natgillin/translations-raw huggingface dataset:
Pharmacokinetic data from volunteers, suggests that no change in starting dose is required in patients with mild, moderate or severe hepatic impairment (see section 5.2).
Farmakokinetični podatki pri prostovoljcih kažejo, da bolnikom z blago, zmerno ali hudo okvaro jeter, začetnega odmerka ni potrebno spreminjati (glejte poglavje 5.2).
Vandetanib inhibits VEGF-stimulated endothelial cell migration, proliferation, survival and new blood vessel formation in in vitro models of angiogenesis.
Vandetanib v modelih angiogeneze in vitro zavre z VEGF stimulirano migracijo, proliferacijo in preživetje endotelijskih celic ter tvorbo novih žil.
• An irritation of the eyes (conjunctivitis).
• draženje oči (konjunktivitis);
• Coughing up of blood.
• izkašljevanje krvi;
In healthy subjects, the Cmax for vandetanib was decreased by 15% while the AUC(0-t) for vandetanib was not affected when given together with omeprazole.
Pri zdravih preiskovancih se je med sočasno uporabo z omeprazolom Cmax vandetaniba zmanjšala za 15 %, AUC(0-t) vandetaniba pa se ni spremenila.
• Bacterial infection.
• bakerijska okužba;
It is expected that these would be uncommon adverse reactions in patients receiving vandetanib for MTC.
Pričakovati je mogoče, da bodo ti neželeni učinki pri bolnikih, ki prejemajo vandetanib zaradi MTC, občasni.
N Response rate ORb
CELOTNI DELEŽ ODZIVAa n delež odziva ORb
Visual impairment, halo vision, photopsia, glaucoma, conjunctivitis, dry eye, keratopathy
okvara vida, vid z odsevi ("halo-vid"), fotopsija, glavkom, konjunktivitis, suho oko, keratopatija katarakta, motnje akomodacije
• Heart rate and rhythm disorders.
• motnje srčnega utripa in ritma;
Pharmacokinetic data from volunteers, suggests that no change in starting dose is required in patients with mild, moderate or severe hepatic impairment (see sections 4.2 and 5.2).
Farmakokinetični podatki pri prostovoljcih kažejo, da bolnikom z blago, zmerno ali hudo okvaro jeter, začetnega odmerka ni potrebno spreminjati (glejte poglavji 4.2 in 5.2).
• Increased levels of glucose in your blood.
• povečanje koncentracije glukoze v vaši krvi;
A value > 1 favors vandetanib.
Vrednost > 1 je v korist vandetaniba.
Patients who develop a single value of a QTc interval of ≥500 msec should stop taking vandetanib.
Bolniki, ki se jim na EKG pojavi posamezna vrednost intervala QTc, ki je ≥ 500 ms, morajo prenehati z jemanjem vandetaniba.
• No change in starting dose is recommended in paediatric patients with mild renal impairment
• začetnega odmerka ni treba spremeniti pediatričnim bolnikom z blago okvaro ledvic.
• Drowsiness.
• dremavost;
* 13.4% vandetanib patients had QTc (Bazett's) ≥ 500 ms compared with 1.0% placebo patients.
zmanjšanje telesne mase, povečanje kreatinina v krvi povečanje serumske amilaze * 13,4 % bolnikov, ki so prejemali vandetanib, je imelo interval QTc (Bazett) ≥ 500 ms v primerjavi z 1,0 % bolnikov, ki so prejemali placebo.
Caprelsa 100 mg tablets Each film-coated tablet contains 100 mg of vandetanib.
Caprelsa 100 mg tablete Ena filmsko obložena tableta vsebuje 100 mg vandetaniba.
Talk to your doctor or pharmacist before taking Caprelsa:
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Caprelsa se posvetujte z zdravnikom ali farmacevtom:
Photosensitivity reaction, rash and other skin rections (including acne, dry skin, dermatitis, pruritus), nail disorders
Bolezni kože in podkožja fotosenzitivna reakcija, izpuščaj in druge kožne reakcije (vključno z aknami, suho kožo, dermatitisom, srbenjem), spremembe nohtov sindrom palmarnoplantarne eritrodizestezije, alopecija bulozni dermatitis
Medicinal products known to prolong QTc interval Vandetanib has been shown to prolong the ECG QTc interval; Torsades de pointes have been uncommonly reported.
Ugotovljeno je, da vandetanib podaljša interval QTc; občasno so poročali o Torsades de pointes.
• Inflammation of the nasal passages.
• vnetje nosnih prehodov;
Rash and other skin reactions including photosensitivity reactions and palmar-plantar erythrodysaesthesia syndrome have been observed in patients who have received vandetanib.
Pri bolnikih, ki so prejemali vandetanib, so opažali izpuščaj in druge kožne reakcije, vključno s fotosenzitivnimi reakcijami in sindromom palmarno-plantarne eritrodizestezije.
Pneumonia, sepsis, influenza, cystitis, sinusitis, laryngitis, folliculitis, furuncle, fungal infection, pyelonephritis
Infekcijske in parazitske bolezni nazofaringitis, bronhitis, okužbe zgornjih dihalnih poti, okužbe sečil pljučnica, sepsa, influenca, cistitis, sinusitis, laringitis, folikulitis, furunkel, glivična okužba, pielonefritis apendicitis, stafilokokna okužba, divertikulitis, celulitis, absces v trebušni steni
Vandetanib doses higher than 150 mg/m2 have not been used in clinical studies in paediatric patients.
V kliničnih študijah pri pediatričnih bolnikih niso uporabljali odmerkov vandetaniba, večjih od 150 mg/m2.
An increase in the frequency and severity of some adverse reactions, like rash, diarrhoea and hypertension was observed at multiple doses at and above 300 mg in healthy volunteer studies and in patients.
V študijah pri zdravih prostovoljcih in bolnikih so po večkratnih odmerkih 300 mg in več opažali večjo pogostnost in izrazitost nekaterih neželenih učinkov, npr. izpuščaja, driske in hipertenzije.
• Increased levels of calcium in your blood.
• povečanje koncentracije kalcija v vaši krvi;
Caprelsa 300 mg tablets Each film-coated tablet contains 300 mg of vandetanib.
Caprelsa 300 mg tablete Ena filmsko obložena tableta vsebuje 300 mg vandetaniba.
Vandetanib 300 mg
300 mg vandetaniba
• CAPRELSA treatment must not be started in patients: o Whose ECG QTc interval is greater than 480 msec; o Who have congenital long QTc syndrome; o Who have a history of Torsades de pointes unless all risk factors that contributed to Torsades de pointes have been corrected;
• Zdravljenja z zdravilom CAPRELSA se ne sme uvesti pri bolnikih: o pri katerih je interval QTc daljši od 480 ms, o ki imajo sindrom prirojenega podaljšanja intervala QTc.
Hypokalaemia, hypercalcaemia, hyperglycemia, dehydration, hyponatremia
Presnovne in prehranske motnje zmanjšan apetit, hipokalciemija hipokaliemija, hiperkalciemija, hiperglikemija, dehidracija, hiponatriemija podhranjenost
It may not be reversible on stopping vandetanib.
Srčno popuščanje je lahko po prenehanju uporabe vandetaniba irreverzibilno.
• Inflammation of the sinuses.
• vnetje sinusov;
There is no specific treatment in the event of overdose with vandetanib and possible symptoms of overdose have not been established.
Specifičnega zdravljenja prevelikega odmerjanja z vandetanibom ni.
Alanine aminotransferase elevations occur commonly in patients treated with vandetanib.
Pri bolnikih, zdravljenih z vandetanibom, se pogosto pojavi zvišanje alanin-aminotransferaze.
100 daily
100 na dan
• In the event of CTCAE grade 3 or higher toxicity or prolongation of the ECG QTc interval, dosing with vandetanib should be at least temporarily stopped and resumed at a reduced dose when toxicity has resolved or improved to CTCAE grade 1.
• V primeru toksičnih učinkov 3. stopnje ali več po CTCAE (Common Terminology Criteria for Adverse Events) ali podaljšanja intervala QTc na EKG je treba odmerjanje vandetaniba vsaj začasno končati in ga znova uvesti v manjšem odmerku, ko toksični učinki izginejo ali se izboljšajo na 1. stopnjo po CTCAE.
• Nose bleed (epistaxis).
• krvavitev iz nosu (epistaksa);
Increased haemoglobin,serum amylase increased
povečanje hemoglobina,
You must not breast-feed during treatment with Caprelsa for the safety of your baby.
Zaradi otrokove varnosti med zdravljenjem z zdravilom ne smete dojiti.
The following adverse reactions have been identified in clinical studies with patients receiving vandetanib as treatment for MTC.
Seznam neželenih učinkov v pregledniciV kliničnih študijah pri bolnikih, ki so prejemali vandetanib za zdravljenje MTC, so ugotovili naslednje neželene učinke.
Dose adjustments in adult patients with MTC
Prilagoditve odmerka pri odraslih bolnikih z MTC
• Decreased levels of calcium in your blood.
• zmanjšanje koncentracije kalcija v vaši krvi.
• Protein or blood in your urine (shown in a urine test).
Naslednji neželeni učinki se lahko pokažejo na preiskavah, ki jih opravi zdravnik: • beljakovine ali kri v urinu (pokažejo se pri preiskavi urina);
The Caprelsa 100 mg tablet is a round, biconvex, white film-coated tablet with ‘Z100' impressed on one side.
Caprelsa 100 mg tableta je okrogla, bikonveksna, bela, filmsko obložena tableta z oznako "Z100" na eni strani.
• Inflammation of the voice box (larynx).
• vnetje grla (larinksa);
Renal impairment in adult patients with MTC
Okvara ledvic pri odraslih bolnikih z MTC
The Caprelsa 300 mg tablet is an oval-shaped, biconvex, white film-coated tablet with ‘Z300' impressed on one side.
Caprelsa 300 mg tableta je ovalna, bikonveksna, bela, filmsko obložena tableta z oznako "Z300" na eni strani.
Median PFS HR 95% CI p-value
95 % IZ p-vrednost
• The Patient Leaflet;
• zamegljenost očesne leče;
Dose adjustments in paediatric patients with MTC
Prilagoditev odmerka pri pediatričnih bolnikih z MTC
A statistically significant advantage was seen for vandetanib for the secondary endpoint of time to worsening of pain (derived as a composite endpoint using the worst pain score from BPI and patient reported opioid analgesic use) (vandetanib 49%, placebo 57%, HR 0.61, 97.5%CI 0.43-0.87, p< 0.006: 8 vs. 3 months).
Opažena je bila statistično značilna prednost vandetaniba glede sekundarnega opazovanega dogodka, časa do poslabšanja bolečin (sestavljenega opazovanega dogodka ocene najhujših bolečin po BPI [brief pain inventory] in uporabe opioidnega analgetika po bolnikovi navedbi) (vandetanib 49 %,
• The need to closely monitor teeth and bone abnormalities in the paediatric population;
• Pediatrične bolnike je treba skrbno spremljati glede nepravilnosti zob in kosti.
Hypertensive crisis, ischaemic cerebrovascular conditions
Žilne bolezni hipertenzija hipertenzivna kriza, ishemične cerebrovaskularne motnje anevrizme in disekcije arterij
NAME OF THE MEDICINAL PRODUCT Caprelsa 300 mg tablets vandetanib
IME ZDRAVILA Caprelsa 300 mg tablete vandetanib
NAME OF THE MEDICINAL PRODUCT Caprelsa 100 mg tablets vandetanib
IME ZDRAVILA Caprelsa 100 mg tablete vandetanib
• Feeling unsteady.
• občutek nestabilnosti;
• methadone (used to treat addiction), haloperidol, chlorpromazine, sulpiride, amisulpride, and zuclopenthixol, (used to treat mental illness)
• metadon (uporablja se za zdravljenje odvisnosti), haloperidol, klorpromazin, sulpirid,
How to store Caprelsa
Shranjevanje zdravila Caprelsa
• proton pump inhibitors (used to treat heartburn)
• zaviralce protonske črpalke (uporabljajo se za zdravljenje zgage)
Colitis, dry mouth, stomatitis, dysphagia, constipation, gastritis, gastrointestinal haemorrhage
Bolezni prebavil bolečine v trebuhu, driska, navzea, bruhanje, dispepsija kolitis, suha usta, stomatitis, disfagija, obstipacija, gastritis, krvavitev iz prebavil pankreatitis, peritonitis, ileus, predrtje črevesa, fekalna inkontinenca
• Skin rash or acne.
• kožni izpuščaj ali akne;
The patient will be provided with the Patient Alert Card with each prescription.
Poleg tega navodila boste dobili tudi Opozorilno kartico za bolnika.
PRES is a syndrome of subcortical vasogenic oedema diagnosed by a MRI of the brain, has been observed infrequently with vandetanib treatment in combination with chemotherapy.
Redko so med zdravljenjem z vandetanibom v kombinaciji s kemoterapijo opažali sindrom PRES, tj. sindrom subkortikalnega vazogenega edema, ki se pokaže na magnetnoresonančnem slikanju možganov.
• Seeing flashes of light (photopsia).
• bliskanje pred očmi (fotopsija);
Posology in paediatric patients with MTC
Odmerjanje pri pediatričnih bolnikih z MTC
Therefore, no change in dose of vandetanib is required when vandetanib is given with either omeprazole or ranitidine.
Če je vandetanib uporabljen skupaj z omeprazolom ali z ranitidinom, odmerka vandetaniba ni treba spremeniti.
• Kidney infection.
• glivična okužba;
A brain MRI should be performed in any patient presenting with seizures, confusion or altered mental status;
Pri bolniku, ki se mu pojavijo krči, zmedenost ali sprememba mentalnega statusa je treba opraviti MRI možganov.
• Weakness (asthenia).
• šibkost (astenija);
• Fever.
• vročina;
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF CAPRELSA 100 mg
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZDRAVILA CAPRELSA 100 mg
Package leaflet: Information for the patient Caprelsa 100 mg film-coated tablets Caprelsa 300 mg film-coated tablets vandetanib
Caprelsa 100 mg filmsko obložene tablete Caprelsa 300 mg filmsko obložene tablete vandetanib
Anxiety
Driska
• How CAPRELSA is used / administered;
• Kako se zdravilo CAPRELSA uporablja in daje.
• Combinations contraindicated (see section 4.3): Cisapride, erythromycin intravenous (IV), toremifene, mizolastine, moxifloxacin, arsenic, Class IA and III antiarrhythmics
), toremifen, mizolastin, moksifloksacin, arzen, antiaritmiki skupin IA in III.
• Inflammation of the pancreas (pancreatitis).
• vnetje trebušne slinavke (pankreatitis);
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg vandetanib.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 100 mg vandetaniba.
Hypertension, including hypertensive crisis, has been observed in patients treated with vandetanib.
Pri bolnikih, zdravljenih z vandetanibom, so opažali hipertenzijo, vključno s hipertenzivno krizo.
If it gets severe, tell your doctor straight away.
morate to nemudoma povedati zdravniku;
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF CAPRELSA 300 mg
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZDRAVILA CAPRELSA 300 mg
• Decreased levels of sodium in your blood.
• zmanjšanje koncentracije natrija v vaši krvi;
• Fatigue.
• utrujenost;
Events such as Torsades de pointes, Stevens-Johnson syndrome, erythema multiforme, interstitial lung disease (sometimes fatal) and PRES (RPLS) have occurred in patients treated with vandetanib monotherapy.
Pri bolnikih, ki so prejemali monoterapijo z vandetanibom, so se pojavili učinki, kot so Torsades de pointes, Stevens-Johnsonov sindrom, multiformni eritem, intersticijska bolezen pljuč in PRES (RPLS).
• Swelling of the brain.
• otekanje možganov;
Caprelsa 300 mg film-coated tablets
Caprelsa 300 mg filmsko obložene tablete vandetanib
Heart failure has been observed in patients who received vandetanib.
Pri bolnikih, ki so prejemali vandetanib, so opažali srčno popuščanje.
NAME OF THE MEDICINAL PRODUCT Caprelsa 100 mg film-coated tablets vandetanib
Caprelsa 100 mg filmsko obložene tablete vandetanib
If another event of common terminology criteria for adverse events (CTCAE) grade 3 or higher toxicity or prolongation of the ECG QTc interval occurs, dosing with Caprelsa should be at least temporarily stopped and resumed at a reduced dose (c in Table 1) when toxicity has resolved or improved to CTCAE grade 1.
CTCAE ali podaljšanje intervala QTc na EKG, je treba odmerjanje zdravila Caprelsa vsaj začasno končati in ga znova uvesti v manjšem odmerku (c v preglednici 1), ko toksični učinki izginejo ali se izboljšajo na 1. stopnjo po CTCAE.
Tremor, lethargy, loss of consciousness, balance disorders, dysgeusia
Bolezni živčevja glavobol, parestezija, dizestezija, omotica tremor, letargija, izguba zavesti, motnje ravnotežja, dizgevzija konvulzije, klonus, možganski edem
Caprelsa 300 mg is a white oval-shaped film-coated tablet with “Z300” imprinted on one side.
Zdravilo Caprelsa 300 mg so bele, filmsko obložene tablete, ovalne oblike z oznako “Z300” na eni strani.
Bullous dermatitis
• huda driska
Dysuria, hematuria, renal failure, pollakiuria, micturition urgency
Bolezni sečil proteinurija, nefrolitiaza disurija, hematurija, odpoved ledvic, polakisurija, nujnost po uriniranju kromaturija, anurija
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 300 mg vandetanib.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 300 mg vandetaniba.
Abdominal pain, diarrhoea, nausea, vomiting, dyspepsia
Bolezni dihal, prsnega koša in mediastinalnega prostora epistaksa, hemoptiza, pnevmonitis odpoved dihanja, aspiracijska pljučnica
• Pain.
• bolečina;
Caution should be used when administering vandetanib to patients with brain metastases, as intracranial haemorrhage has been reported.
Poročali so o krvavitvah znotraj lobanje, zato je potrebna previdnost pri dajanju vandetaniba bolnikom z metastazami v možganih.
• Headache.
• glavobol;
Use caution before driving or using machines.
Vpliv na sposobnost upravljanja vozil in strojev Glede upravljanja vozil in strojev bodite previdni.
• Fungal infection.
• okužba ledvic;
• Vandetanib was found not to impair linear growth in clinical trials conducted in children and adolescents;
• V kliničnih preskušanjih pri otrocih in mladostnikih so ugotovili, da vandetanib ne okvari linearne rasti.
Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Morda boste potrebovali nujno zdravniško pomoč:
Danmark Sanofi A/S
România Sanofi Romania SRL
• Feeling sick (nausea).
• občutek siljenja na bruhanje (navzea);
Impaired healing
Okvara jeter
• Fainting.
• omedlevica;
Respiratory, thoracic and mediastinal disorders
Bolezni jeter, žolčnika in žolčevodov holelitiaza
• Bowel obstruction.
• ledvična odpoved;
Some of this increase may be due to other risk factors.
Del tega povečanja je lahko posledica drugih dejavnikov tveganja.
Date of first authorisation: 12 June 2009 Date of latest renewal: 21 February 2014
Datum prve odobritve: 12. junij 2009 Datum zadnjega podaljšanja: 21. februar 2014
• They have any other serious disease affecting general well-being.
• če imajo katero koli drugo resnejšo bolezen, ki vpliva na splošno zdravstveno stanje.
An excessive increase, however, occurs only in isolated cases.
Do prekomernega povečanja pride samo v posameznih primerih.
Take the tablet before a meal, at the same time every day.
Tableto vzemite pred obrokom, vsak dan ob istem času.
The relevance of this finding to the paediatric population is unclear.
Pomen te ugotovitve za pediatrično populacijo ni jasen.
In these cases, malignancy should be excluded.
V takšnih primerih je treba izključiti maligno obolenje.
Take your next, normal dose, the next day, at your usual time.
Naslednji, običajni odmerek, vzemite naslednji dan ob običajnem času.
Patients should be instructed to consult a doctor if:
Bolnikom je treba naročiti, da se posvetujejo s svojim zdravnikom:
This medicinal product is intended for short-term use (up to 4 weeks) only (Refer to section 4.2).
To zdravilo je namenjeno samo za kratkotrajno uporabo (do 4 tedne) (glejte poglavje 4.2).
On short-term use, in most cases they do not exceed the upper limit of normal.
Pri kratkotrajni uporabi te vrednosti običajno ne presegajo normalne zgornje meje.
This leaflet was last revised in { mm/yyyy}
Navodilo je bilo nazadnje revidirano {MM/LLLL}.
Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
Zdravnik se bo morda odločil opravljati redne krvne preiskave za spremljanje vaših ravni magnezija.
The expiry date refers to the last day of that month.
Rok uporabnosti zdravila se izteče zadnji dan navedenega meseca.
This medicine may not bring immediate relief.
To zdravilo vam morda ne bo prineslo takojšnjega olajšanja.
The absolute bioavailability from the tablet was found to be about 77%.
Absolutna biološka uporabnost tablete znaša približno 77 %.
The increase in gastrin is reversible.
Zvišanje gastrina je reverzibilno.
Tell your doctor immediately or contact the casualty department at your nearest hospital, if you get any of the following serious side effects.
Takoj obvestite svojega zdravnika ali poiščite pomoč na urgentnem oddelku najbližje bolnišnice, če se pojavi kateri koli od naslednjih resnih neželenih učinkov.
• 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 spremenili.
During long-term treatment, gastrin levels double in most cases.
Pri dolgotrajnem zdravljenju pa se nivoji gastrina v večini primerov podvojijo.
As a result, concentration of pantoprazole in the foetus is increased shortly before birth.
Posledično se koncentracija pantoprazola v plodu zviša kratek čas pred porodom.
The most commonly reported adverse reactions are diarrhoea and headache, both occuring in approximately 1% of patients.
Najpogosteje zabeležena neželena učinka sta bila driska in glavobol, oba sta se pojavila pri približno 1 % bolnikov.
Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood.
Nizke ravni magnezija lahko privedejo tudi do zmanjšanja ravni kalija ali kalcija v krvi.
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 osnovi simptomov.
Influence on Vitamin B12 Absorption
Vpliv na absorpcijo vitamina B12
You should take this medicine for at least 2-3 consecutive days.
To zdravilo morate jemati vsaj 2 do 3 zaporedne dni.
Patients should be advised that the tablets are not intended to provide immediate relief.
Bolnikom je treba pojasniti, da tablete niso namenjene za dosego takojšnjega olajšanja simptomov.
Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.
Bolniki, pri katerih obstaja tveganje za osteoporozo, morajo biti deležni zdravljenja v skladu z veljavnimi kliničnimi smernicami in imeti ustrezen vnos vitamina D in kalcija.
If you are due to have a blood test, tell your doctor that you are taking this medicine.
Če morate opraviti krvne preiskave, povejte svojemu zdravniku, da jemljete to zdravilo.
Patients should be warned about additional risks with long-term use of the medicinal products and the need for prescription and regular surveillance should be emphasized.
Bolnike je treba opozoriti na dodatna tveganja pri dolgotrajni uporabi zdravil, ter poudariti, da je zanje potreben recept in redno spremljanje.
Interference with Laboratory Tests
Vpliv na laboratorijske preiskave
In the case of overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.
V primeru prevelikega odmerjanja s kliničnimi znaki zastrupitve, razen simptomatskega in podpornega zdravljenja, drugih posebnih priporočil za zdravljenje ni.
Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10-40%.
Opazovalne študije kažejo, da lahko zaviralci protonske črpalke povečajo splošno tveganje za zlome za 10 - 40 %.
Hallucination; Confusion (especially in pre-disposed patients, as well as the aggravation of these symptoms in case of pre-existence)
halucinacije, zmedenost (predvsem pri bolnikih s predispozicijo in tudi poslabšanje teh simptomov, če so že prisotni)
Once complete relief of symptoms has occurred, treatment should be discontinued.
Ko simptomi popolnoma izginejo, se mora zdravljenje prekiniti.
Distribution Volume of distribution is about 0.15 l/kg and serum protein binding is about 98%.
Porazdelitev Volumen porazdelitve znaša približno 0,15 l/kg, vezava na serumske beljakovine pa približno 98 %.
The effect of pantoprazole on newborns/infants is unknown.
Učinek pantoprazola na dojene novorojence/otroke ni znan.
If affected, patients should not drive or use machines.
V tem primeru bolniki ne smejo voziti vozil ali upravljati strojev.
Do not take PANTOLOC Control: - if you are allergic to pantoprazole, or to any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila PANTOLOC Control - če ste alergični na pantoprazol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
There are no adequate data from the use of pantoprazole in pregnant women.
Ni zadostnih podatkov o uporabi pantoprazola pri nosečnicah.
Stop taking this medicine straight away, but take this leaflet and/or the tablets with you.
Takoj prenehajte jemati to zdravilo, navodilo in/ali tablete pa vzemite s seboj.