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The vocabulary of medicine is a language all its own which is why your medical documents require a skilled linguist who also possesses high-level expertise in various medical fields. That is my strength.
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Sample translations submitted: 1
English to Serbian: SUMMARY OF PRODUCT CHARACTERISTICS (SAŽETAK KARAKTERISTIKA LEKA) General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English VASCULOCIS 10 mg kit for radiopharmaceutical preparation
1. NAME OF THE MEDICINAL PRODUCT
VASCULOCIS 10 mg kit for radiopharmaceutical preparation.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 10 mg of human serum albumin (HSA) The radionuclide is not part of the kit.
Excipient with known effect: 3.6 mg of sodium For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation. White powder.
This medicinal product is for diagnostic use only.
After labelling with sodium pertechnetate (99mTc) solution, the solution of technetium (99mTc) human albumin is indicated for blood pool imaging, angiocardiography and ventriculography.
4.2. Posology and method of administration
Adults:
The recommended activity administered to an adult weighing 70 kg depends on the indication:
Paediatric population
The use in paediatric children and adolescents has to be considered carefully, based upon clinical needs and assessing the risk/benefit ratio in this patient group.
For the ventriculography and the angiocardiography, the activities to be administered to children and to adolescents may be calculated according to the paediatric Task Group of the EANM (2008). This activity can be calculated from the formula below using a multiplying coefficient based on the patient’s body mass (table 1).
Recommended activity [MBq] = 56.0 MBq x Factor (Table 1)
...
Image acquisition
In the course of ventriculography or angiocardiography, the image acquisition starts during the injection of the medicinal product (first-pass images) and continues during 10 to 15 minutes (equilibrium images).
In the course of the blood pool imaging and the circulation and blood flow studies, the image acquisition can start immediately after injection and be repeated at regular intervals until 24 hours after injection.
4.3. Contraindications
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to any of the components of the radiolabelled radiopharmaceutical.
4.4. Special warnings and precautions for use
Potential for hypersensitivity or anaphylactic reactions
If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary. To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.
Individual benefit/risk justification
For each patient, the radiation exposure must be justifiable by the likely benefit. The activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.
Paediatric population
For information on the use in paediatric population, see section 4.2.
Careful consideration of the indication is required since the effective dose per MBq is higher than in adults (see section 11).
Patient preparation
The patient should be well hydrated before the start of the examination and urged to void as often as possible during the first hours after the
examination in order to reduce the radiation.
Specific warnings
This product is not indicated to be administered in the spinal and cerebral fluid for myeloscintigraphy and cisternography.
Vasculocis contains human serum albumin.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal
products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.
It is strongly recommended that every time that Vasculocis is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
This medicinal product contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Precautions with respect to environmental hazard, see section 6.6.
4.5. Interaction with other medicinal product and other forms of interaction
None known.
4.6. Fertility, pregnancy and lactation
Women of childbearing potential:
When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. If in doubt about her
potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient.
Pregnancy:
Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus. Only essential investigations should
therefore be carried out during pregnancy, when the likely benefit far
exceeds the risk incurred by the mother and the foetus.
Breast-feeding:
Before administering radiopharmaceuticals to a mother who is breastfeeding consideration should be given to the possibility of delaying
the administration of radionuclide until the mother has ceased breastfeeding and to what is the most appropriate choice of radiopharmaceuticals, bearing in mind the secretion of activity in breast milk. If the administration is considered necessary, breast feeding should be interrupted for 12 hours and the expressed feeds discarded.
...
Translation - Serbian VASCULOCIS 10 mg kit za pripremu radiofarmaceutika
1. IME MEDICINSKOG SREDSTVA
VASCULOCIS 10 mg kit za pripremu radiofarmaceutika.
2. KVALITATIVNI I KVANTITATIVNI SASTAV
Svaka vijala sadrži 10 mg humanog serumskog albumina (HSA).
Radionuklid nije sastavni deo kita.
Pomoćna supstanca poznate aktivnosti: natrijum, 3.6 mg.
Za punu listu pomoćnih supstanci pogledati odeljak 6.1.
3. FARMACEUTSKI OBLIK
Kit za pripremu radiofarmaceutika.
Beli prah.
4. KLINIČKI PODACI
4.1. Terapijske indikacije
Ovo medicinsko sredstvo se koristi isključivo u dijagnostičke svrhe.
Nakon obeležavanja rastvorom natrijum-pertehnetata (99mTc), rastvor humanog serum-albumina obeleženog tehnecijumom je indikovan za snimanje vaskularnog korita, za angiokardiografiju i ventrikulografiju.
4.2. Doziranje i način primene
Odrasli:
Preporučena primenjena aktivnost kod odrasle osobe od 70 kg zavisi od indikacije:
Pedijatrijska populacija:
Upotreba kod dece i adolescenata se mora pažljivo razmotriti, u skladu sa kliničkim potrebama i procenom odnosa između potencijalnog rizika i koristi za ovu populaciju.
Za ventrikulografiju i angiokardiografiju, primenjena aktivnost za decu i adolescente se može izračunati u skladu sa preporukama radne grupe Evropske asocijacije za nuklearnu medicinu iz 2008. godine (EANM). Preporučena aktivnost se može dobiti iz prikazane formule uz pomoć multiplicirajuceg koeficijenta izvedenog iz telesne mase pacijenta (Tabela 1).
...
Akvizicija snimka
U toku angiokardiografije i ventrikulografije, akvizicija započinje već tokom ubrizgavanja medicinskog sredstva (snimci faze prvog prolaza) nastavljajući se tokom narednih 10 do 15 minuta (snimci faze ekvilibrijuma).
U toku snimanja vaskularnog korita i ispitivanja vaskularizacije i perfuzije, akvizicija započinje odmah nakon ubrizgavanja i može se ponavljati u regularnim vremenskim intervalima do isteka 24h od ubrizgavanja.
4.3 Kontraindikacije
Preosetljivost na aktivnu supstancu, na bilo koju od pomoćnih supstanci navedenih u odeljku 6.1 ili na bilo koju komponentu obeleženog radiofarmaceutika.
4.4 Posebna upozorenja i mere opreza pri upotrebi medicinskog sredstva
Mogućnost preosetljivosti na lek ili anafilaktička reakcija
Ukoliko dođe do reakcije preosetljivosti ili anafilaktičke reakcije, neophodno je odmah prekinuti primenu medicinskog sredstva i, ako za tim postoji potreba, započeti intravensku terapiju. U tu svrhu, neophodni medicinski proizvodi i oprema za endotrahealnu intubaciju i veštačko disanje moraju biti odmah dostupni.
Potvrda odnosa korist/rizik za pojedinca
Za svakog pacijenta izlaganje radioaktivnom zračenju mora biti opravdano potencijalnom koristi od dobijenih rezultata. Primenjena radioaktivnost bi trebalo da bude što manja, a da ne umanji kvalitet zahtevane dijagnostičke informacije.
Pedijatrijska populacija
Za uputstva u vezi da primenom u pedijatrijskoj populaciji, pogledati odeljak 4.2.
Pažljiva procena indikacije za primenu je neophodna, imajući u vidu činjenicu da je efektivna doza zračenja po MBq veća kod dece nego kod odraslih (pogledati odeljak 11).
Priprema pacijenta
Pacijentu treba savetovati povećano unošenje tečnosti pre intervencije, kao i što je moguće češće pražnjenje bešike tokom prvih nekoliko sati nakon intervencije, da bi se smanjio nivo ozračenja.
Posebna upozorenja
Ovo sredstvo nije indikovano za ubrizgavanje u cerebro-spinalnu tečnost za potrebe mijeloscintigrafije i cisternografije.
Vasculocis sadrži humani serumski albumin.
Standardne mere za sprečavanje infekcija koje mogu nastati kao rezultat upotrebe medicinskih sredstava na bazi ljudske krvi ili plazme podrazumevaju selekciju donora, skrining individualnih uzoraka krvi i plazme za markere određenih infekcija, kao i naročite proceduralne korake za inaktivaciju tj. otklanjanje virusa. Uprkos tome, mogućnost prenošenja infektivnih agenasa prilikom primene medicinskih sredstava na bazi ljudske krvi ili plazme nije u potpunosti isključena. Ovo se takođe odnosi na nepoznate ili nove viruse i druge patogene.
Nema prijavljenih slučajeva virusne transmisije putem albumina pripremljenog na način propisan specifikacijama Evropske farmakopeje.
U cilju održavanja povezanosti identiteta pacijenta sa primenjenim proizvodom, strogo se preporučuje evidencija imena pacijenta i serijskog broja proizvoda prilikom svake primene Vasculocisa.
Ovo medicinsko sredstvo sadrži manje od 1 mmola natrijuma (23 mg) po dozi, tj. praktično ne sadrži natrijum.
Za mere opreza u vezi sa očuvanjem spoljašnje sredine, pogledati odeljak 6.6.
4.5. Interakcije sa drugim lekovima i druge vrste interakcija
Nema poznatih interakcija.
4.6. Primena u reproduktivnom periodu i u periodu trudnoće i dojenja
Ženske osobe u reproduktivnom periodu
Ukoliko postoji potreba da se neki radiofarmeceutik primeni kod žene u reproduktivnom periodu, neophodno je utvrditi da li trudnoća postoji ili ne. Svaki izostanak ciklusa kod žene treba tretirati kao trudnoću dok se ne dokaže suprotno. Ukoliko se sumnja na moguću trudnoću (u slučaju izostanka ciklusa, u slučaju neregularnih ciklusa, itd.) pacijentkinji bi trebalo preporučiti alternativne tehnike bez primene jonizujućeg zračenja (ukoliko postoje).
Trudnoća
Procedure koje podrazumevaju primenu radionuklidna kod žena u toku trudnoće povlače sa sobom izloženost fetusa radijaciji. Zbog toga bi u trudnoći trebalo vršiti samo najneophodnije pretrage, kada se proceni da potencijalna korist za pacijentkinju prevazilazi rizik vezan za izloženost majke i fetusa zračenju.
Dojenje
Pre primene radiofarmaceutika kod žena u periodu dojenja, trebalo bi razmotriti mogućnost odlaganja primene radiofarmaceutika do prestanka dojenja, kao i upotrebu najpogodnijeg radiofarmaceutika, s obzirom na eventualnu mogućnost širenja radioaktivnosti kroz majčino mleko.
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Experience
Years of experience: 9. Registered at ProZ.com: Jun 2016.
Adobe Acrobat, Microsoft Excel, Microsoft Word, OmegaT, Powerpoint
CV/Resume
CV available upon request
Bio
I am a Clinical Pharmacology (Clinical Research) specialist, passionate about languages. I completed my medical specialty in Spanish language and spent 8 years living in a Spanish-speaking environment (Madrid, Spain).
My native language is Serbo-Croatian, but besides Spanish, I have a very good command of English language as well. I grew up in an English environment, and being a physician, I use English language on daily basis as it is necessary to understand science papers and publications. As well, I own a Master degree in Molecular Biomedicine that I obtained in English language.
I started translating professionally about 3 years back. Throughout my medical practice in Spain, I worked as an official translator for "Sanidad Militar", the official medical journal of Spanish Armed Forces. I have also worked with some major pharmaceutical companies like Roche.
I am specialized in translating medical and pharmaceutical documents of all kinds, including highly specialized fields like genetics, biochemistry, etc.
I am available both for short-term and long-term assignments.
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