natgillin/translations-raw huggingface dataset:
decreased appetite, feeling anxious, sleep disorder, drowsy feeling, burning sensation, a sensation of movement or spinning, ringing in the ears, eyelid redness, eye pain, vision blurred, bloodshot eyes, awareness of the heartbeat, irregular heartbeats, extra heartbeats, low blood pressure, shortness of breath, hoarseness, runny nose, throat constriction, mouth watering, abdominal pain, constipation, dry mouth, hives, cold sweat, redness, higher blood level of a substance (creatinine) usually eliminated by the kidneys, blood in urine, face swollen, weakness and similar symptoms like fatigue and general feeling of being unwell, fever, swelling in limbs, chill, pain, cold feeling in extremities, liver enzyme increased, urine analysis abnormal, mineral values in urine increased, protein in urine, heart and muscle enzyme increased, decreased haemoglobin, feeling confused and disoriented, shaking, convulsion, pink eye, fast heart beat, high blood pressure, tightening of the airways, swollen throat or voice box, raw throat, cough, itchy nose, sneezing, sweating
zmanjšan apetit, občutek tesnobe, motnje spanja, dremavost, pekoč občutek, občutek gibanja ali vrtenja, zvenenje v ušesih, rdečica vek, bolečine v očeh, zamegljen vid, krvave oči, zavedanje bitja srca, nepravilen srčni utrip, dodatni srčni utripi, nizek krvni tlak, kratka sapa, hripavost, izcedek iz nosu, stiskanje grla, povečano izločanje sline, bolečina v trebuhu, zaprtje, suha usta, koprivnica, hladen pot, rdečica, zvišana raven snovi, ki se po navadi izloča skozi ledvice
It provides contrast enhancement and facilitates visualization and helps with the characterization of focal lesions and abnormal structures in the CNS and liver in adult patients and in children of two years and older with known or highly suspected pathology.
Omogoča krepitev kontrasta ter izboljša prikaz in pomaga pri karakterizaciji fokalnih lezij in nenormalnih struktur v osrednjem živčevju in jetrih odraslih bolnikov in otrok, starih dve leti ali več, z znano patologijo ali močnim sumom nanjo.
Use of Optimark is not recommended in children less than 2 years of age because the safety, efficacy, and impact of immature kidney function have not been studied in this age group.
Optimark ni priporočena pri otrocih, mlajših od dveh let, saj varnosti, učinkovitosti in vpliva na delovanje nerazvitih ledvic pri tej starostni skupini niso raziskovali.
Gadoversetamide has been shown to cause interference in the measurement of serum calcium using the ortho-cresolphthalein complexone (OCP) colorimetric method.
Pokazalo se je, da gadoversetamid povzroča motnje pri merjenju kalcija v serumu s kolorimetrično metodo s kompleksonom orto-krezolftaleina (OCP).
Cases of gadolinium associated skin plaques, with demonstrated sclerotic bodies on histology, have been reported with some gadolinium-containing contrast agents in patients who do not otherwise have symptoms or signs of nephrogenic systemic fibrosis.
Pri nekaterih kontrastnih sredstvih, ki vsebujejo gadolinij, so pri bolnikih, ki drugače nimajo simptomov ali znakov nefrogene sistemske fibroze, poročali o primerih z gadolinijem povezanih kožnih plakov s histološkimi dokazi skleroznih teles.
Solution for injection in pre-filled syringe 10 ml (1, 10 syringes)
raztopina za injiciranje v napolnjeni injekcijski brizgi 10 ml (1, 10 brizg)
• in patients with severe renal impairment (GFR <30ml/min/1.73m2) and/or acute kidney injury,
• pri bolnikih s hudo ledvično okvaro (GFR < 30 ml/min/1,73m²) in/ali akutno poškodbo ledvic,
Treatment should be symptomatic and immediate access to necessary medicinal products and emergency equipment should be available should a serious event occur.
Če pride do resnega neželenega učinka, mora biti zdravljenje simptomatsko, na voljo pa morajo biti nujna zdravila in oprema za nujno ukrepanje.
It is used in adult patients and children of two years and older, who are undergoing magnetic resonance imaging (MRI), a type of scan where images of the internal organs are taken.
Uporablja se pri odraslih in otrocih, starih dve leti ali več, ki bodo slikani z magnetno resonanco (MR).
• you have recently had, or soon expect to have, a liver transplant
• če so vam pred kratkim presadili jetra ali vam jih v kratkem bodo;
Solution for injection in vial 10 ml (1, 10 vials)
raztopina za injiciranje v viali 10 ml (1, 10 vial)
Optimark can be removed using dialysis.
Zdravilo Optimark je mogoče odstraniti iz krvi z dializo.
After screwing the push rod into the syringe piston, it is important to turn the push rod an additional ½ turn so that the grey piston rotates freely
Ko palico za potiskanje navijete na bat brizge, morate palico za potiskanje zaviti še za polovico obrata, tako da se sivi bat prosto obrača.
Most of the adverse reactions were of mild to moderate intensity and transient in nature.
Neželeni učinki so bili večinoma blagi do zmerni in prehodni.
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.
Vidnost hipo- in 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.
• The other ingredients are: versetamide, calcium hydroxide, calcium chloride dihydrate, sodium hydroxide and/or hydrochloric acid, water for injections.
• Druge sestavine zdravila so: versetamid, kalcijev hidroksid, kalcijev klorid dihidrat, natrijev hidroksid in/ali klorovodikova kislina, voda za injekcije.
Assembly and Inspection
Sestava in pregled:
30 ml of the solution contain 43.13 mg sodium.
30 ml raztopine vsebuje 43,13 mg natrija.
Syringe is now ready for needle or infusion tubing attachment.
Na brizgo lahko sedaj namestite iglo ali cev za infundiranje.
Skin and Subcutaneous Tissue Disorders
Bolezni kože in podkožja
How to store Optimark
Kako se daje zdravilo Optimark
< 30ml/min/1.73 m2) and/or acute kidney injury, in
30 ml/min/1,73m2) in/ali akutno poškodbo ledvic,
Pre-filled syringe Solution for injection in pre-filled syringe.
Napolnjena injekcijska brizga raztopina za injiciranje v napolnjeni injekcijski brizgi
Contents of the pack and other information
Shranjevanje zdravila Optimark Vsebina pakiranja in dodatne informacije
Respiratory, Thoracic and Mediastinal Disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora
Prior to administration of Optimark, all patients should be screened for renal dysfunction by obtaining laboratory tests.
Bolniki z okvarjenim delovanjem ledvic Pred apliciranjem zdravila Optimark je treba pri vseh bolnikih z laboratorijskimi preiskavami ugotoviti morebitno ledvično disfunkcijo.
Optimark pre-filled syringes are supplied in the following package sizes: 1 x 10 ml 10 x 10 ml
Napolnjene brizge zdravila Optimark so na voljo v naslednjih velikostih pakiranja: 1 x 10 ml
Very rare (may affect up to 1 in 10,000 people)
Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):
In cranial MRI, if a strong clinical suspicion of a lesion persists despite a single dose contrastenhanced MRI or when more accurate information on the number, size or extent of lesions might influence management or therapy of the patient, in subjects with normal renal function, a second bolus injection of 0.2 ml/kg (100 micromol/kg) may be administered within 30 minutes of the first injection as it may increase the diagnostic yield of the examination.
Pri magnetnoresonančnem slikanju lobanje se lahko, če močan klinični sum na lezijo ne izgine kljub enkratnem odmerku kontrastnega sredstva ali kadar lahko natančnejša informacija o številu, velikosti ali obsegu lezij vpliva na obravnavanje ali zdravljenje bolnika, pri osebah z normalnim delovanjem ledvic v 30 minutah po prvem injiciranju uporabi druga bolusna injekcija z odmerkom 0,2 ml/kg
Caution should be exercised because transient decreases in serum iron and zinc parameters have been observed in clinical trials.
V kliničnih preskušanjih so opazili prehodno znižanje parametrov železa in cinka, zato je treba biti previden.
Vial Solution for injection in vial.
Viala raztopina za injiciranje v viali
Optimark is supplied in vials, fitted with bromobutyl rubber closures and aluminium cap seals.
Zdravilo Optimark je na voljo v vialah, na katerih so pokrovi iz bromobutilne gume in aluminijasta tesnila.
Nausea, Diarrhoea
Navzea, diareja
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.
Optimark vials are supplied in the following package sizes: 1 x 10 ml 10 x 10 ml
Viale zdravila Optimark so na voljo v naslednjih velikostih pakiranja: 1 x 10 ml
Salivary hypersecretion,, Abdominal pain, Constipation, Dry mouth
Prekomerno izločanje sline, bolečina v trebuhu, obstipacija, suha usta
GENERAL CLASSIFICATION FOR SUPPLY Subject to medical prescription.
Predpisovanje in izdaja zdravila je le na recept.
Effect of Renal Impairment
Vpliv ledvične okvare:
20 ml of the solution contain 28.75 mg sodium.
20 ml raztopine vsebuje 28,75 mg natrija.
Rhinorrhoea, Throat tightness, Laryngeal/pharyngeal oedema, Pharyngitis, Rhinitis, Sneezing
Dispneja, disfonija, , rinoreja, stiskanje v grlu, bronhospazem, kašelj, edem larinksa/farinksa, faringitis, rinitis,
Pruritus, Rash
Pruritus, izpuščaj
Headache, Dysgeusia
Glavoboli, disgevzija
• you suffer from epilepsy or brain lesions
• imate epilepsijo ali lezije v možganih; • ste na dieti z malo natrija
The following adverse reactions have been reported from clinical trials and from post-marketing use of gadoversetamide.
V kliničnih preskušanjih in ob uporabi gadoversetamida v obdobju trženja so poročali o naslednjih neželenih učinkih.
• in patients who have had liver transplantation or
• pri bolnikih, pri katerih so opravili presaditev jeter ali
Breast-feeding should be discontinued for at least 24 hours after the administration of Optimark.
Po uporabi zdravila Optimark je treba prenehati z dojenjem za vsaj 24 ur.
General Disorders and Administration Site Conditions
Splošne težave in spremembe na mestu aplikacije
As a result, these agents have been referred to as markers for sites of abnormal BBB breakdown.
Zato so ta sredstva označevalci mest nenormalnega razkroja krvno-možganske pregrade.
No dose adjustment is considered necessary in children more than 2 years of age.
Prilagoditev odmerka pri otrocih, starih več kot 2 leti, ni potrebna.
Vial 20 ml of the solution contain 28.75 mg sodium.
Viala 20 ml raztopine vsebuje 28,75 mg natrija.
Metabolism and Nutrition Disorders
Presnovne in prehranske motnje
Nonclinical data did not reveal special hazards for humans based on conventional studies of reproductive toxicity.
Predklinični podatki na osnovi običajnih študij vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
If you get any side effects, talk to your doctor or pharmacist.
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, ali s farmacevtom.
The mean plasma clearance of gadoversetamide in healthy subjects (111.0 ± 14.1 ml/min/1.73m² BSA) is not significantly different from the mean renal clearance.
Povprečen plazemski očistek gadoversetamida pri zdravih prostovoljcih (111,0 ± 14,1 ml/min/1,73m²
Optimark is filled in pre-filled syringes made of polypropylene.
Zdravilo Optimark je pakirano v polnjene injekcijske brizge iz polipropilena.
Optimark injections should not be repeated unless the interval between injections is at least 7 days.
Ponovno injiciranje zdravila Optimark je dovoljeno šele po poteku vsaj 7 dni.
Acute toxicity symptoms are unlikely to occur in patients with normal renal function.
Pri bolnikih z normalnim delovanjem ledvic ni verjetno, da bi prišlo do simptomov akutne toksičnosti.
The peel-off tracking label on the vials should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used.
Odluščljivo sledilno oznako na vialah pritrdite na kartoteko bolnika, da zagotovite natančno evidentiranje uporabljenega kontrastnega sredstva z gadolinijem.
Allergoid and other idiosyncratic reactions also may occur with gadoversetamide, which could become manifest in form of cardiovascular, respiratory and skin reactions.
Alergoidne in druge idiosinkratične reakcije se lahko pojavijo tudi pri gadoversetamidu.
Prior to using the syringe, twist off grey tip cap and discard.
Pred uporabo brizge odvijte sivo zaporko konice in jo zavrzite.
Each 30 ml syringe contains 9927 mg gadoversetamide.
Ena 30 ml injekcijska brizga vsebuje 9.927 mg gadoversetamida.
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
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 dveh skupinah odraslih (82,1 ± 16,8 ml/h/kg pri starostni skupini od 19 do 64 let in 56,5 ± 9,7 ml/h/kg pri starostni skupini ≥ 65 let).
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).
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).
Each 15 ml vial contains 4963.5 mg gadoversetamide.
Ena 15 ml viala vsebuje 4.963,5 mg gadoversetamida.
15 ml (1, 10 vials)
15 ml (1, 10 vial)
The peel-off tracking label on the pre-filled syringes should be stuck onto the patients record to enable accurate recording of the gadolinium contrast agent used.
Odluščljivo sledilno oznako na napolnjenih injekcijskih brizgah pritrdite na kartoteko bolnika, da zagotovite natančno evidentiranje uporabljenega kontrastnega sredstva z gadolinijem.
Pre-filled syringes:
Napolnjene injekcijske brizge:
Each 30 ml syringe contains 9927 mg gadoversetamide equivalent to 15 millimol.
Ena 30 ml injekcijska brizga vsebuje 9.927 mg gadoversetamida, kar ustreza 15 milimolom.
Vomiting
Bruhanje
Each 10 ml vial contains 3309 mg gadoversetamide.
Ena 10 ml viala vsebuje 3.309 mg gadoversetamida.
Each 20 ml vial contains 6618 mg gadoversetamide equivalent to 10 millimol.
Ena 20 ml viala vsebuje 6.618 mg gadoversetamida, kar ustreza 10 milimolom.
20 ml (1, 10 vials)
20 ml (1, 10 vial)
• to any of the other ingredients of Optimark (see section 6), or
• katero koli sestavino zdravila Optimark (glejte poglavje 6) ali • na druga kontrastna sredstva, ki vsebujejo gadolinij.
Each 20 ml vial contains 6618 mg gadoversetamide.
Ena 20 ml viala vsebuje 6.618 mg gadoversetamida.
Each 15 ml vial contains 4963.5 mg gadoversetamide equivalent to 7.5 millimol.
Ena 15 ml viala vsebuje 4.963,5 mg gadoversetamida, kar ustreza 7,5 milimolom.
- If you get any side effects talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
Rare (may affect up to 1 in 1000 people)
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
As with any paramagnetic contrast agent, enhancement of MRI with Optimark may impair the visualization of existing lesions.
Posebna opozorila in previdnostni ukrepi Kot pri vseh drugih paramagnetnih kontrastnih sredstvih lahko krepitev kontrasta pri magnetnoresonančnem slikanju z zdravilom Optimark okvari vidnost obstoječih lezij.
NAME OF THE MEDICINAL PRODUCT Optimark 500 micromol/ml solution for injection in pre-filled syringe Optimark 500 micromol/ml solution for injection in vial
Optimark 500 mikromolov/ml raztopina za injiciranje v napolnjeni injekcijski brizgi Optimark 500 mikromolov/ml raztopina za injiciranje v viali
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Text for the outer packaging of 10 ml, 15 ml and 20 ml vials
PODATKI NA ZUNANJI OVOJNINI Besedilo za zunanjo ovojnino za 10-, 15- in 20-mililitrske viale
The risk for development of NSF in patients with moderate renal impairment (GFR 30-59 ml/min/1.73 m2) is unknown; therefore, Optimark should only be used after careful risk-benefit evaluation in patients with moderate renal impairment.
Tveganje za nastanek NSF pri bolnikih z zmerno okvaro ledvic (GFR 30-59 ml/min/1,73 m2) ni znano; zato je treba zdravilo Optimark pri bolnikih z zmerno okvaro ledvic uporabljati le po skrbni analizi koristi in tveganj.
SPECIAL STORAGE CONDITIONS Keep the syringe in the outer carton in order to protect from light.
POSEBNA NAVODILA ZA SHRANJEVANJE Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Text for the outer packaging of 10 ml, 15 ml, 20 ml and 30 ml pre-filled syringes
PODATKI NA ZUNANJI OVOJNINI Besedilo za zunanjo ovojnino za 10-, 15-, 20- in 30-mililitrske napolnjene injekcijske brizge
Confusion and disorientation
Anksioznost, motnje spanja, zmedenost in dezorientacija
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Text for the immediate packaging of 15 ml, 20 ml and 30 ml pre-filled syringes
PODATKI NA PRIMARNI OVOJNINI Besedilo za primarno ovojnino za 15-, 20- in 30-mililitrske napolnjene injekcijske brizge
Breast-feeding should be discontinued for at least 24 hours after you receive Optimark.
Po tem, ko prejmete zdravilo Optimark, je treba prenehati z dojenjem za vsaj 24 ur.
Optimark is supplied in pre-filled syringes made of polypropylene.
Zdravilo Optimark je na voljo v polnjenih injekcijskih brizgah iz polipropilena.
30 ml (1, 10 syringes)
30 ml (1, 10 brizg)
Final Study Report:
Za elektronske kartoteke:
Optimark has been studied in children of 2 years and older with a similar safety profile as shown in the adult population.
Varnostni profil je bil podoben kot pri odrasli populaciji.
Optimark 500 micromol/ml solution for injection in vial Gadoversetamide
Optimark 500 mikromolov/ml raztopina za injiciranje v viali gadoversetamid
Each 15 ml syringe contains 4963.5 mg gadoversetamide equivalent to 7.5 millimol.
Ena 15 ml injekcijska brizga vsebuje 4.963,5 mg gadoversetamida, kar ustreza 7,5 milimolom.
Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period (see section 4.3).
Zdravilo Optimark je kontraindicirano pri bolnikih s hudo ledvično okvaro (stopnja glumeralne filtracije (GFR) < 30 ml/min/1,73 m²) in/ali akutno poškodbo ledvic in pri bolnikih, pri katerih so opravili presaditev jeter ali so v perioperativen obdobju presaditve jeter (glejte poglavje 4.3).
Each 20 ml syringe contains 6618 mg gadoversetamide equivalent to 10 millimol.
Ena 20 ml injekcijska brizga vsebuje 6.618 mg gadoversetamida, kar ustreza 10 milimolom.
Each 15 ml syringe contains 4963.5 mg gadoversetamide.
Ena 15 ml injekcijska brizga vsebuje 4.963,5 mg gadoversetamida.
Each 20 ml syringe contains 6618 mg gadoversetamide.
Ena 20 ml injekcijska brizga vsebuje 6.618 mg gadoversetamida.
Each 10 ml vial contains 3309 mg gadoversetamide equivalent to 5 millimol.
Ena 10 ml viala vsebuje 3.309 mg gadoversetamida, kar ustreza 5 milimolom.
15 ml (1, 10 syringes)
15 ml (1, 10 brizg)
20 ml (1, 10 syringes)
20 ml (1, 10 brizg)
Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73 m²) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period.
Zdravilo Optimark je kontraindicirano pri bolnikih s hudo ledvično okvaro (stopnja glumeralne filtracije (GFR) < 30 ml/min/1,73 m²) in/ali akutno poškodbo ledvic in pri bolnikih, pri katerih so opravili presaditev jeter ali so v perioperativen obdobju presaditve jeter.
Sodium hydroxide and/or hydrochloric acid for pH adjustment Water for injections
6.1 Seznam pomožnih snovi versetamid kalcijev hidroksid kalcijev klorid dihidrat natrijev hidroksid in/ali klorovodikova kislina za uravnavanje pH voda za injekcije
Each 10 ml syringe contains 3309 mg gadoversetamide.
Ena 10 ml injekcijska brizga vsebuje 3.309 mg gadoversetamida.
Optimark 500 micromol/ml solution for injection in pre-filled syringe Gadoversetamide
Optimark 500 mikromolov/ml raztopina za injiciranje v napolnjeni injekcijski brizgi gadoversetamid
Higher doses contain 1 mmol sodium or more, which should be taken into consideration for patients on a controlled sodium diet.
Večji odmerki vsebujejo 1 mmol natrija ali več.
Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period.
Zdravilo Optimark je kontraindicirano pri bolnikih s hudo ledvično okvaro (stopnja glumeralne filtracije (GFR) < 30 ml/min/1,73 m2) in/ali akutno poškodbo ledvic in pri bolnikih, pri katerih so opravili presaditev jeter ali so v perioperativen obdobju presaditve jeter.
1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
1 ml vsebuje 330,9 mg gadoversetamida, kar ustreza 500 mikromolom.
Pre-filled syringe
Žilne bolezni
Hypoaesthesia, Paraesthesia, Parosmia
Omotica, hipestezija, parestezija, parozmija
Do not use Optimark if you are allergic
Kaj morate vedeti, preden vam bodo dali zdravilo Optimark Ne uporabljajte zdravila Optimark če ste alergični na: • zdravilno učinkovino gadoversetamid ali
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Optimark 500 micromol/ml solution for injection in pre-filled syringe Gadoversetamide
IME ZDRAVILA IN POT(I) UPORABE Optimark 500 mikromolov/ml raztopina za injiciranje v napolnjeni injekcijski brizgi gadoversetamid i.v.
Vial 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Viala 1 ml vsebuje 330,9 mg gadoversetamida, kar ustreza 500 mikromolom.
Optimark must not be administered with an autoinjector to children of 2 to 11 years.
Otrokom, starih od 2 do 11 let, se zdravila Optimark ne sme dati z avtoinjektorjem.
Ear and Labyrinth Disorders
vključno z motnjami labirinta
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Optimark 500 micromol/ml solution for injection in vial Gadoversetamide
IME ZDRAVILA IN POT(I) UPORABE Optimark 500 mikromolov/ml raztopina za injiciranje v viali gadoversetamid i.v.
Chills, Pain, Face oedema, Asthenic conditions including asthenia, fatigue, and malaise, Fever, Oedema peripheral,
Mrzlica, bolečina, ,edem obraza, astenična stanja vključno z astenijo,
Insertion of a flexible in-dwelling venous catheter is recommended, see section 4.4.
Priporoča se vstavitev prožnega stalnega venskega katetra,
Cardiac Disorders
Srčne bolezni
As with any paramagnetic contrast agent, enhancement of MRI with gadoversetamide may impair the visualization of existing lesions.
4.4 Posebna opozorila in previdnostni ukrepi Kot pri vseh drugih paramagnetnih kontrastnih sredstvih lahko krepitev kontrasta pri magnetnoresonančnem slikanju z gadoversetamidom okvari vidnost obstoječih lezij.
Frequency Common (may affect up to 1 in 10 people)
Pogosti (pojavijo se lahko pri največ 1 od
Each 10 ml syringe contains 3309 mg gadoversetamide equivalent to 5 millimol.
Ena 10 ml injekcijska brizga vsebuje 3.309 mg gadoversetamida, kar ustreza 5 milimolom.
Optimark should only be used after careful risk/benefit evaluation in patients with moderate renal impairment (GFR 30-59 ml/min/1.73 m2) at a dose not exceeding 100 micromol/kg body weight.
Pri bolnikih z zmerno ledvično okvaro (GFR 30-59 ml/min/1,73 m2) je uporaba zdravila Optimark dovoljena le po skrbni oceni razmerja med tveganjem in koristmi pri odmerku, ki ne preseže 100 mikromolov/kg telesne mase.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Text for the immediate packaging of 15 ml and 20 ml vials
PODATKI NA PRIMARNI OVOJNINI Besedilo za primarno ovojnino za 15-, in 20-mililitrske viale
Calcium hydroxide
Tinitus, vertigo