natgillin/translations-raw huggingface dataset:
Solution For Injection Intramuscular Use | Intrathecal Use | Intravenous Injection
Otopina za injekciju Intramuskularna primjena | Supkutana primjena
Intraarterial Use | Intravenous Use
Intraarterijska primjena
Metotrexato Cipla Methotrexate 2.5mg Tablet
Metotrexato Cipla Metotreksat 2,5mg Tablet
Solution For Injection Subcutaneous Use
Otopina za injekciju Supkutana primjena
Solution For Injection Intravenous Use
Otopina za injekciju Intravenska primjena
Methotrexate Cipla Methotrexate 2.5mg Tablet
Methotrexate Cipla Metotreksat 2,5mg Tablet
Methotrexate 0.15ml/7.5mg
Metotreksat 0,15ml/7,,5mg
Methotrexate 7.5mg Tablet
Metotreksat 7,5mg Tablet
Intramuscular Use | Intravenous Use | Subcutaneous Use
| Intravenska primjena | Primjena kroz usta | Supkutana primjena
Methotrexate Disodium 7.5mg Tablet
Metotreksat Disodium 7,5mg Tablet
Methotrexate 2.5mg Tablet
Metotreksat 2,5mg Tablet
Methotrexate Teva Methotrexate 25mg/Ml
Methotrexate Teva Metotreksat 25mg/Ml
Metotressato Teva Methotrexate 25mg/Ml
Metotressato Teva Metotreksat 25mg/Ml
Methotrexat Ebewe Methotrexate 5mg Tablet
Methotrexat Ebewe Metotreksat 5mg Tablet Tableta
Metotreksat Ebewe Methotrexate 100mg/Ml Concentrate For Solution For Infusion
Metotrexato Accord Metotreksat 500mg/5ml Koncentrat za otopinu za infuziju
Methotrexate 10mg Tablet
Metotreksat 10mg Tablet
Methotrexaat Teva Methotrexate 25mg/Ml
Methotrexaat Teva Metotreksat 25mg/Ml
12.5 mg Solution for injection pre-filled syringe (glass) in pre-filled pen
Metotreksat 15mg/30ml Otopina za injekciju u napunjenoj štrcaljki
Intravenous Use
| Intravenska primjena
Methotrexate 5mg Tablet
Metotreksat 5mg Tablet Tableta
Methotrexate 100mg/Ml Concentrate For Solution For Infusion
Metotreksat 500mg/5ml Koncentrat za otopinu za infuziju
Accord Healthcare Limited Methotrexat Accord Methotrexate 50mg/2ml
Accord Healthcare Limited Methotrexat Accord Metotreksat 50mg/2ml
Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/10ml
Accord Healthcare Limited Methotrexat Accord Metotreksat 1000mg/10ml
Accord Healthcare Limited Methotrexat Accord Methotrexate 1000mg/40ml
Accord Healthcare Limited Methotrexat Accord Metotreksat 1000mg/40ml
Accord Healthcare Limited Methotrexat Accord Methotrexate 5000mg/50ml
Accord Healthcare Limited Methotrexat Accord Metotreksat 5000mg/50ml
Accord Healthcare Limited Methotrexat Accord Methotrexate 500mg/20ml
Accord Healthcare Limited Methotrexat Accord Metotreksat 500mg/20ml
Accord Healthcare Limited Metotrexat Accord Methotrexate 50mg/2ml
Accord Healthcare Limited Metotrexat Accord Metotreksat 50mg/2ml
Accord Healthcare Limited Metotrexat Accord Methotrexate 5000mg/50ml
Accord Healthcare Limited Metotrexat Accord Metotreksat 5000mg/50ml
Accord Healthcare Limited Metotreksat Accord Methotrexate 1000mg/10ml
Accord Healthcare Limited Metotreksat Accord Metotreksat 1000mg/10ml
Accord Healthcare Limited Metotrexat Accord Methotrexate 1000mg/10ml
Accord Healthcare Limited Metotrexat Accord Metotreksat 1000mg/10ml
Accord Healthcare Limited Metotrexato Accord Methotrexate 1000mg/10ml
Accord Healthcare Limited Metotrexato Accord Metotreksat 1000mg/10ml
Accord Healthcare Limited Metotreksat Accord Methotrexate 5000mg/50ml
Accord Healthcare Limited Metotreksat Accord Metotreksat 5000mg/50ml
Accord Healthcare Limited Metotrexato Accord Methotrexate 50mg/2ml
Accord Healthcare Limited Metotrexato Accord Metotreksat 50mg/2ml
Accord Healthcare Limited Metotrexat Accord Methotrexate 1000mg/40ml
Accord Healthcare Limited Metotrexat Accord Metotreksat 1000mg/40ml
Accord Healthcare Limited Metotrexato Accord Methotrexate 5000mg/50ml
Accord Healthcare Limited Metotrexato Accord Metotreksat 5000mg/50ml
Accord Healthcare Limited Metotrexat Accord Methotrexate 500mg/20ml
Accord Healthcare Limited Metotrexat Accord Metotreksat 500mg/20ml
Accord Healthcare Limited Metotreksat Accord Methotrexate 1000mg/40ml
Accord Healthcare Limited Metotreksat Accord Metotreksat 1000mg/40ml
Accord Healthcare Limited Metotrexát Accord Methotrexate 1000mg/40ml
Accord Healthcare Limited Metotrexát Accord Metotreksat 1000mg/40ml
Accord Healthcare Limited Metotreksat Accord Methotrexate 500mg/20ml
Accord Healthcare Limited Metotreksat Accord Metotreksat 500mg/20ml
Accord Healthcare Limited Metotrexát Accord Methotrexate 500mg/20ml
Accord Healthcare Limited Metotrexát Accord Metotreksat 500mg/20ml
Accord Healthcare Limited Metotrexato Accord Methotrexate 500mg/20ml
Accord Healthcare Limited Metotrexato Accord Metotreksat 500mg/20ml
Accord Healthcare Limited Metotrexato Accord Methotrexate 1000mg/40ml
Accord Healthcare Limited Metotrexato Accord Metotreksat 1000mg/40ml
Accord Healthcare Limited Metotreksat Accord Methotrexate 50mg/2ml
Accord Healthcare Limited Metotreksat Accord Metotreksat 50mg/2ml
Intramuscular Use | Intravenous Use
| Intraventrikularna primjena
18 months.
18 mjeseci.
• Risk Management Plan (RMP)
• Plan upravljanja rizikom (RMP)
Children and adolescents
Djeca i adolescenti
This leaflet was last revised in
Ova je uputa je zadnji puta revidirana u
An updated RMP should be submitted: • At the request of the European Medicines Agency;
Ažurirani RMP treba dostaviti: • na zahtjev Europske agencije za lijekove;
You will not have to store this medicine.
Vi nećete morati čuvati ovaj lijek.
No other interaction studies have been performed.
Nisu provedena druga ispitivanja interakcija.
However, in the case of an overdose, you will receive the appropriate treatment.
Ipak, u slučaju predoziranja primit ćete odgovarajuće liječenje.
6 hours.
6 sati.
• difficulty speaking
• poteškoće u govoru
Specific warnings
Posebna upozorenja
Injury, poisoning and procedural complications
Ozljede, trovanja i proceduralne komplikacije
4.5 Interaction with other medicinal products and other forms of interaction
4.5. Interakcije s drugim lijekovima i drugi oblici interakcija
UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Nije primjenjivo.
No data are available.
Nema dostupnih podataka.
This means that the doctor can make more than one injection in the area around the tumour.
Ovo znači da liječnik može primijeniti više od jedne injekcije u područje oko tumora.
Elderly population
Starija populacija
Remove the strip from the chamber, let it dry and cut it in half.
Izvadite trakicu iz komore, ostavite je da se osuši i prerežite je na pola.
The dose may be divided up into smaller amounts.
Doza se može podijeliti u nekoliko manjih količina.
Appropriate aseptic precautions should be taken.
Treba poduzeti odgovarajuće aseptičke mjere opreza.
The following side effects may happen with this medicine:
Sljedeće nuspojave mogu se pojaviti uz ovaj lijek:
Contents of the pack and other information
Sadržaj pakiranja i druge informacije
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Pažljivo pročitajte cijelu uputu prije nego primite ovaj lijek jer sadrži Vama važne podatke.
% RCP = Counts (activity) in bottom half x 100
% RCP = Brojevi (aktivnost) u donjoj polovici x 100
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
Other sources of information
Ostali izvori informacija
• high levels of calcium in the blood
• visoke razine kalcija u krvi
For each injection prepare a separate syringe.
Za svaku injekciju pripremite zasebnu štrcaljku.
There are strict laws on the use, handling and disposal of radiopharmaceutical products.
Postoje strogi zakoni o uporabi, rukovanju i zbrinjavanju radiofarmaceutika.
These measures will help protect the environment.
Ove će mjere pomoći u očuvanju okoliša.
Do not vent.
Ne odzračujte.
b Blood represents total body exposure segregated from independent measurements of other organs and tissues.
b Krv predstavlja izlaganje cijelog tijela, odvojeno od neovisnih mjerenja drugih organa i tkiva.
This medicine is not for use in children and adolescents under 18 years of age because it has not been studied in this age group.
Ovaj lijek nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina zato što nije ispitan u toj dobnoj skupini.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika.
The radionuclide is not part of the kit.
Radionuklid nije dio seta.
Any woman who has missed a period should be assumed to be pregnant until proven otherwise.
Za svaku ženu kojoj je izostala mjesečnica mora se pretpostaviti da je trudna dok se ne dokaže suprotno.
To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.
Kako bi se omogućilo trenutno djelovanje u hitnim slučajevima, neophodni lijekovi i medicinska oprema poput endotrahealnog tubusa i ventilatora moraju biti trenutno dostupni.
The safety and efficacy of Lymphoseek in children and adolescents below the age of 18 years has not yet been established.
Sigurnost i djelotvornost lijeka Lymphoseek u djece i adolescenata u dobi mlađoj od 18 godina nisu još ustanovljene.
Date of first authorisation: 19 November 2014 Date of latest renewal:
Datum prvog odobrenja: 19. studenog 2014.
This includes any possible side effects not listed in this leaflet.
To uključuje bilo koju moguću nuspojavu koja nije navedena u ovoj uputi.
Italia
Italija
Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (frequency cannot be estimated from the available data).
Učestalost nuspojava definirana je na sljedeći način: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000) i nepoznato (učestalost se ne može procijeniti iz dostupnih podataka).
This includes medicines obtained without a prescription and herbal medicines.
Ovo uključuje i lijekove koje ste nabavili bez recepta i biljne lijekove.
Their receipt, storage, use, transfer, and disposal are subject to the regulations and/or appropriate licenses of the competent official organisation.
Njihovo preuzimanje, čuvanje, uporaba, prijenos i zbrinjavanje podliježu propisima i/ili odgovarajućim odobrenjima nadležnih službenih tijela.
Package Leaflet: Information for the Patient
Uputa o lijeku: Informacije za bolesnika
The following information is intended for medical or healthcare professionals only:
Sljedeće informacije namijenjene su samo zdravstvenim radnicima:
UNIQUE IDENTIFIER - HUMAN READABLE DATA Not applicable.
JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM Nije primjenjivo.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku specijalistu nuklearne medicine za savjet prije nego primite ovaj lijek.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, and genotoxicity.
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti akutnih i ponovljenih doza te genotoksičnosti.
Other adverse reactions were uncommon, and of mild severity and short duration.
Druge nuspojave su bile manje česte, te su bile blage i kratkog trajanja.
It will be the smallest quantity necessary to get the desired information.
Liječnik će odrediti najmanju količinu koja je potrebna da bi se dobila željena informacija.
The following information is intended for the specialist only.
Sljedeće informacije namijenjene su samo specijalistima.
From a microbiological point of view, the product should be used immediately.
Sa mikrobiološkog stajališta, lijek se mora odmah primijeniti.
Follow aseptic procedures during preparation and administration.
Pridržavajte se aseptičkih postupaka tijekom pripreme i primjene.
Uncommon (may affect up to 1 in 100 people):
Manje često (mogu se javiti u manje od 1 na 100 osoba):
Netherlands
Nizozemska
Summary of safety profile
Sažetak sigurnosnog profila
d. Calculate the percent radiochemical purity (% RCP) as follows:
Izračunajte postotak radiokemijske čistoće kako slijedi (% RCP):
• if you have experienced any signs of allergic reaction (listed in section 4) after previous admistration of Lymphoseek
• ako ste imali bilo kakve znakove alergijske reakcije (navedene u dijelu 4.) nakon prethodne primjene lijeka Lymphoseek
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera koristi i rizika, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and foetus.
Zbog toga je tijekom trudnoće potrebno provoditi samo neophodne pretrage, pri kojima vjerojatna korist od primjene uvelike premašuje rizik za majku i fetus.
Count each half of the strip with a suitable radioactivity counting apparatus (dose calibrator or multichannel analyzer).
Izbrojite svaku polovicu trakice odgovarajućim uređajem za brojanje radioaktivnosti (kalibrator doze ili multikanalni analizator).
For each patient, the radiation exposure must be justifiable by the likely benefit.
Za svakog bolesnika izlaganje zračenju mora biti opravdano vjerojatnom koristi od istog.
Three-sigma threshold value a Average of three 2-second counts or one 10-second count
Tri sigma vrijednost praga a Prosječna tri brojanja od 2 sekunde ili jedno brojanje od 10 sekundi
Lymphoseek will only be used in special controlled areas.
Lymphoseek se primjenjuje samo u posebno kontroliranim prostorima.
Whatman Grade 1, 3MM, 31ET Chromatography strip
Papir Whatman br. 1, 3MM, 31ET kromatografska trakica
CAUTION RADIOACTIVE MATERIAL
OPREZ RADIOAKTIVNI MATERIJAL
Effective preoperative imaging procedures include planar gamma camera scintigraphy, SPECT, and SPECT/CT.
Učinkovit preoperativni postupak oslikavanja uključuje planarnu scintigrafiju gama kamerom, SPECT i SPECT/CT.
Effective dose (E) (males, mSv/MBq)
Efektivna doza (E) (muškarci, mSv/MBq)
g. Remove the needle, gently swirl the vial to mix the contents, and then let it stand at room temperature for at least 15 minutes.
g. Izvadite iglu, pažljivo vrtite bočicu kako biste promiješali sadržaj te zatim ostavite bočicu da stoji pri sobnoj temperaturi najmanje 15 minuta.
The nuclear medicine doctor supervising the procedure will decide the quantity of Lymphoseek to be used in your case.
Specijalist nuklearne medicine koji nadgleda postupak odlučiti će o količini lijeka Lymphoseek koja će se koristiti u Vašem slučaju.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Nositelj odobrenja za stavljanje lijeka u promet podnosit će periodička izvješća o neškodljivosti za ovaj lijek u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
Warnings and precautions Talk to your nuclear medicine doctor before you are given Lymphoseek:
Upozorenja i mjere opreza Razgovarajte sa svojim liječnikom specijalistom nuklearne medicine prije nego što primite Lymphoseek:
Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines.
Obavijestite liječnika specijalista nuklearne medicine ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Pack sizes The glass vials are supplied in a carton containing 1 or 5 vials.
Veličina pakiranja Staklene bočice dolaze u kutiji koja sadrži 1 ili 5 bočica.
• All lymphatic mapping agents use elements of the lymphatic system for distribution.
• Sva sredstva za limfatičko označavanje koriste elemente limfatičkog sustava za distribuciju.
The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine.
Specijalist nuklearne medicine obavijestit će Vas o tome trebate li poduzeti neke posebne mjere opreza nakon primanja ovog lijeka.
c. Place the strip into a chromatography chamber containing 1 mL of acetone as the developing solvent.
c. Stavite trakicu u kromatografsku komoru koja sadrži 1 mL acetona kao otopinu za razvijanje.
Although these are complementary to intraoperative gamma probing, such acquired images should not be considered a substitute for proficient and thorough intraoperative probing with a handheld gamma detection probe.
Iako su isti komplementarni s intraoperativnim gama probirom, slike dobivene na takav način ne mogu se smatrati zamjenom za stručni i temeljiti intraoperativni probir ručnom sondom za gama detekciju.
4.3 Contraindications
4.3. Kontraindikacije
The nuclear medicine doctor uses a special camera to find Lymphoseek.
Specijalist nuklearne medicine koristi posebnu kameru kako bi pronašao Lymphoseek.
Duration of the procedure Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Trajanje postupka Specijalist nuklearne medicine obavijestit će Vas o uobičajenom trajanju postupka.
Elimination
Eliminacija
• frequent or urgent need to urinate
• česta ili hitna potreba za mokrenjem
4.1 Therapeutic indications
4.1. Terapijske indikacije
The place depends on the type of tumour.
Mjesto ubrizgavanja ovisi o tipu tumora.
Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.
Vaš liječnik i liječnik specijalist nuklearne medicine smatraju da je klinička korist od ovog postupka s primjenom radiofarmaceutika veća od rizika izlaganja zračenju.
No dose adjustment is recommended based on age.
Ne preporučuje se prilagodba doze ovisna o dobi.
Total volume: ________mL
Ukupan volumen: ________mL
For patient preparation, see section 4.4.
Za pripremu bolesnika vidjeti dio 4.4.
Before administration of Lymphoseek you should: Follow the instructions of your doctor or nuclear medicine doctor.
Prije primjene lijeka Lymphoseek morate: Pridržavati se uputa koje Vam je dao Vaš liječnik ili liječnik specijalist nuklearne medicine.
Determination of injection volumes
Utvrđivanje volumena injekcije
• if you have kidney or liver problems (renal or heptatic disease)
• ako imate problema s bubrezima ili jetrom (bolesti bubrega ili jetre)
Vials are sealed under nitrogen; air or oxygen is harmful to the contents of the vial and therefore the vial should not be vented.
Bočice su zabrtvljene pod dušikom; zrak ili kisik su štetni za sadržaj bočice te se stoga bočica ne smije odzračivati.
The quantity to be administered usually recommended for an adult ranges from 18.5 to 74 MBq (megabecquerel, the unit used to express radioactivity).
Uobičajena preporučena količina koja se primjenjuje za odrasle je u rasponu od 18,5 do 74 MBq (megabekerel je jedinica kojom se izražava radioaktivnost).
Pharmacotherapeutic group: diagnostic radiopharmaceutical, tumour detection, ATC Code: V09IA09.
Farmakoterapijska skupina: dijagnostički radiofarmaceutik, otkrivanje tumora, ATK oznaka: V09IA09.
The surgeon will also use a machine that finds the 99mTc part of the medicine.
Kirurg također koristi uređaj kojim pronalazi 99mTc dio lijeka.
Use within the expiry time on the label.
Upotrijebite unutar roka trajanja navedenog na naljepnici.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
c. Do not vent the tilmanocept powder vial prior to or during radiolabelling.
c. Ne odzračujte bočicu praška tilmanocepta prije ili tijekom radioaktivnog obilježavanja.
Patient preparation
Priprema bolesnika
• irritation or pain where the injection is given (including the breast and skin)
• nadraženost ili bol na mjestu primjene injekcije (uključujući dojku i kožu)
Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
Radiofarmaceutici se moraju pripremiti na način koji zadovoljava i zahtjeve sigurnosti kod zračenja i zahtjeve farmaceutske kvalitete.
If you are pregnant, the nuclear medicine doctor will only administer this product during pregnancy if a benefit is expected which would outweigh the risks.
Ako ste trudni, liječnik specijalist nuklearne medicine ovaj će lijek primijeniti tijekom trudnoće isključivo ako se očekuje da će korist biti veća od rizika.
Table 4: Example of three-sigma rule threshold Background counta
Tablica 4.: Primjeri praga tri sigma pravila Pozadinski broja
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6 and 12.
Lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelovima 6.6. i 12. 6.3. Rok valjanosti
The European Medicines Agency has deferred the obligation to submit the results of studies with Lymphoseek in one or more subsets of the paediatric population for visualisation of lymphatic drainage of solid malignant tumours for diagnostic purposes (see section 4.2 for information on paediatric use).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Lymphoseek u jednoj ili više podskupina pedijatrijske populacije za vizualizaciju limfatičke drenaže solidnih malignih tumora u dijagnostičke svrhe (vidjeti dio 4.2. za informacije o pedijatrijskoj primjeni).
If you are allergic to tilmanocept or any of the other ingredients of this medicine (listed in section 6) or to any of the ingredients of the radiolabelled pharmaceutical.
Ako ste alergični na tilmanocept ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) ili na bilo koji sastojak radioaktivno obilježenog farmaceutika.
Elderly patients aged 65 or older (32%) were evaluated in clinical studies; no safety issues were identified.
U kliničkim ispitivanjima ocijenjena je primjena u starijih bolesnika u dobi od 65 godina ili više godina (32%); nisu identificirani sigurnosni problemi.
Macrophages are present in high concentrations in lymph nodes.
Makrofagi su prisutni u visokim koncentracijama u limfnim čvorovima.
In clinical trials with 553 patients, the most common adverse reactions were: ◦ Injection site irritation (0.7%; 4 of 553 patients) ◦ Injection site pain (0.2%; 1 of 553 patients)
U kliničkim ispitivanjima koja su uključivala 553 bolesnika, najčešće nuspojave bile su: ◦ nadraženost na mjestu primjene injekcije (0,7%; 4 od 553 bolesnika), ◦ bol na mjestu primjene injekcije (0,2%; 1 od 553 bolesnika).
• In clinical studies, patients received Lymphoseek up to 30 hours before surgery.
• U kliničkim ispitivanjima, bolesnici primaju lijek Lymphoseek do 30 sati prije kirurškog zahvata.
• Keep this leaflet.
• Sačuvajte ovu uputu.
The activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.
Primijenjena aktivnost mora u svakom slučaju biti najniža moguća aktivnost koja će osigurati dobivanje potrebnih dijagnostičkih informacija.
The dose of 50 micrograms should not be adjusted for body weight differences.
Dozu od 50 mikrograma nije potrebno prilagođavati tjelesnoj težini.