natgillin/translations-raw huggingface dataset:
Docetaxel Accord 160 mg/8 ml is supplied in a 10 ml clear glass vial with fluorotec plus rubber stopper and aluminium seal and a red flip-off cap. 
Docetaksel Accord 160 mg/8 ml je na voljo v 10 ml viali iz prozornega stekla s fluorotek plus gumijastim zamaškom in aluminijastim pokrovčkom, in rdečo zaporko.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Accord 80 mg/4 ml sterile concentrate docetaxel 
IME ZDRAVILA IN POT(I) UPORABE Docetaksel Accord 80 mg/4 ml sterilni koncentrat docetaksel i.v.
You must not breast-feed while you are treated with docetaxel. 
Med zdravljenjem z zdravilom Docetaksel Accord ne smete dojiti.
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Clear glass (type I) vial with fluorotec plus (ethylene tetrafluoroethylene film) rubber stopper and aluminium seal and an orange flip-off cap, containing 1 ml of concentrate. 
Docetaksel Accord 20 mg/1 ml koncentrat za raztopino za infundiranje Viala tipa I iz prozornega stekla s fluorotek plus (etilen tetrafluoroetilenskim premazom) gumijastim zamaškom in aluminijastim pokrovčkom, in oranžno zaporko, ki vsebuje 1 ml koncentrata.
Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion Clear glass (type I) vial with fluorotec plus (ethylene tetrafluoroethylene film) rubber stopper and aluminium seal and a red flip-off cap, containing 8 ml of concentrate. 
Docetaksel Accord 160 mg/8 ml koncentrat za raztopino za infundiranje Viala tipa I iz prozornega stekla s fluorotek plus (etilen tetrafluoroetilenskim premazom) gumijastim zamaškom in aluminijastim pokrovčkom, in rdečo zaporko, ki vsebuje 8 ml koncentrata.
Nail disorders (severe: 0.8%) 
vnetje požiralnika (hudo: 0,4 %)
Aseptically withdraw the required amount of Docetaxel Accord concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle. 
S kalibrirano brizgo, opremljeno z iglo 21G, aseptično odvzemite potrebno količino koncentrata za raztopino za infundiranje Docetaksel Accord.
CAUTION: Ready to add to infusion solution 
POSTOPEK IN POT(I) UPORABE ZDRAVILA OPOZORILO: Že pripravljeno za dodatek raztopini za infundiranje intravenska uporaba
• blood clots. 
• krvni strdki
Docetaxel Accord 20 mg/1 ml is supplied in a 5 ml clear glass vial with fluorotec plus rubber stopper and aluminium seal and an orange flip-off cap. 
Docetaksel Accord 20 mg/1 ml je na voljo v 5 ml viali iz prozornega stekla s fluorotek plus gumijastim zamaškom in aluminijastim pokrovčkom, in oranžno zaporko.
Tabulated list of adverse reactions in breast cancer for docetaxel 100 mg/m2 in combination with trastuzumab 
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom docetaksel 100 mg/m2 pri raku dojke v kombinaciji s trastuzumabom
4.8 Undesirable effects 
Pogosti neželeni učinki
Nausea (G3/4: 13.9%); Stomatitis (G3/4: 
Bolezni prebavil navzea (S3/4: 13,9 %), stomatitis (S3/4: 20,7
For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m2 administered as a 30-minute to 3-hour infusion, followed by 5-fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4. 
• Indukcijska kemoterapija in nato kemoradioterapija (TAX 324) Za indukcijsko zdravljenje bolnikov z lokalno napredovalim (neresektabilen, majhna verjetnost kirurške ozdravitve, ohranitev organa) skvamoznoceličnim karcinomom glave in vratu (SCCHN) je priporočen odmerek docetaksela 75 mg/m2 v obliki enourne intravenske infuzije 1. dan, ki mu sledi cisplatin 100 mg/m2 v 30-minutni do 3-urni infuziji in nato stalna intravenska infuzija 5-fluorouracila
Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 4. 
Bolniki v kraku z docetakselom so dobili docetaksel (T) 75 mg/m2 v intravenski infuziji 1. dan, ki mu je sledil cisplatin (P) 100 mg/m2 v 30-minutni do 3-urni intravenski infuziji in nato stalna intravenska infuzija 5
NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion docetaxel 
Docetaksel Accord 160 mg/8 ml koncentrat za raztopino za infundiranje docetaksel
Amenorrhea was observed to be ongoing at the end of the follow-up period (median follow-up time of 8 years) in 121 of 744 TAC patients (16.3%) and 86 FAC patients 
Na koncu spremljanja (mediani čas spremljanja 8 let) so amenorejo še vedno opažali pri 121 od 744 bolnic v kraku TAC (16,3 %) in pri 86 bolnicah v kraku FAC (11,7 %).
G3/4 AST increased G3/4 Blood alkaline phosphatase increased 
S3/4 zvišanje AST (0,5 S3/4 zvišanje alkalne fosfataze v krvi (< 0,3
50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per vial, equivalent to 10 ml of beer or 4 ml wine. 
50 vol % brezvodnega etanola (alkohola), kar ustreza 359 mg brezvodnega etanola na vialo in je ekvivalentno 10 ml piva ali 4 ml vina.
Tabulated list of adverse reactions in head and neck cancer for docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil 
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom docetaksel 75 mg/m2 pri raku glave in vratu v kombinaciji s cisplatinom in 5-fluorouracilom
You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Accord administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel Accord in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain). 
Namen tega je zmanjšanje določenih neželenih učinkov, ki se lahko pojavijo po infuziji zdravila Docetaksel Accord, zlasti alergijskih reakcij in zastajanja tekočine (otekanje dlani, stopal, nog ali zvečanje telesne mase).
MARKETING AUTHORISATION NUMBER EU/1/12/769/001 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/12/769/001
Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion Clear glass (type I) vial with fluorotec plus (ethylene tetrafluoroethylene film) rubber stopper and aluminium seal and a red flip-off cap, containing 4 ml of concentrate. 
Docetaksel Accord 80 mg/4 ml koncentrat za raztopino za infundiranje Viala tipa I iz prozornega stekla s fluorotek plus (etilen tetrafluoroetilenskim premazom) gumijastim zamaškom in aluminijastim pokrovčkom, in rdečo zaporko, ki vsebuje 4 ml koncentrata.
Docetaxel Accord 80 mg/4 ml is supplied in a 5 ml clear glass vial with fluorotec plus rubber stopper and aluminium seal and a red flip-off cap. 
Docetaksel Accord 80 mg/4 ml je na voljo v 5 ml viali iz prozornega stekla s fluorotek plus umijastim zamaškom in aluminijastim pokrovčkom, in rdečo zaporko.
NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion docetaxel 
Docetaksel Accord 20 mg/1 ml koncentrat za raztopino za infundiranje docetaksel
• operable node-positive breast cancer 
• z operabilnim rakom dojke s pozitivnimi bezgavkami.
Neutropenia (G4: 
Nevtropenija (4. stopnje)
MARKETING AUTHORISATION NUMBER EU/1/12/769/003 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/12/769/003
Description of selected adverse reactions in gastric adenocarcinoma cancer for docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil 
Opis izbranih neželenih učinkov zdravljenja z zdravilom docetaksel 75 mg/m2 v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom želodca
G3/4 Blood alkaline phosphatase increased (< 
S 3/4 zvišanje bilirubina v krvi (< 2,5 %) S3/4 zvišanje alkalne fosfataze v krvi (< 2,5
NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion docetaxel 
Docetaksel Accord 80 mg/4ml koncentrat za raztopino za infundiranje docetaksel
Asthenia that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 12 patients (2.3 %) in TAC arm and 4 patients (0.8 %) in FAC arm. At the end of the follow-up period, asthenia was observed to be ongoing in 2 patients (0.4%) in TAC arm, and in 2 patients (0.4%) in FAC arm. 
Nadaljnjo prisotnost astenije, ki se je začela med obdobjem zdravljenja trajala v obdobje spremljanja, so zabeležili pri 12 bolnicah (2,3 %) v kraku TAC in pri 4 bolnicah (0,8 %) v kraku FAC.
G3/4 ALT increased 
S3/4 zvišanje ALT (< 2
Neutropenia (G3/4: 83.2%); Thrombocytopenia (G3/4: Febrile neutropenia 
anemija (S3/4: 12,4 %), trombocitopenija (S3/4: 4,0 %), febrilna nevtropenija
Tabulated list of adverse reactions in breast cancer for docetaxel 75 mg/m2 in combination with capecitabine 
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom docetaksel 75 mg/m2 pri raku dojke v kombinaciji s kapecitabinom
Myalgia (G3/4: 0.7%); Arthralgia (G3/4: 
Bolezni mišičnoskeletnega sistema in vezivnega tkiva mialgija (S3/4: 0,7 %), artralgija (S3/4: 0,2 %)
Diarrhoea (G3/4: 
Očesne bolezni konjunktivitis (S3/4:
Stomatitis (G3/4: 5.3%); Diarrhoea (G3/4: 4%); 
Bolezni prebavil stomatitis (S3/4: 5,3 %), driska (S3/4: 4 %), navzea (S3/4: 4 %), bruhanje (S3/4: 3 %)
Alopecia ( persisting: Skin disorder (G3/4: 
Bolezni kože in podkožja alopecija, kožna reakcija (S3/4:
This regimen is administered every 
To shemo so uporabljali 4
Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); 
Bolezni prebavil navzea (S3/4: 3,3 %), stomatitis (S3/4: 1,7 %), bruhanje (S3/4: 0,8 %), driska (S3/4: 1,7 %)
Fluid retention (severe: Asthenia (severe: 11.2%); Pain 
Splošne težave in spremembe na mestu aplikacije zastajanje tekočine (hudo: 6,5 %), astenija (huda: 11,2 %), bolečine reakcija na mestu infundiranja, bolečine v prsih, ki niso srčne narave (hude:
In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis). 
Druga je na 3 tedne (Tcis) dobivala docetaksel 75 mg/m2 v 1-urni infuziji v kombinaciji s karboplatinom (AUC 6 mg/ml•min) v 30-60 minutah, tretja pa na 4 tedne (Vcis) vinorelbin (V) 25 mg/m2 v 6-10 minutah
Arrhythmia (G3/4: 
Žilne bolezni hipotenzija (S 3/4:
In GEICAM 9805 study alopecia that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 49 patients (9.2 %) in TAC arm and 35 patients (6.7 %) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9 %) in TAC arm and 30 patients (5.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), alopecia was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm. 
V študiji GEICAM 9805 so nadaljnjo prisotnost alopecije, ki se je začela med obdobjem zdravljenja in je trajala v obdobje spremljanja, zabeležili pri 49 bolnicah (9,2 %) v kraku TAC in pri 35 bolnicah (6,7 %) v kraku FAC.
Docetaxel in combination with trastuzumab 
Docetaksel v kombinaciji s trastuzumabom
Docetaxel in combination with platinum agents in chemotherapy-naïve patients 
Docetaksel v kombinaciji s platinskimi zdravili pri bolnikih, ki še niso bili zdravljeni s kemoterapijo
Tabulated list of adverse reactions in gastric adenocarcinoma cancer for docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil 
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom docetaksel 75 mg/m2 v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom želodca
Anaemia (G3/4: 9.4%); Febrile neutropenia; Thrombocytopenia (G4: 0.8%) 
Bolezni krvi in limfatičnega sistema anemija (S3/4: 20,9 %), nevtropenija (S3/4: 83,2 %), trombocitopenija (S3/4: 8,8 %), febrilna nevtropenija
Asthenia (severe: Fluid retention (severe: 
spremembe nohtov (hude:
Dizziness (G3/4: Peripheral motor neuropathy (G3/4: 
Bolezni živčevja disgevzija (S3/4: periferna senzorična nevropatija (S 3/4:
In study GEICAM 9805 peripheral oedema that started during the treatment period persisted into the follow-up period in 4 patients (0.8%) in TAC arm and in 2 patients (0.4%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), no patients (0%) in TAC arm had peripheral oedema and it was observed to be ongoing in 1 patient (0.2%) in FAC arm. 
V študiji GEICAM 9805 so se med zdravljenjem nastali periferni edemi nadaljevali še med obdobjem spremljanja pri 4 bolnicah (0,8 %) v kraku TAC in pri 2 bolnicah (0,4 %) v kraku FAC.
patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (FAC arm). 
Po stratifikaciji glede na število pozitivnih bezgavk (1-3, 4 ali več) je bilo 1.491 bolnic randomiziranih na prejemanje docetaksela 75 mg/m2, apliciranega 1 uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (krak TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (krak FAC).
Rash pruritus (G3/4: 0.7%); Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%) 
zaprtje (S3/4: 1,0 %), bolečine v prebavilih (S3/4: 1,0 %), ezofagitis/disfagija/odinofagija (S3/4: 0,7 %)
Tabulated list of adverse reactions in breast cancer for docetaxel 75 mg/m2 in combination with doxorubicin 
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom docetaksel 75 mg/m2 pri raku dojke v kombinaciji z doksorubicinom Organski sistemi po MedDRA
Nail disorders (severe: Skin reaction (no severe) 
Bolezni kože in podkožja alopecija, spremembe nohtov (hude 0,4 %), kožna reakcija (nobene hude)
Docetaxel Accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. 
Zdravilo Docetaksel Accord v monoterapiji je indicirano za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, pri katerih predhodna citotoksična terapija ni bila uspešna.
G3/4 AST increased (< 3%); G3/4 ALT increased (< 2%) 
S3/4 zvišanje AST (< 1 S3/4 zvišanje ALT (< 1
Thrombocytopenia (G3/4: Febrile neutropenia 
trombocitopenija, (S3/4: 0,6 %), febrilna nevtropenija
Hot flush (G3/4: 0.5%) Hypotension (G3/4: Phlebitis (G3/4: 0%) 
hipotenzija (S3/4: 0 %) vnetje žile (S 3/4: 0 %)
Description of selected adverse reactions in breast cancer for docetaxel 100 mg/m2 single agent 
Opis izbranih neželenih učinkov monoterapije z zdravilom docetaksel 100 mg/m2 pri raku dojke
Hypersensitivity (G3/4: 1.7%) 
Srčne bolezni miokardna ishemija (S3/4: 1,7 %)
Anaemia (G3/4: 6.9%); Thrombocytopenia (G4: 0.5%) 
51,5 %), anemija (S3/4: trombocitopenija (S4: 0,5 %)
Intravenous use 
uporaba
What Docetaxel Accord looks like and contents of the pack Docetaxel Accord concentrate for solution for infusion is a clear pale yellow to brownish-yellow solution. 
Docetaksel Accord koncentrat za raztopino za infundiranje je prozorna bledorumena do rjavorumena raztopina.
Tabulated list of adverse reactions in breast cancer for docetaxel 100 mg/m2 single agent 
Tabelarični prikaz neželenih učinkov monoterapije z zdravilom docetaksel 100 mg/m2 pri raku dojke
Number of patients 
Posebne skupine bolnikov:
Neutropenia (G3/4: 76.3%); Anaemia (G3/4: 9.2%); 
Bolezni krvi in limfatičnega sistema nevtropenija (S3/4: 76,3 anemija (S3/4: 9,2 %), trombocitopenija (S3/4:
Epistaxis (G3/4: < 1%) 
dermatitis, eritematozen izpuščaj (S3/4: < 1 %),
Uncommon adverse reactions connective tissue disorders General disorders and administration site conditions 
Presnovne in prehranske motnje anoreksija Psihiatrične motnje nespečnost
Tabulated list of adverse reactions in non-small cell lung cancer for docetaxel 75 mg/m2 in combination with cisplatin 
Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom docetaksel 75 mg/m2 pri nedrobnoceličnem pljučnem raku v kombinaciji s cisplatinom Organski sistemi po
LIST OF EXCIPIENTS 
DRUGI PODATKI CITOTOKSIČNO
Uncommon adverse reactions disorders 
Organski sistemi po MedDRA Zelo pogosti neželeni učinki
Myalgia (severe: 1.4%) 
1,4 %), astenija (8,5 % v prim.
Pyrexia (G3/4: NA); Oedema peripheral (G3/4: 0.2%) 
Splošne težave in spremembe na mestu aplikacije astenija (S3/4: 10.0 %), vročica (S3/4: NA), periferni edemi (S3/4: 0,2 %)
Stomatitis/Pharyngitis (G3/4: Vomiting (G3/4: 1.2%) 
bolečine v prebavilih (S3/4: 1,2 %), gastrointestinalna krvavitev (S3/4: 0,4 %)
Parameter 
Odmerjanje:
Tabulated list of adverse reactions in non-small cell lung cancer for docetaxel 75 mg/m2 single agent 
Tabelarični prikaz neželenih učinkov monoterapije z zdravilom docetaksel 75 mg/m2 pri nedrobnoceličnem pljučnem raku
Asthenia (severe: 12.4%); Fluid retention (severe: 0.8%); Pain 
Splošne težave in spremembe na mestu aplikacije astenija (huda: 12,4 %), zastajanje tekočine (hudo: bolečine
Ethanol anhydrous Citric acid anhydrous 
6.1 Seznam pomožnih snovi polisorbat 80 brezvodni etanol brezvodna citronska kislina
Docetaxel Accord 20 mg/1 ml contains 
Zdravilo Docetaksel Accord vsebuje etanol (alkohol) Docetaksel Accord 20 mg/1 ml vsebuje
Date of first authorisation:12 June 2009 
Datum prve odobritve: 12. junij 2009
This leaflet was last revised in {MM/YYYY} 
Navodilo je bilo nazadnje revidirano {MM/LLLL}.
The absolute bioavailability from the tablet was found to be about 77 %. 
Absolutna biološka uporabnost tablete znaša približno 77 %.
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. 
• 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
Distribution Volume of distribution is about 0.15 l/kg and serum protein binding is about 98%. 
Volumen porazdelitve znaša približno 0,15 l/kg, vezava na serumske beljakovine pa približno 98 %.
GORD diagnosis in these studies was based on endoscopic assessment, with the exception of one study in which the inclusion of the patients was based on symptomatology alone. 
V teh študijah je diagnoza GERB temeljila na endoskopski oceni, z izjemo ene študije, v katero so bili bolniki vključeni le na
You must not use PANTECTA Control if you are taking atazanavir. 
Control ne smete uporabljati, če jemljete atazanavir.
The expiry date refers to the last day of that month. 
Rok uporabnosti zdravila se izteče zadnji dan navedenega
If affected, patients should not drive or use machines. 
V tem primeru bolniki ne smejo voziti vozil ali upravljati s stroji.
Hypromellose Povidone K25 
Obloga hipromeloza povidon K25
• They are aged over 55 years with new or recently changed symptoms. 
• če so starejši od 55 let in so se jim pojavili novi simptomi ali pa so se ti pred kratkim
It has been shown that co-administration of atazanavir 300 mg/ritonavir 100 mg with omeprazole (40 mg once daily) or atazanavir 400 mg with lansoprazole (60 mg single dose) to healthy volunteers resulted in a substantial reduction in the bioavailability of atazanavir. 
Dokazano je bilo, da se pri sočasni uporabi atazanavirja 300 mg/ritonavirja 100 mg z omeprazolom (40 mg enkrat na dan) ali atazanavirja 400 mg z lansoprazolom (60 mg v enkratnem odmerku) pri zdravih prostovoljcih znatno zmanjša biološka uporabnost atazanavirja.
Doses up to 240 mg administered intravenously over 2 minutes were well tolerated. 
Odmerke do 240 mg intravensko, aplicirane v 2 minutah, so preiskovanci dobro prenašali.
Approximately 5% of patients can be expected to experience adverse reactions . 
Neželeni učinki se lahko pojavijo pri 5 % bolnikov.
It is unknown whether pantoprazole is excreted in human breast milk. 
Ni znano, če se pri človeku pantoprazol izloča v materino mleko.
What PANTECTA Control is and what it is used for 
Kaj je zdravilo PANTECTA Control in za kaj ga uporabljamo
Driving and using machines If you experience side effects like dizziness or disturbed vision, you should not drive or use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Če se pojavijo neželeni učinki, kot so omotica ali motnje vida, ne smete voziti vozil ali upravljati s stroji.
Especially, patients over 55 years taking any non-prescription indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor. 
Bolniki, predvsem starejši od 55 let, ki zaradi dispeptičnih težav ali zgage vsakodnevno jemljejo katero koli zdravilo brez recepta, morajo o tem obvestiti svojega farmacevta ali
What you need to know before you take PANTECTA Control 
Kaj morate vedeti, preden boste vzeli zdravilo PANTECTA Control
‘Other medicines and PANTECTA Control'. 
“Druga zdravila in zdravilo PANTECTA Control” v nadaljevanju.
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). 
Pri uporabi pantoprazola so poročali o naslednjih neželenih učinkih, ki so v tabeli v nadaljevanju navedeni v skladu z navedbo pogostnosti po MedDRA: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Animal studies have shown excretion of pantoprazole in breast milk. 
Študije na živalih so pokazale, da se pantoprazol izloča v mleko samic.
The mechanism leading to the formation of gastric carcinoids by substituted benzimidazoles has been carefully investigated and allows the conclusion that it is a secondary reaction to the massively elevated serum gastrin levels occurring in the rat during chronic high-dose treatment. 
Mehanizem nastanka želodčnih karcinoidov s substituiranimi benzimidazoli so natančno preučili in zaključili, da gre za sekundarno reakcijo na močno zvišano raven gastrina v serumu, ki se pojavi pri podganah med kroničnim
PANTECTA Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole). 
Zdravilo PANTECTA Control lahko zmanjša absorpcijo zdravilnih učinkovin, katerih biološka uporabnost je odvisna od pH želodčnega soka (npr. ketokonazol).
- if you are taking a medicine containing atazanavir (for the treatment of HIV-infection) See 
- če jemljete zdravilo, ki vsebuje atazanavir (za zdravljenje okužbe z virusom HIV).
Do not take PANTECTA Control: - if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6). 
- če ste alergični na pantoprazol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Co-administration with atazanavir (see section 4.5). 
Sočasno zdravljenje skupaj z atazanavirjem (glejte poglavje 4.5).
- You should not take PANTECTA Control tablets for more than 4 weeks without consulting a doctor. 
- PANTECTA Control tablet ne smete jemati dlje kot 4 tedne brez posveta z zdravnikom.
Biotransformation Pantoprazole is almost exclusively metabolized in the liver. 
Pantoprazol se skoraj izključno presnavlja v jetrih.