FrancophonIA/ELRC3.0 huggingface dataset:
English: Immune system disorders Metabolism and nutrition disorders Nervous system disorders neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Slovenian: Presnovne in prehranske motnje Bolezni živčevja periferna senzorična nevropatija (S3: periferna motorična nevropatija (S3/4: 2 %)
English: Cystoid macular oedema (CMO) has been reported in patients treated with docetaxel.
Slovenian: Pri bolnikih zdravljenih z docetakselom, je bil opisan cistoidni makularni edem (CMO).
English: Peripheral motor neuropathy (G3/4: 0%)
Slovenian: Bolezni živčevja periferna motorična nevropatija (S3/4: 0 %)
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m² v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom želodca
English: 2 Estimated median survival
Slovenian: celotna množica za analizo (z-namenom-zdravljenja) 2ocenjeno mediano preživetje
English: What Docetaxel Mylan 20 mg/1 ml looks like and contents of the pack
Slovenian: Izgled zdravila Docetaxel Mylan 20 mg/1 ml in vsebina pakiranja
English: Peripheral sensory neuropathy (G3/4:
Slovenian: periferna motorična nevropatija (S3/4:
English: If not used immediately, inuse storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.
Slovenian: Navadno naj se ne shranjuje dlje kot šest ur pod 25°C, vklučno z eno uro infindiranja.
English: This medicine contains 50 vol % ethanol (alcohol), i.e. up to 1.58g per vial equivalent to 40 ml of beer or 17 ml wine per vial.
Slovenian: Zdravilo vsebuje 50 vol % etanola (alkohola), to je do 158 mg na vialo, kar ustreza 40 ml piva ali 17 ml vina na vialo.
English: Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel 75 mg/m² in combination with cisplatin
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m² pri nedrobnoceličnem pljučnem raku v kombinaciji s cisplatinom
English: Asthenia persisted into the follow-up period (median follow-up time of 10 years and 5 months) and was observed to be ongoing in 12 patients (2.3 %) in TAC arm and 4 patients (0.8 %) in FAC arm.
Slovenian: V študiji GEICAM 9805 je astenija trajala v obdobje spremljanja (mediano obdobje spremljanja 10 let in 5 mesecev); njeno nadaljnjo prisotnost so zabeležili pri 12 bolnicah (2,3 %) v kraku TAC in pri 4 bolnicah (0,8 %) v kraku FAC.
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with capecitabine
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m² pri raku dojke v kombinaciji s kapecitabinom
English: Vascular disorders Hot flush (G3/4: 0.5%) Hypotension (G3/4: 0%) Phlebitis (G3/4: 0%)
Slovenian: Žilne bolezni hipotenzija (S3/4: 0 %) vnetje žile (S 3/4: 0 %)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 200 mg/10 ml sterile concentrate docetaxel
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Docetaxel Mylan 200 mg/10 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba
English: Arrhythmia (G3/4: 0.7%)
Slovenian: Srčne bolezni aritmija (S3/4:0,7 %)
English: Rash pruritus (G3/4: 0.7%); Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Slovenian: zaprtje (S3/4: 1,0 %), bolečine v prebavilih (S3/4: ezofagitis/disfagija/odinofagija (S3/4: 0,7 %)
English: What Docetaxel Mylan 200 mg/10 ml contains
Slovenian: Kaj vsebuje zdravilo Docetaxel Mylan 200 mg/10 ml
English: Nail disorders (severe: 0.7%); Skin reaction (G3/4:< 0.2%)
Slovenian: Bolezni kože in podkožja alopecija, spremembe nohtov (hude: 0,7 %), kožna reakcija (S3/4:
English: Hearing impaired (G3/4: 1.2%)
Slovenian: bolečina zaradi raka (S3/4: 1,2 %)
English: This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 3.95 g per vial, equivalent to 100 ml of beer or 40 ml wine per vial.
Slovenian: Zdravilo vsebuje 50 vol % etanola (alkohola), to je do 3,95 g na vialo, kar ustreza 100 ml piva ali 40 ml vina na vialo.
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with doxorubicin
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaksel 75 mg/m² pri raku dojke v kombinaciji z doksorubicinom Organski sistemi po MedDRA
English: 5-fluorouracil (clinically important treatment related adverse events are presented).
Slovenian: fazi študije), ki so prejemali docetaksel v kombinaciji s cisplatinom in 5-fluorouracilom (navedeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki).
English: Docetaxel Mylan monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Slovenian: Zdravilo Docetaxel Mylan v monoterapiji je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, pri katerih predhodna citotoksična terapija ni bila uspešna.
English: Nervous system disorders
Slovenian: Bolezni živčevja vrtoglavica
English: Arrhythmia (G3/4:
Slovenian: Srčne bolezni aritmija (S3/4:
English: Lacrimation increased (G3/4: <0.1%)
Slovenian: Očesne bolezni motnja solzenja (S3/4: < 0,1 %),
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 80 mg/4 ml sterile concentrate docetaxel
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Docetaxel Mylan 80 mg/4 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba
English: Nausea (G3/4: 0.6%); Stomatitis (G3/4: 4.0%);
Slovenian: Bolezni prebavil navzea (S3/4: 0,6 %), stomatitis (S3/4: 4,0 %), driska (S3/4: 2,9 %), bruhanje (S3/4: 0,6 %)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 20 mg/1 ml sterile concentrate docetaxel
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Docetaxel Mylan 20 mg/1 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba
English: What Docetaxel Mylan 20 mg/1 ml contains
Slovenian: Kaj vsebuje zdravilo Docetaxel Mylan 20 mg/1 ml
English: PSA** response rate (%) 95% CI p-value*
Slovenian: število bolnikov odzivnost na bolečino (%) 95 % IZ p-vrednost*
English: Arrhythmia (G3/4: 0.2%)
Slovenian: Srčne bolezni aritmija (S3/4: 0,2 %),
English: Infusion site reaction
Slovenian: Splošne težave in spremembe na mestu aplikacije reakcija na mestu infundiranja
English: This medicine contains 50 vol % ethanol (alcohol), i.e. up to 3.95g per vial equivalent to 100 ml of beer or 40 ml wine per vial.
Slovenian: Zdravilo vsebuje 50 vol % etanola (alkohola), to je do 395 mg na vialo, kar ustreza 100 ml piva ali 40 ml vina na vialo.
English: What Docetaxel Mylan 80 mg/4 ml contains
Slovenian: Kaj vsebuje zdravilo Docetaxel Mylan 80 mg/4 ml
English: Diarrhoea (G3/4:
Slovenian: eksfoliacijski izpuščaj (S3/4:
English: Stomatitis (G3/4: 18%); Diarrhoea (G3/4: 14%); Nausea (G3/4: 6%);
Slovenian: bruhanje (S3/4: 8,4 %), driska (S3/4: 6,8 %), ezofagitis/disfagija/
English: The following information is intended for healthcare professionals only: PREPARATION GUIDE FOR USE WITH DOCETAXEL MYLAN CONCENTRATE FOR SOLUTION FOR INFUSION
Slovenian: NAVODILA ZA PRIPRAVO DOCETAXEL MYLAN KONCENTRATA ZA RAZTOPINO ZA INFUNDIRANJE
English: Vascular disorders Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora bolečina, nazofaringitis, dispneja, kašelj, rinoreja
English: Overall survival (Primary end-point):
Slovenian: statistična analiza celotno preživetje (primarni opazovani dogodek) mediana preživetja (meseci)
English: Alopecia (G3/4: 6%); Nail disorders (G3/4: 2%)
Slovenian: driska (S3/4: 6,2 %), bruhanje (S3/4: 5 %), zaprtje
English: Immune system disorders Metabolism and nutrition disorders Nervous system disorders
Slovenian: Presnovne in prehranske motnje anoreksija Psihiatrične motnje
English: This medicine contains 50 vol % ethanol (alcohol), i.e. up to 0.395 g per vial equivalent to 10 ml of beer or 4 ml wine per vial.
Slovenian: Zdravilo vsebuje 50 vol % etanola (alkohola), to je do 395 mg na vialo, kar ustreza 10 ml piva ali 4 ml vina na vialo.
English: Disease Free Survival Hazard ratio*
Slovenian: celotno preživetje podskupina bolnic razmerje tveganj*
English: Thrombocytopenia
Slovenian: C-docetakselom.
English: Citric acid (pH adjustment)
Slovenian: 6.1 Seznam pomožnih snovi brezvodni etanol polisorbat 80 citronska kislina (uravnavanje pH)
English: Anaemia (G3/4: 3%); Neutropenia (G3/4:
Slovenian: Bolezni prebavil navzea (S3/4: 5 %), stomatitis (S3/4:
English: Fatigue (G3/4: 3.9%); Fluid retention (severe: 0.6%)
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija (huda: 9,9 %), zastajanje tekočine (hudo: 0,7 %),
English: 1060 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin
Slovenian: 1060 bolnic je bilo naključno razporejenih na prejemanje zdravila docetaksel 75 mg/m² 1 uro po doksorubicinu 50 mg/m² in ciklofosfamidu 500 mg/m² (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m², ki sta mu sledila fluorouracil 500 mg/m² in ciklofosfamid 500 mg/m² (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.-Gallenskih merilih 1998 (velikost tumorja > 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost < 35 let).
English: This medicinal product contains 50 vol % ethanol (alcohol), i.e. up to 0.395 g per vial, equivalent to 10 ml of beer or 4 ml wine per vial.
Slovenian: Zdravilo vsebuje 50 vol % etanola (alkohola), to je 395 mg na vialo, kar ustreza 10 ml piva ali 4 ml vina na vialo.
English: Gastrointestinal haemorrhage (G3/4:
Slovenian: Očesne bolezni motnja solzenja (S3/4:
English: Onycholysis (G3/4: 1%)
Slovenian: Pogosti neželeni učinki oniholiza (S3/4: 1 %)
English: Abdominal pain (G3/4:
Slovenian: Bolezni prebavil bolečine v trebuhu (S3/4:
English: Intravenous use.
Slovenian: viala za enkratno uporabo intravenska uporaba
English: EU (MA) Number Invented name
Slovenian: Izmišljeno ime
English: The European Commission granted a marketing authorisation valid throughout the European Union for Protaphane on 7 October 2002.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Protaphane, veljavno po vsej Evropski uniji, odobrila dne 7. oktobra 2002.
English: What measures are being taken to ensure the safe and effective use of Protaphane?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Protaphane?
English: The full EPAR for Protaphane is available ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Protaphane je na voljo na: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Protaphane
Slovenian: Druge informacije o zdravilu Protaphane
English: This is a summary of the European public assessment report (EPAR) for Protaphane.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Protaphane.
English: A risk management plan has been developed to ensure that Protaphane is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Protaphane je bil pripravljen načrt obvladovanja tveganj.
English: For more information about treatment with Protaphane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Protaphane preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The CHMP decided that Protaphane's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Protaphane večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Protaphane, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Protaphane in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: What benefit has Protaphane shown during the studies?
Slovenian: Kakšne koristi je zdravilo Protaphane izkazalo med študijami?
English: Protaphane has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients).
Slovenian: Zdravilo Protaphane so preučili v štirih glavnih kliničnih preskušanjih, v katere je bilo vključenih skupno 557 bolnikov s sladkorno boleznijo tipa 1, pri kateri trebušna slinavka ne more tvoriti insulina (dve študiji, 81 bolnikov), ali s sladkorno boleznijo tipa 2, pri kateri telo ne more učinkovito izrabiti insulina (dve študiji, 476 bolnikov).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Protaphane.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Protaphane, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: In most patients, Protaphane was compared with other types of human insulin or insulin analogues.
Slovenian: Pri večini bolnikov so zdravilo Protaphane primerjali z drugimi vrstami humanega insulina ali analogi insulina.
English: The most common side effect with Protaphane (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Slovenian: Najpogostejši neželeni učinek zdravila Protaphane (opažen pri več kot 1 bolniku od 10) je hipoglikemija (nizka raven glukoze v krvi).
English: What is the risk associated with Protaphane?
Slovenian: Kakšna tveganja so povezana z zdravilom Protaphane?
English: The active substance in Protaphane, human insulin, is produced by a method known as ‘recombinant technology': it is made by yeast cells into which a gene (DNA) has been introduced which makes them able to produce insulin.
Slovenian: Zdravilna učinkovina v zdravilu Protaphane, humani insulin, se proizvaja z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri se v celice kvasovk vstavi gen (DNK), ki jim daje sposobnost tvorjenja insulina.
English: The studies measured the level of fasting blood glucose or glycosylated haemoglobin (HbA1c, the haemoglobin in the blood that has glucose attached).
Slovenian: V študijah so merili raven glukoze v krvi na tešče ali glikoziliranega hemoglobina (HbA1c, tj. hemoglobina v krvi, na katerega se je vezala glukoza).
English: Protaphane contains insulin mixed with another substance, protamine, in an ‘isophane' form which is absorbed much more slowly during the day.
Slovenian: V zdravilu Protaphane je insulin zmešan z drugo snovjo, tj. protaminom, v obliki „izofan“, ki se čez dan absorbira mnogo počasneje.
English: Protaphane is used to treat diabetes.
Slovenian: Zdravilo Protaphane se uporablja za zdravljenje sladkorne bolezni.
English: Protaphane was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pre-filled pens.
Slovenian: Zdravilo Protaphane se je izkazalo kot učinkovito tako pri sladkorni bolezni tipa 1 kot pri sladkorni bolezni tipa 2, in sicer pri uporabi običajne injekcijske brizge ali enega od napolnjenih peresnikov.
English: Protaphane led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulin.
Slovenian: Zdravilo Protaphane je privedlo do znižanja ravni HbA1c, kar kaže, da so bile ravni glukoze v krvi uravnane na podobno raven kot pri drugih humanih insulinih.
English: Protaphane is a suspension for injection that contains the active substance human insulin.
Slovenian: Zdravilo Protaphane je suspenzija za injiciranje, ki vsebuje zdravilno učinkovino humani insulin.
English: Why has Protaphane been approved?
Slovenian: Zakaj je bilo zdravilo Protaphane odobreno?
English: Protaphane is a replacement insulin which is very similar to the insulin made by the pancreas.
Slovenian: Zdravilo Protaphane je nadomestni insulin, ki je zelo podoben insulinu, ki ga proizvaja trebušna slinavka.
English: Protaphane is given by injection under the skin, usually in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder).
Slovenian: Zdravilo Protaphane se injicira v podkožje stegna, trebušne stene (sprednjega dela trebuha), glutealnega predela (zadnjice) ali deltoidnega predela (ramena).
English: Further studies were also carried out in 225 patients comparing injecting Protaphane using a syringe, or using a pre-filled pen (InnoLet or FlexPen).
Slovenian: V dodatnih študijah zdravila Protaphane, ki so jih opravili na 225 bolnikih, so injiciranje zdravila Protaphane z injekcijsko brizgo primerjali z injiciranjem tega zdravila z napolnjenim peresnikom (InnoLet ali FlexPen).
English: Protaphane is a long-acting insulin.
Slovenian: Zdravilo Protaphane je dolgodelujoči insulin.
English: How has Protaphane been studied?
Slovenian: Kako je bilo zdravilo Protaphane raziskano?
English: This gives Protaphane a longer duration of action.
Slovenian: To podaljša čas delovanja zdravila Protaphane.
English: What is Protaphane used for?
Slovenian: Za kaj se zdravilo Protaphane uporablja?
English: How does Protaphane work?
Slovenian: Kako zdravilo Protaphane deluje?
English: What is Protaphane?
Slovenian: Kaj je zdravilo Protaphane?
English: Pack size l t o r
Slovenian: Pot uporabe Stična ovojnina Velikost pakiranja o č
English: Via Virgilio Maroso, 50, 00142 Rome, Italy
Slovenian: Via Virgilio Maroso, 50, 00142 Rome, Italija
English: Bristol-Myers Squibb GesmbH Rivergate / Gate 1 / 5.OG, Handelskai 92, 1200 Vienna, Austria
Slovenian: Bristol-Myers Squibb GesmbH Rivergate / Gate 1 / 5.OG, Handelskai 92, 1200 Vienna, Avstrija
English: Budějovická 778/3, Michle 140 00 Prague 4, Czech Republic
Slovenian: Budějovická 778/3, Michle 140 00 Prague 4, Češka republika
English: Budějovická 778/3, Michle, 140 00 Prague, Czech Republic
Slovenian: Budějovická 778/3, Michle, 140 00 Prague, Češka republika
English: Orteliuslaan 1000, 3528 BD Utrecht, The Netherlands
Slovenian: Orteliuslaan 1000, 3528 BD Utrecht, Nizozemska
English: Orteliuslaan 1000, Utrecht, 3528 BD, The Netherlands
Slovenian: Orteliuslaan 1000, Utrecht, 3528 BD, Nizozemska
English: Bristol-Myers Squibb S.A. C/Quintanavides, 15, 28050 Madrid, Spain
Slovenian: Bristol-Myers Squibb S.A. C/Quintanavides, 15, 28050 Madrid, Španija
English: Bristol-Myers Squibb Holdings Limited t/a Bristol-Myers Pharmaceuticals, Swords, County Dublin, Ireland
Slovenian: Bristol-Myers Squibb Holdings Limited t/a Bristol-Myers Pharmaceuticals, Swords, County Dublin, Irska kapsule, mehke
English: Chaussée De La Hulpe, 185, 1170 Bruxelles, Belgium
Slovenian: Bristol-Myers Squibb Belgium S.A. Chaussée De La Hulpe, 185, 1170 Bruxelles, Belgija
English: Arnulfstrasse 29, München, 80636,Germany
Slovenian: Bristol-Myers Squibb GmbH & Co. KGaA Arnulfstrasse 29, München, 80636, Nemčija
English: 300 MBq/ml Solution for injection
Slovenian: 300 MBq/ml Raztopina za injiciranje
English: What SOMAC Control is and what it is used for
Slovenian: Kaj je zdravilo SOMAC Control in za kaj ga uporabljamo
English: To avoid this interference, SOMAC Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Slovenian: Da bi to preprečili, je treba vsaj pet dni pred meritvami CgA prekiniti zdravljenje z zdravilom SOMAC Control (glejte poglavje 5.1).
English: 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
Slovenian: Kaj je zdravilo SOMAC Control in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo SOMAC Control Kako jemati zdravilo SOMAC Control Možni neželeni učinki
English: If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping SOMAC Control.
Slovenian: Če se pojavijo lezije, zlasti na koži, ki je izpostavljena soncu, in sočasna artralgija, mora bolnik takoj poiskati zdravniško pomoč, zdravstveni delavec pa mora razmisliti o prekinitvi zdravljenja z zdravilom SOMAC Control.
English: What you need to know before you take SOMAC Control
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo SOMAC Control
English: Production site Oranienburg Lehnitzstraße 70-98, 16515 Oranienburg
Slovenian: Production site Oranienburg Lehnitzstraße 70-98, 16515 Oranienburg Nemčija
English: How to store SOMAC Control Contents of the pack and other information
Slovenian: Shranjevanje zdravila SOMAC Control Vsebina pakiranja in dodatne informacije
English: You must not use SOMAC Control if you are taking HIV protease inhibitors.
Slovenian: Zdravila SOMAC Control ne smete uporabljati, če jemljete zaviralce proteaze
English: SOMAC Control contains the active substance pantoprazole, which blocks the ‘pump' that produces stomach acid.
Slovenian: Zdravilo SOMAC Control vsebuje zdravilno učinkovino pantoprazol, ki zavira “črpalko”, ki proizvaja želodčno kislino.
English: SOMAC Control is available in Alu/Alu blisters with or without cardboard reinforcement.
Slovenian: Zdravilo SOMAC Control je na voljo v Alu/Alu pretisnih omotih s kartonsko oporo ali brez nje.
English: However, you may take SOMAC Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.
Slovenian: Zdravilo SOMAC Control lahko po potrebi jemljete skupaj z antacidi (npr. magaldrat, alginska kislina, natrijev hidrogenkarbonat, aluminijev hidroksid, magnezijev karbonat ali kombinacije naštetih).
English: The following additional risks are considered relevant for long-term use
Slovenian: Pri dolgotrajni uporabi je treba upoštevati naslednja dodatna tveganja:
English: You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with SOMAC Control, but this medicine is not meant to bring immediate relief.
Slovenian: Simptomi kislega refluksa in zgage se lahko ublažijo že po enem dnevu zdravljenja z zdravilom SOMAC Control, vendar pa to zdravilo ni namenjeno za dosego takojšnjega olajšanja.
English: Other medicines and SOMAC Control
Slovenian: Druga zdravila in zdravilo SOMAC Control
English: - reduced absorption of Vitamin B12, and Vitamin B12 deficiency if you already have low body stores of Vitamin B12 - fracture of your hip, wrist or spine, especially if you already suffer from osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
Slovenian: Če zdravilo SOMAC Control prejemate daljše obdobje, lahko to povzroči dodatna tveganja, kot so: - zmanjšana absorpcija vitamina B12 in pomanjkanje vitamina B12, če že imate nizke telesne zaloge vitamina B12 - zlom kolka, zapestja ali hrbtenice, še posebej, če že trpite zaradi osteoporoze ali če jemljete kortikosteroide (ki lahko povečajo tveganje za osteoporozo).