natgillin/translations-raw huggingface dataset:
Co-administration of P-gp inhibitors (e.g., ketoconazole or cyclosporine) or P-gp inducers (e.g., rifampicin) could affect the pharmacokinetics of tigecycline (see section 5.2).
Sočasna uporaba inhibitorjev P-gp (npr. ketokonazola ali ciklosporina) ali induktorjev P-gp (npr. rifampicina) bi lahko vplivala na farmakokinetiko tigeciklina (glejte poglavje 5.2).
Do not use Tygacil
Ne uporabljajte zdravila Tygacil:
If a focus of infection other than cSSTI or cIAI is identified after initiation of tigecycline therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated to be efficacious in the treatment of the specific type of infection(s) present.
Če po začetku zdravljenja s tigeciklinom ugotovimo, da žarišče okužbe ni cSSTI oziroma cIAI, je treba razmisliti o uvedbi zdravljenja z drugim antibiotikom, ki je dokazano učinkovit pri zdravljenju specifične okužbe, ki je prisotna.
Warfarin did not affect the pharmacokinetic profile of tigecycline.
Varfarin ni vplival na farmakokinetični profil tigeciklina.
Tigecycline may have adverse reactions similar to tetracycline class antibiotics.
Tigeciklin lahko povzroča neželene učinke, ki so podobni kot pri antibiotikih tetraciklinske skupine.
Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of any antibacterial agent (see section 4.8).
Zato je pomembno, da pri bolnikih, ki med uporabo ali po uporabi kateregakoli protibakterijskega zdravila dobijo drisko, pomislimo na to diagnozo (glejte poglavje 4.8).
In clinical trials in cIAI patients, impaired healing of the surgical wound has been associated with superinfection.
V kliničnih preskušanjih je bilo pri bolnikih s cIAI slabše celjenje kirurških ran povezano s superinfekcijo.
Dizziness may occur and this may have an effect on driving and use of machines (see section 4.8).
Lahko se pojavi omotica, ki lahko vpliva na sposobnost vožnje in upravljanja strojev (glejte poglavje
How Tygacil is given in this leaflet)
Kako uporabljati zdravilo Tygacil v tem navodilu za uporabo)
Uncommon side effects are (may affect up to 1 in 100 people):
Občasni neželeni učinki so (pojavijo se lahko pri največ 1 od 100 bolnikov):
In Phase 3 and 4 cSSTI and cIAI clinical studies, infection-related serious adverse reactions were more frequently reported for subjects treated with tigecycline (7.1 %) vs comparators (5.3 %).
V kliničnih študijah faze 3 in 4 so pri bolnikih s cSSTI ter cIAI, zdravljenih s tigeciklinom, pogosteje poročali o resnih neželenih učinkih, povezanih z okužbami (7,1 %) kot pri bolnikih, zdravljenih s primerjalnimi zdravili (5,3 %).
Cases of liver injury with a predominantly cholestatic pattern have been reported in patients receiving tigecycline treatment, including some cases of hepatic failure with a fatal outcome.
Pri bolnikih, ki so prejemali zdravljenje s tigeciklinom, so poročali o primerih poškodb jeter s prevladujočim holestatičnim vzorcem, vključno z nekaterimi primeri odpovedi jeter s smrtnim izidom.
In female rats, there were no compound-related effects on ovaries or oestrus cycles at exposures up to 4.7 times the human daily dose based on AUC.
Pri podganjih samicah ni bilo vpliva na ovarije ali cikle estrusa pri izpostavljenostih, ki so bile do 4,7-krat večje od dnevnega odmerka za ljudi na podlagi AUC.
Cross-resistance between tigecycline and minocycline-resistant isolates among the Enterobacteriaceae due to multi-drug resistance (MDR) efflux pumps has been shown.
Pri družini Enterobacteriaceae so dokazali navzkrižno odpornost med izolati, odpornimi proti tigeciklinu in minociklinu, zaradi iztočnih črpalk z multimedikamentozno rezistenco (MDR).
Tigecycline may be associated with permanent tooth discolouration if used during tooth development (see section 4.4).
Tigeciklin je lahko povezan s trajnim obarvanjem zob, če ga dajemo med razvojem zob (glejte poglavje 4.4).
Therefore, no dosage adjustment is necessary when tigecycline is administered with digoxin.
Zato pri sočasni uporabi tigeciklina z digoksinom prilagajanje odmerjanja ni potrebno.
Storage after preparation
Shranjevanje pripravljenega zdravila
It is unknown whether tigecycline/metabolites are excreted in human milk.
Ni znano, ali se tigeciklin/presnovki izločajo v materino mleko.
The target AUC0-12h in adults after the recommended dose of 100 mg loading and 50 mg every 12 hours, was approximately 2500 ng•h/mL.
Tarčna AUC0-12h pri odraslih po priporočenem 100 mg polnilnem odmerku in 50 mg nadaljnjih odmerkih vsakih 12 ur je bila približno 2.500 ng•h/ml.
However, polymicrobial intra-abdominal infections have shown to respond to treatment with tigecycline in clinical trials.
Vendar se je pokazalo, da se v kliničnih preskušanjih polimikrobne intraabdominalne okužbe odzivajo na zdravljenje s tigeciklinom.
Gram-positive Aerobes
Grampozitivni aerobi
Gastrointestinal disorders nausea, vomiting, diarrhoea abdominal pain, dyspepsia, anorexia acute pancreatitis (see section 4.4)
Bolezni prebavil navzea, bruhanje, driska bolečina v trebuhu, dispepsija, anoreksija akutni pankreatitis (glejte poglavje 4.4)
C-labelled material recovered in urine and faeces, but a glucuronide, an N-acetyl metabolite and a tigecycline epimer were also present.
C, ki so jo prestregli iz urina in blata, nespremenjeni tigeciklin, prisotni pa so bili tudi glukuronid, N-acetilni presnovek in tigeciklinov epimer.
Tigecycline may be associated with permanent tooth discolouration in humans if used during tooth development (see section 4.8).
Tigeciklin je lahko povezan s trajnim obarvanjem zob pri ljudeh, če ga dajemo med razvojem zob (glejte poglavje 4.8).
In an open-label, single ascending dose PK study, the safety of tigecycline was investigated in 25 children aged 8 to 16 years who recently recovered from infections.
Varnost tigeciklina so preučili v odprti farmakokinetični študiji s povečevanjem enkratnega odmerka pri 25 otrocih, starih od 8 do 16 let, kmalu po okrevanju po okužbi.
Thereafter, the solution should be immediately withdrawn from the vial and added to a 100 ml intravenous bag or other suitable infusion container in the hospital.
Nato je treba raztopino takoj z brizgo posrkati iz viale in jo dodati 100-mililitrski vrečki za intravensko infundiranje ali kakšnemu drugemu primernemu infuzijskemu vsebniku v bolnišnici.
No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B).
Pri bolnikih z blago do zmerno okvaro jeter prilagajanje odmerjanja ni potrebno (razreda A in B po Child-Pughovi lestvici).
The vial should be gently swirled until the medicine is dissolved.
Vialo je treba nežno vrteti, dokler se zdravilo ne raztopi.
Pseudomembranous colitis which may range in severity from mild to life threatening (see section 4.4).
Psevdomembranski kolitis, katerega stopnja izraženosti lahko sega od blagega do smrtno nevarnega (glejte poglavje 4.4).
• Vein irritations from the injection, including pain, inflammation, swelling and clotting
• draženje vene zaradi injiciranja, ki vključuje bolečino, vnetje, oteklino in krvni strdek
Injection should be made with an infusion solution compatible with tigecycline and any other medicinal product(s) via this common line (see section 6.2)
Injicirati morate z infuzijsko raztopino, ki je kompatibilna s tigeciklinom in morebitnim/-i drugim/-i zdravilom/-i, po tem skupnem kanalu (glejte poglavje 6.2).
Tigecycline should be preferably administered over a 60-minute length of infusion in paediatric patients (see section 4.4).
Zaželeno je, da se tigeciklin pri pediatričnih bolnikih daje z infuzijo, ki traja 60 minut (glejte poglavje 4.4).
Nausea and vomiting are very common adverse reactions in children and adolescents (see section 4.8).
Pri otrocih in mladostnikih sta zelo pogosta neželena učinka navzea in bruhanje (glejte poglavje 4.8).
Injection should be made with an infusion solution compatible with tigecycline and any other medicinal product(s) via this common line.
Injicirati morate z infuzijsko raztopino, ki je kompatibilna s tigeciklinom in morebitnim/-i drugim/-i zdravilom/-i, po tem skupnem kanalu.
Antibiotic class effects
Učinki zdravil iz skupine antibiotikov
These may be symptoms of acute pancreatitis (inflamed pancreas which may result in severe abdominal pain, nausea, and vomiting).
To so lahko simptomi akutnega pankreatitisa (vnetje trebušne slinavke, ki se lahko kaže kot huda bolečina v trebuhu, navzea in bruhanje);
In reproduction toxicity studies, decreased foetal weights in rats and rabbits (with associated delays in ossification) and foetal loss in rabbits have been observed with tigecycline.
V študijah škodljivih vplivov na razmnoževanje so pri tigeciklinu opazili zmanjšano težo plodov pri podganah in kuncih (z njo je bila povezana tudi zapoznela kostenitev) in izgubo plodov pri kuncih.
Adolescents aged 12 to <18 years: 50 mg of tigecycline every 12 hours for 5 to 14 days.
Mladostniki, stari od 12 do < 18 let: 50 mg tigeciklina vsakih 12 ur, 5 do 14 dni.
The effect of cholestasis in the pharmacokinetics of tigecycline has not been properly established.
Vpliva holestaze na farmakokinetiko tigeciklina še niso temeljito raziskali.
Tigecycline is not extensively metabolised.
Tigeciklin se ne presnavlja v večji meri.
• Injection site reaction (pain, redness, inflammation)
• reakcija na mestu injiciranja (bolečina, rdečina, vnetje)
Pseudomembranous colitis may occur with most antibiotics including Tygacil.
Psevdomembranski kolitis se lahko pojavi pri uporabi večine antibiotikov in tudi pri uporabi zdravila Tygacil.
The prevalence of acquired resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections.
Informacije z lokalnega območja o odpornosti mikroorganizmov so zaželene, posebno še pri zdravljenju težkih okužb.
General disorders and administration site conditions impaired healing, injection site reaction, headache injection site inflammation, injection site pain, injection site oedema, injection site phlebitis
Splošne težave in spremembe na mestu aplikacije slabše celjenje, reakcija na mestu injiciranja, glavobol vnetje na mestu injiciranja, bolečina na mestu injiciranja, edem na mestu injiciranja, flebitis na mestu injiciranja
Such reactions may include photosensitivity, pseudotumor cerebri, pancreatitis, and anti-anabolic action which has led to increased BUN, azotaemia, acidosis, and hyperphosphataemia (see section 4.8).
Ti učinki lahko vključujejo preobčutljivost za svetlobo, benigno intrakranialno hipertenzijo, pankreatitis in antianabolno delovanje, ki lahko povzroči zvišan dušik sečnine v krvi, azotemijo, acidozo in hiperfosfatemijo (glejte poglavje 4.8).
Once reconstituted and diluted in the bag or other suitable infusion container (e.g. glass bottle) tigecycline should be used immediately.
Ko je tigeciklin rekonstituiran in razredčen v vrečki ali drugem primernem vsebniku za infundiranje (na primer steklenici), ga morate uporabiti takoj.
Parenteral products should be inspected visually for particulate matter and discolouration (e.g., green or black) prior to administration.
Zdravila za parenteralno uporabo morate s prostim očesom pregledati, da se prepričate, da ne vsebujejo delcev in da niso obarvana (na primer zeleno ali črno), preden jih vbrizgate bolniku.
Very common side effects are (may affect more than 1 in 10 people):
Pogosti neželeni učinki so (pojavijo se lahko pri največ 1 od 10 bolnikov):
Consistent with the limited oral bioavailability of tigecycline, there is little or no systemic exposure to tigecycline in the nursing pups as a result of exposure via maternal milk.
Dojeni mladiči so bili zaradi izpostavljenosti preko materinega mleka komaj kaj ali sploh nič sistemsko izpostavljeni tigeciklinu, kar se sklada z omejeno peroralno biološko uporabnostjo tigeciklina.
The recommended dose in adolescents aged 12 to <18 years is 50 mg given every 12 hours.
Priporočeni odmerek pri mladostnikih, starih od 12 do < 18 let, je 50 mg vsakih 12 ur.
Tigecycline was not teratogenic in the rat or rabbit.
Tigeciklin pri podganah in kuncih ni bil teratogen.
The powder should be reconstituted with 5.3 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, dextrose 50 mg/ml (5 %) solution for injection, or Lactated Ringer's solution for injection to achieve a concentration of 10 mg/ml of tigecycline.
Prašek morate rekonstituirati s 5,3 ml 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida za injiciranje, 5-odstotne (50 mg/ml) raztopine glukoze za injiciranje ali z raztopino Ringerjevega laktata za injiciranje, tako da dosežete koncentracijo tigeciklina 10 mg/ml.
C-tigecycline indicates that 59 % of the dose is eliminated by biliary/faecal excretion, and 33 % is excreted in urine.
Prestrežena celotna radioaktivnost v blatu in urinu po danem odmerku 14C-tigeciklina kaže, da se 59 % odmerka izloči iz telesa z žolčem in blatom, 33 % pa se ga izloči z urinom.
Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life threatening.
Pri skoraj vseh protibakterijskih zdravilih so poročali o psevdomembranskem kolitisu, katerega stopnja izraženosti lahko sega od blage do smrtno nevarne.
Tigecycline should be preferably administered over a 60-minute length of infusion in paediatric patients.
Zaželeno je, da se tigeciklin pri pediatričnih bolnikih daje z infuzijo, ki traja 60 minut.
Acute pancreatitis, which can be serious, has occurred (frequency: uncommon) in association with tigecycline treatment (see section 4.8).
V povezavi z zdravljenjem s tigeciklinom se pojavlja (pogostnost: občasno) akutni pankreatitis, ki je lahko resen (glejte poglavje 4.8).
Patients usually improve after tigecycline discontinuation.
Po ukinitvi tigeciklina se stanje bolnikov navadno izboljša.
As a consequence, care should be paid to the rate of infusion of tigecycline in children and adolescents.
Zaradi tega je pri otrocih in mladostnikih potrebna previdnosti pri hitrosti infundiranja tigeciklina.
Tygacil may cause foetal harm.
Zdravilo Tygacil lahko škoduje plodu.
The first study enrolled children aged 8-16 years (n=24) who received single doses of tigecycline (0.5, 1, or 2 mg/kg, up to a maximum dose of 50 mg, 100 mg, and 150 mg, respectively) administered intravenously over 30 minutes.
V prvo študijo so bili vključeni otroci, stari 8-16 let (n = 24), ki so prejeli enkratni odmerek tigeciklina (0,5, 1 ali 2 mg/kg, do največjega odmerka 50 mg, 100 mg oz. 150 mg), apliciran intravensko v času 30 minut.
However, systemic clearance of tigecycline was reduced by 25 % and 55 % and the half-life of tigecycline was prolonged by 23 % and 43 % in patients with moderate or severe hepatic impairment (Child Pugh B and C), respectively (see section 4.2).
Pri bolnikih z zmerno oziroma s hudo okvaro jeter (razred B oziroma C po Child-Pughovi lestvici) pa se je sistemski očistek tigeciklina zmanjšal za 25 % oziroma 55 %, razpolovni čas tigeciklina pa podaljšal za 23 % oziroma 43 % (glejte poglavje 4.2).
Bolus intravenous administration of tigecycline has been associated with a histamine response in animal studies.
V študijah na živalih je bilo intravensko dajanje tigeciklina v bolusu povezano s histaminskim odzivom.
The recommended dose for adults is an initial dose of 100 mg followed by 50 mg every 12 hours for 5 to 14 days.
Priporočeni začetni odmerek za odrasle je 100 mg, ki mu sledi odmerek po 50 mg vsakih 12 ur, 5 do 14 dni.
Tetracycline class antibiotics
Antibiotiki tetraciklinske skupine
Clearance, weight-normalised clearance, and AUC were not appreciably different among patients with different body weights, including those weighing ≥125 kg. AUC was 24 % lower in patients weighing ≥125 kg. No data is available for patients weighing 140 kg and more.
Očistek, na telesno maso normalizirani očistek in AUC, se med bolniki z različno telesno maso, tudi pri tistih, ki so tehtali ≥ 125 kg, niso znatno razlikovali.
Once the powder has been made into a solution and diluted ready for use, it should be given to you immediately.
Po pripravi raztopine in redčenju je zdravilo pripravljeno za uporabo; zdravilo morate prejeti takoj.
The recommended dose in children aged 8 to <12 years is 1.2 mg/kg given every 12 hours intravenously to a maximum dose of 50 mg every 12 hours.
Priporočeni odmerek pri otrocih, starih od 8 do < 12 let, je 1,2 mg/kg vsakih 12 ur intravensko do največjega odmerka 50 mg vsakih 12 ur.
There is no target-based cross-resistance between tigecycline and most classes of antibiotics.
Med tigeciklinom in večino skupin antibiotikov ni navzkrižne odpornosti na podlagi tarče.
Hepatobiliary disorders elevated aspartate aminotransferase (AST) in serum, and elevated alanine aminotransferase (ALT) in serum, hyperbilirubinaemia jaundice, liver injury, mostly cholestatic hepatic failure
Bolezni jeter, žolčnika in žolčevodov zvišanje aspartataminotransferaze (AST) v serumu in zvišanje alaninaminotransferaze (ALT) v serumu, hiperbilirubinemija zlatenica, poškodba jeter, večinoma holestatska odpoved jeter (glejte poglavje 4.4)
Vascular disorders phlebitis thrombophlebitis
Žilne bolezni flebitis tromboflebitis
What Tygacil looks like and contents of the pack Tygacil is supplied as a powder for solution for infusion in a vial and looks like an orange powder or cake before it is diluted.
Pred redčenjem je videti kot oranžen prašek ali pogača.
• Increase in amylase, which is an enzyme found in the salivary glands and pancreas, increased blood urea nitrogen (BUN).
• zvišana raven amilaze, encima, ki ga najdemo v žlezah slinavkah in trebušni slinavki, zvišana raven dušika sečnine v krvi (BUN)
Results from animal studies using
Rezultati študij na živalih, pri katerih so uporabljali tigeciklin, označen s
Anaphylaxis/anaphylactoid reactions, potentially life-threatening, have been reported with tigecycline (see sections 4.3 and 4.8).
Pri tigeciklinu so poročali o anafilaksiji/anafilaktoidnih reakcijah, ki so lahko smrtno nevarne (glejte poglavji 4.3 in 4.8).
Children aged 8 to <12 years: 1.2 mg/kg of tigecycline every 12 hours intravenously to a maximum dose of 50 mg every 12 hours for 5 to 14 days.
Otroci, stari od 8 do < 12 let: 1,2 mg/kg tigeciklina vsakih 12 ur intravensko do največjega odmerka 50 mg vsakih 12 ur, 5 do 14 dni.
The second study was performed in children aged 8 to 11 years who received multiple doses of tigecycline (0.75, 1, or 1.25 mg/kg up to a maximum dose of 50 mg) every 12 hours administered intravenously over 30 minutes.
V drugo študijo so bili vključeni otroci, stari 8-11 let, ki so prejeli večkratne odmerke tigeciklina (0,75, 1 ali 1,25 mg/kg, do največjega odmerka 50 mg) vsakih 12 ur, aplicirane intravensko v času 30 minut.
• Abdominal pain, dyspepsia (stomach ache and indigestion), anorexia (loss of appetite)
• bolečine v trebuhu, dispepsija (bolečine v trebuhu in prebavne težave), anoreksija
No dosage adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis (see section 5.2).
Pri bolnikih z okvaro ledvic in pri bolnikih, ki se zdravijo s hemodializo, prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
The recommended dose in adults is 100 mg given initially, followed by 50 mg every 12 hours.
Priporočeni začetni odmerek pri odraslih je 100 mg, nato pa 50 mg vsakih 12 ur.
The single dose pharmacokinetic disposition of tigecycline was not altered in patients with renal insufficiency (creatinine clearance 30 ml/min, n=6).
Pri bolnikih z insuficienco ledvic (očistek kreatinina < 30 ml/min, n = 6) se farmakokinetika tigeciklina po enkratnem odmerku ni spremenila.
Nervous system disorders dizziness
Bolezni živčevja omotica
In repeated dose toxicity studies in rats and dogs, lymphoid depletion/atrophy of lymph nodes, spleen and thymus, decreased erythrocytes, reticulocytes, leukocytes, and platelets, in association with bone marrow hypocellularity, and adverse renal and gastrointestinal effects have been seen with tigecycline at exposures of 8 and 10 times the human daily dose based on AUC in rats and dogs, respectively.
V raziskavah toksičnosti ponavljajočih se odmerkov na podganah in psih so pri tigeciklinu ob izpostavljenosti, ki je bila 8-krat oziroma 10-krat večja od dnevnega odmerka za ljudi na podlagi AUC pri podganah oziroma psih, ugotovili limfoidno osiromašenje/atrofijo bezgavk, vranice in priželjca, zmanjšane koncentracije eritrocitov, retikulocitov, levkocitov in trombocitov v povezavi z zmanjšanim številom celic v kostnem mozgu in škodljive učinke na ledvicah in prebavilih.
Compatible intravenous solutions include: sodium chloride 9 mg/ml (0.9 %) solution for injection, dextrose 50 mg/ml (5 %) solution for injection, and Lactated Ringer's solution for injection.
Med kompatibilnimi intravenskimi raztopinami so 0,9-odstotna (9 mg/ml) raztopina natrijevega klorida za injiciranje, 5-odstotna (50 mg/ml) raztopina glukoze za injiciranje in raztopina Ringerjevega laktata za injiciranje.
Each vial contains 50 mg tigecycline.
Ena viala vsebuje 50 mg tigeciklina.
Thereafter, 5 ml of the reconstituted solution should be immediately withdrawn from the vial and added to a 100 ml intravenous bag for infusion or other suitable infusion container (e.g. glass bottle).
Takoj nato odvzemite 5 ml rekonstituirane raztopine iz viale in jo dodajte v 100-mililitrsko vrečko za intravensko infuzijo ali drug primeren vsebnik za infuzijo (na primer steklenico).
• Acute pancreatitis (inflamed pancreas which may result in severe abdominal pain, nausea, and vomiting)
• akutni pankreatitis (vnetje trebušne slinavke, ki lahko povzroči hude bolečine v trebuhu, slabost s siljenjem na bruhanje (navzea) in bruhanje)
For a 100 mg dose, reconstitute using two vials into a 100 ml intravenous bag for infusion or other suitable infusion container (e.g. glass bottle).
Za 100-miligramski odmerek rekonstituirajte dve viali v 100-mililitrsko vrečko za intravensko infuzijo ali drug primeren vsebnik za infuzijo (na primer steklenico).
Tygacil 50 mg powder for solution for infusion
Tygacil 50 mg prašek za raztopino za infundiranje
other than S. pneumoniae S  0.25 mg/L and R  0.5 mg/L Enterococcus spp.
S  0,5 mg/l in R > 0,5 mg/l Streptococcus spp., razen S. pneumoniae, S  0,25 mg/l in R > 0,5 mg/l Enterococcus spp.
Gram-negative Aerobes
Gramnegativni aerobi
No significant effect of a single intravenous dose of tigecycline 50 mg or 200 mg on QTc interval was detected in a randomized, placebo- and active-controlled four-arm crossover thorough QTc study of 46 healthy subjects.
V randomizirani, s placebom in učinkovino nadzorovani navzkrižni podrobni študiji QTc s štirimi skupinami, pri 46 zdravih preiskovancih niso ugotovili pomembnega učinka enkratnega intravenskega odmerka 50 mg ali 200 mg tigeciklina na interval QTc.
Prothrombin time or other suitable anticoagulation test should be used to monitor patients if tigecycline is administered with anticoagulants (see section 4.5).
Bolnike, ki jim dajemo tigeciklin skupaj z antikoagulanti, moramo spremljati s testiranjem protrombinskega časa ali kakim drugim primernim koagulacijskim testom (glejte poglavje 4.5).
Investigations elevated amylase in serum, increased blood urea nitrogen (BUN)
Preiskave zvišana amilaza v serumu, zvišan dušik sečnine v krvi (BUN) neželeni učinki, ugotovljeni v obdobju trženja
Multiple dose
enkratni odmerek večkratni odmerki
Tetracycline class adverse reactions may include photosensitivity, pseudotumour cerebri, pancreatitis, and antianabolic action which has led to increased BUN, azotaemia, acidosis, and hyperphosphataemia (see section 4.4).
Med neželenimi učinki zdravil iz skupine tetraciklinov so lahko preobčutljivost za svetlobo, benigna intrakranialna hipertenzija, pankreatitis in antianabolno delovanje, ki lahko povzroči zvišan dušik sečnine v krvi, azotemijo, acidozo in hiperfosfatemijo (glejte poglavje 4.4).
Adult dose should be reduced to 25 mg every 12 hours following the 100 mg loading dose.
Odmerek za odrasle je treba, po polnilnem odmerku 100 mg, zmanjšati na 25 mg vsakih 12 ur.