natgillin/translations-raw huggingface dataset:
Tabulated list of adverse reactions in breast cancer for adjuvant therapy with docetaxel 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data. 
Tablični popis nuspojava za adjuvantno liječenje docetakselom 75 mg/m2 u kombinaciji s doksorubicinom i ciklofosfamidom u bolesnika s karcinomom dojke s pozitivnim (TAX 316) i negativnim (GEICAM 9805) limfnim čvorovima - skupni podaci
If Docetaxel Mylan concentrate or solution for infusion should come into contact with skin, wash immediately and thoroughly with soap and water. 
Ako Docetaxel Mylan koncentrat ili otopina za infuziju dođu u dodir s kožom, to mjesto odmah dobro i temeljito isperite sapunom i vodom.
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, 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). 
Bolesnici su randomizirani tako da su primali ili docetaksel (T) 75 mg/m u obliku jednosatne infuzije, nakon čega je odmah uslijedila terapija cisplatinom (Cis) 75mg/m tijekom 30-60 minuta svaka 3 tjedna (TCis), ili docetaksel 75 mg/m2 u obliku jednosatne infuzije u kombinaciji s karboplatinom (AUC 6 mg/ml u min) tijekom 30-60 min svaka 3 tjedna ili vinorelbin (V) 25 mg/m primijenjen tijekom 6 do 10 minuta na dan 1, 8, 15, 22, nakon čega je slijedilo davanje cisplatine 100 mg/m2 na dan 1 ciklusa koji se ponavljao svaka 4 tjedna (VCis).
- For the treatment of head and neck cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil. 
- Za liječenje karcinoma glave i vrata docetaxel se primjenjuje u kombinaciji s cisplatinom i 5
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 200 mg/10 ml sterile concentrate docetaxel 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Mylan 200 mg/10 ml sterilni koncentrat docetaksel
Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m² in combination with trastuzumab 
Opis odabranih nuspojava kod karcinoma dojke za docetaksel 100 mg/m² u kombinaciji s trastuzumabom
Peripheral sensory neuropathy (G3/4: 
periferna motorna neuropatija (G3/4:
One vial contains 20 mg of docetaxel. 
Jedna bočica sadržava 20 mg docetaksela.
For patients who are dosed initially at docetaxel 75 mg/m² in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is < 25,000 cells/mm3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m². 
Kombinacija s cisplatinom Bolesnicima koji početnu dozu docetaksela od 75 mg/m primaju u kombinaciji s cisplatinom i u kojih je najniži broj trombocita tijekom prethodnog ciklusa liječenja iznosio < 25.000 stanica/mm
NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 200 mg/10 ml concentrate for solution for infusion 
NAZIV LIJEKA Docetaxel Mylan 200 mg/10 ml koncentrat za otopinu za infuziju
How to store Docetaxel Mylan 80 mg/4 ml 
Kako čuvati Docetaxel Mylan 80 mg/4 ml
• inflammation of the colon, small intestine; intestinal perforation 
• upala debelog crijeva, tankog crijeva; probušenje crijeva
Alopecia; Erythema, Rash; Nail disorders 
Poremećaji kože i potkožnog tkiva alopecija;eritem; osip; poremećaji noktiju
How to store Docetaxel Mylan 20 mg/1 ml 
Kako čuvati Docetaxel Mylan 20 mg/1 ml
Docetaxel Mylan in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition. 
Docetaxel Mylan u kombinaciji s cisplatinom indiciran je za liječenje bolesnika s neoperabilnim, lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća, koji nisu ranije primali kemoterapiju za tu bolest.
10 ml clear glass Type I vial with a bromobutyl rubber stopper and aluminium seal and a plastic flipoff cap containing 4 ml of concentrate for solution for infusion. 
Prozirna staklena bočica od 10 ml (staklo tip I) s 4 ml koncentrata za otopinu za infuziju, bromobutilnim gumenim čepom i aluminijskim prstenom te plastičnim "flip-off" zatvaračem.
Vascular disorders Hot flush (G3/4: 0.5%) Hypotension (G3/4: 0%) Phlebitis (G3/4: 0%) 
Krvožilni poremećaji hipotenzija (G3/4: flebitis (G3/4: 0%)
(539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in 
(539 bolesnika u TAC skupini) ili doksorubicin 50 mg/m nakon kojeg slijedi fluorouracil
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
One vial of 1 ml of concentrate contains 395 mg of ethanol anhydrous. 
Jedna bočica od 1 ml koncentrata sadržava 395 mg etanola, bezvodnog.
NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 80 mg/4 ml concentrate for solution for infusion 
NAZIV LIJEKA Docetaxel Mylan 80 mg/4 ml koncentrat za otopinu za infuziju
G3/4 Blood alkaline phosphatase increased 
G3/4 povećanje bilirubina u krvi G3/4 povećanje alkalne fosfataze u krvi
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 80 mg/4 ml sterile concentrate docetaxel 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Mylan 80 mg/4 ml sterilni koncentrat docetaksel
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 20 mg/1 ml sterile concentrate docetaxel 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Mylan 20 mg/1 ml sterilni koncentrat docetaksel
Docetaxel Mylan 80 mg/4 ml concentrate for solution for infusion Docetaxel 
Docetaxel Mylan 80 mg/4 ml koncentrat za otopinu za infuziju docetaksel
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. 
Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m2 intravenskom. infuzijom na dan 1 nakon čega je slijedio cisplatin (P) 100 mg/m2 primijenjen kao 30-minutna do 3-satna intravenska infuzija praćena kontinuiranom intravenskom infuzijom 5-fluorouracila (F) 1000 mg/m dnevno od dana 1 do dana 4. Liječenje se primjenjivalo svaka 3 tjedna, tijekom 3 ciklusa.
NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 20 mg/1 ml concentrate for solution for infusion 
NAZIV LIJEKA Docetaxel Mylan 20 mg/1 ml koncentrat za otopinu za infuziju
Docetaxel Mylan 20 mg/1 ml concentrate for solution for infusion Docetaxel 
Docetaxel Mylan 20 mg/1 ml koncentrat za otopinu za infuziju docetaksel
15 ml clear glass Type I vial with a bromobutyl rubber stopper and aluminium seal and a plastic flipoff cap containing 10 ml of concentrate for solution for infusion. 
Prozirna staklena bočica od 15 ml (staklo tip I) s 10 ml koncentrata, za otopinu za infuziju, s bromobutilnim gumenim čepom i aluminijskim prstenom te plastičnim "flip off" zatvaračem.
Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with capecitabine 
Tablični popis nuspojava kod karcinoma dojke za docetaksel 75 mg/m² u kombinaciji s kapecitabinom
Docetaxel Mylan in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. 
Docetaxel Mylan u kombinaciji s kapecitabinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije s drugim citostaticima.
If Docetaxel Mylan concentrate or solution for infusion should come into contact with mucous membranes, wash immediately and thoroughly with water. 
Ako Docetaxel Mylan koncentrat ili otopina za infuziju dođu u dodir sa sluznicom, odmah dobro i temeljito isperite vodom.
1060 patients were randomized to receive either docetaxel 75 mg/m administered 1-hour after doxorubicin 50 mg/m 
1060 bolesnika randomizirano je u skupine koje su primale ili docetaksel 75 mg/m primijenjen jedan sat nakon doksorubicina 50 mg/m i ciklofosfamida 500 mg/m
Immune system disorders Metabolism and nutrition disorders Nervous system disorders neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe: 
Poremećaji imunološkog sustava preosjetljivost (G3/4: 1,7%) Poremećaji metabolizma i prehrane anoreksija (G3/4: 11,7%) Poremećaji živčanog sustava periferna senzorna neuropatija omaglica (G3/4: 2,3%); periferna motorna neuropatija (G3/4: 1,3%)
Docetaxel Mylan in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. 
Docetaxel Mylan u kombinaciji s doksorubicinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke koji nisu ranije liječeni citostaticima za tu bolest.
Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m2 single agent 
Opis odabranih nuspojava kod karcinoma dojke za docetaksel 100 mg/m2 u monoterapiji
Docetaxel Mylan monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. 
Docetaxel Mylan kao monoterapija indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije drugim citostaticima.
Anorexia (G3/4: 
aritmija (G3/4:
There are limited available data in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide. 
Podaci o primjeni docetaksela u kombinaciji s doksorubicinom i ciklofosfamidom za bolesnike starije od 70 godina su ograničeni.
Excipients 
Prednizon
Data from a multicenter open label randomized study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥ 80%, between 18 and 70 years of age. 
Docetaksel u kombinaciji s doksorubicinom i ciklofosfamidom: adjuvantno liječenje Bolesnici s operabilnim karcinomom dojke i pozitivnim limfnim čvorovima (TAX 316) Podaci iz multicentričnog, otvorenog, randomiziranog ispitivanja podupiru primjenu docetaksela za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i pozitivnim limfnim čvorovima te s KPS > 80%, u dobi od 18 do 70 godina.
Tabulated list of adverse reactions in prostate cancer for Docetaxel 75 mg/m² in combination with prednisone or prednisolone 
Tablični popis nuspojava kod karcinoma prostate za docetaksel 75 mg/m² u kombinaciji s prednizonom ili prednizolonom MedDRA klasifikacija organskih sustava
Each ml of concentrate for solution for infusion contains 395 mg of ethanol anhydrous. 
Jedna ml koncentrata za otopinu za infuziju sadržava 395 mg etanola, bezvodnog.
Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel 75 mg/m² single agent MedDRA system organ classes 
Tablični popis nuspojava kod karcinoma nemalih stanica pluća za docetaksel 75 mg/m² u monoterapiji MedDRA klasifikacija organskih sustava
Infection (G3/4: 3.6%) Neutropenic infection 
Infekcije i infestacije infekcija (G3/4: 2,4%); neutropenijska
EU/1/11/748/004 - 5 vials 
EU/1/11/748/004 - 5 bočica
Description of selected adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m in combination with cisplatin and 5-fluorouracil 
Opis odabranih nuspojava za docetaksel 75 mg/m² u kombinaciji s cisplatinom i 5-fluorouracilom u terapiji adenokarcinoma želuca
• operable node-negative breast cancer 
• operabilnim karcinomom dojke i negativnim limfnim čvorovima.
Esophagitis/dysphagia/ odynophagia (G3/4: 
Poremećaji reproduktivnog sustava i dojki amenoreja (G3/4: NA)
EU/1/11/748/002 - 5 vials 
EU/1/11/748/002 - 5 bočica
Dehydration (G3/4: 2%) 
Poremećaji metabolizma i prehrane dehidracija (G3/4: 2%)
Psychiatric disorders Nervous system disorders Eye disorders Cardiac disorders 
Poremećaji živčanog sustava parestezija; glavobolja; disgeuzija;
MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/001 - 1 vial 
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/748/001 - 1 bočica
Tabulated list of adverse reactions in head and neck cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil 
Tablični popis nuspojava za docetaksel 75 mg/m2 u kombinaciji s cisplatinom i 5-fluorouracilom za terapiju karcinoma glave i vrata
First episode: reduce docetaxel and 5-FU doses by 20%. 
Proljev stupnja 4 Prva epizoda: smanjiti doze docetaksela i 5-FU za 20 % Druga epizoda: prekinuti liječenje
Citric acid (pH adjustment) 
6.1 Popis pomoćnih tvari polisorbat 80 etanol bezvodni citratna kiselina (prilagodba pH)
Infusion site reaction 
Opći poremećaji i reakcije na mjestu primjene reakcija na mjestu primjene infuzije
MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/003 - 1 vial 
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/748/003 - 1 bočica
Nausea (G3/4: 13.9%); Stomatitis (G3/4: 
Poremećaji probavnog sustava mučnina (G 3/4: 2,4%); stomatitis/faringitis (G3/4:
Dry skin ; Desquamation 
Poremećaji kože i potkožnog tkiva suhoća kože; deskvamacija
Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil 
Tablični popis nuspojava za docetaksel 75 mg/m² u kombinaciji s cisplatinom i 5-fluorouracilom u terapiji adenokarcinoma želuca
Gastrointestinal haemorrhage (G3/4: 
Srčani poremećaji ishemija miokarda (G3/4:
Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² in combination with trastuzumab 
Tablični popis nuspojava kod karcinoma dojke za docetaksel 100 mg/m² u monoterapiji
Vomiting (G3/4: 5%); Constipation 
trombocitopenija (G3/4: 0,6%); febrilna neutropenija
Diarrhoea (G3/4: 6.2%); 
Infekcije i infestacije infekcija (G3/4: 6,3%);
Nausea (G3/4: 5%); Stomatitis (G3/4: 7.8%); 
Poremećaji probavnog sustava mučnina (G3/4: 3,3%); stomatitis (G3/4: 1,7%); povraćanje (G3/4: 0,8%);
Nail disorders (severe: Skin reaction (no severe) 
Poremećaji kože i potkožnog tkiva alopecija; poremećaji noktiju (ne teški)
Immune system disorders Metabolism and nutrition disorders Nervous system disorders 
Poremećaji metabolizma i prehrane anoreksija
Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel 75 mg/m² in combination with cisplatin 
Tablični popis nuspojava kod karcinoma nemalih stanica pluća za docetaksel 75 mg/m² u kombinaciji s cisplatinom MedDRA klasifikacija organskih sustava
Hearing impaired (G3/4: 1.2%) 
bol izazvana karcinomom (G3/4: 1,2%)
256 patients were randomised to treatment with docetaxel alone (100 mg/m² as a 1 hour intravenous infusion every 3 weeks). 
Za liječenje docetakselom u monoterapiji (100 mg/m2 u obliku jednosatne intravenske infuzije svaka 3 tjedna) bilo je randomizirano 256
Arrhythmia (G3/4: 
Krvožilni poremećaji hipotenzija (G3/4:
Peripheral motor neuropathy (G3/4: 2.5%) 
Poremećaji živčanog sustava periferna senzorna neuropatija periferna motorna neuropatija (G3/4: 2,5%)
Nail disorders (severe: 0.7%); Skin reaction (G3/4:< 0.2%) 
Poremećaji kože i potkožnog tkiva kožna reakcija (G3/4: 0,8%)
Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with doxorubicin 
Tablični popis nuspojava kod karcinoma dojke za docetaksel 75 mg/m² u kombinaciji s doksorubicinom MedDRA klasifikacija organskih sustava
Peripheral motor neuropathy (G3/4: 0.4%) 
Poremećaji živčanog sustava neuropatija (G3/4: 0,6%)
Weight increased (G3/4: Weight decreased (G3/4: 
Pretrage porast tjelesne težine (G3/4: 0%); gubitak tjelesne težine (G3/4: 0,2%)
The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in: 
Ishodi djelotvornosti za skupinu docetaksela u odnosu na kontrolnu skupini prikazani su u sljedećoj tablici:
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy 
Pri primjeni docetaksela u kombinaciji s drugim citostaticima i/ili radioterapijom, zabilježeni su slučajevi akutne mijeloične leukemije i mijelodisplastičnog sindroma.
Number 
Ishod
Patients with severe liver impairment (see sections 4.2 and 4.4). 
Docetaksel se ne smije primjenjivati u bolesnika s teškim oštećenjima jetre, jer o tome ne postoje dostupni podaci (vidjeti dio 4.2. i 4.4).
Musculoskeletal, connective tissue bone disorders 
Poremećaji mišićnokoštanog sustava i vezivnog tkiva mialgija
p = Hazard ratio* 
Podskupina bolesnika p= Omjer hazarda
Arrhythmia (G3/4: 0.2%) 
Srčani poremećaji aritmija (G3/4: 0,2%);
Venous disorder (G3/4: 0.6%) 
Poremećaji imunološkog sustava preosjetljivost (G3/4: 0,6%)
Hypotension 
Toksičnost
Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m². 
ili 4 treba smanjiti dozu na 60 mg/m
Patient subset 
Podskupina bolesnika Broj bolesnika u
Vomiting (G3/4: 0.6%) 
bol izazvana karcinomom (G3/4: 0,6%)
Packaging Content Package size 
Pakovanje Sadržaj Veličina pakovan ja
Via Virgilio Maroso, 50, 00142 Rome, Italy 
Via Virgilio Maroso, 50, 00142 Rim, Italija
Arnulfstrasse 29, München, 80636,Germany 
KGaA Arnulfstrasse 29, München, 80636, Njemačka
Budějovická 778/3, Michle 140 00 Prague 4, Czech Republic 
Budějovická 778/3, Michle 140 00 Prague 4, Češka Republika
Bristol-Myers Squibb S.A. C/Quintanavides, 15, 28050 Madrid, Spain 
Bristol-Myers Squibb S.A. C/Quintanavides, 15, 28050 Madrid, Španjolska
Bristol-Myers Squibb GesmbH Rivergate / Gate 1 / 5.OG, Handelskai 92, 1200 Vienna, Austria 
Bristol-Myers Squibb GesmbH Rivergate / Gate 1 / 5.OG, Handelskai 92, 1200 Beč, Austrija
Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands 
Orteliuslaan 1000, 3528 BD Utrecht, Nizozemska
Orteliuslaan 1000, Utrecht, 3528 BD, The Netherlands 
Orteliuslaan 1000, Utrecht, 3528 BD, Nizozemska
Budějovická 778/3, Michle, 140 00 Prague, Czech Republic 
Budějovická 778/3, Michle, 140 00 Prag, Češka Republika
Bristol-Myers Squibb Holdings Limited t/a Bristol-Myers Pharmaceuticals, Swords, County Dublin, Ireland 
Bristol-Myers Squibb Holdings Limited t/a Bristol-Myers Pharmaceuticals, Swords, County Dublin, Irska meke kapsule
s.r.o. 
Prilog I.
Chaussée De La Hulpe, 185, 1170 Bruxelles, Belgium 
Bristol-Myers Squibb Belgium S.A. Chaussée De La Hulpe, 185, 1170 Bruxelles, Belgija
Bristol-Myers Squibb GmbH & Co. KGaA 
Bristol-Myers Squibb GmbH & Co.
Bristol-Myers Squibb spol. 
Bristol-Myers Squibb spol. s.r.o.
300 MBq/ml Solution for injection 
300 MBq/ml Otopina za injekciju U venu
See ‘Do not take 
Pogledajte 'Ne uzimajte
Children and adolescents 
Djeca ili adolescenti
The following additional risks are considered relevant for long-term use 
Sljedeći dodatni rizici smatraju se relevantnim pri dugotrajnoj primjeni:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: 
Za sve dodatne informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovog lijeka u promet:
If you take more SOMAC Control than you should Tell your doctor or pharmacist if you have taken more than the recommended dose. 
Ako uzmete više lijeka SOMAC Control nego što ste trebali Obavijestite liječnika ili ljekarnika ako ste uzeli više od preporučene doze.
What SOMAC Control is and what it is used for 
Što je SOMAC Control i za što se koristi
SOMAC Control may stop certain other medicines from working properly. 
SOMAC Control može zaustaviti djelovanje nekih drugih lijekova.
SOMAC Control has no or negligible influence on the ability to drive and use machines. 
SOMAC Control ne utječe ili neznatno utječe na sposobnost upravljanja vozilima ili rada sa strojevima.
To avoid this interference, SOMAC Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1). 
Kako bi se izbjegla ova interferencija, liječenje lijekom SOMAC Control potrebno je prekinuti najmanje 5 dana prije mjerenja razine CgA (vidjeti dio 5.1.).
SOMAC Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy. 
SOMAC Control se ne preporučuje za primjenu u djece i adolescenata u dobi ispod 18 godina jer nema dovoljno podataka o sigurnosti i djelotvornosti.
SOMAC Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal. 
SOMAC Control 20 mg želučanootporne tablete se ne smiju žvakati ni lomiti, već ih se mora progutati cijele s tekućinom prije obroka.
If you take SOMAC Control for longer periods, this may cause additional risks, such as: 
Uzimanje lijeka Somac Control tijekom duljih razdoblja može izazvati dodatne rizike, kao što su:
SOMAC Control is available in Alu/Alu blisters with or without cardboard reinforcement. 
SOMAC Control je dostupan u Al/Al blisterima sa ili bez kartonskog pojačanja.
You must not use SOMAC Control if you are taking HIV protease inhibitors. 
Ne smijete koristiti SOMAC Control ako uzimate inhibitore HIV proteaze.
What SOMAC Control is and what it is used for What you need to know before you take SOMAC Control How to take SOMAC Control Possible side effects 
Što je SOMAC Control i za što se koristi Što morate znati prije nego počnete uzimati SOMAC Control Kako uzimati SOMAC Control Moguće nuspojave
Stop taking SOMAC Control when you are completely symptom-free. 
Prestanite uzimati SOMAC Control kada nastupi potpuno povlačenje simptoma.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/. 
Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/
- methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your SOMAC Control treatment because pantoprazole can increase levels of methotrexate in the blood. 
- metotreksat (koristi se za liječenje reumatoidnog artritisa, psorijaze ili raka) - ako uzimate metotreksat liječnik će možda preporučiti da privremeno prekinete uzimati SOMAC Control jer pantoprazol može povisiti razine metotreksata u krvi.
- if you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with SOMAC Control. 
- ako dobijete osip na koži, posebice na područjima izloženima suncu obavijestite svojeg liječnika što je prije moguće, jer ćete možda morati prekinuti liječenje lijekom SOMAC Control.
See ‘Other medicines and SOMAC Control'. 
Pogledajte 'Ostali lijekovi i SOMAC Control'.
What SOMAC Control contains - The active substance is pantoprazole. 
Što SOMAC Control sadrži - Djelatna tvar je pantoprazol.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
Recite svom liječniku ili ljekarniku ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
SOMAC Control should not be used by children and adolescents under 18 years of age due to a lack of safety information in this younger age group. 
SOMAC Control ne smiju koristiti djeca i mladi u dobi do 18 godina jer ne postoje podaci o sigurnosti primjene u ovoj mlađoj dobnoj skupini.
Disorientation (and all aggravations) 
dezorijentira nost (i pogoršanje istog)
SOMAC Control contains the active substance pantoprazole, which blocks the ‘pump' that produces stomach acid. 
SOMAC Control sadrži djelatnu tvar pantoprazol, koja blokira „pumpu“ koja proizvodi želučanu kiselinu.
What you need to know before you take SOMAC Control 
Što morate znati prije nego počnete uzimati SOMAC Control