natgillin/translations-raw huggingface dataset:
For patients aged 6 to 11 years 300 mg lumacaftor + 375 mg ivacaftor
Za bolnike, stare 6 do 11 let 300 mg lumakaftorja +
Transaminase elevations uncommon Cholestatic hepatitis‡
Bolezni jeter, žolčnika in žolčevodov pogosti zvišane transaminaze občasni holestatični hepatitis‡
The dose of lumacaftor/ivacaftor should be reduced to one tablet daily for the first week of treatment when initiating lumacaftor/ ivacaftor in patients currently taking clarithromycin or telithromycin.
Odmerek lumakaftorja/ivakaftorja je treba zmanjšati na eno tableto na dan za prvi teden zdravljenja, kadar uvajamo lumakaftor/ivakaftor pri bolnikih, ki trenutno jemljejo klaritromicin ali telitromicin.
A higher dose of bupropion may be required to obtain the desired clinical effect.
Mogoče bo potreben večji odmerek bupropiona, da bomo dosegli želeni klinični učinek.
Lumacaftor/ivacaftor may decrease the exposure of rifabutin, which may reduce its efficacy.
Lumakaftor/ivakaftor lahko zmanjša izpostavljenost rifabutinu, kar lahko zmanjša njegovo učinkovitost.
Patients aged 12 to less than 18 years lumacaftor 400 mg/ivacaftor 250 mg every 12 hours
Bolniki, stari 12 do manj kot 18 let lumakaftor 400 mg/ivakaftor
Orkambi 200 mg/125 mg film-coated tablets
Orkambi 200 mg/125 mg filmsko obložene tablete
Lumacaftor/ivacaftor may decrease the exposure of fluconazole, which may reduce its efficacy.
Lumakaftor/ivakaftor lahko zmanjša izpostavljenost flukonazolu, kar lahko zmanjša njegovo učinkovitost.
Lumacaftor/ivacaftor may decrease the exposure of erythromycin, which may reduce its efficacy.
Lumakaftor/ivakaftor lahko zmanjša izpostavljenost eritromicinu, kar lahko zmanjša njegovo učinkovitost.
Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
natrijev lavrilsulfat magnezijev stearat Filmska obloga polivinilalkohol titanov dioksid (E171)
Due to inhibition of CYP3A by erythromycin
CYP3A z eritromicinom ↓ eritromicin
You may start taking Orkambi on any day of the week.
Zdravilo ORKAMBI lahko začnete jemati kateri koli dan v tednu.
For patients aged 12 years and older 800 mg lumacaftor + 500 mg ivacaftor
Za bolnike, stare 12 let ali več 800 mg lumakaftorja +
Lumacaftor/ivacaftor may decrease the exposure of ibuprofen, which may reduce its efficacy.
Lumakaftor/ivakaftor lahko zmanjša izpostavljenost ibuprofenu, kar lahko zmanjša njegovo učinkovitost.
Mild hepatic impairment (Child-Pugh Class A)
Child-Pughovi lestvici)
No dose adjustment is necessary when CYP3A inhibitors are initiated in patients currently taking Orkambi.
Kadar uvajamo zaviralce CYP3A pri bolnikih, ki trenutno jemljejo zdravilo Orkambi, prilagoditev odmerka ni potrebna.
The dose of lumacaftor/ivacaftor should be reduced to one sachet daily for the first week of treatment when initiating lumacaftor/ivacaftor in patients currently taking clarithromycin or telithromycin.
Odmerek lumakaftorja/ivakaftorja je treba zmanjšati na eno vrečico na dan za prvi teden zdravljenja, kadar uvajamo lumakaftor/ivakaftor pri bolnikih, ki trenutno jemljejo klaritromicin ali telitromicin.
Absolute change from baseline in body mass index (BMI)
Absolutna sprememba indeksa telesne mase (ITM) od izhodišča n = 57
Talk to your child's doctor or pharmacist before taking Orkambi.
Pred začetkom dajanja zdravila Orkambi se posvetujte z otrokovim zdravnikom ali farmacevtom.
NAME OF THE MEDICINAL PRODUCT Orkambi 200 mg/125 mg film-coated tablets lumacaftor/ivacaftor
IME ZDRAVILA Orkambi 200 mg/125 mg filmsko obložene tablete lumacaftorum/ivacaftorum
Orkambi 100 mg/125 mg granules in sachet:
Orkambi 100 mg/125 mg zrnca v vrečici:
Orkambi 100 mg/125 mg film-coated tablets
Orkambi 100 mg/125 mg filmsko obložene tablete
Respiratory Domain Score (points)‡
Izhodiščni rezultat respiracijske domene
↓ esomeprazole, lansoprazole, omeprazole Due to induction of CYP3A/2C19 by LUM
↔ LUM, IVA ↓ ibuprofen Zaradi indukcije CYP3A/2C8/2C9 z
Liver function decompensation, including liver failure leading to death, has been reported in CF patients with preexisting cirrhosis with portal hypertension receiving lumacaftor/ivacaftor.
Pri bolnikih s CF, ki so imeli že od prej cirozo s portalno hipertenzijo in so prejemali lumakaftor/ivakaftor, so poročali o dekompenzaciji funkcije jeter, vključno z odpovedjo jeter, ki je povzročila smrt.
Due to induction of CYP3A by antimycobacterials
Zaradi indukcije CYP3A z zdravili za zdravljenje infekcij z mikobakterijami
Dose
Podalj.
Package leaflet: Information for the patient Orkambi 100 mg/125 mg film-coated tablets Orkambi 200 mg/125 mg film-coated tablets lumacaftor/ivacaftor
Navodilo za uporabo Orkambi 100 mg/125 mg filmsko obložene tablete Orkambi 200 mg/125 mg filmsko obložene tablete lumakaftor (lumacaftorum)/ivakaftor (ivacaftorum)
• Cough with sputum
• kašelj z izmečkom,
STATEMENT OF ACTIVE SUBSTANCE Each sachet of granules contains 100 mg of lumacaftor and 125 mg of ivacaftor.
NAVEDBA UČINKOVINE Ena vrečica zrnc vsebuje 100 mg lumakaftorja in 125 mg ivakaftorja.
Each sachet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Ena vrečica vsebuje 100 mg lumakaftorja in 125 mg ivakaftorja.
Dose adjustment of fexofenadine may be required to obtain the desired clinical effect.
Mogoče bo potrebna prilagoditev odmerka feksofenadina, da bomo dosegli želeni klinični učinek.
Hepatic impairment
občasni hepatična encefalopatija†
Baseline CFQ-R
Absolutna sprememba rezultata CFQ-R
Lumacaftor/ivacaftor may alter the exposure of fexofenadine.
Lumakaftor/ivakaftor lahko spremeni izpostavljenost feksofenadinu.
The dose of lumacaftor/ivacaftor should be reduced to one tablet daily for the first week of treatment when initiating lumacaftor/ ivacaftor in patients currently taking these antifungals.
Odmerek lumakaftorja/ivakaftorja je treba zmanjšati na eno tableto na dan za prvi teden zdravljenja, kadar uvajamo lumakaftor/ivakaftor pri bolnikih, ki trenutno jemljejo te antimikotike.
Orkambi 100 mg/125 mg film-coated tablets and Orkambi 200 mg/125 mg film-coated tablets: The other ingredients are:
Orkambi 100 mg/125 mg filmsko obložene tablete in Orkambi 200 mg/125 mg filmsko obložene tablete:
For patients aged 12 years and older 400 mg lumacaftor + 250 mg ivacaftor or a reduced daily dose
Za bolnike, stare 12 let ali več 400 mg lumakaftorja +
• Tablet core: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate;
Druge sestavine zdravila so: • jedro tablete: mikrokristalna celuloza; premreženi natrijev karmelozat; hipromeloza acetat sukcinat; povidon (K30); natrijev lavrilsulfat; in magnezijev stearat;
Concomitant use of lumacaftor/ivacaftor with these anti-mycobacterials is not recommended.
Sočasne uporabe lumakaftorja/ivakaftorja s temi antimikotiki ne priporočajo.
LUM 400 mg q12h/IVA 250 mg q12h (n = 187)
12 ur/IVA 250 mg na 12 ur (n = 187)
For patients aged 12 years and older 2 tablets of 200 mg/125 mg in the morning +
2 tableti po 200 mg/125 mg zjutraj +
Lumacaftor/ivacaftor may decrease the exposure of repaglinide, which may reduce its efficacy.
Lumakaftor/ivakaftor lahko zmanjša izpostavljenost repaglinidu, kar lahko zmanjša njegovo učinkovitost.
QUALITATIVE AND QUANTITATIVE COMPOSITION Orkambi 100 mg/125 mg film-coated tablets Each film-coated tablet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Orkambi 100 mg/125 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg lumakaftorja (lumacaftorum) in 125 mg ivakaftorja (ivacaftorum).
The dose of lumacaftor/ivacaftor should be reduced to one sachet daily for the first week of treatment when initiating lumacaftor/ivacaftor in patients currently taking these antifungals.
Odmerek lumakaftorja/ivakaftorja je treba zmanjšati na eno vrečico na dan za prvi teden zdravljenja, kadar uvajamo lumakaftor/ivakaftor pri bolnikih, ki trenutno jemljejo te antimikotike.
Multipacks containing 112 film-coated tablets (4 packs of 28 film-coated tablets).
Pakiranje, ki vsebuje 112 filmsko obloženih tablet (4 pakiranja po 28 filmsko obloženih tablet).
NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg granules in sachet lumacaftor/ivacaftor
IME ZDRAVILA Orkambi 100 mg/125 mg zrnca v vrečici lumacaftorum/ivacaftorum
• Antibiotic medicines (used for the treatment of bacterial infections) for example: telithromycin, clarithromycin, rifampicin, rifabutin, rifapentine, erythromycin
telitromicin, klaritromicin, rifampicin, rifabutin, rifapentin, eritromicin;
• Breast inflammation*
zatrdlina v dojki*
Relative change in ppFEV1 at Week 24
Relativna sprememba ppFEV1 v
Lumacaftor/ivacaftor has not been studied in patients with CF who have undergone organ transplantation.
Pri bolnikih s CF, ki so imeli presaditev organa, lumakaftorja/ivakaftorja niso proučevali.
Concomitant use of lumacaftor/ivacaftor with these immunosuppressants is not recommended.
Sočasne uporabe lumakaftorja/ivakaftorja s temi zdravili za zaviranje imunske odzivnosti ne priporočajo.
Lumacaftor/ivacaftor may decrease the exposure of bupropion, which may reduce its efficacy.
Lumakaftor/ivakaftor lahko zmanjša izpostavljenost bupropionu, kar lahko zmanjša njegovo učinkovitost.
Flatulence, vomiting
esomeprazol, lansoprazol, omeprazol
Dose adjustment of ranitidine may be required to obtain the desired clinical effect.
Mogoče bo potrebna prilagoditev odmerka ranitidina, da bomo dosegli želeni klinični učinek.
LUM 400 mg q12h/ IVA 250 mg q12h (n = 182)
12 ur/ IVA 250 mg na 12 ur (n = 182)
Number of Pulmonary exacerbations (events) ** † *** Number of events per patient- year (95% CI) (rate per 48 wks)
Število dogodkov na bolnika leto (95 % IZ) (pogostnost na 48 tednov)
Appropriate clinical monitoring should be employed when co-administered with lumacaftor/ivacaftor.
Pri sočasni uporabi z lumakaftorjem/ivakaftorjem je potrebno ustrezno klinično spremljanje.
For patients aged 6 to 11 years 200 mg lumacaftor + 250 mg ivacaftor or a reduced daily dose
Za bolnike, stare 6 do 11 let 200 mg lumakaftorja +
Absolute change from baseline in stature (cm)
Absolutna sprememba telesne višine (cm) od izhodišča n = 57
OTHER Morning Evening
peroralna uporaba zjutraj zvečer
Herbals:
Antimikotiki:
What you need to know before your child takes Orkambi 3.
Kaj morate vedeti, preden bo vaš otrok vzel zdravilo Orkambi Kako dajati zdravilo Orkambi
No effects on male or female fertility and reproductive performance indices were observed at ≤ 100 mg/kg/day
Pri odmerku ≤ 100 mg/kg/dan niso ugotovili učinkov na indekse plodnosti in reproduktivne uspešnosti pri samcih in samicah podgan (glejte poglavje 5.3).
↓ repaglinide Due to induction of CYP3A/2C8 by LUM
Zaradi indukcije CYP3A/2C8 z
Lumacaftor/ivacaftor may alter the exposure of ranitidine.
Lumakaftor/ivakaftor lahko spremeni izpostavljenost ranitidinu.
1 tablet of 100 mg/125 mg in the evening (12 hours later) or a reduced daily dose
1 tableto po 100 mg/125 mg zvečer (12 ur pozneje)
Each film-coated tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor.
Ena tableta vsebuje 200 mg lumakaftorja in 125 mg ivakaftorja.
Changes in ppFEV1 in response to lumacaftor alone or in combination with ivacaftor were also evaluated in the double-blind, placebo-controlled, Phase 2 trial in patients with CF age 18 years and older.
V dvojno slepem, s placebom kontroliranem preskušanju faze 2 pri bolnikih s CF, starih 18 let ali več, so ovrednotili tudi spremembe ppFEV1 v odzivu na lumakaftor sam ali v kombinaciji z ivakaftorjem.
Lumacaftor/ivacaftor may alter the exposure of warfarin.
Lumakaftor/ivakaftor lahko spremeni izpostavljenost varfarinu.
NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg film-coated tablets lumacaftor/ivacaftor
Orkambi 100 mg/125 mg filmsko obložene tablete lumacaftorum/ivacaftorum
• Enlargement of the breast*
• vnetje dojke*,
Due to potential induction or inhibition of CYP2C9 by LUM
↑ ali ↓ varfarin Zaradi možne indukcije ali zaviranja CYP2C9
• Diarrhoea
• bruhanje,
Carmine (E120)
makrogol 3350 smukec karmin (E120)
Other forms of this medicine (granules in a sachet) are more suitable for children under 6 years of age, ask your doctor or pharmacist.
(zrnca v vrečici) so primernejše za otroke, mlajše od 6 let.
Each film-coated tablet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Ena tableta vsebuje 100 mg lumakaftorja in 125 mg ivakaftorja.
P value Mean (SD)
Izhodiščni in končni povprečje (SD)
NAME OF THE MEDICINAL PRODUCT Orkambi 200 mg/125 mg tablets lumacaftor/ivacaftor
Orkambi 200 mg/125 mg tablete lumacaftorum/ivacaftorum
For patients aged 6 to 11 years 1 tablet of 100 mg/125 mg in the morning +
1 tableto po 100 mg/125 mg zjutraj +
One lumacaftor 100 mg/ivacaftor 125 mg sachet every 12 hours lumacaftor 200 mg/ ivacaftor 250 mg
100 mg/ivakaftor 125 mg na 12 ur lumakaftor 200 mg/
For patients aged 2 to 5 years and < 14 kg lumacaftor 100 mg + ivacaftor 125 mg For patients aged 2 to5 years and ≥ 14 kg lumacaftor 150 mg + ivacaftor 188 mg
stare 2 do 5 let, ki tehtajo manj kot 14 kg; lumakaftor 150 mg/ivakaftor 188 mg za bolnike, stare 2 do
For patients aged 12 years and older 1 tablet of 200 mg/125 mg in the morning +
1 tableto po 200 mg/125 mg zjutraj +
Your doctor may perform some eye examinations prior to and during treatment with Orkambi.Orkambi is not recommended in patients who have undergone an organ transplant.
Mogoče bo zdravnik pred zdravljenjem z zdravilom Orkambi in med njim naredil nekatere očesne preiskave.
STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet of granules contains 150 mg of lumacaftor and 188 mg of ivacaftor.
Ena vrečica vsebuje 150 mg lumakaftorja (lumacaftorum) in 188 mg ivakaftorja (ivacaftorum).
Talk to your doctor or pharmacist before taking Orkambi.
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Orkambi se posvetujte z zdravnikom ali farmacevtom.
Two lumacaftor 200 mg/ivacaftor 125 mg tablets every 12 hours lumacaftor 800 mg/ ivacaftor 500 mg
125 mg na 12 ur lumakaftor 800 mg/
NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg tablets lumacaftor/ivacaftor
Orkambi 100 mg/125 mg tablete lumacaftorum/ivacaftorum
Day 1: lumacaftor 200 mg + ivacaftor 250 mg Day 2: lumacaftor 100 mg + ivacaftor 125 mg
2. dan: 150 mg lumakaftorja +
STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 200 mg lumakaftorja in 125 mg ivakaftorja.
For patients aged 2 to 5 years and ≥ 14 kg Day 1: lumacaftor 300 mg + ivacaftor 376 mg Day 2: lumacaftor 150 mg + ivacaftor 188 mg
Za bolnike, stare 2 do 5 let in ≥ 14 kg 1. dan: 300 mg lumakaftorja +
No dose adjustment is necessary for patients with mild hepatic impairment (Child-Pugh Class A).
Okvara jeter Pri bolnikih z blago okvaro jeter (razred A po Child-Pughovi lestvici) ni potrebno prilagajanje odmerjanja.
• Moderate liver problems: the dose may be reduced on alternate days: two sachets on one day
• Zmerne težave z jetri: odmerek se lahko zmanjša vsak drugi dan: dve vrečici na en dan (zjutraj in zvečer), eno vrečico naslednjega dne (samo zjutraj).
For patients aged 12 years and older 600 mg lumacaftor + 375 mg ivacaftor
Za bolnike, stare 12 let ali več 600 mg lumakaftorja +
Hormonal contraceptives: ethinyl estradiol, norethindrone, and other progestogens
noretindron in drugi progestogeni
Concomitant medicinal products of most clinical relevance Anti-allergics: montelukast
Klinični komentar Sočasno uporabljena zdravila z največjo klinično pomembnostjo
Absolute change from baseline in weight (kg)
Absolutna sprememba telesne mase (kg) od izhodišča n = 57
Content Package size Withdrawal period
Vsebina Velikost pakiranja
1 pre-filled syringe Not applicable
1 napolnjena brizga
No other concern was notified by the reference Member State.
Referenčna država članica ni priglasila nobenega drugega pomisleka.
The calf should be younger than 1 month old, 2.)
tele mora biti mlajše od enega meseca; 2.)
For the mutual recognition procedure (MRP), Belgium acted as a reference Member State and Bulgaria, Croatia, France, Germany, Ireland, Italy, the Netherlands, Poland, Portugal, Romania, Slovenia, Spain and the United Kingdom were concerned Member States.
Pri postopku z medsebojnim priznavanjem je bila Belgija referenčna država članica, Bolgarija, Hrvaška, Francija, Nemčija, Irska, Italija, Nizozemska, Poljska, Portugalska, Romunija, Slovenija, Španija in Združeno kraljestvo pa so bile zadevne države članice.
This thorough investigations includes: 1.
Takšna natančna raziskava vključuje:
− PSURs shall be provided every 6 months for the first 5 years of commercialisation.
− poročilo PSUR se pripravi vsakih šest mesecev v prvih petih letih trženja zdravila;
Additionally, a surveillance and monitoring strategy has been proposed, which together with the suggested studies is deemed adequate and proportionate to the identified risk.
Poleg tega je bila predlagana strategija nadzora in spremljanja, ki se skupaj s predlaganima študijama šteje za ustrezno in sorazmerno ugotovljenim tveganjem.
However, a concern remains and the MAH committed to further investigate this result in two additional similar studies.
Vendar pa zaskrbljenost ostaja, zato se je imetnik dovoljenja za promet z zdravilom zavezal, da bo ta rezultat podrobneje raziskal v dveh dodatnih podobnih študijah.
Data have been provided to demonstrate the efficiency of the filtration step.
Posredovani podatki so prikazovali učinkovitost filtriranja.
The proposed measures, which will be included in a risk management plan, are considered proportionate and the most efficient way to tackle the BNP risk.
Predlagani ukrepi, ki bodo vključeni v načrt za obvladovanje tveganj, veljajo za sorazmerne in so najučinkovitejši način za odpravo tveganja za BNP.
Animal species Route of administration
Živalska vrsta Način uporabe
Vaccines are important tools to combat Bovine Herpesvirus Type 1 Infection which is a notifiable disease in several Member States, e.g. Austria, Denmark, Germany.
Cepiva so pomembno sredstvo za boj proti okužbi z bovinim herpesvirusom tipa 1, pri kateri gre za bolezen, ki jo je treba prijaviti v številnih državah članicah, kot so Avstrija, Danska in Nemčija.
Exclusion of infectious, toxic or any other cause in live animals, to be further detailed in the risk management plan.
1. izključitev infekcioznega, toksičnega ali katerega koli drugega vzroka v živih živalih, ki se nadalje podrobno opiše v načrtu za obvladovanje tveganj;
With Commission Decisions 5694 of 10/08/2010 and 7077 of 07/10/2010 the marketing authorisations for PregSure BVD were suspended.
Z odločbama Komisije 5694 z dne 10. avgusta 2010 in 7077 z dne 7. oktobra 2010 so bila dovoljenja za promet s cepivom PregSure BVD začasno preklicana.
The national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Pristojni nacionalni organi, ki jih medsebojno usklajuje referenčna država članica, bodo zagotovili, da bo imetnik dovoljenja za promet z zdravilom izpolnil naslednje pogoje:
− Show that there is no impact of the scaling-up (considering a worst-case scenario, i.e. the maximum commercial batch) on the efficiency of consistently decreasing the total protein content.
− dokaže, da ni vpliva povečanja (ob upoštevanju najslabšega mogočega primera, tj. največje komercialne serije) na učinkovitost dosledno padajoče skupne vsebnosti beljakovin;
• The marketing authorisation holder shall implement a single risk management plan addressing the following risk mitigation and surveillance measures:
• imetnik dovoljenja za promet z zdravilom izvaja en načrt za obvladovanje tveganj, ki vsebuje naslednje ukrepe za zmanjševanje tveganja in nadzor:
List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant/marketing authorisation holder in the Member States
Seznam imen, farmacevtska oblika, jakost zdravila za uporabo v veterinarski medicini, živalske vrste, način uporabe, vlagatelj/imetnik dovoljenja za promet z zdravilom v državah članicah
Risk management measures
Ukrepi za obvladovanje tveganja
To address the concerns on alloantibody response the marketing authorisation holder should ensure that the results of the study can be reliably interpreted.
Zaradi obravnavanja vprašanja odziva aloprotiteles mora imetnik dovoljenja za promet z zdravilom zagotoviti, da bo mogoče rezultate študije zanesljivo razložiti.
The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so končne različice, dogovorjene med postopkom usklajevalne skupine.
These issues remained unresolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started.
Ta vprašanja so ostala nerazrešena, zato je bil sprožen napotitveni postopek v skladu s členom 33(1) Direktive 2001/82/ES, ki je bil predložen Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v veterinarski medicini (CMD(v)).
The limit should be equal to or below the quantity of total protein of the CattleMarker IBR vaccine used in hyperimmunisation study 9134R-08-11-457.
Meja mora biti enaka ali nižja od količine skupne vsebnosti beljakovin v cepivu CattleMarker IBR, ki se uporablja v študiji hiperimunizacije 9134R-08-11-457;
Should proposals for alternative immunisation schemes, indications, or contraindications be necessary, these regulatory measures should also be handled consistently with the normal operating practices for adverse event reports and variations associated with veterinary medicinal products.
Če so potrebni predlogi za nadomestni program cepljenja, indikacije ali kontraindikacije, se ti regulativni ukrepi prav tako obravnavajo v skladu z običajnimi praksami ukrepanja v zvezi s poročili o neželenih učinkih in spremembami, povezanimi z zdravili za uporabo v veterinarski medicini;
Since the issues raised by Germany remained unresolved, the Member States concerned failed to reach agreement regarding the marketing authorisation CattleMarker IBR Inactivated and consequently the matter was referred to the CVMP on 29 September 2015 under Article 33(4) of Directive 2001/82/EC.
Ker pa so ostala vprašanja, ki jih je izpostavila Nemčija, nerazrešena, zadevne države članice niso dosegle soglasja v zvezi z dovoljenjem za promet s cepivom CattleMarker IBR Inactivated, zato je bila zadeva 29. septembra 2015 v skladu s členom 33(4) Direktive 2001/82/ES predložena odboru CVMP.
− Clinically validate the upper limit for total protein content.
− klinično ovrednoti zgornjo mejo skupne vsebnosti beljakovin.
A large scale post-marketing prospective survey is deemed less effective to identify whether the level of BNP is acceptable when compared with the surveillance and monitoring strategy proposed, because the number of animals to be enrolled in such a study would exceed several thousands of animals (due to the estimated BNP frequency of around 0.01%) and the time span anticipated for BNP cases to occur consecutive to vaccination would not be shorter.
Obsežna prospektivna študija v obdobju trženja bi bila manj učinkovita pri ugotavljanju, ali je stopnja BNP sprejemljiva v primerjavi s predlagano strategijo nadzora in spremljanja, ker bi število živali, vključenih v tako študijo, preseglo nekaj tisoč (zaradi ocenjene pogostnosti BNP okrog 0,01 %), časovni razpon, predviden za pojav primerov BNP po cepljenju, pa ne bi bil krajši.
Active immunisation of female cattle from 6 months of age is also indicated:
Indicirano je tudi za aktivno imunizacijo goveda ženskega spola, starega šest mesecev ali več, zaradi:
According to the definition of BNP, for a calf to be diagnosed with the disease, the following three criteria need to be associated: 1.)
V skladu z opredelitvijo pancitopenije novorojenega goveda morajo teleta z diagnozo bolezni izpolnjevati naslednje tri pogoje: 1.)