natgillin/translations-raw huggingface dataset:
Placebo of parkinsonian symptoms in patients with dementia n (%)
Placebo odražajo poslabšanje simptomov Parkinsonove bolezni pri bolnikih z demenco, povezano s Parkinsonovo boleznijo n (%)
Rivastigmine Actavis may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.
Zdravilo Rivastigmin Actavis lahko povzroči vrtoglavost in zaspanost, predvsem na začetku zdravljenja ali ob povečanju odmerka.
The Cmax of rivastigmine was approximately 60 % higher and the AUC of rivastigmine was more than twice as high in subjects with mild to moderate hepatic impairment than in healthy subjects.
Cmax rivastigmina je bila za približno 60 % večja in AUC rivastigmina več kot dvakrat večja pri osebah z blago do zmerno jetrno okvaro kot pri zdravih osebah.
Patients with severe hepatic impairment have not been studied, however, Rivastigmine Actavis capsules may be used in this patient population provided close monitoring is exercised (see section 4.4 and 5.2).
Uporabe zdravila pri bolnikih s težko jetrno okvaro niso proučili, bolniki iz te populacije lahko kljub temu uporabljajo zdravilo Rivastigmin Actavis v obliki kapsul, vendar jih je treba skrbno spremljati (glejte poglavji 4.4 in
• Problems with your heartbeat such as fast or slow heartbeat
• Motnje srčnega ritma, kot sta prepočasen ali prehiter srčni utrip
The following additional adverse reaction has been observed in a study of patients with dementia associated with Parkinson's disease treated with rivastigmine transdermal patches: agitation (common).
Naslednji neželeni učinek so, poleg že navedenih, opažali v študiji pri bolnikih, ki so imeli demenco v povezavi s Parkinsonovo boleznijo in so bili zdravljeni s transdermalnimi obliži z rivastigminom: agitiranost (pogosti).
There is no relevant use of Rivastigmine Actavis in the paediatric population in the treatment of Alzheimer's disease.
Zdravila Rivastigmin Actavis ni smiselno uporabljati pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
Allergic dermatitis (disseminated)
Hiperhidroza Alergijski dermatitis (diseminirana oblika)
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [Actavis logo]
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Actavis logotip]
Uncommon (may affect up to 1 in 100 people) • Uneven heartbeat and poor control of movements
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) • Nepravilen srčni utrip in motnje koordinacije gibov
Rivastigmine might interfere with the activity of anticholinergic medicinal products (e.g oxybutynin, tolterodine).
Rivastigmin lahko moti delovanje antiholinergičnih zdravil (na primer oksibutinina in tolterodina).
• if you have, or have ever had, irregular or slow heartbeat.
• če imate ali ste kdaj imeli nepravilen ali počasen srčni utrip.
Motor dysfunction
Rigor Motorične motnje
Infections and infestations Very rare
Infekcijske in parazitske bolezni Zelo redki
• Decreased appetite
• Zmanjšan apetit
There is no relevant use of rivastigmine in the paediatric population in the treatment of Alzheimer's disease.
Pediatrična populacija Rivastigmina ni smiselno uporabljati pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
Rivastigmine was not mutagenic in a standard battery of in vitro and in vivo tests, except in a chromosomal aberration test in human peripheral lymphocytes at a dose 10
V standardni bateriji testov in vitro in in vivo rivastigmin ni bil mutagen, razen v testu kromosomskih
Rivastigmine Actavis should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting).
Zdravila Rivastigmin Actavis ne smete jemati sočasno z metoklopramidom (zdravilom, ki ga uporabljamo za ublažitev ali preprečevanje navzee (slabosti s siljenjem na bruhanje) in bruhanja).
Dementia associated with ADAS-Cog ADAS-Cog ADCS- CGIC ADCS-CGIC Parkinson's Disease
ADAS-Cog ADAS-Cog ADCS- CGIC ADCS-CGIC Parkinsonovo boleznijo Rivastigmin Placebo Rivastigmin Placebo
Magnesium stearate Silica colloidal, anhydrous Hypromellose Microcrystalline cellulose
magnezijev stearat brezvoden koloidni silicijev dioksid hipromeloza mikrokristalna celuloza
The following additional adverse reactions have been observed with rivastigmine transdermal patches: delirium, pyrexia, decreased appetite, urinary incontinence (common), psychomotor hyperactivity (uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known).
Pri uporabi transdermalnih obližev rivastigmina so dodatno opažali še naslednje neželene učinke: delirij, zvišano telesno temperaturo, zmanjšan apetit, urinska inkontinenca (pogosto), psihomotorična hiperaktivnost (občasno), eritem, urtikarija, mehurčki, alergijski dermatitis (pogostnost neznana).
The active substance of Rivastigmine Actavis is rivastigmine.
Zdravilna učinkovina v zdravilu Rivastigmin Actavis je rivastigmin.
• The highest dose that should be taken is 6 mg twice a day.
• Najvišji dovoljeni odmerek je 6 mg dvakrat na dan.
How to take Rivastigmine Actavis
Kako jemati zdravilo Rivastigmin Actavis
• Fainting or accidentally falling
• Omedlevica ali nezgodni padci
You should not breast-feed during treatment with Rivastigmine Actavis.
Med zdravljenjem z zdravilom Rivastigmin Actavis ne smete dojiti.
• Accidentally falling
• Nezgodni padec
1.5 mg twice a day.
Začetni odmerek 1,5 mg dvakrat na dan.
If you are pregnant, the benefits of using Rivastigmine Actavis must be assessed against the possible effects on your unborn child. Rivastigmine Actavis should not be used during pregnancy, unless clearly necessary.
V primeru, da ste noseči, je treba pretehtati koristi uporabe zdravila Rivastigmin Actavis in možne učinke na nerojenega otroka.
• Being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with your stomach (oesophagus)
• Močno bruhanje, ki lahko povzroči raztrganje požiralnika (cevi med usti in želodcem)
Dementia associated with ADAS-Cog ADAS-Cog ADAS-Cog ADAS-Cog Parkinson's Disease
ADAS-Cog ADAS-Cog ADAS-Cog ADAS-Cog Parkinsonovo boleznijo Rivastigmin Placebo Rivastigmin Placebo
Caution when Rivastigmine Actavis is taken together with beta-blockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions).
Previdnost je potrebna pri sočasni uporabi zdravila Rivastigmin Actavis in katerega od antagonistov adrenergičnih receptorjev beta (učinkovin, kot je atenolol, ki ga uporabljamo za zdravljenje visokega krvnega tlaka, angine pektoris in drugih bolezni srca).
The ink may or may not contain potassium hydroxide.
Črnilo lahko vsebuje kalijev hidroksid.
Not known
Pogostnost neznana
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 June 2011
Datum prve odobritve: 16.
Dose titration: Adverse reactions (e.g. hypertension and hallucinations in patients with Alzheimer's dementia and worsening of extrapyramidal symptoms, in particular tremor, in patients with dementia associated with Parkinson's disease) have been observed shortly after dose increase.
Titriranje odmerka: V kratkem času po povečanju odmerka so opazili neželene učinke (npr. hipertenzijo in halucinacije pri bolnikih z Alzheimerjevo demenco in poslabšanje ekstrapiramidnih simptomov, zlasti tremorja, pri bolnikih z demenco v povezavi s Parkinsonovo boleznijo).
• Fits (seizures)
• Napadi krčev (epileptični napadi)
Mean change at 24 weeks 2.5 ± 8.4 ± SD
Povprečna sprememba po 2,5 ± 8,4 24 tednih ± SD
Shellac, propylene glycol, red iron oxide (E172).
Tiskarsko črnilo: šelak, propilenglikol, rdeči železov oksid (E172).
• if you have, or have ever had, difficulties in passing urine.
• če imate ali če ste kdaj imeli težave z uriniranjem.
• if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea.
• če imate prebavne težave, kot so slabost s siljenjem na bruhanje (navzea), bruhanje in driska.
Cardiac disorders Rare
Srčne bolezni Redki
- If you have any further questions, ask your doctor, pharmacist or nurse.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali z medicinsko sestro.
• Changes in how well your liver is working
• Spremembe v delovanju jeter
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR CAPSULE CONTAINER
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA VSEBNIK ZA KAPSULE
• Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea
• Prebavne težave, kot so navzea (slabost s siljenjem na bruhanje) ali bruhanje, driska
Rivastigmine Actavis 1.5 mg hard capsules Rivastigmine Actavis 3 mg hard capsules Rivastigmine Actavis 4.5 mg hard capsules Rivastigmine Actavis 6 mg hard capsules rivastigmine
Rivastigmin Actavis 1,5 mg trde kapsule Rivastigmin Actavis 3 mg trde kapsule Rivastigmin Actavis 4,5 mg trde kapsule Rivastigmin Actavis 6 mg trde kapsule
• if you have, or have ever had, an active stomach ulcer.
• če imate ali ste kdaj imeli aktivno želodčno razjedo.
Muscle rigidity
Mišična rigidnost
Some cases of severe vomiting were associated with oesophageal rupture (see section 4.4).
V nekaterih primerih je bilo hudo bruhanje povezano z rupturo požiralnika (glejte poglavje 4.4)
• Feeling restless
• Občutek nemira
Vascular disorders Very rare
Žilne bolezni Zelo redki
Rivastigmine Placebo Rivastigmine Placebo Patients with visual
Rivastigmin Placebo Rivastigmin Placebo 6-12 mg
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Actavis Group PTC ehf.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Actavis Group PTC ehf.
Mean change at 24 weeks 2.1 ± 8.2 ± SD
Povprečna sprememba po 2,1 ± 8,2 24 tednih ± SD
• Ulcers in your stomach or intestine
• Razjede želodca ali črevesja
Pre-defined adverse events that may reflect worsening Rivastigmine
Vnaprej opredeljeni neželeni dogodki, ki lahko
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR CAPSULE CONTAINER
PODATKI NA STIČNI OVOJNINI NALEPKA ZA VSEBNIK ZA KAPSULE
INFORMATION IN BRAILLE Rivastigmine Actavis 1.5 mg
PODATKI V BRAILLOVI PISAVI Rivastigmin Actavis 1,5 mg
INFORMATION IN BRAILLE Rivastigmine Actavis 4.5 mg
PODATKI V BRAILLOVI PISAVI Rivastigmin Actavis 4,5 mg
• Headache
• Glavobol
INFORMATION IN BRAILLE Rivastigmine Actavis 6 mg
PODATKI V BRAILLOVI PISAVI Rivastigmin Actavis 6 mg
Rivastigmine Actavis 3 mg, 4.5 mg and 6 mg hard capsules: Red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172) and gelatine.
Rivastigmin Actavis 3 mg, 4,5 mg in 6 mg trde kapsule: rdeči železov oksid (E172), titanov dioksid (E171), rumeni železov oksid (E172) in želatina.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristic, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Nightmares Agitation
Nočne more
Initial dose
Povprečje ob izhodišču ±
Reykjavíkurvegur 76-78 220 Hafnarfjörður Iceland
Reykjavíkurvegur 76-78 220 Hafnarfjörður Islandija
Each Rivastigmine Actavis 6 mg capsule contains 6 mg of rivastigmine.
Ena kapsula zdravila Rivastigmin Actavis 6 mg vsebuje 6 mg rivastigmina.
INFORMATION IN BRAILLE Rivastigmine Actavis 3 mg
PODATKI V BRAILLOVI PISAVI Rivastigmin Actavis 3 mg
General disorders and administrationsite conditions
Splošne težave in spremembe na mestu aplikacije
Each Rivastigmine Actavis 4.5 mg capsule contains 4.5 mg of rivastigmine.
Ena kapsula zdravila Rivastigmin Actavis 4,5 mg vsebuje 4,5 mg rivastigmina.
Each Rivastigmine Actavis 1.5 mg capsule contains 1.5 mg of rivastigmine.
Ena kapsula zdravila Rivastigmin Actavis 1,5 mg vsebuje 1,5 mg rivastigmina.
Rivastigmine Actavis 1.5 mg hard capsules Titanium dioxide (E171) Yellow iron oxide (E172) Gelatine
Rivastigmin Actavis 1,5 mg trde kapsule titanov dioksid (E171) rumeni železov oksid (E172) želatina
• Nightmares
• Nočne more
Metabolism and nutrition disorders Common
Presnovne in prehranske motnje
What Rivastigmine Actavis looks like and contents of the pack - Rivastigmine Actavis 1.5 mg hard capsules, which contain off-white to slightly yellow powder, have a yellow cap and yellow body, with red imprint “RIV 1.5mg” on body.
Izgled zdravila Rivastigmin Actavis in vsebina pakiranja Rivastigmin Actavis 1,5 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rumen pokrovček in rumeno telo z rdečim napisom “RIV 1,5mg” na telesu.
Rivastigmine Actavis 4.5 mg hard capsules
Rivastigmin Actavis 4,5 mg trde kapsule
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja Pogosti
Rivastigmine Actavis 1.5 mg hard capsules
Rivastigmin Actavis 1,5 mg trde kapsule
• Heartburn
• Tesnoba
Talk to your doctor before taking Rivastigmine Actavis:
Pred začetkom jemanja zdravila Rivastigmin Actavis se posvetujte s svojim zdravnikom:
Capsule shell: Rivastigmine Actavis 1.5 mg hard capsules: Titanium dioxide (E171), yellow iron oxide (E172) and gelatine.
Ovojnica kapsule: Rivastigmin Actavis 1.5 mg trde kapsule: titanov dioksid (E171), rumeni železov oksid (E172) in želatina.
How to store Rivastigmine Actavis
Shranjevanje zdravila Rivastigmin Actavis
Each Rivastigmine Actavis 3 mg capsule contains 3 mg of rivastigmine.
Ena kapsula zdravila Rivastigmin Actavis 3 mg vsebuje 3 mg rivastigmina.
Rivastigmine Actavis 6 mg hard capsules
Rivastigmin Actavis 6 mg trde kapsule
Rivastigmine Placebo Rivastigmine Placebo ITT + RDO population (n=329)
Skupina ITT + RDO (n=329)
- Rivastigmine Actavis 4.5 mg hard capsules, which contain off-white to slightly yellow powder, have a red cap and red body, with white imprint “RIV 4.5mg” on body.
Rivastigmin Actavis 4,5 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rdeč pokrovček in rdeče telo z belim napisom “RIV 4,5mg” na telesu.
• Unusually slow movements or movements you cannot control
• Neobičajno počasni gibi ali nehoteni gibi
Rivastigmine Actavis 3 mg hard capsules
Rivastigmin Actavis 3 mg trde kapsule
Contents of the pack and other information What Rivastigmine Actavis contains - The active substance is rivastigmine hydrogen tartrate.
Kaj vsebuje zdravilo Rivastigmin Actavis - Zdravilna učinkovina je rivastigminijev hidrogentartrat.
Balance disorder Musculoskeletal stiffness Rigors
Otrdelost mišic in skeleta
Always take this medicine exactly as your doctor has told you.
Pri jemanju tega zdravila natančno upoštevajte napotke zdravnika.
Rivastigmine Actavis 6 mg hard capsules EU/1/11/693/013
Rivastigmin Actavis 6 mg trde kapsule EU/1/11/693/013
Somnolence
Nespečnost
• Stomach pain
• Bolečine v trebuhu
EU/1/11/693/007 [112 blister]
EU/1/11/693/007 [112 pretisni omot]
• if you have, or have ever had impaired kidney function.
• če imate ali če ste kdaj imeli okvarjeno delovanje ledvic.
- Rivastigmine Actavis 3 mg hard capsules, which contain off-white to slightly yellow powder, have an orange cap and orange body, with red imprint “RIV 3mg” on body.
Rivastigmin Actavis 3 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo oranžen pokrovček in oranžno telo z rdečim napisom “RIV 3mg” na telesu.
- Rivastigmine Actavis 6 mg hard capsules, which contain off -white to slightly yellow powder, have an red cap and orange body, with red imprint “RIV 6mg” on body.
Rivastigmin Actavis 6 mg trde kapsule, ki vsebujejo belkast do rahlo rumen prašek, imajo rdeč pokrovček in oranžno telo z rdečim napisom “RIV 6mg” na telesu.
EU/1/11/693/015 [112 blister]
EU/1/11/693/015 [112 pretisni omot]
Abdominal pain and dyspepsia
Bolečine v trebuhu in dispepsija
• Anxiety
• Nespečnost
Off-white to slightly yellow powder in a hard capsule with red cap and red body, with white imprint “RIV 4.5mg” on body.
Belkast do rahlo rumen prašek v trdi kapsuli z rdečim pokrovčkom in rdečim telesom, z belim napisom “RIV 4,5mg” na telesu.
Hepatic impairment
Splošno slabo počutje
Paediatric population
Epileptični napadi
MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/012
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/012
STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 4.5 mg rivastigmine (as hydrogen tartrate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 kapsula vsebuje 4,5 mg rivastigmina (v obliki hidrogentartrata).
Cardiac disorders Common
Srčne bolezni Pogosti
MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/004
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/004
MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/008
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/008
MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/016
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/016
associated with Parkinson's disease Total patients studied Total patients with pre-defined AE(s) Tremor
Vsi bolniki z neželenimi dogodki (AE - “adverse event”) Tremor
MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/013[ 28 blister]
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/013[ 28 pretisni omot]
• Urinary tract infection
• Okužbe sečil
STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 6 mg rivastigmine (as hydrogen tartrate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 kapsula vsebuje 6 mg rivastigmina (v obliki hidrogentartrata).
Rivastigmine Actavis 4.5 mg hard capsules EU/1/11/693/009
Rivastigmin Actavis 4,5 mg trde kapsule EU/1/11/693/009
STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 1.5 mg rivastigmine (as hydrogen tartrate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 kapsula vsebuje 1,5 mg rivastigmina (v obliki hidrogentartrata).
Off-white to slightly yellow powder in a hard capsule with orange cap and orange body, with red imprint “RIV 3mg” on body.
Belkast do rahlo rumen prašek v trdi kapsuli z oranžnim pokrovčkom in oranžnim telesom, z rdečim napisom “RIV 3mg” na telesu.
EU/1/11/693/011 [112 blister]
EU/1/11/693/011 [112 pretisni omot]
EU/1/11/693/014 [56 blister]
EU/1/11/693/014 [56 pretisni omot]
Off-white to slightly yellow powder in a hard capsule with red cap and orange body, with red imprint “RIV 6mg” on body.
Belkast do rahlo rumen prašek v trdi kapsuli z rdečim pokrovčkom in oranžnim telesom, z rdečim napisom “RIV 6mg” na telesu.
EU/1/11/693/006 [56 blister]
EU/1/11/693/006 [56 pretisni omot]
Rivastigmine Actavis 1.5 mg hard capsules EU/1/11/693/001
Rivastigmin Actavis 1,5 mg trde kapsule EU/1/11/693/001
• Chest pain
• Bolečina v prsih
MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/005[ 28 blister]
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/005[ 28 pretisni omot]
Rivastigmine Actavis 3 mg hard capsules EU/1/11/693/005
Rivastigmin Actavis 3 mg trde kapsule EU/1/11/693/005
• if you have, or have ever had, impaired liver function.
• če imate ali če ste kdaj imeli okvarjeno delovanje jeter.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 3 mg rivastigmine (as hydrogen tartrate).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 kapsula vsebuje 3 mg rivastigmina (v obliki hidrogentartrata).
Mean baseline ± SD 24.0 ± 10.3 24.5 ± 10.6 n/a n/a
24,0 ± 10,3 24,5 ± 10,6 ni podatka ni podatka
Off-white to slightly yellow powder in a hard capsule with yellow cap and yellow body, with red imprint “RIV 1.5mg” on body.
Belkast do rahlo rumen prašek v trdi kapsuli z rumenim pokrovčkom in rumenim telesom, z rdečim napisom “RIV 1,5mg” na telesu.
Unchanged rivastigmine is not found in the urine; renal excretion of the metabolites is the major route of elimination.
Poglavitna pot odstranjevanja iz telesa je izločanje presnovkov skozi ledvice.
EU/1/11/693/010 [56 blister]
EU/1/11/693/010 [56 pretisni omot]
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PRETISNE OMOTE
Urinary infection
Okužba sečil
MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/009[ 28 blister]
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/693/009[ 28 pretisni omot]
• Uneven heartbeat
• Neredno bitje srca
Mean baseline ± SD 23.8 ± 10.2 24.3 ± 10.5 n/a n/a
23,8 ± 10,2 24,3 ± 10,5 ni podatka ni podatka
• Generally feeling unwell
• Splošno slabo počutje
• Fainting
• Hujšanje
Anxiety
Rivastigmin
If you get any side effects, talk to your doctor, pharmacist or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Rivastigmine Actavis 3 mg, 4.5 mg and 6 mg hard capsules Red iron oxide (E172)
Rivastigmin Actavis 3 mg, 4,5 mg in 6 mg trde kapsule rdeči železov oksid (E172) titanov dioksid (E171) rumeni železov oksid (E172) želatina
Each capsule contains rivastigmine hydrogen tartrate corresponding to 6 mg rivastigmine.
Rivastigmin Actavis 6 mg trde kapsule Ena kapsula vsebuje rivastigminijev hidrogentartrat v količini, ki ustreza 6 mg rivastigmina.
Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg rivastigmine.
Rivastigmin Actavis 1,5 mg trde kapsule Ena kapsula vsebuje rivastigminijev hidrogentartrat v količini, ki ustreza 1,5 mg rivastigmina.
Dizziness
Vrtoglavost
Insomnia
Somnolenca
• Weight loss
• Vrtoglavost
Each capsule contains rivastigmine hydrogen tartrate corresponding to 4.5 mg rivastigmine.
Rivastigmin Actavis 4,5 mg trde kapsule Ena kapsula vsebuje rivastigminijev hidrogentartrat v količini, ki ustreza 4,5 mg rivastigmina.
Each capsule contains rivastigmine hydrogen tartrate corresponding to 3 mg rivastigmine.
Rivastigmin Actavis 3 mg trde kapsule Ena kapsula vsebuje rivastigminijev hidrogentartrat v količini, ki ustreza 3 mg rivastigmina.
5 pre-filled pens
5 napolnjenih injekcijskih peresnikov
The package leaflet will be updated accordingly.
Navodilo za uporabo bo ustrezno posodobljeno.
Scandonest has been authorised in the EU via national procedures.
Zdravilo Scandonest je bilo v EU odobreno po nacionalnih postopkih.
The amended information to doctors and patients is available here.
Dopolnjene informacije za zdravnike in bolnike so na voljo tukaj.
Why was Scandonest reviewed?
Zakaj je bilo zdravilo Scandonest pregledano?
After review of the available data, a number of other contraindications which were only valid in some countries were considered not to be supported by sufficient data, or to be redundant and already included in the current list above.
Po pregledu razpoložljivih podatkov je bilo za več drugih kontraindikacij, ki so veljale samo v nekaterih državah, ugotovljeno, da niso podprte z zadostnimi podatki ali so odvečne in že vključene v trenutni, zgoraj navedeni, seznam.
The European Commission issued an EU-wide legally binding decision to implement these changes on 2 August 2018.
Evropska komisija je 2. avgusta 2018 izdala pravno zavezujoči sklep za vse države članice EU, da uvedejo te spremembe.
In addition, it must not be used in children below 4 years of age, in patients with severe problems affecting the heart's electrical activity which are not resolved by a pace-maker, and in epileptic patients whose disease is not adequately controlled.
Poleg tega se ne sme uporabljati pri otrocih, mlajših od štirih let, pri bolnikih s hudimi težavami v zvezi z električno aktivnostjo srca, ki jih ni mogoče odpraviti s srčnim spodbujevalnikom, ter pri bolnikih z epilepsijo, pri katerih bolezen ni zadostno nadzorovana.
Other harmonised sections of the SmPC include sections 4.4 (special warnings and precautions for use) 4.5 (interactions), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use machines), and 4.8 (side effects).
Druga usklajena poglavja povzetka glavnih značilnosti zdravila vključujejo poglavja 4.4 (Posebna opozorila in previdnostni ukrepi), 4.5 (Medsebojno delovanje z drugimi zdravili), 4.6 (Plodnost, nosečnost in dojenje), 4.7 (Vpliv na sposobnost vožnje in upravljanja strojev) in 4.8 (Neželeni učinki).
In children, the recommended dose is 0.75 mg/kg.
Pri otrocih je priporočeni odmerek 0,75 mg/kg.
Where justified by data, some of the previous contraindications have been included in section 4.4 Special warnings and precautions for use.
Kadar je bilo to utemeljeno s podatki, so bile nekatere od predhodnih kontraindikacij vključene v poglavje 4.4 Posebna opozorila in previdnostni ukrepi.
Scandonest is also available in the EU under the trade names Biocaine and Scandicaine.
V EU je na voljo tudi pod trgovskima imenoma Biocaine in Scandicaine.
In addition, Module 3 of the medicine dossier (which describes how the medicine is produced and its quality controlled) has also been harmonised.
Poleg tega sta bila usklajena modul 3 dokumentacije o zdravilu (v njem je opisano, kako je zdravilo proizvedeno in kako se nadzoruje njegova kakovost).