FrancophonIA/ELRC3.0 huggingface dataset:
English: Extrapyramidal disorders, drowsiness, decreased level of consciousness, confusion, hallucination, and cardio-respiratory arrest may occur.
Slovenian: Pojavijo se lahko ekstrapiramidne motnje, zaspanost, zmanjšana stopnja zavesti, zmedenost, halucinacije in zastoj dihanja in delovanja srca.
English: To prevent delayed nausea and vomiting that may occur after chemotherapy (children aged 1-18 years)
Slovenian: Za preprečevanje zakasnele, s kemoterapijo povzročene slabosti in bruhanja (otroci, stari od 1 do 18 let)
English: For the treatment of nausea and vomiting including nausea and vomiting which may occur with a migraine and for the prevention of nausea and vomiting caused by radiotherapy: the recommended single dose is 10 mg, repeated up to 3 times daily.
Slovenian: Za zdravljenje slabosti in bruhanja, vključno s slabostjo in bruhanjem, ki nastopita zaradi migrene in za preprečevanje z radioterapijo povzročene slabosti in bruhanja: priporočeni enkratni odmerek je 10 mg, ki ga prejmete največ trikrat na dan.
English: Metoclopramide-containing products
Slovenian: Zdravila, ki vsebujejo metoklopramid
English: For immediate release preparations The recommended single dose is 10 mg, repeated up to three times daily.
Slovenian: Za pripravke s takojšnjim sproščanjem Priporočeni enkratni odmerek je 10 mg, ki ga bolnik prejme največ trikrat na dan.
English: Methemoglobinemia which could be related to NADH cytochrome b5 reductase deficiency has been reported.
Slovenian: Poročali so o primerih methemoglobinemije, ki je lahko povezana s pomanjkanjem encima NADH citokrom b5 reduktaze.
English: Alcohol should not be consumed during treatment with metoclopramide because it increases the sedative effect of {Tradename}.
Slovenian: Med zdravljenjem z metoklopramidom uživanje alkohola ni dovoljeno, saj okrepi pomirjevalni učinek zdravila Xyz.
English: Renal and Hepatic Impairment
Slovenian: Okvarjeno delovanje ledvic in jeter
English: Prevention of delayed chemotherapy induced nausea and vomiting (CINV) (paediatric patients aged 118 years)
Slovenian: Preprečevanje zakasnele, s kemoterapijo povzročene slabosti in bruhanja (pediatrični bolniki, stari od 1 do 18 let)
English: The maximum recommended daily dose is 30 mg or 0.5mg/kg body weight.
Slovenian: Največji priporočeni dnevni odmerek je 30 mg ali 0,5 mg/kg telesne mase.
English: For the symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting and for the prevention of radiotherapy induced nausea and vomiting (RINV): the recommended single dose is 10 mg, repeated up to three times daily
Slovenian: Za simptomatsko zdravljenje slabosti in bruhanja, vključno s slabostjo in bruhanjem pri akutni migreni in za preprečevanje z radioterapijo povzročene slabosti in bruhanja je priporočeni enkratni odmerek 10 mg, ki ga bolnik prejme največ trikrat na dan.
English: <Other pharmaceutical forms/strengths may be more appropriate for administration to this/these population(s)> <This formulation is not suitable for administration to this/these population(s)>
Slovenian: <Druge farmacevtske oblike/jakosti bodo morda bolj primerne za uporabo pri naslednji/naslednjih skupini/skupinah bolnikov> <Ta farmacevtska oblika ni primerna za uporabo pri naslednji/naslednjih skupini/skupinah bolnikov>
English: For prolonged release preparations 15mg strength
Slovenian: Pripravki s podaljšanim sproščanjem z jakostjo 15 mg
English: For rectal formulations
Slovenian: Rektalna uporaba
English: Pregnancy, breast-feeding For all routes of administration
Slovenian: Nosečnost in dojenje Velja za vse načine uporabe zdravila.
English: - you have ever had involuntary muscle spasms (tardive dyskinesia), when you have been treated with a medicine.
Slovenian: (feokromocitom), - če ste v preteklosti imeli nehotene mišične krče (tardivna diskinezija) po zdravljenju z zdravili, - če imate epilepsijo,
English: Hepatic impairment: In patients with severe hepatic impairment, the dose should be reduced by 50% (see section 5.2).
Slovenian: Pri bolnikih s hudo okvarjenim delovanjem jeter, je treba dnevni odmerek zmanjšati za 50 % (glejte poglavje 5.2).
English: Tradename is an antiemetic.
Slovenian: Zdravilo Xyz je antiemetik oziroma zdravilo, ki preprečuje bruhanje.
English: Treatment must be discontinued if clinical signs of tardive dyskinesia appear.
Slovenian: Če se pojavijo klinični znaki tardivne diskinezije, je treba zdravljenje prekiniti.
English: Appropriate additional information regarding posologies adaptation should be implemented in the PIL depending on the formulations:
Slovenian: V Navodilo za uporabo je treba vključiti ustrezne dodatne informacije o prilagajanju odmerjanja zdravila glede na farmacevtsko obliko:
English: These medicines include the following: - levodopa or other medicines used to treat Parkinson's disease (see above “Do not take
Slovenian: Ta zdravila so: - levodopa ali druga zdravila za zdravljenje Parkinsonove bolezni (glejte zgoraj »Ne jemljite zdravila Xyz«), - antiholinergiki (zdravila za lajšanje želodčnih krčev ali spazmov),
English: Paediatric population {Tradename} is indicated in children (aged 1-18 years) for: - Prevention of delayed chemotherapy induced nausea and vomiting (CINV) as a second line option Rectal route
Slovenian: Zdravilo Xyz je pri otrocih (starih od 1 do 18 let) indicirano za: - preprečevanje zakasnele, s kemoterapijo povzročene slabosti in bruhanja, in sicer kot zdravilo drugega izbora;
English: Uncontrollable movements (extrapyramidal disorders) may occur in children and young adults.
Slovenian: Pri otrocih in mladostnikih se lahko pojavijo nenadzorovani gibi (ekstrapiramidne motnje).
English: Paediatric population {Tradename} is indicated in children (aged 1-18 years) for: - Prevention of delayed chemotherapy induced nausea and vomiting (CINV) as a second line option - Treatment of established post operative nausea and vomiting (PONV) as a second line option Oral route
Slovenian: Zdravilo Xyz je pri otrocih (starih od 1 do 18 let) indicirano za: - preprečevanje zakasnele, s kemoterapijo povzročene slabosti in bruhanja, in sicer kot zdravilo drugega izbora, - zdravljenje slabosti in bruhanja po operativnih posegih, in sicer kot zdravilo drugega izbora; Peroralna uporaba
English: - Recent history of proctitis or rectal bleeding
Slovenian: Za rektalne farmacevtske oblike - Vnetje rektuma ali rektalna krvavitev v nedavni preteklosti.
English: - to prevent nausea and vomiting that may occur after surgery - to treat nausea and vomiting including nausea and vomiting which may occur with a migraine - to prevent nausea and vomiting caused by radiotherapy
Slovenian: - preprečevanje slabosti in bruhanja, ki se lahko pojavita po operativnih posegih, - zdravljenje slabosti in bruhanja, vključno s slabostjo in bruhanjem, ki nastopita zaradi migrene, - preprečevanje z radioterapijo povzročene slabosti in bruhanja;
English: Rare (may affect up to 1 in 1,000 people) confusional state convulsion (especially in patients with epilepsy).
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov)
English: Uncommon Amenorrhoea, Hyperprolactinaemia, Rare
Slovenian: Bolezni endokrinega sistema* Občasni amenoreja, hiperprolaktinemija
English: 4.1 Therapeutic indications
Slovenian: Povzetek glavnih značilnosti zdravila (SmPC) 4.1 Terapevtske indikacije
English: Adult population {Tradename} is indicated in adults for: - Prevention of post operative nausea and vomiting (PONV) - Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting - Prevention of radiotherapy induced nausea and vomiting (RINV).
Slovenian: Zdravilo Xyz je pri odraslih bolnikih indicirano za: - preprečevanje slabosti in bruhanja po operativnih posegih, - simptomatsko zdravljenje slabosti in bruhanja, vključno s slabostjo in bruhanjem pri akutni migreni, - preprečevanje z radioterapijo povzročene slabosti in bruhanja;
English: For formulations which cannot be used to administer a 5mg dose Tablets/capsules/granules are not suitable for use in children weighing less than 61 kg. Other pharmaceutical forms/strengths may be more appropriate for administration to this population.
Slovenian: Tablete/kapsule/granule niso primerne za uporabo pri otrocih, katerih telesna masa je nižja od 61 kg.
English: Vascular disorder
Slovenian: Ledvična okvara
English: Discontinuation of metoclopramide in breastfeeding women should be considered.
Slovenian: Pri doječih materah je potrebno razmisliti o prekinitvi zdravljenja z metoklopramidom.
English: For formulations which can be used to administer a 5mg dose Tablets/capsules/granules are not suitable for use in children weighing less than 30 kg. Other pharmaceutical forms/strengths may be more appropriate for administration to this population
Slovenian: Tablete/kapsule/granule niso primerne za uporabo pri otrocih, katerih telesna masa je nižja od 30 kg.
English: For prevention of PONV a single dose of 10mg is recommended.
Slovenian: Za preprečevanje slabosti in bruhanja po operativnih posegih je priporočeni enkratni odmerek 10 mg.
English: - to prevent delayed nausea and vomiting that may occur after chemotherapy - to treat nausea and vomiting that has occurred after surgery
Slovenian: - preprečevanje zakasnele, s kemoterapijo povzročene slabosti in bruhanja, - zdravljenje slabosti in bruhanja po kirurških posegih;
English: The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to 3 times daily, given by slow injection into a vein.
Slovenian: Priporočeni odmerek je od 0,1 do 0,15 mg/kg telesne mase, ki ga prejmete največ trikrat na dan, s počasnim injiciranjem v žilo.
English: - to prevent delayed nausea and vomiting that may occur after chemotherapy - to prevent nausea and vomiting caused by radiotherapy
Slovenian: - preprečevanje zakasnele, s kemoterapijo povzročene slabosti in bruhanja, - preprečevanje z radioterapijo povzročene slabosti in bruhanja;
English: The maximum treatment duration is 48 hours for treatment of established post operative nausea and vomiting (PONV).
Slovenian: Najdaljši čas zdravljenja slabosti in bruhanja, ki nastopita pooperativnih posegih je 48 ur.
English: The maximum dose in 24 hours is 0.5 mg/kg body weight.
Slovenian: Največji dnevni odmerek je 0,5 mg/kg telesne mase.
English: Adult population {Tradename} is indicated in adults for: - Prevention of delayed chemotherapy induced nausea and vomiting (CINV) - Prevention of radiotherapy induced nausea and vomiting (RINV).
Slovenian: Zdravilo Xyz je pri odraslih bolnikih indicirano za: - preprečevanje zakasnele, s kemoterapijo povzročene slabosti in bruhanja, - preprečevanje z radioterapijo povzročene slabosti in bruhanja;
English: All routes of administration
Slovenian: Vsi načini uporabe
English: The maximum treatment duration is 5 days for prevention of delayed chemotherapy induced nausea and vomiting (CINV).
Slovenian: Najdaljši čas zdravljenja zakasnele, s kemoterapijo povzročene slabosti in bruhanja je 5 dni.
English: The recommended single dose is 10 mg, repeated up to three times daily.
Slovenian: Priporočeni enkratni odmerek je 10 mg, ki ga bolnik prejme največ trikrat na dan.
English: The dose should be reduced if you have moderate or severe kidney problems.
Slovenian: Če imate zmerne ali hude težave z ledvicami, bo odmerek potrebno zmanjšati.
English: Common: Hypotension, particularly with intravenous formulation
Slovenian: • znižanje krvnega tlaka (zlasti pri intravenski uporabi zdravila),
English: For the 30 mg strengh prolonged release preparations
Slovenian: Pripravki s podaljšanim sproščanjem z jakostjo 30 mg
English: Confusional state
Slovenian: • stanje zmedenosti,
English: Appropriate additional information regarding posologies adaptation should be implemented in the SmPC depending on the strength of the formulations
Slovenian: V Povzetek glavnih značilnosti zdravila je treba vključiti ustrezne dodatne informacije o prilagajanju odmerjanja zdravila glede na jakost formulacij.
English: Do not exceed 3-month treatment because of the risk of involuntary muscle spasms.
Slovenian: Zaradi tveganja za pojav nehotenih mišičnih krčev, zdravljenje ne sme trajati več kot 3 mesece.
English: A minimal interval of 24 hours between two administrations is to be respected, even in case of vomiting or rejection of the dose (see section 4.4).
Slovenian: Časovni razmik med posameznimi odmerki zdravila mora biti najmanj 24 ur, tudi v primeru bruhanja ali zavrnitve odmerka (glejte poglavje 4.4).
English: For formulations which cannot be used to administer a 5mg dose {Tradename} is not suitable for use in children weighing less than 61 kg.
Slovenian: Zdravilo Xyz ni primerno za uporabo pri otrocih, katerih telesna masa je nižja od 61 kg.
English: - to prevent delayed nausea and vomiting that may occur after chemotherapy - to prevent nausea and vomiting caused by radiotherapy - to treat nausea and vomiting including nausea and vomiting which may occur with a migraine.
Slovenian: - preprečevanje zakasnele, s kemoterapijo povzročene slabosti in bruhanja, - preprečevanje z radioterapijo povzročene slabosti in bruhanja, - zdravljenje slabosti in bruhanja, vključno s slabostjo in bruhanjem, ki nastopita zaradi migrene; V primeru migrene se metoklopramid lahko uporablja v kombinaciji s peroralnimi zdravili proti bolečinam, da bodo le-ta delovala bolj učinkovito.
English: A minimal interval of 12 hours between two administrations is to be respected, even in case of vomiting or rejection of the dose (see section 4.4).
Slovenian: Časovni razmik med posameznimi odmerki zdravila mora biti najmanj 12 ur, tudi v primeru bruhanja ali zavrnitve odmerka (glejte poglavje 4.4).
English: General disorders and administra- tion site conditions Common Asthenia
Slovenian: Pogosti diareja Splošne težave in spremembe na mestu aplikacije Pogosti astenija
English: Metoclopramide should be discontinued immediately in the event of extrapyramidal symptoms.
Slovenian: V primeru pojava ekstrapiramidnih simptomov je treba zdravljenje z metoklopramidom nemudoma prekiniti.
English: Not known Cardiac arrest, occurring shortly after injectable use, and which can be subsequent to bradycardia (see section 4.4); Atrioventricular block,
Slovenian: Neznana srčni zastoj, ki se pojavi kmalu po injiciranju in se lahko pojavi po bradikardiji (glejte poglavje 4.4); atrioventrikularni blok, sinusni zastoj, zlasti pri intravenskih farmacevtskih oblikah; elektrokardiogram: podaljšan interval QT; torsade de pointes
English: The dose should be reduced if you have severe liver problems.
Slovenian: Če imate hude težave z jetri, bo odmerek potrebno zmanjšati.
English: - you have bleeding, obstruction or a tear in your stomach or gut.
Slovenian: - če imate krvavitev, zaporo ali predrtje v želodcu ali črevesju, - če imate ali bi lahko imeli redek tumor nadledvične žleze, ki se nahaja v bližini ledvic
English: A minimal interval of 6 hours between two administrations is to be respected, even in case of vomiting or rejection of the dose (see section 4.4).
Slovenian: Časovni razmik med posameznimi odmerki zdravila mora biti najmanj 6 ur, tudi v primeru bruhanja ali zavrnitve odmerka (glejte poglavje 4.4).
English: The recommended single dose is 15 mg, repeated up to twice daily.
Slovenian: Priporočeni enkratni odmerek je 15 mg, ki ga prejmete največ dvakrat na dan. 30 mg jakost
English: Driving and using machines For all routes of administration
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Velja za vse načine uporabe zdravila.
English: The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times daily by intravenous route.
Slovenian: Priporočeni odmerek je od 0,1 do 0,15 mg/kg telesne mase, ki ga bolnik prejme največ trikrat na dan, intravensko.
English: Summary of Product Characteristics
Slovenian: Vse farmacevtske oblike
English: Uncommon (may affect up to 1 in 100 people) raised levels of a hormone called prolactin in the blood which may cause: milk production in men, and women who are not breast-feeding irregular periods hallucination decreased level of consciousness slow heartbeat (particularly with intravenous route) allergy
Slovenian: • povečane ravni hormona, imenovanega prolaktin v krvi, kar lahko vodi k proizvajanju mleka pri moških in ženskah, ki ne dojijo,
English: The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to 3 times daily, taken by mouth (oral route).
Slovenian: Priporočeni odmerek je od 0,1 do 0,15 mg/kg telesne mase, ki ga prejmete največ trikrat na dan in ga zaužijete (peroralna uporaba).
English: Hepatic impairment
Slovenian: Občasni halucinacije
English: You must wait at least 6 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Slovenian: Za peroralne farmacevtske oblike s takojšnjim sproščanjem Med jemanjem posameznih odmerkov metoklopramida morate počakati najmanj 6 ur, tudi v primeru bruhanja ali zavrnitve odmerka, da bi se izognili prevelikemu odmerjanju.
English: For formulations which can be used to administer a 5mg dose {Tradename} is not suitable for use in children weighing less than 30 kg.
Slovenian: Zdravilo Xyz ni primerno za uporabo pri otrocih, katerih telesna masa je nižja od 30 kg.
English: The time interval of at least 24 hours specified in the section 4.2 should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Slovenian: Med posameznimi odmerki metoklopramida je potrebno upoštevati časovni razmik, in sicer najmanj 24 ur, kot je navedeno v poglavju 4.2, tudi v primeru bruhanja in zavrnitve odmerka, da bi se izognili prevelikemu odmerjanju.
English: Oral route
Slovenian: Peroralna uporaba
English: The time interval of at least 12 hours specified in the section 4.2 should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Slovenian: Med posameznimi odmerki metoklopramida je potrebno upoštevati časovni razmik, in sicer najmanj 12 ur, kot je navedeno v poglavju 4.2, tudi v primeru bruhanja in zavrnitve odmerka, da bi se izognili prevelikemu odmerjanju.
English: The time interval of at least 6 hours specified in the section 4.2 should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Slovenian: Med posameznimi odmerki metoklopramida je potrebno upoštevati časovni razmik, in sicer najmanj 6 ur, kot je navedeno v poglavju 4.2, tudi v primeru bruhanja in zavrnitve odmerka, da bi se izognili prevelikemu odmerjanju.
English: Dosing table
Slovenian: Tabela za odmerjanje
English: Very common
Slovenian: Zelo pogosti somnolenca
English: For all formulations - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal perforation for which the stimulation of gastrointestinal motility constitutes a risk - Confirmed or suspected pheochromocytoma, due to the risk of severe hypertension episodes - History of neuroleptic or metoclopramide-induced tardive dyskinesia - Epilepsy (increased crises frequency and intensity) - Parkinson's disease - Combination with levodopa or dopaminergic agonists (see section 4.5) - Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5
Slovenian: Zdravilo Xyz je pri odraslih bolnikih indicirano za: - preprečevanje zakasnele, s kemoterapijo povzročene slabosti in bruhanja, - preprečevanje z radioterapijo povzročene slabosti in bruhanja - simptomatsko zdravljenje slabosti in bruhanja, vključno s slabostjo in bruhanjem pri akutni migreni; Metoklopramid se lahko uporablja v kombinaciji s peroralnimi analgetiki za izboljšanje absorpcije analgetikov pri akutni migreni.
English: How to take {Tradename}
Slovenian: Kako jemati zdravilo Xyz
English: The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times daily by oral route.
Slovenian: Priporočeni odmerek je od 0,1 do 0,15 mg/kg telesne mase, ki ga bolnik prejme največ trikrat na dan, peroralno.
English: Frequency Adverse reactions
Slovenian: Kontraindicirana kombinacija
English: Uncommon Bradycardia, particularly with intravenous formulation
Slovenian: • omedlevica (zlasti pri intravenski uporabi zdravila),
English: Common Diarrhoea
Slovenian: Žilne bolezni
English: Other medicines and {Tradename} For all routes of administration
Slovenian: Druga zdravila in zdravilo Xyz Velja za vse načine uporabe zdravila.
English: Management
Slovenian: Zdravljenje
English: You must wait at least 12 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Slovenian: Za peroralne farmacevtske oblike s podaljšanim sproščanjem z jakostjo 15 mg Med jemanjem posameznih odmerkov metoklopramida morate počakati najmanj 12 ur, tudi v primeru bruhanja ali zavrnitve odmerka, da bi se izognili prevelikemu odmerjanju.
English: This overview was last updated in June 2018.
Slovenian: Ta povzetek je bil nazadnje posodobljen junija 2018.
English: The side effects were seen in the first week after use of the medicine.
Slovenian: Neželene učinke so opazili v prvem tednu po uporabi zdravila.
English: improvement in lameness was considered relevant and positive effects lasted over a period of one year.
Slovenian: Izboljšanje šepavosti je bilo ocenjeno kot pomembno, pozitivni učinki pa so trajali eno leto.
English: Further information on Arti-Cell Forte can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Arti-Cell Forte so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Arti-Cell Forte received a marketing authorisation valid throughout the EU on 29 March 2019.
Slovenian: Zdravilo Arti-Cell Forte je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 29. marca 2019.
English: The European Medicines Agency decided that Arti-Cell Forte's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je odločila, da so koristi zdravila Arti-Cell Forte večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: The addition of the EAP to the stem cells after thawing and just before injection of the medicine increases the viability (ability to live) of the stem cells.
Slovenian: Dodatek EAP matičnim celicam po odtalitvi in tik pred injiciranjem zdravila poveča viabilnost (zmožnost preživetja) matičnih celic.
English: It consists of two vials which are supplied frozen: one vial contains the active substance and a second vial contains equine allogeneic plasma (EAP) which is the liquid part of blood.
Slovenian: Sestavljeno je iz dveh vial, ki sta ob dobavi zamrznjeni: ena viala vsebuje učinkovino, druga pa konjsko alogensko plazmo (EAP), ki je tekoči del krvi.
English: Other information about Arti-Cell Forte
Slovenian: Druge informacije o zdravilu Arti-Cell Forte
English: The stem cells have been prepared by being taken from blood from donor horses and grown in the laboratory to increase their numbers; they are treated so that they develop into cartilage cells which help to protect cartilage.
Slovenian: Matične celice so bile pripravljene tako, da so bile odvzete iz krvi konjev darovalcev in gojene v laboratoriju, da se je njihovo število povečalo; obdelane so tako, da se razvijejo v hrustančne celice, kar pripomore k zaščiti hrustanca.
English: Liquid nitrogen containers should be handled by properly trained personnel only.
Slovenian: Z vsebniki s tekočim dušikom sme ravnati samo ustrezno usposobljeno osebje.
English: Accidental self-injection can cause pain, local inflammatory reactions and swelling at the injection site which may last for several weeks and possibly cause fever.
Slovenian: Nenamerno samoinjiciranje lahko povzroči bolečino, lokalne vnetne reakcije in otekanje na mestu injiciranja, kar lahko traja več tednov in lahko povzroči povišano telesno temperaturo.