natgillin/translations-raw huggingface dataset:
To stimulate active immunity of sheep and cattle against bluetongue virus serotype(s) related to those contained in the vaccine.
Za stimulacijo aktivne imunosti ovac in goveda proti serotipu(om) virusa bolezni modrikastega jezika, povezanega(ih) s tistimi, ki jih vsebuje cepivo.
In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multi injection type vaccination system when larger dose presentations are used.
Da bi se izognili naključni kontaminaciji cepiva med uporabo, je pri uporabi večjih pakiranjih priporočljivo uporabljati sistem multiinjekcijskega cepljenja.
20 ml (10 doses)
20 ml (10 odmerkov)
Al3+ (as hydroxide)
(Al3+) ( kot aluminijev hidroksid)
Detailed information on this veterinary medicinal product is available on the website of the European
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
A local reaction at the injection site may occur very commonly after vaccination.
Zelo pogosto se lahko po cepljenju na mestu injiciranja pojavi lokalna reakcija.
Method of administration (sheep and cattle)
Način dajanja (ovce in govedo)
Overdose (symptoms, emergency procedures, antidotes):
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Ovce:
Interaction with other medicinal products and other forms of interaction: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
SC (sheep) / IM (cattle)
s.c. (ovce) / i.m.
OTHER INFORMATION Pack sizes:
DRUGE INFORMACIJE Pakiranja:
It can be used during lactation in cattle.
Lahko se uporablja v obdobju laktacije pri govedu.
Each dose of 2 ml of vaccine contains:
Vsak odmerek (2 ml) vsebuje:
The safety of the vaccine has not been established during lactation in sheep.
Varnost zdravila v obdobju laktacije ni bila ugotovljena pri ovcah.
Camprodon s/n "la Riba" 17813 Vall de Bianya Girona
17813 Vall de Bianya
Zero days.
dni).
Quil-A (Quillaja saponaria saponin extract)
Qil-A (Quillaja saponaria izvleček saponina)
Pregnancy: Can be used during pregnancy in sheep and cattle.
Brejost: Lahko se uporablja v obdobju brejosti pri ovcah in govedu.
Inactivated bluetongue virus, serotype 4, strain SPA-1/2004
inaktiviran virus bolezni modrikastega jezika, serotip 4, sev SPA-1/2004
100 ml (50 doses) 240 ml (120 doses)
100 ml (50 odmerkov) 240 ml (120 odmerkov)
A transient increase in rectal temperature, not exceeding 2 °C, may occur in 10% of the animals during the 24 hours following administration of a two-fold overdose.
Pri 10 % živali se lahko v 24 urah po dajanju 2-krat prevelikega odmerka pojavi prehodno povišanje rektalne temperature, ki ne presega 2 °C.
High density polyethylene (HDPE) bottles of 20, 100 or 240 ml with chlorobutyl elastomer stopper and aluminium seal.
20 ml, 100 ml ali 240 ml plastenke iz polietilena visoke gostote (HDPE) z zamaškom iz klorobutilnega elastomera in aluminijsko zaporko.
20 ml (10 doses) 100 ml (50 doses) 240 ml (120 doses)
20 ml (10 odmerkov) 100 ml (50 odmerkov) 240 ml (120 odmerkov)
Zulvac BTV suspension for injection for sheep
Zulvac BTV suspenzija za injiciranje za ovce
Once broached, use immediately.
Načeto uporabite takoj.
After administration with a double dose (4 ml), reactions in sheep are similar to those seen after administration of a single dose, but injection site reactions may persist for a longer time (general swelling at the injection site persisting for not more than 9 days or subcutaneous granuloma possibly persisting for more than 63 days).
Po dajanju dvojnega odmerka (4 ml) so reakcije pri ovcah podobne tistim pri dajanju enojnega odmerka, le da reakcije na mestu injiciranja trajajo dalj časa (oteklina na mestu injiciranja običajno traja do 9 dni, subkutani granulomi pa lahko trajajo tudi več kot 63 dni .
Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 12 weeks of age.
Dajte en odmerek (2 ml) v skladu z naslednjim programom cepljenja: 1. injekcija: od 12. tedna starosti.
These reactions take the form in most cases of a diffuse swelling of the injection site (persisting for not more than 7 days) or of palpable nodules up to a size of 60 cm2 (subcutaneous granuloma, decreasing in size over time but possibly persisting for more than 50 days).
Te reakcije so v večini primerov v obliki difuzne otekline na mestu injiciranja (ki ne traja več kot 7 dni) ali kot otipljivi noduli v velikosti do 60 cm2 (subkutani granulomi, ki se sčasoma zmanjšajo in lahko trajajo tudi več kot 50
Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 6 weeks of age.
Dajte en odmerek (2 ml) v skladu z naslednjim programom cepljenja: 1. injekcija: od 6. tedna starosti.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
Local reactions of < 2 cm diameter were very commonly observed while reactions of up to 5 cm diameter were commonly observed after administration of a single dose in field safety studies.
V terenskih študijah o varnosti zdravila so po dajanju enkratnega odmerka zelo pogosto opazili lokalne reakcije premera < 2 cm, ter pogosto reakcije premera do 5 cm po dajanju enkratnega odmerka.
Revaccination:
Ponovno cepljenje
Zulvac BTV suspension for injection for sheep and cattle
Zulvac BTV suspenzija za injiciranje za ovce in govedo
Per dose of 2 ml: Inactivated BTV, serotype 4
V odmerku 2 ml: Inaktiviran virus bolezni modrikastega jezika, serotip 4
Quil-A (Quillaja saponaria saponin extract) Thiomersal
Quil -A (Quillaja saponaria izvleček saponina) Tiomersal
Cardboard box with 1 bottle of 120 doses (240 ml).
Kartonska škatla z 1 plastenko s 120 odmerki (240 ml).
Cardboard box with 1 bottle of 10 doses (20 ml).
Kartonska škatla z 1 plastenko z 10 odmerki (20 ml).
Duration of immunity: 12 months after completion of the primary vaccination scheme.
Trajanje imunosti: 12 mesecev po končanem osnovnem programu cepljenja.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box 1 x 20 ml, 1 x 100 ml and 1 x 240 ml (BTV-4 for sheep)
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla 1 x 20 ml, 1 x 100 ml in 1 x 240 ml (BTV-4 za ovce)
The safety and the efficacy of the vaccine have not been established in breeding males.
Varnost in učinkovitost zdravila ni bila ugotovljena pri plemenskih samcih.
Cardboard box with 1 bottle of 50 doses (100 ml).
Kartonska škatla z 1 plastenko s 50 odmerki (100 ml).
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box 1 x 20 ml, 1 x 100 ml and 1 x 240 ml (BTV-1 for sheep and cattle; BTV-8 for sheep and cattle)
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla 1 x 20 ml, 1 x 100 ml in 1 x 240 ml (BTV-1 za ovce in govedo; BTV-8 za ovce in govedo)
Local reactions of up to 5 cm diameter were very commonly observed and reactions > 5 cm diameter were commonly observed after repeated administration of a single dose in field safety studies.
V študijah o varnosti zdravila so po ponavljajočem dajanju enkratnega odmerka pogosto opazili reakcije > 5 cm.
One of the following inactivated bluetongue virus strains: Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1
En izmed naslednjih inaktiviranih sevov virusa bolezni modrikastega jezika: inaktiviran virus bolezni modrikastega jezika, serotip 1, sev BTV-1/ALG2006/01 E1 RP* ≥ 1 inaktiviran virus bolezni modrikastega jezika, serotip 8, sev BTV-8/BEL2006/02
PACKAGE LEAFLET: Zulvac BTV suspension for injection for sheep and cattle
NAVODILO ZA UPORABO Zulvac BTV suspenzija za injiciranje za ovce in govedo
Pack sizes:
Velikost pakiranj:
A transient increase in rectal temperature, not exceeding 2.7 °C, was commonly observed during the 48 hours following vaccination in field safety studies.
V terenskih študijah o varnosti zdravila so v 48 urah po cepljenju zelo pogosto opazili prehodno povišanje rektalne temperature, ki ne presega 2,7 °C.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 100 ml and 240 ml (BTV-1 for sheep and cattle; BTV-8 for sheep and cattle)
Plastenka po 100 ml in 240 ml (BTV-1 za ovce in govedo; BTV-8 za ovce in govedo)
Al3+ (as hydroxide), Quil-A (Quillaja saponaria saponin extract), thiomersal.
aluminijev hidroksid, Quil-A (Quillaja saponaria izvleček saponina), tiomersal.
Onset of immunity: 21 days after completion of the primary vaccination scheme.
Nastop imunosti: 21 dni po končanem osnovnem programu cepljenja.
*Below the level of detection of < 3.9 log10 genome copies/ml by the validated RT-qPCR method, indicating no presence of viral genome.
* Pod nivojem detekcije < 3,9 log10 kopij genoma/ml, pri validirani metodi RT-qPCR, kar kaže, da virusni genom ni prisoten.
For protection against serotype 1 or serotype 8, administer one dose of 2 ml, every 12 months.
Za zaščito proti serotipu 1 ali serotipu 8, dajte en odmerek (2 ml), vsakih 12 mesecev.
**Below the level of detection of < 3.4 log10 genome copies/ml by a validated RT-qPCR method, indicating no presence of viral genome.
**Pod nivojem detekcije < 3,4 log10 kopij genoma/ml, pri validirani metodi RT-qPCR, kar kaže, da virusni genom ni prisoten.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 100 ml and 240 ml (BTV-4 for sheep)
PODATKI NA ZUNANJI OVOJNINI Plastenka po 100 ml in 240 ml (BTV-4 za ovce)
For protection against serotype 4, administer two doses of 2 ml three weeks apart, every 12 months.
Za zaščito proti serotipu 4, dajte dva odmerka po 2 ml, v razmiku treh tednov, vsakih 12 mesecev.
Bluetongue virus, serotype 8: 25 days after completion of the primary vaccination scheme.
Virus bolezni modrikastega jezika, serotip 8: 25 dni po končanem osnovnem programu cepljenja.
For protection against serotype 8, administer two doses of 2 ml three weeks apart, every 12 months.
Za zaščito proti serotipu 8, dajte dva odmerka po 2 ml, v razmiku treh tednov, vsakih 12 mesecev.
Active immunisation of sheep from 6 weeks of age for the reduction* of viraemia caused by bluetongue virus, serotype 4.
Za aktivno imunizacijo ovac, starejših od 6 tednov, za zmanjšanje* viremije, ki jo povzroča virus bolezni modrikastega jezika, serotipa 4.
For protection against serotype 1, administer one dose of 2 ml, every 12 months.
Za zaščito proti serotipu 1, dajte en odmerek (2 ml), vsakih 12 mesecev.
Bluetongue virus, serotype 8: 12 months after completion of the primary vaccination scheme.
Virus bolezni modrikastega jezika, serotip 8: 12 mesecev po končanem osnovnem programu cepljenja.
Inactivated BTV, serotype 1 Inactivated BTV, serotype 8
inaktiviran virus bolezni modrikastega jezika, serotip 1 inaktiviran virus bolezni modrikastega jezika, serotip 8
Inactivated BTV, serotype 1
Inaktiviran virus bolezni modrikastega jezika, serotip 1
Cattle: Active immunisation of cattle from 12 weeks of age for the prevention** of viraemia caused by bluetongue virus, serotype 1 or serotype 8.
Aktivna imunizacija goveda, starejšega od 12 tednov, za preprečitev** viremije, ki jo povzroča virus bolezni modrikastega jezika, serotip 1 ali serotip 8.
Bluetongue virus, serotype 1: 12 months after completion of the primary vaccination scheme.
Virus bolezni modrikastega jezika, serotip 1: 12 mesecev po končanem osnovnem programu cepljenja.
Bluetongue virus, serotype 1: 15 days after completion of the primary vaccination scheme.
Virus bolezni modrikastega jezika, serotip 1: 15 dni po končanem osnovnem programa cepljenja.
Excipient:
Brejost :
Active immunisation of sheep from 6 weeks of age for the prevention* of viraemia caused by bluetongue virus, serotype 1 or serotype 8.
Za aktivno imunizacijo ovac, starejših od 6 tednov, za preprečitev* viremije, ki jo povzroča virus bolezni modrikastega jezika, serotip 1 ali serotip 8.
Lot
Girona
PROHIBITION OF SALE, SUPPLY AND/OR USE
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
or of palpable nodules up to a size of 60 cm2 (subcutaneous granuloma, decreasing in size over time but possibly persisting for more than 50 days).
Te reakcije so v večini primerov v obliki difuzne otekline na mestu injiciranja (ki ne traja več kot 7 dni) ali kot otipljivi noduli v velikosti 60 cm2 (subkutani granulomi, ki se sčasoma zmanjšajo in lahko trajajo tudi več kot 50 dni).
EU/2/17/207/001-009
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/17/207/001-009
ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin) Zoetis Manufacturing & Research Spain, S.L.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 20 ml (BTV-1 for sheep and cattle; BTV-8 for sheep and cattle)
Plastenka po 20 ml (BTV-1 za ovce in govedo; BTV-8 za ovce in govedo) IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Symptoms are expected to improve within 1 to 2 weeks.
Izboljšanje simptomov se pričakuje v enem do dveh tednih.
In case there is no improvement within 4 weeks, the veterinarian should re-evaluate treatment.
Če po štirih tednih ni izboljšanja, naj veterinar zdravljenje ponovno pretehta.
The European Commission granted a marketing authorisation valid throughout the EU for Reconcile on 8 July 2008.
Evropska komisija je dovoljenje za promet z zdravilom Reconcile, veljavno po vsej Evropski uniji, izdala 8. julija 2008.
It is not intended to provide practical advice on how to use Reconcile.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
This is a summary of the European public assessment report (EPAR) for Reconcile.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Reconcile.
Reconcile is available as tablets (8, 16, 32 and 64 mg) and can only be obtained with a prescription.
Zdravilo Reconcile je na voljo v obliki tablet (8, 16, 32 in 64 mg), njegovo predpisovanje in izdaja pa je le na recept.
The study showed that Reconcile was as effective as clomipramine.
Študija je pokazala, da je bilo zdravilo Reconcile enako učinkovito kot klomipramin.
What is Reconcile and what is it used for?
Kaj je zdravilo Reconcile in za kaj se uporablja?
Reconcile should only be given in combination with behavioural therapy.
Zdravilo Reconcile se lahko daje samo v kombinaciji z vedenjsko terapijo.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Reconcile's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Reconcile večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately.
Če zdravilo nenamerno zaužije človek, se je treba nemudoma posvetovati z zdravnikom.
The full EPAR for Reconcile can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila Reconcile je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Fluoxetine works by increasing the levels of the neurotransmitter serotonin in the central nervous system.
Deluje tako, da poveča ravni živčnega prenašalca serotonina v osrednjem živčnem sistemu.
What benefits of Reconcile have been shown in studies?
Kakšne koristi je zdravilo Reconcile izkazalo v študijah?
Since low levels of serotonin can be linked to depression and anxiety, increasing them can help dogs feel calmer so improving the behaviour in dogs with separation-related problems.
Nizke ravni serotonina so lahko povezane z depresijo in anksioznostjo, zato lahko njihovo zvišanje psom pomaga, da se umirijo, s čimer se izboljša njihovo vedenje, nastalo zaradi težav, povezanih z ločitvijo.
What are the risks associated with Reconcile?
Kakšna tveganja so povezana z zdravilom Reconcile?
Reconcile must not be given to dogs weighing less than 4 kg or to dogs with epilepsy or a history of fits.
Zdravilo Reconcile se ne sme dajati psom, ki tehtajo manj od 4 kg, ali psom z epilepsijo oziroma napadi v anamnezi.
Other information about Reconcile?
Druge informacije o zdravilu Reconcile?
The main measure of effectiveness was the change in each of the nine different behaviours recognised as characteristic indicators of separation anxiety in dogs.
Glavno merilo učinkovitosti je bila sprememba v vsakem od devetih različnih vedenjih, ki so značilne za anksioznost, povezano z ločitvijo, pri psih.
Such problems may include destruction of property, excessive barking or howling and inappropriate defecation and urination in the home.
Te motnje lahko obsegajo uničevanje lastnine, pretirano lajanje ali zavijanje in neprimerno odvajanje blata ali vode v notranjih prostorih.
It must also not be used in dogs which are hypersensitive (allergic) to the active substance, any other ingredients or medicines in the same class as fluoxetine (serotonin-reuptake inhibitors).
Prav tako se ne sme uporabljati pri psih, ki so preobčutljivi za (alergični na) zdravilno učinkovino, katero koli drugo sestavino zdravila ali zdravila iz istega razreda, kot je fluoksetin (zaviralci ponovnega privzema serotonina).
Why is Reconcile approved?
Zakaj je bilo zdravilo Reconcile odobreno?
The most common side effects with Reconcile (which may affect more than 1 in 10 dogs) are loss of appetite and lethargy (lack of energy).
Najpogostejši neželeni učinki zdravila Reconcile (ki lahko prizadenejo več kot 1 psa od 10) so izguba teka in letargija (pomanjkanje energije).
After 8 weeks of treatment, two separation anxiety behaviours were significantly improved in the Reconcile group (inappropriate defecation and destructive behaviour).
Po osmih tednih zdravljenja so v skupini, ki je prejemala Reconcile, opazili občutno izboljšanje dveh vzorcev anksioznega vedenja, povezanega z ločitvijo (neprimerno odvajanje blata in uničevalno vedenje).
For the full list of all side effects and restrictions reported with Reconcile, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev, o katerih so poročali pri uporabi zdravila Reconcile, glejte navodilo za uporabo.
Other common side effects with Reconcile (which may affect up to 1 in 10 dogs) are urinary problems (inflammation of the bladder, lack of control in passing urine, inability to completely empty the bladder, and pain and difficulty in passing urine), and lack of coordination and disorientation.
Drugi pogosti neželeni učinki zdravila Reconcile (ki lahko prizadenejo največ 1 psa od 10) so težave pri uriniranju (vnetje mehurja, pomanjkljiv nadzor nad uhajanjem urina, nesposobnost popolne izpraznitve mehurja ter bolečina in težavno uriniranje), pa tudi zmanjšana koordinacija gibov in izguba orientacije.
All dogs received behavioural therapy and were treated either with Reconcile or with clomipramine (another medicine used to treat dogs with separation-related disorders).
Vsi psi so prejemali vedenjsko terapijo in bodisi zdravilo Reconcile ali klomipramin (drugo vrsto zdravila, ki se uporablja za zdravljenje psov z vedenjskimi težavami, povezanimi z ločitvijo).
A field study was conducted in a large number of dogs that were treated for separation anxiety in two European countries.
V dveh evropskih državah je bila opravljena terenska študija z velikim številom psov, ki so bili zdravljeni zaradi anksioznosti, povezane z ločitvijo.
Reconcile is a veterinary medicine used as an aid to treat dogs with behavioural problems caused by separation from their owners or homes or from other dogs (separation anxiety).
Reconcile je zdravilo za uporabo v veterinarski medicini, ki se uporablja kot dodatek pri zdravljenju psov z vedenjskimi težavami, nastalimi zaradi ločitve od lastnika, doma ali drugih psov.
How is Reconcile used?
Kako se zdravilo Reconcile uporablja?
It contains the active substance fluoxetine.
Vsebuje zdravilno učinkovino fluoksetin.
For practical information about using Reconcile, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za praktične informacije o uporabi zdravila Reconcile naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For more information about treatment with Reconcile, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Za več informacij o zdravljenju z zdravilom Reconcile naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
The tablets are given once a day.
Izbrana jakost tablete je odvisna od telesne mase psa. Tablete se dajejo enkrat na dan.
How does Reconcile work?
Kako zdravilo Reconcile deluje?
The main measure of effectiveness was based on improvements in any of these four symptoms during the first 24 weeks of treatment.
Glavno merilo učinkovitosti je temeljilo na izboljšanju katerega koli izmed teh simptomov v prvih 24 tednih zdravljenja.
The company requested a re-examination of the initial opinion.
Družba je zahtevala ponovno preučitev prvotnega mnenja.
those involved in stimulating the cells to grow and divide.
tistimi, ki sodelujejo pri stimulaciji rasti in delitve celic.
In addition, major changes were made to the study design while the study was ongoing, which made the results difficult to interpret.
Poleg tega so v času izvajanja študije precej spremenili zasnovo študije, zato je rezultate težko razlagati.
The CHMP refusal was confirmed after re-examination.
Zavrnitev odbora CHMP je bila po ponovnem pregledu potrjena.
The CHMP was concerned about the reliability of the study results because a routine GCP (good clinical practice) inspection at the study sites revealed serious failings in the way the study had been conducted.
Odbor CHMP je imel zadržke glede zanesljivosti rezultatov študije, saj je rutinski inšpekcijski pregled dobre klinične prakse na lokacijah klinične študije pokazal resne pomanjkljivosti v načinu izvedbe študije.
After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017.
Po proučitvi razlogov za to zahtevo je odbor CHMP ponovno pregledal mnenje in dne 14. septembra 2017 potrdil zavrnitev vloge za dovoljenje za promet.
Refusal of the marketing authorisation for Masipro (masitinib) EMA/599464/2017
Zavrnitev vloge za dovoljenje za promet z zdravilom Masipro (masitinib) EMA/599464/2017
By blocking these enzymes, Masipro is thought to help slow down the growth of the mast cells.
Z zaviranjem teh encimov naj bi zdravilo Masipro pomagalo upočasniti rast mastocitov.
This means that it blocks enzymes known as tyrosine kinases, which can be found in some receptors in mast cells including
To pomeni, da zavira encime, znane kot tirozin-kinaze, ki se nahajajo v nekaterih receptorjih na mastocitih, vključno s
The applicant presented data from a main study involving 135 patients with systemic mastocytosis who had severe symptoms including at least one of the following four: itching, hot flushes, depression and tiredness.
Predlagatelj je predložil podatke glavne študije, ki je vključevala 135 bolnikov s sistemsko mastocitozo, ki so imeli hude simptome, vključno z vsaj enim izmed naslednjih štirih: srbenje, vročinski oblivi, depresija in utrujenost.