FrancophonIA/ELRC3.0 huggingface dataset:
English: Equisolon 100 mg oral powder for horses Equisolon 300 mg oral powder for horses Equisolon 600 mg oral powder for horses prednisolone
Slovenian: Equisolon 100 mg peroralni prašek za konje Equisolon 300 mg peroralni prašek za konje Equisolon 600 mg peroralni prašek za konje prednizolon
English: People with known hypersensitivity to corticosteroids or any of the excipients must not be in contact with the veterinary medicinal product.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Osebe z znano preobčutljivostjo na kortikosteroide ali katero koli pomožno snov ne smejo biti v stiku z zdravilom.
English: Do not use in known cases of hypersensitivity to the active substance, to corticosteroids and to any other ingredient of the product.
Slovenian: Ne uporabite v primerih znane preobčutljivosti na učinkovino, kortikosteroide ali na katero koli drugo sestavino zdravila.
English: Pharmacotherapeutic group: corticosteroid for systemic use, glucocorticoid.
Slovenian: Farmakoterapevtska skupina: kortikosteroid za sistemsko zdravljenje, glukokortikoid, Oznaka ATC vet: QH02AB06
English: SACHETS (3, 9 and 18 gram)
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA STIČNI OVOJNINI VREČKE (3, 9 in 18 gramov)
English: Cardboard box containing 20 pentalaminate sachets (inner coating LDPE) of 3 g (containing 100 mg prednisolone), or 10 sachets of 9 g (containing 300 mg prednisolone) or 18 g (containing 600 mg prednisolone) of oral powder.
Slovenian: Kartonasta škatla, ki vsebuje 20 vrečk iz pentalaminata (notranja prevleka iz polietilena nizke gostote) s 3 g (100 mg prednizolona) ali 10 vrečk z 9 g (300 mg prednizolona) ali 18 g (600 mg prednizolona) peroralnega praška.
English: A single dose of 1 mg prednisolone/kg body weight per day corresponds to 3 g powder per 100 kg body weight (see dosing table below).
Slovenian: Enkratni odmerek 1 mg prednizolona/kg telesne mase na dan ustreza 3 g praška na 100 kg telesne mase (oglejte si tabelo za odmerjanje v nadaljevanju).
English: 300 mg prednisolone per 9 g sachet.
Slovenian: 300 mg prednizolona v 9 g vrečki.
English: Do not use in known cases of hypersensitivity to the active substance, to corticosteroids or to any of the excipients.
Slovenian: Ne uporabite v primerih znane preobčutljivosti na učinkovino, kortikosteroide ali na katero koli pomožno snov.
English: However, chronic usage of corticosteroids may lead to serious adverse effects (please see section 4.6).
Slovenian: Vendar pa lahko kronična uporaba kortikosteroidov povzroči resne neželene učinke (glejte poglavje
English: Number of spoons
Slovenian: Število žličk
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Kratkoročno dajanje velikih odmerkov verjetno ne bo povzročilo resnih škodljivih sistemskih učinkov.
English: A single dose of 1 mg prednisolone/kg body weight per day corresponds to 100 mg prednisolone in a 3 g sachet per 100 kg body weight (see dosing table below).
Slovenian: Enkratni odmerek 1 mg prednizolona/kg telesne mase na dan ustreza 100 mg prednizolona v 3 g vrečki na 100 kg telesne mase (oglejte si tabelo za odmerjanje v nadaljevanju).
English: 600 mg prednisolone per 18 g sachet.
Slovenian: 600 mg prednizolona v 18 g vrečki.
English: 300 mg prednisolone (9 g sachet)
Slovenian: 300 mg prednizolona (9 g vrečka)
English: CARDBOARD BOX - Jar
Slovenian: KARTONASTA ŠKATLA - lonček
English: 600 mg prednisolone (18 g sachet )
Slovenian: 600 mg prednizolona (18 g vrečka)
English: Equisolon 33 mg/g oral powder for horses
Slovenian: Equisolon 33 mg/g peroralni prašek za konje
English: Prednisolone
Slovenian: KARENCA
English: Luxembourg/Luxemburg Boehringer Ingelheim Animal Health Belgium SA Avenue Ariane/Arianelaan 16
Slovenian: Luxembourg/Luxemburg Boehringer Ingelheim Animal Health Belgium SA
English: Do not use in animals suffering from gastrointestinal ulcers.
Slovenian: Ne uporabite pri živalih, ki imajo razjede v prebavilih.
English: 100 mg prednisolone per 3 g sachet.
Slovenian: 100 mg prednizolona v 3 g vrečki.
English: 100 mg prednisolone (3 g sachet)
Slovenian: 100 mg prednizolona (3 g vrečka)
English: It is recommended to wear gloves and a protective respiratory mask during the handling and administration of the veterinary medicinal product.
Slovenian: Pri rokovanju z zdravilom in dajanjem zdravila za uporabo v veterinarski medicini je priporočljivo nositi rokavice in zaščitno masko za dihala.
English: 4.1 Target species
Slovenian: KLINIČNI PODATKI 4.1 Ciljne živalske vrste Konji.
English: Equisolon 33 mg/g oral powder for horses Prednisolone
Slovenian: Equisolon 33 mg/g peroralni prašek za konje prednizolon
English: Due to the risk of foetal malformation, the veterinary medicinal product must not be administered by pregnant women.
Slovenian: Tega zdravila ne smejo dajati nosečnice, saj obstaja tveganje za malformacije ploda.
English: ATCvet code: QH02AB06
Slovenian: Farmakoterapevtska skupina: kortikosteroid za sistemsko zdravljenje, glukokortikoid, oznaka ATC vet: QH02AB06
English: Deutschland Boehringer Ingelheim Vetmedica GmbH Binger Str. 173
Slovenian: Boehringer Ingelheim GmbHAnimal Health UK Ltd
English: It is recommended to wear gloves and a protective respiratory mask during the handling and administration of the product.
Slovenian: Pri rokovanju z zdravilom in dajanjem zdravila je priporočljivo nositi rokavice in masko za zaščito dihal za dihala.
English: Република България Boehringer Ingelheim RCV GmbH & Co KG Animal Health Dr. Boehringer-Gasse 5-11 1121 Виена
Slovenian: Република България Boehringer Ingelheim RCV GmbH & Co KG Animal Health
English: Batch {number}
Slovenian: Serija {številka}
English: Boehringer Ingelheim RCV GmbH & Co KG Animal Health Dr. Boehringer-Gasse 5-11 1121 Viena
Slovenian: Boehringer Ingelheim RCV GmbH & Co KG Animal Health
English: 300 mg prednisolone per 9 g sachet 600 mg prednisolone per 18 g sachet
Slovenian: 100 mg prednizolona na 3-gramsko vrečko 300 mg prednizolona na 9-gramsko vrečko 600 mg prednizolona na18-gramska vrečko Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta Rok uporabnosti po prvem odpiranju vsebnika: 4 tedne.
English: Date of first authorisation: 25 October 2012
Slovenian: Datum prve odobritve: 25. oktober 2012
English: 18 months for frozen vials.
Slovenian: 18 mesecev za zamrznjene viale
English: The long term consequences of this cellular infiltration are not known.
Slovenian: Dolgoročne posledice te celične infiltracije niso znane.
English: The studies shall enroll at least 4 subjects per year starting in June 2015.
Slovenian: Študiji se bosta začeli junija 2015, vanjo pa bodo vključene vsaj 4 osebe na leto.
English: Your doctor will treat this appropriately.
Slovenian: Zdravnik bo to ustrezno zdravil.
English: This will fade after a short time.
Slovenian: To bo čez nekaj časa izginilo.
English: Results from the study to be reviewed annually.
Slovenian: Rezultati študije bodo pregledani letno.
English: Details of the operation of the registry shall be agreed with the National Competent Authorities in each Member State.
Slovenian: Podrobnosti delovanja registra bodo določene v dogovoru z nacionalnimi zadevnimi organi v posameznih državah članicah.
English: - Educational materials for health care professionals
Slovenian: - Izobraževalno gradivo za zdravstvene delavce
English: All interventional studies continued into long term follow up studies.
Slovenian: Vse intervencijske študije so se nadaljevale z dolgotrajnimi študijami sledenja.
English: Information for patients: Carry this card with you at all times!
Slovenian: Informacije za bolnike: To kartico imejte vedno pri sebi!
English: - if your immune system does not work properly - if you have an increased bleeding risk and or muscle disease
Slovenian: - če vaš imunski sistem ne deluje pravilno; - če imate povečano tveganje za krvavitev ali bolezen mišic;
English: Do not stop taking these without talking to your doctor.
Slovenian: Teh zdravil ne prenehajte jemati, ne da bi se o tem pogovorili z zdravnikom.
English: • Tell your doctor if you are suffering from diabetes.
Slovenian: • Povejte zdravniku, če imate sladkorno bolezen.
English: Effects on male and female fertility have not been evaluated in animal studies.
Slovenian: Učinkov na plodnost pri moških in ženskah niso ocenili v študijah na živalih.
English: It is important that you take these medicines according to the instructions given.
Slovenian: Pomembno je, da ta zdravila jemljete skladno z danimi navodili.
English: Talk to your doctor about this.
Slovenian: O tem se posvetujte z zdravnikom.
English: Your doctor will talk to you about the anaesthetic and how it will be given.
Slovenian: Zdravnik se bo z vami pogovoril o anestetiku in načinu njegovega dajanja.
English: Strict compliance with dietary fat restriction was difficult.
Slovenian: Strogo upoštevanje omejitve vnosa maščobe s hrano je bilo težavno.
English: The biodistribution pattern was very similar in the other tested species (cats and rabbits).
Slovenian: Vzorec biološke porazdelitve je bil zelo podoben tudi pri drugih preučevanih živalskih vrstah (mačkah in kuncih).
English: In addition, an updated RMP should be submitted
Slovenian: Posodobljen RMP je treba predložiti:
English: Information on the back:
Slovenian: Informacije na zadnji strani:
English: Additional monitoring tests
Slovenian: Dodatne preiskave za spremljanje
English: Before launch of the product in each country
Slovenian: Pred dajanjem zdravila v promet v posamezni državi
English: LPLD involves a state of hyperviscosity/hypercoagulability.
Slovenian: LPLD vključuje stanje hiperviskoznosti/hiperkoagulacije.
English: You should consider this when driving or using machines.
Slovenian: To morate upoštevati, ko vozite in upravljate stroje.
English: When reporting possible adverse reactions, please include the individual lot number imprinted on the front of this card.
Slovenian: Pri poročanju morebitnih neželenih učinkov vključite številko posamezne serije, natisnjeno na sprednji strani te kartice.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: An immune response was seen despite the use of immunosuppressants.
Slovenian: Imunogenost Imunski odziv so opazili kljub uporabi imunosupresivnih sredstev.
English: This is the number of vials that must be dispensed.
Slovenian: Tako dobite število vial, ki jih je treba uporabiti.
English: Although there is no fully adequate animal model to address the tumourigenic potential, the available toxicological data do not suggest any concern for tumourigenicity
Slovenian: Čeprav za obravnavo tumorigenega potenciala ne obstaja popolnoma primeren živalski model, razpoložljivi toksikološki podatki ne kažejo nobenih težav s tumorigenostjo.
English: Information on the front:
Slovenian: Informacije na sprednji strani:
English: - if you are taking oral contraceptives
Slovenian: - če jemljete peroralna kontracepcijska sredstva.
English: Read it carefully and follow the related
Slovenian: Pozorno jo preberite in upoštevajte navodila na njej.
English: After thawing, each vial should be gently inverted twice to ensure even mixing.
Slovenian: Ko se viale odtajajo, je treba vsako vialo dvakrat nežno obrniti, da zagotovite enakomerno mešanje.
English: 6.5 Nature and contents of container and special equipment for use, administration or implantation
Slovenian: 6.5 Vrsta ovojnine in vsebina ter posebna oprema za uporabo, dajanje ali implantacijo
English: Local biosafety guidelines applicable for such products should be followed (see section 6.6).
Slovenian: Upoštevati je treba lokalne smernice za biološko varnost, ki veljajo za taka zdravila (glejte poglavje 6.6).
English: Given the small patient population and size of the cohorts, captured adverse reactions and serious adverse reactions do not provide a complete perspective on the nature and frequency of these events.
Slovenian: Glede na majhno populacijo bolnikov in velikost kohort opaženi neželeni učinki in resni neželeni učinki ne dajejo popolne slike o značaju in pogostnosti teh učinkov.
English: Patients experiencing dizziness are advised to not drive or use machines.
Slovenian: Bolnikom, pri katerih se pojavi omotica, je treba priporočiti, naj ne vozijo in ne upravljajo strojev.
English: 15 years follow-up is recommended for every patient treated.
Slovenian: Pri vsakem zdravljenem bolniku se priporoča 15-letno sledenje.
English: Dose of immunosuppressant may need to be adjusted.
Slovenian: Morda bo treba prilagoditi odmerek imunosupresivnih učinkovin.
English: These effects were dose-dependent but showed regression with time.
Slovenian: Ti učinki so bili odvisni od odmerka, vendar so se sčasoma vrnili na prejšnje stanje.
English: The Marketing Authorisation Holder should be informed immediately.
Slovenian: O tem je treba takoj obvestiti imetnika dovoljenja za promet z zdravilom.
English: You will need to stay in hospital for a few hours or overnight to make sure that you have not had any side effects from the medicine or the anaesthetic.
Slovenian: V bolnišnici boste morali ostati nekaj ur ali čez noč, s čimer se bo zdravstveno osebje prepričalo, da nimate kakršnih koli neželenih učinkov zdravila ali anestetika.
English: The educational pack for healthcare professionals must be agreed with the National Competent Authorities prior to distribution and consist of the following components:
Slovenian: Izobraževalni komplet za zdravstvene delavce morajo pred distribucijo odobriti nacionalni pristojni organi, vsebovati pa mora naslednje komponente:
English: Using condoms will reduce the amount of Glybera that may be left in the woman's body.
Slovenian: Uporaba kondomov bo zmanjšala količino zdravila Glybera, ki lahko ostane v ženskem telesu.
English: The most commonly reported adverse reaction is pain in extremity occurring in approximately one third of patients.
Slovenian: Neželeni učinek, o katerem so poročali najpogosteje, je bolečina na okončini, ki se pojavi pri približno tretjini bolnikov.
English: Please ask your doctor for more information about the exact immunosuppressant medicine you will be taking.
Slovenian: Zdravnika prosite za več informacij o dejanskem imunosupresivnem zdravilu, ki ga boste jemali.
English: After this time, triglyceride levels reverted back to baseline.
Slovenian: Po tem obdobju so se ravni trigliceridov povrnile na izhodiščno vrednost.
English: In lipoprotein lipase deficiency, this enzyme is missing due to a genetic defect.
Slovenian: Pri pomanjkanju lipoproteinske lipaze je ta encim odsoten zaradi genetske okvare.
English: Local pain or sensitivity may be managed by symptomatic treatment such as administration of local or systemic pain relievers.
Slovenian: Lokalna bolečina ali občutljivost se lahko obravnavata s simptomatskim zdravljenjem, kot je uporaba lokalnih ali sistemskih sredstev za lajšanje bolečine.
English: EXP Shelf life after first opening in the syringes: 8 hours (if space permitted)
Slovenian: Rok uporabnosti po prvem odpiranju v brizgah: 8 ur (če prostor to dovoljuje)
English: Once thawed, the medicinal product should not be re-frozen.
Slovenian: Ko se zdravilo odmrzne, se ne sme ponovno zamrzniti.
English: - You have been given a patient card by your doctor.
Slovenian: - Zdravnik vam je dal kartico za bolnika.
English: PSUR/ annual reassessment
Slovenian: PSUR/letna ponovna ocena
English: The instructions for use, handling and disposal are given in section 6.6.
Slovenian: Za navodila glede uporabe, ravnanja in odstranjevanja zdravila glejte poglavje 6.6.
English: • Oral contraceptives (see section 2 ‘Do not receive Glybera')
Slovenian: • Peroralna kontracepcijska sredstva (glejte poglavje 2 „Zdravila Glybera ne smete prejeti“)
English: 1) on efficacy data such as biochemical markers as part of normal practice and frequency and severity of pancreatitis and 2) on safety including immunogenicity against Glybera and LPL.
Slovenian: 1) o učinkovitosti, kot so biokemični označevalci, kot del normalne prakse in 2) o varnosti, vključno z imunogenostjo proti zdravilu Glybera in LPL.
English: Lipoprotein lipase (LPL) is a naturally occurring substance in the body (known as an enzyme) that controls the level of certain fats in the blood.
Slovenian: Lipoproteinska lipaza (LPL) je naravno prisotna snov v telesu (znana kot encim), ki nadzoruje raven nekaterih maščob v krvi.
English: The registry should be performed according to an agreed protocol.
Slovenian: Register je treba izvajati skladno z odobrenim protokolom.
English: Follow applicable local or international guidelines for prophylaxis (See also section 4.5).
Slovenian: Upoštevajte ustrezne lokalne in mednarodne smernice za profilakso (glejte tudi poglavje 4.5).
English: It is important that you ask your doctor about the side effects of these other medicines.
Slovenian: Pomembno je, da zdravnika vprašate o neželenih učinkih teh zdravil.
English: Do not use this medicine after the expiry date which is stated on the label after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake
English: If any of the above applies to you, or if you are unsure of any of the above, please talk to your doctor before you receive Glybera.
Slovenian: Če kar koli od navedenega velja za vas ali če niste prepričani glede česar koli zgoraj navedenega, se pred uporabo zdravila Glybera posvetujte z zdravnikom.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu .
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: The indication is restricted to patients with detectable levels of LPL protein (see section 4.4).
Slovenian: Indikacija je omejena na bolnike z določljivimi ravnmi proteina LPL (glejte poglavje 4.4).
English: This medicine contains genetically modified organisms and must be disposed of according to local rules for such medicines.
Slovenian: To zdravilo vsebuje gensko spremenjene organizme, zato ga je treba zavreči skladno z lokalnimi predpisi za taka zdravila.
English: 3) Dietary diary and quality of life data should also be recorded.
Slovenian: 3) Prav tako je treba zbirati tudi podatke o kakovosti življenja in voditi
English: • Oral contraceptive use (see section 4.6).
Slovenian: • Uporaba peroralnih kontracepcijskih sredstev (glejte poglavje 4.6).
English: The expiry date refers to the last day of that month.
Slovenian: Uporabno do. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: The clinical relevance of the antibody response is unknown (see section 4.2 on re-administration).
Slovenian: Klinična pomembnost odziva protiteles ni znana (glejte poglavje 4.2 o ponovni uporabi).
English: Unused medicine must be disposed of in compliance with the local rules for genetically modified organisms.
Slovenian: Neuporabljeno zdravilo je treba odstraniti skladno z lokalnimi predpisi za gensko spremenjene organizme.
English: Diabetes mellitus is common in patients who have the most severe symptoms of LPLD.
Slovenian: Sladkorna bolezen je pogosta pri bolnikih z najhujšimi simptomi LPLD.
English: Further follow-up of patients who took part in study CT-AMT-11-03 (to a median of 5.8 years after exposure to Glybera) has shown a reduction in hospital stay of 1 day per patient per year when compared to the same length of time prior to exposure.
Slovenian: Nadaljnje spremljanje bolnikov, ki so sodelovali v študiji CT-AMT-11-03 (do mediane 5,8 let po izpostavljenosti zdravilu Glybera) je pokazalo zmanjšanje hospitalizacije za 1 dan na bolnika na leto v primerjavi z enako časovno dolžino pred izpostavljenostjo.
English: Glybera should not be administered to pregnant women unless the possible benefit to the mother outweighs the possible risk to the foetus.
Slovenian: Zdravilo Glybera se ne sme uporabljati pri nosečnicah, razen če je morebitna korist za mater večja od morebitnega tveganja za plod.
English: The patient's weight should be divided by 3, then without rounding up this number multiplied by 2 and rounded up to the next higher whole number.
Slovenian: Bolnikovo telesno maso je treba deliti s 3, potem to število brez zaokroževanja pomnožiti z 2 in zaokrožiti na naslednje višje celo število.
English: In addition to being given Glybera, you will be given other medicines called immunosuppressants (see section 3 ‘How Glybera is used').
Slovenian: Poleg zdravila Glybera boste prejeli tudi druga zdravila, imenovana imunosupresivna sredstva (glejte poglavje 3 „Kako uporabljati zdravilo Glybera“).
English: In saliva vector DNA was still detectable up to 12 weeks; in urine up to 10 weeks and in semen up to 26 weeks.
Slovenian: V slini je bilo mogoče DNK vektorja zaznati do 12 tednov, v urinu do 10 tednov, v spermi pa do 26 tednov.
English: The assay to be used in the study needs to be agreed.
Slovenian: Test, ki se bo uporabil v študiji, mora biti odobren.
English: 1105 BA Amsterdam The Netherlands
Slovenian: 1105 BA Amsterdam Nizozemska
English: Treated patients should not donate blood, organs, tissues and cells for transplantation.
Slovenian: Zdravljeni bolniki ne smejo darovati krvi, organov, tkiv in celic za transplantacijo.
English: The PSUR cycle for the medicinal product should follow a half-yearly cycle until otherwise agreed by the CHMP.
Slovenian: Cikel PSUR za zdravilo mora slediti polletnemu ciklu, dokler CHMP ne določi drugače.
English: In a follow-up period of up to 3 years after treatment, there was a decreasing trend in the incidence and severity of pancreatitis in the 12 patients who had multiple attacks during their life time.
Slovenian: V obdobju sledenja, ki je trajalo do 3 leta po zdravljenju, so opazili zmanjševanje incidence in resnosti pankreatitisa pri 12 bolnikih, ki so imeli v življenju več napadov.
English: • bruises in the upper and lower leg muscle due to the injections.
Slovenian: • podplutbe na mišicah zgornjega in spodnjega dela nog zaradi injiciranja.
English: No interaction studies other than preclinical and clinical studies with mycophenolate mofetil and ciclosporin have been performed.
Slovenian: Študij medsebojnega delovanja, razen predkliničnih in kliničnih študij z mofetilmikofenolatom in ciklosporinom, niso izvedli.
English: • Use appropriate barrier contraception such as condoms to avoid becoming pregnant during treatment and for at least 12 months after treatment.
Slovenian: • Uporabljate ustrezno pregradno kontracepcijo, kot so kondomi, da preprečite zanositev med zdravljenjem in še vsaj 12 mesecev po njem.
English: Oral contraceptive use is contraindicated in LPLD patients (see section 4.3) as this may exacerbate the underlying disease.
Slovenian: Pri bolnikih z LPLD so peroralna kontracepcijska sredstva kontraindicirana (glejte poglavje 4.3), saj lahko poslabšajo osnovno bolezen.
English: Serum creatine kinase
Slovenian: Serumska kreatin kinaza
English: 2.2 Qualitative and quantitative composition
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: See also section 3, ‘How Glybera is used'.
Slovenian: Glejte tudi poglavje 3 „Kako uporabljati zdravilo Glybera“.
English: • Information on the use of Glybera and avoidance of pregnancy.
Slovenian: • Informacije o uporabi zdravila Glybera in preprečevanju nosečnosti.
English: Taking these medicines before receiving or at the same time as receiving Glybera, may cause unnecessary bruising or bleeding from the injection sites.
Slovenian: Jemanje teh zdravil pred prejemom zdravila Glybera ali v času njegovega injiciranja lahko povzroči nepotrebno podplutbo ali krvavitev mesta injiciranja.