natgillin/translations-raw huggingface dataset:
WHAT RotaTeq IS AND WHAT IT IS USED FOR
KAJ JE CEPIVO RotaTeq IN ZA KAJ GA UPORABLJAMO
Type of Medicine: vaccine against a virus
Vrsta zdravila: protivirusno cepivo.
RotaTeq is an oral vaccine that helps protect infants and young children against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infection.
Dojenčke in majhne otroke pomaga ščititi pred gastroenteritisom (driska in bruhanje), ki ga povzročajo rotavirusi.
These antibodies help protect against gastroenteritis caused by these types of rotavirus.
Ta protitelesa pomagajo ščititi proti gastroenteritisu, ki ga povzročajo ti tipi rotavirusov.
BEFORE YOUR CHILD RECEIVES RotaTeq
KAJ MORATE VEDETI, PREDEN BO VAŠ OTROK PREJEL CEPIVO RotaTeq
Do not use RotaTeq if:
Ne uporabljajte cepiva RotaTeq:
- your child is allergic to any of the components of the vaccine (see section 6).
- če je vaš otrok alergičen na katerokoli sestavino cepiva (glejte poglavje 6).
- your child developed an allergic reaction after receiving a dose of RotaTeq or other rotavirus
- če se je po predhodno prejetem odmerku cepiva RotaTeq ali drugega cepiva proti rotavirusom
vaccine.
pri vašem otroku pojavila alergijska reakcija.
- your child has previously had intussusception (a bowel obstruction in which one segment of
- če je vaš otrok kdaj imel invaginacijo (zaprtje črevesa, pri katerem se en del črevesa vrine v
bowel becomes enfolded within another segment).
drugi del črevesa).
- your child was born with a malformation of the gastrointestinal system that might predispose for
- če se je vaš otrok rodil z nepravilnostjo v prebavilih, ki bi lahko povzročila invaginacijo.
- your child has any disease which reduces his/her resistance to infection.
- če ima vaš otrok katerokoli bolezen, ki zmanjšuje njegovo odpornost proti okužbam.
- your child has a severe infection with a high temperature.
- če ima vaš otrok hudo okužbo z močno zvišano telesno temperaturo.
It might be necessary to postpone the
Morda bo cepljenje
vaccination until recovery.
potrebno odložiti, dokler se otrok ne pozdravi.
A minor infection such as a cold should not be a problem, but talk to your doctor first.
Blaga okužba, kot je prehlad, ni ovira, vendar se posvetujte z zdravnikom.
- your child has diarrhoea or is vomiting.
- če ima vaš otrok drisko ali bruha.
It might be necessary to postpone the vaccination until
Morda bo cepljenje treba odložiti, dokler se otrok ne pozdravi.
20 Take special care with RotaTeq:
Bodite posebno pozorni pri uporabi cepiva RotaTeq:
Inform your doctor/health care professional if your child:
Zdravniku ali drugemu zdravstvenemu osebju povejte:
- has received a blood transfusion or immunoglobulins within the last 6 weeks.
- če je vaš otrok v zadnjih 6 tednih prejel transfuzijo krvi ali imunoglobuline.
- has a close contact such as a household member who has a weakened immune system, e.g., a
- če je vaš otrok v tesnem stiku z osebo iz skupnega gospodinjstva, ki ima oslabljen imunski
person with cancer or who is taking medicines that may weaken the immune system.
sistem, npr. oseba z rakom ali oseba, ki se zdravi z zdravili, ki lahko oslabijo imunski sistem.
- has any disorder of the gastrointestinal system.
- če ima vaš otrok kakršnokoli bolezen prebavil.
- has not been gaining weight and growing as expected.
- če je otrokovo pridobivanje na telesni masi in rasti počasnejše od pričakovane.
As always, please take care to wash your hands thoroughly after changing soiled nappies.
20 Tako kot vedno si po previjanju dojenčka temeljito umijte roke.
Also see Important information about some of the ingredients of RotaTeq below.
Glejte tudi Pomembne informacije o nekaterih sestavinah cepiva RotaTeq v nadaljevanju.
Using other medicines and other vaccines:
Uporaba drugih zdravil in cepiv
RotaTeq may be given at the same time as your child receives other normally recommended vaccinations, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, inactivated or oral poliomyelitis, hepatitis B and pneumococcal conjugate vaccines.
Cepivo RotaTeq se lahko daje sočasno z drugimi običajno priporočanimi cepivi, kot so cepivo proti davici, tetanusu in oslovskemu kašlju, cepivo proti Haemophilusu influenzae tipa b, inaktivirano ali peroralno cepivo proti otroški ohromelosti, cepivo proti hepatitisu B in konjugirano cepivo proti pnevmokokom.
Please tell your doctor/health care professional if your child is taking or has recently taken any other medicine, including medicines obtained without a prescription.
Obvestite svojega zdravnika ali drugo zdravstveno osebje, če vaš otrok jemlje ali je pred kratkim jemal katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Taking RotaTeq with food and drink:
Uporaba cepiva RotaTeq skupaj s hrano in pijačo
Important information about some of the ingredients of RotaTeq:
Pomembne informacije o nekaterih sestavinah cepiva RotaTeq
RotaTeq contains sucrose.
RotaTeq vsebuje saharozo.
If you have been told that your child has an intolerance to some sugars, inform your doctor/health care professional before the vaccine is administered.
Če veste, da vaš otrok ne prenaša določenih sladkorjev, o tem obvestite svojega zdravnika ali drugo zdravstveno osebje, preden otrok prejme cepivo.
HOW RotaTeq IS GIVEN
KAKO SE CEPIVO RotaTeq DAJE
RotaTeq IS FOR OR AL USE ONLY.
CEPIVO RotaTeq JE NAMENJENO IZKLJUČNO ZA PERORALNO UPORABO.
A doctor or nurse will administer the recommended doses of RotaTeq to your child.
Zdravnik ali medicinska sestra bo vašemu otroku dal priporočeni odmerek cepiva RotaTeq.
The vaccine (2 ml of liquid per dose) will be given by gently squeezing the tube and delivering the vaccine into your child’s mouth.
Cepivo (2 ml tekočine na odmerek) bo dal tako, da bo iz tube cepivo nežno iztisnil v otrokova usta.
The first dose of RotaTeq may be given from the age of 6 weeks and should be given before 12 weeks of age (about 3 months).
Prvi odmerek cepiva RotaTeq lahko otrok prejme, ko je star 6 tednov, in preden je star 12 tednov (približno 3 mesece).
RotaTeq may be given to infants who were born early provided that the pregnancy had lasted at least 25 weeks.
Cepivo RotaTeq lahko prejmejo nedonošenčki, ki so bili rojeni vsaj v 25. tednu nosečnosti.
These infants should receive the first dose of vaccine between 6 and 12 weeks after birth.
Ti otroci morajo prejeti prvi odmerek cepiva med 6. in 12. tednom po rojstvu.
21 Your child will receive 3 doses of RotaTeq given at least four weeks apart.
Otrok bo prejel 3 odmerke cepiva RotaTeq v vsaj štiri- tedenskih presledkih.
It is important that your child receives all 3 doses of the vaccine for protection against rotavirus.
Za zaščito pred rotavirusi je pomembno, da otrok prejme vse 3 odmerke cepiva.
It is preferred that all three doses should be given by the age of 20-22 weeks and at latest all three doses should be given by the age of 26 weeks.
Zaželeno je, da vse tri odmerke cepiva prejme do starosti 20- 22 tednov, vse tri odmerke pa mora dobiti vsaj do 26. tedna starosti.
When RotaTeq is given to your child for the first dose, it is recommended that your child also receives RotaTeq (and not another rotavirus vaccine) to complete the vaccination course.
Če vaš otrok kot prvi odmerek dobi RotaTeq, priporočamo, da RotaTeq (in ne drugo cepivo proti rotavirusom) dobi tudi za ostale odmerke.
If you forget an appointment for RotaTeq:
Če ste pozabili na dogovorjen obisk zaradi cepljenja s cepivom RotaTeq:
It is important that you follow the instructions of your doctor/health care professional regarding your child’s return visits for the follow-up doses.
21 Pomembno je, da upoštevate navodila zdravnika ali drugega zdravstvenega osebja glede ponovnih obiskov zaradi prejema nadaljnjih odmerkov cepiva.
If you forget or are not able to go back to your doctor/health care professional at the scheduled time, ask him or her for advice.
Če ste na dogovorjeni obisk pozabili ali pa niste mogli priti ob načrtovanemu času, se posvetujte z zdravnikom.
Like all medicines, RotaTeq can cause side effects, although not everybody gets them.
Kot vsa cepiva ima lahko tudi cepivo RotaTeq neželene učinke, ki pa se ne pojavijo pri vseh.
The following side effects were reported in clinical studies with the use of RotaTeq:
Pri uporabi cepiva RotaTeq so v kliničnih študijah poročali o naslednjih neželenih učinkih:
Very common (occurs in more than 1 in 10 infants): fever, diarrhoea, vomiting.
Zelo pogosti (pri več kot 1 od 10 dojenčkov): povišana telesna temperatura, driska, bruhanje.
Common (occurs in more than 1 in 100 infants): infections of the upper respiratory system.
Pogosti (pri več kot 1 od 100 dojenčkov): okužbe zgornjih dihal.
Uncommon (occurs in less than 1 in 100 infants): stomach pains, runny nose and sore throat, ear infection, rash.
Občasni (pri manj kot 1 od 100 dojenčkov): bolečine v želodcu, izcedek iz nosu in vnetje žrela, okužba ušesa, izpuščaj.
Rare (occurs in less than 1 in 1000 infants): bronchospasm (wheezing or coughing).
Redki (pri manj kot 1 od 1000 dojenčkov): bronhospazem (pojav piskanja ali kašlja).
Side effects that have been reported during marketed use include: blood in stool, hives.
Neželeni učinki, o katerih so poročali v času trženja cepiva, so: kri v blatu, koprivnica.
In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Pri veliko prezgodaj rojenih dojenčkih (rojenih pred ali v 28. tednu nosečnosti) so lahko 2- 3 dni po cepljenju presledki med vdihi daljši, kot je normalno.
Ask your doctor/health care professional if you want more information about side effects for RotaTeq.
Če želite več informacij o neželenih učinkih cepiva RotaTeq, vprašajte svojega zdravnika ali drugo zdravstveno osebje.
If any of the side effects gets serious, or if you noticed any side effects not listed in this leaflet, please tell your doctor/health care professional.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali drugo zdravstveno osebje.
If the condition persists or worsens, seek medical attention.
Če stanje traja ali se poslabšuje, poiščite zdravniško pomoč.
HOW TO STORE RotaTeq
SHRANJEVANJE CEPIVA RotaTeq
Store in a refrigerator (2 °C to 8 °C).
Zdravilo shranjujte in prevažajte na hladnem (2 °C - 8 °C).
Do not use any of the dosing tubes of RotaTeq after the expiry date which is stated on the label after EXP.
Odmernih tub cepiva RotaTeq ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake EXP.
The expiry date refers to the last day of that month.
Datum izteka roka uporabnost se nanaša na zadnji dan navedenega meseca.
The active substances in RotaTeq are 5 human-bovine reassortant rotavirus strains:
Zdravilna učinkovina cepiva RotaTeq je 5 sevov prerazporejenih * humano- bovinih rotavirusov:
2.2 x 106 Infectious Units 2.8 x 106 Infectious Units 2.2 x 106 Infectious Units 2.0 x 106 Infectious Units 2.3 x 106 Infectious Units
2, 2 x 106 infektivnih enot G1 2, 8 x 106 infektivnih enot G2 2, 2 x 106 infektivnih enot G3 2, 0 x 106 infektivnih enot G4 2, 3 x 106 infektivnih enot P1[ 8]
The other ingredients in RotaTeq are: sucrose, sodium citrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide, polysorbate 80, culture media (containing inorganic salts, amino acids and vitamins), and purified water.
22 Pomožne snovi cepiva RotaTeq so: saharoza, natrijev citrat, natrijev dihidrogenfosfat monohidrat, natrijev hidroksid, polisorbat 80, gojišče (ki vsebuje anorganske soli, aminokisline in vitamine) in prečiščena voda.
RotaTeq is available in pack size of 1, 10.
Cepivo RotaTeq je na voljo v pakiranjih po 1 ali 10.
Sanofi Pasteur MSD SNC, 8, rue Jonas Salk, F-69007 Lyon, France
Sanofi Pasteur MSD SNC, 8, rue Jonas Salk, F- 69007 Lyon, Francija
Manufacturer Responsible for Batch Release:
Izdelovalec, odgovoren za sproščanje serije:
Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN, Haarlem, The Netherlands
Merck Sharp and Dohme, B. V., Waarderweg, 39, 2031 BN Haarlem, Nizozemska
Sanofi Pasteur MSD, Tel: +46.8.564.888.60
Sanofi Pasteur MSD Ltd, Tel: +44. 1. 628. 785. 291
23 United Kingdom:
23 Navodilo je bilo odobreno:
Sanofi Pasteur MSD Ltd, Tel: +44.1.628.785.291
Naslednje informacije so namenjene samo zdravstvenemu osebju:
This leaflet was last approved in:
Aplikacija cepiva:
The following information is intended for medical or health care professionals only:
Raztrgajte zaščitno vrečko in iz nje vzemite odmerno tubo.
Instructions
Tubo držite v navpičnem položaju in s frcanjem pokrovčka iz konice tube odstranite tekočino.
To administer the vaccine:
Odmerno tubo odprite z dvema preprostima giboma:
Tear open the protective bag and remove the dosing tube.
1.
HOW RotaTeq IS GIVEN.
KAKO SE CEPIVO RotaTeq DAJE.
Savene is a powder and diluent which are made into a solution for infusion (drip into a vein).
Zdravilo Savene sta prašek in vehikel, namenjena za pripravo raztopine za infundiranje (dajanje v veno).
Savene contains the active substance dexrazoxane.
Zdravilo Savene vsebuje učinkovino deksrazoksan.
Savene is used to treat extravasation caused by some specific anti-cancer medicines known as ‘ anthracyclines’.
Zdravilo Savene se uporablja za zdravljenje ekstravazacije, ki jo povzročijo specifična zdravila proti raku, imenovana » antraciklini «.
Extravasation happens when an anti-cancer medicine that is normally injected into a vein leaks or is accidentally injected in the tissue surrounding the vein, where it can cause serious damage.
Do ekstravazacije pride v primeru izstopanja zdravila proti raku, ki je bilo normalno injicirano v veno, ali v primeru nehotenega injiciranja zdravila v tkivo, ki obkroža veno, kjer lahko povzroči resne poškodbe.
Because the number of patients who have extravasation due to anthracyclines is low, the condition is rare, and Savene was designated an ‘ orphan medicine’ (a medicine used in rare diseases) on 19 September 2001.
Ker je število bolnikov, pri katerih se pojavlja ekstravazacija zaradi antraciklinov, majhno, in je bolezen redka, je bilo zdravilo Savene 19. septembra 2001 določeno kot zdravilo sirota (zdravilo, ki se uporablja pri redkih boleznih).
Savene must be used under the supervision of doctors experienced in the use of anti-cancer medicines.
Zdravilo Savene je treba uporabiti pod nadzorom zdravnika z izkušnjami z uporabo zdravil proti raku.
The medicine is given as an infusion at doses calculated based on the patient’ s body surface area.
Zdravilo se daje kot infuzija v odmerkih, izračunanih na podlagi bolnikove površine telesa.
The first infusion (1,000 mg/ m2) is given as soon as possible after the accident, and no later than 6 hours after it happened.
Prva infuzija (1. 000 mg/ m2) se da čimprej po nehotenem dogodku in ne več kot 6 ur po njem.
Two further infusions are then given, on day 2 (1,000 mg/ m2) and day 3 (500 mg/ m2), at the same time as the first infusion.
Naslednji dve infuziji se nato aplicirata 2. dan (1. 000 mg/ m2) in 3. dan (500 mg/ m2) ob istem času kot je bila dana prva infuzija.
The infusion should last between 1 and 2 hours, and be given at an injection site other than where the extravasation has happened.
Infuzija mora trajati 1 do 2 uri ter, mesto injiciranja pa ne sme biti isto kot je mesto, kjer je prišlo do ekstravazacije.
The active substance in Savene, dexrazoxane, is an antidote to anthracyclines.
Zdravilna učinkovina deksrazoksan, ki jo vsebuje zdravilo Savene, je antidot (protisredstvo) antraciklinov.
Its mode of action is not entirely clear, but it may be linked to the way it binds to iron in the body (chelation) and to its effect on some enzymes (topoisomerase II).
Njegov način delovanja ni v celoti znan, vendar utegne biti povezan z načinom njegove vezave na železo v telesu (kelacijo) in njegovimi učinki na nekatere encime (topoizomerazo II).
Dexrazoxane has been in use since the 1990s as a medicine to help prevent the cardiomyopathy (harm to the heart muscle) associated with the use of anthracycline medicines.
Deksrazoksan se uporablja od 90- tih let kot zdravilo za preprečevanje kardiomiopatije (poškodb srčne mišice), povezane z uporabo antraciklinov.
The effects of Savene were first tested in experimental models before being studied in humans.
Učinki zdravila Savene so bili najprej preizkušeni s pomočjo eksperimentalnih modelov, nato pa so jih raziskali pri ljudeh.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged any other medicine (uncontrolled studies).
Zdravila Savene niso primerjali z nobenim drugim zdravilom (nekontrolirani raziskavi).
The studies looked at how many patients needed surgery to correct the damage due to the extravasation.
Raziskavi sta merili, koliko bolnikov je potrebovalo operacijo za odpravo posledic ekstravazacije.
What benefit has Savene shown during the studies?
Kakšne koristi je zdravilo Savene izkazalo med raziskavami?
One patient among the 54 in whom the effectiveness of Savene could be measured, had tissue damage requiring surgery.
Izmed 54 bolnikov, pri katerih je bilo mogoče izmeriti učinkovitost zdravila Savene, je imel en bolnik poškodbe tkiv, ki so zahtevale operacijo.
The most common side effects of Savene (seen in more than 1 patient in 10) are nausea (feeling sick) and pain and infection at the site of the injection.
Najpogostejši neželeni stranski učinki zdravila Savene (opaženi pri več kot 1 od 10 bolnikov) so slabost ter bolečina in okužba na mestu injiciranja.
The patient can develop low blood levels of white blood cells and platelets; this can be due in part to their anti-cancer treatment, but also to Savene, as the medicine itself is a cytotoxic (a medicine that destroys cells that are multiplying) that can affect the bone marrow.
Pri bolniku se utegne razviti nizka raven belih krvnih telesc in krvnih ploščic; to je lahko deloma posledica zdravljenja proti raku, vendar pa tudi zdravila Savene, saj je to zdravilo samo citotoksično (zdravilo, ki uničuje celice, ki se množijo) in lahko prizadene kostni mozeg.
Patients will be monitored before, during and after treatment.
Bolniki so nadzorovani pred, med in po zdravljenju.
For the full list of all side effects reported with Savene, see the Package Leaflet.
Celoten seznam vseh neželenih stranskih učinkov, o katerih so poročali pri uporabi zdravila Savene, najdete v Navodilu za uporabo.
Savene should not be used in people who may be hypersensitive (allergic) to dexrazoxane or any of the other ingredients, in women who could become pregnant or who are breastfeeding, and in patients receiving vaccination against yellow fever.
Zdravila Savene se ne sme uporabljati pri bolnikih, ki utegnejo biti preobčutljivi (alergični) na deksrazoksan ali katero drugo sestavino, pri ženskah, ki bi utegnile zanositi ali dojijo, ter pri bolnikih, ki prejemajo cepljenje proti rumeni mrzlici.
Care is needed when it is used in patients who are receiving other vaccinations with live viruses.
Pozornost je potrebna pri uporabi pri bolnikih, ki prejemajo druga cepiva z živimi virusi.
Once diluted, Savene contains potassium and sodium: this must be taken into account when it is given to patients whose blood levels of these substances need to be controlled.
Raztopljeno zdravilo Savene vsebuje kalij in natrij: to dejstvo je potrebno upoštevati pri dajanju zdravila bolnikom, pri katerih je treba vsebnosti teh snovi v krvi nadzorovati.
Anthracycline extravasation is a condition that can currently be managed using various methods, but for which there is no standard authorised treatment.
Ekstravazacija zaradi antraciklinov je stanje, za katerega obvladovanje se trenutno uporabljajo različne metode, vendar pa zanj ni standardnega odobrenega zdravljenja.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Savene had shown its effectiveness in treating anthracycline extravasation, allowing patients to continue their anti-cancer treatment.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da je zdravilo Savene izkazalo učinkovitost pri zdravljenju ekstravazacije zaradi antraciklinov, kar bolnikom omogoča nadaljevanje zdravljenja proti raku.
They decided that Savene’ s benefits are greater than its risks and they recommended that the medicine be given marketing authorisation.
Odločili so, da so koristi zdravila Savene večje od z njim povezanih tveganj, zato so priporočili odobritev dovoljenja za promet z zdravilom.
The European Commission granted a marketing authorisation valid throughout the European Union for Savene to TopoTarget A/ S on 28 July 2006.
Evropska komisija je dovoljenje za promet z zdravilom Savene, veljavno po vsej Evropski uniji, odobrila družbi TopoTarget A/ S dne 28. julija 2006.
The record of Savene’ s designation as an orphan medicine is available here
Zapis o določitvi zdravila Savene kot zdravila sirote najdete tukaj.
The full EPAR for Savene can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Savene je na voljo tukaj.
Bag PP/ polyamide/ PE)
prašek: viala (steklo tipa I); vehikel: vreča PP/ poliamid/ PE)
25 ml (20 mg/ ml) Solution for infusion:
25 ml (20 mg/ ml) raztopina za infundiranje:
10 vials + 3 bags
10 vial + 3 vreče
Savene 20 mg/ ml powder for concentrate and diluent for solution for infusion.
Savene 20 mg/ ml prašek za koncentrat in vehikel za raztopino za infundiranje
Each ml contains 20 mg of dexrazoxane after reconstitution with 25 ml of water for injections.
En ml vsebuje 20 mg dekstrazoksana po rekonstituciji z 25 ml vode za injiciranej.
Each vial contains 500 mg dexrazoxane (as hydrochloride).
Vsaka viala vsebuje 500 mg deksrazoksana (v obliki klorida).
Excipients in the diluent:
Pomožne snovi v vehiklu:
Potassium 98 mg/ 500 ml Sodium 1.61 g/ 500 ml
Kalij 98 mg/ 500 ml Natrij 1, 61 g/ 500 ml
Clear isotonic diluent (295 mOsml/ l, pH approx.
Bister izotonični vehikel (295 mOsml/ l, pH pribl.
Savene is indicated for the treatment of anthracycline extravasation.
Zdravilo Savene je indicirano za zdravljenje antraciklinske ekstravazacije.
Savene must be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.
Zdravilo Savene je treba uporabiti pod nadzorom zdravnika, ki ima izkušnje pri uporabi kemoterapevtikov proti raku.
Savene should be given once daily for 3 consecutive days.
Zdravilo Savene je treba dajati enkrat dnevno 3 zaporedne dni.
Day two:
1000 mg/ m2 prvi dan:
Day three:
1000 mg/ m2 drugi dan:
1000 mg/ m2 1000 mg/ m2 500 mg/ m2
500 mg/ m2 tretji dan:
There is no experience with dose reduction/ increase or modification of the schedule in the treatment of extravasation.
Izkušenj o zniževanju/ zviševanju odmerka ali spremembah urnika zdravljenja ekstravazacij ni.
For patients with a body surface area of more than 2 m2 the single dose should not exceed 2000 mg.
Pri bolnikih, katerih površina telesa presega 2 m2, posamezni odmerek ne sme preseči 2000 mg.
The indicated dose should be administered as an intravenous infusion over 1-2 hours into a large vein in extremity/ area other than the one affected by the extravasation.
Navedeni odmerek je treba dati kot intravensko infuzijo, ki traja 1- 2 uri, v veliko veno na okončini/ področju, ki ga ekstravazacija ni prizadela.
The first infusion should be initiated as soon as possible and within the first six hours after the accident.
S prvo infuzijo je treba začeti čimprej in v roku prvih šest ur po dogodku.
Cooling procedures such as ice packs should have been removed from the area at least 15 min before the Savene administration in order to allow sufficient blood flow.
Na področju je treba prenehati s postopki hlajenja, npr. ledenimi obkladki, najmanj 15
Treatment Day 2 and Day 3 should start at the same hour (+/ - 3 hours) as on the first day.
Zdravljenje je treba drugi in tretji dan začeti ob isti uri (+ / - 3 ure) kot prvi dan.
2 Before infusion, Savene powder must be reconstituted with 25 ml sterile water to give a concentration of 20 mg dexrazoxane per ml sterile water.
Pred infundiranjem je treba prašek Savene pripraviti s 25 ml sterilne vode, da nastane koncentracija 20 mg deksrazoksana na ml sterilne vode.