natgillin/translations-raw huggingface dataset:
In summary, a harmonised wording for inclusion in the harmonised SPCs was agreed and adopted by the CHMP. 
CHMP je potrdil in sprejel usklajeno besedilo, ki se vključi v usklajene povzetke glavnih značilnosti zdravila.
The CHMP also differentiated between the 2:1 tablets (and dispersible tablets) and the powder for oral suspension. 
Besedilo o odmerjanju je popravljeno in sedaj vsebuje priporočila o odmerjanju za uporabo zdravila Augmentin suspenzija pri otrocih, starejših od 6 let in lažjih od 40 kg. CHMP razlikuje tudi med tabletami (in disperzibilnimi tabletami) 2:1 ter praškom za peroralno suspenzijo.
The CHMP noted the clinical trials comparing the efficacy of the different dosing regimens of amoxicillin/clavulanic acid in recurrent tonsillitis and that a number of national guidelines recommend 
CHMP je preučil klinična preskušanja, v katerih so primerjali učinkovitost različnih režimov odmerjanja kombinacije amoksicilin/klavulanska kislina za ponovitve tonzilitisa, in številne nacionalne smernice, ki priporočajo uporabo zdravila Augmentin ali kombinacijo penicilin + zaviralec beta laktamaze kot zdravila prve izbire za akutno vnetje srednjega ušesa, običajno bakterijsko superinfekcijo s prurulentno ali mikroprurulentno tekočino srednjega ušesa.
POSOLOGY AND METHOD OF ADMINISTRATION FOR AUGMENTIN 16:1 RATIO (ORAL - SR) 
ODMERJANJE IN NAČIN UPORABE ZDRAVILA AUGMENTIN Z RAZMERJEM 16:1 (PERORALNO - SR)
Whereas 
• prebavila
THERAPEUTIC INDICATIONS FOR AUGMENTIN 4:1 RATIO (ORAL) 
TERAPEVTSKE INDIKACIJE ZA ZDRAVILO AUGMENTIN Z RAZMERJEM 4:1 (PERORALNO)
The MAH listed the currently approved indications, discussing in particular its use in SSTIs and recurrent tonsillitis, otitis media, sinusitis, LRTIs and UTIs, as well as URTIs and genito-urinary tract infections, and discussed the PK/PD, demonstrating the bacteriological equivalence of the BID and TID formulations. 
Imetniki dovoljenj za promet z zdravilom so navedli trenutno odobrene indikacije in zlasti razpravljali o uporabi tega zdravila pri okužbah kože in mehkih tkiv, ponovitvah tonzilitisa, okužbah srednjega ušesa, sinusitisu, okužbah spodnjih dihal in sečil ter zgornjih dihal in spolovil ter sečil.
• Biliary tract surgery. 
Kirurška profilaksa z zdravilom Augmentin i.v.
POSOLOGY AND METHOD OF ADMINISTRATION FOR AUGMENTIN 10:1 RATIO (INTRAVENOUS) 
ODMERJANJE IN NAČIN UPORABE ZDRAVILA AUGMENTIN Z RAZMERJEM 10:1 (INTRAVENSKO)
Antiadiposo has been used for the treatment of obesity. 
Zdravilo Antiadiposo se je uporabljalo za zdravljenje debelosti.
The CHMP discussed the matter at its September 2009 plenary meeting and the procedure in accordance with Article 107(2) of Directive 2001/83/EC, as amended was started. 
CHMP je o zadevi razpravljal na svojem plenarnem zasedanju septembra 2009 in začel postopek v skladu s členom 107(2) Direktive 2001/83/ES, kakor je bila spremenjena.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCT(S) CONTAINING IODOCASEIN/THIAMINE (see Annex I) 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO KOMBINACIJO JODOKAZEINA IN TIAMINA (glejte Dodatek I)
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE REVOCATION OF THE MARKETING AUTHORISATION 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA RAZVELJAVITEV DOVOLJENJA ZA PROMET Z ZDRAVILOM
The amount of iodine released per each tablet (i.e. 9.4 mg) is noted to be 60 times higher than the daily recommended iodine dose of 150 mcg. 
Količina joda, ki se sprosti iz vsake tablete (tj. 9,4 mg) je 60-krat večja od dnevnega priporočenega odmerka joda, ki znaša 150 mcg.
This over stimulation of the metabolism is also frequently accompanied by tachycardia, palpitations and anxiety. 
To čezmerno stimulacijo presnove pogosto spremljajo tahikardija, palpitacija in anksioznost.
These clinical conditions translate the overproduction and consequent excess of circulating free thyroid hormones with effects in every type of tissue. 
Ti klinični stanji povzročita čezmerno nastajanje in posledično čezmerno količino krožečih prostih ščitničnih hormonov z učinki na vse vrste tkiv.
However, this daily dose represents an iodine dose intake which is 120 times higher than the recommended daily dose. 
Vendar ta dnevni odmerek predstavlja vnos joda, ki je 120-krat večji od priporočenega dnevnega odmerka.
All reported cases were related with iodocasein/thiamine and 6 cases considered serious. 
Vsi prijavljeni primeri so bili povezani s kombinacijo jodokazeina in tiamina, 6 primerov se je štelo za resne.
However, this measure is not sufficient to address the risks for hyperthyroidism and thyrotoxicosis associated with the iodocasein/thiamine treatment as above described. 
Vendar ta ukrep ni zadosten za obravnavo tveganja hipertiroidizma in tirotoksikoze, povezanih z zdravljenjem z zgoraj opisano kombinacijo jodokazeina in tiamina.
• The Committee concluded, after having reviewed the available data, that iodocasein/thiamine is associated with serious cases of hyperthyroidism and thyrotoxicosis. 
• Odbor je po pregledu razpoložljivih podatkov zaključil, da je kombinacija jodokazeina in tiamina povezana z resnimi primeri hipertiroidizma in tirotoksikoze.
On 16 September 2009, the Italian Competent Authority (AIFA) issued a Rapid Alert informing the Members States, the EMEA and the European Commission (EC) in accordance with Article 107 of Directive 2001/83/EC, as amended, of the suspension of the Marketing Authorisation of iodocasein/thiamine containing medicinal product (Antiadiposo) in its Member State, due to serious cases of hyperthyroidism and thyrotoxicosis. 
Dne 16. septembra 2009 je italijanski pristojni organ (AIFA) izdala hitro obvestilo in države članice, agencijo EMEA in Evropsko komisijo (EK) v skladu s členom 107 Direktive 2001/83/ES, kakor je bila spremenjena, obvestil o svoji odločitvi, da v Italiji začasno umakne dovoljenje za promet z zdravilom (Antiadiposo), ki vsebuje kombinacijo jodokazeina in tiamina, zaradi resnih primerov hipertiroidizma in tirotoksikoze.
Iodocasein 125mg (7.6% of iodine) and thiamine as nitrate 12.33 mg are the active substances for Antiadiposo, approved since 1955 in Italy for the treatment of obesity resulting from metabolic disorders. 
Jodokazein 125 mg (7,6 % joda) in tiamin v obliki nitrata 12,33 mg sta zdravilni učinkovini zdravila Antiadiposo, ki je od leta 1955 v Italiji odobren za zdravljenje debelosti zaradi presnovnih bolezni.
The product information lists hyperthyroidism as a contra-indication and advises on the need for a regular control of the thyroid function during treatment with recommendation for discontinuation of the treatment in case of abnormal tests results of thyroid function, with symptoms of hyperthyroidism, tachycardia and arrhythmia. 
V informacijah o zdravilu je hipertiroidizem naveden kot kontraindikacija z nasvetom o potrebnem rednem nadzoru funkcije ščitnice med zdravljenjem in priporočilom o prekinitvi zdravljenja v primeru nenormalnih rezultatov testov funkcije ščitnice, simptomov hipertiroidizma, tahikardije ali aritmije.
The majority of the cases occurred at a dose of two tablets per day which is the recommended daily dose. 
Večina primerov bolezni se je pojavila pri odmerku dveh tablet na dan, kar je priporočeni dnevni odmerek.
• The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing iodocasein/thiamine. 
• Odbor je obravnaval zadevo v skladu s členom 107 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo kombinacijo jodokazeina in tiamina.
Taking all the above elements in consideration and the fact that there are other therapeutic alternatives available for the treatment of obesity, the CHMP concluded that the benefit/risk balance for iodocasein/thiamine is not considered favourable and recommended the revocation of the Marketing Authorisation for the medicinal product referred to in Annex I. 
CHMP je ob upoštevanju zgornjih informacij in dejstva, da obstajajo druge terapevtske možnosti za zdravljenje debelosti, zaključil, da razmerje med koristmi in tveganji, povezanimi s kombinacijo jodokazeina in tiamina, ni ugodno in je zato priporočil razveljavitev dovoljenja za promet z zdravilom, ki je navedeno v Dodatku I.
• The Committee noted that iodocasein/thiamine is approved for a condition for which alternative treatments are available. 
• Odbor je izpostavil, da je kombinacija jodokazeina in tiamina odobrena za stanje, za katerega so na voljo druge možnosti zdravljenja.
The therapeutic effect of Antiadiposo is mainly due to iodocasein, which increases the amount of available iodine, stimulating the thyroid gland and consequently activating the metabolic processes. 
Terapevtski učinek zdravila Antiadiposo je v glavnem zaradi jodokazeina, ki poveča količino razpoložljivega joda, ki spodbuja ščitnico ter posledično aktivira presnovne procese.
Following the provisions under Article 107(2) of Directive 2001/83/EC, as amended, the Agency's Committee for Medicinal Products for Human Use (CHMP) prepared an opinion on 22 October 2009 recommending the revocation of the Marketing Authorisation for iodocasein/thiamine containing medicinal product referred to in Annex I. 
V skladu z določbami člena 107(2) Direktive 2001/83/ES, kakor je bila spremenjena, je Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje v okviru Agencije, dne 22. oktobra 2009 pripravil mnenje, v katerem je priporočil razveljavitev dovoljenja za promet z zdravilom, ki vsebuje kombinacijo jodokazeina in tiamina in je navedeno v Dodatku I.
Antiadiposo (iodocasein 125 mg/thiamine 12.33 mg), approved since 1955 in Italy for the treatment of obesity acts by increasing the amount of available iodine thus stimulating the thyroid gland and consequent metabolic processes. 
Zdravilo Antiadiposo (jodokazein 125 mg/tiamin 12,33 mg), odobren od leta 1955 v Italiji za zdravljenje debelosti, deluje s povečanjem količine razpoložljivega joda, ki spodbuja ščitnico ter posledično presnovne procese.
The majority of the cases occurred at a dose of two tablets per day treatment which is the recommended daily dose. 
Večina primerov bolezni se je pojavila po zdravljenju z odmerkom dveh tablet na dan, kar je priporočeni dnevni odmerek.
• The Committee, in light of the above findings, concluded that the benefit/risk balance of iodocasein/thiamine containing medicinal products is not favourable. 
• Odbor je na podlagi zgoraj navedenih ugotovitev zaključil, da razmerje med koristmi in tveganji za zdravila, ki vsebujejo kombinacijo jodokazeina in tiamina, ni ugodno.
• The Committee considered that clear evidence on the benefits of iodocasein/thiamine in the treatment of obesity is lacking. 
• Odbor je menil, da ni jasnih dokazov o koristih kombinacije jodokazeina in tiamina za zdravljenje debelosti.
Whereas, there are data supporting that thyroid hormone therapy, even at physiological doses, may induce subclinical hyperthyroidism in obese subjects during caloric deprivation and in patients with non-thyroidal illnesses resulting in detrimental effects. 
Vendar obstajajo podatki, ki potrjujejo, da terapija s ščitničnim hormonom, celo pri fizioloških odmerkih, lahko inducira subklinični hipertiroidizem pri debelih bolnikih med kaloričnim stradanjem in pri bolnikih z neščitničnimi boleznimi, kar povzroči škodljive učinke.
Serious cases of hyperthyroidism and thyrotoxicosis, related with iodocasein/thiamine treatment have been reported. 
Prijavljeni so bili resni primeri hipertiroidizma in tirotoksikoze, povezani z zdravljenjem s kombinacijo jodokazeina in tiamina.
However, the benefits of thyroid hormone therapy in inducing weight loss in obese subjects during caloric deprivation or on morbidity and mortality in patients with non thyroidal illnesses are not clear from published data. 
Vendar koristni učinki terapije s ščitničnim hormonom na indukcijo izgubljanja telesne mase pri debelih bolnikih med kaloričnim stradanjem ali na obolevnost in umrljivost bolnikov z neščitničnimi težavami iz objavljenih podatkov niso jasni.
Available data are insufficient to enable the demonstration of the benefits of thyroid hormone therapy in inducing weight loss in obese subjects during caloric deprivation or on morbidity and mortality in patients with non thyroidal illnesses. 
Razpoložljivih podatkov ni dovolj za dokaz koristnih učinkov terapije s ščitničnim hormonom na indukcijo izgubljanja telesne mase pri debelih bolnikih med kaloričnim stradanjem ali na obolevnost in umrljivost bolnikov z neščitničnimi težavami.
There have been publications on the iodine-induced hyperthyroidism which may occur in patients with iodine-deficiency and thyroid dysfunction but also in patients with no evidence of underlying thyroid disease. 
Objavljeni prispevki opisujejo z jodom induciran hipertiroidizem pri bolnikih s pomanjkanjem joda ali disfunkcijo ščitnice in tudi pri bolnikih brez dokazane osnovne bolezni ščitnice.
Cases of hyperthyroidism and thyrotoxicosis, 12 and 3, respectively were reported in subjects being treated with iodocasein/thiamine. 
Pri bolnikih, zdravljenih s kombinacijo jodokazeina in tiamina, so ugotovili 12 primerov hipertiroidizma in 3 primere tirotoksikoze.
You might have any of these symptoms and/or conditions. 
Morda imate kateregakoli od teh simptomov in/ali stanj.
Elderly population(> 65 years) 
Starejša populacija (> 65 let)
• Cycle delay of more than 1 week due to toxicity 
• zakasnitev ciklusa za več kot 1 teden zaradi toksičnosti
Sections 4.5, 4.6, 4.7, 4.8 and 4.9 were also harmonised. 
Uskladil je tudi poglavja 4.5, 4.6, 4.7, 4.8 in 4.9.
The eyes should be rinsed immediately and thoroughly with water. 
Oči takoj in temeljito sperite z vodo.
Clearance for women is approximately 25% lower than the values for men. 
Očistek pri ženskah je bil približno 25 % nižji kot vrednosti pri moških.
169 27 Solna Sweden 
169 27 Solna Švedska
Instructions for use, handling and disposal. 
Navodila za uporabo, ravnanje in odstranjevanje.
• you have recently had, or are going to have radiotherapy, 
• če ste nedavno imeli ali boste imeli radioterapijo.
The aetiology of these effects is unknown. 
Etiologija teh učinkov ni znana.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. 
Zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so navedena v poglavju 6.6.
Unopened vials: 3 years. 
Neodprte viale: 3 leta.
Early use of supportive care measure may help ameliorate the condition. 
Zgodnja uvedba podpornega zdravljenja lahko pomaga izboljšati stanje.
Urinary excretion: Less than 10% is excreted as unchanged drug. 
Izločanje z urinom: manj kot 10 % se izloči v obliki nespremenjenega zdravila.
Formation of dFdU from parent compound: 91%-98%. 
Tvorba dFdU iz osnovne spojine: 91 %-98 %.
Please tell your doctor if: 
Obvestite svojega zdravnika, če
Likewise, a small amount of gemcitabine may also be incorporated into RNA. 
Na enak način se lahko majhna količina gemcitabina vgradi tudi v RNA.
Half-life of terminal elimination: 0.7-12 hours. 
Končni razpolovni čas izločanja: 0,7 - 12 ur.
The 121 women and 232 men ranged in age from 29 to 79 years. 
Razpon starosti pri 121 ženskah in 232 moških je bil med 29 in 79 let.
Although rapid, clearance for both men and women appears to decrease with age. 
Kljub hitrosti je videti, da se očistek s starostjo pri moških in ženskah zmanjšuje.
The CHMP adopted the proposed revised wording: 
CHMP je sprejel predlagano popravljeno besedilo:
The volume of the peripheral compartment was not sensitive to gender. 
Volumen perifernega dela ni bil odvisen od spola.
Your doctor will discuss with you the potential risk of taking Gemzar during pregnancy. 
Vaš zdravnik se bo pogovoril z vami glede možnega tveganja pri jemanju zdravila Gemzar med nosečnostjo.
No specific interaction studies have been performed (see section 5.2) 
Specifičnih študij medsebojnega delovanja niso izvedli (glejte poglavje 5.2).
• not known: frequency can't be estimated from the available data 
• ni znano: ocena pogostnosti iz danih podatkov ni možna
35396 Gießen 
35396 Gießen Nemčija
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including vaccinations and medicines obtained without a prescription. 
Obvestite svojega zdravnika ali bolnišničnega farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, vključno z vakcino, tudi če ste ga dobili brez recepta.
Urinary excretion: All. 
Izločanje z urinom: Celotno.
This 4-week cycle is then repeated. 
Ta 4-tedenski ciklus nato ponavljamo.
The pharmacokinetics of gemcitabine have been examined in 353 patients in seven studies. 
Farmakokinetiko gemcitabina so raziskovali v sedmih študijah, pri 353 bolnikih.
The CHMP also deleted the mention of performance status and adopted the following wording: 
CHMP je prav tako izbrisal omembo statusa učinkovitosti in sprejel naslednje besedilo:
The CHMP considers that the divergences identified at the start of the referral have been resolved and that all issues raised in the List of Questions and in the List of Outstanding Issues have been properly addressed and answered satisfactorily. 
CHMP meni, da so bila razhajanja, opredeljena na začetku napotitvenega postopka, rešena in da so bila vsa vprašanja, ki so bila del seznama vprašanj in seznama posebej težavnih vprašanj, pravilno obdelana in zadovoljivo odgovorjena.
Tissue distribution: Extensive. 
Porazdelitev v tkivih: Obsežna.
• you have, or have previously had liver disease, heart disease or vascular disease. 
• imate ali ste imeli jetrno bolezen, srčno obolenje ali žilno bolezen.
Each pack contains 1 vial 
Vsako pakiranje vsebuje 1 vialo.
These medicines kill dividing cells, including cancer cells. 
Ta zdravila ubijajo celice, ki se delijo, vključno z rakavimi celicami.
Within a cycle 
Med ciklusom
Gangrene of fingers or toes 
Gangrena prstov na rokah in nogah
It is not known whether gemcitabine is excreted in human milk and adverse effects on the suckling child cannot be excluded. 
Ni znano, ali se gemcitabin izloča v materino mleko in ni možno izključiti neželenih učinkov na dojenega otroka.
Frequencies are defined as: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10,000 to <1/1000), Very Rare (<1/10,000). 
Pogostnosti so določene kot: zelo pogosto (≥ 1/10), pogosto (≥ 1/100 do < 1/10), občasno (≥ 1/1.000 do < 1/100), redko (≥ 1/10.000 do < 1/1.000), zelo redko (< 1/10.000).
• Increased gamma-glutamyl transferase (GGT) 
• Zvišana gama-glutamil transferaza (GGT)
The plasma protein binding was considered to be negligible. 
Vezavo na plazemske beljakovine so ocenili kot zanemarljivo.
Frequencies of the observed side effects are defined as: 
Pogostnosti opazovanih neželenih učinkov si definirane kot:
Based on results from animal studies and the mechanism of action of gemcitabine, this substance should not be used during pregnancy unless clearly necessary. 
Na osnovi rezultatov iz študij na živalih in mehanizma delovanja gemcitabina, tega zdravila med nosečnostjo ne smete uporabljati, razen če je nujno potrebno.
If the preparation comes into contact with the eyes, this may cause serious irritation. 
Če zdravilo pride v stik z očmi, lahko to povzroči resno draženje.
If the solution is spilled on the skin, rinse thoroughly with water. 
Če se raztopina polije po koži, temeljito sperite z vodo.
You may want to seek counselling on sperm storage before starting your therapy. 
Morda boste potrebovali nasvet glede shranjevanja semena pred začetkom vašega zdravljenja.
Reconstitution at concentrations greater than 40 mg/ml may result in incomplete dissolution and should be avoided. 
Rekonstiticija pri koncentracijah, višjih od 40 mg/ml lahko vodi v nepopolno raztapljanje in se ji moramo izogibati.
For the recommended dosing schedule, gemcitabine elimination should be virtually complete within 5 to 11 hours of the start of the infusion. 
Pri priporočeni shemi odmerjanja bi moralo biti izločanje gemcitabina praktično zaključeno v 5 do 11 urah po začetku infuzije.
Of these patients, approximately 45% had non-small cell lung cancer and 35% were diagnosed with pancreatic cancer. 
Od teh bolnikov jih je približno 45 % imelo nedrobnocelični karcinom pljuč in 35 % karcinom trebušne slinavke.
The following table of undesirable effects and frequencies is based on data from clinical trials. 
Naslednja preglednica neželenih učinkov in njihove pogostnosti je narejena na osnovi podatkov iz kliničnih preskušanj.
Reconstituted solution: The product should be used immediately. 
Rekonstituirana raztopina: Zdravilo mora biti takoj uporabljeno.
• you have been vaccinated recently 
• če ste nedavno prejeli vakcino.
This metabolite can be found in peripheral blood mononuclear cells and the information below refers to these cells. 
Ta presnovek najdemo v enojedrnih celicah periferne krvi in spodnji podatki se nanašajo na te celice.
Critical Evaluation 
Odločilno ovrednotenje
The proposed revisions to the Product Information were fully implemented. 
Predlagani popravki navodila za uporabo so bili v celoti izvršeni.
Calculate the dose and the number of Gemzar vials needed. 
Izračunajte odmerek ter število potrebnih vial.
Live vaccinations 
Živa cepiva
Your doctor will use this body surface area to work out the right dose for you. 
Vaš zdravnik bo to telesno površino uporabil za določitev za vas ustreznega odmerka.
Eli Lilly Norge AS, Postboks 6090 Etterstad, N-0601 Oslo Norway 
Eli Lilly Norge AS, Postboks 6090 Etterstad, N-0601 Oslo Norveška
Vascular disorders Clinical signs of peripheral vasculitis and gangrene 
Žilne bolezni Klinični znaki perifernega vaskulitisa in gangrene
Particular attention was given to the therapeutic indications of Gemzar. 
Posebno pozornost so namenili terapevtskim indikacijam zdravila Gemzar.
You must tell your doctor as soon as possible when you start experiencing any of these side effects. 
Obvestite svojega zdravnika kakor hitro je mogoče po tem, ko začnete imeti kateregakoli od teh neželenih učinkov.
Eli Lilly Ges.m.b.H Kölblgasse 8-10 1030 Wien Austria 
Eli Lilly Ges.m.b.H Kölblgasse 8-10 1030 Wien Avstrija
However, myelosuppression is short lived and usually does not result in dose reduction and rarely in discontinuation. 
Vendar je mielosupresija kratkoročna in običajno ne vpliva na znižanje odmerka ter redko na prekinitev.
Patients should be cautioned against driving or operating machinery until it is established that they do not become somnolent. 
Bolnike je potrebno opozoriti naj ne vozijo in upravljajo s stroji, dokler ne ugotovijo, da ne postanejo zaspani.
1000 mg gemcitabine 
1.000 mg gemcitabina
Grade 3 Grade 4 Grade 3 Grade 4 
3. stopnja 4. stopnja 3. stopnja 4. stopnja
Liver problems: found through abnormal blood test results Blood in urine 
Težave z jetri: ki se ugotovijo z nenormalnimi rezultati krvnih testov Kri v urinu
Gemzar is used in the treatment of the following types of cancer: 
Zdravilo Gemzar se uporablja za zdravljenje naslednjih tipov raka:
Difficulty breathing 
Težave z dihanjem
Concomitant radiotherapy (given together or ≤7 days apart): Toxicity has been reported (see section 4.5 for details and recommendations for use). 
Sočasna radioterapija (dana skupaj ali ≤ 7 dni narazen): Poročali so o toksičnosti (glejte poglavje 4.5 za podrobnosti in priporočila za uporabo).
Trough concentration following once weekly dosing: 0.07-1.12 µg/ml, with no apparent accumulation. 
Najnižja koncentracija po odmerjanju enkrat tedensko: 0,07-1,12 µg/ml, brez očitnega kopičenja.
If extravasation occurs, generally the infusion must be stopped immediately and started again in another blood vessel. 
Če pride do ekstravazacije, moramo v splošnem infuzijo takoj prekiniti in jo ponovno začeti v drugi žili.
When gemcitabine is administered daily, high mortality among the animals but minimal antitumoural activity is observed. 
Če gemcitabin dajemo dnevno, so opazili visoko smrtnost med živalmi, vendar minimalno protitumorsko aktivnost.
Dose modifications of gemcitabine within a cycle should be performed according to the following tables: 
Spremembe odmerka gemcitabina med ciklusom morajo biti opravljene v skladu z naslednjimi preglednicami: