natgillin/translations-raw huggingface dataset:
Patients who can tolerate the additional fluid load may receive up to a total of 2 litres of 0.9% saline intravenously with each dose of cidofovir. 
Bolniki, ki prenesejo dodatno obremenitev s tekočino, lahko z vsakim odmerkom cidofovira dobijo skupno do 2 litra 0,9-odstotne (normalne) fiziološke raztopine.
No metabolites of cidofovir have been detected in serum or urine of patients. 
V serumu in urinu bolnikov niso odkrili presnovkov cidofovira.
Men should be advised to practice barrier contraceptive methods during and for 3 months after treatment with cidofovir (see section 4.4). 
Moškim je treba svetovati, naj uporabljajo pregradno kontracepcijsko zaščito med zdravljenjem s cidofovirom in do 3 mesece po njem (glejte poglavje 4.4).
The recommended dose of Vistide in patients with normal kidney function is 5 mg per kg of body weight given once weekly for two consecutive weeks. 
Priporočeni odmerek zdravila Vistide pri bolnikih z normalnim delovanjem ledvic je 5 mg na kg telesne mase enkrat na teden, dva tedna zapored.
No tumours were observed in cynomolgus monkeys administered cidofovir intravenously once weekly for 52 weeks at doses up to 2.5 mg/kg/week. 
Tumorjev pa niso opazili pri opicah cynomolgus, ki so 52 tednov dobivale cidofovir intravensko enkrat na teden v odmerkih od 2,5 mg/kg/teden.
The chemical stability of Vistide mixed in saline solution has been demonstrated in glass bottles, in infusion bags composed of either polyvinyl chloride (PVC) composition or ethylene/propylene copolymer, and in PVC based vented IV administration sets. 
Kemična stabilnost zdravila Vistide, zmešanega s fiziološko raztopino, je dokazana v steklenih steklenicah, infuzijskih vrečkah iz polivinilklorida (PVC) ali etilen/propilenskega kopolimera ter v ventiliranih kompletih za intravensko apliciranje, izdelanih na podlagi PVC.
Common side effects possibly related to probenecid (These can affect 1 to 10 users in 100) 
Pogosti neželeni učinki, ki so morda povezani s probenecidom (Pojavijo se lahko pri 1 do 10 od 100 bolnikov)
• amphotericin B (for fungal infection) 
• amfotericin B (za glivične okužbe)
4 g probenecid 
4 g probenecida
1 g probenecid 
1 g probenecida
Prevention of nephrotoxicity 
Preprečevanje nefrotoksičnosti
Hepatic insufficiency: 
Ledvična insuficienca:
2 g probenecid 
2 g probenecida
The chemical and physical stability of Vistide admixed with saline has been demonstrated in glass bottles, in infusion bags composed of either polyvinyl chloride (PVC) or ethylene/propylene copolymer, and in PVC based vented IV administration sets. 
Kemična in fizikalna stabilnost zdravila Vistide, zmešanega s fiziološko raztopino, je dokazana v steklenicah, infuzijskih vrečkah iz polivinilklorida (PVC) ali etilen/propilenskega kopolimera ter v ventiliranih kompletih za intravensko (i.v.)
• Kidney damage is the major side effect of Vistide treatment. 
• Glavni neželeni učinek zdravljenja z zdravilom Vistide je okvara ledvic.
Beginning two weeks after completion of induction treatment, the recommended maintenance dose of Vistide in patients with normal kidney function is 5 mg per kg of body weight given once every two weeks. 
Vzdrževalno zdravljenje se začne dva tedna po koncu začetnega; priporočeni vzdrževalni odmerek zdravila Vistide pri bolnikih z normalnim delovanjem ledvic je 5 mg na kg telesne mase enkrat na dva tedna.
Method of preparation and administration 
Postopek priprave in apliciranja
Pharmacotherapeutic group: Antivirals for systemic use, nucleosides and nucleotides excluding reverse transcriptase inhibitors, ATC code: J05AB12 
Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, nukleozidi in nukleotidi razen zaviralcev reverzne transkriptaze.
The active substance of Vistide 75 mg/ml is cidofovir. 
Zdravilna učinkovina v zdravilu Vistide 75 mg/ml je cidofovir.
Vistide must be administered with oral probenecid and intravenous saline as described below (see section 4.4 for appropriate recommendations, and under section 6.6 for information on obtaining probenecid). 
Z vsako infuzijo zdravila Vistide je treba uporabiti peroralni probenecid in intravensko fiziološko raztopino (za ustrezna priporočila glejte poglavje 4.4, za informacije, kako dobiti probenecid, pa poglavje 6.6).
In addition to probenecid, patients must receive a total of one litre of 0.9% (normal) saline solution intravenously immediately prior to each infusion of cidofovir. 
Poleg probenecida morajo bolniki tik pred vsako infuzijo cidofovira intravensko dobiti skupno en liter 0,9-odstotne fiziološke raztopine.
What Vistide is and what it is used for 
Kaj je zdravilo Vistide in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Vistide
The recommended dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hour) administered once weekly for two consecutive weeks. 
Priporočeni odmerek cidofovira je 5 mg/kg telesne teže (v enourni intravenski infuziji s stalno hitrostjo) enkrat na teden, dva tedna zapored.
Each ml contains 75 mg cidofovir anhydrous. 
En ml vsebuje 75 mg brezvodnega cidofovira.
The entire volume of the bag will be infused into your vein at a constant rate over a period of 1 hour using a standard infusion pump. 
Celotno vsebino vrečke vam bodo s standardno infuzijsko črpalko v teku ene ure s stalno hitrostjo infundirali v veno.
Proteinuria, blood creatinine increased (see section 4.4) Renal failure Fanconi syndrome acquired General disorders and administration site conditions Very common Common 
Proteinurija, zvišanje kreatinina v krvi (glejte poglavje 4.4) Odpoved ledvic
Obtaining probenecid 
Kako dobiti probenecid
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR 
A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA,
Therapy must be accompanied by administration of oral probenecid and adequate intravenous saline prehydration (see section 6.6 for information on obtaining probenecid) with each cidofovir dose. 
Vsak odmerek cidofovira mora spremljati uporaba peroralnega probenecida in primerna intravenska predhidracija s fiziološko raztopino (za informacije, kako dobiti probenecid, glejte poglavje 6.6).
HCMV strains resistant to ganciclovir may still be susceptible to cidofovir. 
Na cidofovir so lahko občutljivi sevi HCMV, ki so odporni proti gancikloviru.
The other ingredients are 
Pomožne snovi so:
The safety and efficacy of Vistide has not been demonstrated in diseases other than CMV retinitis in patients with AIDS. 
Varnost in učinkovitost zdravila Vistide pri drugih boleznih, razen pri citomegalovirusnem retinitisu in pri bolnikih z AIDS-om, nista bili dokazani.
Induction treatment. 
Začetno zdravljenje.
The entire volume should be infused intravenously into the patient at a constant rate over a period of 1 hour by use of a standard infusion pump. 
Celotno količino je treba bolniku infundirati intravensko s standardno infuzijsko črpalko in stalno hitrostjo v obdobju ene ure.
Vistide has not been studied in children. 
Zdravilo Vistide pri otrocih ni raziskano.
Cidofovir is a cytidine analogue with in vitro and in vivo activity against human cytomegalovirus (HCMV). 
Cidofovir je citidinski analog, ki deluje proti humanemu citomegalovirusu (HCMV) in vitro in in vivo.
No cross-resistance between foscarnet and cidofovir was seen with foscarnet-selected mutants. 
Pri mutantih, selekcioniranih s foskarnetom, niso ugotovili navzkrižne odpornosti med foskarnetom in cidofovirom.
With a syringe, transfer under aseptic conditions the appropriate dose of Vistide from the vial to an infusion bag containing 100 ml 0.9% (normal) saline solution, and mix thoroughly. 
Ustrezni odmerek zdravila Vistide v aseptičnih pogojih z brizgo prenesite iz viale v infuzijsko vrečko, v kateri je 100 ml 0,9-odstotne (normalne) fiziološke raztopine, in dobro premešajte.
Cidofovir suppresses HCMV replication by selective inhibition of viral DNA synthesis. 
Cidofovir s selektivno inhibicijo sinteze virusne DNA zavre replikacijo humanega citomegalovirusa.
The appropriate dose of Vistide should be transferred from the vial to an infusion bag containing 100 ml 0.9% (normal) saline solution. 
Ustrezen odmerek zdravila Vistide je treba prenesti iz viale v infuzijsko vrečko, ki vsebuje 100 mililitrov 0,9-odstotne (normalne) fiziološke raztopine.
Cidofovir induced chromosomal aberrations in human peripheral blood lymphocytes in vitro without metabolic activation (S-9 fraction). 
In vitro je cidofovir brez presnovne aktivacije (frakcija S-9) induciral kromosomske aberacije v človeških limfocitih v periferni krvi.
No mutagenic response was elicited by cidofovir at dose levels up to 5 mg/plate, in the presence and absence of metabolic activation by rat liver S-9 fraction, in microbial assays involving Salmonella typhimurium for base pair substitutions or frameshift mutations (Ames) and Escherichia coli for reverse mutations. 
V mikrobnih preizkusih, v katerih so raziskovali substitucijo baznih parov pri Salmonella typhimurium ali mutacije okvirnega položaja (frameshift mutation; Ames) in reverzne mutacije pri Escherichia coli, cidofovir ni bil mutagen v odmerkih do 5 mg/ploščico, s presnovno aktivacijo s frakcijo S-9 podganjih jeter ali brez takšne aktivacije.
Viral resistance 
Odpornost virusov
The saline solution should be infused over a 1 hour period immediately before the Vistide infusion. 
Fiziološko raztopino vam morajo infundirati v enournem obdobju tik pred infuzijo zdravila Vistide.
Very common side effects (These can affect more than 1 user in 10) 
Zelo pogosti neželeni učinki (Pojavijo se lahko pri več kot 1 od 10 bolnikov)
If you could get pregnant, you must use an effective method of contraception to stop you getting pregnant during treatment with Vistide 
Če lahko zanosite, morate med zdravljenjem z zdravilom Vistide in 1 mesec po njem uporabljati učinkovito kontracepcijsko zaščito.
Normal saline is given to lower the risk of kidney damage. 
Normalna fiziološka raztopina se uporablja za zmanjšanje tveganja okvare ledvic.
You should receive a total of one litre of 0.9% (normal) saline solution intravenously (as a drip into a vein) before each Vistide dose. 
Pred vsakim odmerkom zdravila Vistide morate dobiti skupno en liter 0,9-odstotne (normalne) fiziološke raztopine intravensko (vkapljanja v veno).
Vistide 75 mg/ml concentrate for solution for infusion Cidofovir 
Vistide 75 mg/ml koncentrat za raztopino za infundiranje cidofovir
Vistide should be used with caution in diabetic patients due to the potential increased risk of developing low pressure in the eye (ocular hypotony). 
Pri bolnikih z diabetesom je treba zdravilo Vistide uporabljati previdno, ker ga spremlja zvečano tveganje za nizek očesni
The entire volume of the bag should be infused into the patient's vein at a constant rate over a period of 1 hour using a standard infusion pump. 
Celotno količino infuzijske vrečke je treba bolniku infundirati intravensko s standardno infuzijsko črpalko in stalno hitrostjo v obdobju ene ure.
Vistide vials should be visually inspected for particulate matter and discolouration prior to administration. 
Viale zdravila Vistide je treba pred uporabo pregledati in preveriti, da v vsebini ni delcev in da ni obarvana.
Vistide must be diluted in 100 millilitres 0.9% (normal) saline prior to administration. 
Zdravilo Vistide je treba pred uporabo raztopiti s 100 mililitri 0,9-odstotne (normalne) fiziološke raztopine.
Each vial contains 375 mg/5 ml cidofovir anhydrous. 
Ena viala vsebuje 375 mg/5 ml brezvodnega cidofovira.
Adequate precautions including the use of appropriate safety equipment are recommended for the preparation, administration and disposal of Vistide. 
Pri pripravi, uporabi in odstranjevanju zdravila Vistide je treba upoštevati ustrezne previdnostne ukrepe, vključno z uporabo primerne varnostne opreme.
An increase in formation of micronucleated polychromatic erythrocytes was observed in vivo in mice receiving a high, toxic intraperitoneal dose of cidofovir (≥ 2,000 mg/kg). 
Pri miših, ki so dobile velik, toksičen intraperitonealen odmerek cidofovira (≥ 2.000 mg/kg), so in vivo opažali zvečano tvorbo mikronukleusnih polikromatičnih eritrocitov.
NAME OF THE MEDICINAL PRODUCT Vistide 75 mg/ml concentrate for solution for infusion 
IME ZDRAVILA Vistide 75 mg/ml koncentrat za raztopino za infundiranje
Cidofovir therapy should be discontinued and intravenous hydration is advised if serum creatinine increases by ≥ 44 µmol/l (≥ 0.5 mg/dl), or if persistent proteinuria ≥ 2+ develops. 
Če kreatinin v serumu naraste na ≥ 44 µmol/l (≥ 0,5 mg/dl) ali se pojavi trajna proteinurija ≥ 2+, je treba zdravljenje s cidofovirom prekiniti in priporočljiva je intravenska hidracija.
Nervous system disorders Common 
Bolezni živčevja Pogosti
6 weeks prior to mating and for 2 weeks post mating had decreased litter sizes and live births per litter and increased early resorptions per litter. 
Podganje samice, ki so dobivale cidofovir intravensko v odmerkih 1,2 mg/kg/teden ali več enkrat na teden do 6 tednov pred parjenjem in 2 tedna po njem, so imele manjšo velikost legla in manj živorojenih mladičev na leglo ter več zgodnjih resorpcij na leglo.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vistide 75 mg/ml concentrate for solution for infusion Cidofovir 
IME ZDRAVILA IN POT(I) UPORABE Vistide 75 mg/ml koncentrat za raztopino za infundiranje cidofovir
Your treatment with Vistide may be stopped by your doctor if changes in kidney function occur. 
Če se vam delovanje ledvic spremeni, lahko zdravnik zdravljenje z zdravilom Vistide prekine.
Dyspnea 
Odmerek
The table below lists the adverse reactions identified through clinical trials or post-marketing surveillance by system organ class (SOC) and frequency. 
Spodnja tabela po organskih sistemih in pogostnosti navaja neželene učinke, ugotovljene v kliničnih preskušanjih ali med pomarketinškim spremljanjem.
Vistide is used to treat an eye infection called CMV retinitis in patients with AIDS (Acquired Immunodeficiency Syndrome). 
Kaj je zdravilo Vistide in za kaj ga uporabljamo Zdravilo Vistide se uporablja za zdravljenje okužbe oči, imenovane citomegalovirusni retinitis, pri bolnikih z AIDS-om (sindromom pridobljene imunske pomanjkljivosti).
Clear solution. 
Bistra raztopina.
Caution should be applied when considering cidofovir treatment of patients with diabetes mellitus due to the potential increased risk of developing ocular hypotony. 
Zaradi potencialno zvečanega tveganja za očesno hipotonijo je treba zdravljenje s cidofovirom previdno pretehtati pri bolnikih z diabetesom mellitusom.
Date of last renewal 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Beginning two weeks after the completion of induction treatment, the recommended maintenance dose of cidofovir is 5 mg/kg body weight (given as an intravenous infusion at a constant rate over 1 hour) administered once every two weeks. 
Priporočeni vzdrževalni odmerek cidofovira je 5 mg/kg telesne teže (v enourni intravenski infuziji s stalno hitrostjo) enkrat na dva tedna.
• nausea, vomiting, rash and fever. 
• slabost s siljenjem na bruhanje, bruhanje, izpuščaj in vročina.
• low white blood cell counts, headache, nausea, vomiting, protein in the urine, increase in blood creatinine (a measure of kidney function), hair loss, rash, weakness/fatigue and fever. 
• znižano število belih krvnih celic, glavobol, slabost s siljenjem na bruhanje, bruhanje,
Adverse reactions such as asthenia may occur during cidofovir therapy. 
Med zdravljenjem s cidofovirom se lahko pojavijo neželeni učinki, npr. astenija.
The following information is intended for medical or healthcare professionals only: Vistide vials should be inspected visually prior to use. 
Viale zdravila Vistide je treba pred uporabo pregledati.
No adverse effects on fertility or general reproduction were seen following once weekly intravenous injections of cidofovir in male rats for 13 consecutive weeks at doses up to 15 mg/kg/week. 
Po intravenskem injiciranju cidofovira podganjim samcem enkrat na teden 13 tednov zapored v odmerkih do 15 mg/kg/teden niso ugotovili neželenih učinkov na plodnost ali splošno reprodukcijsko sposobnost.
Eye disorders Common 
Očesne bolezni Pogosti
Each vial contains 375 mg/5 ml cidofovir anhydrous as the active substance. 
Ena viala kot zdravilno učinkovino vsebuje 375 mg/5 ml brezvodnega cidofovira.
Food should be taken before you are given Vistide. 
Pred uporabo zdravila Vistide morate zaužiti hrano.
23 April 2007 
Datum zadnjega podaljšanja dovoljenja za promet: 23.4.2007
Elderly population: 
Starejši:
• You should not be given Vistide if you are breast-feeding. 
• Če dojite, ne smete dobiti zdravila Vistide.
particular attention should be paid to assessing renal function before and during administration of Vistide. 
Starejši imajo pogosto zmanjšano delovanje glomerulov, zato je treba pred aplikacijo zdravila Vistide in med njo posebno pozornost nameniti oceni delovanja ledvic.
Interruption, and possibly discontinuation, is required for changes in renal function. 
Če se delovanje ledvic spremeni, je treba uporabo zdravila prekiniti in morda končati.
(Invented) name Strength Pharmaceutical form Route of administration 
(Izmišljeno) ime Jakost Farmacevtska oblika
You may need urgent medical treatment. 
Morda boste potrebovali nujno medicinsko pomoč.
Adopted at the 6-9 July 2015 PRAC 
Sprejeto na seji odbora PRAC, 6.-9. julija 2015
Donepezil - Rhabdomyolysis (EPITT no 18261) 
Donepezil - rabdomioliza (EPITT št. 18261)
Remember to also mention any other ill-effects like pain in your joints. 
Ne pozabite omeniti morebitnih drugih neželenih učinkov, kot je bolečina v sklepih.
• if you have ever had a skin reaction after treatment with a medicine similar to {Drug name} that reduces stomach acid. 
• če ste že kdaj imeli kožno reakcijo po zdravljenju z zdravilom, podobnim zdravilu {Ime zdravila}, ki zmanjšuje izločanje želodčne kisline.
Dexlansoprazole; esomeprazole; lansoprazole; omeprazole; pantoprazole; rabeprazole - Subacute cutaneous lupus erythematosus (EPITT no 18119) 
Dekslansoprazol, esomeprazol, lansoprazol, omeprazol, pantoprazol, rabeprazol - subakutni kožni eritematozni lupus (EPITT št. 18119)
Section 4: Possible side effects • Frequency 'not known': rash, possibly with pain in the joints 
Poglavje 4: Možni neželeni učinki • Pogostnost „neznana“: izpuščaj, lahko z bolečino v sklepih
Summary of Product Characteristics (both prescription and non-prescription) 
Povzetek glavnih značilnosti zdravila (na recept in brez recepta)
Musculoskeletal, connective tissue and bone disorders Frequency ‘very rare': Rhabdomyolysis* (To be inserted in the table footnote): * Rhabdomyolysis has been reported to occur independently of neuroleptic malignant syndrome and in close temporal association with donepezil initiation or dose increase. 
Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogostnost „zelo redki“: rabdomioliza* (vstaviti v opombe preglednice): * Poročali so o pojavu rabdomiolize, neodvisnem od nevroleptičnega malignega sindroma in v tesni časovni povezavi z uvedbo ali povečanjem odmerka donepezila.
Frequency 'not known': Subacute cutaneous lupus erythematosus (see section 4.4). 
Pogostnost „neznana“: subakutni kožni eritematozni lupus (glejte poglavje 4.4).
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 {Drug name}. 
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 {Ime zdravila}.
• Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine. 
• Šibkost mišic, občutljivost na dotik ali bolečina, zlasti če to spremlja slabo počutje, povišana telesna temperatura ali temen urin.
They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis). 
Te simptome lahko povzroča nenormalna razgradnja mišic, ki je lahko smrtno nevarna in povzroči težave z ledvicami (stanje, imenovano rabdomioliza).
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 {Drug name}. 
Če se pojavi kožni izpuščaj, zlasti na koži, ki je izpostavljena soncu, čim prej obvestite zdravnika, saj boste morda morali prekiniti zdravljenje z zdravilom {Ime zdravila}.
Section 4: Possible side effects 
Poglavje 4: Možni neželeni učinki
Proton pump inhibitors are associated with very infrequent cases of SCLE. 
Zaviralci protonske črpalke so povezani z zelo redkimi primeri subakutnega kožnega eritematoznega lupusa.
Talk to your doctor before taking {Drug name}: 
Preden vzamete zdravilo {Ime zdravila}, se morate posvetovati z zdravnikom:
SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors. 
Subakutni kožni eritematozni lupus po predhodnem zdravljenju z zaviralcem protonske črpalke lahko poveča tveganje za pojav subakutnega1 kožnega eritematoznega lupusa z drugimi zaviralci protonske črpalke.
You must tell your doctor immediately if you notice these serious side effects mentioned. 
Če opazite navedene resne neželene učinke, morate o njih takoj obvestiti zdravnika.
Section 2: What you need to know before you take {Drug name} 
Navodilo za uporabo (na recept in brez recepta) Poglavje 2: Kaj morate vedeti, preden boste vzeli zdravilo {Ime zdravila} Opozorila in previdnostni ukrepi
Subacute cutaneous lupus erythematosus (SCLE) 
Subakutni kožni eritematozni lupus
Skin and subcutaneous tissue disorders 
Poglavje 4.8 - Neželeni učinki Bolezni kože in podkožja
The full EPAR for Pantozol Control can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pantozol Control je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The European Commission granted a marketing authorisation valid throughout the EU for Pantozol Control on 12 June 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Pantozol Control, veljavno po vsej Evropski uniji, odobrila dne 12. junija 2009.
The recommended dose of Pantozol Control is one tablet once a day until symptoms have stopped. 
Priporočeni odmerek zdravila Pantozol Control je ena tableta enkrat na dan, dokler simptomi ne izzvenijo.
Pantozol Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Pantozol. 
Zdravilo Pantozol Control je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Pantozol.
This is a summary of the European public assessment report (EPAR) for Pantozol Control. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pantozol Control.
The most common side effects with Pantozol Control (seen in around 1 patient in 100) are diarrhoea and headache. 
Najpogostejša neželena učinka zdravila Pantozol Control (opažena pri približno 1 bolniku od 100) sta driska in glavobol.
For more information about treatment with Pantozol Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Pantozol Control preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Pantozol Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients. 
Zdravila Pantozol Control ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) pantoprazol, sojo ali katero koli drugo sestavino zdravila.
The CHMP therefore decided that Pantozol Control's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Zato je zaključil, da so koristi zdravila Pantozol Control večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.