natgillin/translations-raw huggingface dataset:
The CHMP concluded that, in accordance with EU requirements, Levetiracetam Actavis Group has been shown to have comparable quality and to be bioequivalent to Keppra.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Levetiracetam Actavis Group primerljivo raven kakovosti kot zdravilo Keppra ter da mu je biološko enakovredno.
Because Levetiracetam Actavis Group is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Ker je zdravilo Levetiracetam Actavis Group generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Keppra.
Levetiracetam Actavis Group is a ‘generic medicine'.
Levetiracetam Actavis Group je „generično zdravilo“.
Levetiracetam Actavis Group can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Zdravilo Levetiracetam Actavis Group se lahko uporablja kot samostojno zdravilo pri bolnikih, starejših od 16 let, pri katerih je bila na novo ugotovljena epilepsija, za zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje.
What benefit has Levetiracetam Actavis Group shown during the studies?
Kakšne koristi je zdravilo Levetiracetam Actavis Group pokazalo med študijami?
Levetiracetam Actavis Group is a medicine that contains the active substance levetiracetam.
Levetiracetam Actavis Group je zdravilo, ki vsebuje zdravilno učinkovino levetiracetam.
• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from
• miokloničnih napadov (kratkih, krču podobnih sunkovitih gibov mišice ali skupine mišic) pri bolnikih z juvenilno mioklonično epilepsijo od 12. leta starosti dalje;
When Levetiracetam Actavis Group is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Začetni samostojni odmerek zdravila Levetiracetam Actavis Group je 250 mg dvakrat dnevno, po dveh tednih jemanja pa se poveča na 500 mg dvakrat dnevno.
The active substance in Levetiracetam Actavis Group, levetiracetam, is an anti-epileptic medicine.
Zdravilna učinkovina zdravila Levetiracetam Actavis Group, levetiracetam, je zdravilo proti epilepsiji.
In babies aged between one and six months, the starting dose is 7 mg/kg twice a day, using the oral solution.
Pri otrocih, starih od enega do šestega meseca, začetni odmerek v obliki peroralne raztopine znaša 7 mg/kg dvakrat dnevno.
What is the risk associated with Levetiracetam Actavis Group?
Kakšna tveganja so povezana z zdravilom Levetiracetam Actavis Group?
Why has Levetiracetam Actavis Group been approved?
Zakaj je bilo zdravilo Levetiracetam Actavis Group odobreno?
For the full list of all side effects reported with Levetiracetam Actavis Group, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi tega cepiva, glejte navodilo za uporabo.
What is Levetiracetam Actavis Group?
Kaj je zdravilo Levetiracetam Actavis Group?
How has Levetiracetam Actavis Group been studied?
Kako je bilo zdravilo Levetiracetam Actavis Group raziskano?
What is Levetiracetam Actavis Group used for?
Za kaj se zdravilo Levetiracetam Actavis Group uporablja?
How is Levetiracetam Actavis Group used?
Kako se zdravilo Levetiracetam Actavis Group uporablja?
How does Levetiracetam Actavis Group work?
Kako zdravilo Levetiracetam Actavis Group deluje?
The third study involved 59 children aged 2 to 12 years.
Tretja študija je vključevala 59 otrok, starih od 2 do 12 let.
Further information on Vihuma can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Vihuma.
Nadaljnje informacije o zdravilu Vihuma so na voljo na spletni strani agencije:: ema.europa.eu/medicines/human/EPAR/Vihuma.
Vihuma received a marketing authorisation valid throughout the EU on 13 February 2017.
Zdravilo Vihuma je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 13. februarja 2017.
What measures are being taken to ensure the safe and effective use of Vihuma?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Vihuma?
This medicine is the same as Nuwiq, which is already authorised in the EU.
To zdravilo je enako zdravilu Nuwiq, ki je že odobreno v Evropski uniji (EU).
Vihuma can be used for short-term or long-term treatment.
Zdravilo Vihuma se lahko uporablja za kratkotrajno ali dolgotrajno zdravljenje.
The European Medicines Agency decided that Vihuma's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Vihuma večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Other information about Vihuma
Druge informacije o zdravilu Vihuma
As for all medicines, data on the use of Vihuma are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Vihuma stalno spremljajo.
What is Vihuma and what is it used for?
Kaj je zdravilo Vihuma in za kaj se uporablja?
What benefits of Vihuma have been shown in studies?
Kakšne koristi je zdravilo Vihuma izkazalo v študijah?
Patients or their carers may be able to inject Vihuma themselves at home once they have been trained.
Bolniki ali njihovi negovalci lahko po ustreznem usposabljanju zdravilo Vihuma injicirajo sami doma.
What are the risks associated with Vihuma?
Kakšna tveganja so povezana z zdravilom Vihuma?
An overview of Vihuma and why it is authorised in the EU
Pregled zdravila Vihuma in zakaj je odobreno v EU
Why is Vihuma authorised in the EU?
Zakaj je zdravilo Vihuma odobreno v EU?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vihuma have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Vihuma upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
The dose and duration of treatment depend on whether Vihuma is used to treat or prevent bleeding, or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and weight.
Odmerek in trajanje zdravljenja sta odvisna od tega, ali se zdravilo Vihuma uporablja za zdravljenje ali preprečevanje krvavitev ali med kirurškim posegom, ter od ravni faktorja VIII, resnosti hemofilije, obsega in mesta krvavitve ter bolnikovega stanja in telesne mase.
The company that makes Nuwiq has agreed that its scientific data can be used for Vihuma (‘informed consent').
Družba, ki proizvaja zdravilo Nuwiq, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Vihuma („uporaba dokumentacije s soglasjem“).
Side effects reported with Vihuma are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Vihuma , se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
For more information about using Vihuma, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Vihuma glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
It contains the active substance simoctocog alfa (human coagulation factor VIII).
Vsebuje učinkovino simoktokog alfa (humani koagulacijski faktor VIII).
A total of 986 bleeding episodes were recorded, most of which resolved with one injection of Vihuma.
Med študijo so zabeležili skupno 986 krvavitev, med katerimi so večino epizod obvladali z eno injekcijo zdravila Vihuma.
Vihuma was effective at preventing and treating bleeding episodes in three main studies involving 113 patients with haemophilia A.
Zdravilo Vihuma se je izkazalo za učinkovito pri preprečevanju in zdravljenju krvavitev v treh glavnih študijah, ki so vključevale 113 bolnikov s hemofilijo A.
The Agency concluded that Vihuma was effective at treating and preventing bleeding in patients with haemophilia A and it has an acceptable safety profile.
Zaključila je, da se je zdravilo Vihuma izkazalo za učinkovito pri zdravljenju in preprečevanju krvavenja pri bolnikih s hemofilijo A in da ima sprejemljiv varnostni profil.
Vihuma is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Vihuma je zdravilo, ki se uporablja za zdravljenje in preprečevanje krvavenja pri bolnikih vseh starosti s hemofilijo A (dedno motnjo strjevanja krvi, ki jo povzroča pomanjkanje faktorja VIII).
Some patients treated with factor VIII medicines may develop inhibitors (antibodies) against factor VIII, which may stop the medicine from working and controlling bleeding.
Pri nekaterih bolnikih, zdravljenih z zdravili, ki vsebujejo faktor VIII, se lahko pojavijo zaviralci (protitelesa) faktorja VIII, ki lahko ustavijo delovanje zdravila in nadzor krvavitve.
The active substance in Vihuma, simoctocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Učinkovina v zdravilu Vihuma , simoktokog alfa (humani koagulacijski faktor VIII), je snov, ki pripomore k strjevanju krvi.
When used to prevent bleeding, an average of 0.19 bleeding episode per month was recorded for each patient.
Kadar so zdravilo uporabljali za preprečevanje krvavitev, so pri vsakem bolniku zabeležili povprečno 0,19 epizode krvavitve na mesec.
When used for treating bleeding episodes, Vihuma was mainly rated ‘excellent' or ‘good' at treating major bleeding episodes and most bleeding episodes resolved following one or more injections of Vihuma.
Kadar so zdravilo Vihuma uporabljali za zdravljenje krvavitev, je bilo v glavnem ocenjeno kot „odlično“ ali „dobro“ za zdravljenje večjih krvavitev, večino krvavitev pa so obvladali z eno ali več injekcijami zdravila Vihuma.
Patients with haemophilia A lack factor VIII, and this causes blood clotting problems leading to events such as bleeding in the joints, muscles or internal organs.
Bolnikom s hemofilijo A primanjkuje faktorja VIII, kar povzroča motnje strjevanja krvi, kot so krvavenje v sklepe, mišice ali notranje organe.
Hypersensitivity (allergic) reactions have been reported with factor VIII medicines and they may be severe in some cases.
Pri uporabi zdravil, ki vsebujejo faktor VIII, so poročali o preobčutljivostnih (alergijskih) reakcijah, ki lahko v nekaterih primerih postanejo hude.
For the full list of side effects and restrictions of Vihuma, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Vihuma glejte navodilo za uporabo.
Treatment with Vihuma was rated ‘excellent' or ‘good' for 94% of bleeding episodes.
Zdravljenje z zdravilom Vihuma so pri 94 % krvavitev ocenili kot „odlično“ ali „dobro“.
When Vihuma was used for treatment, bleeding episodes resolved in 81% of cases following 1 or 2 injections.
Kadar so ga uporabljali za zdravljenje, so krvavitve v 81 % primerov obvladali z eno ali dvema injekcijama zdravila Vihuma.
Vihuma can only be obtained with a prescription, and treatment should be supervised by a doctor experienced in the treatment of haemophilia.
Predpisovanje in izdaja zdravila Vihuma je le na recept, zdravljenje pa mora nadzorovati zdravnik z izkušnjami z zdravljenjem hemofilije.
Vihuma corrects the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Zdravilo Vihuma se uporablja za uravnavanje pomanjkanja faktorja VIII, in sicer z nadomeščanjem manjkajočega faktorja VIII, kar vzpostavi začasni nadzor nad krvavitvami.
When Vihuma was used to prevent bleeding, an average of 0.34 bleeding episode per month was recorded for each child.
Kadar so zdravilo Vihuma uporabljali za preprečevanje krvavitev, so pri vsakem otroku na mesec zabeležili povprečno 0,34 krvavitve.
The first study involved 22 patients aged 12 years and above, who were given Vihuma for the treatment of bleeding episodes or to prevent bleeding during surgery.
Prva študija je vključevala 22 bolnikov, starih 12 let in več, ki so prejeli zdravilo Vihuma za zdravljenje krvavitev ali za preprečevanje krvavitve med kirurškim posegom.
Vihuma is available as a powder and solvent to mix together to make a solution that is injected into a vein.
Zdravilo Vihuma je na voljo v obliki praška in vehikla, ki se zmešata za pripravo raztopine za injiciranje v veno.
How is Vihuma used?
Kako se zdravilo Vihuma uporablja?
In the 5 surgeries during the study, Vihuma was rated excellent in preventing bleeding episodes for 4 surgeries and as moderate to prevent bleeding during one surgical intervention.
Pri petih kirurških posegih, ki so jih opravili med študijo, je bilo zdravilo Vihuma pri štirih kirurških posegih ocenjeno kot odlično za preprečevanje krvavitev, pri enem kirurškem posegu pa kot zmerno za preprečevanje krvavitev.
How does Vihuma work?
Kako zdravilo Vihuma deluje?
The second study involved 32 patients aged 12 years and above who were given Vihuma to prevent and treat bleeding events as well as to prevent bleeding during surgery.
Druga študija je vključevala 32 bolnikov, starih 12 let in več, ki so prejeli zdravilo Vihuma za preprečevanje in zdravljenje krvavitev ter za preprečevanje krvavitve med kirurškim posegom.
In the 2 surgeries during the study, Vihuma was rated excellent in preventing bleeding episodes.
Pri dveh kirurških posegih, ki so jih opravili med študijo, je bilo zdravilo Vihuma ocenjeno kot odlično za preprečevanje krvavitev.
Onset of immunity: 3 weeks.
Nastop imunosti: 3 tedne.
0.1 mg Colourless suspension.
0,1 mg Brezbarvna suspenzija
When mixed with these Canigen vaccines, the demonstrated safety and efficacy claims for Canigen L4 are no different from those described for Canigen L4 alone.
Kadar se cepivo meša s temi cepivi Canigen, se podatki o varnosti in učinkovitosti za Canigen L4 ne razlikujejo od tistih, ki so opisani za samo cepivo Canigen L4.
Basic vaccination: The first vaccination can be administered from 6 to 9(*) weeks of age and the second vaccination from 10 to 13 weeks of age.
Osnovno cepljenje: Prvič lahko cepimo pri starosti od 6 do 9(*) tednov, drugič pa pri starosti od 10 do 13 tednov.
0.1 mg For the full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
MARKETING AUTHORISATION NUMBER(S) EU/2/15/183/001-003
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/15/183/001-003
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Tega zdravila za uporabo v veterinarski medicini ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.
Franţa,
Francuska,
MARKETING AUTHORISATION NUMBER(S) EU/2/15/183/001 - 10 vials (1 ml) EU/2/15/183/002 - 50 vials (1 ml) EU/2/15/183/003 - 1 vial (10 ml)
EU/2/15/183/001 - 10 vial (1 ml) EU/2/15/183/002 - 50 vial (1 ml) EU/2/15/183/003 - 1 viala (10 ml)
A mild and transient increase in body temperature (≤ 1°C) has been observed very commonly in clinical studies for a few days after vaccination, with some pups showing less activity and/or a reduced appetite.
Rahlo in prehodno povišanje telesna temperature (≤ 1°C), ki je trajalo nekaj dni po cepljenju, so zelo pogosto opazili v kliničnih študijah, nekateri mladiči so bili manj aktivni in/ali so imeli zmanjšan apetit.
In case of ocular irritation seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru draženja oči takoj poiščite zdravniški nasvet in pokažite zdravniku navodilo ali ovojnino.
When mixed with Canigen vaccines containing canine parainfluenza virus strain Cornell at annual revaccination, it has been established that there is no interference with the anamnestic response induced by the injectable canine parainfluenza virus component.
Kadar se pri letni revakcinaciji to cepivo meša s cepivi Canigen, ki vsebujejo virus pasje parainfluence seva Cornell, je bilo ugotovljeno, da to ne vpliva na anamnestični odziv, ki ga sproži injicirana komponenta virusa pasje parainfluence.
Incompatibilities: Do not mix with any other veterinary medicinal products except the above mentioned vaccines.
Inkompatibilnosti Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicine razen z zgoraj navedenimi cepivi.
Shelf life after reconstitution of Canigen vaccines according to directions: 45 mins.
Rok uporabnosti po rekonstituciji Canigen cepiv skladno z navodili: 45 minut
4.4 Special warnings for each target species
4.4 Posebna opozorila za vsako živalsko vrsto
For example, local swelling, which can be up to 5 cm in diameter and which may take over 5 weeks to completely disappear, may be observed at the site of injection.
Na primer, na mestu injiciranja lahko opazite lokalno oteklino z do 5 cm premera, ki lahko popolnoma izgine po več kot 5 tednih.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
- občasni (pri več kot1, toda manj kot 10 živalih od 1.000 zdravljenih živali) - redki (pri več kot 1 toda manj kot 10 živalih od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključujoč posamezne primere).
Do not mix with any other veterinary medicinal products except those mentioned in section 4.8.
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini razen s tistimi, ki so navedena v poglavju 4.8. 6.3 Rok uporabnosti
Type I glass vial of 1 ml (1 dose) or 10 ml (10 doses) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Viala, steklo tipa I, po 1 ml (1 odmerek) ali 10 ml (10 odmerkov), zaprta z zamaškom iz halogenobutilne gume in zatesnjena z aluminijasto zaporko s šifro.
Bury St. Edmunds, Suffolk, IP30 9UP, Tel: + 44 (0) 1359 243243
Suffolk, IP30 9UP, Tel: + 44 (0) 1359 243243
Before use, ensure that the vaccine is at room temperature (15°C - 25°C).
Pred uporabo zagotovite, da je zdravilo na sobni temperaturi (15°C - 25°C).
The product information of the relevant Canigen vaccines should be consulted before administration of the mixed product.
Pred dajanjem mešanega cepiva je treba preučiti navodila ustreznih cepiv Canigen.
ADVICE ON CORRECT ADMINISTRATION Before use, ensure that the vaccine is at room temperature (15°C - 25°C).
Subkutano dajanje Pred uporabo zagotovite, da je cepivo na sobni temperaturi (15°C - 25°C).
If you notice any side effects,, even those not already 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 če ti niso že navedeni v navodilu za uporabo ali mislite,
PACKAGE LEAFLET: Canigen L4 suspension for injection for dogs
NAVODILO ZA UPORABO Canigen L4 suspenzija za injiciranje za pse
10x 1 ml (1 dose) 50x 1 ml (1 dose) 1x 10 ml (10 doses)
50x 1 ml (1 odmerek) 1x 10 ml (10 odmerkov)
1ère avenue 2065 m - L.I.D.,
13ème rue - L.I.D.,
Pharmacotherapeutic group: Immunologicals for Canidae, inactivated bacterial vaccine.
Farmakoterapevtska skupina: Imunološka zdravila za pse, inaktivirano bakterijsko cepivo Oznaka ATC vet QI07AB01.
Plastic box with 10, or 50 vials of 1 ml Cardboard box with 1 vial of 10 ml
Plastična škatla z 10 ali 50 vialami po 1 ml Kartonska škatla z 1 vialo po10 ml
Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi tiomersal natrijev klorid kalijev klorid dinatrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
1 ml and 10 ml vial
Viala po 1 ml in 10 ml
Vaccinate healthy animals only.
Posebni previdnostni ukrepi za uporabo pri živalih Cepite samo zdrave živali.
Administer two vaccinations of 1 dose (1 ml) of vaccine with an interval of 4 weeks to dogs from 6 weeks of age onwards.
Pse cepite od 6 tednov starosti dalje dvakrat s po 1 odmerkom (1 ml) cepiva z razmikom 4 tednov.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with vaccines of the Canigen series from the same marketing authorisation holder (or national subsidiary) containing Bordetella bronchiseptica strain B-C2 and/or canine parainfluenza virus strain Cornell components for intranasal administration where authorised.
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno dati isti dan, vendar ne mešano s cepivi serije Canigen za intranazalno dajanje istega imetnika dovoljenja za promet (krajevne podružnice), ki vsebujejo bakterijo Bordetella bronchiseptica seva B-C2 in/ali virus parainfluence seva Cornell za intranazalno dajanje, kjer so registrirani.
Special precautions for each target species: Vaccinate healthy animals only.
4.5 Posebni previdnostni ukrepi Posebni previdnostni ukrepi za uporabo pri živalih Cepite samo zdrave živali.
Inactivated Leptospira strains: - L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12
Serološka skupina L. interrogans Canicola serovar Portland-vere (sev Ca-12-000)
QUANTITY OF THE ACTIVE SUBSTANCE(S) See package leaflet.
KOLIČINA UČINKOVIN(E) Glej navodilo za uporabo.
For active immunisation of dogs against: - L. interrogans serogroup Canicola serovar Canicola to reduce infection and urinary excretion - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni to reduce infection and urinary excretion - L. interrogans serogroup Australis serovar Bratislava to reduce infection - L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang to reduce infection and urinary excretion
Za aktivno imunizacijo psov proti: - serološka skupina L. interrogans Canicola serovar Canicola za zmanjšanje okužbe in izločanja z urinom - serološka skupina L. interrogans Icterohaemorrhagiae serovar Copenhageni za zmanjšanje okužbe in izločanja z urinom
For simultaneous use with Canigen vaccines where authorised: 1 dose of a Canigen vaccine from the same marketing authorisation holder (or national subsidiary) containing canine distemper virus strain Onderstepoort, canine adenovirus type 2 strain Manhattan LPV3, canine parvovirus strain 154 and/or canine parainfluenza virus strain Cornell components should be reconstituted with 1 dose (1 ml) of Canigen L4.
Za sočasno dajanje s cepivi Canigen, kjer so registrirana: 1 odmerek cepiva Canigen istega imetnika dovoljenja za promet (ali krajevne podružnice), ki vsebuje virus pasje kuge seva Onderstepoort, pasji adenovirus seva Manhattan LPV3, pasji parvovirus seva 154 in/ali virus pasje parainfluence seva Cornell, je treba rekonstituirati z 1 odmerkom (1 ml) cepiva Canigen L4.
10 ml (10 doses)
1 ml (1 odmerek) 10 ml (10 odmerkov)
Plastic box with 10 or 50 vials of 1 ml (1 dose).
Velikosti pakiranj: Plastična škatla z 10 ali 50 vialami po 1 ml (1 odmerek)
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines of the Canigen series from the same marketing authorisation holder (or national subsidiary) containing canine distemper virus strain Onderstepoort, canine adenovirus type 2 strain Manhattan LPV3, canine parvovirus strain 154 and/or canine parainfluenza virus strain Cornell components for subcutaneous administration where authorised.
Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in daje s cepivi serije Canigen za subkutano dajanje istega imetnika dovoljenja za promet (ali krajevne podružnice), ki vsebujejo virus pasje kuge seva Onderstepoort, pasji adenovirus tipa 2 seva Manhattan LPV3, pasji parvovirus seva 154 in/ali virus pasje parainfluence seva Cornell za subkutano dajanje, kjer so registrirana.