natgillin/translations-raw huggingface dataset:
Dafiro 10 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Dafiro 5 mg/160 mg.
Dafiro 10 mg/160 mg se može primjenjivati u bolesnika čiji krvni tlak nije odgovarajuće kontroliran samo amlodipinom 10 mg ili valsartanom 160 mg ili s Dafirom 5 mg/160 mg.
Uncommon Insomnia, mood changes (including anxiety), depression, tremor, dysgeusia, syncope, hypoesthesia, visual disturbance (including diplopia), tinnitus, hypotension, dyspnoea, rhinitis, vomiting, dyspepsia, alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, exanthema, myalgia, muscle cramps, pain, micturition disorder, increased urinary frequency, impotence, gynaecomastia, chest pain, malaise, weight increase, weight decrease.
Manje često Nesanica, promjene raspoloženja (uključujući anksioznost), depresija, tremor, disgeuzija, sinkopa, hipoestezija, poremećaj vida (uključujući diplopiju), tinitus, hipotenziju, dispneju, rinitis, povraćanje, dispepsija, alopecija, purpura, promjena boje kože, hiperhidroza, svrbež, egzantem, mijalgija, grčevi u mišićima, bol, poremećaj mikturicije, povećana učestalost mokrenja, impotencija, ginekomastija, bol u prsima, malaksalost, povećanje tjelesne težine, smanjenje tjelesne težine.
Rare (may affect up to 1 in 1,000 people): Feeling anxious; ringing in the ears (tinnitus); fainting; passing more urine than normal or feeling more of an urge to pass urine; inability to get or maintain an erection; sensation of heaviness; low blood pressure with symptoms such as dizziness, lightheadedness; excessive sweating; skin rash all over your body; itching; muscle spasm.
Rijetke (mogu se javiti kod 1 na 1000 osoba): Osjećaj tjeskobe; zvonjava u ušima (tinitus); nesvjestica; pojačano mokrenje ili pojačan nagon na mokrenje; nemogućnost postizanja ili održavanja erekcije; osjećaj težine; niski krvni tlak sa simptomima poput omaglice, omamljenosti; pojačanog znojenja; kožni osip po čitavom tijelu; svrbež; grč mišića.
These doses in rats (200 and 600 mg/kg/day) are approximately 6 and 18 times the maximum recommended human dose on a mg/m basis (calculations assume an oral dose of 320 mg/day and a 60-kg patient).
Takve doze u štakora (200 i 600 mg/kg/dan) otprilike su 6 i 18 puta veće od najviše preporučene doze za ljude izražene u mg/m
Extrapyramidal syndrome
Ekstrapiramidni sindrom -
Nasopharyngitis
Nazofaringitis
CYP3A4 inducers (anticonvulsant agents [e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, Hypericum perforatum) Upon co-administration of known inducers of the CYP3A4, the plasma concentration of amlodipine may vary.
CYP3A4 induktori (antikonvulzivni lijekovi [npr. karbamazepin, fenobarbital, fenitoin, fosfenitoin, primidon], rifampicin, Hypericum perforatum)
Uncommon (may affect up to 1 in 100 people): Mood changes, anxiety, depression, sleeplessness, trembling, taste abnormalities, fainting, loss of pain sensation; visual disturbances, visual impairment, ringing in the ears; low blood pressure; sneezing/runny nose caused by inflammation of the lining of the nose (rhinitis); indigestion, vomiting (being sick); hair loss, increased sweating, itchy skin, skin discolouration; disorder in passing urine, increased need to urinate at night, increased number of times of passing urine; inability to obtain an erection, discomfort or enlargement of the breasts in men, pain, feeling unwell, muscle pain, muscle cramps; weight increase or decrease.
Manje često (mogu se javiti kod 1 na 100 osoba): Promjene raspoloženja, tjeskoba, depresija, pospanost, drhtanje, poremećaji okusa, nesvjestica, gubitak osjećaja boli; poremećaji vida, oštećenje vida, zvonjava u ušima; niski krvni tlak; kihanje/curenje iz nosa uzrokovano upalom sluznice nosa (rinitis); loša probava, povraćanje; ispadanje kose, pojačano znojenje, svrbljiva koža, promjena boje kože; poremećaj mokrenja, pojačana potreba za mokrenjem noću, povećan broj mokrenja, nemogućnost postizanja erekcije, nelagoda ili povećanje dojki u muškaraca, bol, loše osjećanje, bol u mišićima, grčevi u mišićima; povećanje ili smanjenje tjelesne težine.
Amlodipine bioavailability is unaffected by food ingestion.
Unos hrane ne utječe na bioraspoloživost amlodipina.
Dafiro 10 mg/160 mg tablets are oval and light yellow with “NVR” on one side and “UIC” on the other side.
Dafiro 10 mg/160 mg tablete su ovalne, svijetložute tablete, s oznakom „NVR“ na jednoj strani i „UIC“ na drugoj strani.
No dosage adjustment of Dafiro is required for patients with mild to moderate renal impairment (GFR >30 ml/min/1.73 m2).
U bolesnika s blagim do umjerenim oštećenjem bubrega (GFR >30 ml/min/1,73 m2) doziranje Dafira nije potrebno prilagođavati.
Micturition disorder
Poremećaj mikturicije
Dafiro 5 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
Dafiro 5 mg/160 mg se može primjenjivati u bolesnika čiji krvni tlak nije odgovarajuće kontroliran samo amlodipinom 5 mg ili valsartanom 160 mg.
Aortic and mitral valve stenosis
Stenoza aortalnog i mitralnog zaliska
Gingival hyperplasia
Hiperplazija gingive
The pharmacokinetics of amlodipine are not significantly influenced by renal impairment.
Oštećenje bubrega ne utječe u značajnoj mjeri na farmakokinetiku amlodipina.
Sodium- and/or volume-depleted patients
Bolesnici sa sniženom razinom natrija i/ili smanjenim volumenom tekućine
Dermatitis bullous
Bulozni dermatitis
Polyuria
Polakiurija
- Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions.
- Teške kožne reakcije, uključujući intenzivan kožni osip, koprivnjaču, crvenilo kože po čitavom tijelu, jaki svrbež, stvaranje mjehurića, ljuštenje i oticanje kože, upalu sluznica (Stevens
Uncommon (may affect up to 1 in 100 people): Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness of the hands or feet; vertigo; fast heart beat including palpitations; dizziness on standing up; cough; diarrhoea; constipation; skin rash, redness of the skin; joint swelling, back pain; pain in joints.
Manje česte (mogu se javiti kod 1 na 100 osoba): Omaglica; mučnina i bol u trbuhu; suha usta; omamljenost, trnci ili obamrlost šaka ili stopala; vrtoglavica; ubrzani otkucaji srca, uključujući osjećaj lupanja srca; omaglica kod ustajanja; kašalj; proljev; zatvor; kožni osip, crvenilo kože; oticanje zglobova, bol u leđima; bol u zglobovima.
* Mostly consistent with cholestasis
* Uglavnom upućuje na kolestazu Dodatne informacije o kombinaciji
Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx and/or tongue, has been reported in patients treated with valsartan.
U bolesnika koji su liječeni valsartanom prijavljena je pojava angioedema, uključujući oticanje grkljana i glotisa, koji uzrokuje opstrukciju dišnih puteva i/ili oticanje lica, usnica, ždrijela i/ili jezika.
Change of bowel habit
Promijenjene navike pražnjenja crijeva
Myalgia
Mijalgija
Dafiro 5 mg/160 mg tablets are oval and dark yellow “NVR” on one side and “ECE” on the other side.
Dafiro 5 mg/160 mg tablete su ovalne, tamnožute tablete, s oznakom „NVR“ na jednoj strani i „ECE“ na drugoj strani.
The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
Drugi sastojci su mikrokristalična celuloza, krospovidon (tip A), koloidni bezvodni silicijev dioksid, magnezijev stearat, hipromeloza (zamjenski tip 2910 (3 mPas)), makrogol 4000, talk, titanijev dioksid (E171), žuti željezov oksid (E172).
Dyspnoea
Dispepsija
Hypromellose, substitution type 2910 (3 mPa.s) Titanium dioxide (E171) Iron oxide, yellow (E172) Macrogol 4000
Ovojnica hipromeloza zamjenski tip 2910 (3 mPas) titanijev dioksid (E171) željezov oksid, žuti (E172) makrogol 4000 talk
The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
Drugi sastojci su mikrokristalična celuloza, krospovidon (tip A), koloidni bezvodni silicijev dioksid, magnezijev stearat, hipromeloza (zamjenski tip 2910 (3 mPas)), makrogol 4000, talk, titanijev dioksid (E171), žuti željezov oksid (E172), crveni željezov oksid (E172).
Facial oedema
Facijalni edem
Dafiro 5 mg/80 mg film-coated tablets Dafiro 5 mg/160 mg film-coated tablets Dafiro 10 mg/160 mg film-coated tablets
Dafiro 5 mg/80 mg filmom obložene tablete Dafiro 5 mg/160 mg filmom obložene tablete
As a consequence of the inhibition of the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals.
U podložnih pojedinaca mogu se očekivati promjene bubrežne funkcije kao posljedica inhibicije reninangiotenzin-aldosteronskog sustava.
Visual impairment
Oštećenje vida
Dafiro 5 mg/80 mg film-coated tablets
Dafiro 5 mg/80 mg filmom obložene tablete
Dafiro 10 mg/160 mg film-coated tablets
Dafiro 10 mg/160 mg filmom obložene tablete
EU/1/06/371/035 280 film-coated tablets (4x70) EU/1/06/371/038 280 film-coated tablets (20x14)
EU/1/06/371/035 280 filmom obloženih tableta (4x70) EU/1/06/371/038 280 filmom obloženih tableta (20x14)
Grapefruit and grapefruit juice should not be consumed by people who are taking Dafiro.
Bolesnici koji uzimaju Dafiro ne smiju konzumirati grejp ili sok od grejpa.
Common (may affect up to 1 in 10 people): Dizziness, sleepiness; palpitations (awareness of your heart beat); flushing, ankle swelling (oedema); abdominal pain, feeling sick (nausea).
Često (mogu se javiti kod 1 na 10 osoba): Omaglica, pospanost; palpitacije (svijest o radu Vašeg srca); crvenilo uz osjećaj vrućine, oticanje gležnjeva (edem); bol u trbuhu, mučnina.
EU/1/06/371/036 280 film-coated tablets (4x70) EU/1/06/371/039 280 film-coated tablets (20x14)
EU/1/06/371/036 280 filmom obloženih tableta (4x70) EU/1/06/371/039 280 filmom obloženih tableta (20x14)
Each tablet contains 5 mg amlodipine and 80 mg valsartan.
Jedna tableta sadrži 5 mg amlodipina i 80 mg valsartana.
EU/1/06/371/034 280 film-coated tablets (4x70) EU/1/06/371/037 280 film-coated tablets (20x14)
EU/1/06/371/034 280 filmom obloženih tableta (4x70) EU/1/06/371/037 280 filmom obloženih tableta (20x14)
Visual disturbance
Poremećaji oka Poremećaj vida
Arthralgia
Artralgija
Paraesthesia
Parestezija
Dafiro 5 mg/160 mg film-coated tablets
Dafiro 5 mg/160 mg filmom obložene tablete
Flushing, hot flush
Crvenilo uz osjećaj vrućine, navale vrućine
Mood swings
Promjene raspoloženja
Hypromellose, substitution type 2910 (3 mPa.s) Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
Ovojnica hipromeloza zamjenski tip 2910 (3 mPas) titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172) makrogol 4000 talk
Dark yellow, round film-coated tablet with bevelled edges, imprinted with “NVR” on one side and “NV” on the other side.
Tamnožuta, okrugla filmom obložena tableta s kosim rubovima i oznakom „NVR“ na jednoj strani te „NV“ na drugoj strani.
Each tablet contains 10 mg amlodipine and 160 mg valsartan.
Jedna tableta sadrži 10 mg amlodipina i 160 mg valsartana.
Dafiro 10 mg/160 mg film-coated tablets amlodipine/valsartan
Dafiro 10 mg/160 mg filmom obložene tablete amlodipin/valsartan
Each tablet contains 5 mg amlodipine and 160 mg valsartan.
Jedna tableta sadrži 5 mg amlodipina i 160 mg valsartana.
Dafiro 5 mg/80 mg film-coated tablets amlodipine/valsartan
Dafiro 5 mg/80 mg filmom obložene tablete amlodipin/valsartan
Dark yellow, oval film-coated tablet, imprinted with “NVR” on one side and “ECE” on the other side.
Tamnožuta, ovalna filmom obložena tableta s oznakom „NVR“ na jednoj strani te „ECE“ na drugoj strani.
Light yellow, oval film-coated tablet, imprinted with “NVR” on one side and “UIC” on the other side.
Svijetložuta, ovalna filmom obložena tableta s oznakom „NVR“ na jednoj strani te „UIC“ na drugoj strani.
Dafiro 5 mg/160 mg film-coated tablets amlodipine/valsartan
Dafiro 5 mg/160 mg filmom obložene tablete amlodipin/valsartan
EU/1/06/371/001 7 film-coated tablets EU/1/06/371/002 14 film-coated tablets EU/1/06/371/003 28 film-coated tablets EU/1/06/371/004 30 film-coated tablets EU/1/06/371/005 56 film-coated tablets EU/1/06/371/006 90 film-coated tablets EU/1/06/371/007 98 film-coated tablets EU/1/06/371/008 280 film-coated tablets EU/1/06/371/025 56x1 film-coated tablet (unit dose) EU/1/06/371/026 98x1 film-coated tablet (unit dose) EU/1/06/371/027 280x1 film-coated tablet (unit dose)
EU/1/06/371/001 7 filmom obloženih tableta EU/1/06/371/002 14 filmom obloženih tableta EU/1/06/371/003 28 filmom obloženih tableta EU/1/06/371/004 30 filmom obloženih tableta EU/1/06/371/005 56 filmom obloženih tableta EU/1/06/371/006 90 filmom obloženih tableta EU/1/06/371/007 98 filmom obloženih tableta EU/1/06/371/008 280 filmom obloženih tableta EU/1/06/371/025 56x1 filmom obloženih tableta (jedinična doza) EU/1/06/371/026 98x1 filmom obloženih tableta (jedinična doza) EU/1/06/371/027 280x1 filmom obloženih tableta (jedinična doza)
Vomiting
Povraćanje
EU/1/06/371/017 7 film-coated tablets EU/1/06/371/018 14 film-coated tablets EU/1/06/371/019 28 film-coated tablets EU/1/06/371/020 30 film-coated tablets EU/1/06/371/021 56 film-coated tablets EU/1/06/371/022 90 film-coated tablets EU/1/06/371/023 98 film-coated tablets EU/1/06/371/024 280 film-coated tablets EU/1/06/371/031 56x1 film-coated tablet (unit dose) EU/1/06/371/032 98x1 film-coated tablet (unit dose) EU/1/06/371/033 280x1 film-coated tablet (unit dose)
EU/1/06/371/017 7 filmom obloženih tableta EU/1/06/371/018 14 filmom obloženih tableta EU/1/06/371/019 28 filmom obloženih tableta EU/1/06/371/020 30 filmom obloženih tableta EU/1/06/371/021 56 filmom obloženih tableta EU/1/06/371/022 90 filmom obloženih tableta EU/1/06/371/023 98 filmom obloženih tableta EU/1/06/371/024 280 filmom obloženih tableta EU/1/06/371/031 56x1 filmom obloženih tableta (jedinična doza) EU/1/06/371/032 98x1 filmom obloženih tableta (jedinična doza) EU/1/06/371/033 280x1 filmom obloženih tableta (jedinična doza)
Dizziness
Dispneja
Hyperlipidaemia
Hiperlipidemija
No dosage adjustment is required for patients with mild to moderate renal impairment.
U bolesnika s blagim do umjerenim oštećenjem bubrega nije potrebno prilagođavati doziranje.
Impairment of fertility
Poremećaj plodnosti
EU/1/06/371/009 7 film-coated tablets EU/1/06/371/010 14 film-coated tablets EU/1/06/371/011 28 film-coated tablets EU/1/06/371/012 30 film-coated tablets EU/1/06/371/013 56 film-coated tablets EU/1/06/371/014 90 film-coated tablets EU/1/06/371/015 98 film-coated tablets EU/1/06/371/016 280 film-coated tablets EU/1/06/371/028 56x1 film-coated tablet (unit dose) EU/1/06/371/029 98x1 film-coated tablet (unit dose) EU/1/06/371/030 280x1 film-coated tablet (unit dose)
EU/1/06/371/009 7 filmom obloženih tableta EU/1/06/371/010 14 filmom obloženih tableta EU/1/06/371/011 28 filmom obloženih tableta EU/1/06/371/012 30 filmom obloženih tableta EU/1/06/371/013 56 filmom obloženih tableta EU/1/06/371/014 90 filmom obloženih tableta EU/1/06/371/015 98 filmom obloženih tableta EU/1/06/371/016 280 filmom obloženih tableta EU/1/06/371/028 56x1 filmom obloženih tableta (jedinična doza) EU/1/06/371/029 98x1 filmom obloženih tableta (jedinična doza) EU/1/06/371/030 280x1 filmom obloženih tableta (jedinična doza)
What Dafiro looks like and contents of the pack Dafiro 5 mg/80 mg tablets are round and dark yellow with “NVR” on one side and “NV” on the other side.
Dafiro 5 mg/80 mg tablete su okrugle, tamnožute tablete, s oznakom „NVR“ na jednoj strani i „NV“ na drugoj strani.
Hyponatraemia
Hiponatrijemija
Hypercalcaemia
Hiperkalcijemija
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 80 mg of valsartan.
Svaka filmom obložena tableta sadrži 5 mg amlodipina (u obliku amlodipinbesilata) i 80 mg valsartana.
Cardiac disorders Palpitations
Stenoza bubrežne arterije
Pruritus
Kašalj
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan.
Svaka filmom obložena tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata) i 160 mg valsartana.
Exanthema
Mučnina
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan.
Svaka filmom obložena tableta sadrži 5 mg amlodipina (u obliku amlodipinbesilata) i 160 mg valsartana.
Hyperuricaemia
Hiperuricemija
Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 80 mg valsartan.
Jedna tableta sadrži 5 mg amlodipina (u obliku amlodipinbesilata) i 80 mg valsartana.
Each tablet contains 10 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.
Jedna tableta sadrži 10 mg amlodipina (u obliku amlodipinbesilata) i 160 mg valsartana.
Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.
Jedna tableta sadrži 5 mg amlodipina (u obliku amlodipinbesilata) i 160 mg valsartana.
Pollakiuria
Poliurija
Muscle spasm
Posturalna omaglica
If you think you may be allergic, talk to your doctor before taking Dafiro.
Ako mislite da biste mogli biti alergični, porazgovarajte sa svojim liječnikom prije uzimanja Dafira. ako imate teške probleme s jetrom ili probleme sa žuči, poput bilijarne ciroze ili kolestaze.
Anxiety
Anksioznost
Non cardiac chest pain
Faringolaringealna bol
Blood potassium increased
Povišen kalij u krvi
Nausea
Nuspojave
Dizziness postural
Tjestasti edemi
Drug substance*
Djelatna tvar lijeka*
Haemoglobin and haematocrit decreased
Smanjenje hemoglobina i hematokrita
100 x 1 tablets
100 x 1 tableta
EU number
Broj (EU) odobrenja
Strength Pharmaceutical Form Route of Administration Packaging
Farmaceutski oblik
Content
Doza
Package size
Sastav (koncentracija) Veličina pakovanja
How does it work?
Kako djeluje?
What measures are being taken to ensure the safe and effective use of this medicine?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena ovog lijeka?
What are the benefits and risks of this medicine?
Koje su koristi i rizici ovog lijeka?
The recommended dose is one tablet daily.
Preporučena je doza jedna tableta dnevno.
Why is the medicine approved?
Zašto je lijek odobren?
Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Dva su lijeka bioekvivalentna ako proizvode iste razine djelatne tvari u tijelu pa se stoga očekuje da imaju jednak učinak.
As for every medicine, the company provided studies on its quality.
Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti.
If patients need to stop taking one of the active substances in the medicine, or need to take different doses, they will need to change to separate individual medicines.
Ako bolesnik treba prestati uzimati jednu od djelatnih tvari u lijeku ili treba uzeti drugačiju dozu, treba se prebaciti na pojedinačne lijekove.
Patients should take the medicine regularly and not miss any doses.
Bolesnici trebaju redovito uzimati lijek i ne preskakati doze.
It does not cure HIV infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Ne liječi infekciju HIV-om ni AIDS, ali može odgoditi oštećenje imunosnog sustava te razvoj infekcija i bolesti povezanih s AIDS-om.
This means that it contains the same active substances and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Atripla.
To znači da sadrži iste djelatne tvari i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Atripla.
It is recommended that the medicine is taken on an empty stomach, preferably at bedtime.
Preporučuje se da se lijek uzima na prazan želudac, po mogućnosti prije odlaska na počinak.
Treatment should be started by a doctor who has experience in the management of HIV infection.
Liječenje mora započeti liječnik s iskustvom u liječenju infekcije HIV-om.
The educational pack also contains recommendations for monitoring kidney function in patients taking the medicine.
Edukacijski paket sadrži i preporuke za nadzor bubrežne funkcije u bolesnika koji primaju lijek.
The company that markets the medicine will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with medicines containing tenofovir disoproxil such as this one.
Tvrtka koja stavlja lijek na tržište osigurat će da svi liječnici od kojih se očekuje propisivanje lijeka dobiju edukacijski paket koji obuhvaća informacije o povećanom riziku od bolesti bubrega prilikom primjene lijekova koji sadrže tenofovirdizoproksil, kao što je ovaj.
Therefore, the Agency's view was that, as for Atripla, the benefit outweighs the identified risk.
Stoga je stav Agencije da, kao i za lijek Atripla, korist nadmašuje utvrđeni rizik.
It must not be used in patients in whom any previous HIV treatment combinations have not worked or have stopped working.
Lijek se ne smije primjenjivati u bolesnika u kojih bilo koja od prethodnih kombiniranih terapija za liječenje infekcije HIV-om nije djelovala ili je prestala djelovati.
It is not intended to provide practical advice on how to use the medicine.
Svrha sažetka nije davati praktične savjete o primjeni lijeka.
All three active substances block the activity of reverse transcriptase, an enzyme that allows HIV to reproduce itself in the cells it has infected.
Sve tri djelatne tvari blokiraju djelovanje reverzne transkriptaze, enzima koji HIV-u omogućuje reprodukciju u zaraženim stanicama.
For more information on generic medicines, see the question-and-answer document here.
Više informacija o generičkim lijekovima potražite u dokumentu s pitanjima i odgovorima ovdje
The European Medicines Agency concluded that, in accordance with EU requirements, the medicine has been shown to have comparable quality and to be bioequivalent to Atripla.
Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, potvrđeno da lijek posjeduje usporedivu razinu kvalitete i da je bioekvivalentan lijeku Atripla.
Tenofovir is a nucleotide reverse transcriptase inhibitor.
Tenofovir je nukleotidni inhibitor reverzne transkriptaze.
The full EPAR for Efavirenz/Emtricitabine/Tenofovir disoproxil Krka can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Efavirenz/Emtricitabine/Tenofovir disoproxil Krka nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Recommendations and precautions to be followed by healthcare professionals and patients for its safe and effective use have also 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 nalaze se i u sažetku opisa svojstava lijeka i u uputi o lijeku.
This medicine is available as tablets and can only be obtained with a prescription.
Lijek je dostupan u obliku tableta i izdaje se samo na liječnički recept.
How is the medicine used?
Kako se lijek koristi?
The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Tvrtka je provela i ispitivanje koje je pokazalo da je lijek „bioekvivalentan” referentnom lijeku.
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is an antiviral medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka antivirusni je lijek koji se primjenjuje za liječenje odraslih osoba zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).