FrancophonIA/ELRC3.0 huggingface dataset:
English: The median (Q1; Q3) recovery was 2.6 (2.3; 3.0) by chromogenic assay.
Slovenian: S kromogeno metodo je bila ugotovljena mediana (Q1; Q3) dviga aktivnosti 2,6 (2,3; 3,0).
English: INFORMATION IN BRAILLE Jivi 3000
Slovenian: PODATKI V BRAILLOVI PISAVI Jivi 3000
English: • whether you have inhibitors and how high their level is
Slovenian: • prisotnost inhibitorjev faktorja VIII in njihova raven,
English: Jivi is for single use only.
Slovenian: Zdravilo Jivi je samo za enkratno uporabo.
English: Ask your pharmacist or physician how to throw away medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom ali zdravnikom.
English: INFORMATION IN BRAILLE Jivi 500
Slovenian: PODATKI V BRAILLOVI PISAVI Jivi 500
English: Jivi 500
Slovenian: 2,5 ml
English: Injection site reactions **, Pyrexia common * Frequency is based on studies with all factor VIII products which included patients with severe haemophilia A. PTPs = previously-treated patients” **includes injection site pruritus, injection site rash and vessel puncture site pruritus ***includes erythema and erythema multiforme ****includes rash and rash papular
Slovenian: Splošne težave in spremembe na mestu aplikacije reakcije na mestu injiciranja **, pireksija pogosti *Pogostnost temelji na študijah z vsemi zdravili s faktorjem VIII, v katere so bili vključeni bolniki s težko stopnjo hemofilije A. PTP = Previously Treated Patients (predhodno zdravljeni bolniki)
English: • rash, skin reddening
Slovenian: • izpuščaj, rdečina na koži
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF A SINGLE PACK (INCLUDING BLUE BOX)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA ZA POSAMEZNO PAKIRANJE (S PODATKI ZA MODRO OKENCE)
English: The pharmacokinetics (PK) of Jivi was compared to that of factor VIII in a crossover Phase I study.
Slovenian: V navzkrižni študiji faze I so farmakokinetiko zdravila Jivi primerjali s farmakokinetiko faktorja VIII.
English: Jivi 250 IU powder and solvent for solution for injection
Slovenian: Jivi 250 i.e. prašek za raztopino za injiciranje
English: • a venipuncture set
Slovenian: • 1 pribor za vensko punkcijo
English: shortness of breath, low blood pressure, for early symptoms see above)
Slovenian: Zgodnji simptomi so opisani zgoraj)
English: • Do not refrigerate after reconstitution.
Slovenian: • Po rekonstituciji zdravila ne shranjujte v hladilniku.
English: EU/1/18/1324/010 - 30 x (Jivi 3000 IU)
Slovenian: EU/1/18/1324/010 - 30 x (Jivi 3000 i.e.)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON OF A MULTIPACK (WITHOUT BLUE BOX)
Slovenian: NOTRANJA ŠKATLA SKUPNEGA PAKIRANJA (BREZ PODATKOV ZA MODRO OKENCE)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1324/006 - 30 x (Jivi 250 IU)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1324/006 - 30 x (Jivi 250 i.e.)
English: PK parameter(unit) 12-<18 years N=12
Slovenian: 12-< 18 let n = 12
English: • a blood clot in the blood vessel
Slovenian: • nastankom krvnih strdkov v krvnih žilah.
English: PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol)
Slovenian: PEGilirani rekombinantni humani koagulacijski faktor VIII brez domene B (damoktokog alfa pegol)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Jivi 2000 IU contains 800 IU damoctocog alfa pegol per mL after reconstitution (2000 IU / 2.5 mL).
Slovenian: Po rekonstituciji zdravilo Jivi 2000 i.e. vsebuje 800 i.e. damoktokog alfa pegola na ml (2000 i.e./2,5 ml).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU (damoctocog alfa pegol) .
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 250 i.e. (damoktokog alfa pegol).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1324/010 - 30 x (Jivi 3000 IU)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1324/010 - 30 x (Jivi 3000 i.e.)
English: EU/1/18/1324/009 - 30 x (Jivi 2000 IU)
Slovenian: EU/1/18/1324/009 - 30 x (Jivi 2000 i.e.)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1324/009 - 30 x (Jivi 2000 IU)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1324/009 - 30 x (Jivi 2000 i.e.)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Jivi 250 IU contains 100 IU damoctocog alfa pegol per mL after reconstitution (250 IU / 2.5 mL).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Po rekonstituciji zdravilo Jivi 250 i.e. vsebuje 100 i.e. damoktokog alfa pegola na ml (250 i.e./2,5 ml).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU (damoctocog alfa pegol).
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2000 i.e. (damoktokog alfa pegol).
English: EU/1/18/1324/006 - 30 x (Jivi 250 IU)
Slovenian: EU/1/18/1324/006 - 30 x (Jivi 250 i.e.)
English: EU/1/18/1324/004 -1 x ( Jivi 2000 IU)
Slovenian: EU/1/18/1324/004 - 1 x (Jivi 2000 i.e.)
English: Stop injecting Jivi immediately and speak to your doctor at once if such reactions occur.
Slovenian: Če se pojavi taka reakcija, takoj prenehajte z injiciranjem zdravila Jivi in se takoj posvetujte z zdravnikom.
English: Jivi 250 IU powder and solvent for solution for injection After reconstitution with the solvent provided, one mL of solution contains approximately 100 IU (250 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa pegol.
Slovenian: Jivi 250 i.e. prašek in vehikel za raztopino za injiciranje Po rekonstituciji s priloženim vehiklom vsebuje 1 ml raztopine približno 100 i.e. (250 i.e./2,5 ml) humanega koagulacijskega faktorja VIII, damoktokog alfa pegol.
English: Jivi 2000 IU powder and solvent for solution for injection After reconstitution with the solvent provided, one mL of solution contains approximately 800 IU (2000 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa pegol.
Slovenian: Jivi 2000 i.e. prašek in vehikel za raztopino za injiciranje Po rekonstituciji s priloženim vehiklom vsebuje 1 m raztopine približno 800 i.e. (2000 i.e./2,5 ml) humanega koagulacijskega faktorja VIII, damoktokog alfa pegol.
English: • one syringe plunger rod
Slovenian: • 1 bat brizge
English: EU/1/18/1324/007 - 30 x (Jivi 500 IU)
Slovenian: EU/1/18/1324/007 - 30 x (Jivi 500 i.e.)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1324/007 - 30 x (Jivi 500 IU)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1324/007 - 30 x (Jivi 500 i.e.)
English: EU/1/18/1324/001 - 1 x (Jivi 250 IU)
Slovenian: EU/1/18/1324/001 - 1 x (Jivi 250 i.e.)
English: Headache very common
Slovenian: pogosti pruritus občasni
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1324/008 - 30 x (Jivi 1000 IU)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1324/008 - 30 x (Jivi 1000 i.e.)
English: Repeat dose every
Slovenian: Žilne bolezni pordelost občasni
English: EU/1/18/1324/005 - 1 x (Jivi 3000 IU)
Slovenian: EU/1/18/1324/005 - 1 x (Jivi 3000 i.e.)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Jivi 3000 IU contains 1200 IU damoctocog alfa pegol per mL after reconstitution (3000 IU / 2.5 mL).
Slovenian: Po rekonstituciji zdravilo Jivi 3000 i.e. vsebuje 1200 i.e. damoktokog alfa pegola na ml (3000 i.e./2,5 ml).
English: • dizziness
Slovenian: • nespečnost
English: EU/1/18/1324/008 - 30 x (Jivi 1000 IU)
Slovenian: EU/1/18/1324/008 - 30 x (Jivi 1000 i.e.)
English: EU/1/18/1324/002 - 1 x (Jivi 500 IU)
Slovenian: EU/1/18/1324/002 - 1 x (Jivi 500 i.e.)
English: Jivi 500 IU powder and solvent for solution for injection After reconstitution with the solvent provided, one mL of solution contains approximately 200 IU (500 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa pegol.
Slovenian: Jivi 500 i.e. prašek in vehikel za raztopino za injiciranje Po rekonstituciji s priloženim vehiklom vsebuje 1 ml raztopine približno 200 i.e. (500 i.e./2,5 ml) humanega koagulacijskega faktorja VIII, damoktokog alfa pegol.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU (damoctocog alfa pegol).
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 3000 i.e. (damoktokog alfa pegol).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Jivi 1000 IU contains 400 IU damoctocog alfa pegol per mL after reconstitution (1000 IU / 2.5 mL).
Slovenian: Po rekonstituciji zdravilo Jivi 1000 i.e. vsebuje 400 i.e. damoktokog alfa pegola na ml (1000 i.e./2,5 ml).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU (damoctocog alfa pegol).
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 500 i.e. (damoktokog alfa pegol).
English: Jivi 1000 IU powder and solvent for solution for injection After reconstitution with the solvent provided, one mL of solution contains approximately 400 IU (1000 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa pegol.
Slovenian: Jivi 1000 i.e. prašek in vehikel za raztopino za injiciranje Po rekonstituciji s priloženim vehiklom vsebuje 1 m raztopine približno 400 i.e. (1000 i.e./2,5 ml) humanega koagulacijskega faktorja VIII, damoktokog alfa pegol.
English: The active substance is PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol).
Slovenian: Učinkovina je rekombinantni humani, PEGilirani koagulacijski faktor VIII brez domene B (damoktokog alfa pegol).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Jivi 3000 IU powder for solution for injection
Slovenian: Jivi 3000 i.e. prašek za raztopino za injiciranje
English: Jivi 3000 IU powder and solvent for solution for injection After reconstitution with the solvent provided, one mL of solution contains approximately 1200 IU (3000 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa pegol.
Slovenian: Jivi 3000 i.e. prašek in vehikel za raztopino za injiciranje Po rekonstituciji s priloženim vehiklom vsebuje 1 m raztopine približno 1200 i.e. (3000 i.e./2,5 ml) humanega koagulacijskega faktorja VIII, damoktokog alfa pegol.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Jivi 500 IU contains 200 IU damoctocog alfa pegol per mL after reconstitution (500 IU / 2.5 mL).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Po rekonstituciji zdravilo Jivi 500 i.e. vsebuje 200 i.e. damoktokog alfa pegola na ml (500 i.e./2,5 ml).
English: EU/1/18/1324/003 - 1 x (Jivi 1000 IU)
Slovenian: EU/1/18/1324/003 - 1 x (Jivi 1000 i.e.)
English: Jivi 250 IU powder and solvent for solution for injection PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol)
Slovenian: Jivi 250 i.e. prašek in vehikel za raztopino za injiciranje PEGilirani rekombinantni humani koagulacijski faktor VIII brez domene B (damoktokog alfa pegol)
English: FVIII inhibitors
Slovenian: Inhibitorji faktorja VIII
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU (damoctocog alfa pegol).
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1000 i.e. (damoktokog alfa pegol).
English: Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration
Slovenian: Zdravilo za paranteralno uporabo je treba pred uporabo vizualno pregledati, če so v njem delci ali se je spremenila barva.
English: How to store Jivi
Slovenian: Shranjevanje zdravila Jivi
English: Jivi 2000 IU powder and solvent for solution for injection PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol)
Slovenian: Jivi 2000 i.e. prašek in vehikel za raztopino za injiciranje PEGilirani rekombinantni humani koagulacijski faktor VIII brez domene B (damoktokog alfa pegol)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Jivi 2000 IU powder for solution for injection
Slovenian: Jivi 2000 i.e. prašek za raztopino za injiciranje
English: Jivi 500 IU powder and solvent for solution for injection PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol)
Slovenian: Jivi 500 i.e. prašek in vehikel za raztopino za injiciranje PEGilirani rekombinantni humani koagulacijski faktor VIII brez domene B (damoktokog alfa pegol)
English: 6.3 Shelf¬life
Slovenian: 6.3 Rok uporabnosti
English: Jivi 3000 IU powder and solvent for solution for injection PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol)
Slovenian: Jivi 3000 i.e. prašek in vehikel za raztopino za injiciranje PEGilirani rekombinantni humani koagulacijski faktor VIII brez domene B (damoktokog alfa pegol)
English: Hypersensitivity common
Slovenian: Psihiatrične motnje nespečnost pogosti
English: Jivi 1000 IU powder and solvent for solution for injection PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol)
Slovenian: Jivi 1000 i.e. prašek in vehikel za raztopino za injiciranje PEGilirani rekombinantni humani koagulacijski faktor VIII brez domene B (damoktokog alfa pegol)
English: • burning and stinging at the application site
Slovenian: • pekoč občutek in občutek zbadanja na mestu injiciranja,
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Jivi 1000 IU powder for solution for injection
Slovenian: Jivi 1000 i.e. prašek za raztopino za injiciranje
English: • where the bleeding is and how serious it is
Slovenian: • mesto in obseg krvavitve,
English: Look to check there are no particles or discoloration before you use the solution.
Slovenian: Pred uporabo zdravila raztopino s prostim očesom preglejte, če so v njej prisotni delci in ali je obarvana.
English: Dizziness common
Slovenian: Rekonstituirana raztopina
English: • nettle¬rash, flushing
Slovenian: • koprivnica, rdečica,
English: KT10 9NW UK
Slovenian: KT10 9NW Velika Britanija
English: As with other antipsychotics, it is recommended that blood pressure is measured periodically in patients over 65 years.
Slovenian: Kot pri drugih antipsihotikih je priporočeno redno merjenje krvnega tlaka pri bolnikih, starejših od 65 let.
English: Your doctor will tell you how many OLANZAPINE CIPLA tablets to take and how long you should continue to take them.
Slovenian: Zdravnik vam bo povedal, koliko OLANZAPIN CIPLA tablet morate vzeti in kako dolgo naj bi jih jemali.
English: • Whenever the risk management system is modified,especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji ali kadar je ta sprememba posledica tega, da je bil dosežen pomembnem mejnik (farmakovigilančni ali
English: Long-term outcomes associated with these events have not been studied and remain unknown (see sections 4.8 and 5.1).
Slovenian: Dolgoročnih posledic, povezanih s temi učinki niso preučevali in ostajajo neznani (glejte poglavji 4.8 in 5.1).
English: OLANZAPINE CIPLA belongs to a group of medicines called antipsychotics and is used to treat the following conditions:
Slovenian: Zdravilo OLANZAPIN CIPLA spada v skupino zdravil, imenovanih antipsihotiki in se uporablja za zdravljenje naslednjih bolezni:
English: In 44 patients with schizophrenia  65 years of age, dosing from 5 to 20 mg/day was not associated with any distinguishing profile of adverse events.
Slovenian: Pri 44 bolnikih s shizofrenijo, starejših od 65 let, odmerjanje od 5 do 20 mg/dan ni bilo povezano s kakim razločevalnim profilom neželenih učinkov.
English: This leaflet was last revised in {month YYYY}
Slovenian: Navodilo je bilo nazadnje revidirano v {MM/YYYY}.
English: If you forget to take OLANZAPINE CIPLA Take your tablets as soon as you remember.
Slovenian: Če ste pozabili vzeti zdravilo OLANZAPIN CIPLA Vzemite tablete, kakor hitro se spomnite.
English: Date of first authorisation: 14 November 2007 Date of latest renewal: 01 October 2012
Slovenian: Datum podaljšanja dovoljenja za promet: 01. oktober 2012
English: Smokers The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
Slovenian: Kadilci Začetnega odmerka in razpona odmerkov za nekadilce ni treba rutinsko spreminjati glede na kadilce.
English: 16 Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
Slovenian: 16O zvišanih plazemskih koncentracijah prolaktina so poročali pri 47,4 % mladostnikov.
English: The experience in adolescents (ages 13 to 17 years) is limited to short term efficacy data in schizophrenia (6 weeks) and mania associated with bipolar I disorder (3 weeks), involving less than 200 adolescents.
Slovenian: Izkušnje pri mladostnikih (starih 13 do 17 let) so omejene na kratkoročne podatke o učinkovitosti pri shizofreniji (6 tednov) in maniji povezani z bipolarno I motnjo (3 tedni), ki vključujejo manj kot 200 mladostnikov.
English: • If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Slovenian: - če so vam v preteklosti ugotovili težave z očmi kot je določena vrsta glavkoma (povišan tlak v
English: Dementia-related psychosis and/or behavioural disturbances Olanzapine is not approved for the treatment of dementia-related psychosis and/or behavioural disturbances and is not recommended for use in this particular group of patients because of an increase in mortality and the risk of cerebrovascular accident.
Slovenian: Psihoza povezana z demenco in/ali vedenjske motnje Olanzapin ni odobren za zdravljenje bolnikov s psihozo, povezano z demenco in/ali vedenjskimi motnjami ter ni priporočljiv za uporabo pri teh skupinah bolnikov zaradi povečane umrljivosti in tveganja za cerebrovaskularne dogodke.
English: In a study in breast feeding, healthy women, olanzapine was excreted in breast milk.
Slovenian: V študiji pri doječih zdravih ženskah se je olanzapin izločal v materino mleko.
English: Pharmacotherapeutic group: diazepines, oxazepines and thiazepines., ATC code: N05A H03.
Slovenian: Farmakoterapevtska skupina: diazepini, oksazepini in tiazepini, Oznaka ATC: N05AH03.
English: 6.2 Incompatibilities
Slovenian: 6.2 Inkompatibilnosti.
English: Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking OLANZAPINE CIPLA and regularly during treatment.
Slovenian: Vaš zdravnik vas mora napotiti na krvne preiskave za določitev koncentracije sladkorja in določenih maščob v krvi pred začetkom jemanja zdravila OLANZAPIN CIPLA in redno tekom zdravljenja.
English: You should take your OLANZAPINE CIPLA tablets once a day following the advice of your doctor.
Slovenian: OLANZAPIN CIPLA tablete jemljite enkrat na dan, in sicer upoštevajte nasvet zdravnika.
English: There are no data on maintenance of effect and limited data on long term safety (see sections 4.4 and 4.8).
Slovenian: Podatkov o vzdrževalnem učinku ni in podatki o dolgoročni varnosti so nezadostni (glejte poglavji 4.4 in 4.8).
English: You should not be given this medicine when breast-feeding, as small amounts of OLANZAPINE CIPLA can pass into breast milk.
Slovenian: Ko dojite, tega zdravila ne smete jemati, ker lahko majhne količine zdravila OLANZAPIN CIPLA prehajajo v materino mleko.
English: Consult your doctor if your symptoms return but do not stop taking OLANZAPINE CIPLA unless your doctor tells you to.
Slovenian: Če se simptomi povrnejo, se posvetujte s svojim zdravnikom, vendar ne prenehajte jemati zdravila OLANZAPIN CIPLA, če vam tega ne naroči vaš zdravnik.
English: It is important that you carry on taking OLANZAPINE CIPLA for as long as your doctor tells you.
Slovenian: Pomembno je, da nadaljujete z jemanjem zdravila OLANZAPIN CIPLA tako dolgo, kot vam naroči zdravnik.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu/
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your OLANZAPINE CIPLA dose.
Slovenian: • karbamazepin (antiepileptik in stabilizator razpoloženja), fluvoksamin (antidepresiv) ali ciprofloksacin (antibiotik) - morda bo treba spremeniti vaš odmerek zdravila OLANZAPIN
English: Do not stop taking your tablets just because you feel better.
Slovenian: Če ste prenehali jemati zdravilo OLANZAPIN CIPLA Ne prenehajte jemati tablet samo zato, ker se počutite bolje.
English: If this happens after you have been given OLANZAPINE CIPLA tell your doctor.
Slovenian: Če se vam to zgodi po tem, ko ste prejeli zdravilo OLANZAPIN CIPLA, povejte svojemu zdravniku.
English: • The use of OLANZAPINE CIPLA in elderly patients with dementia is not recommended as it may have serious side effects.
Slovenian: • Uporaba zdravila OLANZAPIN CIPLA ni priporočljiva pri starejših bolnikih z demenco, saj lahko povzroči resne neželene učinke.
English: Oral use Read the package leaflet before use.
Slovenian: Pred uporabo preberite priloženo navodilo.
English: Absolute oral bioavailability relative to intravenous administration has not been determined
Slovenian: Absolutna peroralna biološka uporabnost glede na intravensko dajanje ni bila določena.
English: Do not use this medicine after the expiry date which is stated on the carton after Exp. Store in the original package.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu.
English: What you need to know before you take OLANZAPINE CIPLA
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo OLANZAPIN CIPLA
English: Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
Slovenian: Študije pri bolnikih, starih 13-17 let kažejo na različne neželene učinke, vključno s povečanjem telesne mase, spremembami v kazalcih presnove in zvišanjih ravni prolaktina.
English: • unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue;
Slovenian: • nenavadne gibe (pogost neželeni učinek, ki lahko prizadene do 1 od 10 bolnikov), predvsem obraza ali jezika;
English: The daily dose of OLANZAPINE CIPLA is between 5 and 20 mg.
Slovenian: Dnevni odmerek zdravila OLANZAPIN CIPLA je med 5 in 20 mg.
English: In patients with Parkinson's disease OLANZAPINE CIPLA may worsen the symptoms.
Slovenian: Pri bolnikih s Parkinsonovo boleznijo lahko zdravilo OLANZAPIN CIPLA poslabša simptome.
English: The starting dose and dose range need not be routinely altered for female patients relative to male patients.
Slovenian: Spol Začetnega odmerka in razpona odmerkov za bolnice ni treba rutinsko spreminjati glede na bolnike.
English: Cipla (EU) Ltd
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Cipla (EU) Ltd
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ POGLEDA IN
English: • blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people) especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
Slovenian: • krvne strdke v venah (občasen neželeni učinek, ki lahko prizadene do 1 od 100 bolnikov), posebej v nogah (simptomi vključujejo oteklino, bolečino in rdečino na nogah), ki lahko po žilah potujejo v pljuča ter povzročijo bolečino v pljučih in težave z dihanjem.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP