FrancophonIA/ELRC3.0 huggingface dataset:
English: After removal of the implant, the doctor will apply a sterile gauze with a pressure bandage to minimize bruising.
Slovenian: Ko bodo implantati odstranjeni, bo zdravnik namestil sterilno gazo s kompresijskim povojem, da bo zmanjšal nastajanje modric.
English: Apply liquid adhesive to the skin margins and allow to dry before closing the incision with the thin adhesive strip around 6 mm wide (butterfly strip).
Slovenian: Na robove kože nanesite tekoče lepilo in pustite, da se posuši, preden rez zaprete s tankim lepilnim trakom širine pribl.
English: Apply a pressure bandage with sterile gauze to minimize bruising.
Slovenian: Namestite kompresijski povoj s sterilno gazo, da čim bolj zmanjšate modrice.
English: Equipment for subcutaneous insertion of Sixmo
Slovenian: Oprema za subkutano vstavljanje zdravila Sixmo
English: All patients receiving Sixmo should be monitored for conditions indicative of diversion, or progression of opioid dependence and addictive behaviours suggesting the need for more intensive and structured treatment for substance use.
Slovenian: Vse bolnike, ki uporabljajo zdravilo Sixmo, je treba spremljati glede znakov, ki kažejo na preusmerjanje uporabe ali poslabšanje odvisnosti od opioidov ter vedenja, ki kaže na zasvojenost,
English: • a history of connective tissue disease such as scleroderma • a history of recurrent methicillin-resistant Staphylococcus aureus infections (MRSA)
Slovenian: • ponavljajoče okužbe z bakterijo Staphylococcus aureus, odporno proti metilicinu (MRSA), v zdravstveni zgodovini.
English: In this double-blind and double-dummy study, patients maintained on doses of sublingual buprenorphine of 8 mg/day or less were transferred to 4 Sixmo implants (and daily sublingual placebo), or sublingual buprenorphine 8 mg/day or less (and 4 placebo implants).
Slovenian: razporedili v skupino s 4 implantati Sixmo (in dnevnim podjezičnim placebom) ali v skupino s podjezičnim buprenorfinom 8 mg/dan ali manj (in 4 implantati s placebom).
English: Implant kit: 4 Sixmo implants with 1 applicator
Slovenian: Komplet implantatov: 4 implantati Sixmo z 1 aplikatorjem 6.6 Posebni varnostni ukrepi za odstranjevanje
English: ITT=intent-to-treat, SL BPN = sublingual buprenorphine Buprenorphine was not included in urine toxicology assessments.
Slovenian: ITT = populacija z namenom zdravljenja (intent-to-treat), SL BPN = podjezični buprenorfin
English: When the first 6-month treatment period is up, a new set of Sixmo implants may be given after removal of the old implants, preferably on the same day.
Slovenian: Ko preteče prvo 6-mesečno obdobje zdravljenja, vam lahko vstavijo nov komplet implantatov Sixmo, ko odstranijo stare implantate.
English: Instructions for subcutaneous insertion of Sixmo
Slovenian: Navodila za subkutano vstavljanje zdravila Sixmo
English: • the patient experiences withdrawal symptoms, e.g. sweating, lacrimation, yawning, nausea,
Slovenian: • če ima bolnik odtegnitvene simptome, npr. potenje, solzenje, zehanje, navzea, bruhanje,
English: Withdraw the cannula until the hub is flush with the obturator, then twist the obturator clockwise to lock onto the cannula (Figure 12).
Slovenian: Kanilo pomikajte nazaj, dokler nastavek ni poravnan z mandrenom, nato mandren zasučite v smeri urnega kazalca, da se zaklene na kanilo (slika 12).
English: • thin adhesive strip around 6 mm wide (butterfly strip)
Slovenian: 6 mm (metuljasti trak).
English: • have had an increased formation of scare tissue
Slovenian: • če se je pri vas pojavilo povečano nastajanje brazgotinastega tkiva.
English: Patients previously treated with sublingual buprenorphine or sublingual buprenorphine + naloxone, must be on stable doses between 2 to 8 mg/day for at least 30 days and deemed clinically stable by the treating healthcare professional.
Slovenian: + naloksonom, morajo vsaj 30 dni jemati stabilne odmerke od 2 do 8 mg/dan in jih mora lečeči zdravnik oceniti kot klinično stabilne.
English: • pregnancy
Slovenian: • Nosečnost
English: In case toxicity or overdose symptoms are observed, the removal of the implants and transition to a medicinal product that allows dose adjustment are required.
Slovenian: Če opazite simptome toksičnosti ali prevelikega odmerjanja, je treba odstraniti implantate in preiti na zdravilo, ki omogoča prilagajanje odmerka.
English: Tell your doctor immediately if you have any signs of infection (such as redness or inflammation) at the site of insertion or removal.
Slovenian: Če se na mestu vstavitve ali odstranjevanja pojavijo znaki okužbe (npr. rdečina ali vnetje) o tem takoj obvestite zdravnika.
English: The healthcare professional should review the patient's treatment history for concomitant use of CYP3A4 inhibitors prior to initiating Sixmo treatment to determine suitability (see section 4.5).
Slovenian: CYP3A4, preden uvede zdravljenje z zdravilom Sixmo, da določi njegovo ustreznost (glejte poglavje 4.5).
English: The physician educational programme, provided in conjunction with the Summary of Product Characteristics (SmPC), should include lecture slides and a detailed, face to face, step-by step description and live demonstration of the surgical procedure for SIXMO insertion and removal.
Slovenian: Vsebovati mora neposredno usposabljanje v obliki predstavitve in podroben opis postopka po korakih ter predstavitev kirurškega postopka za vstavitev in odstranitev implantata Sixmo.
English: • have severly reduced liver function
Slovenian: • če imate močno oslabljeno delovanje jeter;
English: Figure 12
Slovenian: Slika 12
English: IMPORTANT INFORMATION Each implant contains buprenorphine hydrochloride equivalent to 74.2 mg of buprenorphine.
Slovenian: POMEMBNE INFORMACIJE En implantat vsebuje buprenorfinijev klorid v količini, ki ustreza 74,2 mg buprenorfina.
English: • certain medicines to treat depression or Parkinson's disease, called monoamine oxidase inhibitors, such as phenelzine, isocarboxazid, iproniazid and tranylcypromine
Slovenian: • rifampicin: zdravilo za zdravljenje tuberkuloze ali določenih drugih okužb; • določena zdravila za zdravljenje depresije ali Parkinsonove bolezni, ki se jim reče zaviralci monoaminooksidaze, kot so fenelzin, izokarboksazid, iproniazid in tranilcipromin.
English: Removal of Sixmo implants
Slovenian: Odstranjevanje implantatov Sixmo
English: • pain affecting muscles and skeleton, neck, limbs, joints
Slovenian: • bolečina v mišicah in kosteh, v vratu, okončinah in sklepih,
English: • sterile fenestrated drape
Slovenian: • sterilna fenestrirana prevleka,
English: • eye discharge, blurred vision, lacrimal disorder
Slovenian: • izcedek iz očesa, zamegljen vid, motnje solznih žlez,
English: Step 4: Lift the edge of the incision opening with the toothed forceps.
Slovenian: 4. korak: S kirurško pinceto privzdignite rob odprtine reza.
English: Verify the location of the implants by palpation.
Slovenian: S tipanjem znova preverite lokacijo implantatov.
English: Place the implant in a glass jar with a lid. Store it safely away from others, especially children.
Slovenian: Varno ga shranite pred drugimi osebami, zlasti otroki.
English: Figure 17
Slovenian: Slika 17
English: The MAH shall ensure that in each MS where SIXMO is marketed, all physicians expected to insert / remove SIXMO subcutaneous (SC) implant are provided with an educational programme, aiming at preventing / minimising the important identified risk of implant protrusion / (spontaneous) expulsion, the important potential risks of damage to nerves or blood vessels during insertion / removal procedure, (dislocation and) migration / missing (partial) implant.
Slovenian: Namen teh gradiv je preprečevanje/zmanjševanje pomembnega opredeljenega tveganja protruzije/(spontane) ekspulzije implanta in pomembnih možnih tveganj poškodbe živcev ali krvnih žil v postopku vstavljanja/odstranjevanja, (dislokacije in) migracije/manjkajočega (delnega) implantata.
English: Implants should be inserted in the inner side of the opposite upper arm, following the insertion steps below to locate the appropriate insertion site.
Slovenian: Izkušenj s ponovno vstavitvijo za obdobje, daljše od 12 mesecev, ni. Implante je treba vstaviti na notranji strani nasprotne nadlakti, pri tem pa je treba upoštevati korake vstavljanja, ki so opisani v nadaljevanju, da najdete ustrezno mesto vstavitve.
English: What you need to know before you use Sixmo
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Sixmo Ne uporabljajte zdravila Sixmo:
English: Clean the incision site.
Slovenian: Očistite mesto reza.
English: Each implant contains buprenorphine hydrochloride equivalent to 74.2 mg of buprenorphine.
Slovenian: En implantat vsebuje buprenorfinijev klorid v količini, ki ustreza 74,2 mg buprenorfina.
English: • dry mouth, wind, indigestion, bloody stool
Slovenian: • suha usta, vetrovi, prebavne motnje, kri v blatu,
English: Most frequent implant adverse reactions were implant site pain, implant site pruritus, implant site haematoma, implant site haemorrhage, implant site erythema and implant site rash.
Slovenian: Najpogostejši neželeni učinki, povezani z implantatom, so bili bolečina na mestu implantata, pruritus na mestu implantata, hematom na mestu implantata, krvavitev na mestu implantata, eritem na mestu implantata in izpuščaj na mestu implantata.
English: • dilated pupils
Slovenian: • razširjene zenice,
English: • pain, such as abdominal pain, bone pain, muscle pain, chest pain, headache
Slovenian: • druge težave z želodcem in črevesjem, bolezni zob, • bolečina, kot je bolečina v trebuhu, bolečina v kosteh, bolečina v mišicah, bolečina v prsnem košu, glavobol,
English: Rare but serious complications, including nerve damage and migration resulting in embolism and death, may result from improper insertion of drug implants in the upper arm. Additional complications may include local migration, protrusion, expulsion and implant breakage after insertion or during removal.
Slovenian: Redki, toda hudi zapleti, vključno s poškodbo živcev in migracijo, katere posledica sta embolija in smrt, so lahko posledica nepravilne vstavitve zdravila v obliki implantatov v nadlaket.
English: • hot flush, bruising, dilation of blood vessels
Slovenian: • vročinski oblivi, modrice, razširitev krvnih žil,
English: • sleep disorder, disinterest
Slovenian: • motnje spanja, ravnodušnost,
English: Buprenorphine given under the tongue will be stopped 12 to 24 hours before insertion of Sixmo implants.
Slovenian: Z jemanjem buprenorfina, ki se daje pod jezik, boste prenehali 12 do 24 ur pred vstavitvijo implantatov Sixmo.
English: Figure 14
Slovenian: Slika 14
English: • If an implant comes out after insertion, take the following steps: Schedule an appointment with the inserting doctor as soon as possible.
Slovenian: • Če implantat po vstavitvi izstopi, ukrepajte takole:
English: • restlessness, excitement, excitability, abnormal thoughts
Slovenian: • nemirnost, vznemirjenje, razdražljivost, nenormalne misli, • odvisnost od drog,
English: Treatment with Sixmo implants
Slovenian: Zdravljenje z implantati Sixmo
English: In this analysis, the percentage of opioid negative urines in the sublingual buprenorphine group was very similar to the results in the Sixmo group (33% versus 31%), and non-inferiority of Sixmo to sublingual buprenorphine was shown.
Slovenian: Sixmo (33 % proti 31 %) in dokazana je bila neinferiornost zdravila Sixmo v primerjavi z buprenorfinom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (kit)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Zunanja škatla (komplet)
English: • latex, talc-free sterile gloves
Slovenian: • sterilne rokavice iz lateksa brez smukca,
English: Figure 11
Slovenian: Slika 11
English: Retreatment with Sixmo implants
Slovenian: Ponovno zdravljenje z implantati Sixmo
English: NAME OF THE MEDICINAL PRODUCT Sixmo 74.2 mg implant
Slovenian: IME ZDRAVILA Sixmo 74,2 mg implantat
English: In many cases the presence of pre-existing hepatic impairment (genetic disease, liver enzyme abnormalities, infection with hepatitis B or hepatitis C virus, alcohol abuse, anorexia, concomitant use of other potentially hepatotoxic medicines) and ongoing injecting drug use may have a causative or contributory role.
Slovenian: V mnogih primerih so lahko vzrok ali lahko k temu prispevajo že obstoječe okvare jeter (genetska bolezen, nenormalnosti jetrnih encimov, okužba z virusom hepatitisa B ali C,
English: The manifestations of acute buprenorphine overdose include pinpoint pupils, sedation, hypotension, respiratory depression and death.
Slovenian: Manifestacije akutnega prevelikega odmerjanja buprenorfina vključujejo zožene zenice, sedacijo,
English: Clean removal site with alcohol pad prior to marking the skin.
Slovenian: Preden kožo označite, mesto odstranjevanja očistite z alkoholno blazinico.
English: Sixmo should be used with caution in patients with asthma or other breathing problems.
Slovenian: Pri astmatičnih bolnikih ali bolnikih, ki imajo druge težave z dihanjem, je treba zdravilo Sixmo uporabljati previdno.
English: • nefazodone: a medicine to treat depression
Slovenian: določena zdravila za zdravljenje depresije,
English: Furthermore, after establishment of non-inferiority, superiority of Sixmo over sublingual buprenorphine was tested and established (p=0.034).
Slovenian: Poleg tega so po ugotovitvi neiferiornosti testirali in potrdili superiornost zdravila Sixmo v primerjavi podjezičnim buprenorfinom
English: Properly placed implants are those placed just under the skin, using the implant applicator, about 80 to 100 mm (8 to 10 cm) above the medial epicondyle, in the sulcus between the biceps and triceps muscle of the inner side of the upper arm.
Slovenian: 100 mm (8 do 10 cm) nad medialnim epikondilom v sulkus med dvoglavo in triglavo mišico na notranji strani nadlakti.
English: Therefore, use these medicines during Sixmo treatment only on doctor's advice and at the prescribed dosage.
Slovenian: ta kombinacija lahko povzroči smrt zaradi depresije dihanja, zato taka zdravila v času uporabe zdravila Sixmo vzemite le po nasvetu zdravnika in v predpisanem odmerku;
English: Sublingual buprenorphine should be discontinued 12 to 24 hours prior to subcutaneous insertion of Sixmo implants.
Slovenian: Jemanje podjezičnega buprenorfina je treba prekiniti 12 do 24 ur pred subkutano vstavitvijo implantatov Sixmo.
English: • sterile fenestrated drapes
Slovenian: • sterilne fenestrirane prevleke,
English: Weeks 17 to 24
Slovenian: IZ mediane Mediana (razpon) 17. do 24. teden
English: • rash, rash pustular, skin lesion
Slovenian: • izpuščaj, pustularni izpuščaj, kožna lezija,
English: NAME OF THE MEDICINAL PRODUCT Sixmo 74.2 mg implant (buprenorphine)
Slovenian: IME ZDRAVILA Sixmo 74,2 mg implantat (buprenorfin)
English: Cardiac disorders common palpitations** uncommon atrial flutter, bradycardia
Slovenian: občasni atrijsko plapolanje, bradikardija
English: • dizziness, drowsiness
Slovenian: • omotica, zaspanost,
English: The administration of additional buprenorphine sublingual doses should be considered by the treating physician if:
Slovenian: Lečeči zdravnik lahko o dajanju dodatnih odmerkov podjezičnega buprenorfina razmisli v naslednjih primerih:
English: Injury, poisoning and procedural complications common procedural pain*, procedural site reaction* uncommon post procedural complication (*), contusion (*), wound dehiscence*, migration of implanted drug***, device breakage***
Slovenian: občasni zapleti po postopku (*), kontuzija (*), dehiscenca rane*, migracija implantiranega zdravila***,
English: • CYP3A4 inhibitors and inducers: Buprenorphine is metabolized to norbuprenorphine primarily by CYP3A4; therefore, potential interactions may occur when Sixmo is given concurrently with medicinal products that affect CYP3A4 activity.
Slovenian: • zaviralci in induktorji CYP3A4: Buprenorfin se v norbuprenorfin presnavlja predvsem preko
English: • Similarly, inducers of CYP3A4 (e.g. phenobarbital, carbamazepine, phenytoin, rifampin) may have the potential to reduce buprenorphine plasma concentrations because of increased metabolism of buprenorphine to norbuprenorphine.
Slovenian: • Podobno imajo lahko induktorji encima CAP3A4 (npr. fenobarbiral, karbamazepin, fenitoin,
English: • increased sweating, feeling unwell
Slovenian: • povečano potenje, slabo počutje,
English: • Liver damage, including liver failure, has been reported when using buprenorphine.
Slovenian: • Med jemanjem buprenorfina so poročali o poškodbi jeter, vključno z odpovedjo jeter.
English: Talk to your doctor before using Sixmo if you have:
Slovenian: Pred začetkom jemanja zdravila Sixmo se posvetujte z zdravnikom, če imate katerega od naslednjih stanj:
English: Before administering Sixmo implants
Slovenian: Preden vam dajo implantate Sixmo
English: Identify the insertion site, which is at the inner side of the upper arm, about 80 to 100 mm (8 to 10 cm) above the medial epicondyle, in the sulcus between the biceps and triceps muscle.
Slovenian: Določite mesto vstavitve, ki je na notranji strani nadlakti, približno 80 do 100 mm (8
English: Table 3: Percentage of Opioid-Negative Urine Samples for Weeks 1 to 16 and Weeks 17 to 24,
Slovenian: Preglednica 3: Odstotek urinskih vzorcev, negativnih na opioide, od 1. do 16. tedna in od
English: Instructions for removal of Sixmo
Slovenian: Navodila za odstranjevanje implantatov Sixmo
English: • constipation, nausea, vomiting, diarrhoea
Slovenian: • zaprtost, slabost, bruhanje, driska,
English: Cases of acute hepatic injury (including fatal cases) have been reported with the active substance buprenorphine in opioid-dependent addicts both in clinical trials and in post marketing adverse reaction reports.
Slovenian: Pri osebah, zasvojenih z opioidi, so tako v kliničnih preskušanjih kot v poročilih o neželenih učinkih po začetku trženja v povezavi z uporabo učinkovine buprenorfin poročali o primerih akutne okvare jeter (tudi s smrtnim izidom).
English: Nervous system disorders common headache, dizziness, somnolence, hypertonia**, syncope** uncommon hypoaesthesia, migraine, depressed level of consciousness, hypersomnia, paraesthesia, tremor
Slovenian: Bolezni živčevja pogosti glavobol, omotica, zaspanost, hipertonija**, sinkopa**
English: • Monoamine oxidase inhibitors (MAOI): Possible exacerbation of the effects of opioids, based on experience with morphine.
Slovenian: • zaviralci MAO: izkušnje z morfinom kažejo, da sočasna uporaba zaviralcev MAO lahko poudari učinke opioidov.
English: Sublingual buprenorphine should be discontinued 12 to 24 hours prior to insertion of four Sixmo implants.
Slovenian: Jemanje podjezičnega buprenorfina je treba prekiniti 12 do 24 ur pred vstavitvijo implantatov Sixmo.
English: Step 13: The patient should lie on their back, with the implant arm flexed at the elbow and externally rotated, so that the hand is positioned next to the head.
Slovenian: Roka, v kateri je implantat, naj bo v komolcu upognjena in obrnjena navzven, tako da je dlan poleg glave.
English: Insert one implant into the cannula (Figure 9), re-insert the obturator, and gently push the obturator forward (mild resistance should be felt) until the obturator stop line is level with the bevel-up stop marking, which indicates the implant is positioned at the tip of the cannula (Figure 10).
Slovenian: dokler se črta za ustavitev na mandrenu ne poravna z oznako za ustavitev pri navzgor obrnjeni poševnini konice, kar pomeni, da se implantat nahaja na konici kanile (slika 10).
English: Table 4: Percentage of Opioid-Negative Urine Samples for Weeks 1 to 24, Study PRO-806
Slovenian: Preglednica 4: Odstotek urinskih vzorcev, negativnih na opioide, od 1. do 24. tedna, študija
English: Frequency Adverse reactions Infections and infestations common viral infection, bronchitis**, infection**, influenza**, pharyngitis**, rhinitis** uncommon cellulitis, skin infection, peritonsillar abscess, rash pustular, urinary tract infection, vulvovaginal mycotic infection, implant site infection*, implant site abscess*
Slovenian: Infekcijske in parazitske bolezni pogosti virusna okužba, bronhitis**, okužba**, influenca**, faringitis**, rinitis**
English: • migraine, tremor
Slovenian: • migrena, tresavica,
English: Equipment for removal of Sixmo
Slovenian: Oprema za odstranjevanje implantatov Sixmo
English: • enlarged prostate or narrowed urethra
Slovenian: • povečano prostato ali zoženo sečnico, • zmanjšano delovanje ščitnice,
English: • Adson single tooth tissue forceps
Slovenian: • kirurška pinceta Adson,
English: NAME OF THE MEDICINAL PRODUCT Sixmo 74.2 mg implant buprenorphine
Slovenian: IME ZDRAVILA Sixmo 74,2 mg implantat buprenorfin
English: Metabolism and nutrition disorders common decreased appetite uncommon abnormal weight gain, dehydration, increased appetite
Slovenian: apatija, evforično razpoloženje, zmanjšano občutenje orgazma, nemirnost, razdražljivost,
English: Musculoskeletal and connective disorders common bone pain**, myalgia** uncommon muscle spasms, limb discomfort, musculoskeletal pain, neck pain, pain in extremity, temporomandibular joint syndrome, arthralgia*** Renal and urinary disorders uncommon urinary hesitation, micturition urgency, pollakisuria
Slovenian: občasni mišični krči, nelagodje v okončinah, bolečina v mišicah in kosteh, bolečina v vratu, bolečina v okončinah, sindrom temporomandibularnega sklepa, artralgija***
English: Close the incision with sutures.
Slovenian: Rez zaprite s šivanjem.
English: These risks and the patient's stability in treatment for opioid dependence should be considered when determining whether Sixmo is appropriate for the patient.
Slovenian: Pri odločanju, ali je zdravljenje z zdravilom Sixmo primerno za določenega bolnika, je treba razmisliti o tveganjih in stabilnosti bolnika pri zdravljenju odvisnosti od opioidov.
English: Modification of the Sixmo dose is not required in patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic spreminjanje odmerka zdravila Sixmo ni potrebno.
English: Mark the channel tracks where each implant will be inserted by drawing 4 lines - with each line 40 mm long.
Slovenian: Implantati se vstavijo skozi majhen subkutani rez velikosti 2,5 do 3 mm. Označite sledi kanalov, kjer bodo vstavljeni implantati, in sicer narišite 4 črte, vsaka naj bo dolga 40 mm. Implantati bodo razporejeni v pahljačasti obliki od 4 do 6 mm narazen, pri čemer se pahljača odpira proti rami
English: Only a healthcare professional who is trained in the insertion of Sixmo should perform the procedure, using only the implant applicator, with the recommended local anaesthetic available.
Slovenian: pri tem postopku pa mora uporabljati aplikator za implantate in imeti na voljo priporočeni lokalni anestetik.
English: • #15 blade scalpel
Slovenian: • skalpel, rezilo št. 15,
English: • abnormal function of the bile duct
Slovenian: • nenormalno delovanje žolčevoda,
English: Eye disorders common mydriasis** uncommon eye discharge, lacrimal disorder, vision blurred
Slovenian: občasni izcedek iz očesa, motnje solznih žlez, zamegljen vid
English: • high blood pressure, feeling heartbeat
Slovenian: • duševna bolezen, za katero so značilne blodnje in nerazumnost, • visok krvni tlak, zaznaven srčni utrip,
English: • Please note that an ultrasound and MRI facilities need to be available to the clinical site at which the insertion and removal of Sixmo occurs.
Slovenian: • Upoštevajte, da mora biti v bolnišnici, kjer se izvaja vstavljanje in odstranjevanje zdravila
English: Sixmo 74.2 mg implant buprenorphine
Slovenian: Navodilo za uporabo Sixmo 74,2 mg implantat buprenorfin
English: General disorders and administration site conditions common fatigue, chills, asthenia, pain, implant site haematoma*, implant site pain*, implant site pruritus*, implant site haemorrhage*, implant site erythema*, implant site scar*, chest pain**, malaise***, drug withdrawal syndrome*** uncommon oedema peripheral, discomfort, face oedema, feeling cold, pyrexia, swelling, implant site oedema*, implant site reaction*, device expulsion*, impaired healing*, implant site
Slovenian: Neželeni učinki občasni periferni edem, nelagodje, obrazni edem, občutek mrazenja, pireksija, otekanje, edem na mestu implantata*, reakcija na mestu implantata*, iztis pripomočka*, slabše celjenje*, parestezija na mestu implantata*, izpuščaj na mestu implantata*, brazgotinjenje*