FrancophonIA/ELRC3.0 huggingface dataset:
English: 4.2 Posology and method of administration Zoledronic Acid Accord must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Slovenian: Zdravilo Zoledronska kislina Accord smejo predpisovati in dajati bolnikom samo zdravstveni delavci, ki imajo izkušnje z uporabo intravenskih difosfonatov.
English: • Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Slovenian: v primeru bolečine v ušesu, izcedka iz ušesa in/ali okužbe ušesa se posvetujte s svojim zdravnikom.
English: • Zoledronic Acid Accord must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Slovenian: - Zdravilo Zoledronska kislina Accord vam sme dati samo zdravstveni delavec, ki je usposobljen za intravensko (kar pomeni v veno) dajanje difosfonatov.
English: What Zoledronic Acid Accord is and what it is used for
Slovenian: Kaj je zdravilo Zoledronska kislina Accord in za kaj ga uporabljamo
English: Very common Hypocalcaemia Common:
Slovenian: hipokalciemija pogosti:
English: • Severe bone, joint and/or muscle pain, occasionally incapacitating.
Slovenian: hude bolečine v kosteh, sklepih in/ali mišicah, ki bolnika včasih onesposobijo.
English: After dilution: From a microbiological point of view, the product should be used immediately.
Slovenian: Po rekonstituiranju in redčenju: z mikrobiološkega stališča je rekonstituirano in razredčeno raztopino za infundiranje najbolje uporabiti takoj.
English: To avoid potential incompatibilities, the infusion solution used for dilution must be either 0.9% w/v sodium chloride or 5% w/v glucose solution.
Slovenian: Da ne bi prišlo do možnih inkompatibilnosti, mora biti infuzijska raztopina, ki se uporablja za razredčenje, bodisi 0,9odstotna m/v raztopina natrijevega klorida bodisi 5-odstotna m/v raztopina glukoze.
English: In clinical trials 69 patients who relapsed or were refractory to initial treatment (zoledronic acid 4 mg, 8 mg or pamidronate 90 mg) were retreated with 8 mg zoledronic acid.
Slovenian: BPI: povprečne spremembe od izhodišča odporni proti začetnemu zdravljenju (zoledronska kislina 4 mg, 8 mg ali pamidronat 90 mg), ponovno zdravljenih z 8 mg zoledronske kisline.
English: This medicinal product must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Slovenian: Tega zdravila ne smete mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata, in jo je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
English: Zoledronic Acid Accord contains sodium
Slovenian: Zoledronska kislina Accord vsebuje natrij
English: Zoledronic acid 4 mg (N=86) 45.3% (p=0.104) 82.6% (p=0.005)* 88.4% (p=0.002)* Zoledronic acid 8 mg (N=90) 55.6% (p=0.021)* 83.3% (p=0.010)* 86.7% (p=0.015)* Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
Slovenian: 55,6 % (p=0,021)* 83,3 % (p=0,010)* 86,7 % (p=0,015)*
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as zoledronic acid (see section 4.4).
Slovenian: Poročali so o osteonekrozi čeljustnic pri bolnikih, predvsem pri tistih z rakom, ki se zdravijo z zdravili, ki zavirajo resorpcijo kosti, kot je zoledronska kislina.
English: The majority of the reports refer to cancer patients following tooth extractions or other dental surgeries.
Slovenian: Večina primerov, o katerih so poročali, je bila povezana z zobozdravniškimi postopki, na primer ekstrakcijo zoba.
English: Very common ( 1/10)
Slovenian: Zelo pogosti (1/10)
English: p-value Skeletal morbidity rate p-value
Slovenian: vrednost p stopnja obolevnosti skeleta vrednost p zmanjšanje tveganja za pojav
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate) One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala s 5 ml koncentrata vsebuje 4 mg zoledronske kisline (v obliki monohidrata).
English: Zoledronic Acid Accord concentrate must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Slovenian: Koncentrata zdravila Zoledronska kislina Accord se ne sme mešati z infuzijskimi raztopinami, ki vsebujejo kalcij ali druge dvovalentne katione, na primer z raztopino Ringerjevega laktata in jo je treba dajati kot samostojno intravensko raztopino z ločenim infuzijskim sistemom.
English: Patients must be maintained well hydrated prior to and following administration of zoledronic acid.
Slovenian: Bolniki morajo biti pred in po dajanju zoledronske kisline dobro hidrirani.
English: Renal impairment TIH:
Slovenian: Srčne bolezni občasni:
English: Instructions for preparing reduced doses of Zoledronic Acid Accord Withdraw an appropriate volume of the concentrate needed, as follows: 4.4 ml for 3.5 mg dose
Slovenian: Navodila za pripravo zmanjšanih odmerkov zdravila Zoledronska kislina Accord: Odvzemite ustrezni volumen tekočega koncentrata, kot sledi:
English: Proportion of patients with SREs (%) p-value
Slovenian: večkratnih dogodkov** (%) vrednost p
English: Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoasthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Slovenian: Poročali so o razvoju aritmij in nevroloških neželenih učinkih (vključno s konvulzijami, hipestezijo in tetanijo), do katerih je prišlo zaradi hude hipokalciemije.
English: To avoid potential incompatibilities, Zoledronic Acid Accord concentrate is to be diluted with 0.9% w/v sodium chloride solution for Injection or 5% w/v glucose solution.
Slovenian: Da se izognete možnim nezdružljivostim, razredčite koncentrat zoledronske kisline z 0,9-odstotno m/v raztopino natrijevega klorida za injiciranje ali 5-odstotno m/v raztopino glukoze.
English: Prior to administration, 5ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/v sodium chloride solution for Injection or 5% w/v glucose solution).
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Pred dajanjem je treba 5-mililitrski koncentrat iz ene viale ali po navodilih odvzet volumen koncentrata razredčiti s 100 ml infuzijske raztopine v kateri ni kalcija (0,9-odstotna m/v raztopina natrijevega klorida za injiciranje ali 5-odstotna m/v raztopina glukoze).
English: The selective action of bisphosphonates on bone is based on their high affinity for mineralised bone, but the precise molecular mechanism leading to the inhibition of osteoclastic activity is still unclear.
Slovenian: vendar je natančen molekularni mehanizem, ki privede do inhibicije osteoklastne aktivnosti, še nejasen.
English: Rare ( 1/10.000 to < 1/1.000)
Slovenian: Redki (1/10.000 do <1/1.000)
English: For storage conditions of the reconstituted solution for infusion, see section 6.3.
Slovenian: Za pogoje shranjevanja rekonstituirane raztopine za infundiranje glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
English: • Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
Slovenian: Posebno pomembno je, da zdravniku poveste, če jemljete tudi naslednja zdravila: - aminoglikozide (zdravila, ki jih uporabljamo za zdravljenje težkih okužb), kalcitonin (vrsta zdravila, ki ga uporabljamo za zdravljenje pri postmenopavzalni osteoporozi in hiperkalciemiji), diuretike Henlejeve zanke (vrsta zdravila za zdravljenje visokega krvnega tlaka ali otekanja) ali druga zdravila, ki znižujejo koncentracijo kalcija, ker kombinacija le-teh z difosfonati lahko preveč zniža koncentracijo kalcija v krvi, - talidomid (zdravilo, ki ga uporabljamo pri zdravljenju določenih vrst krvnega raka, ki zajemajo kosti) ali druga zdravila, ki lahko škodujejo ledvicam, - druga zdravila, ki prav tako vsebujejo zoledronsko kislino in jih uporabljamo pri zdravljenju osteoporoze in drugih nerakavih bolezni kosti, ali kateregakoli od drugih difosfonatov, saj učinki navedenih zdravil v kombinaciji z zdravilom Zoledronska kislina Accord niso znani, - antiangiogena zdravila (uporabljamo jih pri zdravljenju raka), ker kombinacijo le-teh z zoledronsko kislino povezujejo s povečanim tveganjem za osteonekrozo čeljustnic.
English: NAME OF THE MEDICINAL PRODUCT Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA Zoledronska kislina Accord 4 mg/5 ml koncentrat za raztopino za infundiranje
English: Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Slovenian: Zoledronska kislina Accord 4 mg/5 ml koncentrat za raztopino za infundiranje zoledronska kislina
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH)
Slovenian: Preglednica 4: Rezultati učinkovitosti (bolnice/bolniki z rakom dojke in multiplim mielomom)
English: How to store Zoledronic Acid Accord 6.
Slovenian: Shranjevanje zdravila Zoledronska kislina Accord 6.
English: How Zoledronic Acid Accord is used
Slovenian: Kako se zdravilo Zoledronska kislina Accord uporablja
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA
English: A dental examination with appropriate preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with bisphosphonates in patients with concomitant risk factors.
Slovenian: Pri bolnikih s spremljajočimi dejavniki tveganja je treba pred začetkom zdravljenja z difosfonati razmisliti o zobozdravniškem pregledu z ustreznimi preventivnimi zobozdravstvenimi ukrepi.
English: In clinical trials with zoledronic acid, patients with serum creatinine > 265 µmol/l or > 3.0 mg/dl were excluded.
Slovenian: Bolniki s serumskim kreatininom > 265 µmol/l ali > 3,0 mg/dl so bili iz kliničnih preskušanj z zoledronsko kislino izključeni.
English: (listed in section 6).
Slovenian: navedeno v poglavju 6.1
English: • Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Slovenian: Občasni (lahko se pojavijo pri 1 od 100 ljudi): bolečina v ustih, zobeh in/ali čeljusti, oteklina ali ranice v ustni votlini, odrevelenost ali občutek pritiska v čeljusti ali majanje zoba, kar so lahko znaki poškodbe kosti v čeljusti (osteonekroze).
English: Median time to SRE (days)
Slovenian: SREs (%) vrednost p mediana časa do SRE (dnevi)
English: Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin, burning sensation, have been reported in patients treated with Zoledronic Acid Accord.
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom Zoledronska kislina Accord, so poročali o znižani koncentraciji kalcija v krvi (hipokalciemiji), zaradi katere v nekaterih primerih lahko pride do mišičnih krčev, suhe kože in pekočega občutka.
English: • Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Slovenian: Pogosti (lahko se pojavijo pri 1 od 10 ljudi): glavobol in gripi podoben sindrom, ki ga sestavljajo zvišana telesna temperatura, utrujenost, šibkost, zaspanost, mrazenje in bolečine v kosteh, sklepih in/ali mišicah.
English: Common (1/100 to <1/10)
Slovenian: Pogosti (1/100 do <1/10)
English: The onset time is ≤ 3 days post-zoledronic acid infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Slovenian: Omenjeno reakcijo opisujejo tudi z izrazoma "gripi podobni simptomi" in "simptomi po odmerjanju".
English: • The usual single dose given is 4 mg zoledronic acid.
Slovenian: Koliko zdravila Zoledronska kislina Accord se daje - Običajni posamezni odmerek je 4 mg zoledronske kisline.
English: Radiation therapy to bone zoledronic acid 4 mg
Slovenian: zdravljenje kosti z obsevanjem zoledronska kislina 4 mg
English: The first randomised, double-blind, placebo-controlled study compared zoledronic acid 4 mg to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients.
Slovenian: Rezultati kliničnih preskušanj v preprečevanju z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajemajo kosti V prvi randomizirani, dvojno slepi raziskavi, kontrolirani s placebom, so primerjali zoledronsko kislino 4 mg s placebom za preprečevanje z okostjem povezanih dogodkov (SREs) pri bolnikih z rakom prostate.
English: Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.
Slovenian: Posvetujte se z zdravnikom, če občutite bolečine, šibkost ali nelagodje v stegnu, kolku ali dimljah, saj so to lahko zgodnji znaki možnega zloma stegnenice intersticijska bolezen pljuč (vnetje tkiva okoli zračnih mešičkov v pljučih), simptomi, ki spominjajo na gripo, vključno z artritisom in oteklinami sklepov, boleča rdečina in/ali oteklina očesa.
English: • Urticaria.
Slovenian: NALEPKA VIALE
English: There have been very rare cases of drowsiness and sleepiness with the use of Zoledronic Acid Accord.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ob uporabi zdravila Zoledronska kislina Accord je v zelo redkih primerih prišlo do dremavosti in zaspanosti.
English: • Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Slovenian: Pogosti (lahko se pojavijo pri 1 od 10 ljudi): huda okvara ledvic (običajno jo ugotovi zdravnik z določenimi specifičnimi krvnimi preiskavami), nizka raven kalcija v krvi.
English: • As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Slovenian: Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov): zaradi nizke vrednosti kalcija: motnje srčnega ritma (aritmija, razvije se zaradi hipokalciemije).
English: How to store Zoledronic Acid Accord
Slovenian: Shranjevanje zdravila Zoledronska kislina Accord
English: C.
Slovenian: NR
English: • Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Slovenian: pri bolnicah, ki so prejemale zoledronsko kislino zaradi postmenopavzalne osteoporoze, so opažali nepravilno bitje srca (atrijsko fibrilacijo).
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti:
English: somnolence
Slovenian: Dojenje
English: Uncommon ( 1/1.000 to < 1/100)
Slovenian: Občasni (1/1.000 do <1/100)
English: use after dilution
Slovenian: uporaba po redčenju
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
Slovenian: obsevanje ali operacija kosti ali tumorsko povzročena hiperkalciemija) pri odraslih bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti.
English: you will be given one infusion of Zoledronic Acid Accord every three to four weeks.
Slovenian: Kako pogosto se daje zdravilo Zoledronska kislina Accord - Če prejemate zdravilo za preprečevanje zapletov na kosteh zaradi kostnih metastaz, boste prejeli eno infuzijo zdravila Zoledronska kislina Accord vsake tri do štiri tedne.
English: • High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea constipation,
Slovenian: Občasni (lahko se pojavijo pri 1 od 100 ljudi): preobčutljivostne reakcije, nizek krvni tlak, bolečina v prsih, kožne reakcije (rdečina in otekanje) na mestu infuzije, izpuščaj, srbenje, visok krvni tlak, zadihanost, omotičnost, tesnoba, motnje spanja, motnje okušanja, tresenje, mravljinčenje ali odrevenelost rok ali stopal, driska, zaprtje, bolečine v trebuhu, suha usta, nizka koncentracija levkocitov in trombocitov, nizki koncentraciji magnezija in kalija v krvi.
English: Immune system disorders
Slovenian: Bolezni imunskega sistema občasni:
English: This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in kidney function, including severe kidney impairment.
Slovenian: Če ste prejeli večji odmerek zdravila Zoledronska kislina Accord, kot bi smeli Če ste prejeli odmerek, ki je večji od priporočenega, vas mora zdravnik natančno nadzorovati, zato ker lahko pride do nepravilnosti elektrolitov v serumu (do nepravilnih koncentracij kalcija, fosforja in magnezija) in/ali do spremenjenega delovanja ledvic, vključno z ledvično odpovedjo.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja občasni:
English: You should not be given Zoledronic Acid Accord if you are pregnant.
Slovenian: Če ste noseči, vam ne bi smeli dati zdravila Zoledronska kislina Accord.
English: Zoledronic Acid Accord contains sodium.
Slovenian: Kaj vsebuje zdravilo Zoledronska kislina Accord Zdravilna učinkovina je zoledronska kislina.
English: Additionally, there have been sporadic reports of osteonecrosis of other sites, including the hip and femur, reported predominantly in adult cancer patients treated with Zoledronic Acid .
Slovenian: Poročali so tudi o posameznih primerih osteonekroze na drugih lokacijah, vključno s kolkom in stegnenico.
English: Muscle spasms, osteonecrosis of the jaw
Slovenian: mišični spazmi, osteonekroza čeljustnic zelo redki:
English: Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of a condition called osteonecrosis of the jaw.
Slovenian: Preden vam dajo zdravilo Zoledronska kislina Accord, povejte zdravniku, farmacevtu ali medicinski sestri: - če imate ali ste imeli težave z ledvicami, - če imate ali ste imeli bolečino, oteklino ali odrevenelost čeljusti, občutek pritiska v čeljusti ali če se vam maje zob, - če si zdravite zobe ali če boste imeli zobozdravstveno operacijo, povejte svojemu zobozdravniku, da se zdravite z zdravilom Zoledronska kislina Accord.
English: • Keep Zoledronic Acid Accord out of the reach and sight of children.
Slovenian: Zdravilo Zoledronska kislina Accord shranjujte nedosegljivo otrokom!
English: How to prepare and administer Zoledronic Acid Accord
Slovenian: Kako zdravilo Zoledronska kislina Accord pripravljate in dajete
English: Very common Vomiting, nausea Common
Slovenian: bruhanje, navzea pogosti:
English: Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zoledronic Acid Accord or after stopping treatment.
Slovenian: Če se med zdravljenjem ali po zaključku zdravljenja z zdravilom Zoledronska kisline Accord pojavijo simptomi kot so pojav bolečine, ki je prej ni bilo, poslabšanje obstoječe bolečine ali okornost, takoj obvestite zdravnika.
English: You must not be given Zoledronic Acid Accord if you are breast-feeding.
Slovenian: Če dojite, vam ne smejo dati zdravila Zoledronska kislina Accord.
English: • Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
Slovenian: Redki (lahko se pojavijo pri 1 od 1.000 ljudi): počasno bitje srca, zmedenost, redko se lahko pojavijo neobičajni zlomi stegnenice, še posebno pri bolnikih, ki so na dolgotrajnem zdravljenju osteoporoze.
English: Annex II
Slovenian: PRILOGA II
English: Most of the antihypertensive effect is usually attained within 4 weeks of initiation of treatment.”
Slovenian: Večino antihipertenzivnega učinka se običajno doseže v prvih 4 tednih zdravljenja.“
English: • Other contraindications
Slovenian: • Druge kontraindikacije:
English: • Pregnancy and lactation
Slovenian: • Nosečnost in dojenje
English: The use of AIIRAs in the second and third trimester is contraindicated.
Slovenian: Uporaba AIIRA v drugem in tretjem tromesečju je kontraindicirana.
English: The brief general safety information from clinical studies on doses up to 16/12.5 mg, including withdrawal figures was the same in most countries.
Slovenian: Kratka splošna informacija iz kliničnih študij o odmerkih do 16/12,5 mg, vključno s številkami o odtegnitvi, je bila enaka v večini držav.
English: Overall summary of the scientific evaluation of Atacand Plus and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Atacand Plus in povezanih imen (glejte Prilogo I)
English: Hydroclorthiazide is a diuretic, reduces the volume of the blood, helping control the blood pressure.
Slovenian: Hidroklorotiazid je diuretik, zmanjšuje volumen krvi, in pomaga uravnavati krvni tlak.
English: Withdrawals from treatment due to adverse events were similar with candesartan cilexetil/hydrochlorothiazide (2.3 - 3.3%) and placebo (2.7 - 4.3%)”.
Slovenian: Odtegnitve od zdravljenja zaradi neželenih učinkov so bile podobne pri kombinaciji kandesartan cileksetil/hidroklorotiazid (2,3-3,3 %) in placebu (2,7-4,3 %)“.
English: The information on administration of candesartan/HCT with or without food be located previously in section 4.5 was moved to section 4.2.
Slovenian: Podatek o uporabi kombinacije kandesartan/HCT z ali brez hrane, ki je bil doslej v poglavju 4.5, je bil premaknjen v poglavje 4.2.
English: The CHMP considered the following strengths for Atacand Plus tablets indicated for oral use: 8/12.5 mg, 16/12.5 mg, 32/12.5 mg, and 32/25 mg.
Slovenian: CHMP je obravnaval naslednje jakosti zdravila Atacand Plus tablete, ki je indicirano za peroralno uporabo: 8/12,5 mg, 16/12,5 mg, 32/12,5 mg in 32/25 mg.
English: An additional sentence was introduced by CHMP to stress the preferable practice to titrate with separate components.
Slovenian: CHMP je dodal stavek, s katerim se poudari prednostna praksa titracije z ločenimi komponentami.
English: The CHMP endorsed the proposed harmonised wording: “The recommended dose of Atacand Plus is one tablet once daily.
Slovenian: CHMP je potrdil naslednje usklajeno besedilo: „Priporočeni odmerek zdravila Atacand Plus je ena tableta na dan.
English: The sentence on the clinical significant interactions was corrected in line with the previous Atacand harmonisation referral.
Slovenian: Stavek o kliničnem pomenu interakcij je bil popravljen v skladu s prejšnjo usklajevalno napotitvijo za zdravilo Atacand.
English: However, the CHMP/PhVWP report on the use of ACE inhibitors and angiotensin II receptor antagonists (ARBs) during the 1st trimester of pregnancy (EMEA/CHMP/PhVWP/474692/2007) indicates that a contraindication during the first trimester of pregnancy is not justified; the use of AIIRAs in the first trimester of pregnancy is not recommended.
Slovenian: Vendar poročilo CHMP/PhVWP o uporabi zaviralcev angiotenzin konvertirajočega encima (ACE) in zaviralcev receptorjev angiotenzina II (ARB) v prvem tromesečju nosečnosti (EMEA/CHMP/PhVWP/474692/2007) kaže, da kontraindikacija v prvem tromesečju nosečnosti ni utemeljena; uporaba antagonistov receptorjev angiotenzina II (AIIRA) v prvem tromesečju nosečnosti ni priporočljiva.
English: Information on effects on ability to drive and use machines was included in all countries with slightly different wording in one SPCs.
Slovenian: Informacije o učinkih na sposobnost vožnje in upravljanja s stroji je bila vključena v vseh državah, vendar se je besedilo nekoliko razlikovalo v določenih povzetkih glavnih značilnosti zdravila.