natgillin/translations-raw huggingface dataset:
If you are donating your own blood before surgery, your doctor will need to: • check that you are capable of giving blood, especially if you weigh less than 50 kg • check that you have a sufficient level of red blood cells (haemoglobin of at least 11 g/dL) • make sure that only 12% of your blood will be donated at once.
289 • preveriti, ali ste sposobni dati kri, še posebno, če tehtate manj kot 50 kg, • preveriti, ali je vaša koncentracija rdečih krvnih telesc (hemoglobin najmanj 11 g/ dl) dovolj visoka; • zagotoviti, da boste naenkrat darovali le 12% krvi.
Pregnancy and breast-feeding There is not much experience with NeoRecormon in pregnant women or women who are breast- feeding.
Nosečnost in dojenje O uporabi zdravila NeoRecormon pri nosečnicah in doječih ženskah ni ustreznih izkušenj.
Check the liquid in the syringe:
Iz ovojnine vzemite eno napolnjeno injekcijsko brizgo.
2 Remove a needle from the pack, fix it securely on to the syringe and remove the protective cap from the needle.
Odstranite injekcijsko iglo iz ovojnine in jo varno namestite na injekcijsko brizgo ter odstranite zaščitno zaporko z injekcijske igle.
3 Expel air from the syringe and needle.
Odstranite zrak iz injekcijske brizge in igle.
4 Clean the skin at the injection site using an alcohol wipe.
4.
Form a skin fold by pinching the skin between thumb and forefinger.
Očistite kožo na mestu injiciranja z alkoholno krpico.
287 5 Holding the syringe near the needle, insert the needle into the skin fold with a quick, firm action.
Injekcijsko brizgo primite blizu igle in iglo vstavite v kožno gubo s hitrim in odločnim vbodom.
• Symptom atic anaemia caused by chronic kidney disease
• Simptomatska anemija zaradi kronične ledvične bolezni
• Anaemia in premature infants
• Anemija pri nedonošenčkih
The initial dose is 250 IU per injection for every 1 kg the infant weighs, three times a week.
Začetni odmerek je 250 i. e. na kg telesne mase novorojenčka, trikrat na teden.
Treatment with NeoRecormon should start as early as possible, preferably by day 3 of the infant’s life.
291 Zdravljenje z zdravilom NeoRecormon je treba začeti čim bolj zgodaj, najbolje do 3. dneva po rojstvu otroka.
288 • Adults with symptomatic anaemia receiving chemotherapy for cancer
• Odrasli s simptomatsko anemijo, ki prejemajo kemoterapijo zaradi raka
Injections are given into a vein over 2 minutes, or under the skin.
Injekcije dajemo v veno približno 2 minuti ali pod kožo.
Side effects which can affect any patient • Most people get lower levels of iron in their blood.
292 Neželeni učinki, ki lahko prizadenejo vse bolnike • Pri večini bolnikov pride do zmanjšanja koncentracij železa v krvi.
If you get unusual wheezing or difficulty breathing; swollen tongue, face or throat, or swelling around the injection site; if you feel lightheaded or faint or if you collapse, call your doctor at once.
Če se pri vas pojavijo nenavadno sopenje ali težave z dihanjem, otečen jezik, obraz ali vrat ali oteklina na mestu injiciranja, če se počutite omotično ali slabotno ali če se zgrudite, takoj pokličite svojega zdravnika. • Zelo redko so se pri bolnikih pojavil gripi podobni simptomi, še posebno, če so z zdravljenjem komaj začeli.
289 • Very rarely people experienced flu-like symptoms, especially when they just started treatment.
To vključuje zvišano telesno temperaturo, mrzlico, glavobole, bolečino v udih, bolečino v kosteh in/ ali splošno slabo počutje.
These include fever, chills, headaches, pain in the limbs, bone pain and/or feeling generally unwell.
Te reakcije so bile večinoma blage do zmerne in so izginile po nekaj urah ali dneh.
Your doctor may treat the high blood pressure with drugs or temporarily interrupt your NeoRecormon therapy. • Call a doctor at once if you get headaches, especially sudden, stabbing, migraine-like headaches, confusion, speech disturbance, unsteady walking, fits or convulsions.
Morda bo zvišan krvni tlak zdravil z zdravili ali pa bo začasno prekinil zdravljenje z zdravilom NeoRecormon. • Takoj pokličite zdravnika, če se pojavi glavobol, še posebno nenaden, zbadajoč glavobol, podoben migrenskemu, stanje zmedenosti, motnje govora, nestabilna hoja, krči ali konvulzija.
• Keep out of the reach and sight of children. • Do not use NeoRecormon after the expiry date which is stated on the pack. • Keep the pre-filled syringe in the outer carton, in order to protect from light. • Store in a refrigerator (2°C – 8°C). • The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 3 days (but not above 25°C). • Medicines should not be disposed of via wastewater or household waste.
• Zdravilo shranjujte nedosegljivo otrokom! • Zdravila NeoRecormon ne smete uporabljati po datumu izteka uporabnosti, ki je naveden na ovojnini. • Za zagotovitev zaščite pred svetlobo shranjujte napolnjeno injekcijsko brizgo v zunanji ovojnini. • Shranjujte v hladilniku (2 ºC - 8 °C).
One pre-filled syringe contains either 500, 1,000, 2,000,
Ena napolnjena injekcijska brizga vsebuje 500, 1. 000,
3,000, 4,000, 5,000, 6,000, 10,000, 20,000 or 30,000 IU (international units) epoetin beta in 0.3 ml or 0.6 ml water for injections.
(mednarodnih enot) epoetina beta v 0, 3 ml ali 0, 6 ml vode za injekcije.
- The other ingredients are urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate
- Pomožne snovi so sečnina, natrijev klorid, polisorbat 20, natrijev dihidrogenfosfat dihidrat,
dihydrate, disodium phospate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, and L-Phenylalanine.
natrijev hidrogenfosfat dodekahidrat, kalcijev klorid dihidrat, glicin, L- levcin, L- izolevcin, L - treonin, L- glutaminska kislina in L- fenilalanin.
NeoRecormon is provided as a solution for injection in 1, 4 or 6 pre-filled syringes with 1, 4 or 6 needles.
Zdravilo NeoRecormon je na voljo kot raztopina za injiciranje v 1, 4 ali 6 napolnjenih injekcijskih brizgah z 1, 4 ali 6 injekcijskimi iglami.
Pack size of 1, 4 or 6.
Pakiranje po 1, 4 ali 6.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
294 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Latvija Roche Latvija SIA Tel: +371 - 7 039831
295 Latvija Roche Latvija SIA Tel: +371 - 7 039831
292
296
When NeoSpect is radiolabelled, the radioactive element technetium-99m (99mTc) is attached to depreotide.
Z radioaktivno označitvijo zdravila NeoSpect se radioaktivni element tehnecij- 99m (99mTc) veže na depreotid.
If the solitary pulmonary nodule is labelled with NeoSpect, it is likely to be malignant.
Če zdravilo NeoSpect označi posamezni pljučni vozlič, je le- ta verjetno maligen.
If it is not, then it is likely to be benign (non-malignant).
Če ga ne označi, je le- ta verjetno benigen (nemaligen).
The outcome of the NeoSpect scan was compared to the actual diagnosis, based on the histology of the 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Pri bolnikih so izvedli rentgensko slikanje prsnega koša ali računalniško 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(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 nodule (when the tissue of the nodule is analysed under the microscope after it has been removed in an operation).
(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 tomografijo (CT) ter slikanje SPECT z uporabo radioaktivno označenega zdravila NeoSpect.
The result of the NeoSpect scan was in agreement with the result obtained by histology in between 80 and 90% of the cases.
Rezultat slikanja z uporabo zdravila NeoSpect se je v 80 do 90% primerov ujemal z rezultatom, dobljenim s histološko preiskavo.
The Committee for Medicinal products for Human Use (CHMP) decided that NeoSpect’ s benefits are greater than its risks for the scintigraphic imaging of suspected malignant lung tumours in the lung after initial detection, in combination with CT scan or chest X-ray, in patients with solitary pulmonary nodules.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila NeoSpect pri scintigrafskem slikanju pljučnih tumorjev s sumom na malignost po začetnem odkritju v kombinaciji z računalniško tomografijo (CT) ali rentgenskim slikanjem prsnega koša pri bolnikih s posameznimi vozliči v pljučih večje od z njim povezanih tveganj.
Other information about NeoSpect:
Druge informacije o zdravilu NeoSpect:
Vial (glass)
viala (iz stekla)
After reconstitution with sodium pertechnetate (99mTc) solution for injection, 99mTc-depreotide is formed.
Po rekonstituciji z raztopino natrijevega pertehnetata( 99mTc) za injiciranje, nastane 99m Tc- depreotid.
99m Tc-depreotide is administered intravenously in a single dose.
99m Tc- depreotid se daje intravensko v enkratnem odmerku.
The solution may be diluted with sodium chloride 0.9% w/ v solution for injection for more convenient injection.
Za prikladnejšo injekcijo se raztopino lahko redči z 0, 9% (m/ v) raztopino natrijevega klorida za injiciranje.
SPECT images (Single Photon Emission Computed Tomography) obtained between 2 and 4 hours following 99mTc-depreotide injection are required for optimal image interpretation.
Za optimalno tolmačenje slik, je potrebno SPEC slike (računalniška tomografija emisije posameznih fotonov) posneti 2 do 4 ure po injekciji 99m Tc- depreotida.
Dosage for adults The recommended dosage is approximately 47 micrograms depreotide (one vial) labelled with 555-740 MBq of technetium-99m.
Odmerjanje za odrasle Priporočeno odmerjanje je približno 47 mikrogramov depreotida (ena viala) označenega z 555- 740 Mbq tehnecija- 99m.
Dosage for elderly (> 65 years) Experience from clinical trials indicates that no dose adjustment is required.
Odmerjanje za starejše (> 65 let) Izkušnje iz kliničnih študij kažejo, da prilagajanje odmerka ni potrebno.
Children 99m Tc-depreotide is not recommended for use in patients below the age of 18 as data are not available for this age group.
Otroci Pri bolnikih mlajših od 18 let, uporabe 99mTc- depretoida ne priporočamo, ker za to starostno skupino ni podatkov.
Renal impairment No dose adjustment is required.
Ledvična okvara Prilagajanje odmerka ni potrebno.
See section 4.4
Glejte poglavje 4. 4.
2 4.3 Contraindications
2 Ponovna uporaba 99m Tc- depreotid je namenjen samo za enkratno uporabo.
The contents of NeoSpect are intended only for use in the preparation of 99mTc-depreotide solution for injection (see section 12).
Vsebina NeoSpecta je namenjena za uporabo samo pripravljena z raztopino 99mTc- depreotida za injiciranje (glejte poglavje 12).
Its receipt, storage, use, transfer and disposal are subject to the regulations and/ or appropriate licenses of the local competent official organisations.
Prevzem, shranjevanje, uporaba, prenos in odlaganje so predmet predpisov in/ ali ustreznih dovoljenj lokalnega pristojega urada.
99m Tc-depreotide, must be handled with care, and appropriate safety measures should be used to minimise radiation exposure to clinical personnel.
Z 99mTc- depretoidom se mora ravnati previdno in uporabljati se mora ustrezne varnostne ukrepe za zmanjševanje izpostavljenosti kliničnega osebja sevanju.
Re-administration:
Ponovna uporaba:
Clinical data reflecting safety and efficacy of multiple injections are only available in 13 patients.
O varnosti in učinkovitosti večkratnih injekcij so na voljo klinični podatki za samo 13 bolnikov.
Pregnancy Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus.
Nosečnost Pri radionuklidnem slikanju nosečnic dobi odmerek sevanja tudi plod.
99m Tc-depreotide is therefore contraindicated in pregnancy.
Zato je 99mTc- depretoid v nosečnosti kontraindiciran (Glejte 4. 3).
(See section 4.3) When it is necessary to administer radioactive medicinal products to women of childbearing potential,
Kadar je treba uporabiti radioaktivna zdravila pri ženskah v
3 information should always be sought about pregnancy.
3 rodnem obdobju, moramo vedno pridobiti podatke o nosečnosti.
Lactation It is not known whether 99mTc-depreotide is excreted in human milk, 99mTc-depreotide is therefore contraindicated during lactation.
Dojenje Ni znano, ali se 99mTc- depreotid pri človeku izloča z mlekom, zato je med dojenjem uporaba 99mTc - depreotida kontraindicirana.
All were uncommon (0.1%-1%) in occurrence.
Vsi neželeni učinki so se pojavljali redko (0, 1% - 1%).
PHARMACOLOGICAL PROPERTIES
Farmakološke lastnosti
Diagnostic radiopharmaceutical for use in tumour detection ATC code:
Radiodiagnostiki za tumorje Oznaka ATC:
In vitro data and studies in laboratory animals indicate that 99mTc-depreotide binds with high affinity to somatostatin receptor (SSTR) subtypes 2, 3 and 5.
Podatki in vitro in študije na laboratorijskih živalih kažejo, da se 99mTc- depreotid veže z visoko afiniteto na podtipe 2, 3 in 5 somatostatinskih receptorjevg (SSTR).
The binding affinity of 99mTc-depreotide to SSTR was shown in studies of pancreatic tumours in Lewis rats and in vitro in human tumour membranes.
Vezalna afiniteta 99mTc- depreotida za SSTR je bila dokazana v študijah tumorja trebušne slinavke pri Lewisovih podganah in in vitro na tumorskih membranah pri človeku.
The data indicate that the 99mTc-depreotide displays high-affinity binding to somatostatin receptors.
Podatki kažejo, da ima 99mTc - depreotid visoko vezalno afiniteto za somatostatinske receptorje.
4 In the pivotal studies, the negative predictive value for NeoSpect in association with CT for solitary pulmonary nodules (SPNs) was 90– 96% at a disease prevalence of 30-50%.
4 vozliče( SPN) 90- 96% pri 30 - 50% prevalenci bolezni.
In the same prevalence range the positive predictive value was in the range 52-72%.
Pri istem razponu prevalence je bila pozitivna napovedna vrednost 52- 72%.
The corresponding negative predictive value and positive predictive value for NeoSpect in association with chest X-ray were 96-98% and 61- 78% respectively.
Ustrezna negativna in pozitivna napovedna vrednost za NeoSpect v povezavi z rentgensko sliko prsnega koša je bila 96- 98% oziroma 61- 78%.
In a recent clinical study with a prevalence of malignancy of 49%, the positive predictive value for NeoSpect in association with CT/ chest X-ray was 84% (CI 63.1-94.7%) for all SPNs and 81.8% for lesions equal to or less than 3cm.
V nedavni klinični šudiji s prevalenco malignosti 49%, je bila pozitivna napovedna vrednost za NeoSpect v povezavi s CT / rentgenom prsnega koša 84% (IZ 63, 1- 94, 7) za vse SPN in 81, 8% za lezije enake ali manjše od 3 cm.
The negative predictive value was 87.5% (CI 66.5-96.7%) for all lesions and 87.5% for lesions equal to or less than 3cm.
Negativna napovedna vrednost je bila 87, 5% (IZ 66, 5- 96, 7%) za vse lezije in 87, 5% za lezije enake ali manjše od 3 cm.
In view of the false negative rate of FNA (5-8% false negative rate reported), thoracotomy is considered to be the gold standard.
Glede na odstotek lažnih negativnih rezultatov pri FNA (poročajo o 5- 8% lažno negativnih rezultatov), velja torakotomija za zlati merilo.
The radiation dose from 18FDG-PET (Fluorodeoxyglucose – Positron Emission Tomography) is lower than that from NeoSpect, whilst still achieving high sensitivity and specificity.
Doza sevanja je pri 18FDG- PET (Fluorodeoksiglukoza - pozitron emisijska tomografija) nižji kot pri NeoSpectu, ob ohranjeni visoki občutljivosti in specifičnosti.
Studies in healthy volunteers have demonstrated that the tracer confers three-compartment pharmacokinetic characteristics with a distribution half-life of less than 5 minutes and a terminal half- life of about 20 hours, and a steady-state volume of distribution of 1.5 to 3 l/ kg.
Študije z zdravimi prostovoljci so dokazale, da označevalec daje tridelne farmakokinetične značilnosti s porazdelitvenim razpolovnim časom manj kot 5 minut in končnim razpolovnim časom približno 20 ur, ter volumnom porazdelitve v dinamičnem ravnotežju (“ steady state ”) 1, 5 do 3 l/ kg.
Total clearance averaged 2 to 4 ml/ min/ kg.
Celotni očistek je bil povprečno 2 do 4 ml/ min/ kg.
Renal clearance averaged about 0.3 ml/ min/ kg.
Ledvični očistek je bil povprečno 0, 3 ml/ min/ kg.
Plasma radioactivity is predominantly (> 90%) in parent form, i. e. as 99mTc-depreotide.
Plazemska radioaktivnost je pretežno (90%) v nespremenjeni obliki, to je kot 99mTc- depreotid.
99m Tc-depreotide binds to the extent of about 12% to plasma proteins in patients and healthy volunteers.
99m Tc- depreotid se veže na plazemske proteine v obsegu do približno 12% pri bolnikih in zdravih prostovoljcih.
5.3 Preclinical safety data 99m Tc-depreotide was not mutagenic in vitro in the Ames test or mouse lymphoma test, and it was not clastogenic in vivo in the mouse micronucleus test.
5. 3 Predklinični podatki o varnosti 99m Tc- depreotid ni bil mutagen in vitro v Amesovem testu ali mišjem limfomskem testu in ni bil klastogen in vivo v mišjem mikronukleusnem testu.
Stannous chloride dihydrate 50 micrograms (essential excipient) Sodium α -D-glucoheptonate dihydrate Disodium edetate Hydrochloric acid and/ or sodium hydroxide (pH adjustment)
kositrov (II) klorid dihidrat 50 mikrogramov (obvezna pomožna snov) natrijev α- D- glukoheptonat dihidrat dinatrijev edetat klorovodikova kislina in/ ali natrijev hidroksid (pH uravnavanje)
In the absence of incompatibility studies, 99mTc-depreotide must not be mixed with other medicinal products.
Zaradi pomankanja študij kompatibilnosti, 99mTc- depreotida ne smemo mešati z drugimi zdravili.
5 Following reconstitution and radiolabelling, the material must be used within 5 hours as radiochemical purity and stability have been demonstrated for 5 hours at 25°C.
5 Po rekonstituciji in radioaktivnem označevanju se mora raztopina uporabiti v 5 urah, ker sta bili radiokemična čistost in stabilnost dokazani za 5 ur pri 25°C.
Store in a freezer at or below -10 °C.
Shranjujte v zmrzovalniku pri ali pod - 10°C.
The product is filled in 5 ml type I glass vials.
Zdravilo je polnjeno v 5 ml viale iz stekla tipa I.
The containers are closed with butyl rubber stoppers and sealed with aluminium caps.
Viale so zaprte z butilnimi gumijastimi zamaški in zapečatene z aluminijastimi kapicami.
32 91192 GIF sur YVETTE cedex FRANCE
32 91192 GIF sur YVETTE cedex FRANCIJA
Technetium-99m disintegrates by isomeric transition with the emission of gamma radiation with an energy of 140 keV and a half life of 6 hours to technetium-99, which can be regarded as quasi stable.
Tehnecij- 99m razpada z izomeričnim prehodom z emisijo gama sevanja z energijo 140 keV in razpolovnim časom 6 ur v tehnecij- 99, ki ga lahko štejemo za skoraj stabilnega.
For this product, the effective dose resulting from an administered activity of 555-740 MBq is typically 8.88– 11.84 mSv for a 70 kg individual.
Pri tem zdravilu, je učinkovita doza po dajanju 555- 740 MBq aktivnosti, tipično 8, 88- 11, 84 mSv za 70 kg težko osebo.
The values are listed in descending order as mGy/ MBq and assume urinary bladder emptying at 4.8 hours.
Vrednosti so navedene v padajočem vrstnem redu kot mGy/ MBq in predvidevajo praznenje sečnega mehurja v 4, 8 urah.
6 Estimated absorbed radiation dose
6 Ocena absorbirane doze ionizirajočega sevanja
Target Organ Kidneys Spleen Testes Thyroid gland Bone marrow Liver Bone surface Heart wall Lungs Adrenal glands Pancreas Urinary bladder Uterus Small intestine Upper large intestine Ovaries Lower large intestine
Izpostavljeni organ Ledvice Vranica Moda Ščitnica Kostni mozeg Jetra Površina kosti Srčna stena Pljuča Nadledvična žleza Trebušna slinavka Sečni mehur Maternica Tanko črevo Zgornji del debelega črevesa Jajčniki Spodnji del debelega črevesa
Dose calculations were performed using the standard MIRD method (MIRD Pamphlet No.
Doza je izračunana po standardni MIRD metodi (MIRD
Nucl.
Pamphlet No. 1 rev., So. Nucl.
The effective dose (ED) calculated in accordance with ICRP Publication 60 (Pergamon Press, 1991) gave a value of 0.016 mSv/ MBq, corresponding to 11.84 mSv after administration of 740 MBq.
Učinkovitadoza (ED), izračunana v skladu z ICRP Publication 60 (Pergamon Press, 1991), je dala vrednost 0, 016 mSv/ MBq, kar ustreza 11, 84 mSv po dajanju 740 Mbq.
Due to the short, six-hour half-life of technetium-99m, less than 0.1% of the radioactivity remains 60 hours after administration.
Zaradi kratkega, 6 urnega razpolovnega časa tehnecija- 99m, ostane 60 ur po dajanju manj kot 0, 1% radioaktivnosti.
Sodium pertechnetate (99mTc) solution for injection (Ph. Eur) is used for reconstitution.
Za rekonstitucijo se uporablja raztopino natrijevega pertehnetata (99mTc) za injiciranje (Ph. Eur).
Instructions for the preparation of 99mTc-depreotide:
Navodila za pripravo 99mTc- depreotida:
The activity of 99mTc-depreotide administered to the patient should be measured using a suitably calibrated dose calibrator immediately prior to administration to the patient.
Aktivnost 99mTc- depreotida za dajanje bolniku se mora meriti s pomočjo ustrezno kalibriranega kalibratorja doze neposredno pred dajanjem bolniku.
Allow the vial kit to warm to 15 °C - 30 °C and place it in a suitable shielding container and sanitise the rubber septum with sanitising alcohol swab.
Pustite komplet z vialo, da se segreje na 15˚C- 30˚C in ga namestite v primeren zaščitni vsebnik in očistite gumijasto pregrado s čistilno alkoholno blazinico.
Using a shielded syringe, inject the required radioactivity of up to 1.8 GBq of sodium pertechnetate (99mTc) solution for injection, (diluted as appropriate with sodium chloride 0.9% w/ v solution for injection to a total of 1 ml) into the shielded vial.
Z uporabo brizge s ščitnikom, injicirajte zahtevano radioaktivnost do 1, 8 GBq raztopine natrijevega pertehnetata (99mTc) za injiciranje, (ustrezno razredčene z 0, 9% m/ v raztopino natrijevega klorida za injiciranje do skupno 1 ml) v vialo s ščitnikom.
See Cautionary notes 1 and 2 7 below.
Glejte spodaj Previdnostna opozorila, točka 1 in 2).
Immediately transfer the reaction vial to a lead safe in the boiling water bath, maintaining the vial in the upright position.
Vialo obdržite v pokončnem položaju.
Store the reconstituted solution for injection upright at 15 °C – 25 °C and use within 5 hours of preparation.
Rekonstituirano raztopino shranjujte v pokončnem položaju pri 15˚C- 25˚C in jo uporabite znotraj 5 ur po pripravi.
The volume of diluted sodium pertechnetate (99mTc) solution for injection, added to the vial must be 1 ml.
Volumen razredčene raztopine natrijevega pertehnetata (99mTc) za injiciranje dodane v vialo 1. mora biti 1 ml.
The radioactive amount of the diluted generator eluate must not exceed 1.8 GBq when it is added to the vial.
Količina radioaktivnosti razredčenega eluata iz generatorja ne sme preseči 1, 8 GBq, ko se ga dodaja v vialo.
Safety and effectiveness of 99mTc-depreotide were established using investigational material shown to have a radiochemical purity of at least 90% by ITLC prior to administration to patients in clinical studies.
Količino radioaktivnosti se izračuna glede na načrtovani čas injiciranja bolniku tako, da se doseže odmerek za enega bolnika 555- 740 MBq iz celotne rekonstituirane viale Varnost in učinkovitost 99mTc- depreotida so ugotovili v kliničnih študijah z uporabo 3. raziskovalnega materiala, ki je imel pred dajanjem bolniku z ITLC določeno radiokemijsko čistoto najmanj 90%.
The labelling reaction involved in the preparation of 99mTc-depreotide depends upon maintaining tin in the divalent (reduced) state.
Reakcija označevanja, ki poteka pri pripravi 99mTc depreotida je odvisna od vzdrževanja kositra 5. v dvovalentni (reducirani) obliki.
Sodium chloride 0.9% w/ v solution for injection must be used as the diluent.
Za redčenje moramo uporabljati 0, 9% (m/ v) raztopino natrijevega klorida za injiciranje.
Equipment and Materials 1.
8 Oprema in materiali 1.
Two Gelman ITLC-SG strips (2 cm x 10 cm) 2.
Dva Gelman ITLC- GS trakova (2 cm x 10 cm) 2.