 ml) cepiva z razmikom 4 tednov.
Plastic box with 5, 10, 25 or 50 vials of 1 ml (1 dose).
Velikosti pakiranj: Plastična škatla s 5, 10, 25 ali 50 vialami po 1 ml (1 odmerek)
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
BESEDILO “ ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
Name and address of the manufacturer responsible for batch release
Nizozemska Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines of the Nobivac series containing canine distemper virus, canine adenovirus type 2, canine parvovirus, and/or canine parainfluenza virus components for subcutaneous administration.
Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša s cepivi serije Nobivac za subkutano dajanje, ki vsebujejo virus pasje kuge, pasji adenovirus tipa 2, pasji parvovirus ali virus pasje parainfluence.
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
5831 AN Boxmeer
For active immunisation of dogs against: - L. interrogans serogroup Canicola serovar Canicola to reduce infection and urinary excretion - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni to reduce infection and urinary excretion - L. interrogans serogroup Australis serovar Bratislava to reduce infection - L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang to reduce infection and urinary excretion.
Za aktivno imunizacijo psov proti: - serološka skupina L. interrogans Canicola serovar Canicola za zmanjšanje okužbe in izločanja z urinom - serološka skupina L. interrogans Icterohaemorrhagiae serovar Copenhageni za zmanjšanje okužbe in izločanja z urinom
Ask your veterinary surgeon how to dispose of medicines no longer required.
Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
In vitro and in vivo data in non-target species suggests that the vaccine may provide a degree of crossprotection against L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
Podatki in vivo in in vitro pri neciljnih živalskih vrstah kažejo, da cepivo lahko zagotovi določeno navzkrižno zaščito proti serološki skupini L. interrogans Icterohaemorrhagiae serovar
BATCH NUMBER Lot {number}
Serija {številka}
Excipient:
Učinkovine:
No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a double dose of vaccine.
Po dajanju dvojnega odmerka cepiva niso opazili drugih neželenih učinkov razen tistih, ki so navedeni v poglavju 4.6.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Wim de Körverstraat 35
3550-7100 U
3550-7100 E1
Active substances:
Pomožna snov:
No adverse reactions other than those mentioned in section 6 were observed after the administration of a double dose of vaccine.
Po dajanju dvojnega odmerka cepiva niso opazili drugih neželenih učinkov razen tistih, ki so navedeni v poglavju 6.
5 x 1 ml (1 dose) 10 x 1 ml (1 dose) 25 x 1 ml (1 dose) 50 x 1 ml (1 dose) 10 ml (10 doses)
25x 1 ml (1 odmerek)
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines of the Nobivac series containing canine distemper virus, canine adenovirus type 2, canine parvovirus and/or canine parainfluenza virus components for subcutaneous administration.
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in daje s cepivi serije Nobivac za subkutano dajanje, ki vsebujejo virus pasje kuge, pasji adenovirusa tipa 2, pasji parvovirus in/ali virus pasje parainfluence.
4.11 Withdrawal period
6.3 Rok uporabnosti
QUANTITY OF THE ACTIVE SUBSTANCE(S) See package leaflet.
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E)
ADVERSE REACTIONS
NEŽELENI UČINKI
STATEMENT OF ACTIVE SUBSTANCES Read the package leaflet before use.
NAVEDBA UČINKOVIN(E) Pred uporabo preberite navodilo za uporabo.
Marketing authorisation holder and manufacturer responsible for batch release:
Imetnik dovoljenja za promet z zdravilom in proizvajalec, odgovoren za sproščanje serij
EXPIRY DATE EXP {month/year} Once broached, use within 10 hours.
Načeto/odprto zdravilo uporabite v 10 urah (samo za vialo po 10 ml.
6.3 Shelf life
4.11 Karenca
PACKAGE SIZE
ŠTEVILKA SERIJE
London, 26 June 2008 Doc.
London, 26. junij 2008 Sklic dok.
International non-proprietary name (INN): gusperimus
Mednarodno nelastniško ime (INN): gusperimus
The CHMP normally takes up to 210 days to evaluate a new application.
CHMP običajno potrebuje do 210 dni za ocenjevanje nove vloge.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for SPANIDIN
VPRAŠANJA IN ODGOVORI V ZVEZI Z UMIKOM VLOGE ZA DOVOLJENJE ZA PROMET z zdravilom SPANIDIN
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Če ste vključeni v klinično preskušanje ali program sočutne uporabe ter potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
Ref. EMEA/309003/2008
EMEA/378432/2008 Error!
If left untreated, it can result in organ damage or death.
Če se bolezen ne zdravi, lahko pride do poškodbe organov ali celo smrti.
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Dopis, s katerim družba agencijo EMEA obvešča o umiku vloge, je na voljo tukaj.
Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a license.
Potem ko CHMP izda svoje mnenje, navadno traja približno dva meseca, preden Evropska komisija dovoljenje odobri.
Spanidin was designated as an orphan medicine on 29 March
Zdravilo Spanidin je bilo dne 29. marca 2001 določeno kot zdravilo sirota.
The main measure of effectiveness was the number of patients who stayed in remission (with no signs of active disease) for at least two months during treatment.
Glavno merilo učinkovitosti je bilo število bolnikov, ki so med zdravljenjem ostali v remisiji (brez znakov aktivne bolezni) vsaj dva meseca.
The effects of Spanidin were first tested in experimental models before being studied in humans.
Učinki zdravila Spanidin so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The CHMP noted that an additional study would be necessary to overcome these concerns.
CHMP je pripomnil, da bo potrebno izvesti dodatno študijo, s katero bodo omenjeni zadržki odpravljeni.
The CHMP was concerned that the main study was not sufficient to demonstrate the effectiveness of Spanidin, because of the way it was designed and carried out.
CHMP je bil zaskrbljen glede tega, da glavna študija ne zadostuje za dokaz učinkovitosti zdravila Spanidin zaradi načina, na katerega je bila načrtovana in izvedena.
This causes a range of symptoms that mainly affect the airways, lungs and kidneys.
Posledica tega je vrsta simptomov, ki večinoma prizadenejo dihalne poti, pljuča in ledvice.
In particular, the study included some patients who could have taken other treatments for their disease, so could not be considered to be ‘refractory'.
Še zlasti pa ker je študija vključevala nekaj bolnikov, ki bi lahko jemali druga zdravila za svojo bolezen, zato jih ni mogoče šteti za „refraktarne“.
After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Potem ko je CHMP ocenil odgovore družbe na seznam vprašanj, so nekatera tehtna vprašanja še vedno ostala nerešena.
In addition, Spanidin was not compared with any other treatment, so it was not possible to distinguish the effects of Spanidin and of steroids.
Poleg tega zdravila Spanidin niso primerjali z nobenim drugim zdravljenjem, zato ni mogoče ločiti med učinki zdravila Spanidin in učinki steroidov.
What documentation did the company present to support its application to the CHMP?
Katero dokumentacijo je družba predložila CHMP v podporo svoji vlogi?
What is Spanidin?
Kaj je zdravilo Spanidin?
What were the main concerns of the CHMP at that time?
Kateri so bili takrat glavni zadržki CHMP?
It contains the active substance gusperimus.
Vsebuje zdravilno učinkovino gusperimus.
Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Na podlagi pregleda začetne dokumentacije CHMP pripravi seznam vprašanj (120. dan), ki ga pošlje družbi.