natgillin/translations-raw huggingface dataset:
PROCOMVAX is indicated to help protect your child against invasive disease caused by Haemophilus influenzae type b (infection of brain and spinal cord tissues, infection of the blood, etc.) and against infection of the liver caused by all known subtypes of hepatitis B virus.
PROCOMVAX je namenjen zaščiti vašega otroka pred invazivno boleznijo, ki jo povzroča bakterija Haemophilus influenzae tipa b (okužba možganov in hrbtenjače, okužba krvi idr.), in pred okužbo jeter, povzročeno z vsemi znanimi podvrstami virusa hepatitisa B.
The vaccine can be administered in most infants 6 weeks to 15 months of age.
Cepivo se lahko uporabi pri večini dojenčkov, starih od 6 tednov do 15 mesecev.
Do not use PROCOMVAX:
Ne uporabljajte zdravila PROCOMVAX:
- if your child is allergic to any component of the vaccine.
- če je vaš otrok alergičen na katerokoli sestavino cepiva,
- in infants younger than 6 weeks of age
- pri dojenčkih, mlajših od 6 tednov,
- if your child has fever (vaccination should be delayed).
- pri otrocih, ki imajo zvišano telesno temperaturo (cepljenje je treba prestaviti),
- in infants born to HBsAg positive mothers.
- pri dojenčkih, rojenih HBsAg pozitivnim materam.
- if your child has bleeding disorders such as haemophilia or thrombocytopenia, special
- če ima vaš otrok motnje strjevanja krvi kot sta hemofilija ali trombocitopenija, je treba za
precautions should be taken against the risk of haematoma following injection.
preprečitev podpludbe po injiciranju uporabiti posebne previdnostne ukrepe.
- if you are a hepatitis B virus surface antigen (HBsAg)-positive mother, your infant should
- če je otrokova mati pozitivna na površinski antigen hepatitisa B, mora dojenček dobiti
receive Hepatitis B Immune Globulin (HBIG) and hepatitis B vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series.
imunoglobulin proti hepatitisu B (HBIG) in rekombinantno cepivo proti hepatitisu B ob rojstvu ter opraviti celoten niz cepljenj proti hepatitisu B.
The subsequent administration of PROCOMVAX for completion of the hepatitis B vaccination series in infants who were born of HBsAg-positive mothers and received HBIG or infants born of mothers of unknown status has not been studied.
Nadaljnja uporaba cepiva PROCOMVAX za dokončanje niza cepljenj proti hepatitisu B pri dojenčkih HBsAg pozitivnih mater, ki so dobili HBIG, in pri dojenčkih mater z neznanim statusom ni raziskana.
- as with other similar vaccines, cases of Haemophilus b disease may occur in the week after
- tako kot pri drugih podobnih cepivih se lahko v tednu po cepljenju, torej še pred začetkom
vaccination prior to the onset of the protective effects of the vaccine.
zaščitnih učinkov cepiva, pojavijo primeri bolezni zaradi okužbe s hemofilusom b.
- because hepatitis B infection can go undetected for a long period of time, it is possible that an
- ker lahko okužba s hepatitisom B dolgo ostane neopažena, se lahko zgodi, da je oseba v času
individual may already be infected at the time the vaccine is given.
cepljenja že okužena.
PROCOMVAX can be administered simultaneously with the primary series of diphtheria, tetanus, pertussis vaccine (DTP) and oral polio vaccine (OPV).
Uporaba drugih cepivPROCOMVAX se lahko daje hkrati z osnovnim nizom cepiva proti davici, tetanusu in oslovskemu kašlju (DTP) in peroralnega cepiva proti poliovirusu (OPV).
HOW TO USE PROCOMVAX
KAKO UPORABLJATI ZDRAVILO PROCOMVAX
Infants born of HBsAg negative mothers should be vaccinated with three 0.5 ml doses of PROCOMVAX, ideally at 2, 4, and 12-15 months of age.
Dojenčke HBsAg negativnih mater je treba cepiti s tremi 0, 5 ml odmerki cepiva PROCOMVAX, najbolje pri 2., 4. in od 12. do 15. meseca starosti.
Tell your doctor promptly about these or any other unusual symptoms.
17 Svojega zdravnika takoj obvestite o teh ali katerih koli drugih nenavadnih simptomih.
18 Ελλάδα ΒΙΑΝΕΞ Α .Ε.
Ελλάδα Polska ΒΙΑΝΕΞ Α. Ε.
Τηλ. +30.210.8009111
Τηλ. +30. 210. 8009111 España
España SANOFI PASTEUR MSD S. A.
SANOFI PASTEUR MSD S. A.
The clinical issues were discussed with the MAH at the Vaccine Working Party (VWP) during its February 2006 meeting, while the quality issues were discussed at the February BWP meeting.
Na zasedanju delovne skupine za cepiva (VWP) februarja 2006 je z imetnikom dovoljenja za promet obravnaval klinična vprašanja, medtem ko so vprašanja o kakovosti obravnavali na zasedanju delovne skupine za biotehnologijo (BWP) februarja 2006.
On 13 February 2006, the European Commission (EC) triggered the procedure under Article 20 of Regulation (EC) No 726/ 2004, after the CHMP expressed concerns on the low immunogenicity of the HepB component of Procomvax.
Po tem, ko je CHMP izrazil zadržke glede nizke imunogenosti sestavine HepB v cepivu PROCOMVAX, je Evropska Komisija 13. februarja 2006 sprožila postopek v skladu s členom 20 Uredbe (ES) št.
The CHMP was requested to give an opinion as to whether the marketing authorisation for Procomvax should be maintained, varied, suspended or withdrawn in the context of an Article 20 of Regulation (EC) No726/ 2004 procedure.
Evropska komisija je prosila CHMP za mnenje o tem, ali naj dovoljenje za promet za cepivo PROCOMVAX ohrani, spremeni, ukine ali umakne v skladu s postopkom člena 20 Uredbe (ES) št.
DISCUSSION
726/ 2004.
Notwithstanding, the new proposed model will have only predictive value once it has been fully validated and has shown to be able to discriminate batches of the Hepatitis B component that have elicited a high vs. a low immune response during clinical trials.
Ne glede na to bo imel nov predlagan model, ko bo popolnoma odobren in ko bo med kliničnim preizkušanjem zmožen razlikovati serije PROCOMVAX z visokim od tistih z nizkim imunskim odgovorom, le napovedno vrednost.
The MAH developed an upgraded manufacturing process to increase immunogenicity.
Vmesni izid kliničnega preizkušanja serij rekombinantnega hepatitisa, pridobljenih s posodobljenim postopkom B, potrjuje, da
The interim outcome of a clinical trial with the ‘ process upgraded’ recombinant Hepatitis B batches confirms that the immunogenicity of the current PROCOMVAX vaccine is at the historic standard, and provides evidence for a consistent trend to higher GMTs with PROCOMVAX manufactured with the process modification.
1 je imunogenost trenutnega cepiva PROCOMVAX na standardu izpred nekaj let in kaže nepretrgan trend višanja vrednosti GMT (geometric mean titre) pri cepivu PROCOMVAX, izdelanim s spremenjenim postopkom.
As there are currently no reports on increased numbers of Hepatitis B breakthrough cases after PROCOMVAX vaccination, considering that the EU is a low endemic region, no immediate safety signal could be identified by the CHMP.
Ker trenutno ne poročajo o povečanem številu primerov izbruha hepatitisa B po cepljenju s cepivom PROCOMVAX in ob upoštevanju, da je EU nizko endemično območje, CHMP ne vidi nikakršnega takojšnjega opozorilnega signala.
2 The CHMP requested the MAH to conduct studies regarding neonates, infants, older adults, renal dialysis patients, dose ranging and a booster study with the current formulation and the process upgraded product to further ensure that the vaccine provides a sufficient level of long-term protection against Hepatitis B.
CHMP je prosil imetnika dovoljenja za promet, naj izvede raziskave o novorojenčkih, dojenčkih, starejših odraslih, bolnikih na ledvični dializi, raziskavo z razponom odmerkov in poživitveno raziskavo s trenutnim pripravkom ter s posodobljenim izdelkom, da bi dodatno zagotovila, da cepivo dolgoročno ščiti pred hepatitisom B.
In view of the lack of analytical tools to predict immunogenicity in man, the need for regular testing of recombinant HepB batches in clinical trials was considered, in order to ensure consistent high immunogenicity of PROCOMVAX produced in particular according to the new updated/ improved process.
Zaradi pomanjkanja analitičnih orodij za napoved imunogenosti pri človeku se je pojavila potreba po rednem testiranju serij rekombinantnega HepB v kliničnih preizkušanjih, z namenom zagotoviti nepretrgano visoko imunogenost cepiva PROCOMVAX, posebej izdelanega v skladu z novim/ izboljšanim postopkom.
Revised SPCs and PLs provide updated information in relation to best use of the product considering latest clinical data.
Spremenjen Povzetek glavnih značilnosti zdravila (SPC) in Navodila za uporabo vsebujeta posodobljene podatke o najboljši 2 uporabi izdelka, upoštevajoč najnovejše klinične podatke.
Pending the outcome of the studies, the MAH committed to amend the SPC section 5.1 in order to update this section with the latest results from clinical studies regarding anti-HBs responses in individuals previously vaccinated and not vaccinated with Hepatitis B Vaccine as well as anti-PRP responses.
Imetnik dovoljenja za promet z zdravilom (MAH) se je zavezal, da bo dokler ne bodo znani rezultati študij, dopolnil poglavje 5. 1 Povzetka glavnih značilnosti zdravila z najnovejšimi rezultati kliničnih raziskav v zvezi z odzivi anti- HBs pri posameznikih, ki so ali niso bili predhodno cepljeni s cepivom proti hepatitisu B, kakor tudi z odzivi anti- PRP.
The CHMP also considered the commitments given by the MAH in response to CHMP’ s requests to meticulously control the performance of PROCOMVAX from now on in a broad array of appropriate clinical trials including all age and risk categories.
Prav tako je CHMP upošteval obljubo imetnika dovoljenja za promet, kot odgovor na prošnjo odbora CHMP, naj od sedaj dalje temeljito preverja delovanje cepiva PROCOMVAX v širokem spektru primernih kliničnih preizkušanj, vključno z vsemi starostnimi kategorijami in kategorijami tveganja.
3 GROUNDS FOR THE VARIATION OF THE MARKETING AUTHORISATION OF PROCOMVAX
3 PODLAGA ZA SPREMEMBO DOVOLJENJA ZA PROMET S CEPIVOM PROCOMVAX
• The CHMP considered that the benefit/ risk balance of PROCOMVAX concerning protection against hepatitis B virus infection caused by all known subtypes in all age categories considered at risk of exposure to hepatitis B virus remains favourable.
• CHMP je mnenja, da je razmerje med koristmi in tveganji cepiva PROCOMVAX, glede zaščite pred okužbo z virusom hepatitisa B z vsemi znanimi podtipi virusa pri vseh starostnih skupinah, ki jih ogroža okužba s tem virusom, ugodno.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Če potrebujete več informacij o vaši bolezni ali zdravljenju, preberite Navodila za uporabo (ki so prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Procoralan is a salmon-coloured tablet (oblong 5 mg, triangular 7.5 mg) for oral use.
Zdravilo Procoralan so tablete lososove barve (podolgovate 5 mg; trikotne 7, 5 mg) za peroralno uporabo.
Procoralan contains the active ingredient ivabradine at strengths of 5 mg or 7.5 mg.
Zdravilo Procoralan vsebuje zdravilno učinkovino ivabradin z jakostjo 5 mg ali 7, 5 mg.
Procoralan is used to treat the symptoms of chronic stable angina pectoris (pains to the chest, jaw, back, brought on by physical effort, and due to problems with the blood flow to the heart).
Zdravilo Procoralan se uporablja za zdravljenje simptomov kronične stabilne angine pektoris (bolečin v prsih, čeljusti, hrbtu zaradi telesnega napora in težav z dotokom krvi v srce).
Procoralan is used in patients with a normal sinus rhythm (heartbeat), who cannot take, or cannot tolerate, beta- blockers (another type of medicine to treat angina).
Zdravilo Procoralan se uporablja pri bolnikih z normalnim sinusnim ritmom (srčnim utripom), ki ne morejo jemati blokatorjev receptorjev beta (druge vrste zdravila za angino) ali jih ne prenašajo.
Procoralan is taken orally, twice daily, i. e. once in the morning and once in the evening during meals.
Zdravilo Procoralan morajo bolniki jemati peroralno dvakrat dnevno, to je enkrat zjutraj in enkrat zvečer med obroki.
The usual recommended starting dose of Procoralan is 5 mg twice daily.
Običajni priporočeni začetni odmerek zdravila Procolaran je 5 mg dvakrat dnevno.
Procoralan is a pure heart rate lowering agent.
Zdravilo Procoralan je specifično zdravilo za zniževanje srčne frekvence.
Ivabradine, the active substance in Procoralan, works by inhibiting the lf channels: these are specialised cells in the sinus node, the‘ pacemaker ’ for the heart that controls the heart contractions and regulates heart rate.
Ivabradin, zdravilna učinkovina zdravila Procoralan, deluje z zaviranjem kanalov lf: to so specializirane celice v sinusnem vozlu, „ spodbujevalnik “ srca, ki nadzoruje krčenje srca in uravnava srčno frekvenco.
Procoralan therefore reduces or prevents the symptoms of angina.
Zdravilo Procoralan tako zmanjša ali prepreči simptome angine.
Procoralan has been studied in four clinical trials; lasting 3 or 4 months and including a total of 3,222 patients, of whom 2,168 received Procoralan.
Zdravilo Procoralan je bilo preučeno v štirih kliničnih preizkušanjih, ki so trajala 3 oz. 4 mesece in v katere je bilo vključenih 3222 bolnikov, od katerih jih je 2168 prejelo zdravilo Procoralan.
It was also studied as an ‘ add on ’ treatment in patients who also received amlodipine.
Zdravilo Procoralan so primerjali s placebom (zdravilom brez zdravilne učinkovine), atenololom ali amlodipinom (drugima zdraviloma za zdravljenje angine).
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Preučili so tudi dodajanje zdravila 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int  EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Procoralan shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Procoralan k obstoječemu zdravljenju pri bolnikih, ki so sočasno prejemali amlodipin.
Procoralan was significantly better than placebo at improving exercise capacity and was as effective as atenolol and amlodipine.
Zdravilo Procoralan je bilo statistično značilno boljše od placeba pri izboljšanju vadbene zmogljivosti in enako učinkovito kot atenolol in amlodipin.
However, adding Procoralan to amlodipine did not provide extra benefit.
Zdravilo Procoralan kot dodatek amlodipinu ni pokazalo dodatnih koristnih učinkov.
For the full description of all side effects reported with Procoralan, please see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Procoralan, najdete v Navodilih za uporabo.
Procoralan should not be used in people who may be hypersensitive (allergic) to ivabradine or any of the other ingredients, who have a resting heart rate below 60 beats/ minute, who have very low blood pressure, who have various types of heart disorders (cardiogenic shock, rhythm disorders, heart attack or heart failure), who have severe liver problems, or who are pregnant or breastfeeding.
Zdravila Procoralan ne smejo jemati osebe, ki utegnejo biti preobčutljive za (alergične na) ivabradin ali katerokoli drugo sestavino zdravila, ali osebe, ki imajo srčno frekvenco med mirovanjem pod 60 utripov/ minuto), zelo nizek krvni tlak, razne vrste bolezni srca (kardiogeni šok, motnje ritma, srčni napad, srčno popuščanje), hude težave z jetri, ali nosečnice ali doječe matere.
The Committee for Medicinal products for Human Use (CHMP) concluded that Procoralan has sufficient effectiveness against angina, and an acceptable safety profile, for Procoralan to provide an alternative treatment for patients with chronic stable angina pectoris with normal sinus rhythm who cannot take beta-blockers.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da je zdravilo Procoralan dovolj učinkovito proti angini in ima zadosten varnostni profil za alternativno zdravljenje bolnikov s kronično angino pektoris in normalnim sinusnim ritmom, ki ne morejo jemati blokatorjev receptorjev beta.
They decided that Procoralan’ s benefits are greater than its risks and recommended that Procoralan be given marketing authorisation.
Odbor je mnenja, da so koristi zdravila Procoralan večji od z njim povezanih tveganj, zato je priporočil odobritev dovoljenja za promet z zdravilom Procoralan.
The European Commission granted a marketing authorisation valid throughout the European Union, for Procoralan to Les Laboratoires Servier on 25 October 2005.
Evropska Komisija je dovoljenje za promet z zdravilom Procoralan, veljavno po vsej Evropski uniji, odobrila družbi Les Laboratoires Servier dne 25. oktobra 2005.
The full EPAR for Procoralan is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Procoralan je na voljo tukaj.
EU number EU/ 1/ 05/ 316/ 001 EU/ 1/ 05/ 316/ 002 EU/ 1/ 05/ 316/ 003 EU/ 1/ 05/ 316/ 004 EU/ 1/ 05/ 316/ 005 EU/ 1/ 05/ 316/ 006 EU/ 1/ 05/ 316/ 007 EU/ 1/ 05/ 316/ 008 EU/ 1/ 05/ 316/ 009 EU/ 1/ 05/ 316/ 010 EU/ 1/ 05/ 316/ 011 EU/ 1/ 05/ 316/ 012 EU/ 1/ 05/ 316/ 013 EU/ 1/ 05/ 316/ 014
Številka EU EU/ 1/ 05/ 316/ 001 EU/ 1/ 05/ 316/ 002 EU/ 1/ 05/ 316/ 003 EU/ 1/ 05/ 316/ 004 EU/ 1/ 05/ 316/ 005 EU/ 1/ 05/ 316/ 006 EU/ 1/ 05/ 316/ 007 EU/ 1/ 05/ 316/ 008 EU/ 1/ 05/ 316/ 009 EU/ 1/ 05/ 316/ 010 EU/ 1/ 05/ 316/ 011 EU/ 1/ 05/ 316/ 012 EU/ 1/ 05/ 316/ 013 EU/ 1/ 05/ 316/ 014
Invented name Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan
Zaščiteno ime Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan Procoralan
The tablet can be divided into equal halves.
Podolgovata, filmsko obložena tableta lososove barve z zarezo na obeh straneh in vrezano oznako “ 5 ” na drugi strani. na eni ter Tableta se lahko deli na enaki polovici.
Children and adolescents Procoralan is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Otroci in mladostniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Procoralan pri otrocih in mladostnikih ni priporočljiva.
3 Combination with other antianginal therapies Concomitant use of ivabradine with heart rate reducing calcium channel blockers such as verapamil or diltiazem is not recommended (see section 4.5).
Kombinacija z drugimi antianginoznimi zdravljenji 3 Sočasno jemanje ivabradina s kalcijevimi antagonisti, ki znižujejo srčno frekvenco, kot sta verapamil in diltiazem, ni priporočljivo (glejte poglavje 4. 5).
5 Other concomitant use Specific drug-drug interaction studies have shown no clinically significant effect of the following medicinal products on pharmacokinetics and pharmacodynamics of ivabradine: proton pump inhibitors (omeprazole, lansoprazole), sildenafil, HMG CoA reductase inhibitors (simvastatin), dihydropyridine calcium channel blockers (amlodipine, lacidipine), digoxin and warfarin.
Drugo sočasno jemanje Specifične študije o medsebojnih delovanjih z zdravili niso pokazale klinično signifikantnega učinka 5 naslednjih zdravil na farmakokinetiko in farmakodinamiko ivabradina: zaviralcev protonske črpalke (omeprazola, lansoprazola), sildenafila, zaviralcev hidroksimetilglutaril koencim A (HMG CoA) reduktaze (simvastatina), dihidropiridinskih kalcijevih antagonistov (amlodipina, lacidipina), digoksina in varfarina.
The possible occurrence of such luminous phenomena should be taken into account when driving or using machines in situations where sudden variations in light intensity may occur, especially when driving at night.
Možen nastanek tovrstnih svetlečih pojavov svetlikanja morate upoštevati pri vožnji ali upravljanju s stroji v pogojih, kjer se lahko nenadno spreminja jakost svetlobe, zlasti med vožnjo ponoči.
Procoralan has been studied in clinical trials involving nearly 5,000 participants.
Procoralan so proučevali v kliničnih študijah, ki so vključile skoraj 5000 bolnikov.
7 Ivabradine can interact also with the retinal current Ih which closely resembles cardiac If.
Sodeluje v časovni ločljivosti vidnega sistema s skrajšanjem odziva mrežnice na močne svetlobne 7 dražljaje.
It participates in the temporal resolution of the visual system, by curtailing the retinal response to bright light stimuli.
V sprožilnih okoliščinah (na primer ob hitrih spremembah svetlosti) je delno zaviranje Ih ob ivabradinu osnova za pojave svetlikanja, ki jih lahko občasno opažajo bolniki.
Under triggering circumstances (e. g. rapid changes in luminosity), partial inhibition of Ih by ivabradine underlies the luminous phenomena that may be occasionally experienced by patients.
Pojave svetlikanja (fosfene) opisujejo kot prehodno povečanje svetlosti na omejenem področju vidnega polja (glejte poglavje 4. 8).
The antianginal and anti-ischaemic efficacy of Procoralan was studied in four double-blind randomised trials (two versus placebo, and one each versus atenolol and amlodipine).
Antianginozno in antiishemično učinkovitost zdravila Procoralan so proučevali v štirih dvojno slepih randomiziranih študijah (dveh v primerjavi s placebom ter po eni z atenololom in amlodipinom).
8 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti
Under physiological conditions, ivabradine is rapidly released from tablets and is highly water-soluble (> 10 mg/ ml).
V fizioloških pogojih se ivabradin hitro sprošča iz tablet in je zelo topen v vodi (> 10 mg/ ml).
Ivabradine is the S-enantiomer with no bioconversion demonstrated in vivo.
8 Ivabradin je S- enantiomer in ni dokazov za njegovo biološko konverzijo in vivo.
At higher doses, the decrease in heart rate is no longer proportional to ivabradine plasma concentrations and
Ob večjih odmerkih znižanje srčne frekvence ni več sorazmerno s koncentracijo ivabradina v plazmi in kaže težnjo k doseganju platoja.
High exposures to ivabradine that may occur when ivabradine is given in combination with strong CYP3A4 inhibitors may result in an excessive decrease in heart rate although this risk is reduced with moderate CYP3A4 inhibitors (see sections 4.3, 4.4 and 4.5).
Velika izpostavljenost ivabradinu, ki lahko nastaja ob jemanju ivabradina v kombinaciji z močnimi zaviralci citokroma P450 3A4, lahko povzroči preveliko znižanje srčne frekvence, medtem ko je ob zmernih zaviralcih citokroma P450 3A4 tovrstno 9 tveganje zmanjšano (glejte poglavja 4. 3, 4. 4 in 4. 5).
6.6 Special precautions for disposal
10 6. 6 Posebni varnostni ukrepi za odstranjevanje
Procoralan 7.5 mg film-coated tablets
Procoralan 7, 5 mg filmsko obložene tablete
Salmon-coloured, triangular, film-coated tablet engraved with “ 7.5” on one face and face.
Trikotna, filmsko obložena tableta lososove barve z zarezo na obeh straneh in vrezano oznako “ 7, 5 ” na drugi strani. na eni ter
Contra-indication of concomitant use The concomitant use of potent CYP3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone is contra-indicated (see section 4.3).
Kontraindikacije za sočasno jemanje Sočasno jemanje močnih zaviralcev citokroma P4503A4, kot so azolski antimikotiki (ketokonazol, itrakonazol), makrolidnimi antibiotiki (klaritromicin, eritromicin peroralno, josamicin, telitromicin), zaviralci proteaze virusa HIV (nelfinavir, ritonavir) in nefazodon, je kontraindicirano (glejte poglavje 4. 3).