natgillin/translations-raw huggingface dataset:
How is Mysimba used?
Kako se Mysimba koristi?
Patients should have their response and tolerability to the medicine checked regularly and treatment should be stopped in patients who have certain side effects such as an increase in blood pressure.
Terapiju treba prekinuti u bolesnika koji imaju određene nuspojave poput povišenje krvnoga tlaka.
For the full list of all side effects reported with Mysimba, see the package leaflet.
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Mysimba potražite u uputi o lijeku.
Date of first authorisation: 06/11/2017.
Datum prvog odobrenja: 06/11/2017.
Pregnancy and lactation: Do not use in pregnant cats.
Graviditet i laktacija: Ne primjenjivati u gravidnih mačaka.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju : 2 godine.
Do not mix with any other veterinary medicinal products except FELIGEN RCP or FELIGEN CRP.
Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim s FELIGEN RCP ili FELIGEN CRP.
Nobivac LeuFel suspension for injection for cats
Nobivac LeuFel, suspenzija za injekciju za mačke
After the second injection, and subsequent administrations, this reaction is markedly reduced.,
Nakon druge primjene kao i svih narednih, ova reakcija je znatno umanjena.
No adverse reactions were observed after an overdose administration of the veterinary medicinal product other than those mentioned in section 6, except local reactions that can last longer (from 5 to 6 weeks at the most).
Nakon predoziranja veterinarsko-medicinskim proizvodom nisu opažene druge nuspojave do onih već spomenutih u dijelu 6, osim lokalnih reakcija koje mogu trajati duže (najviše 5-6 tjedana).
Primary vaccination: - first injection in kittens from eight weeks of age - second injection 3 or 4 weeks later.
- prva primjena mačićima starijim od 8 tjedana - druga primjena 3 ili 4 tjedna kasnije
Box of 10 or 50 vials
KUTIJA S 10 ILI 50 BOČICA
The vaccine contains the purified p45 FeLV-envelope antigen, obtained by genetic recombination of the E. coli strain.
Cjepivo sadrži pročišćeni antigen omotača p45 FeLV virusa dobiven genetskim rekombiniranjem soja E. coli.
1ère avenue 2065 m LID 06516 Carros France
1ère avenue 2065 m LID 06516 Carros FRANCUSKA
Administer subcutaneously one dose (1 ml) of the veterinary medicinal product according to the following regimen of vaccination.
Aplicirajte subkutano jednu dozu (1 ml) veterinarsko medicinskog proizvoda sukladno sljedećem režimu cijepljenja.
Veterinary medicinal product subject to prescription.
Veterinarsko-medicinski proizvod se izdaje na recept.
Adjuvants: 3% aluminium hydroxide gel expressed as mg Al
3% aluminijev hidroksid gel (izraženo u mg Al
The transient signs following vaccination such as hyperthermia (lasting 1 to 4 days), apathy and digestive disturbances may also be commonly observed.
Također se mogu opaziti i uobičajeni prolazni simptomi nakon cijepljenja poput hipertermije (traje 1 do 4 dana), apatije (ravnodušnost) i probavnih smetnji (bolovi u trbuhu).
Adjuvants: 3% aluminium hydroxide gel expressed as mg Al3+
Adjuvans: 3% aluminijev hidroksid gel (izraženo u mg Al3+):
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with FELIGEN CRP or FELIGEN RCP.
Dostupni podaci o neškodljivosti i djelotvornosti pokazuju da se ovo cjepivo može primijeniti pomiješan s FELIGEN CRP ili FELIGEN RCP.
ère avenue 2065 m LID 06516 Carros France
ère avenue 2065 m LID 06516 Carros FRANCUSKA
Sodium chloride Disodium phosphate anhydrous Potassium dihydrogen phosphate Aluminium hydroxide gel Quillaja saponaria Water for injections
Dinatrijev hidrogen fosfat bezvodni Kalijev dihidrogen fosfat Aluminijev hidroksid gel Quillaja saponaria.
PSUR submissions for Nobivac LeuFel shall be synchronised and submitted at the same frequency as for LEUCOGEN.
PSUR-evi za Nobivac LeuFel uskladit će se i podnosit jednako često kao i za VMP Leucogen.
C/Josefa Valcárcel n°38 28027 Madrid, Spain
MSD Animal Health, S.L. C/Josefa Valcárcel n°38 28027 Madrid, Spain
Active substance: Minimum quantity of purified p45 FeLV-envelope antigen 102 µg
Djelatna tvar: Najmanja količina pročišćenog antigena omotača p45 FeLV 102 µg
No adverse reactions were observed after an overdose administration (2 doses) of the veterinary medicinal product other than those mentioned in section 4.6 except local reactions that can last longer (from 5 to 6 weeks at the most).
4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Nakon predoziranja (dvije doze) veterinarsko-medicinskim proizvodom nisu opažene druge nuspojave do onih već spomenutih u dijelu 4.6, osim lokalnih reakcija koje mogu trajati duže (najviše 5-6 tjedana).
Active substance: Minimum quantity of purified p45 FeLV-envelope antigen
Djelatna tvar: Najmanja količina pročišćenog antigena omotača p45 FeLV:
4.2 Indications for use, specifying the target species
KLINIČKE POJEDINOSTI 4.1 Ciljne vrste životinja Mačke 4.2 Indikacije za primjenu, navesti ciljne vrste životinja
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČI ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
Vial label
ETIKETA NA BOČICI
Excipients: Buffered isotonic solution to
Pomoćna tvar: Izotonična puferska otopina do
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
UPUTA O VMP Nobivac LeuFel, suspenzija za injekciju za mačke NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE SERIJE U PROMET, AKO JE RAZLIČITO
Marketing authorisation holder and manufacturer responsible for the batch release
Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet: Virbac,
Excipients: Buffered isotonic solution to 1 ml.
Pomoćna tvar: Izotonična puferska otopina do:
CLINICAL PARTICULARS
Natrijev klorid
VIRBAC
NUSPOJAVE
ivabradine
ivabradin
In stable angina, these symptoms occur during physical effort.
U slučaju stabilne angine ti se simptomi pojavljuju tijekom fizičkog napora.
It is used in combination with standard therapy which can include a beta-blocker.
Primjenjuje se u kombinaciji sa standardnom terapijom, koja može uključivati beta-blokatore.
Also, the doctor should consider stopping treatment if the medicine has only a limited effect on reducing symptoms or reducing the heart rate.
Također, liječnik treba razmisliti o prekidu liječenja ako lijek ima samo ograničeni učinak na smanjenje simptoma ili smanjenje brzine otkucaja srca.
The recommended starting dose is 5 mg twice a day with meals, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on the patient's heart rate and symptoms.
Preporučena početna doza jest 5 mg dva puta na dan uz obrok, koju liječnik može povećati na 7,5 mg dva puta na dan ili smanjiti na 2,5 mg (pola tablete od 5 mg) dva puta na dan ovisno o brzini srčanih otkucaja i simptomima bolesnika.
When used for angina, treatment should be stopped if symptoms do not improve after 3 months.
Kad se primjenjuje u bolesnika s anginom, liječenje je potrebno prekinuti ako ne dođe do poboljšanja simptoma nakon tri mjeseca.
When this current is blocked, the heart rate is lowered, so that the heart has less work to do and needs less oxygenated blood.
Kad je ta struja blokirana, brzina otkucaja srca smanjuje se tako da srce mora manje raditi i treba manje oksigenirane krvi.
The full EPAR for Ivabradine JensonR can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjelovito europsko javno izvješće o procjeni (EPAR) za lijek Ivabradine JensonR nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It is used either in patients who cannot take beta-blockers (another type of medicine to treat angina) or in combination with a beta-blocker in patients whose disease is not controlled by a beta-blockers alone.
Primjenjuje se u bolesnika koji ne mogu uzimati beta-blokatore (druga vrsta lijeka za liječenje angine) ili u kombinaciji s beta-blokatorima u bolesnika čija se bolest ne kontrolira samo primjenom beta-blokatora.
Ivabradine JensonR is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription.
Lijek Ivabradine JensonR dostupan je u obliku tableta (od 5 i 7,5 mg) i izdaje se samo na recept.
Treatment must be stopped if the heart rate decreases persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue.
Liječenje se mora prekinuti ako se brzina otkucaja srca stalno smanjuje na razinu nižu od 50 otkucaja u minuti ili ako se nastave simptomi bradikardije (spora brzina otkucaja srca).
This means that Ivabradine JensonR is similar to a ‘reference medicine' already authorised in the European Union (EU) called Procoralan.
To znači da je lijek Ivabradine JensonR sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Procoralan.
The medicine is used in patients with a normal heart rhythm whose heart rate is at least 70 beats per minute.
Lijek se primjenjuje u bolesnika s normalnim srčanim ritmom čija brzina srčanih otkucaja iznosi najmanje 70 otkucaja u minuti.
Ivabradine JensonR is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (heart disease caused by blockage of the blood vessels that supply the heart muscle).
Ivabradine JensonR je lijek za srce koji se primjenjuje za simptomatsko liječenje kronične stabilne angine (bol u prsnom košu, čeljusti i leđima koja je uzrokovana fizičkim naporom) u odraslih osoba s bolešću koronarnih arterija (bolest srca koju uzrokuje opstrukcija krvnih žila koje opskrbljuju srčani mišić).
Ivabradine JensonR therefore reduces or prevents the symptoms of angina.
Stoga lijek Ivabradine JensonR smanjuje ili sprečava simptome angine.
Ivabradine JensonR is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) and a normal heart rhythm whose heart rate is at least 75 beats per minute.
Lijek Ivabradine JensonR također se primjenjuje u bolesnika s kroničnim zatajenjem srca (kad srce ne može opskrbiti ostatak tijela dovoljnom količinom krvi) i normalnim srčanim ritmom čija je brzina srčanih otkucaja najmanje 75 otkucaja u minuti.
By lowering the heart rate, Ivabradine JensonR reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Snižavanjem brzine otkucaja srca lijek Ivabradine JensonR smanjuje pritisak na srce i time usporava napredak zatajenja srca i poboljšava simptome.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivabradine JensonR have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ivabradine JensonR nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ivabradine JensonR has been shown to have comparable quality and to be bioequivalent to Procoralan.
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, lijek Ivabradine JensonR dokazao usporedivu kakvoću te da je bioekvivalentan lijeku Procoralan.
This is a summary of the European public assessment report (EPAR) for Ivabradine JensonR.
Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Ivabradine JensonR.
Because Ivabradine JensonR is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Budući da je lijek Ivabradine JensonR generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
What measures are being taken to ensure the safe and effective use of Ivabradine JensonR?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ivabradine JensonR?
For more information about treatment with Ivabradine JensonR, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o liječenju lijekom Ivabradine JensonR pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
Therefore, the CHMP's view was that, as for Procoralan, the benefit outweighs the identified risk.
Stoga je stav CHMP-a da korist nadmašuje identificiran rizik, kao i za lijek Procoralan.
Because Ivabradine JensonR is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Procoralan.
Budući da je Ivabradine JensonR generički lijek, ispitivanja na bolesnicima bila su ograničena na utvrđivanje činjenice je li lijek bioekvivalentan referentnom lijeku Procoralan.
It is not intended to provide practical advice on how to use Ivabradine JensonR.
Svrha sažetka nije davati praktične savjete o primjeni lijeka Ivabradine JensonR.
What is Ivabradine JensonR and what is it used for?
Što je Ivabradine JensonR i za što se koristi?
The Committee recommended that Ivabradine JensonR be approved for use in the EU.
Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Ivabradine JensonR u EU-u.
The symptoms of heart failure are caused by the heart not pumping enough blood around the body.
Do simptoma zatajenja srca dolazi ako srce ne opskrbljuje tijelo dovoljnom količinom krvi.
For practical information about using Ivabradine JensonR, patients should read the package leaflet or contact their doctor or pharmacist.
Praktične informacije o primjeni lijeka Ivabradine JensonR bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
Ivabradine JensonR contains the active substance ivabradine.
Lijek Ivabradine JensonR sadrži djelatnu tvar ivabradin.
What are the benefits and risks of Ivabradine JensonR?
Koje su koristi i rizici lijeka Ivabradine JensonR?
Why is Ivabradine JensonR approved?
Zašto je Ivabradine JensonR odobren?
Other information about Ivabradine JensonR
Ostale informacije o lijeku Ivabradine JensonR
The active substance in Ivabradine JensonR, ivabradine, blocks the ‘If current' in the sinus node, the natural ‘pacemaker' regulates the heart rate.
Djelatna tvar u lijeku Ivabradine JensonR, ivabradin, blokira „If struju” u sinusnom čvoru, prirodnom elektrostimulatoru koji regulira brzinu otkucaja srca.
How is Ivabradine JensonR used?
Kako se Ivabradine JensonR koristi?
How does Ivabradine JensonR work?
Kako djeluje Ivabradine JensonR?
How has Ivabradine JensonR been studied?
Kako je Ivabradine JensonR ispitivan?
1 ml (120 mg/ml) 1 pre-filled pen + 2 alcohol pads
1 ml (120 mg/ml) 1 napunjena brizgalica + 2 jastučića natopljena alkoholom
75014 PARIS
75014 Paris France
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for cyproterone acetate/ethinylestradiol containing medicinal products
Popis naziva, farmaceutskih oblika, jačina lijekova, puteva primjene, nositelja odobrenja za stavljanje u promet u državama članicama
LABORATOIRES MAJORELLE 80-82 rue Gallieni 92100 BOULOGNE BILLANCOURT FRANCE
Laboratoires Majorelle 80-82 rue Gallieni 92100 Boulogne Billancourt
BAYER HISPANIA, S.L.
BAYER HISPANIA, S.L. Avda.
Parc d'Activités des Peupliers - 25 rue des Peupliers 92000 NANTERRE FRANCE
25 rue des Peupliers 92000 Nanterre France
Pliva Hungária Kereskedelmi és Szolgáltató Kft. Rákóczi út 70-72 Budapest 1074 Hungary
Rákóczi út 70-72 Budapest 1074 Hungary
Jan Emiel Mommaertslaan 14 1831 Machelen Belgium
Mommaertslaan 14 1831 Machelen Belgium
Baix Llobregat 3 y 5 08970 Sant Joan Despi (Barcelona)
08970 Sant Joan Despi Barcelona
220, avenue de la Recherche 59120 Loos
Bayer Santé 220, avenue de la Recherche 59120 Loos France
SANOFI AVENTIS FRANCE 1-13 BOULEVARD ROMAIN ROLLAND
1-13 Boulevard Romain Rolland
EFFIK bâtiment ''le Newton'' 9-11 rue Jeanne Braconnier 92366 MEUDON LA FORET FRANCE
EFFIK bâtiment ''le Newton'' 9-11 rue Jeanne Braconnier
Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul.
Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul. Marszałka J.
Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-Gasse 3 1140 Wien
Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-Gasse
LADEEPHARMA PHARMACEUTICAL Limited Lajos u. 48-66, E ép.
Ladeepharma Pharmaceutical Limited Lajos u.
Praga 10, Dolni Mecholupy
Baix Llobregat 3 y
Sandoz A/S, Edvard Thomsens Vej 14, DK-2300 København S
Edvard Thomsens Vej 14 DK-2300 København
Pelpharma Handels GmbH Stammhausstraße 31 1140 Wien
Stammhausstraße 31 1140 Wien Austria
11-15 quai de Dion Bouton 92800 PUTEAUX FRANCE
92800 Puteaux France
92931 PARIS LA DEFENSE FRANCE
110 Esplanade du Général de Gaulle 92931 Paris la Defence France
EG LABO - LABORATOIRES EUROGENERICS 12 rue Danjou le Quintet bâtiment A 92517 BOULOGNE BILLANCOURT CEDEX FRANCE
LABORATOIRES EUROGENERICS 12 rue Danjou le Quintet bâtiment
London SW5 9JL
Pharmaceuticals Limited Kramer Mews London SW5 9JL United Kingdom
Medico Uno Worldwide Ltd.,2 Grigori Afxentiou Street + Larnaca 6023
2 Grigori Afxentiou Street
FIDIA Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/A, 35031 Abano Terme (PD) Italy
Via Ponte della Fabbrica 3/A
Człekówka 75
Piłsudskiego 5
110 Esplanade du Général de Gaulle
110 Esplanade du Général de Gaulle 92931 Paris la Defence Francuska
Orifarm Generics Energivej 15 - POB 69 DK-5260 Odense S Denmark
DK-5260 Odense S.
HEATON a.s. Na Pankráci 14 Praha 4
Na Pankráci 332/14 14000 Praha 4
RANBAXY PHARMACIE GENERIQUES
Ranbaxy Pharmacie Generiques 11-15 quai de Dion Bouton
RATIOPHARM GMBH Keilaranta 10
Taurus Pharma GmbH Benzstr. 11
This is especially important if you are taking:
To je posebice važno ako uzimate:
This may take up to 2 years.
To može potrajati do dvije godine.
After this, most patients need a dose of:
Nakon toga većina bolesnika treba dozu:
• if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
• ako ste ikad imali tuberkulozu ili ako ste bili u bliskom kontaktu s nekim tko ima ili je imao tuberkulozu.
It may take about 4 weeks or longer until you start to feel an improvement in your condition.
Može biti potrebno oko 4 tjedana ili dulje da se počnete osjećati bolje.
Date of latest renewal: 23 March 2015
Datum posljednje obnove: 23 ožujak 2015
Postmarketing studies
Postmarketinške studije
If possible, take your tablets or the box with you to show the doctor.
Ako je moguće, ponesite sa sobom tablete ili kutiju kako biste ih pokazali liječniku.
The tablets are packed in bottles.
Tablete su pakirane u boce.
If you are affected, do not drive or use machines.
Ako Vam se to dogodi, nemojte voziti ili upravljati strojevima.
For more information on these, please read section 4 (Possible Side Effects).
Za daljnje informacije molimo pročitajte dio 4 (Moguće nuspojave).
Before starting treatment, all patients should be evaluated for active and inactive (“latent”) tuberculosis, as per local recommendations.
Prije početka liječenja, svim bolesnicima je potrebno utvrditi imaju li aktivnu ili neaktivnu („latentnu“) tuberkulozu, prema lokalnim preporukama.
If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose.
Ako ste zaboravili uzeti dozu lijeka, uzmite je čim se sjetite osim ako se ne bliži vrijeme da uzmete drugu dozu.
C study indicated that at least about 82 to 95 % of the dose is absorbed.
C, najmanje 82 % do 95 % doze se apsorbira.
Some patients may even still feel further improvements after 4 to 6 months of therapy.
Neki bolesnici čak mogu osjetiti daljnje poboljšanje i nakon 4 do 6 mjeseci liječenja.
• increased hair loss,
• pojačan gubitak kose,
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100), rijetko (≥ 1/10 000 do < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (nije moguće procijeniti iz dostupnih podataka).
• if you suffer from any problem which affects your immune system (e.g. AIDS),
• ako bolujete od bilo kojeg problema koji utječe na Vaš imunološki sustav (npr. AIDS),
• loss of appetite, weight loss (usually insignificant),
• gubitak apetita, gubitak težine (obično beznačajan),
• if you are pregnant, think you may be pregnant, or are breast-feeding.
• ako ste trudni, mislite da biste mogli biti trudni ili dojite.
• if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction,
• ako ste ikada imali alergijsku reakciju na leflunomid (pogotovo ako imate teške kožne reakcije,
Leflunomide medac with food, drink and alcohol Leflunomide medac may be taken with or without food.
Leflunomid medac s hranom, pićem i alkoholom Leflunomid medac može se uzeti s hranom ili bez nje.
Tell your doctor immediately if you experience:
Odmah obavijestite svog liječnika u slučaju:
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Leflunomide medac
Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Leflunomid medac
Pharmacokinetic data in elderly (> 65 years) are limited but consistent with pharmacokinetics in younger adults.
Podaci o farmakokinetici u starijih bolesnika (> 65 godina) ograničeni su, ali odgovaraju farmakokinetici mlađih odraslih osoba.
Tell your doctor immediately and stop taking Leflunomide medac:
Odmah obavijestite svog liječnika i prestanite uzimati Leflunomid medac:
• zidovudine for HIV infection
• zidovudin za liječenje HIV infekcije
Leflunomide medac can occasionally cause some problems with your blood, liver, lungs or nerves in your arms or legs.
Leflunomid medac može povremeno uzrokovati probleme s krvi, jetrom, plućima ili živcima u rukama ili nogama.
• tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the feet or hands),
• tendinitis (bol izazvana upalom membrane koja okružuje tetive, obično na stopalima ili šakama),
The efficacy of Leflunomide medac in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III).
Djelotvornost Leflunomida medac u liječenju reumatoidnog artritisa pokazala se u 4 kontrolirana ispitivanja (1 u fazi II i 3 u fazi III).
• problems in the nerves of the arms or legs (peripheral neuropathy).
• problemi sa živcima u rukama ili nogama (periferna neuropatija).
Leflunomide medac is not recommended for use in children and adolescents below 18 years of age.
Djeca i adolescenti Leflunomid medac se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina.
UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.> UNIQUE IDENTIFIER - HUMAN READABLE DATA
17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD <Sadrži 2D barkod s jedinstvenim identifikatorom.>
Women of childbearing potential have to use effective contraception during and up to 2 years after treatment (see “waiting period” below) or up to 11 days after treatment (see abbreviated “washout period” below).
Žene reproduktivne dobi moraju koristiti učinkovitu metodu kontracepcije tijekom liječenja i do dvije godine nakon liječenja (vidjeti „razdoblje čekanja“ u nastavku teksta) ili do 11 dana nakon liječenja (vidjeti skraćeno „period ispiranja“ u nastavku teksta).
Warfarin and other coumarin anticoagulants
Varfarin i drugi kumarinski antikoagulansi