FrancophonIA/ELRC3.0 huggingface dataset:
English: ZIMULTI is available in blister packs of 14, 28, 30, 56, 84, 90 and 98 tablets, in perforated unit dose blister packs containing 70 x 1 tablets, and in white plastic bottles containing 28, 98 and 500 tablets.
Slovenian: ZIMULTI je na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 in 98 tabletami,perforiranih pretisnih omotih za enkratni odmerek, ki vsebujejo 70 x 1 tableto in belih plastenkah z 28, 98 ali 500 tabletami.
English: Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking ZIMULTI.
Slovenian: Če med jemanjem zdravila ZIMULTI zanosite, sumite, da ste zanosili, ali načrtujete nosečnost, se morate takoj posvetovati z zdravnikom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/345/007
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/06/345/007
English: If you experience symptoms of depression (see below) during treatment with ZIMULTI you should contact your doctor and stop the treatment.
Slovenian: Če se med zdravljenjem z zdravilom ZIMULTI pojavijo simptomi depresije (glejte spodaj), zdravilo ZIMULTI prenehajte jemati in se posvetujte s svojim zdravnikom.
English: What ZIMULTI looks like and contents of the pack ZIMULTI 20 mg is supplied as teardrop-shaped, white film-coated tablets debossed with “20”on one side.
Slovenian: Izgled zdravila ZIMULTI in vsebina pakiranja ZIMULTI 20 mg so bele filmsko obložene tablete v obliki solze, ki imajo na eni strani vtisnjeno oznako "20".
English: ZIMULTI should be used with caution in patients over 75 years of age (see section 4.4).
Slovenian: Pri bolnikih, starejših od 75 let, ZIMULTI uporabljajte previdno (glejte poglavje 4.4).
English: ZIMULTI 20 MG FILM-COATED TABLETS (RIMONABANT)
Slovenian: ZIMULTI 20 mg filmsko obložene tablete (rimonabant)
English: − gastrointestinal disorders:stomach discomfort, dry mouth.
Slovenian: − bolezni prebavil: nelagodje v želodcu, suha usta.
English: What ZIMULTI is and what it is used for Before you take ZIMULTI How to take ZIMULTI Possible side effects
Slovenian: Kaj je zdravilo ZIMULTI in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo ZIMULTI Kako jemati zdravilo ZIMULTI Možni neželeni učinki
English: HOW TO TAKE ZIMULTI
Slovenian: KAKO JEMATI ZDRAVILO ZIMULTI
English: The difference was statistically significant (Difference 7.9% CI95% 6.6%; 9.2%, p<0.001).
Slovenian: Razlika je bila statistično značilna (razlika 7,9 %, IZ95 % 6,6 %, 9,2 %; p<0,001).
English: 5 How to store ZIMULTI Further information
Slovenian: 5 Shranjevanje zdravila ZIMULTI Dodatne informacije
English: The difference was statistically significant (Difference -13.3% CI95% -16.5; -10.2% p<0.001).
Slovenian: Razlika je bila statistično značilna (razlika13,3 %, IZ95 % -16,5 %, -10,2 %; p<0,001).
English: MARKETING AUTHORIZATION NUMBER EU/1/06/345/001-011
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/345/001-011
English: NAME OF THE MEDICINAL PRODUCT ZIMULTI 20 mg film-coated tablets
Slovenian: IME ZDRAVILA ZIMULTI 20 mg filmsko obložene tablete
English: ZIMULTI 20 mg
Slovenian: ZIMULTI 20 mg placebo
English: If you forget to take ZIMULTI Take it as soon as you remember but do not take a double dose to make up for any forgotten dose.
Slovenian: Ne vzenite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Serious psychiatric events including depression or mood changes have been reported in patients taking ZIMULTI (see section POSSIBLE SIDE EFFECTS).
Slovenian: Pri bolnikih, ki so jemali zdravilo ZIMULTI, so poročali o pojavu resnih duševnih motenj, vključno z depresijo ali motnjami razpoloženja (glejte poglavje MOŽNI NEŽELENI UČINKI).
English: The percentage of patients who lost 5% and 10% of their baseline body weight after 1 year of treatment are given in table 2:
Slovenian: Spodaj v tabeli 2 so prikazani deleži bolnikov, ki so imeli po 1 letu zdravljenja telesno maso za 5 % oz. 10 % manjšo kot izhodiščno:
English: sanofi-aventis 174 avenue de France F-75013 Paris France
Slovenian: sanofi-aventis 174 Avenue de France F-75013 Paris Francija
English: A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN
English: Sanofi Winthrop Industrie, 30-36 Avenue Gustave Eiffel, BP 27166, F-37071 Tours Cedex 2, France sanofi-aventis S.p.A., Strada Statale 17, Km 22 , 67019 Scoppito (AQ), Italy
Slovenian: (ODGOVORNI) ZA SPROŠČANJE SERIJE Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije Sanofi Winthrop Industrie, 30-36 Avenue Gustave Eiffel, BP 27166, F-37071 Tours Cedex 2, Francija sanofi-aventis S.p.A., Strada Statale 17, Km 22 , 67019 Scoppito (AQ), Italija V natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov izdelovalca, odgovornega za sproščanje zadevne serije.
English: ZIMULTI should not be used in patients with severe renal impairment (see section 4.4 and 5.2).
Slovenian: ZIMULTI ne smete uporabljati pri bolnikih s hudo okvaro ledvic (glejte poglavji 4.4 in 5.2).
English: Caution is advised during concomitant use of ZIMULTI and potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone).
Slovenian: Med sočasno uporabo zdravila ZIMULTI in močnih zaviralcev CYP3A4 (npr. ketokonazola, itrakonazola, ritonavirja, telitromicina, klaritromicina, nefazodona) je potrebna previdnost.
English: The difference in mean body weight change between the 20 mg and placebo groups was 3.8 kg (CI95% -5.0, -2.6 p<0.001).
Slovenian: Razlika v povprečni spremembi telesne mase med prejemniki 20 mg rimonabanta in prejemniki placeba je bila 3,8 kg (IZ95 % -5,0, -2,6, p < 0,001).
English: ZIMULTI should not be used in patients with severe hepatic impairment (see section 4.4 and 5.2).
Slovenian: ZIMULTI ne smete uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavji 4.4 in 5.2).
English: MARKETING AUTHORIZATION HOLDER
Slovenian: IMETNIK DOVOLJENJA ZA PROMET
English: Weight loss at two years was 5.1 kg for patients who received ZIMULTI 20 mg and 1.2 kg for placebo (Difference -3.8 kg; CI95% -4.4, -3.3; p<0.001).
Slovenian: Zmanjšanje telesne mase po dveh letih je bilo pri bolnikih, ki so dobivali ZIMULTI 20 mg, 5,1 kg in pri bolnikih, ki so dobivali placebo, 1,2 kg (razlika -3,8 kg, IZ95 % -4,4, -3,3; p<0,001).
English: Tell your doctor before you start to take this medicine
Slovenian: Bodite posebno pozorni pri jemanju zdravila ZIMULTI Preden začnete jemati zdravilo, morate zdravniku povedati:
English: ZIMULTI is not recommended for use in children below age 18 due to a lack of data on efficacy and safety.
Slovenian: Zaradi pomanjkanja podatkov o učinkovitosti in varnosti uporaba zdravila ZIMULTI pri otrocih pod 18 let ni priporočljiva.
English: The active ingredient of ZIMULTI is rimonabant.
Slovenian: Zdravilna učinkovina v zdravilu ZIMULTI je rimonabant.
English: ZIMULTI should be used with caution in patients with moderate hepatic impairment.
Slovenian: Pri bolnikih z zmerno okvaro jeter je ZIMULTI potrebno uporabljati previdno.
English: (See section 4.3 and 4.8).Obesity is a condition that can be associated with depressive disorders.
Slovenian: Debelost je stanje, ki je lahko povezano z depresivnimi motnjami.
English: Sleepiness (lethargy), tremor, night sweats, panic symptoms, hiccups, anger, restlessness (dysphoria), emotional disorder, suicidal thoughts, aggressiveness or aggressive behaviour, hypoglycaemia (low blood sugar).
Slovenian: Občasni neželeni učinki, ki se pojavijo pri manj kot 1 od 100, a več kot 1 na 1000 oseb, in so bili zabeleženi pri bolnikih, ki so uporabljali zdravilo ZIMULTI, vključujejo: zaspanost (letargija), drhtenje (tremor), nočno znojenje, simptome panike, kolcanje, jezo, nemir (disforijo), čustveno motnjo, samomorilne misli, agresivnost ali agresivno vedenje, hipoglikemija (nizek krvni sladkor).
English: What ZIMULTI contains
Slovenian: Kaj vsebuje zdravilo ZIMULTI
English: At two years, patients continuing on rimonabant had a mean total weight loss of 7.5 kg over 2 years whereas patients re-randomized to placebo group during the second year had a mean total weight loss of 3.1 kg over 2 years.
Slovenian: V dveh letih je bilo pri bolnikih, ki so dobivali rimonabant, povprečno skupno zmanjšanje telesne mase 7,5 kg, pri bolnikih, ki so bili v drugem letu randomizirani v skupino s placebom, pa je bilo povprečno skupno zmanjšanje telesne mase v dveh letih 3,1 kg.V dveh letih je bila razlika v skupnem zmanjšanju telesne mase med zdravilom ZIMULTI in placebom -4,2 kg (IZ95 % -5,0, -3,4; p<0,001).
English: At one year a mean weight loss of 5.3 kg was shown for ZIMULTI 20 mg versus a loss on placebo of 1.4 kg (Difference -3.9 kg CI95% -4.6;-3.3 p<0.001).
Slovenian: Ob uporabi 20 mg zdravila ZIMULTI se je telesna masa po enem letu v povprečju zmanjšala za 5,3 kg, ob uporabi placeba pa za 1,4 kg (razlika -3,9 kg, IZ95 % -4,6, -3,3, p < 0,001).
English: A mean weight loss of 6.5 kg from baseline to one year was shown for ZIMULTI 20 mg versus a mean weight loss of 1.6 kg for placebo (Difference -4.9 kg CI95% -5.3;-4.4, p< 0.001).
Slovenian: Povprečno zmanjšanje telesne mase po enem letu v primerjavi z izhodiščem je bilo z zdravilom ZIMULTI 20 mg 6,5 kg in s placebom 1,6 kg (razlika -4,9 kg, IZ95 % -5,3, -4,4; p<0,001).
English: Significant mean weight reductions from baseline to one year for ZIMULTI 20 mg versus placebo were demonstrated in three studies conducted in non-diabetic patients.
Slovenian: V treh študijah pri nediabetičnih bolnikih so po enem letu zdravljenja z zdravilom ZIMULTI 20 mg v primerjavi s placebom dokazali značilno zmanjšanje povprečne telesne mase od izhodišča.
English: In a second trial in treatment naïve type 2 diabetic obese patients (Serenade), the absolute change in HbA1c (with a baseline of 7.9% for both groups) at six months was -0.8 for rimonabant 20 mg and -0.3 under placebo (Difference -0.51 CI95% -0.78, -0.24 p<0.001).
Slovenian: Absolutna sprememba HbA1c po šestih mesecih je bila v skupini, ki je prejemala 20 mg rimonabanta, -0,8 in v skupini, ki je prejemala placebo, -0,3 (razlika0,51, IZ95 % -0,78, -0,24, p < 0,001).
English: Like all medicines, ZIMULTI can cause side effects, although not everybody gets them Very common side effects, that affect more than 1 per 10, that have occurred in patients on ZIMULTI include: nausea and upper respiratory tract infection.
Slovenian: Zelo pogosti neželeni učinki, ki se pojavijo pri več kot 1 od 10 oseb in so bili zabeleženi pri bolnikih, ki so uporabljali zdravilo ZIMULTI, vključujejo: slabost v želodcu in okužbo zgornjih dihal.
English: Anger
Slovenian: Serija
English: Always take ZIMULTI exactly as your doctor has told you.
Slovenian: Natančno upoštevajte zdravnikova navodila.
English: If psychiatric illness is diagnosed during rimonabant therapy, treatment must be stopped.
Slovenian: Če bolnica med zdravljenjem z zdravilom ZIMULTI zanosi, mora o tem obvestiti zdravnika.
English: Do not take ZIMULTI
Slovenian: Ne uporabljajte zdravila ZIMULTI
English: Date of renewal authorisation:13 February 2008
Slovenian: Datum zadnjega podaljšanja: 13. februar 2008
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:18 March 1998
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 18. marec 1998
English: If the submission of a PSUR and the update of an RMP coincide, they can be submitted at the same time.
Slovenian: Če predložitev PSUR in posodobitev RMP sovpadata, se ju lahko predloži istočasno.
English: Recent findings indicate that exposure in children <6 years of age may be reduced by about 30% compared with other age groups.
Slovenian: Najnovejše ugotovitve kažejo, da je izpostavljenost pri otrocih, mlajših od 6 let, lahko za približno 30 % manjša od izpostavljenosti pri drugih starostnih skupinah.
English: The observed lamivudine half-life of elimination is 5 to 7 hours.
Slovenian: Izločanje: Opazovan eliminacijski razpolovni čas lamivudina znaša 5 do 7 ur.
English: CD4 cells are a type of white blood cells that are important in helping your body to fight infection.
Slovenian: CD4 celice so vrsta belih krvnih celic, ki so pomembne za premagovanje okužb.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: If you cannot swallow the tablets whole, you may crush and combine them with a small amount of food or drink, and take all the dose immediately.
Slovenian: Če tablet ne morete zaužiti, jih lahko zdrobite in vzamete skupaj z majhno količino hrane ali pijače ter vzamete celoten odmerek naenkrat.
English: If you are pregnant, if you become pregnant or if you are planning to become pregnant talk to your doctor about the risks and benefits to you and your baby of taking Combivir.
Slovenian: Če ste noseči, zanosite ali če načrtujete nosečnost, se posvetujte s svojim zdravnikom o tveganjih in koristih jemanja zdravila Combivir za vas in vašega otroka.
English: • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop Combivir without your doctor's advice, as your hepatitis may come back)
Slovenian: • če ste kdaj imeli bolezen jeter, vključno s hepatitisom B ali C (če ste okuženi z virusom hepatitisa B, ne prenehajte z jemanjem zdravila Combivir brez zdravnikovega navodila, kajti vaš hepatitis se lahko ponovi);
English: If you have taken Combivir during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Slovenian: Če ste zdravilo Combivir jemali med nosečnostjo, vas lahko zdravnik naroči na redne preiskave krvi in druge diagnostične preiskave, da bo spremljal razvoj vašega otroka.
English: • if you are allergic to lamivudine or zidovudine, or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • če ste alergični na lamivudin ali zidovudin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6);
English: Your doctor may need to monitor you while you are taking Combivir.
Slovenian: Vaš zdravnik vas bo morda dodatno opazoval, medtem ko jemljete zdravilo Combivir.
English: Combivir helps to control your condition.
Slovenian: Zdravilo Combivir pomaga obvladovati vašo bolezen.
English: Tell your doctor or pharmacist if you are taking any other medicines, or if you have taken any recently, including herbal medicines or other medicines you bought without a prescription.
Slovenian: Povejte svojemu zdravniku ali farmacevtu, če jemljete katera druga zdravila, ali ste jih pred kratkim jemali, vključno z zdravili rastlinskega izvora ali drugimi zdravili, ki ste jih kupili brez recepta.
English: Keep in touch with your doctor, and do not stop taking Combivir without your doctor's advice.
Slovenian: Bodite v stiku z vašim zdravnikom in ne prenehajte jemati zdravila Combivir brez zdravnikovega nasveta.
English: Combivir does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Slovenian: Zdravilo Combivir okužbe z virusom HIV ne ozdravi, vendar zmanjša količino virusa v telesu in jo vzdržuje na nizki ravni.
English: A small amount of the ingredients in Combivir can also pass into your breast-milk.
Slovenian: Majhna količina sestavin zdravila Combivir lahko prehaja v materino mleko.
English: Women who are HIV-positive must not breastfeed, because HIV infection can be passed on to the baby in breast milk.
Slovenian: Ženske, ki so HIV pozitivne, ne smejo dojiti, kajti okužba z virusom HIV se lahko z mlekom prenese na otroka.
English: Patients receiving Combivir should be frequently examined and questioned for signs of lipoatrophy.
Slovenian: Bolnike, ki prejemajo zdravilo Combivir, je treba pogosto pregledovati in vprašati po znakih lipoatrofije.
English: Very common : Headache
Slovenian: Zelo pogosti: glavobol
English: Each pack type contains 60 film-coated tablets.
Slovenian: Vsako pakiranje vsebuje po 60 filmsko obloženih tablet.
English: Combivir should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine.
Slovenian: Zdravila Combivir se ne sme jemati skupaj s katerimkoli zdravilom, ki vsebuje lamivudin ali z zdravilom, ki vsebuje emtricitabin.
English: Combivir and similar medicines may cause side effects in unborn babies.
Slovenian: Zdravilo Combivir in podobna zdravila lahko povzročijo neželene učinke pri nerojenemu otroku.
English: If you get any symptoms of infection while you are taking Combivir: Tell your doctor immediately.
Slovenian: Če dobite znake okužbe, medtem ko jemljete zdravilo Combivir: se takoj posvetujte s svojim zdravnikom.
English: The usual dose of Combivir is one tablet twice a day.
Slovenian: Običajni odmerek zdravila Combivir je ena tableta dvakrat na dan.
English: Cmax ↓ 28%; 52%, 55%.
Slovenian: AUC ↓ 14%; 32%; 36% Cmax ↓ 28%; 52%, 55%.
English: Zidovudine plasma protein binding is 34% to 38%.
Slovenian: Obseg vezave na plazemske proteine znaša pri zidovudinu od 34 do 38 %.
English: It is recommended that mothers infected by HIV do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Slovenian: Priporočljivo, da matere, ki so okužene z virusom HIV,v nobenem primeru ne dojijo svojih otrok in se tako izognejo eni od možnosti za prenos virusa HIV na otroka.
English: What Combivir is and what it is used for
Slovenian: Kaj je zdravilo Combivir in za kaj ga uporabljamo
English: If you forget to take a dose, take it as soon as you remember.
Slovenian: Če ste pozabili vzeti zdravilo Combivir Če ste pozabili vzeti odmerek, ga vzemite takoj, ko se spomnite.
English: The active ingredients of Combivir may inhibit cellular DNA replication and zidovudine has been shown to be transplacental carcinogen in one animal study (see section 5.3).
Slovenian: Učinkovini zdravila Combivir lahko inhibirata replikacijo celične DNK in zidovudin se je izkazal za transplacentalno karcinogenega v eni študiji na živalih (glejte poglavje 5.3).
English: Not everyone responds to treatment with Combivir in the same way.
Slovenian: Na zdravilo Combivir se ne odzovejo vsi bolniki enako.
English: If you accidentally take too much Combivir, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Slovenian: Če ste pomotoma vzeli preveč zdravila Combivir, se morate za dodatni nasvet obrniti na svojega zdravnika ali farmacevta ali pa na oddelek nujne pomoči najbližje bolnišnice.
English: However, for the treatment of HIV infection only a 300 mg daily dose of lamivudine (in combination with other antiretroviral agents) has been shown to be efficacious.
Slovenian: Vendar pa se je za zdravljenje infekcij z virusom HIV izkazal kot učinkovit edino dnevni odmerek lamivudina v višini 300 mg (v kombinaciji z drugimi protiretrovirusnimi zdravili).
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: • Načrt za obvladanje tveganja (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Other medicines and Combivir
Slovenian: Druga zdravila in zdravilo Combivir
English: A very rare side effect that may show up in blood tests is: • a failure of the bone marrow to produce new red or white blood cells (aplastic anaemia).
Slovenian: Zelo redek neželeni učinek, ki se lahko pokaže v preiskavah krvi, je:  nezmožnost kostnega mozga za tvorbo novih rdečih ali belih krvnih celic (aplastična anemija).
English: When these signs occur, Combivir should be stopped and your HIV treatment changed.
Slovenian: Če se pojavijo ti znaki, je treba zdravljenje z zdravilom Combivir prekiniti in spremeniti zdravljenje okužbe z virusom HIV.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Slovenian: Ustrezni primeri so citomegalovirusni retinitis, generalizirane in/ali žariščne okužbe z mikobakterijami in s Pneumocystis jiroveci povzročena pljučnica (pogosto omenjena kot PCP).
English: Combivir is used to treat HIV (human immunodeficiency virus) infection in adults and children.
Slovenian: Zdravilo Combivir se uporablja za zdravljenje okužbe z virusom HIV (virus humane imunske pomanjkljivosti) pri odraslih in otrocih.
English: • clarithromycin, an antibiotic if you are taking clarithromycin, take your dose at least 2 hours before or after you take your Combivir.
Slovenian: Če jemljete klaritromicin, vzemite vaš odmerek vsaj 2 uri pred ali po tem, ko vzamete zdravilo Combivir.
English: Lamivudine: AUC ↑40% Trimethoprim: AUC ↔ Sulfamethoxazole: AUC ↔ (organic cation transporter inhibition)
Slovenian: lamivudin: AUC 40% trimetoprim: AUC ↔ sulfametoksazol: AUC ↔ (zavrtje organskega kationskega transporterja)
English: These thymidine analogue mutations alone do not cause high-level cross-resistance to any of the other nucleosides, allowing for the subsequent use of any of the other approved reverse transcriptase inhibitors.
Slovenian: Te mutacije timidinovih analogov same po sebi ne povzročajo visoke stopnje navzkrižne odpornosti na kateri koli drugi nukleozid, kar dovoljuje naknadno uporabo katerega koli drugega zaviralca reverzne transkriptaze.
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited binding to the major plasma protein albumin (<36% serum albumin in vitro).
Slovenian: Lamivudin izkazuje linearno farmakokinetiko v terapevtskem razponu odmerjanja in se le omejeno veže na glavni plazemski protein albumin (<36 % serumskega albumina in vitro).
English: There are no additional precautions and warnings relevant to the combination Combivir.
Slovenian: Dodatnih previdnostnih ukrepov in opozoril, ki bi se nanašala na kombinirano zdravilo Combivir, ni.
English: The mean systemic clearance of lamivudine is approximately 0.32 l/h/kg, with predominantly renal clearance (>70%) via the organic cationic transport system.
Slovenian: Srednja vrednost sistemskega očistka lamivudina je približno 0,32 l/h/kg, pri čemer glavni delež odpade na ledvični očistek (>70 %), ki poteka preko organskega kationskega transportnega sistema.
English: This conclusion is based on the physiochemical and pharmacokinetic data assuming that the patient crushes and transfers 100% of the tablet and ingests immediately.
Slovenian: Ta zaključek temelji na fizikalnokemijskih in farmakokinetičnih podatkih ter predpostavki, da bolnik tableto zdrobi in jo nato v celoti doda redki hrani ali tekočini ter takoj zaužije.
English: If concomitant therapy with Combivir and any of these medicinal products is necessary then extra care should be taken in monitoring renal function and haematological parameters and, if required, the dosage of one or more agents should be reduced.
Slovenian: Če je sočasno zdravljenje z zdravilom Combivir in katerim od teh zdravil potrebno, je treba posebej paziti na spremljanje delovanja ledvic in hematoloških parametrov ter v kolikor je potrebno, je treba odmerke enega ali več zdravil zmanjšati.
English: Combination therapy for HIV can also cause: • increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis
Slovenian: Kombinirano zdravljenje okužbe s HIV lahko povzroči tudi: • povišane vrednosti mlečne kisline v krvi, kar v redkih primerih lahko povzroči laktacidozo.