natgillin/translations-raw huggingface dataset:
Since the marketing authorisation application was submitted in accordance with Article 13(1) of Directive 2001/82/EC, the therapeutic benefits for Gutal are considered to be the same as those for the reference product, ZincoTec - Zinc Oxide 100% Premix for Medicated Feeding Stuff and are not reevaluated under this procedure.
Ker je bila vloga za pridobitev dovoljenja za promet z zdravilom predložena v skladu s členom 13(1) Direktive 2001/82/ES, se šteje, da so terapevtske koristi zdravila Gutal enake kot pri referenčnem zdravilu ZincoTec - Zinc Oxide 100 % predmešanica za zdravilno krmno mešanico, zato v okviru tega postopka niso bile ponovno ovrednotene.
variable, where zinc sulfides are formed PNECs may be greatly exceeded before adverse effects are observed.
Slednji lahko zmanjšajo biološko uporabnost cinka, zato so kljub temu, da so koncentracije spremenljive, lahko vrednosti PNEC na območjih, kjer nastajajo cinkovi sulfidi, znatno presežene, preden je mogoče opaziti kakršne koli škodljive učinke.
Since the marketing authorisation application was submitted in accordance with Article 13(1) of Directive 2001/82/EC and bioequivalence was accepted, the therapeutic benefits for Gutal are considered to be the same as those for the reference product, ZincoTec - Zinc Oxide 100% Premix for Medicated Feeding Stuff and have not been re-evaluated as part of this procedure.
Ker je bila vloga za pridobitev dovoljenja za promet z zdravilom predložena v skladu s členom 13(1) Direktive 2001/82/ES in ker je bila biološka enakovrednost potrjena, se šteje, da so terapevtske koristi zdravila Gutal enake kot pri referenčnem zdravilu ZincoTec - Zinc Oxide 100 % predmešanica za zdravilno krmno mešanico, zato v okviru tega postopka niso bile ponovno ovrednotene.
Secondly, as the bioavailability of zinc varies between soil types, manure from treated piglets should not be spread on the soil types which have been identified as most vulnerable, i.e. freely draining, acidic (pH ≤6), sandy soils.
Drugi ukrep je, da se zaradi različne biološke uporabnosti cinka v različnih vrstah tal gnoj zdravljenih prašičkov ne sme trositi po vrstah tal, ki so opredeljena kot najranljivejša - to so dobro propustna, kisla (pH ≤ 6), peščena tla. Tretji ukrep je, da se gnoj zdravljenih živali ne sme trositi po istem predelu zemlje več let zapored, s čimer naj bi zmanjšali kopičenje cinka.
• Since the marketing authorisation application was submitted in accordance with Article 13(1) of Directive 2001/82/EC and bioequivalence was accepted, the benefit-risk for Gutal is considered to be equivalent to that of the reference product, ZincoTec - Zinc Oxide 100% Premix for Medicated Feeding Stuff.
• ker je bila vloga za pridobitev dovoljenja za promet z zdravilom predložena v skladu s členom 13(1) Direktive 2001/82/ES in ker je bila biološka enakovrednost potrjena, se šteje, da je razmerje med tveganji in koristmi zdravila Gutal enako kot pri referenčnem zdravilu ZincoTec - Zinc Oxide 100 % predmešanica za zdravilno krmno mešanico;
Romania Huvepharma NV Uitbreidingstraat 80
Romunija Huvepharma NV Uitbreidingstraat 80
Since the marketing authorisation application was submitted in accordance with Article 13(1) of Directive 2001/82/EC and bioequivalence was accepted, the benefit-risk for Gutal is considered to be equivalent to that of the reference product, ZincoTec - Zinc Oxide 100% Premix for Medicated Feeding Stuff.
Ker je bila vloga za pridobitev dovoljenja za promet z zdravilom predložena v skladu s členom 13(1) Direktive 2001/82/ES in ker je bila biološka enakovrednost potrjena, se šteje, da je razmerje med tveganji in koristmi zdravila Gutal enako kot pri referenčnem zdravilu ZincoTec - Zinc Oxide 100 % predmešanica za zdravilno krmno mešanico.
Slovakia Huvepharma NV Uitbreidingstraat 80
Slovaška Huvepharma NV Uitbreidingstraat 80
Bulgaria Huvepharma NV Uitbreidingstraat 80
Bolgarija Huvepharma NV Uitbreidingstraat 80
Hungary Huvepharma NV Uitbreidingstraat 80
Madžarska Huvepharma NV Uitbreidingstraat 80
Therefore, exposure on application rates that are considered relevant from the use of zinc containing veterinary medicinal products are calculated from the predefined loading rates of the IDMM.
Tako je bila izpostavljenost pri ustreznih odmerkih, značilnih za uporabo zdravil za uporabo v veterinarski medicini,
RMMs.
Ciper
However, in some cases, swelling may persist for up to 4 weeks.
Vendar je v nekaterih primerih oteklina vztrajala tudi do 4 tedne.
Protection of animals not vaccinated following this program has not been demonstrated.
Zaščita živali, ki niso cepljene po tem programu, ni bila dokazana.
This should be considered in case of herd vaccination.
To je treba upoštevati v primeru cepljenja črede.
ATCvet code: QI02AB .
Oznaka ATC vet: QI02AB.
This swelling will have disappeared or be clearly reduced in size by 17 days post vaccination.
Ta oteklina izgine ali se opazno zmanjša do 17. dne po cepljenju.
White homogeneous emulsion.
Bela homogena emulzija.
Duration of immunity: approximately the first 5 months of lactation.
Trajanje imunosti: približno prvih 5 mesecev laktacije.
<{MM/YYYY}>
{MM/LLLL}
The full immunisation program should be repeated with each gestation.
Celoten program imunizacije naj se ponovi ob vsaki brejosti
Onset of immunity: approximately 36 days after the second dose.
Nastop imunosti: približno 36 dni po drugem odmerku.
The excipients (including adjuvants) 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 are 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.
Pharmacotherapeutic group: Immunologicals for bovidae, inactivated bacterial vaccines for cattle.
Farmakoterapevtska skupina: Imunološka zdravila za votloroge (bovidae), inaktivirana bakterijska cepiva za govedo.
Store and transport refrigerated (2 ºC - 8 °C) and protected from light.
Posebna navodila za shranjevanje Shranjujte in prevažajte v hladilniku (2°C - 8 °C) in zaščitite pred svetlobo.
Overdose (symptoms, emergency procedures, antidotes): No information is available.
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Ni podatkov.
LTA from BAC of Streptococcus uberis, strain 5616 Relative Potency ≥ 1 RPU
LTA iz BAC bakterije Streptococcus uberis, sev 5616 Relativna Potenca ≥ 1 RPU
Subunit vaccine to stimulate active immunity against Streptococcus uberis.
Podenota cepiva za spodbujanje aktivne imunizacije proti Streptococcus uberis.
Allow the vaccine to reach a temperature of +15 to + 25 °C before administration.
Pustite, da se cepivo pred uporabo ogreje na temperaturo med +15 in +25 °C.
Bearing in mind that some cows had suffered more than one episode of Streptococcus uberis clinical intramammary infection, the incidence of cows with clinical intramammary infection was 52.5% lower in the vaccinated group than those of the placebo group (4.7% versus 9.9%), with a statistical significance of p<0.017.
Ob upoštevanju dejstva, da so nekatere krave preživele več kot eno epizodo klinične intramamarne okužbe s Streptococcus uberis, je bila pojavnost pri kravah s klinično intramamarno okužbo za 52,5 % nižja v skupini, ki je prejela cepivo, kot pri skupini, ki je prejela placebo (4,7 % v primerjavi z 9,9 %), s statistično značilnostjo p < 0,017.
Administer one dose (2 ml) by deep intramuscular injection in the neck muscles according to the following immunisation program: - First dose at approximately 60 days before the expected parturition date
En odmerek (2 ml) dajte z globoko intramuskularno injekcijo v vratno mišičevje v skladu z naslednjim programom cepljenja: - prvi odmerek približno 60 dni pred predvidenim datumom telitve.
In a multicentre field study, the incidence of new cases of Streptococcus uberis clinical intramammary infection in the group vaccinated with UBAC was 50% lower than the incidence in the placebo group (6.1% versus 12.2%) which was statistically significantly different (p=0.012).
V multicentrični študiji na terenu je bila pojavnost novih primerov klinične intramamarne okužbe s Streptococcus uberis v skupini, ki je bila cepljena z UBAC, za 50 % nižja kot pojavnost v placebo skupini (6,1 % v primerjavi z 12,2 %), kar je bilo statistično značilno zelo različno (p = 0,012).
- 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)
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
Carretera C63 Km 48, 300, Poligono Industrial El Rieral 17170 Amer (Girona) Spain
Carretera C63 Km 48,300, Polígono Industrial El Rieral 17170 Amer (Girona) Španija
Special warnings for each target species: Only healthy animals should be immunised.
POSEBNO(A) OPOZORILO(A) Posebna opozorila za vsako ciljno živalsko vrsto: Imuniziralo naj se samo zdrave živali.
Name and address of the manufacturer of the biological active substance:
Ime in naslov proizvajalca biološke učinkovine
Type I colourless glass vials of 3 ml.
3 ml brezbarvne viale iz stekla tipa I.
Date of first authorisation: <{DD/MM/YYYY}>
Datum pridobitve dovoljenja za promet: {DD/MM/LLLL}
Polyethylene (PET) vials of 10, 50 and 100 ml.
Polietilenske (PET) viale z vsebino 10, 50 in 100 ml.
Local swelling more than 5 cm in diameter at the injection site is a very common reaction after administration of the vaccine.
Po dajanju cepiva je zelo pogosta reakcija lokalna oteklina s premerom več kot 5 cm na mestu injiciranja.
1 dose (2 ml) 5 doses (10 ml)
1 odmerek (2 ml) 5 odmerkov (10 ml)
Monophosphoryl Lipid A (MPLA) Disodium phosphate dodecahydrate Potassium dihydrogen phosphate
Seznam pomožnih snovi montanid ISA monofosforil lipid A (MPLA) natrijev hidrogenfosfat dodekahidrat kalijev dihidrogenfosfat natrijev klorid kalijev klorid voda za injekcije
UBAC emulsion for injection for cattle
UBAC emulzija za injiciranje za govedo
Special precautions to be taken by the person administering the veterinary medicinal product to animals To the user:
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo:
Immunisation has to be considered as one component in a complex intramammary infection control program that addresses all important udder health factors (e.g. milking technique, dry-off and breeding management, hygiene, nutrition, housing, bedding, cow comfort, air and water quality and health monitoring) and other management practices.
upravljanje presuševanja in razploda, higiena, hrana, nastanitev, nastilj, udobje krav, kakovost zraka in vode, spremljanje zdravja) in druge načine upravljanja.
Vial of 25 and 50 doses.
Viala s 25 ali 50 odmerki.
Vial label 1 dose and 5 doses
Nalepka na viali po 1 odmerek in 5 odmerkov
25 doses (1 vial of 50 ml) 50 doses (1 vial of 100 ml) 25 doses (50 ml) 50 doses (100 ml)
20 x 1 odmerek (1 viala z 2 ml) 5 odmerkov (1 viala s 10 ml) 25 odmerkov (1 viala s 50 ml) 50 odmerkov (1 viala s 100 ml) 25 odmerkov (50 ml) 50 odmerkov (100 ml)
Cardboard box with 20 glass vials of 1 dose.
- kartonska škatla z 20 steklenimi vialami po 1 odmerkom.
Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of Streptococcus uberis, strain 5616 .................................................................................................................................. ≥ 1 RPU*
lipoteihojska kislina (LTA) iz komponente lepljivega biofilma (Biofilm Adhesion Component - BAC) bakterije Streptococcus uberis, sev 5616 ................................................................................... ≥ 1 RPU* *Enote relativne potence (ELISA)
Cardboard box with 20 glass vials of 1 dose (2 ml).
Kartonska škatla z 20 steklenimi vialami z 1 odmerkom (2 ml).
Cardboard box with 1 PET vial of 5, 25 and 50 doses.
- kartonska škatla z 1 PET vialo po 5, 25 in 50 odmerki.
IMMUNOLOGICAL PROPERTIES
MUNOLOŠKE LASTNOSTI
17170- AMER (Girona) SPAIN
17170- AMER (Girona) Španija
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na ovojnini po EXP. Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti
For active immunisation of healthy cows and heifers to reduce the incidence of clinical intramammary infections caused by Streptococcus uberis, to reduce the somatic cell count in
INDIKACIJA(E) Za aktivno imunizacijo zdravih krav in telic za zmanjšanje pojavnosti kliničnih intramamarnih okužb, ki jih povzroča Streptococcus uberis, in za zmanjšanje števila somatskih celic v vzorcih mleka z četrtin vimen pozitivnih na Streptococcus uberis, in za zmanjšanje izgub pri proizvodnji mleka, ki so posledica intramamarnih okužb, ki jih povzroča Streptococcus uberis.
Vaccinate only healthy animals.
Posebni previdnostni ukrepi za uporabo pri živalih Cepite samo zdrave živali.
- First dose at approximately 60 days before the expected parturition date - Second dose at least 21 days before the expected parturition date - Third dose should be administered about 15 days after the calving.
- drugi odmerek najmanj 21 dni pred predvidenim datumom telitve.
Montanide ISA ............................................................................................................................907.1 mg
Montanid ISA ..............................................................................................................................907,1 mg Monofosforil lipid A (MPLA)
One dose (2 ml) contains: Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of Streptococcus uberis, strain
En odmerek (2 ml) vsebuje: lipoteihojska kislina (LTA) iz komponente lepljivega biofilma (Biofilm Adhesion Component - BAC) bakterije Streptococcus uberis, sev 5616 ................................................................... ≥ 1 RPU* *Enote relativne potence (ELISA)
A transient increase in rectal temperature (mean increase of 1°C but may be up to 2°C in individual animals) may very commonly occur in the first 24 hours after injection.
(povprečno povečanje za 1 °C, pri določenih živalih je lahko tudi do 2 °C).
- Second dose at least 21 days before the expected parturition date - Third dose should be administered about 15 days after the calving.
- tretji odmerek je treba aplicirati približno 15 dni po telitvi.
Cardboard box with 1 PET vial of 50 doses (100 ml).
Kartonska škatla z 1 PET vialo s 50 odmerki (100 ml).
Cardboard box with 1 PET vial of 5 doses (10 ml).
Kartonska škatla z 1 PET vialo s 5 odmerki (10 ml).
Cardboard box with 1 PET vial of 25 doses (50 ml).
Kartonska škatla z 1 PET vialo s 25 odmerki (50 ml).
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
A. PROIZVAJALEC BIOLOŠKE (BIOLOŠKIH) UČINKOVINE IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
A transient increase in rectal temperature (mean increase of 1 °C but may be up to 2 °C in individual animals) may very commonly occur in the first 24 hours after injection.
V prvih 24 urah po injekciji se zelo pogosto pojavi prehodno povečanje rektalne temperature
La Selva, 135 17170 Amer (Girona) Spain
17170 Amer (Girona) Španija
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, applicants in the member states
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
Diclofenac ALTERGON 50 mg
Diclofenac ALTERGON 50 mg 50 mg Tableta
After first opening: 7 months
Po prvem odprtju: 7 mesecev.
Do not use after 7 months of first opening the bottle.
Ne uporabljajte več kot 7 mesecev po prvem odprtju steklenice.
Then CLcr is adjusted for body surface area (BSA) as follows:
CLcr je prilagojen na telesno površino (BSA - »body surface area«) na sledeč način:
Abnormal and aggressive behaviours
Nenormalno in nasilno vedenje
It also contains maltitol liquid; patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Vsebuje tudi raztopino maltitola; bolniki z redko prirojeno intoleranco za fruktozo ne smejo jemati tega zdravila.
• Close the bottle with the plastic screw cap.
• Zaprite steklenico s plastično navojno zaporko.
If such behaviours are noticed, treatment adaptation or gradual discontinuation should be considered.
Če so take spremembe vedenja opažene, je treba razmisliti o prilagoditvi zdravljenja ali postopni prekinitvi zdravljenja.
• Drink the whole contents of the glass/baby's bottle.
• Popijte celotno vsebino kozarca/steklenice za hranjenje otrok.
Date of first authorisation: 29 September 2000 Date of latest renewal: 20 August 2015
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 29. september 2000 Datum zadnjega podaljšanja: 20. avgust 2015
• Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or your family and friends notice important changes in mood or behaviour.
• Nenormalno razmišljanje, občutek razdraženosti ali bolj nasilno odzivanje, kot običajno, ali če vi ali vaša družina in prijatelji opazite pomembne spremembe razpoloženja ali vedenja.
Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:
Obvestite zdravnika ali farmacevta, če kateri koli od naslednjih neželenih učinkov postane resen ali traja dlje kot nekaj dni:
Dose and frequency
odmerjanje in pogostnost
As with all antiepileptic medicines, sudden discontinuation of levetiracetam should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child.
Kot pri vseh drugih antiepileptikih se je treba nenadni prekinitvi uporabe levetiracetama izogniti, saj lahko to povzroči izbruh napadov, ki imajo lahko resne posledice za žensko in nerojenega otroka.
A doctor or a nurse will administer you Keppra as an intravenous infusion.
Zdravnik ali medicinska sestra vam bodo zdravilo Keppra dali kot intravensko infuzijo.
Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Neželeni učinki so navedeni po padajoči resnosti in njihova pogostnost je opredeljena takole: zelo pogosti: (≥ 1/10); pogosti: (≥ 1/100 do < 1/10); občasni: (≥ 1/1.000 do < 1/100); redki: (≥ 1/10.000 do < 1/1.000) in zelo redki: (< 1/10.000).
Turn the bottle upside down (figure 5).
Steklenico obrnite navzdol (slika 5).
NextPharma SAS, 17 Route de Meulan, F-78520 Limay, France.
NextPharma SAS, 17 Route de Meulan, F-78520 Limay, Francija ali
* The colourants are:
*Barvila so:
The following information is intended for healthcare professionals only: Directions for the proper use of Keppra is provided in section 3.
Naslednje informacije so namenjene samo zdravstvenemu osebju: Navodila za pravilno uporabo zdravila Keppra se nahajajo v poglavju 3.
• Wash the syringe with water only (figure 8).
• Sperite brizgo samo z vodo (slika 8).
• Turn the bottle the right way up (figure 6A).
• Obrnite steklenico pokonci (slika 6A).
• Empty the contents of the syringe in a glass of water or baby's bottle by pushing the piston to the bottom of the syringe (figure 7).
• Vsebino brizge spraznite v kozarec vode ali v steklenico za hranjenje otrok tako, da potisnete bat navzdol (slika 7).
• A small number of people being treated with anti-epileptics such as Keppra have had thoughts of harming or killing themselves.
• pri majhnem številu bolnikov, ki so se zdravili z antiepileptiki, kot je zdravilo Keppra, so se pojavile misli na samopoškodovanje ali samomor.
What Keppra is and what it is used for
Kaj je zdravilo Keppra in za kaj ga uporabljamo
Keppra is for intravenous use.
Zdravilo Keppra je za intravensko uporabo.
After measuring the correct dosage with an appropriate syringe, Keppra oral solution may be diluted in a glass of water or baby's bottle.
Po tem, ko ste izmerili pravilen odmerek z ustrezno brizgo, lahko peroralno raztopino zdravila Keppra razredčite v kozarcu vode ali v steklenici za hranjenje otrok.
Patients treated with levetiracetam should be monitored for developing psychiatric signs suggesting important mood and/or personality changes.
Bolnike, zdravljene z levetiracetamom, je treba spremljati glede razvoja psihiatričnih znakov, ki kažejo na pomembne spremembe v razpoloženju in/ali spremembe osebnosti.
• Take the syringe and put it in the adaptor opening (figure 4).
• Vzemite brizgo in jo dajte v odprtino adapterja (slika 4).
Keppra may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy.
Zdravilo Keppra lahko oslabi vašo sposobnost vožnje ali upravljanja z orodjem ali stroji, saj lahko povzroči zaspanost.
Instructions for use: • Open the bottle: press the cap and turn it anticlockwise (figure 1)
Navodila za uporabo: • Odprite steklenico: pritisnite zaporko in jo obrnite v nasprotni smeri urinega kazalca (slika1).
You should continue Keppra treatment for as long as your doctor has told you.
Zdravljenje z zdravilom Keppra morate nadaljevati tako dolgo, kot vam je naročil zdravnik.
Should your doctor decide to stop your Keppra treatment, he/she will instruct you about the gradual withdrawal of Keppra.
Če se bo vaš zdravnik odločil za prekinitev zdravljenja z zdravilom Keppra, vam bo dal napotke o postopni ukinitvi zdravila Keppra.
Levetiracetam may cause psychotic symptoms and behavioural abnormalities including irritability and aggressiveness.
Levetiracetam lahko povzroči psihotične simptome in vedenjske spremembe, vključno z razdražljivostjo in agresivnostjo.
Date of opening only for the outer carton
Datum odprtja (samo za škatlo)
These data are supplemented with the use of levetiracetam in corresponding openlabel extension studies, as well as post-marketing experience.
Ti podatki so dopolnjeni s podatki iz ustreznih odprtih, razširjenih študij o uporabi levetiracetama ter s postmarketinškimi podatki.
Keppra oral solution also contains maltitol.
Zdravilo Keppra peroralna raztopina vsebuje tudi maltitol.
Aluminium/PVC blister
Aluminij/PVC pretisni omot
Swallow Keppra tablets with a sufficient quantity of liquid (e.g. a glass of water).
Tablete zdravila Keppra zaužijte z dovolj tekočine (npr. s kozarcem vode).
Keppra must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
Zdravilo Keppra morate prejeti dvakrat na dan, enkrat zjutraj in enkrat zvečer, vsak dan ob približno istem času.
If discontinuation is considered, please refer to section 4.2.
Če razmišljate o prekinitvi zdravljenja, glejte poglavje 4.2.
All other packs are available in standard aluminium/PVC blisters.
Ostala pakiranja so na voljo v standardnih aluminij/PVC pretisnih omotih.
Remove the syringe from the adaptor (figure 6B).
Odstranite brizgo iz adapterja (slika 6B).
Aesica Pharmaceuticals S.r.l., Via Praglia, 15, I-10044 Pianezza, Italy.
Aesica Pharmaceuticals S.r.l., Via Praglia, 15, I-10044 Pianezza, Italija.
You may take Keppra with or without food.
Zdravilo Keppra lahko vzamete s hrano ali brez.
It is therefore recommended to adjust the maintenance daily dose of Keppra, based on creatinine clearance in patients with moderate and severe renal impairment (see section 4.2).
Zato je priporočljivo dnevni vzdrževalni odmerek zdravila Keppra pri bolnikih z zmerno in hudo ledvično okvaro prilagoditi očistku kreatinina (glejte poglavje 4.2).
Insert the adaptor into the bottle neck (figure 3).
Vstavite adapter v vrat steklenice (slika 3).