natgillin/translations-raw huggingface dataset:
* produced in Madin Darby Canine Kidney (MDCK) cells (this is influenza virus is grown) ** haemagglutinin
* razmnoženi v celicah pasjih ledvic Madin Darby (MDCK) (to je posebna virus gripe) ** hemaglutinin
the special cell culture in which the
celična kultura, v kateri se goji
The other ingredients are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Pomožne snovi so: natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, natrijev hidrogenfosfat dihidrat, kalijev dihidrogenfosfat in voda za injekcije.
What Optaflu looks like and contents of the pack Optaflu is a suspension for injection in a pre-filled syringe (ready-to-use syringe).
Izgled cepiva Optaflu in vsebina pakiranja Cepivo Optaflu je suspenzija za injiciranje v napolnjeni injekcijski brizgi (brizga, pripravljena za uporabo).
A single syringe contains 0.5 ml of suspension for injection.
Posamezna brizga vsebuje 0, 5 ml suspenzije za injiciranje.
Pack sizes of 1, 10 or 20 (2 x 10), each with or without needle are available.
Na voljo so velikosti pakiranj po 1, 10 ali 20 (2 x 10) brizg, z iglo ali brez nje.
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What is OptiMARK?
Kaj je zdravilo OptiMARK?
OptiMARK is a solution for injection that contains the active substance gadoversetamide.
Zdravilo OptiMARK je raztopina za injiciranje, ki vsebuje zdravilno učinkovino gadoversetamid.
It is available in a pre-filled syringe and in a vial (500 micromoles per millilitre).
Na voljo je v predhodno napolnjeni brizgi in viali (500 mikromolov na mililiter).
What is OptiMARK used for?
Za kaj se zdravilo OptiMARK uporablja?
OptiMARK is for diagnostic use.
Zdravilo OptiMARK je namenjeno diagnostični uporabi.
It is used in patients who are undergoing magnetic resonance imaging (MRI), a special type of scan where images of the internal organs are taken.
Uporablja se pri bolnikih, pri katerih se izvaja magnetnoresonančno slikanje (MRS), t. j. posebna vrsta slikanja notranjih organov.
OptiMARK is used to obtain a clearer scan in patients who have, or are thought to have abnormalities in the brain, spine or liver.
Zdravilo OptiMARK se uporablja za doseganje jasnejše slike pri bolnikih z znanimi ali domnevanimi nenormalnostmi v možganih, hrbtenjači ali jetrih.
How is OptiMARK used?
Kako se zdravilo OptiMARK uporablja?
OptiMARK should only be given by a doctor who has experience in using MRI.
Zdravilo OptiMARK sme dajati samo zdravnik, ki ima izkušnje z uporabo MRS.
It is given as an intravenous injection (into a vein) of 100 micromoles per kilogram body weight.
Daje se kot intravenska injekcija (v veno) 100 mikromolov na kilogram telesne mase.
OptiMARK allows images to be taken for up to an hour, although the best time to take a scan after injection depends on the location and type of abnormality that is being examined.
Zdravilo OptiMARK omogoča izvajanje slikanja največ eno uro po injekciji, čeprav je najboljši čas za slikanje odvisen od predela in vrste obravnavane nenormalnosti.
When looking at certain abnormalities in the brain, OptiMARK may need to be used at a higher dose, or the dose may need to be repeated.
Pri preučevanju določenih nenormalnosti v možganih utegne biti potrebno uporabiti večji odmerek zdravila OptiMARK ali pa odmerek ponoviti.
OptiMARK is not recommended for use in children below 2 years of age, because of a lack of information on safety and effectiveness in this group.
Uporaba zdravila OptiMARK pri otrocih, mlajših od 2 let, zaradi pomanjkanja informacij o varnosti in učinkovitosti v tej skupini ni priporočljiva.
How does OptiMARK work?
Kako zdravilo OptiMARK deluje?
The active substance in OptiMARK, gadoversetamide, contains gadolinium, a ‘ rare earth’ metal element.
Zdravilna učinkovina zdravila OptiMARK, gadoversetamid, vsebuje redko kovino gadolinij.
Gadolinium is used as a ‘ contrast enhancer’ to help obtain better images with MRI scans.
Gadolinij se uporablja kot sredstvo za povečanje kontrasta, kar zagotavlja boljše slike, izdelane z MRS.
MRI is an imaging method that relies on the tiny magnetic fields produced by water molecules in the body.
MRS je metoda slikanja, ki temelji na majhnih magnetnih poljih, ki jih ustvarijo vodne molekule v telesu.
Once injected, gadolinium interacts with the water molecules.
Gadolinij stopa po injiciranju v interakcijo z vodnimi molekulami.
As a result of this interaction, the water molecules give a stronger signal, and this helps to obtain a brighter picture.
Zaradi te interakcije dajejo vodne molekule močnejši signal, to pa vodi do jasnejše slike.
In OptiMARK, the gadolinium is bound to another chemical in a ‘ chelate ’ (a type of chemical) so that the metal is not released in the body but stays ‘ trapped’ in the chelate until it is eliminated from the body in the urine.
V zdravilu OptiMARK je gadolinij vezan na drugo kemično snov v „ kelat “ (vrsto kemične snovi), tako da se kovina ne sprošča v telo, ampak ostane v kelatu, dokler se z urinom ne izloči iz telesa.
How has OptiMARK been studied?
Kako je bilo zdravilo OptiMARK raziskano?
The effects of OptiMARK were first tested in experimental models before being studied in humans.
Učinki zdravila OptiMARK so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged studies in 403 patients).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Zdravilo OptiMARK so preučevali v štirih glavnih študijah s skupno 804 odraslimi z znanimi ali domnevami nenormalnostmi v možganih ali hrbtenjači (dve študiji s skupaj 401 bolnikom) ali jetrih (dve študiji s skupaj 403 bolniki).
In all studies, the effects of OptiMARK were compared with those of gadopentetate dimeglumine (another contrast agent containing gadolinium).
V vseh študijah so učinke zdravila OptiMARK primerjali z učinki gadopentetat dimeglumina (drugega kontrastnega sredstva, ki vsebuje gadolinij).
The main measure of effectiveness was the difference in the ability to see the abnormalities on MRI scans taken with and without the contrast agent.
Glavno merilo učinkovitosti je bila razlika v vidnosti nenormalnosti na MRS slikah, posnetih s kontrastnim sredstvom oziroma brez njega.
Each scan’ s clarity was scored on a four-point scale.
Jasnost vsake slike je bila ocenjena s štiristopenjsko lestvico.
The scans were analysed by three radiologists (specialised physicians) who did not know what treatment the patient had received beforehand, to make sure the findings were as accurate as possible.
Da bi pridobili čim bolj točne rezultate, so slike analizirali trije radiologi (specializirani zdravniki), ki niso vedeli, kakšna zdravila je bolnik predhodno prejemal.
What benefit has OptiMARK shown during the studies?
Kakšne koristi je zdravilo OptiMARK izkazalo med raziskavami?
In all studies, OptiMARK was as effective as the comparator contrast agent in improving the ability to see abnormalities on the scans.
Zdravilo OptiMARK je bilo pri izboljšanju vidnosti nenormalnosti na slikah v vseh študijah enako učinkovito kot primerjalno kontrastno sredstvo.
Both medicines were associated with similar improvements in the score given to the scans.
Obe zdravili sta podobno izboljšali oceno, pripisano slikam.
In the two studies of brain and spine abnormalities taken together, scans taken with OptiMARK had a score increase of 0.63 points on average (from a ‘ baseline ’ of 1.58 points without OptiMARK).
V dveh študijah nenormalnosti v možganih in hrbtenjači je bilo na slikah, posnetih ob jemanju zdravila OptiMARK, doseženo povprečno izboljšanje rezultata za 0, 63 točke (izhodiščna vrednost brez zdravila OptiMARK je bila 1, 58 točke).
This compared with a very similar increase of 0.66 points with the comparator contrast agent, from a baseline of 1.60 points.
Pri primerjalnem kontrastnem sredstvu je bilo opaženo zelo podobno izboljšanje za 0, 66 točke, pri čemer je bila izhodiščna vrednost 1, 60 točke.
In the studies of liver abnormalities, both medicines increased the score by an average of 0.38 points from a baseline of 1.82 points.
V raziskavah nenormalnosti v jetrih sta obe zdravili izboljšali rezultat za povprečno 0, 38 točke, gledano od izhodiščne vrednosti 1, 82 točke.
What is the risk associated with OptiMARK?
Kakšna tveganja so povezana z zdravilom OptiMARK?
The most common side effects with OptiMARK (seen in between 1 and 10 patients in 100) are dizziness, headaches, dysgeusia (taste disturbances) and feeling hot.
Najpogostejši neželeni učinki zdravila OptiMARK (opaženi pri 1 do 10 bolnikih izmed 100) so omotica, glavobol, disgevzija (popačenje okusa) in občutek vročine.
For the full list of all side effects reported with OptiMARK, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila OptiMARK, glejte Navodilo za uporabo.
OptiMARK should not be used in people who may be hypersensitive (allergic) to gadoversetamide, any of the other ingredients or other medicines containing gadolinium.
Zdravilo OptiMARK ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) gadoversetamid, katero koli drugo sestavino zdravila ali druga zdravila, ki vsebuje gadolinij.
It should also not be used in patients who have severe problems with their kidneys or in liver transplant patients, due to a risk of a condition called nephrogenic systemic fibrosis (NSF), which causes thickening of the skin and connective tissues.
Prav tako zdravila ne smejo uporabljati bolniki, ki imajo hude težave z ledvicami, ali bolniki s presaditvijo jeter, ker obstaja tveganje nefrogene sistemske fibroze (NSF), ki povzroča odebelitev kože in vezivnih tkiv.
Why has OptiMARK been approved?
Zakaj je bilo zdravilo OptiMARK odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that OptiMARK’ s benefits are greater than its risks for use with MRI of the central nervous system and liver.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila OptiMARK za uporabo pri magnetnoresonančnem slikanju centralnega živčnega sistema in jeter večje od z njim povezanih tveganj.
The Committee recommended that OptiMARK be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo OptiMARK odobri dovoljenje za promet.
Other information about OptiMARK:
Druge informacije o zdravilu OptiMARK:
The European Commission granted a marketing authorisation valid throughout the European Union for OptiMARK to Tyco Healthcare Deutschland GmbH on 23 July 2007.
Evropska komisija je dovoljenje za promet z zdravilom OptiMARK, veljavno po vsej Evropski uniji, odobrila družbi Tyco Healthcare Deutschland GmbH dne 23. julija 2007.
The full EPAR for OptiMARK can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo OptiMARK je na voljo tukaj.
Solution for Injection
raztopina za Intravenska injiciranje uporaba
Vial (glass)
viala
Pre-filled syringe
napolnjena injekcijska brizga
10 pre-filled syringes
10 napolnjena injekcijska brizg
Optimark 500 micromol/ ml solution for injection in a pre-filled syringe
Optimark 500 mikromolov/ ml raztopina za injiciranje v napolnjeni injekcijski brizgi
1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
1 ml vsebuje 330, 9 mg gadoversetamida, kar ustreza 500 mikromolom.
Clear, colourless to pale yellow solution. pH:
raztopina za injiciranje Bistra, brezbarvna do bledo rumena raztopina. pH:
6.0 – 7.5 Osmolality (37°C):
6, 0– 7, 5 Osmolalnost (37 °C):
1000 – 1200 mOsm/ kg
1000– 1200 mOsm/ kg
It provides contrast enhancement and facilitates visualization and helps with the characterization of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology.
Omogoča krepitev kontrasta, izboljša prikaz in pomaga pri karakterizaciji fokalnih lezij in nenormalnih struktur v osrednjem živčevju in jetrih bolnikov z znano patologijo ali močnim sumom nanjo.
The agent should be administered as a bolus peripheral intravenous injection at a dose of 0.2 ml/ kg (100 micromol/ kg) body weight.
Sredstvo je treba uporabiti v obliki bolusne periferne intravenske injekcije z odmerkom 0, 2 ml/ kg (100 mikromolov/ kg) telesne mase.
To ensure complete injection of the contrast medium, the injection should be followed by a 5 ml flush of sodium chloride 9 mg/ ml (0.9%) injection.
Da se zagotovi popolno injiciranje kontrastnega sredstva, mora injiciranju slediti izpiranje z injiciranjem 5 ml 0, 9- odstotne raztopine natrijevega klorida (9 mg/ ml).
In cranial MRI, if a strong clinical suspicion of a lesion persists despite a single dose contrast- enhanced 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 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 100 mikromolov/ kg, ker lahko poveča diagnostični izkoristek pregleda.
The safety of repeat doses has not been established in children and adolescents, in patients with renal impairment, or the elderly.
Varnost ponavljajočih se odmerkov pri otrocih in mladostnikih, pri bolnikih z ledvično okvaro ali starejših bolnikih ni bila ugotovljena.
Limited data with other gadolinium contrast agents suggests that for the exclusion of additional cranial metastases in a patient with a known solitary resectable metastasis, an MR exam with the injection of the dose of 300 micromol/ kg body weight of Optimark may lead to higher diagnostic confidence.
Omejeni podatki z drugimi kontrastnimi sredstvi, ki vsebujejo gadolinij, kažejo, da lahko pri izločanju kranialnih metastaz pri bolnikih z znano posamezno resektabilno metastazo magnetnoresonančno slikanje z injiciranjem odmerka 300 mikromolov/ kg telesne mase zdravila Optimark poveča zanesljivost diagnoze.
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.
2 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.
Optimark has been studied in children of 2 years and older with a similar safety profile as shown in the adult population.
Pri tem je bil varnostni profil podoben kot pri odraslih.
The container and the solution should be inspected prior to use as described in section 6.6.
Vsebnik in raztopino je treba pred uporabo pregledati, kot je opisano v poglavju 6. 6.
2 Insertion of a flexible in-dwelling venous catheter is recommended, see section 4.4.
Priporoča se vstavitev prožnega stalnega venskega katetra, glejte poglavje 4. 4.
Hypersensitivity to gadoversetamide or to any of the excipients or to other gadolinium containing products.
Preobčutljivost za gadoversetamid ali katero koli pomožno snov ali na druga zdravila, ki vsebujejo gadolinij.
Optimark is contraindicated in patients with severe renal impairment (GFR < 30ml/ min/ 1.73m2), and those who have had or are undergoing liver transplantation (see section 4.4).
Zdravilo Optimark je kontraindicirano pri bolnikih s hudo ledvično okvaro (GFR < 30 ml/ min/ 1, 73m2) in pri bolnikih, pri katerih so opravili ali opravljajo presaditev jeter (glejte poglavje 4. 4).
The usual contraindications of MR examinations must be applied, such as exclusion of patients with infusion pumps, pacemakers, ferro-magnetic clips etc.
Treba je upoštevati običajne kontraindikacije za magnetnoresonančno slikanje, kot je izključitev bolnikov z infuzijskimi črpalkami, spodbujevalniki, sponkami iz feromagnetnih snovi itn.
 Hypersensitivity Allergoid and other idiosyncratic reactions may occur with all contrast media for intravenous application, also with gadoversetamide, which could become manifest in form of cardiovascular, respiratory and skin reactions (see section 4.8).
Te reakcije se lahko pokažejo v obliki kardiovaskularnih, respiratornih ali kožnih reakcij (glejte poglavje 4. 8).
To enable immediate action in emergencies, the necessary medicinal products (e. g. epinephrine/ adrenaline, theophylline, antihistamines, corticosteroids and atropines), endotracheal tube and ventilator must be immediately available.
Za takojšnje ukrepanje v nujnih primerih morajo biti na voljo nujna zdravila (npr. epinefrin/ adrenalin, teofilin, antihistaminiki, kortikosteroidi in atropini), endotrahealni tubus in respirator.
- patients with allergic predisposition
- bolnikih z nagnjenjem do alergij;
- patients with bronchial asthma; in these patients it is especially the risk of bronchospasm which is
- bolnikih z bronhialno astmo; pri teh bolnikih je zlasti povečano tveganje za pojav bronhospazmov;
- patients with a history of reactions to contrast agents, including a previous history of reaction to
- bolnikih z reakcijami na kontrastna sredstva v anamnezi, vključno z reakcijami na kontrastna
iodine-based contrast agents Before the injection of contrast media, patients should be asked whether they have any allergies (e. g. allergies to seafood or medicinal products, hay fever, urticaria), whether they are hypersensitive to contrast media and whether they have bronchial asthma.
Pred injiciranjem kontrastnega sredstva je treba bolnike vprašati, ali imajo kakršnekoli alergije (npr. alergije na morsko hrano ali zdravila, seneni nahod, urtikarijo) ali so preobčutljivi za kontrastna sredstva ali imajo bronhialno astmo.
Premedication with antihistamines and/ or glucocorticoids may be considered.  Patients taking beta-blockers It should be noted that patients using beta-blockers do not necessarily respond to the beta-agonists usually used for the treatment of hypersensitivity reactions.  Patients with cardiovascular disease In this group of patients hypersensitivity reactions may be severe.
Treba je pretehtati možnost predhodnega zdravljenja z antihistaminiki in/ ali glukokortikoidi.  Bolniki, ki jemljejo beta- blokatorje Treba je biti pozoren na to, da ni nujno, da se bolniki, ki uporabljajo beta- blokatorje, odzovejo na betaagoniste, ki se po navadi uporabljajo pri zdravljenju preobčutljivostnih reakcij.  Bolniki s kardiovaskularnimi boleznimi Pri tej skupini bolnikov so lahko preobčutljivostne reakcije hude.
Especially in patients with serious heart diseases (e. g. severe heart failure, coronary artery disease) cardiovascular reactions may deteriorate.
Kardiovaskularne reakcije se lahko poslabšajo zlasti pri bolnikih z resnimi srčnimi boleznimi (npr. hudo srčno popuščanje, koronarna srčna bolezen).
However, these were not evident from clinical trials with Optimark.  Central nervous system disorders In patients suffering from epilepsy or brain lesions the likelihood of convulsions during the examination may be increased.
Vendar pa teh reakcij v kliničnih preskušanjih zdravila Optimark ni bilo.  Bolezni osrednjega živčevja
3  Renal impairment and liver transplant patients There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with severe renal impairment (GFR < 30ml/ min/ 1.73m2) and those who have had or are undergoing liver transplantation.
Pri pregledu teh bolnikov je treba biti previden (npr. bolnika nadzorovati), na voljo pa morajo biti oprema in zdravila za hitro zdravljenje morebitnih konvulzij.  Ledvična okvara in bolniki, pri katerih so opravili presaditev jeter Pri bolnikih s hudo ledvično okvaro (GFR < 30 ml/ min/ 1, 73m2) in pri bolnikih, pri katerih opravljajo presaditev jeter, so poročali o nefrogeni sistemski fibrozi (NSF), povezani z uporabo nekaterih kontrastnih sredstev, ki vsebujejo gadolinij.
Therefore Optimark should not be used in these populations (see section 4.3).
Zato se zdravilo Optimark pri teh skupinah bolnikov ne sme uporabljati (glejte poglavje 4. 3).
Optimark should be used in these patients with caution.
Pri bolnikih z zmerno ledvično okvaro (GFR < 60 ml/ min/ 1, 73m2) so tudi poročali o primerih NSF pri uporabi kontrastnih sredstev, ki vsebujejo gadolinij, zato je treba pri teh bolnikih zdravilo Optimark uporabljati previdno.
Haemodialysis shortly after Optimark administration in patients currently receiving haemodialysis may be useful at removing Optimark from the body.
Hemodializa kmalu po uporabi zdravila Optimark pri bolnikih, ki so trenutno na hemodializi, je lahko uporabna pri odstranjevanju zdravila Optimark iz telesa.
There is no evidence to support the initiation of haemodialysis for prevention or treatment of NSF in patients not already undergoing haemodialysis.  Children Optimark must not be administered with an autoinjector.
Ni dokazov, ki podpirajo uporabo hemodialize za preprečevanje ali zdravljenje NSF pri bolnikih, ki niso na hemodializi.  Otroci Zdravilo Optimark se ne sme dajati z avtoinjektorjem.
The required dose should be administered by hand to children to avoid overdosage by mistake.  Neonates and infants Optimark should not be used in children below the age of two years.
Otrokom je treba potrebni odmerek injicirati ročno, da se tako prepreči nenamerno preveliko odmerjanje.  Novorojenčki in dojenčki Zdravilo Optimark se ne sme uporabljati pri otrocih, mlajših od dveh let.
Safety and efficacy have not been studied in this age group.  Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose of up to 17 ml, i. e. essentially ‘ sodium- free’.
Varnosti in učinkovitosti v tej starostni skupini niso raziskovali.  Natrij 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 should be taken into consideration for patients on a controlled sodium diet.  Serum iron and zinc Caution should be exercised because transient decreases in serum iron and zinc parameters have been observed in clinical trials.
Večji odmerki vsebujejo 1 mmol natrija ali več, kar je treba upoštevati pri bolnikih, ki so na dieti z malo natrija.  Železo in cink v serumu V kliničnih preskušanjih so opazili prehodno znižanje parametrov železa in cinka, zato je treba biti previden.
Optimark has been shown to cause interference in the measurement of serum calcium using the ortho- cresolphthalein complexone (OCP) colorimetric method.
Pokazalo se je, da zdravilo Optimark povzroča motnje pri merjenju kalcija v serumu s kolorimetrično metodo s kompleksonom orto- krezolftaleina (OCP).
4.6 Pregnancy and Lactation
4. 6 Nosečnost in dojenje
There is no clinical experience with the use of gadoversetamide during pregnancy.
Kliničnih izkušenj z uporabo gadoversetamida med nosečnostjo ni.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive na sposobnost razmnoževanja (glejte poglavje 5. 3).
Optimark should not be used during pregnancy except in cases where a contrast enhanced MR scan is determined to be critical, with no acceptable alternative imaging examination.
Zdravila Optimark ne smete uporabljati med nosečnostjo, razen kadar je kontrastno okrepljeno slikanje MRI nujno, druge sprejemljive metode slikanja pa ni.
The degree of excretion of gadoversetamide in breast milk has not been studied in humans.
Stopnje izločanja gadoversetamida v materino mleko pri človeku niso raziskovali.