natgillin/translations-raw huggingface dataset:
VEGF is a secreted protein that induces angiogenesis, vascular permeability and inflammation, all of which are thought to contribute to the progression of the neovascular (wet) form of AMD.
VEGF je secernirana beljakovina, ki inducira angiogenezo, žilno prepustnost in vnetje.
Adequate anaesthesia and a broad-spectrum topical microbicide should be administered prior to the injection.
Pred injiciranjem mora bolnik dobiti ustrezno anestezijo in širokospektralni lokalni antibiotik.
Dosing line 3rd Rib (top edge)
Odmerna črta Tretje rebro (zgornji rob)
The syringe should be checked with the needle pointing up for the presence of bubbles.
Injekcijsko brizgo obrnite z iglo navzgor in preverite, ali so v brizgi prisotni mehurčki.
• small erosion on the central part of the surface of the eye (cornea)
• drobna razjeda na osrednjem delu površine očesa (roženice)
Each pack contains a pouch in a carton containing a 1 ml pre-filled syringe, Type 1 glass, sealed with an elastomeric (brombutyl rubber) plunger stopper and a pre-attached plunger rod, held by a plastic clip.
Ena škatla vsebuje vrečko z napolnjeno 1-ml injekcijsko brizgo iz stekla tipa I, z že vstavljenim potisnim batom in gumijastim tesnilom (bromobutilna guma).
As expected with intravitreal injections, transient increases in intraocular pressure may be seen.
Pojavi se lahko prehodno zvišanje očesnega tlaka, kot je mogoče pričakovati pri vseh injiciranjih v steklovino.
Ask your doctor or pharmacist for advice before starting Macugen treatment.
Pred začetkom zdravljenja z zdravilom Macugen se posvetujte z zdravnikom ali farmacevtom.
If you get any side effects, talk to your doctor , pharmacist or nurse.
Če opazite kateregakoli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Gastrointestinal disorders Uncommon vomiting, dyspepsia
Bolezni prebavil občasni bruhanje, dispepsija
Prior to the administration, the syringe should be removed from the plastic clip and the tip cap removed.
Pred apliciranjem z injekcijske brizge odstranite plastični zatič in z vrha injekcijske brizge snemite zaporko.
Macugen 0.3 mg solution for injection Pegaptanib
Macugen 0,3 mg raztopina za injiciranje pegaptanib
• night sweats, back pain, tiredness, shivering, tenderness, chest pain, sudden fever and flu-like symptoms (generalised aches and pains)
• nočno znojenje, bolečine v hrbtu, utrujenost, drgetanje, občutljivost, bolečine v prsnem košu,
• visual disturbance
• uvlek vidnega živca
One pre-filled syringe provides a usable amount to deliver a single dose of 90 microlitres containing pegaptanib sodium, corresponding to 0.3 mg of the free acid form of the oligonucleotide.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga vsebuje ustrezno količino za zagotovitev enkratnega odmerka 90 mikrolitrov, ki vsebuje natrijev pegaptanib, kar ustreza 0,3 mg oligonukleotida v obliki proste kisline.
• inflammation of the higher respiratory tract, vomiting, indigestion
• vnetje zgornjega dela dihal, bruhanje, prebavne težave
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva občasni bolečine v hrbtu
discontinued
Odmerjanje
No statistical difference was found in the incidence of increased IOP between patients with a history of increased IOP or glaucoma versus patients without.
V incidenci zvišanega očesnega tlaka med bolniki z zvišanim očesnim tlakom ali glavkomom v anamnezi in bolniki brez njiju niso ugotovili nobene statistične razlike.
Ear and labyrinth disorders Uncommon deafness, Meniere's disease aggravated, vertigo
Ušesne bolezni, vključno z motnjami labirinta občasni gluhost, poslabšanje Ménièrove bolezni, vrtoglavica
• eye discomfort
• nelagodje v očesu
A few cases of arterial thromboembolic events were observed in the pegaptanib clinical trials in patients with AMD, DME, and there were no major differences between the groups treated with pegaptanib compared to control.
Med skupino, zdravljeno s pegaptanibom, in kontrolno skupino ni bilo večjih razlik.
NAME OF THE MEDICINAL PRODUCT Macugen 0.3 mg solution for injection
Macugen 0,3 mg raztopina za injiciranje
• clouding of the lens (cataract)
• zamotnitev leče (katarakta)
• small lump on your eyelid due to inflammation (chalazion)
• zaradi vnetja nastala majhna zadebelina na veki (halazij)
See section 6.6 for instructions to expel the excess volume before injection.
Za navodila glede odstranitve odvečnega volumna pred injiciranjem glejte poglavje 6.6.
• eye inflammation
• naprezanje očesa
However, no special considerations are needed in this population (see section 5.2)
Zdravila Macugen niso preučevali pri bolnikih z okvaro jeter, vendar posebna pazljivost pri tej populaciji ni potrebna (glejte poglavje 5.2).
The absolute bioavailability of pegaptanib after intravitreal administration has not been assessed in humans, but is approximately 70-100% in rabbits, dogs and monkeys.
Pri kuncih, psih in opicah znaša približno 70-100 %.
There are no reproductive toxicity studies in rabbits.
Študij vpliva na sposobnost razmnoževanja pri kuncih ni.
Reductions in the growth of mean total lesion size, choroidal neovascularisation (CNV size), and fluorescein leak size, have been shown in patients with AMD treated with Macugen.
Pri bolnikih z AMD, ki so dobivali zdravilo Macugen, so ugotovili manjši porast srednje celotne velikosti lezije, manjšo horoidno neovaskularizacijo in manjše izstopanje fluoresceina.
Systemic adverse events including non-ocular haemorrhages and arterial thromboembolic events have been reported following intravitreal injection of VEGF inhibitors and there is a theoretical risk that these may relate to VEGF inhibition.
Po intravitrealnem injiciranju zaviralcev VEGF so poročali o sistemskih neželenih dogodkih, med drugim o izvenočesnih krvavitvah in arterijskih trombemboličnih dogodkih.
Product-class-related adverse reactions
Na skupino zdravil vezani neželeni učinki
Uncommon non-visual side effects reported to be possibly caused by the medicine or by the injection procedure include:
Med občasnimi neočesnimi neželenimi učinki, za katere je opisano, da so morda posledica zdravila ali postopka injiciranja, so:
PHARMACEUTICAL FORM Solution for injection (injection).
raztopina za injiciranje (injekcija) Raztopina je bistra in brezbarvna.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POUCH containing pre-filled syringe, a plunger stopper and a pre-attached plunger rod
Vrečka, ki vsebuje napolnjeno injekcijsko brizgo z že vstavljenim potisnim batom in gumijastim tesnilom
NAME OF THE MEDICINAL PRODUCT Macugen 0.3 mg solution for injection pegaptanib
Macugen 0,3 mg injekcija pegaptanib
• disorder of the pupil, of the coloured part of the eye (iris)
• motnje zenice, obarvanega dela očesa (šarenice)
Other common non-visual side effects reported to be possibly caused by the medicine or by the injection procedure include:
Med drugimi pogostimi očesnimi neželenimi učinki, za katere je opisano, da so morda posledica zdravila ali postopka injiciranja, so:
Uncommon eye side effects reported to be possibly caused by the medicine or by the injection procedure include:
Med občasnimi očesnimi neželenimi učinki, za katere je opisano, da so morda posledica zdravila ali postopka injiciranja, so:
• eye strain
• vnetje očesa
• eye pain
• bolečine v očesu
Spontaneous resolution of such reaction was observed within 4 hours.
Opazili so, da je ta reakcija spontano izzvenela v 4 urah.
No efficacy has been demonstrated in these animals.
Pri teh živalih učinkovitost ni bila dokazana.
The impact of the vaccine in terms of public health and control of the human infection cannot be estimated from available data.
Vpliva cepiva v smislu javnega zdravja in nadzora nad okužbo pri ljudeh iz razpoložljivih podatkov ni mogoče oceniti.
Plastic box
Plastična škatla
Date of first authorisation: 20/04/2016
Datum pridobitve dovoljenja za promet: 20/04/2016
Vaccinate healthy and non-infected animals only.
Cepite le zdrave in neokužene živali.
Re-vaccination of infected dogs did not worsen the course of the disease (during the 2-month observation period).
Revakcinacija okuženih psov ni poslabšala poteka bolezni (v 2mesečnem obdobju opazovanja).
The vaccine is safe in infected dogs.
Cepivo je varno pri okuženih psih.
Primary vaccination scheme:
Shema primarne vakcinacije:
≥ 36.7 ELISA Units (EU)* * Antigen content determined in an ELISA against an internal standard.
≥ 36,7 enot ELISA (EU)* * Vsebnost antigena je določena s testom ELISA v primerjavi z internim standardom.
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
SPC, so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa, ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
EXP {mm/yyyy} Once reconstituted use immediately.
EXP {mm/llll} Rekonstituirano zdravilo uporabite takoj.
1 vial of lyophylisate and 1 vial of solvent (1 dose) 4 vials of lyophylisate and 4 vials of solvent (4 doses) 5 vials of lyophylisate and 5 vials of solvent (5 doses) 10 vials of lyophylisate and 10 vials of solvent (10 doses) 20 vials of lyophylisate and 20 vials of solvent (20 doses) 25 vials of lyophylisate and 25 vials of solvent (25doses) 50 vials of lyophylisate and 50 vials of solvent (50 doses) 100 vials of lyophylisate and 100 vials of solvent (100 doses)
1 viala z liofilizatom in 1 viala z vehiklom (1 odmerek) 4 viale z liofilizatom in 4 viale z vehiklom (4 odmerki) 5 vial z liofilizatom in 5 vial z vehiklom (5 odmerkov) 10 vial z liofilizatom in 10 vial z vehiklom (10 odmerkov) 20 vial z liofilizatom in 20 vial z vehiklom (20 odmerkov) 25 vial z liofilizatom in 25 vial z vehiklom (25 odmerkov) 50 vial z liofilizatom in 50 vial z vehiklom (50 odmerkov) 100 vial z liofilizatom in 100 vial z vehiklom (100 odmerkov)
C/ Mocholi 2, Poligono Industrial Mocholi, Noain, 31110 Navarra SPAIN
C/ Mocholi 2, Poligono Industrial Mocholi, Noain, 31110 Navarra, ŠPANIJA
Duration of immunity: 1 year after vaccination.
Trajanje imunosti: 1 leto po cepljenju.
Shake gently to give a clear solution, and administer immediately the entire content (0.5 ml) of the reconstituted product.
Nežno mešajte, da dobite bistro raztopino, nato takoj injicirajte celotno vsebino (0,5 ml) rekonstituiranega zdravila.
To stimulate active immunity against disease caused by Leishmania infantum parasites.
Stimulacija aktivne imunosti proti bolezni, ki jo povzročajo paraziti Leishmania infantum.
The manufacture, import, possession, sale, supply and/or use of LETIFEND may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Izdelava, uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba zdravila LETIFEND je lahko v državi članici prepovedana na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
Pharmacotherapeutic group: Immunologicals for Canidae - dog - inactivated parasitic vaccinesleishmania.
Farmakoterapevtska skupina: Imunološko zdravilo za Canidae - psi - inaktivirana cepiva proti parazitom - lišmaniozi.
Diagnostic tools designed to detect Leishmania antibodies (SLA or IFAT or rk-39 rapid diagnostic tests) should be suitable to enable discrimination between dogs vaccinated with this vaccine and dogs infected with Leishmania infantum.
Diagnostična orodja, zasnovana za odkrivanje protiteles parazita Leishmania (hitri diagnostični testi SLA ali IFAT ali rk-39) morajo biti primerna, da omogočajo ločevanje med psi, cepljenimi s tem cepivom, in psi, okuženimi s parazitom Leishmania infantum.
In laboratory studies including experimental challenge with Leishmania infantum, the vaccine reduced the severity of the disease, including clinical signs and parasite burden in spleen and lymph nodes.
V laboratorijskih študijah, ki so vključevale eksperimentalno provokacijo s parazitom Leishmania infantum, je cepivo zmanjšalo resnost bolezni, vključno s kliničnimi znaki in obremenjenost s parazitom v vranici in bezgavkah.
Any person intending to manufacture, import, possess, sell, supply and use LETIFEND must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Vsakdo, ki namerava izdelovati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati zdravilo LETIFEND, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo, uvozom oziroma vnosom, posedovanjem, prodajo, oskrbo in/ali uporabo.
The data has shown that a vaccinated dog has 9.8 times less risk to develop clinical signs, 3.5 times less risk of having detectable parasites and 5 times less risk to develop clinical disease than a non-vaccinated dog.
Podatki so pokazali, da je bilo tveganje razvoja kliničnih znakov pri cepljenih psih 9,8-krat manjše, tveganje za prisotnost zaznavnih parazitov 3,5-krat manjše, tveganje za razvoj klinične bolezni pa 5-krat manjše kot pri necepljenih psih.
ATCvet code: QI07AO01
Oznaka ATC vet: QI07AO01.
Vials are both closed with a bromobutyl stopper and an aluminium cap.
Viale so zaprte z bromobutilnim zamaškom in aluminijasto zaporko.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.5 ml vaccine contains:
KAKOVOSTNA IN KOLIČINSKA SESTAVA En odmerek z 0,5 ml cepiva vsebuje:
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Učinkovina biološkega izvora, namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo (ES) št.
Water for injections.
Vehikel: voda za injekcije
Therefore, the use is not recommended during pregnancy and lactation.
Uporaba ni priporočljiva v obdobju brejosti in laktacije.
Recombinant Protein Q from Leishmania infantum MON-1
Rekombinantni protein Q iz Leishmania infantum MON-1
Each dose of 0.5 ml vaccine contains:
En odmerek z 0,5 ml cepiva vsebuje:
QUANTITY OF THE ACTIVE SUBSTANCE(S) CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
KOLIČINA UČINKOVIN(E) VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
Re-vaccination scheme:
Shema revakcinacije:
Per dose of 0.5 ml: Recombinant Protein Q from Leishmania infantum MON-1 ≥ 36.7 EU
Na 0,5 ml odmerek: rekombinantni protein Q iz Leishmania infantum MON-1 ≥ 36,7 EU.
It is essential that measures to reduce exposure to sand-flies are employed in vaccinated animals.
Pri cepljenih živalih je bistvenega pomena upoštevati ukrepe za zmanjšanje izpostavljenosti peščenim muham.
For active immunisation of non-infected dogs from 6 months of age to reduce the risk of developing an active infection and/or clinical disease after exposure to Leishmania infantum.
Za aktivno imunizacijo neokuženih psov od 6 meseca starosti za zmanjšanje tveganja razvoja aktivne okužbe in/ali klinične bolezni po izpostavljenosti parazitu Leishmania infantum.
WITHDRAWAL PERIOD(S) SPECIAL WARNING(S), IF NECESSARY
POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A)
De-worming of infested dogs prior to vaccination is recommended.
Pred cepljenjem se priporoča razglistenje infestiranega psa.
4.2 Indications for use, specifying the target species For active immunisation of non-infected dogs from 6 months of age to reduce the risk of developing an active infection and/or clinical disease after exposure to Leishmania infantum.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Za aktivno imunizacijo neokuženih psov od 6 meseca starosti za zmanjšanje tveganja razvoja aktivne okužbe in/ali klinične bolezni po izpostavljenosti parazitu Leishmania infantum.
White lyophilisate.
Bel liofilizat.
Do not mix with any other veterinary medicinal product, except solvent supplied for use with the medicinal product.
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen z vehiklom, ki je priložen za uporabo s tem zdravilom.
Type I glass vials containing 1 dose of vaccine;
Viale iz stekla tipa I, ki vsebujejo 1 odmerek cepiva.
Lyophilisate (white lyophilisate)
Liofilizat (bel liofilizat)
Shelf life after reconstitution according to directions: use immediately Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki po EXP.
Sodium chloride Arginine hydrochloride Boric acid.
Liofilizat: natrijev klorid argininijev klorid borova kislina
The efficacy of the vaccine was demonstrated in a field study where seronegative dogs from a variety of breeds were naturally exposed to Leishmania infantum in zones with high infection pressure over a two year period.
Učinkovitost cepiva je bila dokazana v terenski študiji, kjer so bili seronegativni psi različnih pasem dve leti naravno izpostavljeni parazitu Leishmania infantum na območjih z veliko jakostjo okužbe.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Subcutaneous use.
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
The efficacy of the vaccine was demonstrated in a field study where dogs were naturally exposed to Leishmania infantum in zones with high infection pressure over a two year period.
Učinkovitost cepiva je bila dokazana v terenski študiji, kjer so bili psi dve leti naravno izpostavljeni parazitu Leishmania infantum na območjih z veliko jakostjo okužbe.
BATCH NUMBER Lot {number} EXPIRY DATE EXP {mm/yyyy} THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
ŠTEVILKA SERIJE Lot {številka} DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mm/llll} BESEDILO »SAMO ZA ŽIVALI« Samo za živali.
A test for the detection of Leishmania infection is recommended prior to vaccination.
Pred cepljenjem je priporočljivo opraviti test za ugotavljanje okužbe s parazitom Leishmania.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
PRILOGA II A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
Following administration of a double dose, reactions are similar in nature to those observed following the administration of a single dose (see section 4.6).
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po dajanju dvojega odmerka so opazili reakcije, podobne po naravi, kot po dajanju enega odmerka (glejte poglavje 4.6).
Shelf life of the solvent: 5 years.
Rok uporabnosti v vehikel: 5 leti.
Primary vaccination scheme: A single dose of the vaccine (0.5 ml) to be administered to dogs from 6 months of age.
Shema primarne vakcinacije: En odmerek cepiva (0,5 ml) se da psom od starosti 6 mesecev.
4 doses
4 odmerki
A single dose of the vaccine (0.5 ml) to be given annually thereafter.
En odmerek cepiva (0,5 ml) je treba dati enkrat letno.
Re-vaccination scheme: A single dose of the vaccine (0.5 ml) to be given annually thereafter.
Shema revakcinacije: En odmerek cepiva (0,5 ml) je treba dati enkrat letno.
A single dose of the vaccine (0.5 ml) to be administered to dogs from 6 months of age.
En odmerek cepiva (0,5 ml) se da psom od starosti 6 mesecev.
20 doses
20 odmerkov
After vaccination, scratching at the injection site has been observed very commonly in dogs.
Po cepljenju so zelo pogosto opazili, da se psi praskajo na mestu injiciranja.
Type I glass vials containing 0.8 ml of solvent.
Viale iz stekla tipa I, ki vsebujejo 0,8 ml vehikla.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial of lyophilisate
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Reconstitute one vial of the white lyophilisate using 0.5 ml of solvent.
Rekonstituirajte eno vialo belega liofilizata z 0,5 ml vehikla.
QUANTITY OF THE ACTIVE SUBSTANCE(S) Recombinant Protein Q from L. infantum MON-1
Rekombinantni protein Q iz L. infantum MON-1
Overdose (symptoms, emergency procedures, antidotes) if necessary:
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno: Po dajanju dvojega odmerka so opazili reakcije, podobne po naravi kot po dajanju enega odmerka.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Jih ni.
NAME OF THE VETERINARY MEDICINAL PRODUCT LETIFEND, lyophilisate and solvent for solution for injection for dogs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI LETIFEND, liofilizat in vehikel za raztopino za injiciranje za pse
Laboratorios LETI, S.L.unipersonal C/ Del Sol, 5, Poligono Industrial Norte, Tres Cantos, 28760, Madrid SPAIN
unipersonal C/ Del Sol, 5, Poligono Industrial Norte, Tres Cantos, 28760, Madrid ŠPANIJA
NAME OF THE VETERINARY MEDICINAL PRODUCT LETIFEND lyophilisate for dogs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI LETIFEND liofilizat za pse
Name and address of the manufacturer responsible for batch release:
Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega za sproščanje serij
6.5 Nature and composition of immediate packaging Lyophilisate vial
6.5 Vrsta ovojnine in vsebina
Lyophilisate and solvent for solution for injection.
Liofilizat in vehikel za raztopino za injiciranje.
LETIFEND, lyophilisate and solvent for solution for injection for dogs.
LETIFEND, liofilizat in vehikel za raztopino za injiciranje za pse.
LETIFEND, lyophilisate and solvent for solution for injection for dogs
LETIFEND, liofilizat in vehikel za raztopino za injiciranje za pse
Plastic box containing 25 vials of 1 dose of lyophilisate and 25 vials of 0.8 ml of solvent.
Plastična škatla, ki vsebuje 25 vial z 1 odmerkom liofilizata in 25 vial z 0,8 ml vehikla.
NAME OF THE VETERINARY MEDICINAL PRODUCT LETIFEND solvent for dogs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI LETIFEND vehikel za pse
Plastic box containing 4 vials of 1 dose of lyophilisate and 4 vials of 0.8 ml of solvent.
Plastična škatla, ki vsebuje 4 viale z 1 odmerkom liofilizata in 4 viale z 0,8 ml vehikla.
Plastic box containing 20 vials of 1 dose of lyophilisate and 20 vials of 0.8 ml of solvent.
Plastična škatla, ki vsebuje 20 vial z 1 odmerkom liofilizata in 20 vial z 0,8 ml vehikla.
Plastic box containing 100 vials of 1 dose of lyophilisate and 100 vials of 0.8 ml of solvent.
Plastična škatla, ki vsebuje 100 vial z 1 odmerkom liofilizata in 100 vial z 0,8 ml vehikla.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin)
Plastic box containing 50 vials of 1 dose of lyophilisate and 50 vials of 0.8 ml of solvent.
Plastična škatla, ki vsebuje 50 vial z 1 odmerkom liofilizata in 50 vial z 0,8 ml vehikla.
Plastic box containing 5 vials of 1 dose of lyophilisate and 5 vials of 0.8 ml of solvent.
Plastična škatla, ki vsebuje 5 vial z 1 odmerkom liofilizata in 5 vial z 0,8 ml vehikla.
Plastic box containing 10 vials of 1 dose of lyophilisate and 10 vials of 0.8 ml of solvent.
Plastična škatla, ki vsebuje 10 vial z 1 odmerkom liofilizata in 10 vial z 0,8 ml vehikla.
Plastic box containing 1 vial of 1 dose of lyophilisate and 1 vial of 0.8 ml of solvent.
Plastična škatla, ki vsebuje 1 vialo z 1 odmerkom liofilizata in 1 vialo z 0,8 ml vehikla.
PACKAGE LEAFLET: LETIFEND, lyophilisate and solvent for solution for injection for dogs
NAVODILO ZA UPORABO LETIFEND, liofilizat in vehikel za raztopino za injiciranje za pse
Wash your hands
Umijte si roke.
In Period 2, analyses demonstrated stability of improvements achieved during Period 1 for both doses regimen.
V obdobju 2 so analize pokazale stabilnost izboljšanj, doseženih v obdobju 1 za oba režima odmerjanja.
Tilt your head back and look up at the ceiling 8.
Glavo nagnite nazaj in poglejte v strop.
EXCELVISION 27 rue de la Lombardière ZI la Lombardière 07100 Annonay France
EXCELVISION 27 rue de la Lombardière ZI la Lombardière 07100 Annonay Francija