natgillin/translations-raw huggingface dataset:
• allergic reactions or other infusion-related reactions Tell your doctor or nurse if you have any kind of reaction during or after the infusion, such as: fever, shivering and/or low blood pressure difficulties in breathing skin rash, hives You will receive appropriate treatment to prevent these reactions and be closely monitored for these symptoms during infusion of Qarziba. 
• alergijske reakcije ali druge reakcije, povezane z infuzijo Obvestite svojega zdravnika ali medicinsko sestro, če se pojavi katera koli reakcija med infuzijo ali po njej, kot so npr.:
Each 4.5 mL vial contains 20 mg dinutuximab beta. 
ena 4,5-mililitrska viala vsebuje 20 mg dinutuksimaba beta.
Qarziba 4.5 mg/mL concentrate for solution for infusion dinutuximab beta 
Qarziba 4,5 mg/ml koncentrat za raztopino za infundiranje dinutuksimab beta
Recommended dose modifications for dinutuximab beta Adverse reaction Severity 
Priporočene prilagoditve odmerka dinutuksimaba beta
Talk to your doctor before you receive Qarziba if you are of childbearing age. 
Če ste ženska v rodni dobi, se posvetujte z zdravnikom, preden prejmete zdravilo Qarziba.
Hypersensitivity reaction e.g. hypotension 
Preobčutljivostna reakcija npr. hipotenzija
Eye disorders mydriasis, pupillotonia, eye oedema (eyelid, periorbital) 
Očesne bolezni midriaza, pupilotonija, očesni edem (edem veke ali periorbitalni edem)
In order to evaluate the add-on effect of IL-2 in patients with relapsed refractory neuroblastoma, the MAH will submit the results of study APN311202v3. 
Imetnik dovoljenja za promet z zdravilom mora za oceno dodatnega učinka IL-2 pri bolnikih z recidivnim/neodzivnim nevroblastomom predložiti rezultate študije APN311-202v3.
There are no data on pregnant women. 
Podatkov o uporabi dinutuksimaba beta pri nosečnicah ni.
Neuropathic pain usually occurs at the beginning of the treatment and premedication with analgesics, including intravenous opioids, prior to each infusion of dinutuximab beta is required. 
Pred vsako infuzijo dinutuksimaba beta je treba uporabiti premedikacijo z analgetiki, vključno z intravenskimi opioidi.
• have acute grade 3 or 4, or extensive long-lasting graft-versus-host disease This disease is a reaction in which cells of transplanted tissue attack cells of the recipient. 
Ta bolezen je reakcija, pri kateri celice presajenega tkiva napadajo celice prejemnika.
It is unknown whether dinutuximab beta is excreted in human milk. 
Podatkov o uporabi dinutuksimaba beta pri doječih ženskah ni. Ni znano, ali se dinutuksimab beta izloča v materino mleko.
• grade 3 vision eye toxicity 
• toksičnost za vid oz. oko stopnje 3,
Hydrochloric acid (for pH adjustment) 
6.1 Seznam pomožnih snovi histidin saharoza polisorbat 20 voda za injekcije klorovodikova kislina (za prilagoditev pH)
What Qarziba contains 
Kaj vsebuje zdravilo Qarziba
Breast-feeding should be discontinued during treatment with Qarziba and for 6 months after the last dose. 
Ženske morajo med zdravljenjem z zdravilom Qarziba prekiniti dojenje in ne smejo dojiti še vsaj šest mesecev po zadnjem odmerku.
Recurrent 
Opioidi
QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL of concentrate contains 4.5 mg dinutuximab beta. 
NAVEDBA ENE ALI VEČ UČINKOVIN 1 ml koncentrata vsebuje 4,5 mg dinutuksimaba beta.
Water for injections 
Dajanje infuzije
Decrease infusion rate to 50%, After resolution, resume infusion at original rate 
Po odpravi neželenega učinka ponovno vzpostavite prvotno hitrost infuzije.
breathing difficulties, dizziness, hives, rapid or noticeable heartbeat, low blood pressure, hives, 
povišana telesna temperatura, drgetanje in/ali nizek krvni tlak težave z dihanjem kožni izpuščaj, koprivnica.
Tell your doctor immediately if you notice any of these problems. 
Če se pri vas pojavi kateri koli od navedenih simptomov, takoj obvestite zdravnika.
> 60 mL/min/1.73 m2 
10 mg/m2
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY MEMBER STATES 
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH MORAJO UVESTI DRŽAVE ČLANICE
The information pack should contain the following: 
Izobraževalno gradivo mora vsebovati naslednje:
The MAH, in agreement with the competent authorities in the Member States, shall implement, prior to the launch, an educational programme for physicians aiming to provide educational material on the correct prescription of Esbriet. 
Preden imetnik dovoljenja za promet z zdravilom da zdravilo v promet, mora v dogovoru s pristojnimi organi držav članic izvesti izobraževalni program za zdravnike, katerega cilj je zagotoviti izobraževalno gradivo o pravilnem predpisovanju zdravila Esbriet.
• Patients are advised to avoid or reduce exposure to direct sunlight (including sunlamps). 
• Bolnikom je treba svetovati, naj se izogibajo izpostavljenosti neposredni sončni svetlobi ali jo zmanjšajo (vključno s svetilkami za sončenje).
• Physician information (safety checklists) 
• informacije za zdravnike (kontrolne sezname za zagotavljanje varnosti);
• Patients should be instructed to use a sunblock daily, to wear clothing that protects against sun exposure, and to avoid other medications known to cause photosensitivity. 
• Bolnikom je treba naročiti, naj vsak dan uporabljajo kremo za sončenje, nosijo oblačila, ki jih ščitijo pred izpostavljenostjo soncu, in se izogibajo drugim zdravilom, za katera je znano, da povzročajo preobčutljivost na svetlobo.
• Photosensitivity reactions and skin rashes 
• reakcije preobčutljivosti na svetlobo in kožne izpuščaje;
• Esbriet is contraindicated in patients with severe hepatic impairment or end stage liver disease. 
• Zdravilo Esbriet je kontraindicirano za bolnike s hudo okvaro ali končno odpovedjo jeter.
• Abnormal liver function tests 
• nenormalne rezultate testov delovanja jeter;
• Any other clinically significant ADRs based on the judgment of the prescriber 
• katerekoli druge klinično pomembne neželene učinke po presoji zdravnika, ki predpiše zdravilo.
• Elevations of serum transaminases can occur during treatment with Esbriet. 
• Med zdravljenjem z zdravilom Esbriet se lahko poviša raven transaminaz v serumu.
• There is a need to monitor liver function tests prior to initiation of treatment with Esbriet and at regular intervals thereafter. 
• Pred začetkom zdravljenja z zdravilom Esbriet je treba preveriti delovanje jeter in ga nato redno spremljati.
• Patients should be informed that Esbriet is known to be associated with photosensitivity reactions and that preventative measures have to be taken. 
• Bolnike je treba obvestiti, da se pri jemanju zdravila Esbriet lahko pojavijo reakcije preobčutljivosti na svetlobo in da je treba izvesti ustrezne zaščitne ukrepe.
• Close monitoring is required of any patients who develop liver enzyme elevation with appropriate dose adjustment or discontinuation. 
• Bolnike, pri katerih se je pojavilo povišanje jetrnih encimov, je treba pozorno spremljati in po potrebi prilagoditi odmerek ali prekiniti zdravljenje.
• Patient information (PIL) 
• informacije za bolnike (navodilo za uporabo).
Do not use after {Month/Year}. 
Ne uporabljaj po {Mesec/Leto}.
4.4 Special warnings <for each target species> None. 
4.4 Posebna opozorila <za vsako ciljno živalsko vrsto> Jih ni.
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Aktivna sestavina:
100 % oxygen. 
100 % kisik.
Dogs, cats and horses. 
Psi, mačke in konji.
Following these catalytic reactions it reappears in the form of CO2 and H2O. 
Po tem katalitičnim procesu se ponovno pojavi v obliki CO2 and H2O.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu 
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na razpolago na spletni strani Evropske agencije za evaluacijo zdravil (EMEA) http://www.emea.europa.eu/
SPECIAL WARNING(S), IF NECESSARY Keep away from naked flames. 
POSEBNO OPOZORILO(A), ČE JE/SO POTREBNO(A) Zavarujte pred odprtim ognjem.
PHARMACEUTICAL FORM Inhalation gas. 
FARMACEVTSKA OBLIKA Inhalacijski plin.
Do not lubricate. 
Ne naoljite.
Full and empty cylinders should be stored separately. 
Polne in prazne cilindre shranjujte ločeno.
The variation of the partial pressure of oxygen in the blood affects the cardiovascular system, the respiratory system, cellular metabolism, and the central nervous system. 
Sprememba delnega pritiska kisika v krvi vpliva na kardiovaskularni system, dihalni sistem, celični metabolizem in osrednji živčni sistem.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable 
BESEDILO “SAMO ZA ZDRAVLJENJE ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
STATEMENT OF ACTIVE AND OTHER SUBSTANCES 100 % oxygen. 
NAVEDBA ZDRAVILNIH/AKTIVNIH UČINKOVIN IN DRUGIH SNOVI 100 % kisik.
TARGET SPECIES Dogs, cats and horses. 
CILJNE ŽIVALSKE VRSTE Psi, mačke in konji.
Pharmacotherapeutic group: Medical Gases, ATCvet code: QV03AN01. 
Farmakološka skupina: Medical Gases, ATCvet koda: QV03AN01.
Oxygen in concentration over 80 % (FiO2 0.8) should not exceed 18 hours. 
Kisik v koncentraciji preko 80% (FiO2 0.8) ne sme preseči 18 ur.
It is involved in cellular metabolism and catabolism and permits production of energy in the form of adenosine triphosphate (ATP). 
Vključen je v celični metabolizem in katabolizem in zagotavlja prizvodnjo energije v obliki adenozin trifosfata (ATP).
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. 
NAČINI IN POT(I) UPORABE Pred uporabo preberite navodila za uporabo.
If you have been working in an oxygen-enriched atmosphere avoid smoking, open flames or other sources of ignition for at least 15 minutes. 
Če ste delali v prostoru, obogatenem s kisikom, vsaj 15 minut ne kadite, ne uporabljajte odprtega ognja in drugih virov vžiga.
No smoking. 
Prepovedano kajenje.
Cylinders should be protected from falling, from being hit, from sources of heat or ignition, from temperatures of more than 50 °C and from combustible materials. 
Cilindri morajo biti zavarovani pred padci, udarci, pred viri toplote ali vžiga, pred temperaturami nad 50 °C in pred vnetljivimi materiali.
Adverse effects can occur if mammals are exposed to excessive levels of oxygen for long periods of time or if high levels of oxygen are administered under hyperbaric conditions. 
Neželeni učinki se lahko pojavijo, če so sesalci izpostavljeni prekomernim deležem kisika v daljšem časovnem obdobju ali če so visoki deleži kisika uporabljeni v hiperbaričnih pogojih.
Unwanted partially full, or empty, Medicinal Oxygen Air Liquide Santé cylinders should be returned to the manufacturer or their authorised distributor. 
Nepotrebne, delno polne ali prazne cilindre z Medicinal Oxygen Air Liquide Santé je treba vrniti proizvajalcu ali njihovemu pooblaščenemu distributerju.
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 
DODATEK I POVZETEK ZNAČILNOSTI ZDRAVILA
Since even the smallest spark can cause violent ignition, electrical equipment capable of sparking should not be used in the vicinity of patients receiving oxygen. 
Ker že najmanjša iskrica lahko povzroči silovit vžig, uporaba električne opreme, ki lahko povzroči iskrenje, ni dovoljena v bližini pacientov, ki dobivajo kisik.
For oxygen supplementation during recovery. 
Za dodajanje kisika med okrevanjem.
Cylinders should be stored in a locked, clean and ventilated area reserved for the storage of medical gases, protected from weather and with no inflammable materials. 
Cilindre shranjujte v zaklenjenem, čistem in prezračenem prostoru za shranjevanje medicinskih plinov, zavarovanem pred vremenskimi vplivi in brez vnetljivih materialov.
10, rue Cognacq-Jay 75341 Paris Cedex 07 FRANCE 
10, rue Cognacq-Jay 75341 Paris Cedex 07 FRANCIJA
15 l cylinders filled at 200 bar, containing 3.2 m³ oxygen under a pressure of 1 bar at 15 ºC. 
15 l cilinder, polnjen pri 200 barih, ki vsebujejo 3.2 m³ kisika pod pritiskom 1 bar pri 15 ºC.
As a rule, and if oxygen tension cannot be measured, the inspired oxygen fraction should be maintained at more than 50 %. 
Praviloma in če se pritiska kisika ne da zmeriti, se mora delež vdihnjenega kisika vzdrževati na več kot 50 %.
4.2 Indications for use, specifying the target species For oxygen supplementation and as a carrier gas during inhalation anaesthesia. 
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Za dodajanje kisika in kot nosilni plin med inhalacijsko anestezijo.
SPECIAL WARNING(S) 
POSEBNO(A) OPOZORILO(A )
It is present in the plasma in the solution and is transported by erythrocytes in the form of oxyhaemoglobin. 
Prisoten je v plazmi v raztopini in se prenaša z eritrociti v obliki oksihemoglobina.
50 l cylinders filled at 200 bar, containing 10.6 m³ oxygen under a pressure of 1 bar at 15 ºC. 
50 l cilinder polnjen pri 200 barih, ki vsebujejo 10.6 m³ kisika pod pritiskom 1 bar pri 15 ºC.
Manufacturer for the batch release: AIR LIQUIDE Santé FRANCE ZI Est, BP 34 
Izdelovalec, odgovoren za izdajo serije: AIR LIQUIDE Santé FRANCE ZI Est, BP 34
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Medicinal Oxygen Air Liquide Santé is an inhalation gas consisting of 100 % oxygen. 
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SESTAVIN Medicinal Oxygen Air Liquide Santé je inhalacijski plin, ki vsebuje 100 % kisik.
This veterinary medicinal product should only be used by persons who have been fully trained to use pressure regulators and associated equipment. 
To zdravilo lahko uporabljajo samo osebe, ki so popolnoma usposobljene za uporabo aparatov na pritisk in pripadajoče opreme.
The first signs of oxygen toxicity include dyspnoea and cyanosis, but should only be suspected after at least 12 hours of 100 % oxygen administration or 18 hours of 80 % oxygen administration under normobaric conditions. 
Prvi znaki zastrupitve s kisikom se kažejo kot težko dihanje in cianoza na kar se posumi po vsaj 12- ih urah uporabljanja 100 % kisika ali po 18-ih urah uporabljanja 80 % kisika pod normobaričnimi pogoji.
Oxygenation can be assessed using pulse oximetry or arterial blood gas analysis. 
Oksigenacijo se oceni s pulznim oksimetrom ali z analizo plina v arterijski krvi.
Cylinder valves and associated equipment must not be lubricated and must be kept entirely free from carbon-based oils and grease because otherwise there is a risk of spontaneous combustion and a violent explosion may occur. 
Ventil silovite eksplozije cilindra in s tem povezana oprema ne smejo biti izpostavljeni masti in olju, ki je zasnovano na ogljiku, ker se sicer pojavi nevarnost spontanega vžiga in nevarne eksplozij.
Medicinal Oxygen Air Liquide Santé has no known incompatibilities with other products likely to be administered concomitantly 
Medicinal Oxygen Air Liquide Santé nima poznanih inkopatibilnosti z drugimi proizvodi ob hkratni uporabi.
Both metabolised and excess, unmetabolised oxygen are eliminated from the body during exhalation. 
Oba, presnovljen in presežen nepresnovljen kisik, se izločita iz telesa z izdihavanjem.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Information to appear on a durable plastic label appended directly to the cylinder body. 
Podatki na trpežni plastični etiketi, ki je pripeta neposredno na cilinder.
Shelf-life of the veterinary medicinal product as packaged for sale: 
Rok uporabnosti zdravila v pakiranju za prodajo:
NAME OF THE VETERINARY MEDICINAL PRODUCT Medicinal Oxygen Air Liquide Santé 100 % inhalation gas for dogs, cats and horses. 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Medicinal Oxygen Air Liquide Santé 100% inhalacijski plin za pse, mačke in konje.
Oxygen administered by inhalation is absorbed by alveolar-capillary exchange. 
Kisik, ki se ga daje z vdihavanjem, se absorbira z alveolarno-kapilarno izmenjavo.
The oxygen concentration can be reduced to 50 % by including 50 % nitrogen or approximately 60 % medical air. 
Koncentracija kisika se lahko zmanjša na 50 % z dodatkom 50 % dušika ali približno 60 % medicinskega zraka, kar se najlažje nadzoruje z merilci kisika.
In cases where oxygen toxicity is suspected, the fresh gas flow rate should be maintained, but the oxygen concentration of the inspired gas should be reduced to approximately 50 % or less if adequate oxygenation can be maintained. 
V primerih, kjer obstaja sum zastrupitve s kisikom, mora biti ohranjena stopnja dotoka svežega plina, vendar pa mora biti koncentracija vdihnjenega kisika zmanjšana na približno 50 % ali manj, če se lahko ohranja ustrezno oksigenacijo.
Animals with pre-existing oxygen radical damage to the lung may have this damage exacerbated by oxygen therapy e.g. in the treatment of paraquat poisoning. 
Pri živalih z obstoječo okvaro pljuč zaradi kisika se lahko okvara zaradi terapije s kisikom še poslabša, na primer pri zdravljenju zastrupitve s paraquatom.
Oxygen released at tissue level by oxyhaemoglobin is then used in mitochondria for the synthesis of ATP. 
Kisik, ki ga v tkivu sprosti oksihemoglobinom, se v mitohondrijih uporabi za sintezo ATP.
Lot number 
Številka serije
6.5 Nature and composition of immediate packaging 15 l and 50 l metal cylinders with pressure control valves (body and nozzle painted in white). 
15 l in 50 l kovinski cilinder s tlačnim ventilom (belo pobarvano telo in odprtina).
54181 Heillecourt Cedex FRANCE 
54181 Heillecourt Cedex FRANCIJA
Marketing authorisation holder: AIR LIQUIDE Santé INTERNATIONAL 10, rue Cognacq-Jay 
Imetnik dovoljenja za promet z zdravilom: AIR LIQUIDE Santé INTERNATIONAL 10, rue Cognacq-Jay
Due to the high partial pressure of oxygen inhaled by animals during the administration of the veterinary medicinal product, oxygen toxicity may be seen in animals after extended periods of use. 
Glede na visoki delni pritisk kisika, ki ga vdahnejo živali med uporabo zdravila za uporabo v veterinarski medicini, je pri prekomerni uporabi le-tega na živalih vidna zastrupitev s kisikom.
Medicinal Oxygen Air Liquide Santé can be safely administered as a carrier gas for inhalation anaesthetics. 
Medicinal Oxygen Air Liquide Santé se lahko varno uporablja kot nosilni plin med inhalacijsko anestezijo.
Whilst oxygen is non-flammable, it strongly supports combustion and no naked flames should be allowed near the container. 
Čeprav kisik ni vnetljiv, močno pomaga pri gorenju, zato v bližini embalaže tega zdravila ni dovoljena uporaba odprtega ognja.
The animal must be monitored closely, preferably by means of a pulse oximeter, and the flow rate adapted during anaesthesia to meet their individual requirements. 
Žival je treba ves čas nadzorovati, po možnosti s pulznim oksimetrom ter s prilaganjem stopnje dotoka kisika med anestezijo za dosego optimalnih individualnih potreb.
In-circuit oxygen meters can be used to measure the inspired oxygen fraction and depending on the individual animal, a level of 50 - 100 % of the veterinary medicinal product may be required. 
Za merjenje vdihnjenega deleža kisika se lahko uporabi merilce kisika, s katerimi se lahko, glede na potrebe posamezne živali določi stopnjo potrebnega zdravila med 50 - 100 % .
Oxygen in concentration up to 100 % (FiO2 1.0) should not exceed 12 hours. 
Posebni previdnostni ukrepi za uporabo pri živalih Kisik v koncentraciji do 100% (FiO2 1.0) ne sme preseči 12 ur.
The veterinary medicinal product can also be used for oxygen supplementation during recovery. 
Zdravilo se uporablja tudi za dodajanje kisika med okrevanjem.
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE 
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM ALI OMEJITVE GLEDE OSKRBE IN UPORABE
MARKETING AUTHORISATION NUMBER(S) EU/2/06/067/001 - 15 l 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/067/001 - 15 l
F-54181 Heillecourt France 
F-54181 Heillecourt Cedex Francija
Name and address of the manufacturer responsible for batch release 
Ime in naslov izdelovalca(izdelovalcev) zdravila, odgovornega za sproščanje serije
MARKETING AUTHORISATION NUMBER(S) EU/2/06/067/001 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/067/001
PACKAGE LEAFLET Medicinal Oxygen Air Liquide Santé 100 % inhalation gas for dogs, cats and horses. 
NAVODILO ZA UPORABO Medicinal Oxygen Air Liquide Santé 100% kisikov inhalator za pse, mačke in konje
Alternatively, supplementary oxygen can be given to an animal breathing air, and the flow rate adjusted to provide the appropriate inspired concentration. 
Kot altrenativna možnost se lahko kisik doda zraku, ki ga vdihava žival, pri čemer je potrebno prilagoditi delež kisika za dosego primerne vdihane koncentracije.
The precise fresh gas flow rate required by an animal during anaesthesia and recovery should be determined by a suitably experienced veterinarian, taking into consideration the bodyweight and health status of the animal and the anaesthetic equipment and agents being used. 
Natančno kličino dotoka svežega plina pri živali med anestezijo in okrevanjem, mora določiti ustrezno izkušen veterinar.
Precautions to be taken by the person administering the veterinary medicinal product to animals Medicinal Oxygen Air Liquide Santé should only be used by persons who have been fully trained to use pressure regulators and associated equipment. 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo To zdravilo lahko uporabljajo samo osebe, ki so popolnoma usposobljene za uporabo aparatov na pritisk in pripadajoče opreme.
Pregnancy and lactation Medicinal Oxygen Air Liquide Santé can be used during pregnancy and lactation. 
Brejost in laktacija Medicinal Oxygen Air Liquide Santé se lahko uporablja med brejostjo in laktacijo.
D. STATEMENT OF THE MRLs Not applicable 
D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Navedba ni smiselna.
WITHDRAWAL PERIOD Zero days. 
Cilindre shranjujte v pokončnem položaju.
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH 
A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
Deprivation of oxygen, resulting in tissue hypoxia, results in a rapid deterioration of myocardial and central nervous activity. 
pomanjkanje kisika povzroča hipoksijo tkiv in se odraža v poslabšanju delovanja srca in na aktivnosti osrednjega živčevja.Zdravljenje s kisikom je bistvenega pomena za ponovno vzpostavitev primerne oksigenacije tkiv.
Lot {Number} 
Ga ni.
4.11 Withdrawal period(s) 
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA ( MRL)
Whereas, 
Trenutno ni
Overall summary of the scientific evaluation of vancomycin-containing products (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo vankomicin (glejte Prilogo I)
It is also used in patients who are allergic to penicillins and cephalosporins. 
Uporablja se tudi pri bolnikih, ki so alergični na peniciline in cefalosporine.
The emergence of multidrug-resistant pathogens is a growing problem worldwide. 
Pojav bolezenskih povzročiteljev, odpornih na več zdravil, je čedalje večja težava po vsem svetu.
Furthermore, the role of selective intestinal decontamination is controversial. 
Poleg tega je vloga selektivne dekontaminacije črevesja sporna.
• Treatment of acute bacterial meningitis. 
• Zdravljenje akutnega bakterijskega meningitisa.
The data submitted in support of the vancomycin use for decontamination were not deemed as sufficiently robust. 
Podatki, predloženi v podporo uporabi vankomicina za dekontaminacijo, ne štejejo za dovolj zanesljive.
Vancomycin containing products are commercially available as: 
Zdravila, ki vsebujejo vankomicin, so komercialno na voljo v obliki:
• Vancomycin-containing medicinal products has an increasingly important role in the treatment of Gram-positive bacterial infections, 
• Zdravila, ki vsebujejo vankomicin, imajo čedalje pomembnejšo vlogo pri zdravljenju okužb z grampozitivnimi bakterijami;
Due to insufficient elements establishing the efficacy and safety of this the CHMP does not recommend this indication. 
Zaradi nezadostnih elementov, ki dokazujejo učinkovitost in varnost uporabe pri tej indikaciji, je odbor CHMP ne priporoča.