natgillin/translations-raw huggingface dataset:
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.
Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe
The syringe fits onto the bottle and has a 2 ml scale.
Brizga se prilega plastenki in ima merilno lestvico z oznakami za 2ml.
4.2 Indications for use, specifying the target species Cattle:
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Govedo:
When the product is used according to the recommended dosage regime, the oral bioavailability is approximately 98%.
Absorpcija Če dajemo zdravilo po priporočeni shemi odmerjanja, je njegova peroralna biološka uporabnost približno
Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli endotoxin administration in calves and pigs.
Deluje tudi antiendotoksično, saj so dokazali, da zavira nastajanje tromboksana B2, izzvano z intravenskim vnosom endotoksina E. Coli pri teletih in prašičih.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PROIZVAJALCA ZDRAVILA, ODGOVORNEGA ZA SPROŠČANJE SERIJ, ČE STA
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 µg/ml and 2.7 µg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
Po enkratnem subkutanem odmerku meloksikama po 0,5 mg/kg je znašala Cmax pri mladem govedu in kravah v obdobju laktacije 2,1 µg/ml in 2,7 µg/ml po 7,7 ure in 4 urah.
Pregnancy and lactation: Do not use in pregnant or lactating mares.
Brejost in laktacija: Ne uporabite pri kobilah v obdobju brejosti in laktacije.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
BESEDILO “ZDRAVILO SHRANJUJTE IZVEN DOSEGA IN POGLEDA OTROK” Zdravilo shranjujte nedosegljivo otrokom.
Sodium benzoate
Natrijevega benzoata:
BATCH NUMBER Lot {number}
Številka serije {številka}
Single I.V.
Enkratna i.v.
Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively.
Razpolovna doba izločanja meloksikama je po subkutani injekciji pri mladem govedu in kravah v obdobju laktacije 26 ur oziroma 17,5 ure.
Honey flavoured, off-white to yellow viscous oral suspension.
Umazano bela do rumena viskozna peroralna suspenzija, z aromo medu.
QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains:
KAKOVOSTNA IN KOLIČINSKA SESTAVA
In very rare cases, adverse reactions typically associated with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) were observed in clinical trials (slight urticaria, diarrhoea).
V zelo redkih primerih so v kliničnih študijah zasledili neželene učinke, ki so značilni za nesteroidna protivnetna zdravila NSAID (blaga urtikarija, driska).
See also section 4.7.
4.3 Kontraindikacije Glejte tudi poglavje 4.7.
Cardboard box containing one HDPE bottle of 100 or 250 ml with a tamper proof child resistant closure and a polypropylene measuring syringe.
Škatla z eno HDPE plastenko po 100 ali 250 ml, z za otroke varnim zapiralom ter polipropilensko merilno brizgo.
Not authorised for use in horses producing milk for human consumption.
Ni dovoljena uporaba pri živalih v laktaciji, katerih mleko je namenjeno prehrani ljudi.
Manufacturers responsible for batch release:
Proizvajalca, odgovorna za sproščanje serij:
METHOD AND ROUTE(S) OF ADMINISTRATION Cattle:
INDIKACIJA(E) Govedo:
and
ali
Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids (oxicams).
protivnetna in protirevmatična zdravila, nesteroidna (oksikami)
ROUTES OF ADMINISTRATION Cattle: SC or IV.
POT(I) UPORABE ZDRAVILA Govedo: s.c. ali i.v.
Saccharin sodium Carmellose sodium Silica, colloidal anhydrous Citric acid monohydrate Sorbitol, liquid (non-crystallising) Disodium phosphate dodecahydrate Sodium benzoate
Seznam pomožnih snovi natrijev saharinat natrijev karmelozat, premreženi silicijev dioksid, koloidni, premereženi citronska kislina monohidrat sorbitol, tekoči (nekristalizirajoči)
EXPIRY DATE EXP {month/year} Once broached use by…..
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
Shelf- life after first opening the container: 3 months.
Rok uporabnosti po prvem odpiranju vsebnika: 3 mesece.
Cardboard box containing one colourless glass vial of 20 ml, 50 ml, 100 ml or 250 ml.
Kartonska škatla z 1 brezbarvno stekleno injekcijsko vialo po 20 ml, 50 ml, 100 ml ali 250 ml.
Oral use.
Peroralno dajanje.
Maximum number of piercings is 14 for the 20 ml, 50 ml and 100 ml stoppers and 20 for the 250 ml stopper.
Največje število prebadanj zamaška je 14 -krat za viale po 20 ml, 50 ml in 100 ml in 20-krat za vialo po 250 ml .
Excipient: Sodium benzoate
Pomožna snov: Natrijev benzoat
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Enkratna subkutana ali intravenska injekcija v odmerku po 0,5 mg meloksikama na kilogram telesne mase (to je 2,5 ml/100 kg telesne mase), po potrebi v kombinaciji z antibiotičnim zdravljenjem ali s peroralno rehidracijsko terapijo.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and vial after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini in viali za EXP. Rok uporabnosti se nanaša na zadnji dan v mesecu.
MARKETING AUTHORISATION NUMBER(S) EU/2/12/144/005 100 ml
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/12/144/005 100 ml
Common adverse reactions include slight transient swelling at the injection site following subcutaneous administration in cattle and pigs.
Pogosti neželeni učinki pri govedu in prašičih vključujejo rahlo prehodno otekanje na mestu injiciranja, po subkutanem dajanju zdravila.
In very rare cases anaphylactoid reactions, which may be serious (including fatal), when they occur, they should be treated symptomatically.
Zelo redko se lahko pojavijo anafilaktoidne reakcije, ki so lahko resne (tudi fatalne); ko se pojavijo, jih je treba zdraviti simptomatsko.
Shelf- life after first opening the immediate packaging: 28 days Once broached, use by…
Rok uporabnosti po prvem odpiranju stične ovojnine: 28 dni Načeto/odprto zdravilo uporabite do…
Meloxicam 20 mg
Meloksikam 20 mg/ml
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE B.
NAME OF THE VETERINARY MEDICINAL PRODUCT Contacera 15 mg/ml oral suspension for horses
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Contacera 15 mg/ml, peroralna suspenzija za konje
NAME OF THE VETERINARY MEDICINAL PRODUCT Contacera 15 mg/ml oral suspension for horses meloxicam
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Contacera 15 mg/ml, peroralna suspenzija za konje meloksikam
PACKAGE LEAFLET: Contacera 20 mg/ml solution for injection for cattle, pigs and horses
Contacera 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje
Active substance:
učinkovina:
Single S.C. or I.V.
Govedo: Enkratna s.c. ali i.v.
PACKAGE LEAFLET: Contacera 15 mg/ml oral suspension for horses
NAVODILO ZA UPORABO Contacera 15 mg/ml, peroralna suspenzija za konje
If required, a second administration of meloxicam can be given after 24 hours.
24 urah damo še en odmerek meloksikama.
Horses: Do not use in pregnant or lactating mares.
Konji: Ne uporabite pri brejih kobilah ali kobilah v obdobju laktacije.
SPECIAL STORAGE CONDITIONS Do not freeze.
POSEBNA NAVODILA ZA SHRANJEVANJE Ne zamrzujte.
THE WORDS ‘FOR ANIMAL TREATMENT ONLY' AND CONDITIONS OF RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
BESEDILO “SAMO ZA ŽIVALI” TER POGOJI IN OMEJITVE GLEDE OSKRBE IN
MARKETING AUTHORISATION HOLDER Zoetis Belgium SA
Imetnik dovoljenja za promet z zdravilom Zoetis Belgium SA,
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton for 20 ml, 50 ml, 100 ml and 250 ml
PODATKI NA ZUNANJI OVOJNINI Škatla za 20 ml, 50 ml, 100 ml ali 250 ml vialo
Marketing authorisation holder:
Datum zadnjega podaljšanja dovoljenja za promet:
4.8 Interaction with other medicinal products and other forms of interaction Do not administer concurrently with glucocorticosteroids, other Non-Steroidal Anti-Inflammatory Drugs or with anticoagulant agents.
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Zdravila ne smemo dajati hkrati z glukokortikosteroidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulanti.
Interactions with other medicinal products and other forms of interaction: Do not administer concurrently with glucocorticosteroids, other Non-Steroidal Anti-Inflammatory Drugs or with anticoagulant agents.
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij: Ne uporabljajte hkrati z glukokortikosteroidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulanti.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu).
Bovine, caprine
GovedoG ovedo Koze
NAME OF THE VETERINARY MEDICINAL PRODUCT Contacera 20 mg/ml solution for injection for cattle, pigs and horses meloxicam
Contacera 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje meloksikam
Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3ml/100 kg body weight).
Enkratna intravenska injekcija odmerka po 0,6 mg meloksikama na kilogram telesne mase (to je 3,0 ml/100 kg telesne mase).
Meloxicam 20 mg Ethanol (96%) 159.8 mg Clear, yellow solution.
Meloksikam 20 mg Etanol (96%)
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton for 100 ml or 250 ml bottle
PODATKI NA ZUNANJI OVOJNINI Škatla za 100 ml ali 250 ml plastenko
Shelf life after first opening of the immediate packaging: 3 months.
Rok uporabnosti po prvem odpiranju stične ovojnine: 3 mesecev
Meat and offal: 15 days;
Meso in organi: 15 dni
Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3 ml/100 kg body weight).
Enkratna intravenska injekcija odmerka po 0,6 mg meloksikama na kilogram telesne mase (to je 3 ml na 100 kg telesne mase).
TARGET SPECIES Horses.
CILJNE ŽIVALSKE VRSTE
ADVICE ON CORRECT ADMINISTRATION Avoid introduction of contamination during use.
NASVET O PRAVILNI UPORABI ZDRAVILA Navedba ni smiselna.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu).
METHOD AND ROUTE(S) OF ADMINISTRATION Shake well before use.
NAČIN IN POT(I)UPORABE
Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Meloksikam je nesteroidno protivnetno zdravilo (NSAID) iz skupine oksikamov.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Label for 100 ml and 250 ml bottles
Nalepka za 100 ml in 250 ml plastenke
Meloxicam is a NSAID of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects.
Deluje protivnetno, antieksudativno, analgetično in antipiretično.
Equidae
OVOJNINAH
once a day.
enkrat na dan.
Date of first authorisation: 04 June 2004 Date of latest renewal: 04 June 2009
Datum prve odobritve: 04. junij 2004 Datum zadnjega podaljšanja: 04. junij 2009
Over 75 % of patients were less than 13 years of age.
Več kot 75 % bolnikov je bilo mlajših od 13 let.
You will probably need to lie down until you feel better.
Do izboljšanja boste verjetno morali ležati.
3 years After first opening: 6 months.
3 leta Po prvem odprtju: 6 mesecev.
• altered or increased sexual interest,
• spremenjeno ali povečano spolno zanimanje,
Up to three injections in 24 hours may be given.
V 24 urah lahko prejmete do tri injekcije.
• thoughts of suicide, suicide attempt and suicide,
• misli na samomor, poskus samomora in samomor,
The European Medicines Agency has deferred the obligation to submit the results of studies with
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom
The doctor may also want to measure your blood pressure and pulse.
Zdravnik vam bo morda tudi izmeril krvni tlak in pulz.
The medical supervision and monitoring should continue until the patient recovers.
Zdravniški nadzor in spremljanje je treba nadeljevati dokler si bolnik ne opomore.
• if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na aripiprazol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
It does not matter whether you take it with or without food.
Ni pomembno, ali ga vzamete s hrano ali brez nje.
No long-term data are available with regard to the efficacy and the safety of aripiprazole in this fluctuating disorder.
Dolgoročni podatki za učinkovitost in varnost aripiprazola pri tej spremenljivi motnji niso na voljo.
18 months After opening: use product immediately.
18 mesecev Po odprtju: zdravilo uporabite nemudoma po odprtju.
It is ready to use and intended for short-term use only (see section 5.1).
Namenjena je le za kratkotrajno uporabo (glejte poglavje 5.1).
ABILIFY with food, drink and alcohol
Zdravilo ABILIFY skupaj s hrano, pijačo in alkoholom
Do not push the tablet through the foil because this could damage the tablet.
Tablete ne potiskajte skozi folijo, ker lahko tableto tako poškodujete.
Dose adjustments due to interactions
Prilagajanje odmerka zaradi medsebojnega delovanja
Less than 1 % of unchanged aripiprazole was excreted in the urine and approximately 18 % was recovered unchanged in the faeces.
Manj kot 1 % aripiprazola se je nespremenjenega izločilo v urinu in približno 18 % ga je bilo mogoče nespremenjenega najti v blatu.
Also contains: lactose monohydrate.
Vsebuje tudi: laktoza monohidrat.
Blood pressure-lowering medicines: ABILIFY may increase the effect of medicines used to lower the blood pressure.
Zdravila za zniževanje krvnega tlaka: zdravilo ABILIFY lahko okrepi učinek zdravil, ki se uporabljajo za zniževanje krvnega tlaka.
Try to take ABILIFY at the same time each day.
Prizadevajte si vzeti zdravilo ABILIFY vsak dan ob istem času.
• unusual movements (especially of the face or tongue) and reduced level of consciousness.
• nenavadne gibe (posebno v mišicah obraza ali jezika) in zmanjšano stopnjo zavesti.
This should be considered in cases where full alertness is required, e.g., when driving a car or handling machines.
To je treba upoštevati, ko je potrebna popolna zbranost, npr. pri vožnji avtomobila ali upravljanja strojev.
Pathological gambling and other impulse control disorders
Patološko hazardiranje in druge motnje nadzora impulzov
If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day.
Če ste pozabili vzeti odmerek, ga vzemite takoj, ko se spomnite, vendar ne vzemite dveh odmerkov na en dan.
This medicine can be taken regardless of meals.
To zdravilo lahko jemljete ne glede na obroke.
This medicine will be given to you under medical supervision; it is therefore unlikely that you will be given too much.
To zdravilo se daje pod zdravniškim nadzorom, zato verjetnost, da bi dobili prekomerni odmerek, ni velika.
Due to insufficient safety information in humans and concerns raised by animal reproductive studies, this medicinal product should not be used in pregnancy unless the expected benefit clearly justifies the potential risk to the foetus.
Zaradi nezadostnih podatkov o varnosti pri človeku in zaradi pomislekov, ki jih porajajo študije vpliva na sposobnost razmnoževanja pri živalih, se tega zdravila pri nosečnicah ne sme uporabljati, razen če pričakovana korist nedvomno prevlada nad možnim tveganjem za plod.
Alternatively, disperse the tablet in water and drink the resulting suspension.
Druga možnost je, da tableto raztopi v vodi in popije nastalo suspenzijo.
Blood pressure, pulse, respiratory rate and level of consciousness should be monitored regularly.
Redno je treba nadzirati krvni tlak, pulz, frekvenco dihanja in stopnjo zavesti.
Fructose may damage teeth.
Fruktoza lahko poškoduje zobe.
Even if you feel better, do not alter or discontinue the daily dose of ABILIFY without first consulting your doctor.
Tudi če se počutite bolje, ne spreminjajte dnevnega odmerka in ne nehajte jemati zdravila ABILIFY, ne da bi se prej posvetovali z zdravnikom.
If you have the impression that the effect of ABILIFY is too strong or too weak, talk to your doctor or pharmacist.
Če menite, da je učinek zdravila ABILIFY premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
Care must be taken to avoid inadvertent injection of this medicinal product into a blood vessel.
Potrebna je previdnost, da ne pride do nenamernega injiciranja tega zdravila v krvno žilo.
Therefore cardiovascular monitoring should be started immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
Zato je treba takoj uvesti kardiovaskularni nadzor, ki mora vključevati stalno elektrokardiografsko spremljanje za odkritje morebitnih motenj srčnega ritma.
The correct amount of solution will be injected into your muscle by your doctor or nurse.
Ustrezen odmerek raztopine za injiciranje vam bo v mišico injiciral zdravnik ali medicinska sestra.
Do not open the blister until ready to administer.
Pretisnega omota ne odprite, dokler niste pripravljeni, da zdravilo zaužijete.
The highest nontumorigenic exposure in female rats was 7 times the human exposure at the recommended dose.
Največja netumorogena izpostavljenost samic podgan je bila 7-krat večja od izpostavljenosti človeka pri priporočenem odmerku.
It is important not to miss your dose.
Pomembno je, da ne izpustite načrtovanega odmerka.
Use within 6 months after first opening.
Porabite v 6 mesecih po prvem odprtju.
• high blood sugar,
• visok krvni sladkor,
If you cannot reach your doctor, go to the nearest hospital and take the pack with you.
pojdite v najbližjo bolnišnico in škatlo z zdravilom vzemite s seboj.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Nosečnost, dojenje in plodnost Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Contains aspartame and lactose.
Vsebuje aspartam in laktozo.
• rapid heartbeat, agitation/aggressiveness, problems with speech.
• hitro bitje srca, vznemirjenost/agresivnost, težave pri govoru,
Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Obvestite svojega zdravnika, če vi sami ali vaša družina/skrbnik opazite, da se pri vas razvija nagib ali želja po vedenju, ki za vas ni običajno, in se ne morete upreti impulzu, težnji ali skušnjavi po dejanjih,
• involuntary loss of urine (incontinence),
• nehotno uhajanje urina (inkontinenca),
Caution should be taken, particularly if you are an elderly patient or have some debility.
zlasti če ste starejši ali oslabeli bolnik.
The total body clearance of aripiprazole is 0.7 mL/min/kg, which is primarily hepatic.
Celotni telesni očistek aripiprazola je 0,7 ml/min/kg in je v prvi vrsti hepatičen.
The orodispersible tablet can be taken with or without liquid.
Orodisperzibilno tableto lahko vzamete s tekočino ali brez nje.
• low levels of white blood cells,
• nizke ravni belih krvnih celic,
The point estimate of the hazard ratio (HR) was 0.461 (95 % confidence interval, 0.242 to 0.879) in the full population.
Ocenjena vrednost razmerja ogroženosti (RO) je bila 0,461 (95-% interval zaupanja, 0,242 do 0,879) pri celotni poulaciji.
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)
• določene antibiotike, ki se uporabljajo za zdravljenje tuberkuloze (rifabutin, rifampicin).
Following a single oral dose of [14C]-labelled aripiprazole, approximately 27 % of the administered radioactivity was recovered in the urine and approximately 60 % in the faeces.
Po enem samem peroralnem odmerku aripiprazola, označenega s [14C], se je približno 27 % aplicirane radioaktivnosti pojavilo v urinu in približno 60 % v blatu.
If you miss an injection, you should contact your doctor to arrange your next injection as soon as you can.
Če ste izpustili injiciranje, takoj pokličite zdravnika, da vas čim prej naroči na naslednji odmerek.
< 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
In subpopulation analyses on patients with mixed episodes or on patients with severe agitation, a similar pattern of efficacy to the overall population was observed but statistical significance could not be established due to a reduced sample size.
V analizi bolnikov z mešanimi epizodami in bolnikov s hudo agitacijo so opazili podoben vzorec učinkovitosti, kot pri splošni populaciji, vendar statistične pomembnosti zaradi premajhnega vzorca ni bilo mogoče ugotoviti.
People with this condition may also feel depressed, guilty, anxious or tense.
Osebe s to boleznijo so lahko tudi depresivne, imajo občutek krivde, tesnobnosti ali napetosti.
The singledose pharmacokinetics of aripiprazole was linear and dose-proportional.
Farmakokinetika posamičnih odmerkov aripiprazola je bila linearna in sorazmerna odmerku.
Do not use this medicine in children and adolescents under 18 years of age.
To zdravilo ni namenjeno uporabi pri otrocih in mladostnikih, mlajših od 18 let.
If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/relative should tell your doctor if you have ever had a stroke or "mini" stroke.
Če ste starejša oseba in imate demenco (slabšanje spomina in drugih duševnih sposobnosti), morate vi ali vaš skrbnik/sorodnik zdravniku povedati, če ste kdaj imeli možgansko kap ali „malo” kap.
In the same trials, cerebrovascular adverse reactions (e.g. stroke, transient ischaemic attack), including fatalities, were reported in patients (mean age: 84 years; range: 78 to 88 years).
V istih preskušanjih so poročali o cerebrovaskularnih neželenih učinkih (npr. možganski kapi, prehodnem ishemičnem napadu), vključno s smrtnimi primeri (povprečna starost bolnikov: 84 let, razpon: 78 do 88 let).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili, ki ste jih dobili brez recepta.