natgillin/translations-raw huggingface dataset:
In conclusion, a therapeutic dose of 20 mg/kg body weight administered for 5 consecutive days was confirmed for the treatment of respiratory disease caused by M. gallisepticum in chicken, on basis of a clinical field study in broiler chickens with respiratory disease and confirmed M. gallisepticum infection. 
Na podlagi klinične terenske študije pri pitovnih piščancih z boleznijo dihal in potrjeno okužbo z M. gallisepticum je zato potrjeni terapevtski odmerek za zdravljenje bolezni dihal zaradi M. gallisepticum pri piščancih 20 mg/kg telesne mase, ki se daje 5 zaporednih dni.
Indications: 
Equipamentos
200 mg/g Powder for oral solution 
200 mg/g prašek za peroralno raztopino
Product name 
Produtos e
200mg/g powder for oral solution poultry for oral administration, via drinking water. 
200 mg/g prašek za peroralno raztopino perutnina za peroralno uporabo, s pitno vodo
10 -20 mg doxycyclini hyclas/ kg bw/ day for 3-5 days 
10-20 mg doksiciklina na kg telesne mase na dan 3-5 dni
Water soluble powder broiler drinking water 
(pitovni) piščanci peroralno s pitno vodo
Chicken and turkeys: 1020 mg doxycycline hyclate per 1 kg of body weight daily, administrate d pulse dosed when the daily requirement is given in limited quantity of water to be consumed by the birds within 4-8 hours or supplied 
100 mg/g prašek za peroralno raztopino piščanci, purani, gosi neprekinjeno zdravljenje: 1 g zdravila/1 liter pitne vode pulzno zdravljenje: izračunano količino zdravila raztopiti v pitni vodi in porabiti v 6-8 urah mg/doksicikli na/kg
Colibacillosis, CRD, mycoplasmosiscaused by previously mentioned germs sensitive to doxycycline. 
indikacije: kolibaciloza, kronična bolezen dihal, mikoplazmoze zaradi prej omenjenih mikroorganizmov, občutljivih za doksiciklin
Poultry (not for use in animals from which eggs are produced for human consumption) Calves Pig 
peroralna raztopina piščanci (pitovni) (ni za uporabo pri živalih, katerih jajca so namenjena prehrani ljudi), prašiči peroralno (pitna voda)
Doxiciclina 50% Doxycycline hyclate 
Doxiciclina 50% doksiciklinijev hiklat
In chickens: 10-20 mg doxycycline hyclate per kg bodyweight per day for 3 to 5 days (i.e. 0.5-1.0 ml product/litre water/day) 
10-20 mg doksiciklina/ kg telesne mase/dan (tj. 0,5-1,0 ml zdravila /l pitne vode /dan)
Indications: respiratory infections (M gallisepticum, M, synoviae in M, melagridis), Escherichia coli, Haemophilus paragallinarum, Ornithobacterium rhinotracheale; 
meso in drobovina: perutnina: 4 dni indikacije: okužbe dihal (M gallisepticum, M, synoviae in M, melagridis), Escherichia coli, Haemophilus paragallinarum, Ornithobacterium rhinotracheale; enteritis (Clostridium perfringens in Clostridium colinum; septikemija (Pasteurella multocida)
500 mg/g Powder for oral solution 
500 mg/g prašek za peroralno raztopino
SYVADOX 10 % Doxycycline hyclate 
Syvadox 10% doksiciklinijev hiklat
100 mg/ml doxycycline (as doxycycline hyclate) 
100 mg/ml doksiciklina (v obliki doksiciklinije vega hiklata)
Meat and offal: 4 days, Not permitted for use in laying hens from which eggs are produced for human consumption. 
(pitovni) piščanci: meso in drobovina: 4 dni, ni dovoljena uporaba pri kokoših nesnicah, katerih jajca so namenjena prehrani ljudi;
Indications: Treatment and prevention of respiratory and gastrointestinal diseases caused by organism sensitive to doxycycline: broilers: CRD, mycoplasmosis, aerosaculitis, synovitis, pasteurellosis, infectious cholera, colibacillosis, chlamidiosis, necrotic enteritis 
meso pitovnih piščancev in prašičev: 7 dni indikacije: zdravljenje in preprečevanje okužb dihal in prebavil zaradi organizmov, občutljivih za doksiciklin: pitovni piščanci: kronična bolezen dihal, mikoplazmoza, aerosakulitis, sinovitis, pasteureloza, infekciozna kolera, kolibaciloza, klamidioza, nekrotični enteritis
Indications: treatment of respiratory, intestinal and systemic infections caused by doxycycline sensitive organisms: CRD (Mycoplasma gallisepticum, E. Coli), airsaculitis (Mycoplasma maleagridis), infectious synovitis (Mycoplasma synoviae), fowl cholera (Pasteurella multocida), infectious coryza (Haemophylus paragallinarum), colibacillosis (E. Coli), turkeys bordetellosis (Bordetella avium), necrotic enteritidis (Clostridium perfringens), chlamydiosis (Chlamidia psittaci). 
indikacije: zdravljenje okužb dihal in prebavil ter sistemskih okužb zaradi mikroorganizmov, občutljivih za doksiciklin kronična okužba dihal (Mycoplasma gallisepticum, E. coli), aerosakulitis (Mycoplasma meleagridis), infekcijski sinovitis (Mycoplasma synoviae), kolera perutnine (Pasteurella multocida), infekciozna korica (Haemophilus paragallinarum), kolibaciloza (E. coli), okužbe z bordetelo pri puranih (Bordetella avium), nekrotični enteritis (Clostridium perfringens), klamidioza (Chlamydia psittaci); preprečevanje sekundarnih bakterijskih okužb zaradi stresnih okoliščin, cepljenja,
Denmark CHEMO IBERICA, S.A. 
Nizozemska CHEMO IBERICA, S.A.
Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms 
indikacije: preprečevanje in zdravljenje kronične bolezen dihal in mikoplazmoze zaradi mikroorganizmov,
Via drinking water 0,5-1 ml in 1 l drinking water per day \3-5 days\ 50 
0,5-1 ml v 1 l pitne vode na dan/3-5 dni/50-100 mg doksiciklina meso - 7 dni
100mg/g Water soluble powder 
100 mg/ml vodotopni prašek
Poultry, including pigeons pigs bovine (calves) 
(pitovni) piščanci in prašiči peroralno (pitna voda)
Indications: Chicken (broilers): prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganism sensitive to doxycycline. 
3-5 dni indikacije: (PITOVNI) PIŠČANCI: preprečevanje in zdravljenje kronične bolezni dihal (CRD) in mikoplazmoze zaradi mikroorganizmov, občutljivih za doksiciklin
500 mg/g powder for oral solution chicken (broiler) 
500 mg/g prašek za peroralno raztopino piščanci
Meat: 7 days.Do not administer to chickens producing eggs for human consumption.Indicatio n non-egg laying chickens: 
meso in drobovina: pitovni piščanci: 6 dni ne uporabljajte pri kokoših, katerih jajca so namenjena prehrani ljudi; prašiči: 5 dni indikacije: pitovni piščanci: kronične
50 - 100 mg Doxycycline / litre of drinking water / day (equivalent to 0.5 - 1.0 ml DOXIVEX 10 % / litre of drinking water / day) for 3-5 days 
50-100 mg doksiciklina v 1 l pitne vode/3-5 dni/ enakovredno 0,1-0,2 g Polidoxichem vodotopnega praška v 1 l pitne vode na dan meso - 7 dni
Poultry (chickens) (not for use in animals from which eggs are produced for human consumption) pigs 
peroralna raztopina perutnina (piščanci) (ni za uporabo pri živalih, katerih jajca so namenjena prehrani ljudi), prašiči peroralno (pitna voda)
500 mg/g doxycycline hyclate 
500 mg/g doksiciklinije vega hiklata prašek za peroralno raztopino
Doxyril 50% Doxycycline hyclate 
Doxyril 50% doksiciklinijev hiklat
DOXYRIL 50% Doxycycline hyclate 
DOXYRIL 50% doksiciklinijev hiklat
Poultry: 50mg/kg/day days500g/10 00L drinking water 
500 mg/g vodotopni prašek prašiči, perutnina perutnina: 10-20mg/kg/dan
Indication non-egg laying chickens:Respiratory infections caused by Mycoplasma spp (M. gallisepticum, M.synoviae en M. meleagridis), E. coli and Haemophilus paragallinarum; - Enteritis caused by Clostridium perfringens en Clostridium colinum. 
4 dni indikacije: pitovni piščanci: zdravljenje in preprečevanje kronične bolezni dihal zaradi Mycoplasma spp, Haemophilus paragallinarum, Escherichia coli; enteritis zaradi Clostridium perfringens in Clostridium colinum
Turkey:Respiratory and joints syndroms caused by Mycoplasms and/or Staphilococcus 
Karenca/ indikacije dni mikoplazem in/ali stafilokokov
300 mg/g Powder for oral solution chicken, turkey 40 g product/1200 kg bw/day, calculated amount of the product should be dissolved in the drinking water consumed during 
500 mg/g prašek za peroralno raztopino piščanci neprekinjeno zdravljenje: 0,2 g zdravila/1 liter pitne vode pulzno zdravljenje: izračunano količino zdravila raztopiti v pitni vodi in porabiti v 8 urah
Denmark Huvepharma N.V. Uitbreidingstraat 
Francija Huvepharma N.V.
Broilers: 50 - 100 mg Doxycycline hyclate/L drinking water/day (0,5-1,0 ml of VMP/ drinking water/day) 3-5 days. 
50-100 mg doksiciklina/l iter pitne vode/dan (enakovredn o 0,5-1,0 ml DOXIVEX
Doxyfar 50% Doxycycline hyclate 
Doxycycline hyclate 50%
Lithuania Lavet Pharmaceuticals Ltd., 1161 
Slovaška Lavet Pharmaceuticals Ltd., 1161
for consecutive days or 2 g of product /10 litres drinking water and equivalent to 100 mg of doxycycline /litre of drinking water 
15 mg doksiciklina/ kg TM 5 zaporednih dni ali 2 g zdravila/10 litrov pitne vode in enakovredno 100 mg doksiciklina/l iter pitne vode perutnina (piščanci in purani) 7 dni (ni za uporabo pri živalih, katerih jajca so namenjena prehrani ljudi)
Poultry: CRD, colibacillosis, inflammation of nasal mucosa, synovitis, salmonelosis, fowl cholera, chlamydiosis 
indikacije: zdravljenje okužb zaradi mikroorganizmov, občutljivih za doksiciklin; perutnina: CRD, kolibaciloza, vnetje nosne sluznice, sinovitis, salmoneloza, kolera perutnine, klamidioza
500 mg/g Water soluble powder 
50 mg/g vodotopni prašek
100 mg/g Powder for oral solution 
100 mg/g prašek za peroralno raztopino
200 mg/ml doxycycline hyclate 
100 mg/ml peroralna raztopina
3-5 days 500g/1000L drinking water 
3-5 dni 500 g/1000 l pitne vode meso in drobovina: 6 dni;
200mg/g powder for oral solution chicken (broilers) 
200 mg/g prašek za peroralno raztopino piščanci
100mg/g powder for oral solution chicken (broilers) 
100 mg/g prašek za peroralno raztopino piščanci
Indications: colibacilosis, C.R.D., and associated infections 
Karenca/ indikacije indikacije: kolibaciloza, kronična bolezen dihal in povezane okužbe.
Non-egg laying chickens and turkeys: 20 mg doxycycline hyclate per kg 
(pitovni) piščanci in prašiči peroralno, s pitno vodo pitovni piščanci in purani: 20 mg doksiciklinije vega hiklata/kg TM, 5 dni
Belgium DOPHARMA B.V. Zalmweg 24, 
Portugalska DOPHARMA B.V.
Date of opening: _______ 
Datum odprtja: _______
Tell your doctor: 
- Povejte zdravniku:
Date of first authorisation: 8 February 2018 
Datum prve odobritve: 8. februar 2018
Risk Management Plan (RMP) 
- Načrt za obvladovanje tveganj (RMP)
LABEL for a bottle 
NALEPKA za steklenico
Tablet dimension: 20 x 11 mm. 
Velikost tablet: 20 x 11 mm.
if any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems. 
- če je kateri koli član vaše družine (starši, stari starši, bratje ali sestre) nenadoma umrl zaradi težav s srcem ali je bil rojen s težavami srca.
Additional risk minimisation measures 
- Dodatni ukrepi za zmanjševanje tveganj
Modified LOCF 
Prilagojeni LOCF
The HIV renal educational brochure should contain the following key messages: 
Izobraževalna brošura o virusu HIV in ledvičnem delovanju mora vsebovati naslednja sporočila:
→ Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection. 
→ Zdravnika takoj obvestite o kakršnihkoli novih ali nenavadnih simptomih po prenehanju zdravljenja, zlasti o simptomih, ki jih povezujete z okužbo z virusom hepatitisa B.
if you have severe liver disease. 
- če imate hudo jetrno bolezen.
It is important to tell your doctor or pharmacist if you are taking any of the following: 
Pomembno je, da zdravniku ali farmacevtu poveste, če jemljete katerokoli izmed naslednjih zdravil:
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000). 
Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100) ali redki (≥ 1/10.000 do < 1/1000).
- any signs of skin rash. 
- kakršnekoli znake kožnega izpuščaja.
EU/1/17/1263/001 30 film-coated tablets EU/1/17/1263/002 90 (3 x 30) film-coated tablets 
EU/1/17/1263/001 30 filmsko obloženih tablet EU/1/17/1263/002 90 (3 x 30) filmsko obloženih tablet
if your doctor has told you that you have high or low levels of electrolytes such as potassium or magnesium in your blood. 
- če vam je zdravnik povedal, da imate v krvi visok ali nizek nivo elektrolitov, kot sta kalij ali magnezij.
No virus analysed contained the K65R or K70E mutation. 
- Noben analiziran virus ni vseboval mutacije K65R ali K70E.
Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in every 1,000 patients) but serious side effect that can be fatal. 
- Laktacidoza (čezmerna količina mlečne kisline v krvi) je redek (pojavi se lahko pri največ 1 od 1.000 bolnikov), vendar resen neželeni učinek, ki je lahko smrten.
Common: - anorexia 
Pogosti: - anoreksija.
Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients. 
Anemija je bila pogosta in sprememba obarvanosti kože (povečana pigmentacija) je bila zelo pogosta, ko so emtricitabin prejemali pediatrični bolniki.
Instructions on the use of the creatinine clearance slide ruler 
- Navodila o uporabi drsnega ravnila za očistek kreatinina
severe disturbances of electrolyte balance e.g. hypokalemia or hypomagnesemia. 
- hudo motnjo elektrolitskega ravnotežja, npr. hipokaliemijo ali hipomagneziemijo.
There have also been post-marketing reports of severe depression, death by suicide, delusions psychosis-like behaviour, and catatonia. 
V postmarketinškem obdobju so poročali tudi o hudi depresiji, smrti zaradi samomora, blodnjah, vedenju, podobnem psihozam in katatoniji.
Genotoxicity and repeated-dose toxicity studies of one month or less with the combination of these two components found no exacerbation of toxicological effects compared to studies with the separate components. 
Študije genotoksičnosti in toksičnosti pri ponavljajočih odmerkih, ki so trajale en mesec ali manj pri kombinaciji teh dveh učinkovin, niso pokazale poslabšanja toksikoloških učinkov v primerjavi s študijami posameznih učinkovin.
Cross resistance profiles for efavirenz, nevirapine and delavirdine in vitro demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs. 
Profili navzkrižne odpornosti na efavirenz, nevirapin in delavirdin in vitro so pokazali, da substitucija K103N povzroči izgubo občutljivosti za vse tri NNRTI-je.
Pharmacotherapeutic group: Antiviral for systemic use, antivirals for treatment of HIV infections, combinations, ATC code: J05AR06. 
Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, zdravila za zdravljenje infekcij s HIV, kombinacije, oznaka ATC: J05AR06.
liver failure, in some cases leading to death or liver transplant. 
- jetrna odpoved, ki v nekaterih primerih povzroči smrt ali zahteva presaditev jeter.
Osteomalacia (manifested as bone pain and infrequently contributing to fractures) 
Redki osteomalacija (ki se kaže kot bolečine v kosteh in redko prispeva k zlomom)
In virologically suppressed patients, the clinical relevance of this reduction can be expected to be limited (see section 5.1). 
Pričakuje se lahko, da bo pri bolnikih z virološko supresijo klinični pomen tega zmanjšanja majhen (glejte poglavje 5.1).
In other studies (prospective and crosssectional), the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil as part of a regimen containing a boosted protease inhibitor. 
V drugih študijah (prospektivne in presečne) so najbolj izrazito zmanjšanje mgK opazili pri bolnikih, zdravljenih z dizoproksiltenofoviratom kot del režima, ki je vseboval okrepljen zaviralec proteaze.
PVR (KM): Pure virologic response assessed using the Kaplan Meier (KM) method M: Missing 
PVR (KM): čisti virološki odziv, ocenjen po metodi Kaplan Meier (KM).
→ If you think you may have lactic acidosis, contact your doctor immediately. 
→ Če menite, da imate laktacidozo, se takoj posvetujte z zdravnikom.
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART. 
Poročali so o primerih osteonekroze, zlasti pri bolnikih s splošno priznanimi dejavniki tveganja, napredovalo boleznijo HIV ali dolgotrajno izpostavljenostjo zdravljenju CART.
There were insufficient data to determine whether moderate or severe hepatic impairment (Child-Pugh-Turcotte Class B or C) affects efavirenz pharmacokinetics. 
Ni bilo dovolj podatkov, da bi ugotovili, ali zmerna ali huda jetrna okvara (razreda B ali C po Child-PughTurcotteovi lestvici) vpliva na farmakokinetiko efavirenza.
(CYP3A4 induction 
(CYP3A4 indukcija)
Cmax: ↑ 64% (mechanism of interaction unknown) 
Cmax: ↑ 64 % (mehanizem interakcije ni znan)
Skin and subcutaneous tissue disorders: Very common rash (moderate-severe, 11.6%, all grades, 18%) 
Bolezni kože in podkožja: Zelo pogosti izpuščaj (zmeren do hud, 11,6 %; (vseh stopenj,
itchy rash to the skin caused by a reaction to sunlight 
- srbeč kožni izpuščaj, ki ga povzroči reakcija na sončno svetlobo.
Bupropion, a medicine used to treat depression or to help you stop smoking, as your doctor may need to change your dose of bupropion. 
- Bupropion, zdravilo, ki se uporablja za zdravljenje depresije ali za pomoč pri odvajanju od kajenja, ker bo zdravnik morda moral prilagoditi vaš odmerek bupropiona.
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products. 
Pri sočasnem protivirusnem zdravljenju hepatitisa B ali C glejte ustrezne povzetke glavnih značilnosti teh zdravil.
Similar results were found by other investigators, although the MPA plasma levels were more variable in the second study. 
raziskovalci, čeprav so bile koncentracije MPA v plazmi v drugi študiji bolj spremenljive.
Thymidine analogue associated mutations included D67N (n=1) and K70R (n=1). 
Mutacije, povezane z analogom timidina (TAM = thymidine-analogue associated mutations), vključno z D67N (n = 1) in K70R (n = 1).
Verapamil, Felodipine, Nifedipine and 
verapamil, felodipin, nifedipin in nikardipin
You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. 
- Med jemanjem tega zdravila lahko še vedno prenesete okužbo z virusom HIV na druge, čeprav učinkovito protiretrovirusno zdravljenje to tveganje zmanjša.
The Summary of Product Characteristics HIV renal educational brochure, including the creatinine clearance slide ruler 
- Povzetek glavnih značilnosti zdravila - Izobraževalno brošuro o virusu HIV in delovanju ledvic, vključno z drsnim ravnilom za očistek kreatinina
Efavirenz concentrations not measured, no effect is expected. 
Koncentracij efavirenza niso merili, učinkov ni pričakovati.
Medicines used to lower blood fats (also called statins): Atorvastatin, pravastatin, simvastatin. 
- Zdravila za znižanje količine maščob v krvi (imenovana tudi statini): Atorvastatin, pravastatin, simvastatin.
Medicines used to prevent organ transplant rejection (also called immunosuppressants), such as cyclosporine, sirolimus or tacrolimus. 
- Zdravila za preprečevanje zavrnitve presajenih organov (imenovana tudi imunosupresivi), kakršna so ciklosporin, sirolimus ali takrolimus.
Rare hepatic failure hepatic steatosis, hepatitis 
Redki jetrna odpoved jetrna steatoza, hepatitis
if you have a heart condition, such as an abnormal electrical signal called prolongation of the QT interval that puts you at high risk for severe heart rhythm problems (Torsade de Pointes). 
- če imate bolezen srca, kot je nenormalen električni signal, kar se imenuje podaljšanje intervala QT, zaradi česar imate večje tveganje za hude težave s srčnim ritmom (torsade de pointes).
In clinical controlled studies of efavirenz, nervous system symptoms of moderate to severe intensity were experienced by 19% (severe 2%) of patients, and 2% of patients discontinued therapy due to such symptoms. 
zmerne do hude simptome živčnega sistema doživelo 19 % (hude 2 %) bolnikov in 2 % bolnikov sta prenehala z zdravljenjem zaradi teh simptomov.
Medicines used to treat bacterial infections, including tuberculosis and AIDS-related mycobacterium avium complex: Clarithromycin, rifabutin, rifampicin. 
- Zdravila za zdravljenje bakterijskih okužb, vključno s tuberkulozo in z AIDS-om povezanim kompleksom Mycobacterium avium: Klaritromicin, rifabutin, rifampicin.
Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline. 
- Sertralin, zdravilo, ki se uporablja za zdravljenje depresije: Zdravnik vam bo morda moral spremeniti odmerek sertralina.
These side effects may start in the first 1 or 2 days of treatment and usually go away after the first 2 to 4 weeks. 
i neželeni učinki se lahko pojavijo v prvem dnevu ali prvih dveh dneh zdravljenja in navadno izginejo po prvih dveh do štirih tednih.
A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicates no malformations or foetal/neonatal toxicity associated with emtricitabine and tenofovir disoproxil. 
Večje število podatkov o uporabi pri nosečnicah (več kot 1000 izpostavljenih nosečnosti) kaže, da ni povezave med uporabo emtricitabina in dizoproksiltenofovirata in malformacijsko ali feto-/neonatalno toksičnostjo.
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'. 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni "brez natrija".
When efavirenz is coadministered with a calcium channel blocker that is a substrate of the CYP3A4 enzyme, there is a potential for reduction in the plasma concentrations of the calcium channel blocker. 
Pri sočasni uporabi efavirenza in zaviralca kalcijevih kanalčkov, ki je substrat za encim CYP3A4, obstaja možnost za zmanjšanje plazemskih koncentracij zaviralca kalcijevih kanalčkov.
The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Efavirenz/Emtricitabine /Tenofovir disoproxil Krka are provided with a physician educational pack containing the following: 
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo vsi zdravniki, pri katerih se pričakuje, da bodo predpisovali/uporabljali zdravilo Efavirenz/emtricitabin/dizoproksiltenofovirat Krka, dobili izobraževalni komplet za zdravnike, ki vsebuje naslednje:
n/N (%) 
GMR (%)
In vitro and clinical pharmacokinetic interaction studies have shown the potential for CYP-mediated interactions involving emtricitabine and tenofovir disoproxil with other medicinal products is low. 
In vitro in klinične farmakološke študije interakcij so pokazale, da je potencial za CYP interakcije, ki vključujejo emtricitabin in dizoproksiltenofovirat z drugimi zdravili, nizek.
if you are allergic to efavirenz, emtricitabine, tenofovir disoproxil or any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na efavirenz, emtricitabin, tenofovir, dizoproksiltenofovirat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
Posodobljen RMP je treba predložiti: - na zahtevo Evropske agencije za zdravila; - ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Other medicines used for HIV infection: The following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or ritonavir boosted atazanavir or saquinavir. 
- Druga zdravila proti okužbi z virusom HIV: Naslednji zaviralci proteaze: darunavir, indinavir, lopinavir/ritonavir, ritonavir ali z ritonavirjem okrepljen atazanavir ali sakvinavir.