natgillin/translations-raw huggingface dataset:
Brug ikke doseringstuberne med RotaTeq efter den udløbsdato, der er anført på etiketten efter EXP.
Do not use any of the dosing tubes of RotaTeq after the expiry date which is stated on the label after EXP.
Aktive stoffer i RotaTeq er 5 human- bovine reassortante rotavirus- stammer.
The active substances in RotaTeq are 5 human-bovine reassortant rotavirus strains:
2, 2 x 106 Infektiøse enheder 2, 8 x 106 Infektiøse enheder 2, 2 x 106 Infektiøse enheder 2, 0 x 106 Infektiøse enheder 2, 3 x 106 Infektiøse enheder
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
De øvrige indholdsstoffer i RotaTeq er: sukrose, natriumcitrat, natriumdihydrogenfosfatmonohydrat, natriumhydroxid, polysorbat 80, dyrkningsmedier (indeholdende uorganiske salte, aminosyrer og vitaminer) og renset vand.
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.
RotaTeqs udseende og pakningsstørrelse
What RotaTeq looks like and contents of the pack
RotaTeq fås i pakningsstørrelser på 1 eller 10stk.
RotaTeq is available in pack size of 1, 10.
Sanofi Pasteur MSD SNC, 8, rue Jonas Salk, F- 69007 Lyon, Frankrig
Sanofi Pasteur MSD SNC, 8, rue Jonas Salk, F-69007 Lyon, France
Fremstiller med ansvar for batchfrigivelse:
Manufacturer Responsible for Batch Release:
Merck Sharp and Dohme, B. V., Waarderweg, 39, 2031 BN, Haarlem, Holland
Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN, Haarlem, The Netherlands
Мерк Шарп и Доум България ЕООД, тел. + 359 2 819 3740 Česká republika:
Мерк Шарп и Доум България ЕООД, тел. + 359 2 8193740 Česká republika:
Merck Sharp & Dohme, IDEA, Inc., org. sl., Tel: +420. 233. 010. 111 Danmark:
Merck Sharp & Dohme IDEA, Inc., org. sl., Tel: +420.233.010.111 Danmark:
Sanofi Pasteur MSD, Tlf: +45 2332 6929 Deutschland:
Sanofi Pasteur MSD, Tlf: +45.23.32.6929 Deutschland:
UAB Merck Sharp & Dohme, Tel: +370 5 2780 247 Luxembourg/ Luxemburg:
UAB Merck Sharp & Dohme, Tel. +370 5 2780 247 Luxembourg/Luxemburg:
A. M. Mangion Ltd., Tel: + 357 22866700
Merck Sharp & Dohme (Middle East) Limited., Tel: +357 22866700 Nederland:
Tel: + 4021 529 29 00 Slovenija:
Merck Sharp & Dohme Romania S.R.L., Tel: + 4021 529 29 00 Slovenija:
Merck Sharp & Dohme, inovativna zdravila d. o. o, Tel: +386. 1. 520. 4201 Slovenská republika:
Merck Sharp & Dohme, inovativna zdravila d.o.o., Tel: +386.1.520.4201 Slovenská republika:
25 Følgende oplysninger er kun til læger og sundhedspersonale:
The following information is intended for medical or health care professionals only:
Indgiv dosis ved forsigtigt at trykke væsken ind i barnets mund mod indersiden af kinden, til doseringstuben er tom.
Administer dose by gently squeezing liquid into infant's mouth toward the inner cheek until dosing tube is empty.
Ubrugt produkt eller affaldsmateriale skal bortskaffes i overensstemmelse med lokale krav.
Any unused product or waste material should be disposed of in accordance with local requirements.
3.
See also section 3.
SÅDAN SKAL DU BRUGE ROTATEQ.
HOW RotaTeq IS GIVEN.
Savene er et pulver, der indgives ved infusion (dråbetilførsel i en vene) efter opløsning i den medføl - gende væske.
Savene is a powder and diluent which are made into a solution for infusion (drip into a vein).
Savene indeholder det aktive stof dexrazoxan.
Savene contains the active substance dexrazoxane.
Savene anvendes til behandling af ekstravasation af en bestemt type kræftmedicin, der kaldes antra - cykliner.
Savene is used to treat extravasation caused by some specific anti-cancer medicines known as ‘ anthracyclines’.
Ekstravasation vil sige, at kræftmidlet, der normalt indsprøjtes i en vene, siver ud af venen eller ved et uheld indsprøjtes i det omgivende væv, hvor det kan medføre alvorlig skade.
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.
Da kun ganske få patienter bliver udsat for ekstravasation af antracykliner, er Savene blevet udpeget som "lægemiddel til sjældne sygdomme" den 19. september 2001.
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.
Savene skal anvendes under opsyn af læger med erfaring i brug af kræftmedicin.
Savene must be used under the supervision of doctors experienced in the use of anti-cancer medicines.
Lægemidlet gives som infusion i en dosering, der beregnes efter patientens kropsoverflade.
The medicine is given as an infusion at doses calculated based on the patient’ s body surface area.
Den første infusion (1 000 mg/ m2) gives snarest efter uheldet, senest efter 6 timer.
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.
Der gives to infusioner mere på dag 2 (1 000 mg/ m2) og dag 3 (500 mg/ m2) på samme klokkeslæt som den første infusion.
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.
Infusio - nen skal vare mellem 1 og 2 timer og skal gives i et område, hvor der ikke er ekstravasation.
The infusion should last between 1 and 2 hours, and be given at an injection site other than where the extravasation has happened.
Stoffets virkningsmekanisme kendes endnu ikke helt, men kan hænge sammen med den måde, det bindes til jern i kroppen på (che - latering) og med dets virkning på visse enzymer (topoisomerase II).
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).
Dexrazoxan har siden 1990' erne været anvendt til at forebygge skade på hjertemuskulaturen i forbindelse med brug af lægemidler af antracyklintypen.
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.
Virkningerne af Savene er først testet i forsøgsmodeller, inden de er undersøgt hos mennesker.
The effects of Savene were first tested in experimental models before being studied in humans.
Dets virkning er afprøvet i to undersøgelser med tilsammen 80 patienter, der var blevet udsat for eks - travasation af antracykliner såsom epirubicin eller doxorubicin.
Two studies of its effectiveness were carried out, involving a total of 80 patients who had extravasation due to anthracyclines such as epirubicin or doxorubicin.
(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 streret, hvor mange patienter, der måtte gennemgå kirurgisk behandling for den skade, de havde på - draget sig ved ekstravasationen.
The studies looked at how many patients needed surgery to correct the damage due to the extravasation.
Hvilken fordel viser undersøgelserne, der er ved Savene?
What benefit has Savene shown during the studies?
Ud af de 54 patienter, hos hvilke virkningen af Savene kunne måles, fik én patient vævsbeskadigelse, der gjorde operation nødvendig.
One patient among the 54 in whom the effectiveness of Savene could be measured, had tissue damage requiring surgery.
De hyppigste bivirkninger (som ses hos flere end 1 ud af 10 patienter) er kvalme samt smerte og infek - tion på indsprøjtningsstedet.
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.
Dette kan til dels skyldes kræftmedicinen, men kan også skyldes Savene, der ligesom kræftmedicinen er vævs - giftigt (det ødelægger celler, der deler sig), og denne virkning kan ramme knoglemarven.
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.
Patienten vil blive overvåget før, under og efter behandlingen.
Patients will be monitored before, during and after treatment.
Den fuldstændige liste over de indberettede bivirk - ninger for Savene fremgår af indlægssedlen.
For the full list of all side effects reported with Savene, see the Package Leaflet.
Savene bør ikke anvendes til patienter, som kan være overfølsomme (allergiske) over for dexrazoxan eller andre af indholdsstofferne, patienter, som er gravide eller ammer eller patienter, der undergår vaccination mod gul feber.
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.
Efter fortynding indeholder Savene kalium og natrium.
Care is needed when it is used in patients who are receiving other vaccinations with live viruses.
Dette skal der tages hensyn til, når lægemidlet gives til patienter, der kræver overvågning af blodets indhold af disse stoffer.
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.
Hvorfor er Savene blevet godkendt?
Why has Savene been approved?
Der findes forskellige metoder til behandling af ekstravasation af antracykliner, men ingen standard - behandling.
Anthracycline extravasation is a condition that can currently be managed using various methods, but for which there is no standard authorised treatment.
Udvalget for Humanmedicinske Lægemidler (CHMP) har konkluderet, at Savene har vist sig effektivt til behandling af ekstravasation af antracykliner og således giver patienterne mulighed for at fortsætte deres kræftbehandling.
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.
Udvalget har fundet, at fordelene ved Savene opvejer risiciene, og har anbefalet udstedelse af markedsføringstilladelse.
They decided that Savene’ s benefits are greater than its risks and they recommended that the medicine be given marketing authorisation.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Savene til TopoTarget A/ S den 28. juli 2006.
The European Commission granted a marketing authorisation valid throughout the European Union for Savene to TopoTarget A/ S on 28 July 2006.
Registreringen af udpegelsen af Savene til lægemiddel til sjældne sygdomme kan ses her
The record of Savene’ s designation as an orphan medicine is available here
Den Europæiske Offentlige Vurderingsrapport (EPAR) for Savene kan ses i sin helhed her.
The full EPAR for Savene can be found here.
Hætteglas (Type I glas); Opløsningsvæske:
Vial (Type I glass); Diluent:
Pose PP/ polyamid/ PE)
Bag PP/ polyamide/ PE)
25 ml (20 mg/ ml) Opløsningsvæske til infusionsvæske:
25 ml (20 mg/ ml) Solution for infusion:
10 hætteglas + 3 poser
10 vials + 3 bags
Savene 20 mg/ ml pulver til koncentrat og opløsningsvæske til infusionsvæske.
Savene 20 mg/ ml powder for concentrate and diluent for solution for infusion.
Hver ml indeholder 20 mg dexrazoxan efter rekonstituering med 25 ml vand til injektion.
Each ml contains 20 mg of dexrazoxane after reconstitution with 25 ml of water for injections.
Hvert hætteglas indeholder 500 mg dexrazoxan (som hydroklorid).
Each vial contains 500 mg dexrazoxane (as hydrochloride).
Hjælpestoffer i opløsningsvæsken:
Excipients in the diluent:
Kalium 98 mg/ 500 ml Natrium 1, 61 g/ 500 ml
Potassium 98 mg/ 500 ml Sodium 1.61 g/ 500 ml
Savene- pulver:
Savene powder:
Savene- opløsningsvæske:
Savene diluent:
Klar isotonisk opløsningsvæske (295 mOsml/ l, pH- værdi cirka 7, 4).
7.4).
Savene er indiceret til behandling af ekstravasation af antracykliner.
Savene is indicated for the treatment of anthracycline extravasation.
Savene skal indgives under tilsyn af en læge, der har erfaring med anvendelse af cancerkemoterapeutika.
Savene must be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.
Savene bør indgives en gang dagligt i 3 på hinanden følgende dage.
Savene should be given once daily for 3 consecutive days.
Dag et:
Day one:
Dag to:
Day two:
Dag tre:
Day three:
1. 000 mg/ m2 1. 000 mg/ m2 500 mg/ m2
1000 mg/ m2 1000 mg/ m2 500 mg/ m2
Der er ingen erfaring med dosisreduktion / - stigning eller ændring i skemaet for behandling af ekstravasation.
There is no experience with dose reduction/ increase or modification of the schedule in the treatment of extravasation.
Hos patienter med en legemsoverflade på mere end 2 m2 bør enkeltdosis ikke overstige 2. 000 mg.
For patients with a body surface area of more than 2 m2 the single dose should not exceed 2000 mg.
Den indicerede dosis skal indgives som intravenøs infusion af 1- 2 timers varighed i en stor vene i en ekstremitet/ et område, som ikke er angrebet af ekstravasationen.
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.
Den første infusion skal påbegyndes så hurtigt som muligt og inden for de første seks timer efter uheldet.
The first infusion should be initiated as soon as possible and within the first six hours after the accident.
Procedurer for nedkøling, som f. eks. isposer, skal være fjernet fra området mindst 15 minutter før indgivelse af Savene for at give en
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.
Behandlingen på dag 2 og dag 3 skal starte på samme klokkeslæt (+ / - 3 timer) som på dag 1.
Treatment Day 2 and Day 3 should start at the same hour (+/ - 3 hours) as on the first day.
Inden infusion skal Savene- pulveret rekonstitueres med 25 ml sterilt vand for at opnå en koncentration på 20 mg dexrazoxan pr. ml sterilt vand.
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.
Efter rekonstituering skal opløsningen fortyndes yderligere i posen med Savene- opløsningsvæske.
After reconstitution the solution should be further diluted in the bag with the Savene diluent.
6. 6).
(See section 6.6).
Børnepatienter Savene anbefales ikke til brug hos børn pga. mangel på data vedrørende sikkerhed og effekt.
Paediatric patients Savene is not recommended for use in children due to a lack of data on safety and efficacy.
4. 4).
Patients with renal impairment Savene has not been studied in patients with impaired renal function and its use in such patients is not recommended (see section 4.4).
4. 4).
Patients with hepatic impairment Savene has not been studied in patients with impaired hepatic function and its use in such patients is not recommended (see section 4.4).
Ældre patienter Sikkerhed og effekt er ikke vurderet hos ældre patienter.
Elderly patients Safety and efficacy have not been evaluated in the elderly.
4. 4 og 4. 6).
Women of childbearing potential not using contraceptive measures (see section 4.4 and 4.6).
4. 5).
Concomitant vaccination with yellow fever vaccine (see section 4.5).
Lokale undersøgelser skal foretages regelmæssigt efter behandlingen indtil resolution.
Local examination should be performed on regular basis after treatment until resolution.
Hvis der er mistanke om ekstravasation gennem samme intravenøse adgang af andre blæredannende stoffer end antracykliner, f. eks. vinkristin, mitomycin og vinorelbin, har Savene ingen virkning imod reaktionen på disse stoffer.
If there is suspicion of extravasation by vesicant compounds other than anthracyclines through the same IV access, e. g. vincristine, mitomycin, and vinorelbine, Savene would not be effective against the reaction from these compounds.
Dets cytotoksiske potentiale (især det som fører til reversibel hæmatologisk toksicitet med et nadir, der forekommer på dag 11- 12) lægges derfor til det, som findes hos den anden indgivne kemoterapi.
Savene will be administered to patients undergoing cytotoxic therapy with anthracycline containing chemotherapy and its cytotoxic potential (especially resulting in reversible haematological toxicity with a nadir occurring on days 11-12) will therefore be added to that of the other chemotherapy administered.
Hæmatologisk monitorering skal derfor foretages regelmæssigt.
Haematological monitoring should therefore be undertaken regularly.
Patienter med neutropeni og trombocytopeni > Common Toxicity Criteria (CTC) grad 1 er ikke inkluderet i de kliniske forsøg.
Patients with neutropenia and thrombocytopenia > Common Toxicity Criteria (CTC) grade 1 have not been included in the clinical studies.
Da leverdysfunktion (forhøjede transaminase - og bilirubinværdier) kan forekomme (især efter doser på over 1. 000 mg/ m2 dexrazoxan), anbefales det, at leverfunktionstest udføres regelmæssigt før hver indgivelse af dexrazoxan til patienter, hos hvem der er kendskab til leverfunktionsforstyrrelser.
Since liver dysfunction (increases in transaminases and bilirubin) may occur (especially after doses of above 1 000 mg/ m2 dexrazoxane), it is recommended that routine liver function tests are performed before each administration of dexrazoxane in patients with known liver function disorders.
3 Da dexrazoxan har mutagen aktivitet, tilrådes mænd, som behandles med dexrazoxan, at anvende præventionsmiddel under og op til 3 måneder efter behandlingen er afsluttet.
As dexrazoxane possesses mutagenic activity, men being treated with dexrazoxane are advised not to father a child during and up to three months after treatment.
Kvinder i den fødedygtige alder skal bruge prævention under behandlingen.
Women of childbearing potential must use contraceptive measures during treatment.
4. 5).
This product is generally not recommended in combination with live attenuated vaccines, or with phenytoin (see section 4.5).
Dimetylsulfoxid (DMSO) bør ikke anvendes hos patienter, som får dexrazoxan til behandling af antracyklin- induceret ekstravasation.
3 Dimethylsulfoxide (DMSO) should not be used in patients who are administered dexrazoxane to treat anthracycline-induced extravasation.
Da Savene- opløsningsvæsken indeholder kalium (98 mg/ 500 ml), skal patientens kalium- plasma- niveau monitoreres, hvis der er risiko for hyperkaliæmi.
As the Savene diluent contains potassium (98 mg/ 500 ml) the plasma potassium level of the patient must be closely monitored in patients at risk of hyperkalaemia.
Den indeholder også natrium (1, 61 g/ 500 ml), der kan være skadelig for patienter på diæt med lavt natriumindhold.
It also contains sodium (1.61 g/ 500 ml) which may be harmful to patients on a low sodium diet.
Interaktioner som er fælles for alle cytotoksiner:
Interactions common to all cytotoxics:
På grund af den øgede risiko for trombose hos patienter med ondartede sygdomme er behandling med antikoagulanter ofte anvendt.
Due to increase of thrombotic risk in patients with malignant diseases, the use of anticoagulants treatment is frequent.
Der kan forekomme interaktion mellem cytotoksiske virkemidler og perorale antikoagulanter.
Cytotoxic agents may interact with oral anticoagulants.
Patienter i behandling med antikoagulanter skal monitoreres oftere.
Patients treated with anticoagulant should be monitored more frequently.
Vaccine mod gul feber:
Yellow fever vaccine:
4. 3).
Risk of fatal generalised vaccinial disease (see section 4.3).
Denne risiko øges hos personer, som allerede er immunsupprimerede af deres grundsygdom.
Live attenuated vaccines: risk of systemic, possible fatal disease.
Samtidig brug af cytotoksiske lægemidler kan nedsætte absorptionen af fenytoin og dermed føre til øget hyppighed af kramper.
This risk is increased in subjects who are already immunosuppressed by their underlying disease Phenytoin: concomitant use of cytotoxic medicinal products may reduce the absorption of phenytoin leading to an exacerbation of convulsions.
Samtidig anvendelse, der bør overvejes:
Concomitant use to take into consideration:
Ciklosporin, tacrolimus:
Ciclosporine, Tacrolimus:
Kraftig immunsuppression med risiko for lymfoproliferativ sygdom.
Excessive immunosuppression with risk of lymphoproliferative disease.
Interaktion specifik for dexrazoxan:
When tested in five major cytochrome P450 isoenzymes:
Ved test i fem vigtige cytokrom P450- isoenzymer, CYP1A, CYP2C9, CYP2C19, CYP2D6 og CYP3A4, blev ingen af disse hæmmet af dexrazoxan.
CYP1A, CYP2C9, CYP2C19, CYP2D6 and CYP3A4, none of these were inhibited by dexrazoxane.
Derfor er en omhyggelig monitorering af hæmatologiske parametre nødvendig.
Savene may add to the toxicity induced by the chemotherapy cycle during which the accident took place, requiring careful monitoring of haematological parameters.
Der foreligger ingen data om brugen af dexrazoxan hos gravide kvinder.
There are no data from the use of dexrazoxane in pregnant women.
Savene kan forårsage fosterskader, hvis det gives til gravide kvinder.
Savene may cause foetal harm when administered to pregnant women.
5. 3).
Few pre-clinical data are available with respect to reproductive toxicity (see section 5.3).
Savene bør kun gives til gravide kvinder, hvis det er absolut nødvendigt.
Savene should not be administered to pregnant women unless clearly necessary.
(Se pkt.
Women of childbearing potential should use contraceptive measures during treatment and should inform their doctor immediately if they become pregnant.
Da dexrazoxan har mutagen aktivitet, skal mandlige patienter anvende præventionsmidler under behandlingen og i 3 måneder efter, at behandlingen med dexrazoxan er afsluttet (se pkt.
(See section 4.3) As dexrazoxane possesses mutagenic activity, male patients should use contraceptives during treatment and for 3 months after treatment with dexrazoxane has been concluded (see section 4.4).
Det vides ikke, om dexrazoxan udskilles i modermælk.
It is not known whether dexrazoxane is excreted in human milk.
På grund af risikoen for alvorlige bivirkninger hos ammende børn, som eksponeres for dexrazoxan, skal mødre ophøre med at amme under behandlingen med Savene.
Because of the potential for serious adverse reactions in nursing infants exposed to dexrazoxane, mothers should discontinue nursing during Savene therapy.
4. 3).
(See section 4.3)
Der er ikke foretaget forsøg af effekten på evnen til at føre bil eller betjene maskiner, men det er usandsynligt, at Savene vil påvirke denne funktion, da det sjældent forbindes med påvirkning af centralnervesystemet, som f. eks. forvirring.
No studies on the effects on the ability to drive and use machines have been performed but it is unlikely that Savene will affect this function, as it has rarely been associated with any impairment of the central nervous system such as confusion.
En række publicerede rapporter, som omfatter mere end 1. 000 patienter, har vist et ensartet mønster af dosisafhængige bivirkninger, som f. eks. kvalme/ opkastning, diarré, stomatitis, knoglemarvsdepression (neutropeni, trombocytopeni) og påvirket leverfunktion (forhøjet ALAT/ ASAT).
A number of published reports comprising more than 1000 patients have demonstrated a uniform pattern of dose dependant adverse reactions such as nausea/ vomiting, diarrhoea, stomatitis, bone marrow suppression (neutropenia, thrombocytopenia) and affected liver function (increased ALT/ AST).
Følgende oplysninger er baseret på to kliniske forsøg, TT01 og TT02, med Savene, som blev indgivet til patienter med ekstravasation, som allerede får cyklusser af kemoterapeutika.
The following information is based on two clinical studies, TT01 and TT02, of Savene administered to extravasation patients already receiving cycles of chemotherapeutic agents.