natgillin/translations-raw huggingface dataset:
Side effects occured during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines or with the adult formulation of Twinrix include:
43 Možni neželeni učinki, ki so se zgodili med kliničnimi študijami ali rutinskem cepljenju s cepivom Twinrix za otroke ali posameznim cepivom proti hepatitisu A in hepatitisu B ali s cepivom Twinrix za odrasle:
However, if you get any of these symptoms you should contact a doctor urgently. • Abnormal laboratory liver test results • Multiple sclerosis, swelling of the spinal cord (myelitis) • Drooping eyelid and sagging muscles on one side of the face (facial palsy) • A temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barré syndrome) • A disease of the nerves of the eye (optic neuritis)
44 • Začasno vnetje živcev, ki povzročajo bolečino, šibkost in paralizo v ekstremitetah in često napredujejo proti prsnemu košu in obrazu (Guillain- Barré- jev sindrom) • Bolezen očesnih živcev (optični nevritis)
HOW TO STORE TWINRIX PAEDIATRIC
SHRANJEVANJE CEPIVA TWINRIX ZA OTROKE
44 Do not use Twinrix Paediatric after the expiry date which is stated on the carton.
Cepiva Twinrix za otroke ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
What Twinrix Paediatric contains
Kaj vsebuje cepivo Twinrix za otroke
3 Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4
0, 025 miligrama Al3+ Adsorbiran na hidratirani aluminijev hidroksid 3 Pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk (Saccharomyces cerevisiae) 4 0, 2 miligrama Al3+ Adsorbiran na aluminijev fosfat
- The other ingredients in Twinrix Paediatric are: sodium chloride, water for injections.
- Pomožne snovi cepiva Twinrix za otroke so: natrijev klorid in voda za injekcije.
Twinrix Paediatric is a white, slightly milky liquid presented in a glass vial (0.5 ml).
Cepivo Twinrix za otroke je bela, rahlo mlečna tekočina v stekleni viali (0, 5 ml).
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
45 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Tel:+ 39 04 59 21 81 11
46 Tel: + 39 04 59 21 81 11
47 PACKAGE LEAFLET:
47 NAVODILO ZA UPORABO
Twinrix Paediatric, Suspension for injection in prefilled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Twinrix za otroke, suspenzija za injiciranje v napolnjeni injekcijski brizgi Cepivo proti hepatitisu A, inaktivirano, in hepatitisu B, rekombinantno (HAB), adsorbirano
Do not pass it on to others.
- Cepivo je bilo predpisano vam / vašemu otroku osebno in ga ne smete dajati drugim.
48 Take special care with Twinrix Paediatric:
Bodite posebno pozorni pri cepljenju s cepivom Twinrix za otroke:
If you miss/ your child misses a scheduled injection, talk to your doctor and arrange a nother visit.
Če ste izpustili/ je vaš otrok izpustili odmerek ob dogovorjenem času, se pogovorite z zdravnikom in se dogovorite za naslednji obisk.
Side effects occured during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines or with the adult formulation of Twinrix include:
49 Možni neželeni učinki, ki so se zgodili med kliničnimi študijami ali rutinskem cepljenju s cepivom Twinrix za otroke ali posameznim cepivom proti hepatitisu A in hepatitisu B ali s cepivom Twinrix za odrasle:
However, if you get any of these symptoms you should contact a doctor urgently. • Abnormal laboratory liver test results • Multiple sclerosis, swelling of the spinal cord (myelitis) • Drooping eyelid and sagging muscles on one side of the face (facial palsy) • A temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barré syndrome) • A disease of the nerves of the eye (optic neuritis)
50 • Začasno vnetje živcev, ki povzročajo bolečino, šibkost in paralizo v ekstremitetah in često napredujejo proti prsnemu košu in obrazu (Guillain- Barré- jev sindrom) • Bolezen očesnih živcev (optični nevritis)
50 Do not use Twinrix Paediatric after the expiry date which is stated on the carton.
Cepiva Twinrix za otroke ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
Twinrix Paediatric is a white, slightly milky liquid presented in a glass prefilled syringe (0.5 ml).
Cepivo Twinrix za otroke je bela, rahlo mlečna tekočina v stekleni napolnjeni injekcijski brizgi (0, 5 ml).
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
51 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
The vaccine should be well shaken to obtain a slightly opaque, white suspension and visually inspected for any foreign particulate matter and/or variation of physical aspect prior to administration.
Pred uporabo morate cepivo dobro pretresti, da nastane rahlo motna, bela suspenzija in ga vizualno pregledati glede morebitnih tujih delcev in/ ali odstopanja od fizikalnega videza cepiva.
EMEA/ 245771/ 2008
EMEA/ 402817/ 2008 Error!
The active substance in Tygacil, tigecycline, belongs to the group of antibiotics called ‘ glycylcyclines’, which are similar to tetracycline.
Zdravilna učinkovina zdravila Tygacil, tigeciklin, spada v skupino antibiotikov, imenovanih „ glicilciklini “, ki so podobni tetraciklinu.
Tigecycline works by blocking the bacteria’ s ribosomes, the parts of the bacterial cells where new proteins are made.
Tigeciklin deluje tako, da blokira ribosome bakterij oziroma tiste dele bakterijskih celic, ki proizvajajo nove beljakovine.
Following the CHMP’ s opinion, it usually takes around six weeks for the European Commission to update the licence.
Ko CHMP poda mnenje, Evropska komisija v približno šestih tednih posodobi dovoljenje.
Based on the review of the data and the company’ s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Tygacil could not have been approved for the treatment of community-acquired pneumonia.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Tygacil ni mogoče odobriti za zdravljenje pljučnice, pridobljene izven bolnišnice.
Therefore, at the time of the withdrawal, the CHMP’ s view was that a benefit of Tygacil had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
CHMP je bil zato v času umika mnenja, da koristi zdravila Tygacil niso zadostno dokazane in da niso večje od znanih tveganj.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist..
Če potrebujete več informacij o vašem zdravstvenem stanju ali zdravljenju, preberite Navodila za uporabo (ki so prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Tygacil is an orange powder for solution for infusion (drip into a vein).
Zdravilo Tygacil je oranžni prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
Tygacil contains the active substance tigecycline.
Tycagil vsebuje zdravilno učinkovino tigeciklin.
Tygacil is an antibiotic.
Tygacil je antibiotik.
It is used to treat adults with complicated infections of the abdomen or complicated skin and soft tissues infections (infections of the skin and the tissues below the skin).
Uporablja se za zdravljenje odraslih z zapleteno trebušno ali kožno okužbo ali z zapleteno okužbo mehkega tkiva (okužbo kože in podkožnega tkiva).
Before using Tygacil, doctors need to look at official guidance they may have on the appropriate use of antibiotics.
Pred uporabo zdravila Tygacil mora zdravnik prebrati morebitne uradne smernice za ustrezno uporabo antibiotikov.
The recommended dose is a starting dose of 100 mg followed by 50 mg every 12 hours for 5 to 14 days.
Priporočeni začetni odmerek je 100 mg, ki mu sledi 50 mg zdravila vsakih 12 ur v trajanju 5 do 14 dni.
Each infusion should last between 30 and 60 minutes.
Vsaka infuzija sme trajati od 30 do 60 minut.
The length of treatment depends on where the infection is, how severe it is, and the patient ’ s response to treatment.
Trajanje zdravljenja je odvisno mesta okužbe, resnosti okužbe ter od bolnikovega odziva na zdravljenje.
Doses are lower in patients with severe liver problems.
Pri bolnikih z resnimi obolenji jeter morajo biti odmerki primerno nižji.
Tygacil contains the active substance tigecycline, which belongs to a group of antibiotics, similar to tetracycline, the glycylcyclines.
Zdravilo Tygacil vsebuje zdravilno učinkovino tigeciklin, ki spada v skupino antibiotikov, podobnih tetraciklinu in glicilciklinom.
Tygacil works by blocking the bacteria's ribosomes, the parts of the cell where new proteins are produced.
Tygacil deluje tako, da blokira ribosome bakterij oziroma tiste dele celice, ki proizvajajo nove beljakovine.
When proteins cannot be produced, bacteria cannot multiply and eventually die.
Ko je proizvodnja beljakovin onemogočena, se bakterija ne more več razmnoževati in sčasoma umre.
The list of bacteria against which Tygacil is active can be found in the Summary of Product Characteristics.
Seznam bakterij, proti katerim je zdravilo Tygacil učinkovito, je na voljo v Povzetku glavnih značilnosti zdravila.
The effectiveness of Tygacil has been studied in four main studies.
Učinkovitost zdravila Tygacil so preučevali v štirih večjih raziskavah.
Two studies were in 1,568 patients with complicated intra-abdominal infections (half of those were complicated appendicitis), where Tygacil was compared with imipenem/ cilastatin.
Dve raziskavi, ki sta bili izvedeni na 1. 568 bolnikih z zapletenimi notranjimi okužbami trebušne votline (pri polovici od teh je šlo za zapleteno vnetje slepiča), sta primerjali zdravilo Tygacil z imipenemom/ cilastatinom.
Two studies were in 1,129 patients with complicated skin and soft tissue infections (half of those were cases of cellulitis requiring hospitalisation), where Tygacil was compared with a combination of vancomycin and aztreonam.
Dve raziskavi, ki sta bili izvedeni na 1. 129 bolnikih z zapletenimi kožnimi okužbami in okužbami mehkih tkiv (pri polovici od teh je šlo za celulitis, ki je zahteval hospitalizacijo), sta primerjali zdravilo Tygacil s kombinacijo vankomicina in aztreonama.
All studies measured the clinical response (cure of the infection or failure to cure).
Vse raziskave so merile klinični odziv (ozdravitev okužbe ali neuspešno zdravljenje okužbe).
(44-20) 74 18 84 00, Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Tygacil shown during the studies?
(44- 20) 74 18 84 00, Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kakšne koristi je zdravilo Tygacil izkazalo med raziskavami?
In all studies, Tygacil was as effective as the comparator antibiotics, and the percentages of patients whose infections were cured after treatment were similar:
V vseh raziskavah je Tygacil pokazal enako učinkovitost kot primerjalni antibiotiki, podoben pa je bil tudi odstotek uspešno ozdravljenih bolnikov:
80.6 and 91.3% in the studies of abdominal infection, against 82.4 and 89.9% for the comparator, and 82.9% and 89.7% in skin and soft tissue infections, against 82.3 and 94.4% for the comparator combination.
80, 6 in 91, 3% ozdravljenih bolnikov s trebušno okužbo napram 82, 4 in 89, 9% pri zdravljenju s primerjalnimi antibiotiki, ter 82, 9% in 89, 7% ozdravljenih bolnikov s kožno okužbo in okužbo mehkega tkiva napram 82, 3 in 94, 4% pri zdravljenju s primerjalnimi kombinacijami antibiotikov.
The most common side effects (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting and diarrhoea.
Najpogostejši neželeni učinki (opaženi pri več kot 1 od 10 bolnikov) so slabost, bruhanje in driska.
For the full list of all side effects reported with Tygacil, see the Package Leaflet.
Celovit seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tygacil, najdete v Navodilih za uporabo.
Tygacil should not be used in people who may be hypersensitive (allergic) to tigecycline or any of the other ingredients.
Zdravila Tygacil ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) tigeciklin ali katerokoli drugo sestavino zdravila.
Patients allergic to tetracycline antibiotics may also be allergic to Tygacil.
Bolniki, ki so alergični na tetraciklinske antibiotike utegnejo biti alergični tudi na zdravilo Tygacil.
The Committee for Medicinal Products for Human Use (CHMP) decided that Tygacil’ s benefits are greater than its risks for the treatment of complicated skin and soft tissue infections and for the treatment of complicated intra-abdominal infections.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Tygacil pri zdravljenju zapletenih oblik kožne okužbe in okužb mehkega tkiva ter pri zdravljenju zapletenih notranjih trebušnih okužb večje od z njim povezanih tveganj.
They recommended that Tygacil be given marketing authorisation.
Zato je za zdravilo Tygacil priporočil odobritev dovoljenja za promet z zdravilom.
What measures are being taken to ensure the safe use of Tygacil?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Tygacil?
The Company that makes Tygacil will monitor the development of resistance (when a germ that was sensitive to the action of an antibiotic develops ways of fighting its effects), they will also look at the mechanism of interaction of Tygacil with warfarin (a medicine used to thin blood), and the use of Tygacil in patients who have problems eliminating bile (cholestasis)
Proizvajalec zdravila Tygacil bo skrbno spremljal razvoj odpornosti bakterije (ko bakterija, ki je bila prej občutljiva na delovanje antibiotika, razvije nov način za boj proti njegovemu delovanju), poleg tega pa bo preučil tudi mehanizem interakcije med zdravilom Tygacil in varfarinom (zdravilom za preprečevanje krvnih strdkov) ter uporabo zdravila Tygacil pri bolnikih z zastojem žolča (holestazo).
The European Commission granted a marketing authorisation valid throughout the European Union, for Tygacil to Wyeth Europa Limited on 24 April 2006.
Evropska komisija je dovoljenje za promet z zdravilom Tygacil, veljavno po vsej Evropski uniji, odobrila družbi Wyeth Europa Limited dne 24. aprila 2006.
The full EPAR for Tygacil is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Tygacil je na voljo tukaj.
Powder for solution for infusion
prašek za raztopino intravenska za infundiranje uporaba
Tygacil 50 mg powder for solution for infusion.
Tygacil 50 mg prašek za raztopino za infundiranje
Each 5 ml Tygacil vial contains 50 mg of tigecycline.
Ena 5- mililitrska viala zdravila Tygacil vsebuje 50 mg tigeciklina.
Lyophilised orange cake or powder.
Liofilizirana oranžna pogača ali prašek.
Tygacil is indicated for the treatment of the following infections (see sections 4.4 and 5.1):
Tygacil je indiciran za zdravljenje naslednjih okužb (glejte poglavji 4. 4. in 5. 1):
• Complicated skin and soft tissue infections • Complicated intra-abdominal infections
• komplicirane okužbe kože in mehkih tkiv, • komplicirane intraabdominalne okužbe.
The recommended dose for adults is an initial dose of 100 mg followed by 50 mg every 12 hours for 5 to 14 days.
Odmerjanje Priporočeni začetni odmerek za odrasle je 100 mg, ki mu sledi odmerek po 50 mg vsakih 12 ur, 5 do 14 dni.
The duration of therapy should be guided by the severity, site of the infection, and the patient’ s clinical response.
Trajanje zdravljenja je odvisno od resnosti okužbe, mesta okužbe in bolnikovega kliničnega odziva.
Hepatic insufficiency No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B).
Insuficienca jeter Pri bolnikih z blago do zmerno okvaro jeter prilagajanje odmerjanja ni potrebno (razreda A in B po Child- Pughovi lestvici).
In patients with severe hepatic impairment (Child Pugh C), the dose of Tygacil should be reduced to 25 mg every 12 hours following the 100 mg loading dose.
Pri bolnikih s hudo okvaro jeter (razred C po Child- Pughovi lestvici) morate odmerek Tygacila po nasičevalnem odmerku 100 mg zmanjšati na 25 mg vsakih 12 ur.
Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response (see sections 4.4 and 5.2).
Bolnike s hudo okvaro jeter (razred C po Child- Pughovi lestvici) morate zdraviti previdno in spremljati odziv na zdravljenje (glejte poglavji 4. 4 in 5. 2).
2 Renal insufficiency No dosage adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis (see section 5.2).
Insuficienca ledvic Pri bolnikih z okvaro ledvic in pri bolnikih, ki se zdravijo s hemodializo, prilagajanje odmerka ni potrebno (glejte poglavje 5. 2).
Elderly patients No dosage adjustment is necessary in elderly patients (see section 5.2).
Starostniki Pri starostnikih odmerka ni treba prilagoditi (glejte poglavje 5. 2).
Paediatric patients Tygacil is not recommended for use in children and adolescents below 18 years due to the lack of data on safety and efficacy (see sections 5.2 and 4.4).
2 Otroci Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Tygacil pri otrocih in mladostnikih, mlajših od 18 let ni priporočljiva (glejte poglavji 5. 2 in 4. 4).
Tygacil is administered only by intravenous infusion over 30 to 60 minutes (see section 6.6).
Način uporabe Tygacil se daje samo z intravensko infuzijo, ki teče 30 do 60 minut (glejte poglavje 6. 6).
Patients hypersensitive to tetracycline class antibiotics may be hypersensitive to tigecycline.
Bolniki, ki so preobčutljivi za antibiotike tetraciklinske skupine, utegnejo biti preobčutljivi za tigeciklin.
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).
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).
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).
The diagnosis of acute pancreatitis should be considered in patients taking tigecycline who develop clinical symptoms, signs, or laboratory abnormalities suggestive of acute pancreatitis.
Na diagnozo akutnega pankreatitisa moramo pomisliti pri bolnikih na tigeciklinu, pri katerih se razvijejo klinični simptomi, znaki ali laboratorijske nenormalnosti, ki kažejo na akutni pankreatitis.
Experience in the use of tigecycline for treatment of infections in patients with severe underlying diseases is limited.
Izkušenj z uporabo tigeciklina za zdravljenje okužb pri bolnikih s težkimi osnovnimi boleznimi je malo.
In clinical trials in complicated skin and soft tissue infections, the most common type of infection in tigecycline treated-patients was cellulitis (59%), followed by major abscesses (27.5%).
V kliničnih preskušanjih z zapletenimi okužbami kože in mehkih tkiv je bila najpogostejša vrsta okužbe pri bolnikih, zdravljenih s tigeciklinom, flegmona (59%), ki so mu sledili večji abscesi (27, 5%).
Patients with severe underlying disease, such as those that were immunocompromised, patients with decubitus ulcer infections, or patients that had infections requiring longer than 14 days of treatment (for example, necrotizing fasciitis), were not enrolled.
Bolniki s kako hujšo osnovno boleznijo, na primer imunokompromitirani bolniki, bolniki z okužbami preležaninskih razjed ali bolniki z okužbami, pri katerih je bilo potrebno zdravljenje, daljše od 14 dni (na primer nekrotizirajoči fasciitis), niso bili vključeni.
Few patients with diabetic foot infections (5%) were enrolled.
Vključenih je bilo nekaj bolnikov z okužbami diabetičnega stopala (5%).
A limited number of patients were enrolled with co-morbid factors such as diabetes (20%), peripheral vascular disease (7%), intravenous drug abuse (2%), and HIV-positive infection (1%).
Vključeno je bilo majhno število bolnikov s sočasnimi dodatnimi bolezenskimi dejavniki, na primer sladkorno boleznijo (20%), boleznimi perifernega žilja (7%), intravensko zlorabo drog (2%) in okužbo z virusom HIV (1%).
Limited experience is also available in treating patients with concurrent bacteraemia (3%).
Na voljo je tudi malo izkušenj z zdravljenjem bolnikov s sočasno bakteriemijo (3%).
Therefore, caution is advised when treating such patients.
Zato je pri zdravljenju takih bolnikov priporočljiva previdnost.
3 In clinical trials in complicated intra-abdominal infections, the most common type of infection in tigecycline treated-patients was complicated appendicitis (51%), followed by other diagnoses less commonly reported such as complicated cholecystitis (14%), intra-abdominal abscess (10%), perforation of intestine (10%) and gastric or duodenal ulcer perforation less than 24 hours (5%).
V kliničnih preskušanjih pri kompliciranih intraabdominalnih okužbah je bila najpogostejša vrsta okužb pri bolnikih, zdravljenih s tigeciklinom, vnetje slepiča s komplikacijami (51%), sledile so mu druge diagnoze, o katerih so redkeje poročali, na primer vnetje žolčnika s komplikacijami (14%), intraabdominalni absces (10%), perforacija črevesa (10%) in perforacija želodčne ali duodenalne razjede, stara največ 24 ur (5%).
Of these patients, 76% had associated diffuse peritonitis (surgically-apparent peritonitis).
Od teh bolnikov jih je imelo 76% pridružen difuzni peritonitis (kirurško ugotovljen peritonitis).
There were a limited number of patients with severe underlying disease such as immunocompromised patients, patients with APACHE II scores > 15 (4%), or with surgically apparent multiple intra-abdominal abscesses (10%).
Majhno število bolnikov je imelo hujšo osnovno bolezen, na primer imunokompromitirani bolniki, bolniki z ocenami > 15 po lestvici APACHE II (4%) ali s kirurško ugotovljenimi multiplimi intraabdominalnimi abscesi (10%).
Limited experience is also available in treating patients with concurrent bacteraemia (6%).
Na voljo je tudi malo izkušenj z zdravljenjem bolnikov s sočasno bakteriemijo (6%).
Consideration should be given to the use of combination antibacterial therapy whenever tigecycline is to be administered to severely ill patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation or patients with incipient sepsis or septic shock (see section 4.8).
3 Kadarkoli nameravamo dati tigeciklin težko bolnim bolnikom s kompliciranimi intraabdominalnimi infekcijami (cIAI), ki so nastale zaradi klinično očitne perforacije črevesa, ali bolnikom z začetno sepso ali septičnim šokom, moramo pretehtati možnost kombiniranega protibakterijskega zdravljenja (glejte poglavje 4. 8).
Biliary excretion accounts for approximately 50% of the total tigecycline excretion.
Izločanje z žolčem predstavlja okrog 50% celotnega izločanja tigeciklina.