natgillin/translations-raw huggingface dataset:
Vizimpro 30 mg film-coated tablets are supplied as blue film-coated, round biconvex tablet, debossed with “Pfizer” on one side and “DCB30” on the other.
- Filmsko obložene tablete zdravila Vizimpro 30 mg so na voljo kot modre, okrogle, bikonveksne, filmsko obložene tablete z vtisnjeno oznako ''Pfizer'' na eni strani in ''DCB30'' na drugi strani.
Dose modification and management for Vizimpro adverse reactions Adverse reactions
Prilagajanje odmerkov in ukrepanje v primeru neželenih učinkov zdravila Vizimpro
Transaminases increasedj Weight decreased
Preiskave zvečanje vrednosti transaminaz zmanjšanje telesne mase
Blue film-coated, 7.5 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB30” on the other.
Modra, okrogla, bikonveksna filmsko obložena tableta velikosti 7,5 mm, z vtisnjeno oznako ''Pfizer'' na eni strani in ''DCB30'' na drugi strani.
Microcrystalline cellulose Sodium starch glycolate
6.1 Seznam pomožnih snovi jedro tablete laktoza monohidrat mikrokristalna celuloza natrijev karboksimetilškrob magnezijev stearat filmska obloga
Blue film-coated, 6.35 mm, round biconvex tablet, debossed with “Pfizer” on one side and “DCB15” on the other.
Modra, okrogla, bikonveksna filmsko obložena tableta velikosti 6,35 mm, z vtisnjeno oznako ''Pfizer'' na eni strani in ''DCB15'' na drugi strani.
i Nail disorder includes the following PTs: Ingrowing nail, Nail discolouration, Nail disorder, Nail infection, Nail toxicity, Onychoclasis, Onycholysis, Onychomadesis, Paronychia.
Bolezni nohtov vključujejo naslednje priporočene izraze: vraščen noht, obarvanje nohta, bolezni nohtov, okužba nohta, toksičnost za nohte, onihoklaza, oniholiza, onihomadeza, paronihija.
Each film-coated tablet contains dacomitinib monohydrate equivalent to 15 mg dacomitinib.
Ena filmsko obložena tableta vsebuje dakomitinibijev monohidrat v količini, ki ustreza 15 mg dakomitiniba.
How to store Vizimpro
Shranjevanje zdravila Vizimpro
• Permanently discontinue dacomitinib if ILD/Pneumonitis is confirmed.
• Če potrdite ILD/pnevmonitis, trajno prekinite zdravljenje z dakomitinibom.
Vizimpro 15 mg film-coated tablets
Vizimpro 15 mg filmsko obložene tablete
The median duration of any grade and Grade ≥ 3 exfoliative skin conditions was 10 weeks and approximately 2 weeks, respectively.
Mediano trajanje eksfoliativnih kožnih bolezni katerekoli stopnje je bilo 10 tednov, mediano trajanje eksfoliativnih kožnih bolezni stopnje ≥ 3 pa 2 tedna.
Second dose reduction
30 mg drugo zmanjšanje odmerka
Duration of Response in Responders (per IRC) Number of responders per IRC review, n
Trajanje odziva pri odzivnih bolnikih (glede na IRC) število odzivnih bolnikov glede na pregled IRC, n (%) mediano DoR v mesecih (95 % IZ) HR (95% IZ)
Upon recovery, resume dacomitinib with a reduction of 1 dose level.
Po izboljšanju nadaljujte zdravljenje z dakomitinibom v odmerku, zmanjšanem za 1 odmerno raven.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg dacomitinib (as dacomitinib monohydrate).
Ena filmsko obložena tableta vsebuje 30 mg dakomitiniba (v obliki dakomitinibijevega monohidrata).
Tell your doctor as soon as possible if you notice any of the other following side effects:
Če opazite katerekoli izmed naslednjih neželenih učinkov, čim prej obvestite zdravnika:
PPIs should be avoided while receiving treatment with dacomitinib (see section 4.4).
Med zdravljenjem z dakomitinibom se je treba izogibati zaviralcem protonske črpalke (glejte poglavje 4.4).
• For Grade 1 rash or erythematous skin conditions, no dose modification is required.
• Pri izpuščaju ali eritematoznih kožnih boleznih stopnje 1 prilagajanje odmerka ni potrebno.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 45 mg dacomitinib (as dacomitinib monohydrate).
Ena filmsko obložena tableta vsebuje 45 mg dakomitiniba (v obliki dakomitinibijevega monohidrata).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 15 mg dacomitinib (as dacomitinib monohydrate).
Ena filmsko obložena tableta vsebuje 15 mg dakomitiniba (v obliki dakomitinibijevega monohidrata).
PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets
30 filmsko obloženih tablet
NAME OF THE MEDICINAL PRODUCT Vizimpro 30 mg film-coated tablets dacomitinib
Vizimpro 30 mg filmsko obložene tablete dakomitinib
NAME OF THE MEDICINAL PRODUCT Vizimpro 45 mg film-coated tablets dacomitinib
Vizimpro 45 mg filmsko obložene tablete dakomitinib
Keep this leaflet.
PRETISNI OMOTI
General disorders and administration site conditions Asthenia
Splošne težave in spremembe na mestu aplikacije utrujenost astenija
f Rash includes the following PTs: Acne, Dermatitis acneiform, Erythema, Rash, Rash erythematous, Rash generalised, Rash macular, Rash maculo-papular, Rash papular.
Izpuščaj vključuje naslednje priporočene izraze: akne, akneiformni dermatitis, eritem, izpuščaj, eritematozni izpuščaj, generalizirani izpuščaj, makulozni izpuščaj, makulopapulozni izpuščaj, papulozni izpuščaj.
• if you develop skin rash.
• pojavi izpuščaj na koži.
NAME OF THE MEDICINAL PRODUCT Vizimpro 15 mg film-coated tablets dacomitinib
Vizimpro 15 mg filmsko obložene tablete dakomitinib
All Grades
ŠTEVILKA SERIJE
Skin-related adverse reactions
s kožo povezani neželeni učinki
First dose reduction
45 mg prvo zmanjšanje odmerka
Vizimpro 15 mg tablet: each tablet contains 15 mg dacomitinib Vizimpro 30 mg tablet: each tablet contains 30 mg dacomitinib Vizimpro 45 mg tablet: each tablet contains 45 mg dacomitinib
Vizimpro 45 mg tableta: ena tableta vsebuje 45 mg dakomitiniba.
General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije astenija
What Vizimpro looks like and contents of the pack Vizimpro 15 mg film-coated tablets are supplied as blue film-coated, round biconvex tablets, debossed with “Pfizer” on one side and “DCB15” on the other.
Izgled zdravila Vizimpro in vsebina pakiranja - Filmsko obložene tablete zdravila Vizimpro 15 mg so na voljo kot modre, okrogle, bikonveksne,
Impairment of fertility
Zmanjšanje plodnosti
BATCH NUMBER Lot
Odmerna raven
Hepatic impairment
Očesne bolezni konjunktivitis
75 mg Solution for injection
75 mg Raztopina za injiciranje
Content (concentration)
Pot uporabe Ovojnina Vsebina (koncentracija)
2 pre-filled syringes + 2 alcohol pads
2 napolnjeni injekcijski brizgi + 2 alkoholni zloženec
Subcutaneous use Pre-filled syringe (glass)
Subkutana uporaba Napolnjena injekcijska brizga (steklo)
MA EU Number (Invented) name
Izmišljeno ime
ATCvet code: QI05AI01.
ATCvet oznaka: QI05AI01.
Date of first authorisation: 6/03/2003 Date of last renewal: 6/03/2013
Datum pridobitve dovoljenja za promet: 06/03/2003 Datum zadnjega podaljšanja dovoljenja za promet: 06/03/2013
4.6 Adverse reactions (frequency and seriousness)
4.6 Stranski učinki (pogostost in resnost)
10x1 ml (10 doses).
10x1 ml (10 odmerkov)
• Do not use after the expiry date stated on the label.
• Ne uporabljajte po pretečenem roku uporabnosti, navedenem na nalepki.
The active substances being a principle of biological origin intended to produce active immunity are not within the scope of Regulation (EC) 470/2009.
Učinkovine biološkega izvora namenjene vzbujanju aktivne imunosti, niso vključene v Uredbo(ES) št. 470/2009.
Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE
Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCIJA
• A slight increase in temperature (max. 1.5 °C) may occur for 1 day, exceptionally 2 days.
• Rahlo povišanje temperature (največ 1,5 °C) lahko traja 1 dan, izjemoma 2 dni.
• In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
• V izjemnih okoliščinah lahko pride do preobčutljivostne reakcije, ki jo je treba ustrezno simptomatično zdraviti.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but at different sites and not mixed with MERIAL's inactivated vaccine against rabies.
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno aplicirati na isti dan ampak na različni mesti in ne zmešano z Merialovim inaktiviranim cepivom proti steklini.>
Special precautions for use in animals: Only healthy animals should be vaccinated.
Posebni previdnostni ukrepi za uporabo pri živalih: Cepite samo zdrave živali.
Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Rok uporabnosti zdravila v pakiranju za prodajo: 18 mesecev.
- Revaccination:
- Revakcinacija:
The periodic safety update report (PSUR) cycle would be re-started for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at three-yearly intervals.
Cikel rednih posodobljenih poročil o varnosti zdravila (PSUR) se ponovno začne z oddajo šestmesečnih poročil (vključene so vse odobrene oblike zdravila) v obdobju naslednjih dveh let, ki mu sledi oddaja dveh letnih poročil za naslednji dve leti, po tem obdobju pa se poročila oddajajo v triletnih obdobjih.
One dose of 1 ml contains:
En odmerek (1 ml) vsebuje:
Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality.
Aktivna imunizacija konj, starih 4 mesece ali več proti konjski influenci za ublažitev kliničnih znakov in zmanjšanje izločanja virusov po okužbi, ter proti tetanusu za preprečitev mortalnosti.
Name and address of the manufacturers of the biological active substances
Ime in naslov proizvajalcev biološko aktivnih učinkovin
Store and transport refrigerated (2 °C - 8 °C).
Shranjujte in prevažajte v hladilniku (2 °C 8 °C).
* vCP content checked by global FAID50 (fluorescent assay infectious dose 50 %) and qPCR ratio between vCP.
* vCP vsebnost določena s celokupnim FAID50 (fluorescenčni test infektivnega odmerka 50 %) in qPCR razmerjem med vCP.
Tetanus component: MERIAL Toulouse 4, chemin du Calquet 31057 Toulouse Cedex FRANCE
MERIAL Toulouse 4, chemin du Calquet 31057 Toulouse Cedex FRANCIJA
Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous Water for injections
Dinatrijev hidrogen ortofosfat Monokalijev fosfat, brezvodni Voda za injiciranje
Box of 10 vials of 1 dose.
Škatla z 10 vialami po 1 odmerek.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI
The excipients, including adjuvants, listed in section 6.1 of the SPC are either allowed substances for which table 1 if the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
SPC tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
• In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination.
• V izjemnih okoliščinah se lahko dan po cepljenju pojavita apatičnosti in zmanjšan tek.
Manufacturer for the batch release: MERIAL
Izdelovalec, odgovoren za sproščanje serij: MERIAL
• In very rare occasions, abscessation may be observed.
• Zelo redko se lahko pojavi abscediranje.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
Use immediately after opening.
Uporabite takoj po prvem odpiranju.
• Use immediately after opening.
• Uporabite takoj po prvem odpiranju.
• A transient swelling which usually regresses within 4 days may appear at the injection site.
• Na mestu injiciranja se lahko pojavi prehodna oteklina, ki običajno izgine v 4 dneh.
The vaccine stimulates active immunity against equine influenza and tetanus.
Cepivo spodbuja aktivno imunost proti konjski influenci in tetanusu.
** antitoxic antibody titre induced after repeated vaccination in guinea pig sera according to Ph. Eur.
** titer protiteles proti toksinu po večkratnem cepljenju v serumu morskih prašičkov po Ph. Eur.
Following the administration of overdoses of vaccine, no side-effects other than those described under “Adverse reactions” have been observed.
Po dajanju prevelikih odmerkov niso ugotovili nobenih drugih stranskih učinkov razen tistih, navedenih v navedbi »Stranski učinki ».
For the administration of the vaccine, use sterile and antiseptic-free and/or disinfectant-free material.
Za pripravo in dajanje cepiva uporabljajte sterilen pribor, brez aseptikov in/ali dezinficiensov.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
NAVEDBA ZDRAVILNE UČINKOVIN(E) IN DRUGE(IH) SESTAVIN(E)
Onset of immunity: 14 days after primary vaccination course.
Nastop imunosti 14. dan po končanem primarnem cepljenju.
Intramuscular use (preferably in the neck region).
Intramuskularno dajanje (priporočljivo v predel vratu).
EXP Use immediately after opening.
EXP {mesec/leto} Uporabite takoj po prvem odpiranju.
CLINICAL PARTICULARS 4.1 Target species
4.1 Ciljna živalska vrsta
6.2 Incompatibilities
6.2 Glavne inkompatibilnosti
Only healthy animals should be vaccinated.
Cepite le zdrave živali.
4.2 Indications for use, specifying the target species
4.2 Indikacije za uporabo opredelitev ciljne živalske vrste
After inoculation, the viruses do not multiply in the horse but express the protective proteins.
Po inokulaciji se virusi v konjih ne razmnožujejo, ampak izražajo zaščitne proteine, ki spodbudijo imunost proti virusu konjske influence (H3N8).
In case of increased infection risk or insufficient colostrum intake, an additional initial injection of ProteqFlu-Te can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 5-6 months of age and 4-6 weeks later followed by revaccination).
V primeru povečanega tveganja okužbe ali nezadostnega zaužitja kolostruma se lahko injicira dodaten začetni odmerek Proteqflu TE v starosti štirih mesecev, ki mu sledi popoln program cepljenja (prvi odmerek v starosti petih do šestih mesecev, drugi odmerek 4 do 6 tednov pozneje, sledi revakcinacija).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
• 5 months after primary vaccination course with ProteqFlu-Te.
• 5 mesecev po primarnem cepljenju.
Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Imetnik dovoljenja za promet z zdravilom : Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
- Redki (pojavijo se pri 1 od 10 živali od 10.000 živali) - Zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
Shake the vaccine gently before use.
Cepivo pred uporabo rahlo pretresite.
• Pain, local hyperthermia and muscle stiffness can occur in rare cases.
• V redkih primerih se lahko pojavijo bolečina, lokalno povišana temperatura in otrdelost mišic.
Incompatibilities: Do not mix with any veterinary medicinal product.
Inkompatibilnosti: Ne mešajte z nobenim drugim zdravilom razen s priloženim vehiklom.
6.5 Nature and composition of immediate packaging
6.5 Vrsta in vsebina vsebnika
• Store and transport refrigerated (2 °C - 8 °C).
• Shranjujte in prevažajte v hladilniku 2 °C 8 °C.
In rare occasions, swelling can reach a diameter up to 15-20 cm, with duration up to 2-3 weeks,
V redkih primerih se lahko pojavi oteklina s premerom do 15 - 20 cm, ki traja od 2 - 3 tedne in lahko zahteva simptomatsko zdravljenje.
Carbomer ......................................................................................................................................... 4 mg. For the full list of excipients, see section 6.1.
Karbomer ........................................................................................................................................... 4 mg Celoten seznam pomožnih snovi, glej razdelek 6.1.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
ODMEREK ZA POSAMEZNE ŽIVALSKE VRSTE TER NAČIN UPORABE IN
Name and address of the manufacturer responsible for batch release
Ime in naslov proizvajalca odgovornega za sprostitev serije
STATEMENT OF THE MRLs
ZDRAVILA (MRL)
Veterinary medicinal product subject to prescription.
Zdravila za uporabo v veterinarski medicini na recept.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni) Po dajanju prevelikih odmerkov niso ugotovili nobenih drugih stranskih učinkov razen tistih,
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, če obstajajo
Intramuscular use
Intramuskularno dajanje
Administer one dose (1 ml), by intramuscular injection, preferably in the neck region, according to the following schedule: - Primary vaccination course with ProteqFlu-Te: first injection from 5-6 months of age, second injection 4-6 weeks later.
Injicirajte 1 odmerek (1 ml) intramuskularno, priporočljivo v predel vratu, po naslednjem razporedu: - Primarno cepljenje s Proteqflu-TE: prvi odmerek pri starosti petih do šestih mesecev, drugi odmerek 4 do 6 tednov pozneje.
Intramuscular use.
Intramuskularno dajanje.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer package for 10 doses: 10 vials of 1 dose
PODATKI NA ZUNANJI OVOJNINI Zunanja ovojnina za 10 odmerkov suspenzije
4.9 Amounts to be administered and administration route
4.9 Odmerjanje in način uporabe
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
The vaccine strains vCP2242 and vCP3011 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/eq/Ohio/03 (American strain, Florida sublineage clade 1) and A/eq/Richmond/1/07 (American strain, Florida sublineage clade 2), respectively.
Seva cepiva vCP3011 in vCP2242 sta rekombinantna canarypox virusa, ki izražata hemaglutinin HA gen sevov A/eq/Ohio/03 (ameriški sev, podvrsta Florida 1) in A/eq/Richmond/1/07 (ameriški sev, podvrsta Florida 2) virusa konjske influence.
SPECIAL WARNING(S)
POSEBNO(A) OPOZORIL(O)A
ProteqFlu-Te suspension for injection for horses
ProteqFlu-Te suspenzija za injiciranje za konje
Butyl elastomer closure and aluminium cap.
Viala iz stekla tipa I Zamašek iz butilnega elastomera in aluminijska zaporka za vialo.
Influenza A/eq/Ohio/03 [H3N8] (vCP2242) ............................................................. ≥ 5.3 log10 FAID50 Influenza A/eq/Richmond/1/07 [H3N8] (vCP3011) .................................................. ≥ 5.3 log10 FAID50 Clostridium tetani toxoid ............................................................................................................. ≥ 30 IU
Influenza A/eq/Ohio/03 [H3N8] (vCP2242) .............................................................. ≥ 5,3 log10 FAID50 Influenza A/eq/Richmond/1/07 [H3N8] (vCP3011) ................................................... ≥ 5,3 log10 FAID50 Clostridium tetani toksoid.
Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ............ ≥ 5.3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) .
Influenza A/eq/Ohio/03 [H3N8] rekombinantni Canarypox virus (vCP2242) .......... ≥ 5,3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] rekombinantni
Duration of immunity induced by the vaccination scheme: - 5 months after the primary vaccination course; - after the primary vaccination course and the booster injection 5 months later: 1 year with regard to equine influenza and 2 years with regard to tetanus.
- Po primarnem cepljenju in poživitvenem cepljenju čez 5 mesecev: 1 leto za influenco konj in 2
• Keep out of the sight and reach of children.
• Zdravilo shranjujte nedosegljivo otrokom.
Influenza A/eq/Ohio/03 [H3N8] recombinant Canarypox virus (vCP2242) ........... ≥ 5.3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] recombinant Canarypox virus (vCP3011) ≥ 5.3 log10 FAID50* Clostridium tetani toxoid ......................................................................................................... ≥ 30 IU**
Influenza A/eq/Ohio/03 [H3N8] rekombinantni Canarypox virus (vCP2242) .......... ≥ 5,3 log10 FAID50* Influenza A/eq/Richmond/1/07 rekombinantni Canarypox virus (vCP3011) .......... ≥ 5,3 log10 FAID50* Clostridium tetani toksoid.
o against equine influenza: injection of 1 dose every year, alternatively with ProteqFlu or ProteqFlu-Te, respecting an interval of maximum 2 years for the tetanus component.
• Nadaljnje cepljenje: o Proti tetanusu: 1 odmerek Proteqflu TE največ vsaki dve leti o Proti influenci konj: 1 odmerek vsako leto, izmenjaje Proteqflu in Proteqflu TE,
EXP
Rp-Vet.
No interaction has been observed when the vaccine was administered simultaneously, but at a separate site, with MERIAL's inactivated vaccine against rabies.
Pri sočasnem dajanju cepiva, vendar na različnih mestih niso ugotovili nobenih interakcij, z
PACKAGE LEAFLET FOR: ProteqFlu-Te suspension for injection for horses
NAVODILO ZA UPORABO ProteqFlu-Te suspenzija za injiciranje za konje.
Date of first authorisation: 16 January 2014 Date of latest renewal: 28 September 2018
Datum prve odobritve: 16. januar 2014 Datum zadnjega podaljšanja: 28. september 2018
It can also help prevent heart disease.
Pomaga lahko tudi preprečiti srčno bolezen.
Results at Week 24 (LOCF
Rezultati po 24 tednih (LOCF
• Take your tablet twice daily, once in the morning (breakfast) and once in the evening (dinner).
• Tableto vzemite dvakrat na dan, enkrat zjutraj (zajtrk) in enkrat zvečer (večerja).
• if you have ever had a diabetic coma.
• če ste kdaj imeli diabetično komo.
The events occurred evenly distributed over the study period.
Primeri so bili enakomerno porazdeljeni skozi obdobje študije.
Frequency is based on annual rate.
Pogostnost temelji na podlagi letnega deleža.
Time to first event was analysed in a Cox proportional hazards model.
Čas do prvega dogodka je bil analiziran s Coxovim modelom sorazmernih ogroženosti.
Consumption of alcohol and medicinal products containing alcohol should be avoided.
Izogibati se je treba uživanju alkohola ali zdravil, ki vsebujejo alkohol.
These effects were sustained in longer-term trials.
Ti učinki so se ohranili v dolgoročnejših preskušanjih.
The mean age of the study population was 63.9 years, 37.4% were female.
Povprečna starost študijske populacije je bila 63,9 leta in 37,4 % je bilo žensk.
• awakening from sleep at night to pass urine
• prebujanje ponoči, da bi šli na vodo
LOCF: last observation (prior to rescue for rescued patients) carried forward.
LOCF: prenos zadnjega opažanja (pred rešilnim zdravljenjem za rešene bolnike) [Last Observation Carried Forward].
Your doctor may ask you to stop taking this medicine.
Zdravnik vam lahko naroči, da nehajte jemati to zdravilo.
Take the medicine pack with you.
S seboj vzemite škatlico zdravila.
Your doctor will tell you exactly which strength of this medicine to take.
Zdravnik vam bo natančno povedal, katero jakost tega zdravila morate jemati.