natgillin/translations-raw huggingface dataset:
In a population pharmacokinetic analysis of patients with partial-onset seizures (age range 12 to 74 years) and primary generalised tonic-clonic seizures (age range 12 to 58 years), and receiving perampanel up to 8 or 12 mg/day in placebo-controlled clinical trials, no significant effect of age on perampanel clearance was found.
U populacijskoj farmakokinetičkoj analizi bolesnika s parcijalnim napadajima (u rasponu dobi od 12 do 74 godine) i primarno generaliziranim toničko-kloničkim napadajima (u rasponu dobi od 12 do 58 godina) koji su primali perampanel u dozi do 8 ili 12 mg na dan u placebom kontroliranim kliničkim ispitivanjima, nije pronađen značajni učinak dobi na klirens perampanela.
Weight increased
Pretrage povećanje tjelesne težine
In a population pharmacokinetic analysis of patients with partial-onset seizures having creatinine clearances ranging from 39 to 160 mL/min and receiving perampanel up to 12 mg/day in placebo-controlled clinical trials, perampanel clearance was not influenced by creatinine clearance.
U populacijskoj farmakokinetičkoj analizi bolesnika s parcijalnim napadajima koji su imali klirens kreatinina u rasponu od 39 do 160 ml/min i primali perampanel u dozama do 12 mg na dan u placebom kontroliranim kliničkim ispitivanjima, klirens kreatinina nije utjecao na klirens perampanela.
Treatment with Fycompa should be initiated with a dose of 2 mg/day.
Liječenje Fycompom treba započeti dozom od 2 mg na dan.
Systemic Symptoms (DRESS)*
Reakcija na lijek s eozinofilijo m i sustavnim simptomima (DRESS)*
In a population pharmacokinetic analysis of patients with partial-onset seizures receiving perampanel up to 12 mg/day and patients with primary generalised tonic-clonic seizures receiving perampanel up to 8 mg/day in placebo-controlled clinical trials, perampanel clearance in females (0.54 l/h) was 18% lower than in males (0.66 l/h).
U populacijskoj farmakokinetičkoj analizi bolesnika s parcijalnim napadajima koji su primali perampanel u dozi do 12 mg na dan i bolesnika s primarno generaliziranim toničko-kloničkim napadajima koji su primali perampanel u dozi do 8 mg na dan u placebom kontroliranim kliničkim ispitivanjima, klirens perampanela u žena (0,54 l/h) bio je 18% niži nego u muškaraca (0,66 l/h).
Fycompa 6 mg, 8 mg, 10 mg, 12 mg film-coated tablets
Fycompa 6 mg, 8 mg, 10 mg, 12 mg filmom obložene tablete
Open label extension study
Otvoreni produžetak ispitivanja
Sorbitol (E420) liquid (crystallising)
- Drugi sastojci su sorbitol (E420) tekući (kristalizirajući), mikrokristalična celuloza (E460),
Treatment with Fycompa should be initiated with a dose of 2 mg/day (4 ml/day).
Liječenje Fycompom treba započeti dozom od 2 mg na dan (4 ml na dan).
Perampanel oral suspension is bioequivalent on a mg per mg basis to perampanel tablets under fasted conditions.
Uzet natašte, 1 mg oralne suspenzije perampanela bioekvivalent je 1 mg perampanela u tabletama.
A similar result was seen in a population pharmacokinetic analysis of patients with partial-onset seizures receiving perampanel up to 12 mg/day and patients with primary generalised tonic-clonic seizures receiving perampanel up to 8 mg/day in placebo-controlled clinical trials.
Sličan se rezultat dobio populacijskom farmakokinetičkom analizom bolesnika s parcijalnim napadajima koji su primali perampanel u dozi do 12 mg na dan i bolesnika s primarno generaliziranim toničko-kloničkim napadajima koji su primali perampanel u dozi do 8 mg na dan u placebom kontroliranim kliničkim ispitivanjima.
Fycompa is not recommended during pregnancy.
Ne preporučuje se koristiti lijek Fycompa tijekom trudnoće.
Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported (frequency unknown; see section 4.8) in association with perampanel treatment.
Prijavljene su teške kožne nuspojave (engl. severe cutaneous adverse reactions, SCAR) povezane s liječenjem perampanelom, uključujući reakciju na lijek s eozinofilijom i sustavnim simptomima (engl. drug reaction with eosinophilia and systemic symptoms, DRESS), koje mogu biti opasne po život ili smrtonosne (nepoznata učestalost, vidjeti dio 4.8).
Insert adaptor into the neck of the bottle until a tight seal is made.
U vrat boce umetnite nastavak tako da bude dobro učvršćen.
Fycompa 0.5 mg/ml oral suspension perampanel
Fycompa 0,5 mg/ml oralna suspenzija perampanel
In a placebo controlled study conducted in adolescent patients, no significant changes in cognition relative to placebo as measured by Cognitive Drug Research (CDR) System Global Cognition Score were observed for perampanel.
Global Cognition Score) mjereno pomoću Cognitive Drug Research (CDR) sustava testova za ispitivanje kognitivne sposobnosti u kliničkim ispitivanjima, nisu opažene značajne promjene u kognitivnim sposobnostima uz perampanel u odnosu na placebo.
- If you have missed less than 7 days of treatment with Fycompa, continue taking your daily dose as originally instructed by your doctor.
- Ako ste propustili uzimati Fycompu manje od 7 dana, nastavite svakodnevno uzimati dozu kako
Levels of alertness (arousal) decreased in a dose-related manner in healthy subjects dosed with perampanel from 4 to 12 mg/day.
Razina budnosti (pobuđenosti) u zdravih ispitanika koji su primali doze perampanela od 4 do 12 mg na dan snižavala se ovisno o dozi.
Abuse potential
Moguća zloporaba
Perampanel dosing for patients with mild and moderate impairment should not exceed 8 mg. Use in patients with severe hepatic impairment is not recommended.
Doza perampanela u bolesnika s blagim i umjerenim oštećenjem ne smije biti veća od 8 mg.
2 oral syringes
2 štrcaljke za usta
The effects of perampanel on tasks involving alertness and vigilance such as driving ability were additive or supra-additive to the effects of alcohol itself, as found in a pharmacodynamic interaction study in healthy subjects.
Kako se pronašlo u ispitivanju farmakodinamičkih interakcija u zdravih ispitanika, učinci perampanela na aktivnosti koje zahtijevaju budnost i brzinu, kao što je sposobnost upravljanja vozilima, bili su aditivni ili supraaditivni učincima samog alkohola.
Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg film-coated tablets Perampanel
Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg i 12 mg filmom obložene tablete perampanel
Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of perampanel.
Ozbiljne kožne nuspojave, uključujući reakciju na lijek s eozinofilijom i sustavnim simptomima (DRESS) prijavljene su pri primjeni perampanela.
Diplopia Vision blurred
Poremećaji oka diplopija zamagljen vid
Fycompa 0.5 mg/ml oral suspension
Fycompa 0,5 mg/ml oralna suspenzija
Tell your doctor if you are taking or have recently taken this medicine as your dose may need to be adjusted.
Obavijestite svog liječnika ako uzimate ili ste nedavno uzimali ovaj lijek jer će Vam možda trebati prilagoditi dozu.
Depending upon individual clinical response and tolerability at a dose of 8 mg/day, the dose may be increased up to 12 mg/day, which may be effective in some patients (see section 4.4).
Ovisno o kliničkom odgovoru pojedinog bolesnika i podnošljivosti doze od 8 mg na dan, doza se može povisiti do 12 mg na dan, što može biti učinkovito u nekih bolesnika (vidjeti dio 4.4).
perampanel oral suspension achieves equivalent AUC0-inf and approximately 23 % lower Cmax and 2 hours delay in time to peak exposure (tmax) compared to the tablet formulation.
Kada se jedna doza od 12 mg obiju formulacija primijeni uz obrok s visokim udjelom masti, u usporedbi s formulacijom u tabletama oralna suspenzija perampanela dosegne ekvivalentnu vrijednost za AUC0-inf, približno 23% niži Cmax te vršnu izloženost (tmax) s odgodom od 2 sata.
Carbamazepine 2.75 fold decrease
Utjecaj Fycompe na koncentraciju antiepileptika karbamazepin sniženje za 2,75 puta
Red, round, biconvex tablet, engraved with E277 on one side and ‘4' on other side
Crvena, okrugla, bikonveksna tableta, s utisnutim E277 na jednoj strani i ‘4' na drugoj.
In a population pharmacokinetic analysis of patients with partial-onset seizures receiving perampanel up to 12 mg/day and patients with primary generalised tonic-clonic seizures receiving perampanel up to 8 mg/day in placebo-controlled clinical trials, a linear relationship was found between dose and perampanel plasma concentrations.
U populacijskoj farmakokinetičkoj analizi bolesnika s parcijalnim napadajima koji su primali perampanel u dozi do 12 mg na dan i bolesnika s primarno generaliziranim toničko-kloničkim napadajima koji su primali perampanel u dozi do 8 mg na dan u placebom kontroliranim kliničkim ispitivanjima, pronašao se linearni odnos između doze i koncentracije perampanela u plazmi.
Depending upon individual clinical response and tolerability at a dose of 8 mg/day, the dose may be increased by increments of 2 mg/day to 12 mg/day.
Ovisno o kliničkom odgovoru pojedinog bolesnika i podnošljivosti doze od 8 mg na dan, doza se može povećavati za 2 mg na dan do 12 mg na dan.
Tell your doctor if you are taking or have recently taken these medicines as your dose may need to be adjusted.
Obavijestite svog liječnika ako uzimate ili ste nedavno uzimali ove lijekove jer će Vam možda trebati prilagoditi dozu.
Clonazepam No influence
<10% sniženje klonazepam nema utjecaja nema utjecaja lamotrigin nema utjecaja
Depending upon individual clinical response and tolerability at a dose of 8 mg/day (16 ml/day), the dose may be increased up to 12 mg/day (24 ml/day), which may be effective in some patients (see section 4.4).
Ovisno o kliničkom odgovoru pojedinog bolesnika i podnošljivosti doze od 8 mg na dan (16 ml na dan), doza se može povisiti do 12 mg na dan (24 ml na dan), što može biti učinkovito u nekih bolesnika (vidjeti dio 4.4).
Drug metabolising enzyme induction
Indukcija enzima koji metaboliziraju lijekove
Each ml contains 0.5 mg perampanel.
Jedan ml sadrži 0,5 mg perampanela.
Each ml of oral suspension contains 0.5 mg perampanel
Jedan ml oralne suspenzije sadrži 0,5 mg perampanela.
Lactose monohydrate Low-substituted hydroxypropyl cellulose Povidone K-29/32
Jezgra laktoza hidrat nisko supstituirana hidroksipropilceluloza povidon K-29/32 magnezijev stearat (E470b)
In a population pharmacokinetic analysis of patients with primary generalised tonic-clonic seizures receiving perampanel up to 8 mg/day in a placebo-controlled clinical study, perampanel clearance was not influenced by baseline creatinine clearance.
U populacijskoj farmakokinetičkoj analizi bolesnika s primarno generaliziranim toničko-kloničkim napadajima koji su primali perampanel u dozi do 8 mg na dan u placebom kontroliranom kliničkom ispitivanju, početni klirens kreatinina nije utjecao na klirens perampanela.
hypericum (St. John's Wort) (a medicine used to treat mild anxiety) and ketoconazole (a medicine used to treat fungal infections) may affect Fycompa.
- Neki drugi lijekovi, kao što je rifampicin (lijek koji se primjenjuje za liječenje bakterijskih infekcija), gospina trava (kantarion) (lijek za liječenje blage tjeskobe) i ketokonazol (lijek za liječenje gljivičnih infekcija) mogu utjecati na Fycompu.
- It is also used to treat certain fits that affect all of your brain from the start (called “generalised seizures”) and cause convulsions or staring spells.
- Također se primjenjuje za liječenje određenih napadaja koji zahvaćaju cijeli mozak od početka
Depending upon individual clinical response and tolerability at a dose of 8 mg/day (16 ml/day), the dose may be increased by increments of 2 mg/day (4 ml/day) to 12 mg/day (24 ml/day).
Ovisno o kliničkom odgovoru pojedinog bolesnika i podnošljivosti doze od 8 mg na dan (16 ml na dan), doza se može povećavati za 2 mg na dan (4 ml na dan) do 12 mg na dan (24 ml na dan).
Excipient with known effect: Each 2 mg tablet contains 78.5 mg of lactose (as monohydrate).
Pomoćna tvar s poznatim učinkom: jedna tableta od 2 mg sadrži 78,5 mg laktoze (u obliku hidrata).
Orange, round, biconvex tablet, engraved with E275 on one side and ‘2' on other side
Narančasta, okrugla, bikonveksna tableta, s utisnutim E275 na jednoj strani i ‘2' na drugoj.
Fycompa 2 mg, 4 mg film-coated tablets
Fycompa 2 mg, 4 mg filmom obložene tablete
Green, round, biconvex tablet, engraved with E296 on one side and ‘10' on other side
Zelena, okrugla, bikonveksna tableta, s utisnutim E296 na jednoj strani i ‘10' na drugoj.
Each tablet contains 8 mg perampanel.
Jedna tableta sadrži 8 mg perampanela.
Blue, round, biconvex tablet, engraved with E297 on one side and ‘12' on other side
Plava, okrugla, bikonveksna tableta, s utisnutim E297 na jednoj strani i ‘12' na drugoj.
Aggressive and hostile behaviour has been reported in patients receiving perampanel therapy.
U bolesnika koji su primali terapiju perampanelom zabilježeni su slučajevi agresivnog i neprijateljskog ponašanja.
Fycompa 8 mg tablets Perampanel
Fycompa 8 mg tablete perampanel
Excipient with known effect: Each 8 mg tablet contains 149.0 mg of lactose (as monohydrate).
Pomoćna tvar s poznatim učinkom: jedna tableta od 8 mg sadrži 149,0 mg laktoze (u obliku hidrata).
Each film-coated tablet contains 8 mg perampanel.
Jedna filmom obložena tableta sadrži 8 mg perampanela.
Each millilitre contains 0.5 mg of perampanel.
Jedan mililitar sadrži 0,5 mg perampanela.
Pink, round, biconvex tablet, engraved with E294 on one side and ‘6' on other side
Ružičasta, okrugla, bikonveksna tableta, s utisnutim E294 na jednoj strani i ‘6' na drugoj.
Gait disturbance Fatigue
Opći poremećaji smetnje hoda umor
Excipient with known effect: Each 6 mg tablet contains 151.0 mg of lactose (as monohydrate).
Pomoćna tvar s poznatim učinkom: jedna tableta od 6 mg sadrži 151,0 mg laktoze (u obliku hidrata).
Purple, round, biconvex tablet, engraved with E295 on one side and ‘8' on other side
Ljubičasta, okrugla, bikonveksna tableta, s utisnutim E295 na jednoj strani i ‘8' na drugoj.
Push plunger of oral syringe completely down.
Potisnite klip štrcaljke za usta do kraja prema dolje.
Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with perampanel treatment (see section 4.4).
Prijavljene su teške kožne nuspojave (SCAR) povezane s liječenjem perampanelom, uključujući reakciju na lijek s eozinofilijom i sustavnim simptomima (DRESS) (vidjeti dio 4.4).
Patients should be up-titrated using 2 mg (4 ml) doses no faster than every 2 weeks based on tolerability and effectiveness.
Bolesnike treba titrirati na temelju podnošljivosti i učinkovitosti povećavanjem doze za 2 mg (4 ml) u intervalima od najmanje 2 tjedna.
Excipient with known effect: Each 10 mg tablet contains 147.0 mg of lactose (as monohydrate).
Pomoćna tvar s poznatim učinkom: jedna tableta od 10 mg sadrži 147,0 mg laktoze (u obliku hidrata).
Each tablet contains 12 mg perampanel.
Jedna tableta sadrži 12 mg perampanela.
Each tablet contains 10 mg perampanel.
Jedna tableta sadrži 10 mg perampanela.
The dose may be increased based on clinical response and tolerability by increments of 2 mg (4 ml) (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day (8 ml/day) to 8 mg/day (16 ml/day).
Ovisno o kliničkom odgovoru i podnošljivosti, ta se doza može povećavati za 2 mg (4 ml) (bilo svaki tjedan, bilo svaka 2 tjedna, uzimajući u obzir poluvijek kako je opisano niže) do doze održavanja od 4 mg na dan (8 ml na dan) do 8 mg na dan (16 ml na dan).
Each tablet contains 4 mg perampanel.
Jedna tableta sadrži 4 mg perampanela.
Fycompa 8 mg film-coated tablets 8 mg - packs of 7, 28, 84 and 98
Fycompa 8 mg filmom obložene tablete 8 mg - pakiranje od 7, 28, 84 i 98 tableta
Each tablet contains 6 mg perampanel.
Jedna tableta sadrži 6 mg perampanela.
Patients should be up-titrated using 2 mg doses no faster than every 2 weeks based on tolerability and effectiveness.
Bolesnike treba titrirati na temelju podnošljivosti i učinkovitosti povećavanjem doze za 2 mg u intervalima od najmanje 2 tjedna.
Excipient with known effect: Each 12 mg tablet contains 145.0 mg of lactose (as monohydrate).
Pomoćna tvar s poznatim učinkom: jedna tableta od 12 mg sadrži 145,0 mg laktoze (u obliku hidrata).
Each tablet contains 2 mg perampanel.
Jedna tableta sadrži 2 mg perampanela.
Each film-coated tablet contains 10 mg perampanel.
Jedna filmom obložena tableta sadrži 10 mg perampanela.
Excipient with known effect: Each 4 mg tablet contains 157.0 mg of lactose (as monohydrate).
Pomoćna tvar s poznatim učinkom: jedna tableta od 4 mg sadrži 157,0 mg laktoze (u obliku hidrata).
Lamotrigine
Levodopa
Fycompa 8 mg film-coated tablets
Fycompa 8 mg filmom obložene tablete
Each film-coated tablet contains 12 mg perampanel.
Jedna filmom obložena tableta sadrži 12 mg perampanela.
Fycompa 10 mg tablets Perampanel
Fycompa 10 mg tablete perampanel
Post-marketing use
Primjena nakon stavljanja lijeka u promet
Each film-coated tablet contains 4 mg perampanel.
Jedna filmom obložena tableta sadrži 4 mg perampanela.
Fycompa 8 mg film-coated tablets Perampanel
Fycompa 8 mg filmom obložene tablete perampanel
Each film-coated tablet contains 6 mg perampanel.
Jedna filmom obložena tableta sadrži 6 mg perampanela.
Fycompa 12 mg tablets Perampanel
Fycompa 12 mg tablete perampanel
Each film-coated tablet contains 2 mg perampanel.
Jedna filmom obložena tableta sadrži 2 mg perampanela.
Titanium dioxide (E171) Ferric oxide, yellow (E172) Ferric oxide, red (E172)
Film-ovojnica hipromeloza 2910 talk makrogol 8000 titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
Fycompa 2 mg tablets Perampanel
Fycompa 2 mg tablete perampanel
Fycompa 4 mg tablets Perampanel
Fycompa 4 mg tablete perampanel
Fycompa 6 mg tablets Perampanel
Fycompa 6 mg tablete perampanel
How to store Fycompa
Kako čuvati Fycompu
Fycompa 12 mg film-coated tablets 12 mg - packs of 7, 28, 84 and 98
Fycompa 12 mg filmom obložene tablete 12 mg - pakiranje od 7, 28, 84 i 98 tableta
7 Turn upright and remove the oral syringe.
Bocu vratite u uspravni položaj i izvucite štrcaljku.
Fycompa 4 mg film-coated tablets 4 mg - packs of 7, 28, 84 and 98
Fycompa 4 mg filmom obložene tablete 4 mg - pakiranje od 7, 28, 84 i 98 tableta
Fycompa contains lactose
Fycompa sadrži laktozu
Fycompa 10 mg film-coated tablets 10 mg - packs of 7, 28, 84 and 98
Fycompa 10 mg filmom obložene tablete 10 mg - pakiranje od 7, 28, 84 i 98 tableta
Fycompa 10 mg film-coated tablets Perampanel
Fycompa 10 mg filmom obložene tablete perampanel
Fycompa 12 mg film-coated tablets Perampanel
Fycompa 12 mg filmom obložene tablete perampanel
Fycompa 10 mg film-coated tablets
Fycompa 10 mg filmom obložene tablete
Fycompa 12 mg film-coated tablets
Fycompa 12 mg filmom obložene tablete
How to take Fycompa
Kako uzimati Fycompu
Fycompa 2 mg film-coated tablets
Fycompa 2 mg filmom obložene tablete
Fycompa 4 mg film-coated tablets
Fycompa 4 mg filmom obložene tablete
Fycompa 6 mg film-coated tablets 6 mg - packs of 7, 28, 84 and 98
Fycompa 6 mg filmom obložene tablete 6 mg - pakiranje od 7, 28, 84 i 98 tableta
The cap fits properly when the PIBA is in place.
Zatvarač dobro zatvara bocu kada je nastavak umetnut.
Levetiracetam No influence
<10% sniženje zonisamid nema utjecaja nema utjecaja
Fycompa 6 mg film-coated tablets
Fycompa 6 mg filmom obložene tablete
Fycompa 6 mg film-coated tablets Perampanel
Fycompa 6 mg filmom obložene tablete perampanel
4 mg, 6 mg, 8 mg, 10 mg, 12 mg tablets - packs of 7, 28, 84 and 98
Fycompa je dostupna u pakiranjima od: tableta od 2 mg - pakiranja od 7, 28 i 98 tablete od 4 mg, 6 mg, 8 mg, 10 mg, 12 mg - pakiranja od 7, 28, 84 i 98
Fycompa 2 mg film-coated tablets Perampanel
Fycompa 2 mg filmom obložene tablete perampanel
Fycompa 4 mg film-coated tablets Perampanel
Fycompa 4 mg filmom obložene tablete perampanel
The dose may be increased based on clinical response and tolerability by increments of 2 mg (4 ml/day) (either weekly or every 2 weeks, as per half-life considerations described below) to a maintenance dose of up to 8 mg/day (16 ml/day).
Ovisno o kliničkom odgovoru i podnošljivosti, ta se doza može povećavati za 2 mg (4 ml) (bilo svaki tjedan, bilo svaka 2 tjedna, uzimajući u obzir poluvijek kako je opisano niže) do doze održavanja od najviše 8 mg na dan (16 ml na dan).
The dose may be increased based on clinical response and tolerability by increments of 2 mg (either weekly or every 2 weeks, as per half-life considerations described below) to a maintenance dose of up to 8 mg/day.
Ovisno o kliničkom odgovoru i podnošljivosti, ta se doza može povećavati za 2 mg (bilo svaki tjedan, bilo svaka 2 tjedna, uzimajući u obzir poluvijek kako je opisano niže) do doze održavanja od najviše 8 mg na dan.
The dose may be increased based on clinical response and tolerability by increments of 2 mg (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day to 8 mg/day.
Ovisno o kliničkom odgovoru i podnošljivosti, ta se doza može povećavati za 2 mg (bilo svaki tjedan, bilo svaka 2 tjedna, uzimajući u obzir poluvijek kako je opisano niže) do doze održavanja od 4 mg na dan do 8 mg na dan.
Film coating Hypromellose 2910 Talc
Film-ovojnica hipromeloza 2910 talk makrogol 8000 titanijev dioksid (E171)
How to use Fycompa
Fycompom.
(called a “secondary generalisation”).
(zovu se “generalizirani napadaji”) i uzrokuju konvulzije ili epizode zurenja.
Titanium dioxide (E171) Ferric oxide, red (E172)
Film-ovojnica hipromeloza 2910 talk makrogol 8000 titanijev dioksid (E171) željezov oksid, crveni (E172)
1000 doses
1000 doza
Date of first authorisation: 14/06/2011 Date of last renewal: 17/05/2016
Datum prvog odobrenja: 14/06/2011 Datum posljednjeg produljenja odobrenja: 17/05/2016
One dose (30 µl) contains:
Jedna doza (30 µl) sadrži:
See also section 4.7
Također pogledati odjeljak 4.7.
MAH Number: EU/2/11/126/001 To be supplied only on veterinary prescription.
Broj odobrenja: EU/2/11/126/001 Izdaje se samo na veterinarski recept.
Avoid introduction of contamination.
Izbjeći kontaminaciju.
The MS-H vaccine should always be protected from direct sunlight.
Cjepivo MS-H treba uvijek biti zaštićeno od direktne sunčeve svjetlosti.
This may occur during the whole life of the vaccinated bird.
To se može dogoditi čitav tijekom života cijepljene ptice.
Once thawed, use within 2 hours.
Kad se otopi, upotrijebiti u roku od 2 sata.
Do not thaw at higher temperatures or for longer time periods.
Ne otapati na većim temperaturama ili na duže vremenske periode.
Allow the bird to blink before releasing it.
Pustite da ptica trepne prije ispuštanja kapi.
DO7 PF53
Dublin DO7 PF53 Ireland
Do not use antibiotics with anti-Mycoplasma activity 2 weeks before or 4 weeks after vaccination.
Ne koristiti antibiotike s djelovanjem protiv mikoplazmi, 2 tjedna prije ili 4 tjedna poslije cijepljenja.
Do not use after the expiry date which is stated on the label.
Ne koristiti poslije isteka roka valjanosti naznačenog na etiketi.
Chickens from 5 weeks of age
Pilići od 5 tjedana starosti
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.
Djelatna tvar, se sastoji od tvari biološkog podrijetla, namijenjena je za stvaranje aktivnog imuniteta na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
If necessary, further differentiation of the 2 Mycoplasma species can be done by using PCR in a laboratory.
Ako je nužno, za daljnju diferencijaciju 2 vrste mikoplazmi može se koristiti PCR u laboratoriju.
The animal will be immune for 40 weeks after the vaccination.
Životinja će biti imuna 40 tjedana poslije cijepljenja.
Invert the dropper bottle or prepare the device allowing a single drop to form at the tip and fall freely into the open eye, gently flooding it.
Okrenuti bocu s kapaljkom ili pripremiti uređaj koji omogućava da se na vrhu formira kapljica i slobodno padne u otvoreno oko i blago ga natopi.
Chickens should be vaccinated once by applying one eye drop (30 µl) from 5 weeks of age and at least 5 weeks before the onset of the laying period.
Piliće treba cijepiti jedanput, primjenom jednom kapi za oči (30 µl) počevši od 5 tjedana starosti i najmanje 5 tjedana prije početka perioda nesenja.