natgillin/translations-raw huggingface dataset:
These materials will explain the effects of Nerlynx on the gut, such as diarrhoea, and how to manage them, and will give advice on the need for patients to tell their healthcare professionals of side effects.
V tem gradivu bodo razloženi učinki zdravila Nerlynx na črevo, kot je na primer driska, ter napotki za njihovo obvladovanje, gradivo pa bo vsebovalo tudi navodilo, da naj bolniki o neželenih učinkih obvestijo zdravstvene delavce.
Nerlynx is a breast cancer medicine used to reduce the risk of the disease coming back in patients with early breast cancer who have had surgery.
Nerlynx je zdravilo za zdravljenje raka dojke, ki se uporablja za zmanjševanje tveganja ponovitve bolezni pri bolnicah z zgodnjim rakom dojke po kirurškem posegu.
The most common side effect with Nerlynx is diarrhoea, which affects nearly all patients.
Najpogostejši neželeni učinek zdravila Nerlynx je driska; pojavi se pri skoraj vseh bolnicah.
Nerlynx must not be used in patients with severely reduced liver function.
Zdravila Nerlynx ne smejo uporabljati bolnice s hudo okvaro delovanja jeter.
Nerlynx treatment should be started and supervised by a doctor experienced in giving cancer medicines and can only be obtained with a prescription.
Zdravljenje mora uvesti in nadzorovati zdravnik, ki ima izkušnje z dajanjem zdravil za zdravljenje raka, predpisovanje in izdaja zdravila pa je le na recept.
How is Nerlynx used?
Kako se zdravilo Nerlynx uporablja?
For the full list of side effects of Nerlynx, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Nerlynx, glejte navodilo za uporabo.
The doctor may reduce the dose or stop treatment if a patient has severe side effects, including diarrhoea.
Če ima bolnica hude neželene učinke, vključno z drisko, lahko zdravnik zmanjša odmerek ali ustavi zdravljenje.
Patients are given treatment to prevent diarrhoea when starting Nerlynx.
Bolnice ob začetku jemanja zdravila Nerlynx prejmejo zdravljenje za preprečevanje driske.
How does Nerlynx work?
Kako zdravilo Nerlynx deluje?
Target species
Ciljna živalsk a vrsta
Package size Withdrawal period
Vsebina Velikost pakiranja
Lyophilisate: vial (glass); Solvent: vial (PET)
Liofilizat: viala (steklena) Topilo: viala (PET)
Content
Jakost
Lyophilisate: 5 vials; Solvent: 5 vials
Liofilizat: 50 odmerkov + Solvent: 10 ml
Annex A
EMEA številka
--1 Live myxoma vectored RHD virus strain 009: ≥103.0 and ≤106.1 FFU* *Focus Forming Units
Liofilizat:50 odmerkov + topilo: 50 ml
56 tablets (multipack)
56 tablet (večkratno pakiranje)
MA(EU) Number
Številka (EU) dovoljenja za promet
Blister (PVC/PE/PCTFE/ALU)
250 mg filmsko obložena tableta peroralna uporaba pretisni omot (PVC/PE/PCTFE/ALU)
Strength Pharmaceutical Form
(Izmišljeno) ime Jakost Farmacevtska oblika
The application was withdrawn after ‘day 181'.
Vlogo je bila umaknjena po „181.
FEV1 is the most air a person can breathe out in one second.
FEV1 je največja količina zraka, ki jo lahko posameznik izdiha v eni sekundi.
The main measures of effectiveness in the studies were based on the change in FEV1 after 12 weeks.
Glavno merilo učinkovitosti v teh študijah je bila sprememba FEV1 po 12 tednih.
Formoterol is a long-acting beta-2 agonist.
Formoterol je dolgo delujoči beta-2-agonist.
The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Dopis, s katerim družba agencijo obvešča o umiku vloge, je na voljo v rubriki „All documents“.
This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
To pomeni, da je CHMP ocenil dokumentacijo, ki jo je predložila družba, in pripravil seznam vprašanj.
Both formoterol and mometasone have been available in the European Union for the maintenance treatment of asthma for a number of years.
Formoterol in mometazon sta v Evropski uniji za vzdrževalno zdravljenje astme na voljo že vrsto let.
What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Kakšne so posledice tega umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe?
The effects of Zenhale were first tested in experimental models before being studied in humans.
Učinki zdravila Zenhale so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Two studies also looked at the how long it took before the patients had their first severe exacerbation.
V dveh študijah so pri bolnikih opazovali tudi časovno obdobje do prvega hujšega poslabšanja.
Mometasone is a corticosteroid with anti-inflammatory effects.
Mometazon je kortikosteroid s protivnetnimi učinki.
On 5 November, Schering-Plough Europe officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zenhale, for the maintenance treatment of asthma.
Družba Schering-Plough Europe je dne 5. novembra 2010 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Zenhale, ki je namenjeno vzdrževalnemu zdravljenju astme.
Following a routine inspection of study sites, the CHMP had concerns over the way the studies were conducted in some sites, which cast doubt on the reliability of the results.
Po rednem inšpekcijskem pregledu mest študij je CHMP izrazil zadržke glede načina izvajanja študij na nekaterih mestih, zaradi česar bi bila lahko zanesljivost rezultatov dvomljiva.
The company informed the CHMP that this withdrawal does not have any consequences for patients in ongoing trials or on compassionate use programmes.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v preskušanjih ali v programih sočutne uporabe.
After the CHMP had assessed the company's responses to the last round of questions, there were still unresolved issues.
Potem ko je CHMP ocenil odgovore družbe na zadnja vprašanja, so nekatera vprašanja še vedno ostala nerešena.
The CHMP also had concerns with one of the comparator medicines, mometasone furoate, which was not in an approved formulation.
CHMP je prav tako izrazil zadržke glede primerjalnega zdravila, mometazon furoata, ki ni bilo v odobreni formulaciji.
The company was asked to provide further data to justify the use of that comparator, specifically to show how mometasone furoate in the comparator was released in the body compared with the approved mometasone furoate.
Družbo so prosili, da zagotovi dodatne podatke, ki bi utemeljili uporabo tega primerjalnega zdravila, in predvsem prikaže, kako se v telesu sprošča mometazon furoat v primerjalnem zdravilu v primerjavi z odobrenim mometazon furoatom.
What is Zenhale?
Kaj je zdravilo Zenhale?
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zenhale could not have been approved for the maintenance treatment of asthma.
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 Zenhale ni mogoče odobriti za vzdrževalno zdravljenje astme.
It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax.
Deluje tako, da se veže na receptorje beta 2, ki so prisotni v mišičnih celicah več organov in povzročajo sproščanje mišic.
Zenhale was expected to be used in adults and adolescents aged 12 years and older as a maintenance treatment for asthma, including for reducing exacerbations (where asthma gets worse, requiring rescue treatment with other medicines).
Zdravilo Zenhale naj bi se uporabljalo pri odraslih in mladostnikih, starih 12 let in več, za vzdrževalno zdravljenje astme, vključno z zmanjševanjem možnosti poslabšanja (kadar se astma tako poslabša, da je potrebno reševalno zdravljenje z drugimi zdravili).
It was to be available as a suspension for inhalation in a metered-dose inhaler.
Na voljo naj bi bilo kot suspenzija za vdihavanje z inhalatorjem z odmernim ventilom.
When inhaled, it causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Pri inhaliranju povzroča sproščanje mišic dihalnih poti, s čimer pomaga, da dihalne poti ostanejo odprte, kar bolnikom omogoča lažje dihanje.
There were four main studies involving a total of 2,977 adults and adolescents who had been receiving treatment with inhaled corticosteroids or a combination of inhaled corticosteroid and a long-acting beta-2 agonist.
Izvedene so bile štiri glavne študije, v katerih je sodelovalo 2 977 odraslih in mladostnikov, ki so se zdravili z inhalacijskimi kortikosteroidi ali s kombinacijo inhalacijskega kortikosteroida in dolgo delujočega beta-2-agonista.
When inhaled, it relieves the symptoms of asthma by blocking the release from white blood cells of substances that are involved in inflammatory reactions in the airways.
Pri vdihavanju blaži simptome astme, tako da zavira sproščanje snovi iz belih krvnih celic, ki vplivajo na vnetne reakcije v dihalnih poteh.
The patients were treated with one of the following: Zenhale, mometasone furoate alone, formoterol fumarate alone, an asthma medicine containing fluticasone propionate and salmeterol (another combination of a steroid and a long-acting bronchodilator used in asthma), or placebo (a dummy treatment).
Bolniki so prejemali eno izmed naslednjih terapij: zdravilo Zenhale, samostojno zdravljenje z mometazon furoatom, samostojno zdravljenje s formoterol fumaratom, zdravilo za astmo, ki vsebuje flutikazon propionat in salmeterol (drugačna kombinacija steroida in dolgo delujočega bronhodilatorja, ki se uporablja pri astmi) ali placebo (zdravilo brez zdravilne učinkovine).
It was developed for use in patients whose asthma was not adequately controlled by an inhaled corticosteroid used, when needed, with an inhaled short-acting ‘beta-2 agonist' (a bronchodilator, a medicine that widens the airways in the lungs).
Razvito je bilo za uporabo pri bolnikih, pri katerih ni mogoče doseči zadostnega nadzora astme z inhalacijskim kortikosteroidom, ki se po potrebi uporablja z inhalacijskim kratko delujočim „beta-2agonistom“ (bronhodilator, zdravilo, ki širi dihalne poti v pljučih).
Zenhale is a medicine that contains the active substances mometasone furoate and formoterol fumarate.
Zenhale je zdravilo, ki vsebuje zdravilni učinkovini mometazon furoat in formoterol fumarat.
It was also expected to be used in patients whose asthma was already controlled with both an inhaled corticosteroid and a long-acting beta-2 agonist.
Zdravilo naj bi se uporabljalo tudi pri bolnikih, pri katerih je astma že nadzorovana z inhalacijskim kortikosteroidom in dolgo delujočim beta2-agonistom.
What was Zenhale expected to be used for?
Za kaj naj bi se zdravilo Zenhale uporabljalo?
How is Zenhale expected to work?
Kako naj bi zdravilo Zenhale delovalo?
Use within 24 hours.
Uporabite v 24 urah.
It is eliminated from the plasma in 5-7 days.
Iz plazme se izloči po 5-7 dneh.
DATE OF REVISION OF THE TEXT
10 DATUM REVIZIJE BESEDILA
Do not store above 30 °C.
Ne shranjujte pri temperaturi nad 30 °C.
125 ml - 5years
125 ml - 5 leta
<EXP {month/year}>
<EXP {mesec/leto}>
Date of first authorisation: 29/11/1999 Date of last renewal: 01/10/2009
Datum pridobitve dovoljenja za promet: 29/11/1999 Datum zadnjega podaljšanja dovoljenja za promet: 01/10/2009
Do not overheat.
Ne pregrevajte ga.
Haematology: No interference.
Hematologija: Ni vpliva.
For a full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
(Contact the distributor for specific data.)
(Kar zadeva posebne podatke, se obrnite na distributerja.)
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
(See Table A Pharmacokinetic Parameters)
(Glej Preglednico A Farmakokinetični parametri.)
None known.
Niso znane
The use in such animals is not recommended.
Uporaba zdravila pri teh živalih ni priporočljiva.
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilna učinkovina:
Do not combine the contents of more than one bag.
Ne združujte vsebine več vrečk.
The plasma half-life is 30-40 hours.
Njegova razpolovna doba v plazmi je 30-40 ur.
Do not add medications or other solutions to the bag.
V vrečko ne dodajajte zdravil ali drugih raztopin.
<Batch> <Lot> {number}
<Serija> <lot>{številka}
In certain clinical situations, a dosage of 15-30 ml/kg may be appropriate.
Pri nekaterih kliničnih stanjih je primeren odmerek 15-30 ml/kg.
MA 02141
Cambridge MA 02141
Concomitant treatment of the cause of the anaemia should be instituted.
Začeti je treba s sočasnim zdravljenjem vzroka anemije.
Coagulation: Prothrombin time (PT) and activated partial thromboplastin time (aPTT) can be accurately determined using methods that are mechanical, magnetic, and light scattering.
Koagulacija: Protrombinski čas (PT) in aktivirani delni tromboplastinski čas (aPTT) je mogoče natančno določiti z uporabo mehanskih in magnetnih metod in z razprševanjem svetlobe.
The optimum dosage is based upon the degree and chronicity of the anaemia and the desired duration of the effect.
Optimalni odmerki so odvisni od stopnje in kroničnosti anemije ter od želenega trajanja učinka.
Clinical Pathology
Klinična patologija
A box with one (1) polyolefin infusion bag (containing either 60 ml or 125 ml), within an overwrap.
Škatla z eno (1) poliolefinsko infuzijsko vrečko (ki vsebuje bodisi 60 ml bodisi 125 ml) v zunanjem ovoju.
Do not use in animals previously treated with Oxyglobin.
Ne uporabite v živali, ki so jih predhodno zdravili z Oxyglobinom.
Pharmacotherapeutic group: Blood substitutes, ATCvet code: QB05AA10.
Farmakoterapevtska skupina: Nadomestki za kri, oznaka ATC vet : QB05AA10
Signs of circulatory overload should be carefully monitored or central venous pressure (CVP) measured (increase in CVP has been recorded in all treated dogs in which it was measured).
Znake preobremenjenosti krvnega obtoka je treba skrbno spremljati ali meriti centralni venski tlak (CVP) (zvečanje CVP so opazili pri vseh zdravljenih psih, pri katerih so ga merili).
Shelf-life of the veterinary medicinal product as packaged for sale: 60 ml - 3 years
Rok uporabnosti zdravila v pakiranju za prodajo : 60 ml - 3 leta
Use within 24 hours of removing overwrap.
Uporabite v 24 urah po odstranitvi zunanjega ovoja.
Confirm that haemoglobin is measured, not calculated from red blood cell number.
Dokaz, da se hemoglobin meri, ne pa izračuna iz števila rdečih krvnih telesc.
Do not use after the expiry date stated on the label.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.
* range based on mean ± SD ** range based on estimated mean value with bounds of a 95 % prediction interval *** range based on 5 terminal half-lives
* razpon na osnovi srednje vrednosti ± SD ** razpon, zasnovan na ocenjeni srednji vrednosti, z mejami 95 % napovedanega intervala
Signs of circulatory overload should be carefully monitored or central venous pressure (CVP) measured.
Znake preobremenjenosti krvnega obtoka je treba skrbno spremljati ali meriti centralni venski tlak (CVP).
A small amount of unstabilised tetrameric haemoglobin (<5 %) may be excreted through the kidneys, resulting in transient haemoglobinuria for < 4 hours.
Majhna količina nestabiliziranega tetramernega hemoglobina (< 5 %) se lahko izloči skozi ledvice, kar povzroči prehodno hemoglobinurijo, ki traja manj kot 4 ure.
A. LABELLING
A OZNAČEVANJE
Urinalysis: Sediment examination is accurate.
Preiskava urina: Preiskava sedimenta je točna.
Do not administer with other fluids or medicinal products concurrently via the same infusion set.
Zdravila ne dajajte istočasno z drugimi tekočinami ali zdravili s pomočjo istega infuzijskega seta.
4.5 Special precautions for use Special precautions for use in animals
4.5 Posebni previdnostni ukrepi Posebni previdnostni ukrepi za uporabo pri živalih
Metabolism and excretion: Haemoglobin dissociates in plasma and is progressively incorporated in the protein pool of the organism.
Presnova in izločanje: Hemoglobin se razkroji v plazmi in se postopoma vgrajuje v beljakovinske zaloge v organizmu.
Do not freeze.
Ne shranjujte zamrzovalniku.
For animal treatment only - to be supplied only on veterinary prescription.
Samo za živali - oskrba le na podlagi veterinarskega recepta.
If CVP increases to a clinically unacceptable level and/or if signs of circulatory overload are observed, the infusion of Oxyglobin should be temporarily discontinued and re-instituted at a slower rate when signs abate and/or CVP decreases.
Če se CVP zveča na klinično nesprejemljivo vrednost in/ali če so opaženi znaki preobremenjenosti krvnega obtoka, je treba začasno prenehati dajati Oxyglobin in ga ponovno začeti dajati počasneje, ko se znaki ublažijo in/ali ko se vrednost CVP
Treatment of circulatory overload may be necessary.
Lahko je potrebno zdravljenje prevelike obremenitve krvnega obtoka.
Remove overwrap prior to use.
Pred uporabo odstranite zunanji ovoj.
Cleared from plasma (days)***
Izčistek iz plazme (dnevi)***
Modified Lactated Ringer's Solution containing the standard components: Water for injection, NaCl
Modificirana raztopina Ringerjevega laktata, ki vsebuje običajne sestavine: vodo za injekcije,
Shelf-life after first opening the immediate packaging: 24 hours.
Rok uporabnosti po prvem odpiranju stične ovojnine : 24 ur
Dipstick measurements (i.e., pH, glucose, ketones, protein) are inaccurate while gross discolouration of the urine is present.
Meritve z merilnimi trakovi (pH, krvni sladkor, ketoni, beljakovine) niso točne, opazno pa je tudi močno obarvanje urina.
Hemoglobin glutamer-200 (bovine) - 130 mg/ml
Hemoglobin glutamer-200 (goveji) - 130 mg/ml
To be supplied only on veterinary prescription.
Izdaja zdravila je le na veterinarski recept.
Use of Oxyglobin does not require typing or cross-matching of the recipient's blood.
Pri uporabi Oxyglobina ni treba določati krvne skupine ali navzkrižno preverjati krvi prejemnika infuzije.
125 ml infusion bag.
125 ml infuzijska vrečka
Marketing authorisation holder: OPK Biotech Netherlands BV Teleportboulevard 140
Imetnik dovoljenja za promet z zdravilom: OPK Biotech Netherlands BV Teleportboulevard 140
Chemistry: The presence of Oxyglobin in serum may interfere with colorometric readings and result in artifactual increases or decreases in the results of serum chemistry tests depending on the dosage administered, the time since infusion, the type of analyzer and the reagents used.
Biokemija: Prisotnost Oxyglobina v serumu lahko vpliva na odčitke kolorimetričnih vrednosti in povzroči umetno zvečanje ali zmanjšanje vrednosti biokemičnih preiskav seruma, odvisno od danih odmerkov, časa, ki je pretekel od infuzije, vrste analizatorja in uporabljenih reagentov.
60 ml infusion bag.
60 ml infuzijska vrečka
Oxyglobin Dose (ml/kg)
Odmerek (ml/kg)
Oxyglobin provides oxygen carrying support to dogs improving the clinical signs of anaemia for at least 24 hours independent of the underlying condition.
Oxyglobin zagotavlja oksiforno podporo pri psih in izboljša klinične znake anemije za najmanj 24 ur,
During the clinical safety and efficacy study, adverse events were seen which may have been related to Oxyglobin and/or the underlying disease causing anaemia.
V raziskavi o klinični varnosti in učinkovitosti zdravila so opazili neželene pojave, ki so bili morda povezani z Oxyglobinom in/ali osnovno boleznijo, ki povzroča anemijo.
Treatment with Oxyglobin results in a mild decrease in PCV (packed cell volume) immediately post infusion.
Zdravljenje z Oxyglobinom povzroči manjše zmanjšanje PCV (hematokritov) takoj po infuziji.
Oxyglobin is a haemoglobin-based oxygen carrying fluid that increases plasma and total haemoglobin concentrations and thus increases arterial oxygen content.
5.1 Farmakodinamične lastnosti Oxyglobin je oksiforna tekočina na podlagi hemoglobina, ki povečuje koncentracije v plazmi ter celotne koncentracije hemoglobina, in s tem vsebnost kisika v arterijah.
Oxyglobin should be administered using aseptic technique via a standard intravenous infusion set and catheter.
Oxyglobin se aplicira z uporabo aseptičnega postopka s pomočjo standardnega intravenskega infuzijskega seta in katetra.
Undesirable effects include mild to moderate yellow/orange discoloration of the skin, mucous membranes, sclera, dark faeces and discoloured or turbid urine due to metabolism and/or excretion of haemoglobin.
Neželeni učinki vključujejo blago do zmerno rumeno/oranžno obarvanje kože, sluznic, beločnice, temno blato in obarvan ali moten urin zaradi presnove in/ali izločanja hemoglobina.
The recommended dosage of Oxyglobin is 30 ml/kg of body weight administered intravenously at a rate up to 10 ml/kg/h.
Priporočeni odmerek Oxyglobina je 30 ml/kg telesne mase, dan intravensko s hitrostjo do 10
Plasma volume expanders, such as Oxyglobin, are contraindicated in dogs predisposed to circulatory overload with conditions such as oliguria or anuria or advanced cardiac disease (i.e., congestive heart failure) or otherwise severely impaired cardiac function.
Raba ekspanderjev volumna plazme kot je Oxyglobin, je kontraindicirana pri psih, ki so nagnjeni k preveliki obremenitvi krvnega obtoka v stanjih, kot so oligurija ali anurija ali napredujoča bolezen srca (tj. kongestivna srčna odpoved), ali pri kaki drugi hudi okvari srčne funkcije.
Immediate postinfusion plasma concentration* (g/dl)
Koncentracija v plazmi takoj po infuziji * (g/dl)
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM”
As with any intravenous fluid administration, Oxyglobin should be warmed to 37 °C prior to administration.
Tako kot pred uporabo vsake intravenske tekočine, je treba Oxyglobin segreti na 37 ° C. Ne segrevajte v mikrovalovni pečici.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN
Adverse events related to Oxyglobin and/or the underlying disease causing anaemia have been observed.
Opazili so neželene pojave v zvezi z Oxyglobinom in/ali osnovno boleznijo, ki povzroča anemijo.
Table A: Pharmacokinetic Parameters at Multiple Dose Levels after a Single Infusion of Oxyglobin Dose (ml/kg)
Preglednica A: Farmakokinetični parametri pri ponovljenih odmerkih po enkratni infuziji Oxyglobina
The safety of Oxyglobin for use in pregnant or lactating bitches has not been determined.
Varnost uporabe Oxyglobina pri brejih ali doječih psicah ni bila ugotovljena.
Solution for infusion.
Raztopina za infundiranje.
Duration (hours): Oxyglobin levels over 1 g/dl**
Trajanje (ure): koncentracije Oxyglobina nad 1 g/dL
Occasionally noted effects were diarrhoea, discolouration of the skin, cardiac arrhythmias and very rarely nystagmus.
Občasno opaženi neželeni učinki so bili diareja, obarvanje kože, srčne aritmije in zelo poredko nistagmus.
The animal should not be over-hydrated prior to administration.
Pred uporabo zdravila žival ne sme preveč piti.
Oxyglobin 130 mg/ml solution for infusion for dogs
Oxyglobin 130 mg/ml, raztopina za infundiranje za pse
Circulatory overload may be controlled by slowing the rate of administration.
Preveliko obremenitev krvnega obtoka je mogoče nadzorovati z upočasnjenim dajanjem zdravila.
Occasionally noted adverse events were diarrhoea, cardiac arrhythmias and very rarely nystagmus.
Občasno opaženi neželeni pojavi so bili diareja, srčne aritmije in zelo poredko nistagmus.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9 DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET