natgillin/translations-raw huggingface dataset:
Cerenia solution for injection should be injected subcutaneously or intravenously, once daily, at a dose of 1 mg/kg bodyweight (1 ml/10 kg bodyweight) for up to 5 consecutive days.
Cerenia otopina za injekciju daje se subkutano, jednom dnevno u dozi od 1 mg/kg tjelesne težine (1 ml/10 kg tjelesne težine) do maksimalno 5 uzastopnih dana.
The volume of distribution at steady-state (Vss) was 9.3 l/kg and systemic clearance was 1.5 l/h/kg.
Volumen distribucije u stabilnom stanju-(Vss) bio je 9,3 l/kg, a sustavni klirens 1,5 l/h/kg.
Clinical signs including vomiting on first administration, excess salivation and watery faeces have been observed when the product has been overdosed in excess of 20 mg/kg.
Klinički znakovi koji uključuju povraćanje kod prve primjene, pojačano slinjenje i mekani feces primijećeni su kada se proizvod daje u dozi većoj od 20 mg/kg.
A variety of in vitro assays have demonstrated that maropitant binds selectively at the NK1 receptor with dose-dependent functional antagonism of substance P activity.
Niz in vitro testova je pokazao da se maropitant selektivno veže za NK1 receptore funkcionalnim antagonizmom aktivnosti
Maropitant is highly bound to plasma proteins and may compete with other highly bound drugs.
Maropitant se dobro veže na proteine plazme te može stvarati interakcije s drugim proizvodima koji imaju istu karakteristiku.
Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t1/2) of 8.84 hours.
Najviše koncentracije praćene su smanjenjem sustavne izloženosti s vidljivim vremenom polueliminacije (t1/2) od 8,84 sata.
Metacresol (as preservative)
Pomoćne tvari: Metakrezola (kao konzervans)
Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t1/2) of 16.8 hours.
Najviše koncentracije praćene su smanjenjem sustavne izloženosti s vidljivim vremenom polueliminacije (t1/2) od 16,8 sati.
Pain at injection site may occur when injected subcutaneously.
Prilikom subkutane primjene može se pojaviti bolnost na mjestu injiciranja.
For prevention of vomiting induced by motion sickness, (only for dogs 16 weeks of age or older)
Za sprječavanje povraćanja uzrokovanog bolešću putovanja, (samo za pse starije od 16 tjedana)
Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t0.5) of 4.03 hours.
Najviše koncentracije praćene su smanjenjem sustavne izloženosti s vidljivim vremenom polueliminacije (t1/2) od 4,03 sata.
Cerenia can be used to treat or prevent vomiting either as tablets or as solution for injection administered once daily.
Cerenia se može davati za liječenje ili sprječavanje povraćanja u obliku tableta ili otopine za injekcije jednom dnevno.
Renal and faecal clearances are minor routes of elimination for maropitant, with less than 1% of a 1 mg/kg subcutaneous dose appearing in the urine or faeces as maropitant.
Izlučivanje putem bubrega i fecesa je manje značajan put eliminacije maropitanta, manje od 1% od subkutane doze 1mg/kg eliminira se kao maropitant u urinu ili fecesu.
For motion sickness a light meal or snack before dosing is recommended, prolonged fasting before administration should be avoided.
Za sprječavanje bolesti putovanja preporučuje se dati lagani obrok prije davanja lijeka, prethodni produženi post se ne preporučuje.
Dogs and cats.
CILJNE VRSTE ŽIVOTINJA Psi i mačke.
Increases of approximately 10% in the QT interval of the ECG were observed in a study on healthy beagle dogs administered 8 mg/kg orally; however, such an increase is unlikely to be of clinical significance.
Povećanje QT intervala kod pretrage EKG-om od otprilike 10% zabilježena je u studiji napravljenoj na zdravim psima pasmine bigl, koji su primili dozu od 8 mg/kg p.o.
• For the prevention of vomiting except that induced by motion sickness.
• Za sprječavanje povraćanja osim onog uzrokovanog bolešću putovanja.
Dogs and cats
CILJNE VRSTE ŽIVOTINJA Psi i mačke
FAREVA AMBOISE Zone Industrielle, 29 route des Industries 37530 Pocé-sur-Cisse FRANCE
FAREVA AMBOISE Zone Industrielle, 29 route des Industries
Following repeated subcutaneous administration of once-daily doses of 1 mg/kg bodyweight for five consecutive days, accumulation was 146%.
Praćenjem ponovljene subkutane aplikacije jedne dnevne doze od 1 mg/kg kroz pet uzastopnih dana akumulacija (povećanje koncentracije) je bila 146%.
Maropitant is metabolised in the liver and therefore should be used with caution in dogs with liver disease.
Maropitant se metabolizira u jetri te se s toga treba oprezno koristiti kod pasa s bolestima jetre.
For the prevention of nausea induced by chemotherapy and treatment and prevention of vomiting (except motion sickness), (only for dogs 8 weeks of age or older).
Sprječavanje mučnine izazvane kemoterapijom, liječenje i sprječavanje povraćanja (osim bolesti putovanja), (samo za pse starije od 8 tjedana).
METHOD AND ROUTE(S) OF ADMINISTRATION
NAČIN I PUT(EVI) PRIMJENE s.c., i.v.
In dogs, Cerenia can be used to treat or prevent vomiting either as tablets or as solution for injection administered once daily.
Kod pasa Cerenia se može davati za liječenje ili sprječavanje povraćanja u obliku tableta ili otopine za injekciju, jednom dnevno.
The volume of distribution at steady-state (Vss) was 2.3 l/kg and systemic clearance was 0.51 l/h/kg.
Volumen distribucije u stabilnom stanju-(Vss) bio je 2,3 l/kg, a sustavni klirens 0,5 l/h/kg.
The safety of Cerenia has not been established in dogs less than 16 weeks of age for the 8 mg/kg dose (motion sickness), and in dogs less than 8 weeks of age for the 2 mg/kg dose (vomiting) as well as in pregnant or lactating bitches.
Neškodljivost Cerenie nije utvrđena kod pasa mlađih od 16 tjedana pri dozi od 8 mg/kg (bolest putovanja) i kod pasa mlađih od 8 tjedana pri dozi od 2 mg/kg (povraćanje), te isto tako kod gravidnih i dojnih kuja.
The pharmacokinetic profile of maropitant when administered as a single oral dose of 2 mg/kg body weight to dogs was characterised by a maximum concentration (Cmax) in plasma of approximately 81 ng/ml; this was achieved within 1.9 hours post-dosing (Tmax).
Farmakokinetički profil maropitanta kada je jednokratno peroralno dan psu u dozi od 2 mg/kg tjelesne težine karakterizira maksimalna koncentracija (Cmax) u plazmi od otprilike 81 ng/ml, koncentracija je postignuta unutar 1,9 sati nakon aplikacija (Tmax).
Cerenia 10 mg/ml injection for dogs and cats maropitant
Cerenia 10 mg/ml otopina za injekcije za pse i mačke maropitant
EU/2/06/062/005
BROJ ODOBRENJA ZA STAVLJANJE U PROMET EU/2/06/062/005
The pharmacokinetic profile of maropitant when administered as a single subcutaneous dose of 1 mg/kg body weight to cats was characterised by a maximum concentration (Cmax) in plasma of approximately 165 ng/ml; this was achieved on average 0.32 hours (19 min) post-dosing (Tmax).
Farmakokinetički profil maropitanta kod mačaka nakon jednokratne subkutane aplikacije u dozi od 1 mg/kg tjelesne težine karakterizira maksimalna koncentracija (Cmax) u plazmi od otprilike 165 ng/ml, koncentracija je postignuta unutar 0,32 sati (19 minuta) nakon aplikacija (Tmax).
The pharmacokinetic profile of maropitant when administered as a single subcutaneous dose of 1 mg/kg body weight to dogs was characterised by a maximum concentration (Cmax) in plasma of approximately 92 ng/ml; this was achieved within 0.75 hours post-dosing (Tmax).
Farmakokinetički profil maropitanta kod pasa nakon jednokratne subkutane aplikacije u dozi od 1 mg/kg tjelesne težine karakterizira maksimalna koncentracija (Cmax) u plazmi od otprilike 92 ng/ml, koncentracija je postignuta unutar 0,75 sati nakon aplikacija (Tmax).
For prevention of nausea induced by chemotherapy and treatment and prevention of vomiting (except motion sickness), only for dogs 8 weeks of age or older
Sprječavanje mučnine izazvane kemoterapijom, liječenje i sprječavanje povraćanja (osim bolesti putovanja), samo za pse starije od 8 tjedana.
Pharmacotherapeutic group: Antiemetics.
Farmakoterapijska skupina: antiemetici ATCvet kôd: QA04AD90
The safety of the veterinary medicinal product has not been established in dogs less than 16 weeks of age for the 8 mg/kg dose (motion sickness), and in dogs less than 8 weeks of age for the 2 mg/kg dose (vomiting) as well as in pregnant or lactating bitches.
Neškodljivost VMP nije utvrđena kod pasa mlađih od 16 tjedana pri dozi od 8 mg/kg (bolest putovanja) i kod pasa mlađih od 8 tjedana pri dozi od 2 mg/kg (povraćanje), te isto tako kod gravidnih i dojnih kuja.
The duration of the effect is approximately 24 hours and, therefore, tablets can be given the night before administration of an agent that may cause emesis (e.g. chemotherapy).
Procijenjena učinkovitost je 24 sata, tako da se tablete mogu davati večer prije nego se očekuje povraćanje (npr. kemoterapija).
Following repeated subcutaneous administration of once-daily doses of 1 mg/kg bodyweight for five consecutive days, accumulation was 250%.
Praćenjem ponovljene subkutane aplikacije jedne dnevne doze od 1 mg/kg kroz pet uzastopnih dana akumulacija (povećanje koncentracije) je bila 250%.
Following repeated oral administration for five consecutive days at a daily dose of 2 mg/kg, accumulation was 151%.
Praćenjem ponovljene p.o. aplikacije kroz pet uzastopnih dana u dozi od 2 mg/kg akumulacija (povećanje koncentracije) je bila 151%.
• For the prevention of vomiting induced by motion sickness.
• Za sprječavanje povraćanja uzrokovanog bolešću putovanja.
• Find the pull-back notch (or cut) as shown by the arrow symbol .
• Pronađite zarez označen simbolom strelice .
NAME OF MARKETING AUTHORISATION HOLDER
NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET
To prevent vomiting, Cerenia solution for injection should be administered more than 1 hour in advance.
Cerenia otopina za injekciju daje se za sprječavanje povraćanja barem jedan sat unaprijed.
Renal clearance is a minor route of elimination, with less than 1% of a 1 mg/kg subcutaneous dose appearing in the urine as either maropitant or its major metabolite.
Izlučivanje putem bubrega je manje značajan put eliminacije, maropitant ili njegovi glavni metaboliti pojavljuju se u urinu u iznosu manjem od 1% pri subkutanoj dozi od 1 mg/kg.
Prevention of nausea induced by chemotherapy Treatment and prevention of vomiting (except motion sickness) Dog body weight (kg)
Sprječavanje mučnine uzrokovane kemoterapijom Liječenje i sprječavanje povraćanja (osim bolesti putovanja)
Renal clearance is a minor route of elimination, with less than 1% of an 8 mg/kg oral dose appearing in the urine as either maropitant or its major metabolite.
Izlučivanje putem bubrega je manje značajan put eliminacije, maropitant ili njegovi glavni metaboliti pojavljuju se u urinu u iznosu manjem od 1% pri peroralnoj dozi od 8 mg/kg.
The safety of Cerenia has not been established in dogs less than 8 weeks of age, or in cats less than 16 weeks of age, and in pregnant or lactating dogs and cats.
Neškodljivost Cerenie nije utvrđena kod pasa mlađih od 8 tjedana i kod mačaka mlađih od 16 tjedana, te isto tako kod gravidnih i dojnih kuja i mačaka.
Special precautions for storage
11. POSEBNI UVIJETI ČUVANJA
SC, IV Read the package leaflet before use.
POSEBNA UPOZORENJA, UKOLIKO JE POTREBNO Pročitati uputu o VMP prije primjene.
• Remove tablet from blister and administer as instructed.
• Izvadite tabletu i primijenite ju u skladu s uputom.
PACKAGE LEAFLET: Cerenia 10 mg/ml solution for injection for dogs and cats
UPUTA O VMP: Cerenia 10 mg/ml otopina za injekciju za pse i mačke
− uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
− manje česte (više od 1 ali manje od 10 životinja na tretiranih 1.000 životinja)
The safety of the veterinary medicinal product has not been established in dogs less than 8 weeks of age, or in cats less than 16 weeks of age, and in pregnant or lactating dogs and cats.
Neškodljivost VMP nije utvrđena kod pasa mlađih od 8 tjedana i kod mačaka mlađih od 16 tjedana, te isto tako kod gravidnih i dojnih kuja i mačaka.
Cerenia Tablets:
Cerenia tablete
Each tablet contains 24 mg maropitant as maropitant citrate monohydrate.
Svaka tableta sadržava 24 mg maropitanta u obliku maropitant citrat monohidrata.
Maropitant is metabolised in the liver and therefore should be used with caution in patients with hepatic disease.
Maropitant se metabolizira u jetri te shodno tome treba ga uz oprez davati životinjama s poremećenom funkcijom jetre.
Dog body weight (kg)
Pas, tjelesna masa (kg)
Each tablet contains 16 mg maropitant as maropitant citrate monohydrate.
Svaka tableta sadržava 16 mg maropitanta u obliku maropitant citrat monohidrata.
Each tablet contains 160 mg maropitant as maropitant citrate monohydrate.
Svaka tableta sadržava 160 mg maropitanta u obliku maropitant citrat monohidrata.
Each tablet contains 60 mg maropitant as maropitant citrate monohydrate.
Svaka tableta sadržava 60 mg maropitanta u obliku maropitant citrat monohidrata.
1 ml of solution contains 10 mg maropitant (as maropitant citrate monohydrate).
I DRUGIH TVARI 1 ml otopine sadržava10 mg maropitanta u obliku maropitant citrat monohidrata.
Name and address of the manufacturers responsible for batch release
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije u promet
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vial / Solution for injection
OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
The solution for injection contains 10 mg maropitant per ml as maropitant citrate monohydrate as a clear, colourless to light yellow solution.
Otopina za injekciju sadržava 10 mg maropitanta po mililitru u obliku maropitant citrat monohidrata.
Oral use.
P tvari.
The correct dose is determined individually for each animal depending on weight and needs to be adjusted depending on the response to treatment.
Točna doza određuje se pojedinačno za svaku životinju ovisno o težini i potrebno ju je prilagoditi ovisno o odgovoru na terapiju.
Further information on ProZinc can be found on the Agency's website: ema.europe.eu/medicines/veterinary/EPAR/prozinc
Više informacija o VMP-u ProZinc dostupno je na internetskim stranicama Agencije: ema.europe.eu/medicines/veterinary/EPAR/prozinc
It is given as an injection under the skin twice daily for cats and once daily for dogs either at the same time or immediately after a meal.
Daje se injekcijom pod kožu dvaput dnevno mačkama, a psima jednom dnevno tijekom obroka ili neposredno nakon njega.
ProZinc (human insulin)
ProZinc (ljudski inzulin)
What is ProZinc and what is it used for?
Što je ProZinc i za što se koristi?
These hypoglycaemic events are generally mild in nature.
Te hipoglikemijske reakcije uglavnom su blage prirode.
After 12 weeks, 113 out of 134 ProZinc treated dogs (84%) were successfully treated, compared to 91 out of the 111 control dogs (82%).
Nakon 12 tjedana 113 pasa od 134 psa koji su primili ProZinc (84 %) bilo je uspješno izliječeno, u usporedbi s 91 od 111 pasa u kontrolnoj skupini (82 %).
ProZinc (human insulin) EMA/300817/2013
ProZinc (ljudski inzulin) EMA/300817/2013
For dogs, if there is insufficient response to treatment after 4 - 6 weeks, the dose and/or frequency can be changed.
Ako odgovor na terapiju u pasa nije dostatan nakon 4 - 6 tjedana, doza i/ili učestalost primjene mogu se promijeniti.
ProZinc can only be obtained with a prescription and is available as a suspension for injection (40 IU/ml).
ProZinc se izdaje samo na recept i dostupan je kao suspenzija za injekciju (40 IU/ml).
ProZinc must not be used in cats or dogs which are hypersensitive (allergic) to insulin or any of the other ingredients.
ProZinc se ne smije davati mačkama ili psima koji su preosjetljivi (alergični) na inzulin ili bilo koji od ostalih sastojaka.
ProZinc received a marketing authorisation valid throughout the EU on 12 July 2013.
VMP ProZinc dobio je odobrenje za stavljanje u promet koje je na snazi u EU-a od 12. srpnja 2013.
It contains the active substance human insulin.
Sadrži djelatnu tvar ljudski inzulin.
ProZinc is a veterinary medicine used to treat cats and dogs with diabetes.
ProZinc je veterinarsko-medicinski proizvod koji se koristi za liječenje mačaka i pasa oboljelih od dijabetesa.
There is a low chance of an allergic reaction in sensitised people.
Kod senzibiliziranih osoba postoji mala mogućnost alergijske reakcije.
By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.
Kontrolom razine glukoze u krvi ublažavaju se simptomi i komplikacije dijabetesa.
This results in increased blood glucose levels and associated clinical signs such as polyuria (increase in urine volume), polydipsia (increase in water intake) and weight loss.
To uzrokuje povišenu razinu glukoze u krvi i s njome povezane kliničke znakove kao što su poliurija (povećana količina urina), polidipsija (povećan unos vode) i gubitak težine.
Other information about ProZinc
Ostale informacije o VMP-u ProZinc
Because of its prolonged action, it must also not be used for the short-term management of diabetic ketoacidosis (a serious complication of diabetes with high levels of ketones in the blood).
Zbog svojeg produljenog djelovanja ne smije se primjenjivati ni za akutnu kontrolu dijabetičke ketoacidoze (ozbiljne komplikacije dijabetesa s visokom razinom ketona u krvi).
What are the risks associated with ProZinc?
Koji su rizici povezani s VMP-om ProZinc?
Why is ProZinc authorised in the EU?
Zašto je VMP ProZinc odobren u EU-u?
Diabetes is a disease in which the pancreas does not make enough insulin to control the level of blood glucose (sugar) and/or when the body is unable to use insulin effectively.
Dijabetes je bolest pri kojoj gušterača ne proizvodi dovoljno inzulina za kontrolu razine glukoze (šećera) u krvi i/ili tijelo ne može učinkovito iskoristiti inzulin.
The active ingredient of ProZinc, human insulin, is produced by a method known as ‘recombinant DNA technology': it is made by yeast cells into which a gene (segment of DNA) has been introduced that makes the yeast cells able to produce insulin.
Djelatna tvar VMP-a ProZinc, ljudski inzulin, proizvodi se metodom poznatom pod nazivom „tehnologija rekombinantne DNK”: proizvode ga stanice kvasca u koje je uveden gen (dio DNK) koji stanicama kvasca omogućuje proizvodnju inzulina.
The European Medicines Agency decided ProZinc's benefits are greater than its risks and it can be authorised for use in the EU.
Europska agencija za lijekove zaključila je da koristi od VMP-a ProZinc nadmašuju s njim povezane rizike te da on može biti odobren za primjenu u EU-u.
The most common side effect during treatment with ProZinc (which may affect more than 1 in 10 animals) is hypoglycaemia (low blood glucose levels) which may result in signs such as hunger, anxiety, unsteady movement, muscle twitching, stumbling or sinking in the rear legs and disorientation.
Najčešće nuspojave tijekom liječenja VMP-om ProZinc (koje su mogu javiti u više od 1 na 10 životinja) jesu hipoglikemija (niska razina glukoze u krvi), što može prouzročiti znakove kao što su glad, tjeskoba, nestabilno kretanje, trzanje mišića, posrtanje ili gubljenje tla pod stražnjim nogama te dezorijentacija.
An overview of ProZinc and why it is authorised in the EU
Pregled informacija o VMP-u ProZinc i zašto je odobren u EU-u
ProZinc works in the same way as naturally produced insulin with a longer duration of action, and helps glucose enter cells from the blood.
ProZinc djeluje na isti način kao i prirodno proizveden inzulin, ima duže razdoblje djelovanja i pomaže glukozi da uđe u stanice iz krvi.
Accidental self-injection can result in clinical signs of low blood glucose levels which can be treated by taking sugar by mouth.
Nehotično samoinjiciranje može dovesti do kliničkih znakova niske razine glukoze u krvi, što se može riješiti uzimanjem šećera kroz usta.
A glucose containing solution or gel and/or food is required to be given to the animal immediately.
Životinji je nužno odmah dati otopinu ili gel koji sadrže glukozu i/ili hranu.
These are absorbed more slowly after injection and take longer to reach their target in the body than naturally produced insulin.
Oni se nakon injekcije apsorbiraju sporije od prirodno proizvedenog inzulina i potrebno im je više vremena da dosegnu svoj cilj u tijelu.
ProZinc is an insulin to which protamine and zinc have been added to create crystals.
ProZinc je inzulin kojem su dodani protamin i cink radi stvaranja kristala.
In an EU field study involving diabetic dogs, ProZinc was as effective as an authorised veterinary insulin, with improvement of at least one blood sugar measurement and at least one of three clinical signs: bodyweight, polyuria and polydipsia.
Tijekom terenskog ispitivanja na razini EU-a kojim su bili obuhvaćeni psi s dijabetesom, VMP ProZinc bio je jednako učinkovit kao i odobreni veterinarski inzulin, pri čemu je došlo do poboljšanja najmanje jedne izmjerene vrijednosti šećera u krvi i najmanje jednog od tri klinička znaka: tjelesne težine, poliurije i polidipsije.
If the product is accidentally self-injected, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
U slučaju da se VMP nehotično samoinjicira, potrebno je odmah potražiti savjet liječnika te mu pokazati uputu o VMP-u ili njegovu etiketu.
For a full list of the side effects and restrictions with ProZinc, see the package leaflet.
Potpuni popis nuspojava i ograničenja povezanih s VMP-om ProZinc potražite u uputi o VMP-u.
For more information about using ProZinc, see the package leaflet or contact your veterinarian or pharmacist.
Za dodatne informacije o primjeni VMP-a ProZinc pogledajte uputu o VMP-u odnosno obratite se veterinaru ili ljekarniku.
How does ProZinc work?
Kako djeluje ProZinc?
What benefits of ProZinc have been shown in studies?
Koje su koristi od VMP-a ProZinc utvrđene u ispitivanjima?
In a field study involving 139 diabetic cats of various ages and breeds, after 6 weeks of treatment with ProZinc average blood sugar levels decreased and clinical signs improved, for example average body weight increased; 116 out of 139 cats (84%) were considered to be treated successfully.
Tijekom terenskog ispitivanja kojim je bilo obuhvaćeno 139 mačaka s dijabetesom različite starosti i pasmina, nakon 6 tjedana primjene VMP-a ProZinc prosječna razina šećera u krvi se snizila, a klinički
How is ProZinc used?
Kako se ProZinc primjenjuje?
Strength Pharmaceutical Form Route of Administration Packaging
Doza Farmaceutski oblik Put primjene Unutarnje pakovanje Veličina pakovanja
Package size l t o r
28 x 1 tableta (jedinična doza) (kalendarsko pakiranje)
Over 75 % of patients were less than 13 years of age.
Više od 75 % bolesnika bilo je mlađe od 13 godina.
• thoughts of suicide, suicide attempt and suicide,
• misli o samoubojstvu, pokušaj samoubojstva i samoubojstvo;
• strong impulse to gamble excessively despite serious personal or family consequences
- snažan nagon za pretjeranim kockanjem usprkos ozbiljnim posljedicama za osobu ili obitelj,
This medicine can be taken regardless of meals.
Ovaj lijek se može uzimati neovisno o obrocima.
Aripiprazole Accord with food, drink and alcohol
Aripiprazol Accord s hranom, pićem i alkoholom
CARTON FOR BOTTLE AND BOTTLE LABEL
KUTIJA ZA BOCU I NALJEPNICA ZA BOCU
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 November 2015
Datum prvog odobrenja: 16 studeni 2015
• high blood pressure,
• visoki krvni tlak,
• binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
- prejedanje (jedenje ogromnih količina hrane u kratkom razdoblju) ili kompulzivno jedenje (jedenje veće količine hrane nego što je normalno i više nego je potrebno za utaženje gladi),
Even if you feel better, do not alter or discontinue the daily dose of this medicine without first consulting your doctor.
Čak i ako se osjećate bolje, nemojte mijenjati dozu niti prekidati svakodnevno uzimanje ovog lijeka bez prethodnog savjetovanja s liječnikom.
Consequently, the frequency of these adverse events is qualified as “not known”
Posljedično tome, učestalost ovih nuspojava navodi se kao "nepoznata".