natgillin/translations-raw huggingface dataset:
Fever and chills, headache, feeling sick, pain in your muscles, pain in your bones and/ or joints, tiredness, weakness, dizziness, vomiting, pain in your back, arms or legs.
Pogosti neželeni učinki (do katerih pride pri manj kot 10 na vsakih 100 bolnikov): vročina z mrzlico, glavobol, slabost, bolečine v mišicah, bolečine v kosteh in/ ali sklepih, utrujenost, oslabelost, omotičnost, bruhanje, bolečine v hrbtu, rokah ali nogah.
In patients with Paget’ s disease: symptoms due to low blood calcium, such as muscle spasms, or numbness, or a tingling sensation especially in the area around the mouth.
Pri bolnikih s Pagetovo boleznijo: simptomi zaradi nizke koncentracije kalcija v krvi, kot so mišični krči, odrevenelost ali občutek zbadanja, posebno v predelu okrog ust.
Flu, sleeplessness, tiredness, feeling of pins and needles or tingling sensation, drowsiness, tremor, temporary loss of consciousness, taste disturbance, diarrhoea, indigestion, abdominal pain, dry mouth, inflammation of oesophagus, toothache, joint pain, joint swelling, stiffness, eating disorder, redness, itching and pain in the eyes, chest pain, increased blood pressure, flushing, shortness of breath, rash,
Občasni neželeni učinki (do katerih pride pri manj kot 1 od 100 bolnikov): gripa, nespečnost, utrujenost, občutek zbadanja ali mravljinčenja, zaspanost, tremor, začasna izguba zavesti, motnje okušanja, driska, prebavne težave, bolečine v trebuhu, suha usta, vnetje požiralnika, zobobol, bolečine v sklepih, otekanje sklepov, okorelost, motnje hranjenja, rdečina, zbadanje in
28 sweating, itching, redness of the skin, frequent urination, transient increases in serum creatinine, swelling of tissues and thirst.
29 bolečina v očeh, bolečina v prsnem košu, zvišan krvni tlak, navali rdečice, zadihanost, izpuščaj, znojenje, srbenje, rdečina kože, pogosto uriniranje, prehodno zvišanje vrednosti kreatinina v serumu, otekanje tkiv in žeja.
Painful red eye.
Redek neželeni učinek (do katerega pride pri manj kot 1 od 1. 000 bolnikov): boleče pordelo oko
Skin reactions such as redness, swelling and/ or pain at the infusion site may occur.
Lahko pride do kožnih reakcij, kot so rdečina, oteklina in/ ali bolečina na mestu infuzije.
Bisphosphonates (the group of substances Aclasta belongs to) may cause swelling, redness, pain and itching of the eyes or eye sensitivity to light.
Difosfonati (skupina učinkovin, v katero sodi tudi zdravilo Aclasta) lahko povzročajo otekanje, pordelost, bolečino in srbenje v očeh ali občutljivost na svetlobo.
Persistent pain and/ or non-healing sores of the mouth or jaw have been reported primarily in patients treated with bisphosphonates for other illnesses.
O trdovratni bolečini in/ ali ranicah v ustih, ki se ne zacelijo, so poročali predvsem pri bolnikih, ki se zdravijo z difosfonati zaradi drugih bolezni.
If you experience these symptoms, tell your doctor or dentist.
Če do teh simptomov pride pri vas, obvestite svojega zdravnika ali zobozdravnika.
Allergic reactions have been reported including rare cases of difficulty breathing, hives and angioedema (such as swollen face, tongue or throat).
Poročali so o alergijskih reakcijah, vključno z redkimi primeri oteženega dihanja, izpuščaja in angioedema (kot je otekanje v obraz, jezik ali grlo oziroma žrelo).
There have been isolated reports of very serious allergic reactions.
Obstajajo tudi posamezna poročila o zelo resnih alergijskih reakcijah.
If you notice any of these side effects, tell your doctor.
Če opazite kateregakoli od teh neželenih učinkov, obvestite svojega zdravnika.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika, farmacevta ali medicinsko sestro.
HOW TO STORE ACLASTA
SHRANJEVANJE ZDRAVILA ACLASTA
- Keep Aclasta out of the reach and sight of children.
- Zdravilo Aclasta shranjujte nedosegljivo otrokom!
- Do not use Aclasta after the expiry date which is stated on the carton and bottle.
- Zdravila Aclasta ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli
- The unopened bottle does not require any special storage conditions.
- Za shranjevanje neodprte steklenice niso potrebna posebna navodila.
- After opening the bottle, the product should be used immediately in order to avoid microbial
- Po odpiranju steklenice je treba zdravilo uporabiti takoj, da ne bi prišlo do kontaminacije z
contamination.
mikroorganizmi.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C – 8°C.
Čas do uporabe naj praviloma ne presega 24 ur pri temperaturi 2 °C – 8 °C.
What Aclasta contains
Kaj vsebuje zdravilo Aclasta
Each bottle with 100 ml of solution contains 5 mg
Vsaka steklenica s 100 ml raztopine vsebuje 5 mg
zoledronic acid anhydrous, corresponding to 5.330 mg zoledronic acid monohydrate.
brezvodne zoledronske kisline, kar ustreza 5, 330 mg zoledronske kisline monohidrata.
One ml solution contains 0.05 mg zoledronic acid anhydrous corresponding to 0.05330 mg zoledronic acid monohydrate.
En ml raztopine vsebuje 0, 05 mg brezvodne zoledronske kisline, kar ustreza 0, 05330 mg zoledronske kisline monohidrata.
- The other ingredients are mannitol, sodium citrate and water for injections.
- Pomožne snovi so manitol, natrijev citrat in voda za injekcije.
What Aclasta looks like and contents of the pack Aclasta is a clear and colourless solution.
Izgled zdravila Aclasta in vsebina pakiranja Zdravilo Aclasta je bistra brezbarvna raztopina.
It comes in 100 ml plastic bottles as a ready-to-use solution for infusion.
Pakirana je v 100- mililitrskih plastičnih steklenicah v obliki raztopine za infundiranje, pripravljene za uporabo.
It is supplied in packs containing one bottle as unit pack or in multi-packs comprising 5 packs, each containing 1 bottle.
Na voljo je v škatlah, ki vsebujejo eno steklenico kot posamično pakiranje ali v skupnem pakiranju s 5 škatlami, ki vsebujejo po 1 steklenico.
29 Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
30 Imetnik dovoljenja za promet z zdravilom Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Velika Britanija
Manufacturer Novartis Pharma GmbH Roonstraße 25 D-90429 Nuremberg Germany
Izdelovalec Novartis Pharma GmbH Roonstraße 25 D- 90429 Nürnberg Nemčija
This leaflet was last approved in {date}
Navodilo je bilo odobreno
31 INFORMATION FOR THE HEALTHCARE PROFESSIONAL
32 INFORMACIJE ZA ZDRAVSTVENO OSEBJE
The dose of 5 mg of zoledronic acid must be administered over at least 15 minutes.
Odmerek 5 mg zoledronske kisline je treba dajati vsaj 15 minut.
Aclasta is not recommended for patients with severe renal impairment (creatinine clearance < 35 ml/ min) due to lack of adequate clinical experience in this population.
Zdravila Aclasta ne priporočajo za bolnike s hudo ledvično okvaro (očistek kreatinina < 35 ml/ min) zaradi pomanjkanja kliničnih izkušenj pri tej skupini bolnikov.
In patients with a recent low-trauma hip fracture, it is recommended to give the Aclasta infusion two or more weeks after hip fracture repair.
Pri bolnikih z nedavnim zlomom kolka po lažji poškodbi je priporočeno dati infuzijo zdravila Aclasta dva ali več tednov po zacelitvi zloma kolka.
Patients must be appropriately hydrated prior to and following administration of Aclasta; this is especially important for patients receiving diuretic therapy.
Bolnike je treba pred odmerjanjem zdravila Aclasta in po njem ustrezno hidrirati, kar je zlasti pomembno za bolnike, ki prejemajo tudi diuretike.
Caution is indicated when Aclasta is administered in conjunction with medicinal products that can significantly impact renal function (e. g. aminoglycosides or diuretics that may cause dehydration).
Kadar dajete zdravilo Aclasta skupaj z zdravili, ki lahko znatno vplivajo na ledvično funkcijo (npr. z aminoglikozidi ali diuretiki, ki lahko povzročijo dehidracijo), je potrebna previdnost.
Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with Aclasta.
Prej obstoječo hipokalciemijo je treba zdraviti z zadostnim uživanjem kalcija in vitamina D, pred uvedbo zdravljenja z zdravilom Aclasta.
Other disturbances of mineral metabolism must also be effectively treated (e. g. diminished parathyroid reserve, intestinal calcium malabsorption).
Učinkovito je treba zdraviti tudi druge motnje presnove mineralov (kot sta zmanjšano delovanje ostanka obščitnice in motena absorpcija kalcija v črevesju).
Elevated bone turnover is a characteristic of Paget’ s disease of the bone.
Povečana kostna presnova je značilna za Pagetovo bolezen kosti.
Due to the rapid onset of effect of zoledronic acid on bone turnover, transient hypocalcaemia, sometimes symptomatic, may develop and is usually maximal within the first 10 days after infusion of Aclasta.
Zaradi hitrega začetka delovanja zoledronske kisline na kostno presnovo se utegne razviti prehodna hipokalciemija, ki je včasih simptomatska in ki je navadno najbolj izražena v prvih 10 dneh po infuziji zdravila Aclasta.
Adequate calcium and vitamin D intake are recommended in association with Aclasta administration.
Skupaj z uporabo zdravila Aclasta priporočajo zadostno uživanje kalcija in vitamina D.
In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Aclasta administration.
Poleg tega je zelo priporočljivo, da bolnikom s Pagetovo boleznijo zagotovljamo zadostno dodajanje kalcija, ki ustreza vsaj 500 mg elementarnega kalcija dvakrat na dan vsaj 10 dni po prejetju zdravila Aclasta.
Measurement of serum calcium before infusion of Aclasta is recommended for patients with Paget´s disease.
Pri bolnikih s Pagetovo boleznijo je pred infuzijo zdravila Aclasta priporočeno merjenje ravni kalcija v serumu.
- Aclasta 5 mg solution for infusion is ready for use.
Aclasta 5 mg raztopina za infundiranje je že pripravljena za uporabo.
Aclasta must not be mixed or given intravenously with any other medication and must be given through a separate vented infusion line at a constant infusion rate.
Zdravila Aclasta ne smete mešati ali dajati intravensko z drugim zdravilom, dajati ga morate po ločenem prezračevanem infuzijskem sistemu s stalno hitrostjo infundiranja.
Aclasta must not be allowed to come into contact with any calcium-containing solutions.
Ne smete dovoliti, da bi Aclasta prišla v stik z raztopino, ki vsebuje kalcij.
- After opening the bottle, the product should be used immediately in order to avoid microbial
- Ko steklenico odprete, morate zdravilo porabiti takoj, da bi preprečili onesnaženje z
or EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR)
ACOMPLIA
et ACOMPLIA
uth EPAR summary for the public
m Povzetek EPAR za javnost
ra This document is a summary of the European Public Assessment Report (EPAR).
pro Ta dokument je povzetek Evropskega javnega poročila o oceni zdravila (EPAR).
ge Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
za Če potrebujete več informacij o vašem zdravstvenem stanju ali zdravljenju, preberite Navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali s farmacevtom.
What is ACOMPLIA?
nja Kaj je zdravilo ACOMPLIA?
ACOMPLIA is used together with diet and exercise to treat adult patients: • who are obese (very overweight) with a body mass index (BMI) greater than or equal to 30 kg/ m², • who are overweight (with a BMI greater than or equal to 27 kg/ m²) and also have other risk factors, ct
Na voljo je v obliki tablet bele barve, ki imajo obliko solze. lje Za kaj se zdravilo ACOMPLIA uporablja? vo ACOMPLIA se kot dodatek k dieti in telesni dejavnosti uporablja za zdravljenje odraslih bolnikov, ki: • so debeli (z zelo prekomerno telesno maso) s indeksom telesne mase (BMI) večjim ali enakim 30 kg/ m², ali do
such as type 2 diabetes or dyslipidaemia (abnormal levels of fat in their blood).
• imajo čezmerno telesno maso (imajo BMI večji ali enak 27 kg/ m²) in pri katerih obstajajo dodatni dejavniki tveganja, kot so na primer diabetes tipa 2 ali dislipidemija (nenormalne ravni maščobe v krvi). eā
The medicine can only be obtained with a prescription. du
Zdravilo se dobi samo na recept.
How is ACOMPLIA used?
Kako se zdravilo ACOMPLIA uporablja? av
The medicine should not be used in patients who ro
Zdravila ne smejo jemati osebe, ki imajo hude težave z jetri ali ledvicami. nim
The receptors are ina
Receptorji se ilo
also found in adipocytes (fat tissue).
nahajajo tudi v adipocitih (maščobnem tkivu).
How has ACOMPLIA been studied?
Kako je bilo zdravilo ACOMPLIA raziskano? rav
The effects of ACOMPLIA were first tested in experimental models before being studied in humans. dic
Zdravilo ACOMPLIA je bilo raziskano v štirih študijah, v katerih je sodelovalo skoraj 7000 debelih Zd
Four studies of ACOMPLIA in overweight and obese patients were carried out, involving almost 7,000 patients, whose weight at the start of the studies was on average 94 to 104 kg.
bolnikov in bolnikov s čezmerno telesno maso, katerih teža je bila na začetku študij povprečno med 94 in 104 kg.
The Me
Ena študija je preučevala tudi, kako doseženo zmanjšanje telesne mase obdržati tekom drugega leta.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
V štirih študijah, v 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
ise Four studies of ACOMPLIA as a help to stop smoking were also carried out in over 7,000 patients, comparing it with placebo, and measuring the effect of the medicine given for 10 weeks (one year in one of the studies) on smoking cessation, and on relapses in the following year.
Zdravilo so primerjali s placebom in merili učinek zdravila, uporabljanega 10 tednov (eno leto v eni od študij), na prenehanje kajenja ter na ponoven začetek kajenja v naslednjem letu.
or What benefit has ACOMPLIA shown during the studies?
Kakšne koristi je zdravilo ACOMPLIA izkazalo med raziskavami?
After one year, all patients who received ACOMPLIA lost more weight than those who received placebo: they lost on average 4.9 kg more than placebo, except in the study in diabetic patients, where the
Po enem letu se je pri bolnikih, ki so prejemali zdravilo ACOMPLIA telesna masa zmanjšala bolj kot pri
uth difference in the weight loss was 3.9 kg.
Zdravilo je tudi zmanjšalo
The medicine also reduced the risk of regaining weight.
m tveganje za ponovno povečanje telesne mase.
The studies in smoking cessation did not show consistent results, and the effect of ACOMPLIA in this area was difficult to estimate.
Študije v zvezi s prenehanjem kajenja niso pokazale konsistentnih rezultatov, učinek zdravila
ra What is the risk associated with ACOMPLIA?
za Kakšna tveganja so povezana z zdravilom ACOMPLIA?
For the full list of all side effects
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila ACOMPLIA, glejte Navodilo za uporabo.
ACOMPLIA should not be used in patients who may be hypersensitive (allergic) to rimonabant or any of the other ingredients, or in women who are breast feeding.
nja Zdravila ACOMPLIA ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) rimonabant ali katero koli drugo sestavino zdravila ter ženske, ki dojijo.
It must also not be used in patients with ongoing major depression or who are being treated with antidepressants, since it can increase the risk of lon depression, including thoughts about suicide in a small minority of patients.
Zdravilo lahko poveča tveganje za depresijo in pri majhnem številu bolnikov povzroči samomorilne misli, zato se ne sme uporabljati pri lje bolnikih s trenutno potekajočo veliko depresivno motnjo ali bolnikih, ki se zdravijo z antidepresivi.
Patients who experience symptoms of depression should speak to their doctor and may need to stop treatment.
Bolniki, pri katerih se pojavi depresija, se morajo pogovoriti z zdravnikom, zdravljenje pa bo morda vo potrebno prekiniti.
Caution should be used when taking ACOMPLIA with some medicines, such as ketoconazole or itraconazole (anti-fungal medicines), ritonavir (used in HIV infection), or telithromycin or clarithromycin (antibiotics). no
Pri sočasnem jemanju zdravila ACOMPLIA in nekaterih drugih zdravil, kot so ketokonazol ali itrakonazol (zdravili proti glivicam), ritonavir (ki se uporablja pri okužbi s HIV), telitromicin ali klaritromicin (antibiotika) je potrebna previdnost. do
The Committee for Medicinal products for Human Use (CHMP) concluded that ACOMPLIA had shown its effectiveness in weight reduction in obese or overweight patients with associated risk factors.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da je zdravilo ACOMPLIA izkazalo učinkovitost pri zmanjšanju telesne mase pri debelih bolnikih in bolnikih s čezmerno telesno maso, pri eā
The Committee decided that ACOMPLIA’ s benefits are greater than its risks when used, in addition to diet and ct
Odločil je, da so koristi zdravila ACOMPLIA, kadar se uporablja kot dodatek k dieti in telesni dejavnosti pri zdravljenju debelih bolnikov in bolnikov s čezmerno av
exercise, to treat obese patients and overweight patients with risk factors such as type 2 diabetes or dyslipidaemia.
telesno maso z dodatnimi dejavniki tveganja kot so diabetes tipa 2 ali dislipidemija, večje od z njim povezanih tveganj.
The Committee recommended that ACOMPLIA be given marketing authorisation. du
Odbor je priporočil odobritev dovoljenja za promet z zdravilom ACOMPLIA.
Which measures are being taken to ensure the safe use of ACOMPLIA?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila ACOMPLIA? nim
patients and doctors, and to monitor how the medicine is used.
Podjetje, ki izdeluje zdravilo ACOMPLIA, bo pripravilo program z izobraževalnim gradivom za bolnike in zdravnike za zagotovitev, da se zdravilo uporablja pri bolnikih, ki ga potrebujejo zaradi zdravja in ne iz kozmetičnih razlogov ter bo nadzorovalo njegovo uporabo.
The company will use specific databases to monitor ACOMPLIA’ s side effects, especially those linked to the nervous system. lp
Podjetje bo uporabilo specifične zbirke podatkov za spremljanje neželenih učinkov zdravila ACOMPLIA, zlasti tistih, povezanih z živčnim ilo
Other information about ACOMPLIA:
Druge informacije o zdravilu ACOMPLIA: rav
The European Commission granted a marketing authorisation valid throughout the European Union for ACOMPLIA to sanofi-aventis on 19 June 2006. ina
Zd
This summary was last updated in 10-2007. dic Me
Povzetek je bil nazadnje posodobljen 10- 2007.
e d is EU number
et Številka EU
Route of
pot uporabe
or administration EU/ 1/ 06/ 344/ 001 EU/ 1/ 06/ 344/ 002
EU/ 1/ 06/ 344/ 001
Film-coated tablet Film-coated tablet
filmsko obložena tableta
Oral use Oral use
za peroralno uporabo
Blister (PVC/ aluminium) Blister (PVC/ aluminium)
pretisni omot (PVC/ aluminij)
14 tablets 28 tablets
14 tablet
th EU/ 1/ 06/ 344/ 003 EU/ 1/ 06/ 344/ 004
om EU/ 1/ 06/ 344/ 002 EU/ 1/ 06/ 344/ 003
Film-coated tablet Film-coated tablet
filmsko obložena tableta filmsko obložena tableta
Oral use Oral use
za peroralno uporabo za peroralno uporabo
Blister (PVC/ aluminium) Blister (PVC/ aluminium)
pretisni omot (PVC/ aluminij) pretisni omot (PVC/ aluminij)
56 tablets 70x1 tablets
28 tablet 56 tablet
u EU/ 1/ 06/ 344/ 005
r EU/ 1/ 06/ 344/ 004
Blister (PVC/ aluminium)
pretisni omot (PVC/ aluminij)
84 tablets
70x1 tableta
a EU/ 1/ 06/ 344/ 006 EU/ 1/ 06/ 344/ 007
p EU/ 1/ 06/ 344/ 005 EU/ 1/ 06/ 344/ 006
Blister (PVC/ aluminium) Bottle (HDPE)
pretisni omot (PVC/ aluminij) pretisni omot (PVC/ aluminij)
98 tablets 28 tablets
84 tablet 98 tablet
r EU/ 1/ 06/ 344/ 008
za EU/ 1/ 06/ 344/ 007 EU/ 1/ 06/ 344/ 008 EU/ 1/ 06/ 344/ 009
ACOMPLIA
ACOMPLIA ACOMPLIA ACOMPLIA
20 mg
20 mg 20 mg 20 mg
Film-coated tablet
filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta
Oral use
za peroralno uporabo za peroralno uporabo za peroralno uporabo
Bottle (HDPE)
steklenica (HDPE) steklenica (HDPE) steklenica (HDPE)
98 tablets
28 tablet 98 tablet 500 tablet
e EU/ 1/ 06/ 344/ 009
ja EU/ 1/ 06/ 344/ 010
Bottle (HDPE)
pretisni omot (PVC/ aluminij)
500 tablets
30 tablet
pro l i na d ic M e 1/ 1
lje o ov d eā v a im n ilo v ra Zd 1/ 1
d ise or uth ra ge lon ANNEX I
t me pro za nja DODATEK I lje
SUMMARY OF PRODUCT CHARACTERISTICS no ct du ro lp ina dic Me
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA vo do eā av nim ilo rav Zd
d ACOMPLIA 20 mg film-coated tablets
ACOMPLIA 20 mg filmsko obložene tablete
or Excipients:
Pomožne snovi:
115 mg lactose.
Tablete vsebujejo približno 115 mg laktoze.
uth 3.
t 3.
ra Film-coated tablet Biconvex, teardrop-shaped, white tablets debossed with “ 20 ” on one side.
pro Bikonveksne bele tablete v obliki solze z vtisnjeno oznako "20" na eni strani.
ge 4.
4.
4.1 Therapeutic indications lon As an adjunct to diet and exercise for the treatment of obese patients (BMI ≥ 30 kg/ m2), or overweight patients (BMI > 27 kg/ m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1). no
za 4. 1 Terapevtske indikacije nja Kot dodatek k dieti in telesni dejavnosti za zdravljenje debelih bolnikov (ITM ≥ 30 kg/ m2), ali bolnikov s čezmerno telesno maso (ITM > 27 kg/ m2) z enim ali dvema spremljajočima dejavnikoma lje
4.2 Posology and method of administration
tveganja, kot sta diabetes tipa 2 ali dislipidemija (glejte poglavje 5. 1). vo
In adults, the recommended dosage is one 20 mg tablet daily to be taken in the morning before breakfast. ct
Vzeti jo je treba zjutraj pred zajtrkom. eā
The treatment should be introduced with a mildly reduced calorie diet. du
Zdravljenje se mora začeti z dieto z nekoliko zmanjšano vsebnostjo kalorij. av
The safety and efficacy of rimonabant have not been evaluated beyond 2 years.
Varnost in učinkovitost rimonabanta nista ocenjeni v obdobju, daljšem od 2 let. nim
• Special Populations ro
• Posebne populacije
No dosage adjustment is required in elderly (see section 5.2).
Pri starejših bolnikih odmerjanja ni treba prilagoditi (glejte poglavje 5. 2).
ACOMPLIA should be used with lp
Pri bolnikih, starejših od 75 ilo
caution in patients over 75 years of age (see section 4.4).
let, zdravilo ACOMPLIA uporabljajte previdno (glejte poglavje 4. 4). rav
Patients with hepatic insufficiency: ina
Pri bolnikih z blago ali zmerno okvaro jeter odmerka ni potrebno prilagoditi.
ACOMPLIA should be used with caution in patients with moderate hepatic impairment.
okvaro jeter je zdravilo ACOMPLIA potrebno uporabljati previdno.
ACOMPLIA should not be used in patients with severe hepatic impairment (see section 4.4 and 5.2). dic
Zdravila ACOMPLIA ne smete uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavji 4. 4 in 5. 2).
No dosage adjustment is required for patients with mild and moderate renal impairment (see section 5.2).
Pri bolnikih z blago ali zmerno okvaro ledvic odmerka ni potrebno prilagoditi (glejte poglavje 5. 2).
Me
Zdravila ACOMPLIA ne smete uporabljati pri bolnikih s hudo okvaro ledvic (glejte poglavji 4. 4 in 5. 2).
2 4.3 Contraindications
2 4. 3 Kontraindikacije
d Lactation.
Dojenje.
Ongoing major depressive illness and/ or ongoing antidepressive treatment (see section 4.4)
Trenutno potekajoča velika depresivna motnja in/ ali antidepresivno zdravljenje (glejte poglavje 4. 4).
ise 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
or Depressive disorders or mood alterations with depressive symptoms have been reported in up to 10%, and suicidal ideation in up to 1%, of patients receiving rimonabant (see section 4.8).
• Depresivne motnje Pri do 10% bolnikov, ki so se zdravili z rimonabantom, so poročali o depresivnih motnjah ali spremembah razpoloženja s simptomi depresije, pri do 1% bolnikov pa o pojavu samomorilnih misli (glejte poglavje 4. 8).
In patients with current suicidal ideations and/ or with a history of suicidal ideation and depressive disorder rimonabant
Pri bolnikih, ki imajo samomorilne misli in/ ali bolnikih, ki so kdaj imeli