natgillin/translations-raw huggingface dataset:
- Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration.
- Preprečevanje obolenja srčne glistavosti, ki jo povzroča Dirofilaria immitis, z mesečnim nanosom.
Part the hair at the base of the cat's neck in front of the shoulder blades to expose a small area of skin.
Razmaknemo dlako v predelu zatilja pred lopaticami, da se pokaže nekoliko kože.
Felisecto Plus 60 mg/10 mg (green cap)
Felisecto Plus 60 mg/10 mg (zelen pokrovček)
This veterinary medicinal product is to be applied to the skin surface only.
Zdravilo se nanaša le na površino kože.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in animals intended for breeding.
Varnost zdravila v obdobju brejosti in laktacije ali pri plemenskih živalih ni bila ugotovljena.
- Treatment of ear mites (Otodectes cynotis).
- Zdravljenje ušesnih garij (Otodectes cynotis).
Translucent polypropylene unit dose pipettes individually packed in aluminium and aluminium/PVC blisters.
Prosojne polipropilenske merilne kapalke z enkratnim odmerek pakirane v aluminijevem in aluminijevem/PVC pretisnem omotu.
Excipients: 0.2 mg/ml butylated hydroxytoluene.
Pomožne snovi: 0,2 mg/ml butilhidroksitoluen.
The veterinary medicinal product has immediate and persistent acaricidal effect for 5 weeks against Ixodes ricinus and Ixodes hexagonus, and 4 weeks against Dermacentor reticulatus and Rhipicephalus sanguineus.
To zdravilo za uporabo v veterinarski medicini ima takojšen in trajen učinek ubijanja klopov najmanj 5 tednov za klope vrste Ixodes ricinus in Ixodes hexagonus ter 4 tedne za klope vrste Dermacentor reticulatus in Rhipicephalus sanguineus.
Activity has also been demonstrated against heartworm (D. immitis) larvae.
Učinkovitost je bila dokazana tudi proti ličinkam srčne gliste (D. immitis).
Felisecto Plus should be administered as a single spot-on (topical) application in accordance with the following table (corresponding to a minimum of 6 mg/kg selamectin and 1 mg/kg sarolaner).
Zdravilo Felisecto Plus se daje kot enkratni kožni nanos (lokalno), v skladu s tabelo (ki zagotavlja najmanj 6 mg selamektina na kg telesne mase in 1 mg sarolanerja na kg telesne mase):
In cats the primary route of selamectin elimination is in faeces and the majority is parent compound.
Pri mačkah je primarna pot izločanja selamektina v blato in je večinoma matična molekula.
The primary route of elimination for sarolaner is biliary elimination of parent sarolaner, with contributions by metabolic clearance.
Glavna pot izločanja sarolanerja je izločanje matične molekule z žolčem s prispevkom metaboličnega očistka.
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 PROIZVAJALEC ZDRAVILA, ODGOVORNEGA ZA SPROŠČANJE SERIJ, ČE STA RAZLIČNA
Appropriate combination of pipettes
Ustrezna kombinacija merilnih kapalk.
Selamectin is active against adult fleas (Ctenocephalides spp.)
Selamektin deluje proti odraslim bolham (Ctenocephalides spp.)
Used pipettes should be disposed of immediately.
Uporabljene merilne kapalke odvrzite takoj.
Following administration of the product, the adult fleas on the animal are killed within 24 hours, no viable eggs are produced, and larvae (found only in the environment) are also killed.
Po dajanju zdravila odrasle bolhe na živali odmrejo v 24 urah, produkcija jajčec je ustavljena in tudi ličinke (prisotne le v okolju) odmrejo.
Felisecto Plus 30 mg/5 mg (orange cap)
Felisecto Plus 30 mg/5 mg (oranžen pokrovček)
Strength and number of pipettes to be administered Felisecto Plus 15 mg/2.5 mg (yellow cap)
Moč in število merilnih kapalk, ki jih moramo dati Felisecto Plus 15 mg/2,5 mg (rumen pokrovček)
Sarolaner blocks GABA- and glutamate-gated chloride channels in the central nervous system of insects and acarines.
Sarolaner blokira GABA- in glutamat- odvisne kloridne kanale v centralnem živčnem sistemu insektov in pršic.
Do not remove the pipette from the blister until ready to use.
Merilne kapalke ne odstranjujte iz pretisnega omota do uporabe.
Cats ≤2.5 kg Cats >2.5-5 kg Cats >5-10 kg
mačke ≤2,5 kg mačke >2,5-5 kg mačke >5-10 kg
The pipette caps are colour-coded as follows:
Zaporke merilnih kapalk so različno obarvane in sicer:
Nematodes: - Treatment of adult roundworms (Toxocara cati) and adult intestinal hookworms (Ancylostoma tubaeforme).
Nematodi: - Zdravljenje infestacij z odraslimi valjastimi črvi (Toxocara canis) in odraslimi intestinalnimi kavljastimi črvi (Ancylostoma tubaeforme).
For optimal control of tick and fleas infestations, the veterinary medicinal product should be administered at monthly intervals and continued throughout the flea and/or tick season based on local epidemiological situations.
Za optimalni nadzor nad infestacijami z bolhami in klopi, zdravilo dajemo v mesečnih intervalih skozi celo sezono bolh in klopov glede na lokalno epidemiološko situacijo.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Spot-on use.
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
The product is available in packs of three pipettes (all pipette sizes).
Zdravilo je na voljo v pakiranju s tremi merilnimi kapalkami (vse velikosti merilnih kapalk).
Apply the tip of the pipette directly to the skin, without massaging.
Konico merilne kapalke z zdravilom namestimo neposredno na kožo in ne masiramo.
Wash hands after use and wash off any product in contact with the skin immediately with soap and water.
Po uporabi zdravila si roke temeljito umijte ter sperite dele kože, ki so prišli v stik z zdravilom zdravilu z vodo in milom.
Holding the pipette upright, firmly depress the cap to puncture the applicator seal, then remove the cap.
Merilno kapalko držimo pokončno, trdno pritisnemo zaporko, da predremo zaporo na aplikatorju, nato pa odstranimo zaporko.
For ticks (I. ricinus), the onset of efficacy is within 24 hours of attachment for one month after product application.
Pri klopih (I.ricinus), začne zdravilo učinkovati znotraj 24 ur po pritrditvi in deluje en mesec po nanosu.
>2.5-5 kg >5-10 kg selamectin/sarolaner
≤2,5 kg >2,5-5 kg >5-10 kg selamektin/sarolaner
Disruption of these receptors by sarolaner prevents the uptake of chloride ions by GABA and glutamate gated ion channels, thus resulting in increased nerve stimulation and death of the target parasite.
Motnje v delovanju receptorjev, ki jih povzroča sarolaner preprečujejo prehod kloridnih ionov preko GABA in glutamat odvisnih ionskih kanalov, kar se kaže v povečani živčni stimulaciji in smrti ciljnih parazitov.
The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for 5 weeks.
To zdravilo ima takojšen in trajen ubijajoči učinek na bolhe na nove infestacije z bolhami vsaj 5 tednov.
Method and route of administration
Odmerjanje in pot uporabe
Mild to moderate alopecia at the application site, erythema and drooling have been uncommonly observed.
Blago do zmerno alopecijo na mestu nanosa, pordelost kože in slinjenje so opazili občasno.
Do not apply when the animal's hair coat is wet.
Zdravila ne nanašamo na mokro dlako živali.
Debris from selamectin-treated pets kills flea eggs and larvae not previously exposed to selamectin and thus may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Ostružek kože živali, zdravljene s selamektinom, ubije jajčeca in ličinke bolh, ki še niso bile izpostavljene selamektinu in tako lahko pomaga pri kontroli infestacije okolja z bolhami na področjih, ki so dostopna živalim.
Avoid contact between the product and your fingers.
Pazimo, da zdravilo ne pride v stik s prsti.
For cats with, or at risk from, mixed parasitic infestations by ticks and fleas, lice, mites, gastrointestinal nematodes or heartworm.
Pri mačkah, za zdravljenje in preprečevanje infestacij s klopi, bolhami, ušmi, garjami, gastrointestinalnimi nematodi ali srčno glisto.
Through its ovicidal and larvicidal action, the veterinary medicinal product may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Zaradi svojega ovicidnega in larvicidnega delovanja pa lahko pomaga pri kontroli infestacije okolja z bolhami na področjih, ki so dostopna živalim.
Use of the veterinary medicinal product may result in mild and transient pruritus at the application site.
Uporaba zdravila lahko povzroči rahel in prehoden srbež na mestu nanosa.
For fleas, the onset of efficacy is within 24 hours for 5 weeks after product application.
Pri bolhah je učinek viden znotraj 24 ur in deluje 5 tednov po nanosu.
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije
Sarolaner exhibits higher functional potency to block insect/acarine receptors compared to mammalian receptors.
Sarolaner ima večjo afiniteto za funkcionalno blokado receptorjev pri insektih in pršicah kot pri receptorjih sesalcev.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each unit dose (pipette) delivers: Active substances: Felisecto Plus spot-on solution
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Vsaka odmerna enota (merilna kapalka) zdravila vsebuje: Učinkovina:
as well as mites (Otodectes cynotis), lice (Felicola subrostratus) and gastrointestinal nematodes (Toxocara cati, Ancylostoma tubaeforme).
uši (Felicola subrostratus) in gastrointestinalne nematode (Toxocara cati, Ancylostoma tubaeforme).
Marketing authorisation holder and manufacturer responsible for batch release:
Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij:
Treatment of roundworm and hookworm infections A single dose of the product should be administered.
Zdravljenje infestacij z valjastimi in kavljastimi črvi Da se enkratni odmerek.
Apply topically to the skin at the base of the neck in front of the shoulder blades.
Nanašamo na kožo na predel zatilja, oziroma v sprednjem delu lopatic.
Medicines should not be disposed of via wastewater.
Ne odvrzite zdravila v odpadno vodo ali med gospodinjske odpadke.
Total volume of unit dose (ml)
Vsebnost merilne kapalke (ml)
After accidental ingestion of a full product dose, transient gastrointestinal effects such as salivation, soft faeces, emesis, and reduced food consumption may occur, however these should resolve without treatment.
Po nenamernem zaužitju celotnega odmerka so se pojavili prehodni gastrointestinalni znaki kot so slinjenje, mehko blato, bruhanje in zmanjšan apetit, ki so izzveneli brez zdravljenja.
METHOD AND ROUTE(S) OF ADMINISTRATION Spot-on use.
NAČIN IN POT(I) UPORABE Nanos na kožo.
The pipette should be removed from the protective package immediately prior to administration.
Merilno kapalko vzamete iz zaščitne ovojnine tik pred nanosom.
TARGET SPECIES
CILJNE ŽIVALSKE VRSTE Mačke
Pregnancy and lactation:
Brejost in laktacija:
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PIPETTE
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
4.9 Amounts to be administered and administration route Spot-on use.
4.9 Odmerjanje in pot uporabe
QUANTITY OF THE ACTIVE SUBSTANCE(S) 15 mg selamectin / 2.5 mg sarolaner 30 mg selamectin / 5 mg sarolaner 60 mg selamectin / 10 mg sarolaner
KOLIČINA UČINKOVIN(E) 15 mg selamectin / 2.5 mg sarolaner 30 mg selamectin / 5 mg sarolaner 60 mg selamectin / 10 mg sarolaner
Keep the product in the original packaging until use, in order to prevent children from getting direct access to the product.
Da bi preprečili otrokom dostop do zdravila, zdravilo do uporabe hranite v originalni ovojnini.
Transient cosmetic effects may occur at the application site such as temporary clumping or spiking of the hair, greasiness or dry white deposits, which normally resolve within 24 hours after product application.
Na mestu nanosa se lahko pojavijo prehodni kozmetični stranski učinki kot so začasno zlepljanje, vozlanje ali mastenje dlake na mestu nanosa ali občasen pojav manjših količin belega prahu.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each unit dose (pipette) delivers: Active substances: Felisecto Plus spot-on solution
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka odmerna enota (merilna kapalka) zdravila vsebuje: Učinkovina(e):
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
This stops flea reproduction, breaks the flea lifecycle and may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Na ta način se razmnoževanje bolh ustavi in prekine se razvojni krog bolhe, kar pa lahko pomaga pri kontroli infestacije okolja z bolhami na področjih, ki so dostopna živalim.
Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z veterinarjem ali farmacevtom.
Keep away from heat, sparks, open flame or other sources of ignition.
Zdravilo je lahko vnetljivo, zato ga hranite zaščitenega pred vročino, iskrami, odprtim plamenom ali drugimi vnetljivimi viri.
STATEMENT OF ACTIVE SUBSTANCES 15 mg selamectin/2.5 mg sarolaner 30 mg selamectin/5 mg sarolaner 60 mg selamectin/10 mg sarolaner
NAVEDBA UČINKOVIN(E) 15 mg selamektin/2,5 mg sarolaner 30 mg selamektin /5 mg sarolaner 60 mg selamektin /10 mg sarolaner
If significant ingestion occurs, transient gastrointestinal effects such as hypersalivation, emesis, soft faeces or reduced food consumption may be observed and should normally resolve without treatment.
V primeru večjega zaužitja lahko pride do prehodnega prekomernega slinjenja, bruhanja, mehkih iztrebkov in zmanjšane ješčnosti, ti znaki navadno izzvenijo brez zdravljenja.
AUTHORISATION
Odmerjanje
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 0.25 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
The product may cause eye irritation.
Zdravilo lahko draži oči.
Treatment of ear mites
Zdravljenje infestacij z ušmi
Pipette content
Vsebnost tube
Specific pharmacovigilance requirements:
D. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Posebne farmakovigilančne zahteve:
These effects do not affect the safety or efficacy of the veterinary medicinal product.
Ti učinki običajno izginejo v 24 urah po nanosu in ne vplivajo na varnost, niti na učinkovitost zdravila.
Pipettes with yellow caps contain 0.25 ml of product and deliver 15 mg selamectin and 2.5 mg sarolaner Pipettes with orange caps contain 0.5 ml of product and deliver 30 mg selamectin and 5 mg sarolaner Pipettes with green caps contain 1 ml of product and deliver 60 mg selamectin and 10 mg sarolaner
- merilna kapalka z rumenim pokrovčkom vsebuje 0,25 ml raztopine in sprosti 15 mg selamektina in 2,5 mg sarolanerja.
Butylated hydroxytoluene
Felisecto Plus raztopina kožnih kapljic
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC UČINKOVINE IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA,, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
NAME OF THE VETERINARY MEDICINAL PRODUCT Felisecto Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Felisecto Plus 30 mg/5 mg spot-on solution for cats >2.5-5 kg Felisecto Plus 60 mg/10 mg spot-on solution for cats >5-10 kg Selamectin/sarolaner
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Felisecto Plus 15 mg/2.5 mg kožna raztopina, nanos za mačke ≤2.5 kg Felisecto Plus 30 mg/5 mg kožna raztopina, nanos za mačke >2.5-5 kg Felisecto Plus 60 mg/10 mg kožna raztopina, naos za mačke >5-10 kg Selamektin/sarolaner
Selamectin has adulticidal, ovicidal and larvicidal activity against fleas.
Selamektin učinkuje na odrasle bolhe, jajčeca in ličinke ubijajoče.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi butilhidroksitoluen dipropilenglikol monometil eter isopropilni alkohol 6.2 Glavne inkompatibilnosti
Treatment of biting lice A single dose of the product should be administered.
Zdravljenje infestacij z ušmi Da se enkratni odmerek.
PACKAGE LEAFLET: Felisecto Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg Felisecto Plus 30 mg/5 mg spot-on solution for cats >2.5-5 kg Felisecto Plus 60 mg/10 mg spot-on solution for cats >5-10 kg
NAVODILO ZA UPORABO Felisecto Plus 15 mg/2.5 mg kožna raztopina, nanos za mačke ≤2.5 kg Felisecto Plus 30 mg/5 mg kožna raztopina, nanos za mačke >2.5-5 kg Felisecto Plus 60 mg/10 mg kožna raztopina, nanos za mačke >5-10 kg
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX
VELIKOST PAKIRANJA 3 merilne kapalke
Spot-on solution.
Da se enkratni odmerek.
This summary was last updated in 01-2014.
Povzetek je bil nazadnje posodobljen 01-2014.
In addition, the company presented results from two other main studies.
Poleg tega je družba predstavila tudi rezultate iz dveh drugih glavnih študij.
The usual dose is 10 mg once a day.
Običajni odmerek je 10 mg enkrat na dan.
Side effects were usually mild or moderate, short-lasting and occurred in the first two weeks of treatment.
Neželeni učinki so bili običajno blagi ali zmerni ter kratkotrajni in so se pojavili v prvih dveh tednih zdravljenja.
It is used to treat major depression in adults.
Uporablja se za zdravljenje epizod velike depresije pri odraslih.
Supportive data from 52-week extensions of several of these studies suggested that the improvements that were seen were maintained longer-term.
Spremljajoči podatki iz 52-tedenskih podaljšanih faz nekaterih od teh študij so pokazali, da so izboljšanja, ki so jih opazili, trajala dlje časa.
The European Commission granted a marketing authorisation valid throughout the European Union for Brintellix on 18 December 2013.
Evropska komisija je dovoljenje za promet z zdravilom Brintellix, veljavno po vsej Evropski uniji, izdala dne 18 decembra 2013.
This is a summary of the European public assessment report (EPAR) for Brintellix.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Brintellix.
Patients 65 years of age and over should be started on a lower dose of 5 mg daily.
Pri bolnikih, starih 65 let ali več, je treba zdravljenje začeti z manjšim odmerkom, ki znaša 5 mg na dan.
Treatment with Brintellix should continue for at least 6 months after the depressive symptoms have resolved.
Zdravljenje z zdravilom Brintellix je treba nadaljevati še vsaj 6 mesecev po tem, ko simptomi depresije izginejo.
The full EPAR for Brintellix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Brintellix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Major depression is a condition in which patients have mood disturbances that interfere with their everyday life.
Velika depresija je stanje, za katerega so pri bolnikih značilne motnje razpoloženja, ki vplivajo na njihovo vsakodnevno življenje.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Brintellix's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Brintellix večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Brintellix can only be obtained with a prescription and is available as tablets (5, 10, 15 and 20 mg) and oral drops (20 mg/ml).
Zdravilo Brintellix se izdaja le na recept in je na voljo v obliki tablet (5, 10, 15 in 20 mg) ter peroralnih kapljic (20 mg/ml).
Serotonin is a neurotransmitter, a chemical that transmits signals between nerve cells.
Serotonin je živčni prenašalec, tj. kemična snov, ki prenaša signale med živčnimi celicami.
Effects on the gut such as nausea are more common in women than in men.
Učinki na črevesje, kot je navzea, so pogostejši pri ženskah kot pri moških.
Symptoms often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, a feeling of being slowed down, feelings of anxiety and changes in weight.
Med pogostimi simptomi so globoka žalost, občutki ničvrednosti, izguba zanimanja za stvari, ki so bolnika prej veselile, motnje spanja, občutek splošne upočasnjenosti, občutek tesnobe in sprememba telesne mase.
What measures are being taken to ensure the safe and effective use of Brintellix?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Brintellix?
Although there was limited information about the use of doses above 10 mg daily in the elderly this was addressed in the product information.
O uporabi odmerkov, večjih od 10 mg na dan, pri starejših je na voljo malo informacij, vendar pa je to vprašanje ustrezno obravnavano v informacijah o zdravilu.
A risk management plan has been developed to ensure that Brintellix is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Brintellix je bil pripravljen načrt obvladovanja tveganj.
Brintellix must be used with care and sometimes in adjusted doses in patients taking certain other medicines; it must not be used in patients also taking medicines known as nonselective monoamine oxidase inhibitors (MAOIs) or selective monoamine oxidase A (MAO-A) inhibitors.
Zdravilo Brintellix je treba previdno uporabljati pri bolnikih, ki jemljejo določena druga zdravila, pri čemer je včasih treba prilagoditi tudi odmerek; zdravilo se ne sme uporabljati pri bolnikih, ki jemljejo tudi zdravila, imenovana neselektivni zaviralci monoaminooksidaze (MAOI) ali selektivni zaviralci monoaminooksidaze tipa A (MAO-A).
Brintellix has been studied in 12 main short-term studies involving more than 6,700 patients with major depression (including one study in patients aged 65 and over), in which it was compared with placebo (a dummy treatment) for 6 or 8 weeks.
Zdravilo Brintellix so proučili v 12 glavnih kratkoročnih študijah z več kot 6 700 bolniki z veliko depresijo (vključno z eno študijo na bolnikih, starih 65 let ali več), v katerih so ga v obdobju od 6 do 8 tednov primerjali s placebom (zdravilom brez zdravilne učinkovine).
Lower doses may also be needed in patients taking certain medicines that reduce the breakdown of vortioxetine in the body and conversely higher doses may be considered in those taking medicines that increase the breakdown of vortioxetine.
Manjši odmerki so včasih potrebni tudi pri bolnikih, ki jemljejo določena zdravila, ki zavirajo razgradnjo vortioksetina v telesu, večji odmerki pa se lahko uporabijo pri tistih, ki jemljejo zdravila, ki spodbujajo razgradnjo vortioksetina.
Other information about Brintellix
Druge informacije o zdravilu Brintellix
Studies have shown a clinically relevant improvement in major depressive episodes, and the types of side effects seen were similar to those with other antidepressants that act through serotonin.
Študije so pokazale klinično pomembno izboljšanje epizod velike depresije, opaženi neželeni učinki pa so bili podobni tistim, ki so jih zabeležili pri uporabi drugih antidepresivov, ki delujejo preko serotonina.
Because serotonin is involved in the control of mood, and can regulate the actions of other neurotransmitters that may be involved in depression and anxiety, these actions of vortioxetine are thought to result in its effect in improving depression.
Ker serotonin sodeluje pri uravnavanju razpoloženja in lahko vpliva na delovanje drugih živčnih prenašalcev, ki so lahko vpleteni v pojav depresije in tesnobe, naj bi vortioksetin z omenjenim delovanjem povzročil izboljšanje depresije.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Brintellix, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Brintellix in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.