natgillin/translations-raw huggingface dataset:
A fourth study in 945 previously untreated advanced melanoma adult patients investigated Opdivo in combination with ipilimumab, Opdivo used alone or ipilimumab used alone.
V četrti študiji pri 945 predhodno nezdravljenih odraslih bolnikih z napredovalim melanomom so preiskovali uporabo zdravila Opdivo v kombinaciji z ipilimumabom, zdravila Opdivo kot samostojnega zdravila ali ipilimumaba kot samostojnega zdravila.
Opdivo is given as an infusion (drip) into a vein.
Zdravilo Opdivo se daje z infundiranjem (kapalno infuzijo) v veno.
• squamous cell cancer of the head and neck (SCCHN) that has come back or spread to other parts of the body.
• ploščatoceličnega karcinoma glave in vratu, ki se je ponovil ali razširil na druge dele telesa.
• urothelial cancer, a cancer of the bladder and urinary tract, that has spread locally and cannot be surgically removed or has spread to other parts of the body.
• urotelnega raka, tj. raka mehurja in sečil, ki se širi lokalno in ga ni mogoče kirurško odstraniti ali se je razširil na druge dele telesa.
Supportive information was also provided from another study indicating that Opdivo could produce a response in patients with squamous NSCLC whose disease had progressed despite several previous treatments.
Predloženi so bili tudi podporni podatki iz druge študije, ki kažejo, da lahko zdravilo Opdivo povzroči odziv pri bolnikih s ploščatoceličnim nedrobnoceličnim pljučnim rakom, pri katerih je kljub večkratnemu predhodnemu zdravljenju bolezen napredovala.
Opdivo is used on its own in patients who have previously been treated with other cancer medicines (chemotherapy);
Zdravilo Opdivo se uporablja kot samostojno zdravilo pri bolnikih, ki so se predhodno že zdravili z drugimi zdravili proti raku (kemoterapijo);
Opdivo is used on its own after treatment with brentuximab vedotin (another cancer medicine);
Zdravilo Opdivo se uporablja kot samostojno zdravilo po zdravljenju z brentuksimabom vedotinom (drugim zdravilom za zdravljenje raka);
Opdivo contains the active substance nivolumab.
Zdravilo Opdivo vsebuje učinkovino nivolumab.
For squamous NSCLC, a study involving 272 adults showed that patients given Opdivo survived for 9.2 months, compared with 6.0 months in patients given docetaxel.
V študiji ploščatoceličnega nedrobnoceličnega pljučnega raka, v katero je bilo vključenih 272 odraslih bolnikov, so dokazali, da so bolniki, ki so prejemali zdravilo Opdivo, živeli približno 9,2 meseca v primerjavi z bolniki, ki so prejemali docetaksel, ki so živeli 6,0 meseca.
Patients given Opdivo survived on average for 7.5 months, compared with 5.1 months in patients given other treatments.
Bolniki, ki so prejemali Opdivo, so preživeli 7,5 meseca, tisti, ki so prejemali druga zdravljenja, pa 5,1 meseca.
• a lung cancer called non-small cell lung cancer (NSCLC) that has spread locally or to other parts of the body.
• pljučnega raka, imenovanega nedrobnocelični rak pljuč, ki se je razširil lokalno ali v druge dele telesa.
Patients given Opdivo survived for 25.0 months, compared with 19.6 months for patients given everolimus.
Bolniki, ki so prejemali zdravilo Opdivo, so preživeli 25,0 meseca, tisti, ki so prejemali everolimus, pa 19,6 meseca.
Opdivo was investigated in one main study involving 270 adults with urothelial cancer whose cancer got worse or returned despite previous treatment with platinum medicines.
Zdravilo Opdivo so proučevali v eni glavni študiji, v katero je bilo vključenih 270 odraslih bolnikov z urotelnim rakom, pri katerih je rak napredoval ali se ponovil kljub predhodnemu zdravljenju z zdravili na osnovi platine.
Opdivo is used on its own in patients who have been previously treated with other cancer medicines; it is used in combination with ipilimumab (another cancer medicine) in patients with previously untreated disease that is considered to be at moderate or high risk of worsening;
Pri bolnikih, ki so predhodno že bili zdravljeni z drugimi zdravili proti raku, se zdravilo Opdivo uporablja kot samostojno zdravilo, medtem ko se pri bolnikih s predhodno nezdravljeno boleznijo, za katero obstaja zmerno ali visoko tveganje poslabšanja, uporablja v kombinaciji z ipilimumabom (drugim zdravilom za zdravljenje raka);
For non-squamous NSCLC, one main study involved 582 adults whose disease had progressed despite previous treatments.
V eno glavno študijo neploščatoceličnega nedrobnoceličnega pljučnega raka je bilo vključenih 582 odraslih bolnikov, pri katerih je bolezen kljub predhodnemu zdravljenju napredovala.
Opdivo was investigated in one main study involving 361 adults with SCCHN whose cancer progressed despite previous treatment with platinum medicines.
Zdravilo Opdivo so proučevali v eni glavni študiji, v katero je bilo vključenih 361 odraslih bolnikov s ploščatoceličnim karcinomom glave in vratu, pri katerih je rak napredoval kljub predhodnemu zdravljenju z zdravili na osnovi platine.
Opdivo used on its own was studied in two main studies in adults with advanced melanoma who had not undergone surgery.
Pri odraslih z napredovalim melanomom so zdravilo Opdivo kot samostojno zdravljenje proučevali v dveh glavnih študijah.
How does Opdivo work?
Kako zdravilo Opdivo deluje?
Each dose of 1 ml contains:
Vsak odmerek po 1 ml vsebuje:
None known.
Ni znano.
Date of first authorisation: 10/02/2015.
Datum pridobitve dovoljenja za promet: 10/02/2015.
Basic vaccination
Osnovno cepljenje
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Učinkovina, ki je v osnovi biološkega izvora, namenjena vzbujanju aktivne imunosti, ne spada v področje uporabe Uredbe (ES) št. 470/2009.
According to Community Legislation on classical swine fever (Council Directive 2001/89/EC, as amended), in the European Union:
Zakonodaja Skupnosti, ki obravnava klasično prašičjo kugo (Direktiva Sveta 2001/89/ES, z vsemi spremembami) v Evropski uniji določa:
Council Directive 2001/89/EC and Commission Decision 2002/106 prohibit prophylactic vaccination within the European Union.
Direktiva Sveta 2001/89/ES in Odločba Komisije 2002/106 prepovedujeta cepljenje za potrebe profilakse na območju Evropske unije.
Shedding of vaccine virus has however not been detected but cannot be excluded.
Izločanje virusa iz cepiva niso odkrili, vendar ga ni mogoče izključiti.
The virus is grown in porcine cells.
Virus je vzgojen na celicah prašičjega izvora.
Diagnostic tools targeted to detection of antibody responses could enable DIVA strategies.
Diagnostične metode, ki ciljajo k odkrivanju odziva protiteles bi lahko omogočile DIVA strategije.
If you notice any side effects, whether or not listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon..
Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo ali mislite, da zdravilo ni delovalo,, obvestite svojega veterinarja.
DIVA tests:
DIVA testi:
However, the use of vaccines may be authorised in the framework of an emergency vaccination plan, implemented by the competent authority of a Member State following confirmation of disease, in accordance with Community Legislation on control and eradication of classical swine fever.
Vendar se uporaba cepiv lahko odobri v sklopu načrta za cepljenje v izrednih razmerah, ki ga po potrditvi bolezni izvede pristojni organ v državi članici v skladu z zakonodajo Skupnosti o nadzoru in izkoreninjenju klasične prašičje kuge.
EU/2/14/179/001 (10 doses) EU/2/14/179/002 (50 doses)
EU/2/14/179/001 (10 odmerkov) EU/2/14/179/002 (50 odmerkov)
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 veterinar odloči od primera od primera.
Use of the vaccine in experimental studies in breeding boars has not revealed safety concerns.
Uporaba cepiva v eksperimentalnih študijah na plemenskih merjascih ni odkrila varnostnih pomislekov.
Shelf-life after reconstitution according to directions: use immediately.
Rok uporabnosti po rekonstituciji v skladu z navodili: uporabite takoj.
* min 100 PD50 ** Tissue culture infectious dose
* najmanj 100 PD50 ** infektivni odmerek za tkivno kulturo
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti.
EU/2/14/179/001-002
ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/14/179/001-002
Documentation provided for this vaccine supports that it is only to be used in an outbreak situation in herds within restricted control zones.
Predložena dokumentacija podpira uporabo tega cepiva le v primeru izbruha bolezni v čredah znotraj omejenih nadzorovanih območij.
Specific derogation is required to use this vaccine in an outbreak situation.
Posebno odstopanje je zahtevano za uporabo tega cepiva v primerih izbruha bolezni.
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Pomožne snovi (vključno z dodatki), navedene v poglavju 6.1 SPC, tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št.
Persistently infected immunotolerant piglets represent a very high risk since they are shedding field virus and they cannot be identified serologically due to their seronegative status.
Trajno okuženi pujski z imunsko toleranco predstavljajo zelo veliko tveganje, ker izločajo terenski virus in jih zaradi njihovega negativnega serološkega stausa ni mogoče identificirati s serološkimi preiskavami.
Therefore, the decision to vaccinate breeding boars and piglets with maternally derived antibodies should be taken based on the actual outbreak case and associated control zones.
Odločitev o cepljenju plemenskih merjascev in pujskov z maternalnimi protitelesi je treba sprejeti na podlagi dejanskega primera izbruha bolezni in pridruženih nadzorovanih območij.
Solvent for Suvaxyn CSF Marker
Vehikel za Suvaxyn CSF Marker
Sodium chloride 9 mg/ml Water for injections q.s.p.
natrijev klorid 9 mg/ml voda za injekcije q.s.p.
Onset of immunity: 14 days after vaccination Duration of immunity: at least 6 months after vaccination
Trajanje imunosti: vsaj 6 mesecev po cepljenju.
b) the manipulation, manufacture, storage, supply, distribution and sale of classical swine fever vaccines must be carried out under supervision and in accordance with the eventual instructions established by the competent authority of the Member State.
Izdelavo, skladiščenje, oskrbo, distribucijo in prodajo cepiv proti klasični prašičji kugi in ravnanje z njimi je treba izvajati pod nadzorstvom pristojnega organa v državi članici in v skladu z morebitnimi navodili, ki jih ta organ uvede.
Serological DIVA concept has been shown in principle, while actual DIVA tools remain to be tested on large panels of samples from emergency vaccination in outbreak situations.
Serološki DIVA koncept je bil načeloma predstavljen, medtem ko bo treba dejanske DIVA metode preskusiti na večjem številu vzorcev ob nujnem cepljenju v primerih izbruha bolezni.
Sodium chloride solution 9 mg/ml
Raztopina natrijevega klorida 9 mg/ml
a) the use of classical swine fever vaccines is prohibited.
Uporaba cepiv proti klasični prašičji kugi je prepovedana.
Incompatibilities: Do not mix with any other veterinary medicinal product.
Inkompatibilnost: Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
To stimulate active immunity to Classical Swine Fever virus.
Za vzpodbuditev aktivne imunosti proti virusu klasične prašičje kuge.
Name and address of the manufacturers of the biological active substance
Ime in naslov proizvajalcev bioloških učinkovin:
Challenge studies have shown lack of protection against transplacental transmission of CSFV.
Provokacijske študije so pokazale, da ni zaščite pred prenosom virusa KPK preko placente.
After reconstitution, the suspension should be slightly pink clear liquid.
Po rekonstituciji mora biti suspenzija bistra tekočina, rahlo rožnate barve.
Active substance: Lyophilisate:
Učinkovina: Liofilizat:
Dulbecco's Modified Eagle culture medium (DMEM)
DMEM (Dulbecco's Modified Eagle gojišče za celične kulture)
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, ČE JE SMISELNO
Live recombinant CP7-E2Alf:
KOLIČINA UČINKOVINE Živi rekombinatni (CP7_E2alf):
Limited studies in young pigs support protection against CSF1045 (genotype 2, Germany 2009) and CSF1047 (genotype 2, Israel 2009) field strains.
CSF1045 (genotip 2, Germany 2009) in CSF1047 (genotip 2, Izrael 2009).
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 snovi
Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP {month/year}.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po
The vaccine has shown reduced protection in studies of piglets with maternally derived antibodies compared to studies of piglets without maternally derived antibodies.
V študijah pri pujskih z maternalnimi protitelesi je bila zaščita, ki jo nudi cepivo, zmanjšana v primerjavi s študijami pri pujskih brez maternalnih protiteles.
MANUFACTURER'S BATCH NUMBER
PROIZVAJALČEVA ŠTEVILKA SERIJE Lot{številka}
c) special provisions regulate the movement of pigs from areas where classical swine fever vaccine is being or has been used and the processing or marking of pig meat from vaccinated pigs.
Premike prašičev z območij, kjer uporabljajo ali so uporabljali cepivo proti klasični prašičji kugi, ter označevanje mesa cepljenih prašičev urejajo posebne določbe.
Therefore, sows should not be vaccinated, due to the risk of birth of immunotolerant persistently infected offspring.
Svinj se ne sme cepiti, ker obstaja tveganje za rojstvo trajno okuženih mladičev z imunsko toleranco.
Date of last renewal:
Datum zadnjega podaljšanja dovoljenja za promet:
Basic vaccination A single 1 ml dose should be administered intramuscularly to pigs from 7 weeks of age.
Osnovno cepljenje Enkratni 1 ml odmerek je treba dati intramuskularno prašičem, v starosti od 7 tednov naprej.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
Studies in vaccinated breeding boars addressing potential shedding of virulent challenge virus in semen have not been conducted.
Študij o morebitnem izločanju virulentnega virusa v seme cepljenih plemenskih merjascev niso izvedli.
Challenge studies were conducted with the Koslov strain (genotype 1) of CSFV.
Provokacijske študije so bile narejene na Koslov sevu (genotip 1) virusa klasične prašičje kuge.
DIVA efficiency depends on the performance of tests related to fitness for purpose in outbreak situations.
Učinkovost DIVA cepiv je odvisna od izvedbe testov in njihove primernosti za uporabo v primerih izbruha bolezni.
A single 1 ml dose should be administered to pigs from 7 weeks of age.
Enkratni 1 ml odmerek je treba dati intramuskularno prašičem, v starosti od 7 tednov naprej.
Reconstitute the lyophilisate aseptically with the solvent to obtain a suspension for injection.
Aseptično rekonstituirajte liofilizat z vehiklom, da nastane suspenzija za injiciranje.
For active immunisation of pigs from 7 weeks of age onwards to prevent mortality and reduce infection and disease caused by classical swine fever virus (CSFV).
Aktivna imunizacija prašičev, starejših od 7 tednov za preprečevanje smrtnosti, za zmanjšanje tveganja okužbe in kliničnih znakov bolezni, ki jih povzroča virus klasične prašičje kuge (KPK).
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance:
NAVEDBA UČINKOVIN IN DRUGIH SESTAVIN Učinkovina:
Zero days.
KARENCA Nič dni.
Camprodon s/n “La Riba”, 17813 Vall de Bianya
17813 Vall de Bianya
Type I hydrolytic glass vials containing 10 or 50 doses of lyophilisate and 10 or 50 ml of solvent.
Viala iz hidrolitskega stekla tipa I, ki vsebuje 10 ali 50 odmerekov liofilizata in10 ali 50 ml vehikla.
10 doses 50 doses
50 odmerkov
Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/.
Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/.)
Serological DIVA tools based on detection of CSFV antibodies other than those raised against E2, such as Erns antibody detection should be able to differentiate between antibody responses against Erns-BVDV after solely herd vaccination with CP7_E2alf from responses against Erns-CSFV after natural field CSFV infection.
Serološke metode DIVA, ki temeljijo na odkrivanju protiteles virusa KPK, razen tistih proti E2, kot je odkrivanje protiteles proti Erns - BVDV (BVDV - virus goveje virusne driske), bi morale razlikovati med odzivom protiteles izključno pri čredah, cepjenih s CP_7E2alf, od odziva protiteles proti Erns - CSFV (CSFV - virus klasične prašičje kuge) pri živalih, ki so bile naravno okužene s terenskim virusom klasične prašičje kuge.
Lyophilisate: Off-white pellet Solvent: Clear colourless liquid
Liofilizat: pelet belkaste barve Vehikel: bistra, brezbarvna tekočina
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Boxes of 1 vial of 10 or 50 doses
PODATKI NA ZUNANJI OVOJNINI Škatla z 1 vialo z 10 ali 50 odmerki
Cardboard box containing 1 vial with 10 doses of lyophilisate and 1 vial with 10 ml solvent.
Kartonska škatla, ki vsebuje 1 vialo z 10 odmerki liofilizata in 1 vialo z 10 ml vehikla.
Cardboard box containing 1 vial with 50 doses of lyophilisate and 1 vial with 50 ml solvent.
Kartonska škatla, ki vsebuje 1 vialo z 50 odmerki liofilizata in 1 vialo z 50 ml vehikla.
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 so na voljo na spletni strani Evropske agencije za zdravila
EXP {month/year} Once reconstituted use immediately.
Rekonstituirano zdravilo uporabite takoj.
10 ml 50 ml
50 ml
RT-PCR tools could be used in outbreak situations to differentiate between the vaccine virus genome and those of fields strains based on sequences unique to the CP7_E2alf.
V primeru izbruha bolezni bi se na podlagi edinstvenosti sekvenc za CP7_E2alf, za razlikovanje med virusnim genomom iz cepiva in tistimi iz izoliranih sevov na terenu lahko uporabilo RT-PCR
Lyophilisate: bromobutyl rubber stoppers and aluminium caps Solvent: chlorobutyl rubber stoppers and aluminium caps Cardboard box containing 1 vial with 10 doses of lyophilisate and 1 vial with 10 ml solvent.
Liofilizat: zamaški iz brombutilne gume in aluminijaste zaporke Vehikel: zamaški iz klorbutilne gume in aluminijaste zaporke
The recombinant vaccine virus has potential marker properties for use in DIVA (differentiation between field virus infected and solely vaccinated animals).
Rekombinantno cepivo ima potencialne lastnosti markerja za uporabo kot DIVA cepivo (DIVA, ang.
Live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene (CP7_E2alf)
ki vsebuje gen E2 klasične prašičje kuge (CP7_E2alf)
TARGET SPECIES
CILJNE ŽIVALSKE VRSTE Prašiči
MARKETING AUTHORISATION HOLDER
IMETNIK( DOVOLJENJA ZA PROMET
Marketing authorisation holder and manufacturer responsible for batch release:
Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovren za sproščanje serij:
Name and address of the manufacturer responsible for batch release
Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij:
Suvaxyn CSF Marker lyophilisate for suspension for injection for pigs
Suvaxyn CSF Marker liofilizat za suspenzijo za injiciranje za prašiče
Vaccine virus genome is rarely detectable by RT-PCR in tonsils and lymph nodes for up to 63 days after vaccination and vaccine virus is very rarely detectable by virus isolation in tonsil for the first week after vaccination.
Do 63. dneva po cepljenju je virusni genom iz cepiva v tonzilah in bezgavkah redko možno dokazati z RT-PCR diagnostičnimi metodami.
The vaccine is a live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene.
Cepivo je živi rekombinatni virus goveje virusne driske z izbrisanim genom E2, ki vsebuje gen E2
Lyophilisate and solvent for suspension for injection for pigs
Liofilizat in vehikel za suspenzijo za injiciranje za prašiče
Pharmacotherapeutic group: live viral vaccines, live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene, ATC vet code: QI09AD04
IMUNOLOŠKE LASTNOSTI Farmakoterapevtska skupina: živa virusna cepiva, živi rekombinatni virus goveje virusne driske z izbrisanim genom E2, ki vsebuje gen E2 klasične prašičje kuge.
Lyophilisate: Off-white pellet
Liofilizat: pelet belkaste barve
Lyophilisate
INDIKACIJA
MARKETING AUTHORISATION NUMBER(S)
16. ŠTEVILKI DOVOLJENJA ZA PROMET
4.4 Special warnings for each target species
Posebna opozorila za vsako ciljno živalsko vrsto:
6 BATCH NUMBER
10 odmerkov
Lot {number}
{EXP}.
Suvaxyn CSF Marker lyophilisate and solvent for suspension for injection for pigs
Suvaxyn CSF Marker liofilizat in vehikel za suspenzijo za injiciranje za prašiče
Solvent:
Brejost:
METHOD AND ROUTE(S) OF ADMINISTRATION
NAČIN IN POT UPORABE
C. STATEMENT OF THE MRLs
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA ( MRL)
PACKAGE LEAFLET: Suvaxyn CSF Marker lyophilisate and solvent for suspension for injection for pigs
NAVODILO ZA UPORABO Suvaxyn CSF Marker liofilizat in vehikel za suspenzijo za injiciranje za prašiče
EXP {month/year} Once broached, use immediately.
Rekonstituirano zdravilo uporabite uporabite takoj.
Withdrawal period: Zero days.
Nastop imunosti: 14 dni po cepljenju.
IMMUNOLOGICAL PROPERTIES
KLINIČNI PODATKI
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for diacerin containing medicinal products
Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila in imetnikov dovoljenja za promet z zdravilom v državah članicah
DIACEREIN /NORMA 50 mg capsule, hard
DIACEREIN/NORMA 50 mg peroralna raba
Children (under 18 years of age)
Otroci (mlajši od 18 let)
Contact a doctor immediately and say how many capsules you have taken.
Nemudoma pokličite zdravnika in mu povejte, koliko kapsul ste vzeli.
Taking Zerene with food and drink
Jemanje zdravila Zerene s hrano in pijačo
This feeling may be even worse when you sleep for less than 7 to 8 hours after taking your medication.
Vse to je lahko še slabše, če ste po zaužitju zdravila spali manj kot 7 do 8 ur.
• myasthenia gravis (very weak or tired muscles)
• če imate miastenijo gravis (zelo šibke ali utrujene mišice)
Children under 18 years of age must not take Zerene.
Otroci, mlajši od 18 let, ne smejo jemati zdravila Zerene.
Zerene will help you to sleep.
Zdravilo Zerene vam bo pomagalo zaspati.
This affects the ability to drive or use machines (see section 4.7).
To vpliva na sposobnost vožnje ali upravljanja s stroji (glejte poglavje 4.7).
6.6 Special precautions for disposal and handling No special requirements.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Ni posebnih zahtev.
Capsule core
Jedro kapsule:
hepatotoxicity (mostly described as transaminase increased)
Hepatotoksičnost (večinoma opisana kot povišanje transminaz)
To reduce the risk, patients should not undertake activities requiring psychomotor co-ordination until 4 hours or more after taking Zerene (see section 4.7).
Za zmanjšanje tveganja bolniki ne bi smeli opravljati aktivnosti, ki zahtevajo psihomotorično koordinacijo do 4 ure ali več po zaužitju zdravila Zerene (glej poglavje 4.7).