natgillin/translations-raw huggingface dataset:
In the absence of bone safety data in patients with severe renal impairment treated with strontium ranelate, PROTELOS is not recommended in patients with a creatinine clearance below 30 ml/min (see section 5.2).
zdravilo PROTELOS ni priporočeno pri bolnikih z očistkom kreatinina pod 30 ml/min (glejte poglavje
MARKETING AUTHORISATION NUMBER(S) EU/1/04/288/003
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/04/288/003
When a VTE occurs, PROTELOS should be stopped.
Če se pojavi venska trombembolija, moramo zdravljenje z zdravilom PROTELOS ukiniti.
Flatulence
OVOJNINAH
• PROTELOS should only be used with caution in: o Patients with significant risk factors for cardiovascular events such as hypertension, hyperlipidaemia, diabetes mellitus or smoking.
o bolnikih s pomembnimi dejavniki tveganja za srčno-žilne dogodke, kot so npr.
This should be taken into account when interpreting BMD changes during treatment with PROTELOS.
Med razlaganjem sprememb mineralne kostne gostote ob zdravilu
• The treatment should be either discontinued or stopped in the following situations: o If the patient develops ischaemic heart disease, peripheral arterial disease, cerebrovascular disease or if hypertension is uncontrolled, the treatment should be stopped.
možgansko-žilna bolezen ali nenadzorovana arterijska hipertenzija, je potrebno z zdravljenjem prenehati, o v primeru bolezni ali stanja, ki privede do nepokretnosti bolnika, je potrebno zdravljenje z zdravilom PROTELOS prekiniti,
Servier Laboratories (Ireland) Ltd. Tel: +353 (0)1 6638110
Tel: +353 (0)1 6638110 Ísland
PHARMACEUTICAL FORM AND CONTENTS
Izgled zdravila PROTELOS in vsebina pakiranja
Date of first authorisation: 19 March 2015
Datum prve odobritve: 19. marec 2015
This leaflet was last approved in 12/2016.
Navodilo je bilo nazadnje revidirano dne 12/2016
Such substances should be removed as much as possible before applying the product.
Takšne snovi je treba pred uporabo zdravila čim bolj odstraniti.
The frequency of the type of event is not known (cannot be estimated from available data).
Pogostnost te vrste neželenega učinka je neznana (ni mogoče oceniti iz razpoložljivih podatkov).
1.5 Bar (22 psi)
1,5 bara (22 psi)
The application can be repeated, if necessary.
Po potrebi lahko uporabo ponovite.
DATE OF REVISION OF TEXT
DATUM ZADNJE REVIZIJE BESEDILA
If these symptoms occur, the administration should be discontinued immediately.
Če se pojavijo ti simptomi, je treba z dajanjem takoj prenehati.
Elderly Dose adjustment not required.
Starejši Odmerka ni treba prilagajati.
35041 Marburg (Stadtteil Michelbach) Germany
35041 Marburg (Stadtteil Michelbach) Nemčija
The fibrin adhesion system initiates the last phase of physiological blood coagulation.
Fibrinski adhezijski sistem sproži zadnjo fazo fiziološke koagulacije krvi.
Maximum amount of Raplixa recommended is 3 gram.
Največja priporočena količina zdravila Raplixa je 3 grame.
In case of shock, standard medical treatment for shock should be implemented.
V primeru šoka je potrebno standardno zdravljenje šoka.
• Guide for healthcare professionals
• smernice za zdravstvene delavce
Store between + 2 °C to + 25 °C.
Shranjujte med + 2 °C in + 25 °C.
Fibrin sealants may, in rare cases (up to 1 in 1,000 people), cause an allergic reaction.
Na splošno lahko fibrinska lepila v redkih primerih (pri največ 1 od 1000 bolnikov) povzročijo alergijsko reakcijo.
The following is intended for healthcare professionals only:
Naslednje informacije so namenjene samo zdravstvenemu osebju:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke.
As with any protein product, allergic type hypersensitivity reactions are possible.
Kot z vsemi proteinskimi zdravili so možne preobčutljivostne reakcije alergijskega tipa.
In addition, the spray device should not be used closer than the recommended distances.
Poleg tega se pršila ne sme uporabljati bližje od priporočene razdalje.
Excessive clot thickness may negatively interfere with the product's efficacy and the wound healing process.
Pretirana debelina strdka lahko negativno vpliva na učinkovitost zdravila in proces zdravljenja rane.
Martin House, Gloucester Crescent, Wigston, Leicester, Leicestershire, LE18 4YL, United Kingdom
Martin House, Gloucester Crescent, Wigston, Leicester, Leicestershire, LE18 4YL, Velika Britanija
Conventional surgical techniques such as suture, ligature and cautery were ineffective or impractical.
Običajne kirurške tehnike kot so šivanje, ligature in kavteterizacija so bile neučinkovite ali neizvedljive.
Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis.
Podporno zdravljenje, kjer standardne kirurške tehnike ne zadoščajo za izboljšanje hemostaze.
In the event of overdose, patients must be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment and supportive measures instituted.
V primeru prevelikega odmerjanja je treba bolnike skrbno spremljati zaradi znakov ali simptomov neželenih učinkov in uvesti ustrezno simptomatsko zdravljenje in podporne ukrepe.
• Use preferred pressurised CO2 instead of pressurised air
• prednost se daje uporabi stisnjenega CO2 namesto stisnjenega zraka
Raplixa is indicated in adults over 18 years of age.
Zdravilo Raplixa je indicirano pri odraslih, starih več kot 18 let.
The pressure should be within the range recommended by ProFibrix.
Tlak mora biti v razponu, ki ga priporoča ProFibrix.
Raplixa may also be used with medical air (see sections 4.4 and 6.6).
Zdravilo Raplixa se lahko uporablja tudi z medicinskim zrakom (glejte poglavji 4.4 in 6.6).
Name and address of the manufacturers of the biological active substances CSL Behring GmbH
Ime in naslov izdelovalcev bioloških zdravilnih učinkovin CSL Behring GmbH
• Use of the correct pressure (not exceed 1.5 bars or 22 psi) and distance from tissue not closer than
• uporabiti je treba pravilni tlak (ne več kot 1,5 bara ali 22 psi), razdalja do tkiva pa mora biti vsaj
Raplixa should not be sprayed at a distance closer than that recommended by the spray device manufacturer and in no case closer than 5 cm from the tissue surface.
Zdravila Raplixa ne smete pršiti bližje kot z razdalje, ki jo priporoča proizvajalec pršila, in v nobenem primeru ne bližje kot 5 cm od površine tkiva.
What you need to know before you are treated with Raplixa
Kaj morate vedeti, preden vas bodo zdravili z zdravilom Raplixa
Name and address of the manufacturer responsible for batch release Nova Laboratories Limited
Ime in naslov izdelovalca, odgovornega za sproščanje serij Nova Laboratories Limited
The safety of Raplixa for use in human pregnancy or during breast-feeding has not been established in controlled clinical trials.
Varnost zdravila Raplixa med nosečnostjo ali dojenjem pri ljudeh ni bila ugotovljena v nadzorovanih kliničnih preskušanjih.
Use and Application
Uporaba in aplikacija
It is called an air or gas embolism.
To se imenuje zračna ali plinska embolija.
There is not enough information available to know whether any particular risks are associated with the use of Raplixa during pregnancy or whilst breast-feeding.
Na voljo ni dovolj podatkov, da bi lahko ugotovili, ali obstajajo posebna tveganja, ki so povezana z uporabo zdravila Raplixa med nosečnostjo ali v obdobju dojenja.
The educational programme is aimed at increasing awareness about the risk of air or gas embolism with the use of Raplixa spray device and providing instructions for the correct usage of pressure regulators.
Namen izobraževalnega programa je povečati zavedanje o tveganju zračne ali plinske embolije z uporabo pripomočka Raplixa Spray in dati navodila za pravilno uporabo regulatorjev tlaka.
In absence of compatibility studies, Raplixa must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti zdravila Raplixa ne smemo mešati z drugimi zdravili.
Keep the vial in the outer packaging in order to protect from light.
Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
This event occurs when an air or gas bubble or bubbles enter a vein or artery and block it.
Ta dogodek se pojavi, če zračni ali plinski mehurček vstopi v veno ali arterijo in jo zamaši.
Prior to launch of Raplixa in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred začetkom prodaje zdravila Raplixa v vsaki državi članici se bo imetnik dovoljenja za promet z zdravilom z nacionalnim pristojnim organom dogovoril o obliki in vsebini izobraževalnega programa, vključno z mediji za komunikacijo, načinom razdeljevanja in drugimi vidiki programa.
Pressure regulator to be used
Regulator tlaka, ki se uporabi
Spray distance from tissue and pressure should be within the ranges recommended by the manufacturer (see table in section 6.6 for pressure and distance).
Razdalja pršenja od tkiva in tlak morata biti v razponu, ki ju priporoča proizvajalec pršila (za tlak in razdaljo glejte preglednico v poglavju 6.6).
• When medicines are made from human blood or plasma, certain measures are put into place to prevent infections being passed on to patients.
• Pri zdravilih, ki se izdelajo iz humane krvi ali plazme, se izvajajo določeni ukrepi za preprečevanje prenosa okužb na bolnike.
The combination of Raplixa and a gelatin sponge reduced the median time to haemostasis at target sites by up to 2 minutes compared to a gelatin sponge alone.
Kombinacija zdravila Raplixa in želatinske gobice je skrajšala mediani čas do hemostaze na ciljnih mestih do 2 minuti v primerjavi s samo želatinsko gobico.
The MAH shall ensure that in each Member State where Raplixa is marketed, all healthcare professionals who are expected to use Raplixa are provided with the following educational material:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vsaki državi članici, kjer bo zdravilo Raplixa na trgu, vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali zdravilo Raplixa, imeli prejeli naslednje izobraževalno gradivo:
The amount of Raplixa to be applied and the frequency of application should always be oriented towards the underlying clinical needs for the patient.
Količina zdravila Raplixa, ki jo je treba dati, in pogostnost nanosa se morata vedno ravnati glede na osnovne klinične potrebe bolnika.
No data are available, Raplixa is therefore not recommended for use in children and adolescents.
Podatkov ni na voljo, zato se uporaba zdravila Raplixa pri otrocih in mladostnikih ne priporoča.
Do not use Raplixa (and gelatin sponge) in contaminated areas of the body, or in the presence of active infection.
Zdravila Raplixa (želatinske gobice) ne uporabljajte na kontaminiranih predelih telesa ali v prisotnosti aktivne okužbe.
Such reactions may especially be seen, if the preparation is applied repeatedly, or administered to patients known to be hypersensitive to constituents of the product.
Takšne reakcije lahko vidimo zlasti, če se zdravilo nanaša večkrat ali če se uporablja pri bolnikih z znano preobčutljivostjo na sestavine zdravila.
There is also a possibility that you could develop antibodies to the proteins in Raplixa, which could potentially interfere with blood clotting.
Obstajajo tudi možnosti, da bi se lahko razvila protitelesa na beljakovine v zdravilu Raplixa, ki bi lahko potencialno motile strjevanje krvi.
The Guide for healthcare professionals shall inform on the following key elements:
V smernicah za zdravstvene delavce morajo biti navedeni ključni elementi:
• Nearby areas should be protected to make sure that Raplixa is only applied onto the surface which is to be treated.
• Bližnje predele je treba zaščititi in zagotoviti, da se zdravilo Raplixa nanaša le na površino, ki se
The European Medicines Agency has deferred the obligation to submit the results of studies with Raplixa in one or more subsets of the paediatric population in the treatment of haemorrhage resulting from surgical procedure as per Paediatric Investigational Plan (PIP) decision, for the granted indication (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Raplixa za eno ali več podskupin pediatrične populacije za zdravljenje krvavitve, ki nastane kot posledica kirurškega postopka, pod pogoji, ki so za odobreno indikacijo zdravila navedeni v izvedbenem načrtu za pediatrično populacijo (PIP) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Transmissible infectious agents
Prenosljivi povzročitelji okužb
Clinical studies with Raplixa demonstrating haemostasis were conducted in patients undergoing spinal (n=146), vascular (n=137), liver (n=158) and soft tissue surgery (n=125).
Klinične študije z zdravilom Raplixa, ki kažejo hemostazo so opravili pri bolnikih s kirurškim posegom na hrbtenici (n=146), žilju (n=137), jetrih (n=158) in mehkem tkivu (n=125).
The safety and efficacy of Raplixa in children and adolescents under the age of 18 years have not been established.
Varnost in učinkovitost zdravila Raplixa pri otrocih in mladostnikih, starih do 18 let, nista bili dokazani.
For instructions on use of the medicinal product before administration, see section 6.6.
Za navodila glede uporabe zdravila pred dajanjem glejte poglavje 6.6.
Data are not available to support the use of this product in tissue gluing, neurosurgery, application through a flexible endoscope for treatment of bleeding or in gastrointestinal anastomoses.
Ni podatkov, ki bi podprli uporabo tega zdravila pri lepljenju tkiva, nevrokirurgiji, nanosu skozi prilagodljivi endoskop za zdravljenje krvavitev ali pri gastrointestinalnih anastomozah.
Other medicines and Raplixa Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
If application of a single layer of Raplixa does not completely stop the bleeding, more may be applied.
Če nanos enega sloja zdravila Raplixa krvavitve ne ustavi popolnoma, je mogoče nanesti več zdravila.
Raplixa must be used in combination with an approved gelatin sponge (see section 5.1).
Zdravilo Raplixa je treba uporabljati v kombinaciji z odobreno želatinsko gobico (glejte poglavje 5.1).
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Standardni ukrepi za preprečevanje okužb zaradi uporabe zdravil, pripravljenih iz humane krvi ali plazme, vključujejo izbiro darovalcev, presejanje posameznih odvzetih enot in združene plazme za specifične označevalce okužbe in vključevanje učinkovitih proizvodnih stopenj za inaktivacijo/odstranitev virusov.
What Raplixa is and what it is used for
Kaj je zdravilo Raplixa in za kaj ga uporabljamo
It is known from in vitro testing that 1 g can cover 100 cm² using the RaplixaSpray device.
Na podlagi testov in vitro je znano, da se lahko z uporabo pripomočka RaplixaSpray z 1 g prekrije 100 cm².
0.5 g, 1 g, 2 g of powder per vial (Type I glass) with a rubber stopper and aluminium/ plastic tear-off.
0,5 g, 1 g, 2 g praška na vialo (steklo tipa I) z gumijastim zamaškom in aluminijasto/plastično odtržno zaporko.
Known hypersensitivity to the Raplixa active substances or to any of the excipients listed in section 6.1.
Znana preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
Pharmacotherapeutic group: local haemostatics, other haemostatics ATC code: B02BC30
5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: lokalni hemostatiki, drugi hemostatiki oznaka ATC: B02BC30
Raplixa must be used within 2 hours of opening the vial.
Zdravilo Raplixa je treba porabiti v 2 urah od odprtja viale.
Manufacturers of these products also include steps in the processing of the blood and plasma that can inactivate or remove viruses.
Proizvajalci teh zdravil vključijo tudi stopnje priprave krvi in plazme, kjer se virusi inaktivirajo ali odstranijo.
3 years In use shelf life: Once the vial is opened Raplixa should be applied within 2 hours.
3 leti Rok uporabnosti med uporabo: odprto vialo zdravila Raplixa je treba uporabiti v 2 urah.
Raplixa is supplied in three different presentations 0.5 grams (39.5 mg human fibrinogen and 363 IU human thrombin), 1 gram (79 mg human fibrinogen and 726 IU human thrombin) and 2 grams (158 mg human fibrinogen and 1452 IU human thrombin).
Zdravilo Raplixa je na voljo v treh različnih pakiranjih po 0,5 grama (39,5 mg humanega fibrinogena in 363 i.e. humanega trombina), 1 gram (79 mg humanega fibrinogena in 726 i.e. humanega trombina) in 2 grama (158 mg humanega fibrinogena in 1452 i.e. humanega trombina).
• Risk of life-threatening air or gas embolism if the product is sprayed incorrectly
• tveganje življenjsko nevarne zračne ali plinske embolije ob nepravilnem pršenju zdravila
The dose to be applied is governed by variables including, but not limited to, the type of surgery, the size of the bleeding surface area, the severity of bleeding, the mode of application selected by the surgeon, and the number of applications.
Za uporabljeni odmerek veljajo številne spremenljivke, ki med drugim vključujejo vrstno kirurškega posega, predel krvaveče površine, resnost krvavitve, način aplikacije, ki ga izbere kirurg, in število aplikacij.
Air or gas emboli
Zračna ali plinska embolija
The vial must be opened in a sterile field.
Vialo je treba odpreti v sterilnih pogojih.
Factor XIIIa, which is activated from factor XIII by thrombin, crosslinks fibrin.
Trombin aktivira faktor XIII v faktor XIIIa, ta pa navzkrižno poveže fibrin.
There are three methods of administration of Raplixa:
Za uporabo zdravila Raplixa so na voljo tri metode:
Table 1: Composition of Raplixa (per gram powder) Component
Preglednica 1: Sestava zdravila Raplixa (na gram praška)
Raplixa may also be used with medical air.
Zdravilo Raplixa se lahko uporablja tudi z medicinskim zrakom.
College Business & Technology Park, Cruiserath, Blanchardstown, Dublin 15, Ireland
College Business & Technology Park, Cruiserath, Blanchardstown, Dublin 15, Irska
Sterile
sterilno
What Raplixa is and what it is used for What you need to know before you are treated with Raplixa How to use Raplixa
Kaj je zdravilo Raplixa in za kaj ga uporabljamo Kaj morate vedeti, preden vas bodo zdravili z zdravilom Raplixa
Do not use Raplixa for treatment of severe arterial bleeding.
Zdravila Raplixa se ne sme uporabljati za zdravljenje hudih arterijskih krvavitev.
These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of viruses/infections.
Ti ukrepi so med drugim natančna izbira darovalcev krvi in plazme, da se izključi osebe s tveganjem prenosa okužbe, in testiranje vsake odvzete enote in združene plazme za znake virusov/okužb.
The risk appears to be higher when fibrin sealants are sprayed with air as compared to CO2 and therefore cannot be excluded with Raplixa.
Kaže, da je tveganje večje, pri pršenju fibrinskih lepil z zrakom v primerjavi s CO2, zato ga pri uporabi zdravila Raplixa ni mogoče izključiti.
General disorders and administrative site conditions Insomnia Pruritus
Splošne težave in spremembe na mestu aplikacije insomnia pruritus
Raplixa must not be used as a glue for intestines (gastrointestinal anastomoses).
Zdravilo Raplixa se ne sme uporabljati kot lepilo za črevesje (gastrointestinalne anastomoze).
Inadvertent intravascular injection could lead to thromboembolic event and disseminated intravascular coagulation (DIC), and there is also a risk of anaphylactic reaction (see section 4.4).
Nenamerno intravaskularno injiciranje lahko povzroči trombembolični dogodek in diseminirano intravaskularno koagulacijo, prav tako pa obstaja tveganje za anafilaktično reakcijo (glejte poglavje
Raplixa may be denatured after exposure to solutions containing alcohol, iodine or heavy metals (e.g. antiseptic solutions).
Zdravilo Raplixa se lahko po izpostavljenosti raztopinam, ki vsebujejo alkohol, jod ali težke kovine (npr. antiseptične raztopine) denaturira.
Conversion of fibrinogen into fibrin occurs by the splitting of fibrinogen into fibrin monomers and fibrinopeptides.
Pretvorba fibrinogena v fibrin se zgodi s cepitvijo fibrinogena v fibrinske monomere in fibrinopeptide.
In clinical trials, smaller bleeding sites (< 10 cm²) used 0.5 g to 1 g on average.
V kliničnih preskušanjih so za manjše krvaveče predele (< 10 cm²) povprečno uporabili 0,5 g do 1 g. Za večje krvaveče predele so porabili 1 do 2 grama (10 - 100 cm²).
instructions for use
NAVODILA ZA UPORABO
Raplixa should not be administered during pregnancy and breast-feeding.
Zdravila Raplixa se ne sme uporabljati med nosečnostjo in dojenjem.
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the application site, bronchospasm, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may occur in isolated cases in patients treated with fibrin sealants / haemostatics: these reactions have progressed to severe anaphylaxis.
Preobčutljivostne ali alergijske reakcije (ki lahko vključujejo angioedem, pekoč občutek in zbadanje na mestu aplikacije, bronhospazem, mrazenje, vročinske oblive, generalizirano urtikarijo, glavobol, koprivnico, hipotenzijo, letargijo, navzeo, nemir, tahikardijo, stiskanje v prsih, mravljinčenje, bruhanje, sopenje) se lahko v posameznih redkih primerih pojavijo pri bolnikih, ki jih zdravimo s fibrinskimi lepili/hemostatiki: te reakcije so napredovale do hude anafilaksije.
Follow specific instructions for use of the absorbable gelatin sponge.
Upoštevajte specifična navodila za uporabo vpojne želatinske gobice.
Table 1: Required Dose of Raplixa Maximum Surface Area Direct Application from Vial
Preglednica 1: Potrebni odmerek zdravila Raplixa Največja površina nanosa Neposredni nanos iz viale
The outer aluminium foil sachet may be opened in a non-sterile operating area.
Zunanja vrečka iz aluminijaste folije se lahko odpre v nesterilnih pogojih.
In combination with a gelatin sponge, Raplixa is applied or sprayed onto cut tissue where it forms a layer that helps to stop bleeding.
V kombinaciji z želatinsko gobico se zdravilo Raplixa nanaša ali naprši na prerezano tkivo, kjer oblikuje plast, ki pomaga ustaviti krvavitev.
See section 4.
Glejte poglavje 4.4.
Children and adolescents Raplixa has not been evaluated for safety and effectiveness in children.
Otroci in mladostniki Varnosti in učinkovitosti zdravila Raplixa niso ocenili pri otrocih.
Before administration of Raplixa care is to be taken that parts of the body outside the desired application area are sufficiently protected (covered) to prevent tissue adhesion at undesired sites.
Pred uporabo zdravila Raplixa je treba predele okoli nameravanega predela aplikacije ustrezno zaščititi (prekriti), da se prepreči zlepljenje tkiva na neželenih predelih.
If you experience any symptoms such as vomiting with blood, blood in your stool, blood in your draining tube from your abdomen, swelling or skin discolouration in your extremities, chest pain and shortness of breath, and/or any other symptoms related to your surgery, please contact your doctor or surgeon immediately.
Če se pojavijo kateri koli simptomi, kot so bruhanje s krvjo, kri v stolici, kri v drenažni cevki iz trebuha, oteklina ali obarvanje kože okončin, bolečina v prsnem košu in zasoplost in/ali kateri koli drugi simptomi, povezani s posegom, se takoj posvetujte z zdravnikom ali kirurgom.
The following side effects have also been reported: Common side effects (may affect up to 1 in 10 people):
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):