natgillin/translations-raw huggingface dataset:
Gadoversetamide is a chelate containing gadolinium - which has paramagnetic properties and is responsible for the contrast enhancement effect in MRI - and the ligand versetamide.
Gadoversetamid je gadolinij, ki vsebuje kelat, ki ima paramagnetne lastnosti in povzroča krepitev kontrasta pri slikanju MRI, in ligand versetamida.
For liver metastases, the signal difference between the tumour and surrounding liver tissue is significantly improved during the first 90 seconds after an extracellular
Pri jetrnih metastazah je razlika v jakosti signala med tumorjem in jetrnim tkivom močno izboljšana v prvih 90 sekundah po uporabi zunajceličnega gadolinijevega kontrastnega sredstva.
Since the hepatic artery and portal venous system supply approximately 20% and 80% of the hepatic blood supply, respectively, the earlier (hepatic arterial phase) images provide optimal lesion conspicuity for hypervascular lesions and the portal venous phase images are useful for hypovascular lesions (most metastatic lesions are relatively hypovascular and are better demonstrated during the portal venous phase, manifesting as areas of lower signal intensity compared with the markedly enhanced liver).
Vidnost hipo - in
Lesion conspicuity of hypo- and hypervascular lesions may be reduced if imaging is delayed more than 3 minutes due to the diffusion of the contrast agent into the interstitial spaces of both the liver parenchyma and lesion (e. g. metastasis) making the lesion isointense with the normal liver parenchyma.
15 hipervaskularnih lezij je lahko zaradi difuzije kontrastnega sredstva v intersticijski prostor jetrnega parenhima in lezij (npr. metastaz) zmanjšana, če slikanje zamuja več kot tri minute, zaradi česar so lezije enako krepke kot normalni jetrni parenhim.
16 Special Populations
Posebne populacije
When corrected for body weight, the total body clearance of gadoversetamide is greater in the 2 to 11 year age group (143 ± 27.9 ml/ h/ kg) than that observed in the 12 to 18 year age group (117 ± 26.1 ml/ h/ kg) and the two adult populations (82.1 ± 16.8 and 56.5 ± 9.7 ml/ h/ kg in the 19 to 64 and ≥ 65 year of age groups, respectively).
Pri popravku na telesno maso je skupni očistek gadoversetamida iz telesa večji pri starostni skupini od 2 do 11 let (143 ± 27, 9 ml/ h/ kg) kakor pri starostni skupini od 12 do 18 let (117 ± 26, 1 ml/ h/ kg) ter
Nevertheless, because of reported cases of NSF that may be associated with renal impairment for other gadolinium containing contrast agents and for gadoversetamide, Optimark should not be used in these patients.
Zaradi primerov NSF, o katerih so poročali pri drugih kontrastnih sredstvih, ki vsebujejo gadolinij in pri gadoversetamidu, ki so lahko povezani z ledvično okvaro, se zdravila Optimark pri teh bolnikih ne sme uporabljati.
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute toxicity, reproductive toxicity, local tolerance, antigenicity, and genotoxicity.
Neklinični podatki na osnovi običajnih študij farmakološke varnosti, akutne toksičnosti, sposobnosti razmnoževanje, lokalne tolerance, antigenosti in genotoksičnosti ne kažejo posebnega tveganja za ljudi.
17 From a microbiological point of view, the product should be used immediately.
Zaradi mikrobioloških razlogov je treba zdravilo porabiti takoj.
6.5 Nature and contents of container
17 6. 5 Vrsta ovojnine in vsebina
Optimark is also available in pre-filled syringes of 10 ml, 15 ml, 20 ml and 30 ml.
Zdravilo Optimark je na voljo tudi v napolnjenih injekcijskih brizgah po 10, 15, 20 in 30 ml.
If frozen, presentations of gadoversetamide in glass containers may be warmed to room temperature and shaken vigorously.
Če je zamrznjeno, lahko gadoversetamid v steklenih posodah segrejete na sobno temperaturo in močno pretresete.
{MM/ YYYY}
B.
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca, odgovornega za sproščanje serije:
Mallinckrodt Medical Imaging Ireland Damastown Mulhuddart Dublin 15 Ireland
Mallinckrodt Medical Imaging Ireland Damastown Mulhuddart Dublin 15 Irska
 CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
(See Annex I:
(Glejte Dodatek I:
Summary of Product Characteristics, section 4.2).
Povzetek glavnih značilnosti zdravila, Poglavje 4. 2.)
 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
Prior to the launch, the MAA shall provide to all potential prescribers a copy of the SPC with a cover letter highlighting the safety information included in Sections 4.3 and 4.4.
Pred lansiranjem zdravila na trg mora imetnik dovoljenja za promet z zdravilom vsem morebitnim predpisovalcem predložiti kopijo povzetka glavnih značilnosti zdravila in spremno pismo, v katerem so poudarjene varnostne informacije iz poglavij 4. 3 in 4. 4.
The text shall be agreed by the CHMP and shall also contain the following key element:
Besedilo mora odobriti Odbor za zdravila za uporabo v humani medicini (CHMP) in vsebovati tudi naslednje ključne elemente:
 Optimark is not recommended for use in children below the age of two years because the safety, efficacy, and impact of immature kidney function have not been studied in this age group.
Uporaba zdravila Optimark ni priporočena pri otrocih, mlajših od dveh let, saj varnosti, učinkovitosti in vpliva na delovanje nerazvitih ledvic pri tej starostni skupini niso raziskovali.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2009/ 02 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici z dne 2009/ 02, predstavljen v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version dated 22 May 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici načrta za obvladovanje tveganja (RMP) z dne 22. maja 2007, predstavljene v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Po smernicah CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen sočasno z naslednjim periodičnim poročilom o varnosti (PSUR).
In addition, an updated RMP should be submitted  When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities  Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached  At the request of the EMEA
Poleg tega je treba posodobljen RMP predložiti:  kadar imetnik dovoljenja za uporabo z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne varnostne specifikacije, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja;
Text for the outer packaging of 10 ml, 15 ml, 20 ml and 30 ml pre-filled syringes
Besedilo za zunanjo ovojnino za 10 -, 15 -, 20 - in 30- mililitrske napolnjene injekcijske brizge
Optimark 500 micromol/ ml solution for injection in a pre-filled syringe Gadoversetamide
Optimark 500 mikromolov/ ml raztopina za injiciranje v napolnjeni injekcijski brizgi gadoversetamid
Excipients: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/ or hydrochloric acid, water for injections.
Pomožne snovi: versetamid, kalcijev hidroksid, kalcijev klorid dihidrat, natrijev hidroksid in/ ali klorovodikova kislina, voda za injekcije.
Solution for injection 10 ml (1, 10 syringes) 15 ml (1, 10 syringes) 20 ml (1, 10 syringes) 30 ml (1, 10 syringes)
raztopina za injiciranje 10 ml (1, 10 brizg) 15 ml (1, 10 brizg) 20 ml (1, 10 brizg) 30 ml (1, 10 brizg)
Covidien Deutschland GmbH, Gewerbepark 1, 93333 Neustadt/ Donau, Germany
Covidien Deutschland GmbH, Gewerbepark 1, 93333 Neustadt/ Donau, Nemčija
Subject to medical prescription.
Izdaja zdravila je le na recept.
Text for the immediate packaging of 15 ml, 20 ml and 30 ml pre-filled syringes
Besedilo za primarno ovojnino za 15 -, 20 - in 30- mililitrske napolnjene injekcijske brizge
Solution for injection 15 ml 20 ml 30 ml
Raztopina za injiciranje 15 ml 20 ml 30 ml
Text for the immediate packaging of the 10 ml pre-filled syringe
Besedilo za stično ovojnino za 10- mililitrsko napolnjeno injekcijsko brizgo
Optimark 500 micromol/ ml solution for injection in a pre-filled syringe Gadoversetamide IV use.
Optimark 500 mikromolov/ ml raztopina za injiciranje v napolnjeni injekcijski brizgi gadoversetamid i. v. uporaba
Text for the outer packaging of 10 ml, 15 ml and 20 ml vials
Besedilo za zunanjo ovojnino za 10 -, 15 - in 20- mililitrske viale
Optimark 500 micromol/ ml solution for injection in a vial Gadoversetamide
Optimark 500 mikromolov/ ml raztopina za injiciranje v viali gadoversetamid
Solution for injection 10 ml (1, 10 vials) 15 ml (1, 10 vials) 20 ml (1, 10 vials)
Raztopina za injiciranje 10 ml (1, 10 vial) 15 ml (1, 10 vial) 20 ml (1, 10 vial)
30 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
30 PODATKI NA PRIMARNI OVOJNINI
Text for the immediate packaging of 15 ml and 20 ml vials
Besedilo za primarno ovojnino za 15 -, in 20 - mililitrske viale
Solution for injection 15 ml 20 ml
raztopina za injiciranje 15 ml 20 ml
Text for the immediate packaging of the 10 ml vial
Besedilo za stično ovojnino za 10- mililitrsko vialo
Optimark 500 micromol/ ml solution for injection in a vial Gadoversetamide IV use.
Optimark 500 mikromolov/ ml raztopina za injiciranje v viali gadoversetamid i. v. uporaba
Read all of this leaflet carefully before you are being given this medicine.
Pred uporabo natančno preberite navodilo!
What Optimark is and what it is used for 2.
Kaj je zdravilo Optimark in za kaj ga uporabljamo 2.
Before you are given Optimark 3.
Kaj morate vedeti, preden vam bodo dali zdravilo Optimark 3.
How Optimark is given 4.
Kako se daje zdravilo Optimark 4.
How to store Optimark 6.
Shranjevanje zdravila Optimark 6.
WHAT Optimark IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO Optimark IN ZA KAJ GA UPORABLJAMO
Optimark is an injectable contrast medium.
Zdravilo Optimark je kontrastno sredstvo za injiciranje.
It is used to make clearer diagnostic images of the brain, spine and of the liver, in adults and children.
Uporablja se za izdelavo jasnejših diagnostičnih slik možganov, hrbtenjače in jeter pri odraslih in otrocih.
As a result, it helps to clearly show abnormalities in the brain and spine, and in the liver.
Tako pomaga pri jasnejšem prikazu abnormalnosti v možganih, hrbtenjači in jetrih.
BEFORE YOU ARE GIVEN Optimark
KAJ MORATE VEDETI, PREDEN VAM BODO DALI ZDRAVILO Optimark
Do not use Optimark if you are allergic (hypersensitive)  to the active substance gadoversetamide or  to any of the other ingredients of Optimark, or  to other gadolinium contrast agents
Ne uporabljajte zdravila Optimark če ste alergični na (preobčutljivi za):  zdravilno učinkovino gadoversetamid ali  katero koli sestavino zdravila Optimark ali  na druga kontrastna sredstva, ki vsebujejo gadolinij.
You should not be given Optimark if you suffer from severe kidney impairment, or if you are a liver transplant patient as use of Optimark in patients with these conditions has been associated with a disease called Nephrogenic Systemic fibrosis (NSF).
Če imate hudo ledvično okvaro ali če ste imeli presaditev jeter, vam zdravila Optimark ne smejo dati, saj je njegova uporaba pri bolnikih s temi boleznimi povezana z boleznijo, imenovano nefrogena sistemska fibroza (NSF).
NSF may result in debilitating joint immobility, muscle weakness or impairment of the function of internal organs which may potentially be life threatening.
NSF lahko povzroči nepremičnost zaradi oslabitve sklepov, šibkost mišic ali okvaro delovanja notranjih organov, ki je lahko tudi smrtno nevarna.
Take special care with Optimark Diagnostic procedures involving the use of contrast agents should be conducted under supervision of a physician with the prerequisite training and a thorough knowledge of the procedure to be performed.
Bodite posebno pozorni pri uporabi zdravila Optimark Diagnostični postopki, pri katerih se uporabljajo kontrastna sredstva, morajo biti opravljeni pod nadzorom ustrezno usposobljenega zdravnika in ob dobrem poznavanju postopka.
Tell your doctor, if:  you suffer from allergies (e. g. medicinal products, seafood, hay fever, hives) or asthma  you had any reactions to previous injections of a contrast agent, including a previous history of reaction to iodine-based contrast agents  your kidneys do not work properly  Optimark is planned to be used in your child which is below the age of two years
Povejte zdravniku, če:  imate alergijo (npr. na zdravila, morsko hrano, seneni nahod ali koprivnico) ali astmo;  ste v preteklosti imeli reakcijo pri injiciranju kontrastnih sredstev, vključno z reakcijami na kontrastna sredstva na osnovi joda;  vaše ledvice ne delujejo ustrezno;  nameravajo uporabiti zdravilo Optimark pri vašem otroku, ki je mlajši od dveh let.
35 Tell your doctor, if:  you are feeling thirsty and/ or if you have only had small quantities or nothing to drink before the examination  you have a cardiac pacemaker or any ferromagnetic implant (vascular clips, etc.) or a metallic stent in your body  you are taking a special kind of antihypertensive medicine, i. e. a beta-blocker  you have heart disease  you suffer from epilepsy or brain lesions  you are or your child is on a controlled sodium diet If any of these apply to you, your doctor will decide whether the intended examination is possible or not.
Če za vas velja karkoli od naštetega, se bo zdravnik odločil, ali bo nameravani pregled opravil.
Pregnancy and breast-feeding Tell your doctor if you are pregnant and ask your doctor or pharmacist for advice before you are given Optimark.
Nosečnost in dojenje Povejte zdravniku, da ste noseči in se posvetujte z zdravnikom ali farmacevtom, preden vam dajo zdravilo Optimark.
Driving and using machines If you are an ambulant patient and plan to drive or use tools or machines, take into acount that dizziness may incidentally occur after you undergo a procedure involving the injection of Optimark.
Vpliv na sposobnost upravljanja vozil in strojev Če ste ambulantni bolnik in nameravate voziti ali uporabljati orodja ali stroje, upoštevajte, da se lahko po postopku, pri katerem vam injicirajo zdravilo Optimark, pojavi omotica.
Important information about some of the ingredients of Optimark This medicine contains less than 1 mmol sodium (23 mg) per dose of up to 17 ml, i. e. essentially ‘ sodium- free’.
Pomembne informacije o nekaterih sestavinah zdravila Optimark To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek do 17 ml, tj. skoraj "ne vsebuje natrija".
Higher doses contain 1 mmol of sodium or more, which have to be taken into consideration if you are or your child is on a controlled sodium diet.
Večji odmerki vsebujejo 1 mmol natrija ali več, kar je treba upoštevati, če ste vi ali vaš otrok na dieti z malo natrija.
HOW Optimark IS GIVEN
KAKO SE DAJE ZDRAVILO Optimark
The usual dose The usual dose is about 14 ml injected over about 7 -14 seconds into a vein, usually a vein in an arm.
Običajni odmerek Običajni odmerek je približno 14 ml, injiciran v 7– 14 sekundah v veno, po navadi v veno na roki.
A second dose may be given within 30 minutes of the first injection.
V 30 minutah po prvem odmerku vam bodo morda dali drugega.
Certain questions regarding treatment of a brain disease may require the injection of three times the usual dose in one injection.
Zaradi nekaterih vprašanj pri zdravljenju možganskih bolezni vam bodo morda pri enem injiciranju injicirali trikratni običajni odmerek.
You must tell the doctor or nurse/ technologist immediately if you feel pain around the area where the needle is placed.
Zdravniku ali medicinski sestri/ zdravstvenemu delavcu morate takoj povedati, če začutite bolečino na mestu injiciranja.
If you think you have been injected with too much Optimark, tell the doctor or nurse/ technologist immediately.
Če mislite, da so vam injicirali preveč zdravila Optimark, takoj povejte zdravniku ali medicinski sestri/ zdravstvenemu delavcu.
Like all medicinal products, Optimark can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Optimark neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Most of the undesirable effects observed after the use of Optimark were of mild to moderate intensity and transient in nature.
36 Neželeni učinki, ki so jih opazili po uporabi zdravila Optimark, so bili večinoma blagi do zmerni in prehodni.
The most common undesirable effects were a strange taste in the mouth, feeling hot, headache and dizziness.
Najpogostejši neželeni učinki so bili nenavaden okus v ustih, občutek vročine, glavobol in omotica.
Immediately tell the doctor or nurse/ technologist who is giving you the injection, if you feel unwell, especially if you feel any tightness, pain or discomfort in your chest, face or throat, or you have difficulty breathing.
Zdravniku ali medicinski sestri/ zdravstvenem delavcu, ki vam daje injekcijo, takoj povejte, če se ne počutite dobro, zlasti če čutite kakršnokoli stiskanje, bolečino ali neprijeten občutek v prsnem košu, obrazu ali grlu ali če imate težave pri dihanju.
The majority of adverse reactions observed after the use of Optimark were found to be adverse reactions of the nervous system, followed by general adverse reactions, digestive tract disorders/ skin disorders.
Ugotovili so, da je bila večina neželenih učinkov, ki so jih opazili po uporabi zdravila Optimark, učinkov na živčevje, sledile pa so jim splošne neželene reakcije, bolezni prebavil ter bolezni kože in podkožja.
very common: common: uncommon: rare: very rare:
pri več kot 1 bolniku, ki je prejemal zdravilo, od 10 zelo pogosti: pri manj kot 1 bolniku, ki je prejemal zdravilo, od 10, vendar več kot pri pogosti:
In more than 1 of 10 treated patients In less than 1 of 10, but more than 1 of 100 treated patients In less than 1 of 100, but more than 1 of 1,000 treated patients In less than 1 of 1,000, but more than 1 of 10,000 treated patients In 1 case or less of 10,000 treated patients including isolated reports
1 bolniku od 10. 000 v enem primeru ali manj od 10. 000 bolnikov, ki so prejemali zdravilo, zelo redki: vključno s posameznimi poročili
Frequency common uncommon
Pogostnost pogosti: občasno:
Possible side effects dizziness, headache, strange taste in the mouth, feeling hot allergic/ hypersensitivity reaction, tingling sensation, numbness, reduced sense of smell, skin red and warm, nasal congestion, sore throat, nausea, diarrhoea, hives, itching, rash, chest discomfort, feeling cold, administration site reactions
Možni neželeni učinki omotica, glavobol, nenavaden občutek v ustih, občutek vročine alergijske/ preobčutljivostne reakcije, mravljinčenje, otrplost, oslabljen voh, rdeča in topla koža, zamašen nos, boleče grlo, slabost, driska, koprivnica, srbenje, izpuščaj, neprijeten občutek v prsnem košu, občutek mraza, reakcije na mestu injiciranja
rare
redko:
decreased appetite, feeling anxious, sleep disorder, fainting, shaking, drowsy feeling, burning sensation, ringing in the ears, eyelid redness, eye pain, vision blurred, fast heart beat, awareness of the heartbeat, irregular heartbeats, extra heartbeats, low blood pressure, high blood pressure, shortness of breath, hoarseness, cough, runny nose, throat constriction, mouth watering, vomiting, abdominal pain, constipation, dry mouth, cold sweat, redness, sweating, higher blood level of a substance (creatinine) usually eliminated by the kidneys, blood in urine, chest pain, face swollen, fatigue, fever, swelling in limbs, pain, cold feeling in extremities, liver enzyme increased, urine analysis abnormal, mineral values in urine increased, heart and muscle enzyme increased, decreased haemoglobin, changes in blood calcium levels
zmanjšan apetit, občutek tesnobe, motnje spanja, omedlevica, tresenje, dremavost, pekoč občutek, zvenenje v ušesih, rdečica vek, bolečine v očeh, zamegljen vid, hitro bitje srca, zavedanje bitja srca, nepravilen srčni utrip, dodatni srčni utripi, nizek krvni tlak, visok krvni tlak, kratka sapa, hripavost, kašelj, izcedek iz nosu, stiskanje grla, povečano izločanje sline, bruhanje, bolečina v trebuhu, zaprtje, suha usta, hladen pot, rdečica, potenje, zvišana raven snovi, ki se po navadi izloča skozi ledvice (kreatinin) v krvi, kri v urinu, bolečina v prsnem košu, otekanje obraza, utrujenost, zvišana telesna temperatura, otekanje okončin, bolečina, občutek mraza v okončinah, zvišanje jetrnih encimov, nenormalna analiza urina, zvišanje vrednosti mineralov v urinu, zvišanje vrednosti srčnih in mišičnih encimov, znižan hemoglobin, spremembe ravni kalcija v krvi
very rare
zelo redki:
Feeling confused, convulsion, bloodshot eyes, heart beat irregularities, tightening of the airways, swollen throat or vocal cords, raw throat, itchy nose, sneezing, swelling around the eyes, flu-like symptoms, feeling unwell, problems with the electrical rhythm of the heart (long QT)
občutek zmedenosti, krči, krvave oči, nepravilnosti srčnega utripa, stiskanje dihalnih poti, oteklo grlo ali glasilke, boleče grlo, srbenje nosu, kihanje, otekanje okrog oči, simptomi, podobni gripi, slabo počutje, težave z električnim srčnim ritmom (podaljšanje intervala QT)
Cases of abnormalities of the skin including thickening/ inflammation or fibrosis (NSF) have been reported.
Poročali so o primerih anomalije kože, vključno z odebelitvijo/ vnetjem ali fibrozo (NSF).
You must report any of the following symptoms immediately to the doctor or nurse/ technologist, and get immediate treatment as they can be or can become very serious: side effects affecting the heart (fainting, extra heart beats, chest pain) or the respiratory system (shortness of breath, tightening of the airways, swollen or tight throat, itchy or runny nose, sneezing).
O naslednjih simptomih morate takoj obvestiti zdravnika ali medicinsko sestro/ zdravstvenega delavca in prejeti takojšnje zdravljenje, ker so ti simptomi lahko zelo resni ali lahko postanejo zelo resni: neželeni učinki, ki vplivajo na srce (omedlevica, dodatni srčni utrip, bolečina v prsnem košu) ali dihala (kratka sapa, stiskanje dihalnih poti, oteklo ali stisnjeno grlo, srbeč nos ali izcedek iz nosu, kihanje).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
37 Če kateri koli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
HOW TO STORE Optimark
SHRANJEVANJE ZDRAVILA Optimark
Do not use Optimark after the expiry date which is stated on the label.
Zdravila Optimark ne smete uporabljati po izteku roka uporabnosti, ki je naveden na oznaki.
Medicinal products should not be disposed of via wastewater or household waste.
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
What Optimark contains  The active substance is gadoversetamide.
Kaj vsebuje zdravilo Optimark  Zdravilna učinkovina je gadoversetamid.