natgillin/translations-raw huggingface dataset:
Bivirkningerne er dem, som normalt forekommer i forbindelse med normal kemoterapi, og som også ses med dexrazoxan:
The adverse reactions are those typically seen with standard chemotherapy and also with dexrazoxane:
Kvalme/ opkastning hos cirka en tredjedel af patienterne, neutropeni og trombocytopeni hos cirka halvdelen af patienterne og mere sjældent, forhøjede koncentrationer af leverenzymer (ALAT/ ASAT).
Nausea/ vomiting in about one third of the patients, neutropenia and thrombocytopenia in about half of the patients, more rarely increased concentration of liver enzymes (ALT/ AST).
De behandlingsrelaterede uønskede hændelser, der blev observeret i de kliniske forsøg, angives nedenfor.
The treatment related adverse events observed in the clinical studies are listed below.
Bivirkningsincidensen (MedDRA) i forsøgene TT01 og TT02, der er relateret til eller muligvis relateret til behandlingen.
Incidence of adverse reactions (MedDRA) in studies TT01 and TT02 that are related or possible related to treatment.
Bivirkninger, der beskrives som meget almindelige, forekom hos mere end hver tiende patient (≥ 1/ 10).
(Note that numbers for Blood and Lymphatic System Disorders are described in a separate table of laboratory examinations) Adverse reactions described as very common were experienced in more than 1 in 10 patients (≥ 1/ 10).
Bivirkninger, der beskrives som almindelige, forekom hos op til hver tiende patient (> 1/ 100 til < 1/ 10).
Adverse reactions described as common were experienced by up to 1 in 10 patients (> 1/ 100 to < 1/ 10).
De mest alvorlige skal anføres først.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
(Antal patienter = 80) Systemorgan - klasser (SOC)
(Number of patients = 80) System Organ Classes (SOC)
Foretrukne termer (PT)
Preferred Terms (PT)
Grad 3+4
Grade 3+4
Gastrointestinale sygdomme
Gastrointestinal Very common disorders
Almene lidelser og Meget reaktioner på almindelig
General Very common disorders and
indgivelsesstedet
administration site conditions
Pyreksi Flebitis på injektionsstedet
Pyrexia Injection site phlebitis
5 Systemorgan - klasser (SOC)
Infections and Very common infestations
Foretrukne termer (PT)
Postoperative infection
Alle grader
8 (10.0%)
Grad 3+4
3 (3.8%)
Postoperativ infektion
Infection Neutropenic infection
3 (3, 8%)
1 (1.3%) 1 (1.3%)
sygdomme
0 (0%) 1 (1.3%)
Almindelig
Injury, Common poisoning and procedural complications
Infektion Neutropenisk infektion
Wound complication
1 (1, 3%) 1 (1, 3%)
3 (3.8%)
0 (0%) 1 (1, 3%)
0 (0%)
Almindelig
Investigations Common
Sårkomplikation
Weight decreased
Undersøgelser
5 System Organ Classes (SOC)
Vægttab
Preferred Terms (PT)
Stofskifte - sygdomme og ernæringsbetingede sygdomme
Metabolism and nutrition disorders
Myoser
Myalgia
Svimmelhed Nedsat føleevne Synkope Tremor
Dizziness Sensory loss Syncope Tremor
Sygdomme i åndedrætsorganer,
Respiratory, thoracic and
brysthule og mediastinum
mediastinal disorders
Alopeci Kløe
Alopecia Pruritus
Flebitis Superficiel tromboflebitis
Phlebitis Thrombophlebit is superficial
Venøs trombose i ekstremitet
Venous thrombosis limb
Incidens af anormale laboratorieværdier (alle patienter) i TT01 og TT02
Incidence of laboratory abnormalities (all patients) in TT01 and TT02
Antallet af pt. med
No of pts with post
CTC grad 3- 4
CTC grade 3-4
post- baselineværdi
baseline value
Kalium (Hyper) Alkalisk fosfatase Bilirubin ASAT ALAT Kreatinin LDH Total kalcium (Hypo)
WBC Neutrophils Platelets Sodium (Hypo) Potassium (Hypo) Potassium (Hyper) Alkaline Phosphatase Bilirubin AST ALT Creatinine LDH Calcium Total (Hypo)
79 77 77 57 71 76 78 28
80 78 80 79 79 79 77 77 57 71 76 78 28
0 0 1 2 3 2 0 2
36 36 17 5 2 0 0 1 2 3 2 0 2
0, 0% 0, 0% 1, 3% 3, 5% 3, 9% 2, 6% 0, 0% 7, 1%
45.0% 46.2% 21.3% 6.3% 2.5% 0.0% 0.0% 1.3% 3.5% 3.9% 2.6% 0.0% 7.1%
Afgiftningsmidler til antineoplastiske midler, ATC- kode:
Detoxifying agents for antineoplastic agents, ATC code:
To farmakodynamiske egenskaber ved dexrazoxan, dets antineoplastiske effekt og dets anvendelse til forebyggelse af kardiotoksicitet i forbindelse med antracyklin er beskrevet i litteraturen.
Two pharmacodynamic properties of dexrazoxane, its antineoplastic effect and its use in the prevention of anthracycline cardiotoxicity, are described in the literature.
Virkningsmekanisme Dexrazoxan har to vigtige virkningsmekanismer:
Mechanism of action Dexrazoxane has two major mechanisms of action:
Kelation af jern især gennem en “ åben ring ” - metabolit reducerer oxidativt stress forårsaget af jernafhængige frie radikaler i forbindelse med antracyklin- induceret kardiotoksicitet.
Prevention of anthracycline cardiotoxicity: chelation of iron especially through its ring-opened metabolite reduces the iron-dependant free radical oxidative stress associated with anthracycline- induced cardiotoxicity.
Hæmning af topoisomerase II.
Antineoplastic effect: inhibition of topoisomerase II.
Det vides ikke, i hvilken udstrækning alle disse mekanismer bidrager til den beskyttende effekt mod vævsskader efter ekstravasation af antracyklin.
It is not known to which extent each of these mechanisms contributes to the protective effect of tissue destruction following anthracycline extravasation.
De kelerende egenskaber fører sandsynligvis også til øget udskillelse af jern og zink med urinen og til en mindsket serumkoncentration af kalcium, hvilket beskrives i nogle få forsøg.
The chelating property is probably also responsible for an increased urinary excretion of iron and zinc and a decreased serum concentration of calcium as described in a few studies.
Følgende effektdata angår anvendelsen af Savene ved behandling af ekstravasation af antracykliner.
The following efficacy data relate to Savene used as treatment of anthracycline extravasation.
Det kliniske program for Savene (dexrazoxan) omfattede to åbne, enkeltgruppe, multicenterforsøg.
The clinical programme for Savene (dexrazoxane) included two open, single arm, multicentre studies.
Der overordnede formål med begge forsøg var at undersøge effekten af intravenøs indgivelse af Savene med henblik på at forhindre vævsskade fra utilsigtet ekstravaseret antracyklin og derved undgå den rutinemæssigt anvendte kirurgiske ekscision af det angrebne væv.
The overall purpose of each trial was to investigate the efficacy of intravenous Savene in preventing tissue damage from accidentally extravasated anthracycline, and thus preventing the patients from undergoing the routinely used surgical excision of the affected tissue.
Da sygdommen er sjælden, har det kun været muligt at anvende historiske data til sammenligning (de viste operationsfrekvenser på 35- 50%, i et land 100% i tilfælde, der er bekræftet ved biopsi) I begge forsøg var doseringsregimet det samme.
Due to the rarity of the condition only historical data could be used for comparison (demonstrating surgical rates of 35-50%, in one country 100% in biopsy proven cases) In both studies, the dosage regimen was the same.
Den første og den anden dosis var 1. 000 mg/ m2 og den tredje var 500 mg/ m2.
The first and second doses were at 1000 mg/ m2 and the third was 500 mg/ m2.
Et inklusionskriterium i effektdelen af forsøget var, at ekstravasation af antracyklin blev bekræftet ved fluorescensmikroskopi af en eller flere biopsier.
A requirement for inclusion in the efficacy part of the study was that the anthracycline extravasation was proven by fluorescence microscopy of one or more biopsies.
Patienter med neutropeni og trombocytopeni > CTC grad 1 er ikke inkluderet i de kliniske forsøg.
Patients with neutropenia and thrombocytopenia > CTC grade 1 have not been included in the clinical studies.
7 I forsøg TT01 deltog 23 patienter, som fik behandling med Savene.
In study TT01 23 patients were entered and received treatment with Savene.
I forsøg TT02 deltog 57 patienter, som fik den første dosis af Savene.
In study TT02, 57 patients entered the study and received the first dose of Savene.
I begge forsøg havde alle patienterne fået antracyklin.
In both studies all patients had received anthracycline.
Stort set var epirubicin det antracyklin, der blev indgivet mest (56% af patienterne).
Overall, the most commonly received anthracycline was epirubicin (56% of the patients).
Patienter med ekstravasation fra et centralt venekateter (CVAD) blev ikke inkluderet i effektevalueringen.
Patients with extravasations from a central venous access device (CVAD) were not included in the efficacy evaluation.
I begge forsøg forhindrede behandlingen med dexrazoxan udviklingen af nekrose, gjorde det muligt at fortsætte cancerbehandlingen i henhold til planen hos størstedelen af patienterne og reducerede forekomsten af sequelae (kun få eller lettere langvarige sequelae blev observeret).
In both studies dexrazoxane treatment prevented the development of necrosis, allowed cancer treatment to continue as scheduled in the majority of patients, and reduced the occurrence of sequelae (only few and mild long-term sequelae were observed).
Savene indgives kun intravenøst.
Savene is only administered intravenously.
Bibliografiske data viser, at serum- reaktionskinetikken for dexrazoxan efter intravenøs indgivelse følger en åben to- kompartment model uafhængig af plan og dosis.
The apparent volumes of
Distributionsvolumenerne er 0, 13- 1, 3 l/ kg (median 0, 49 l/ kg).
7 distribution are 0.13-1.3 l/ kg (median 0.49 l/ kg).
Distributionsvolumen er uafhængig af dosis.
Volume of distribution is independent of dose.
Vævsfordelingen er hurtig, idet de højeste niveauer af uforandret stampræparat og hydrolyseret produkt forekommer i lever og nyrer.
Tissue distribution is rapid, with the highest levels of unchanged parent compound and hydrolysed product appearing in liver and kidneys.
Sidstnævnte har en struktur, der ligner EDTA, og er en stærk kelator af jern og divalente kationer som kaliumioner.
Dexrazoxane undergoes intracellular hydrolysis first to its two one-ring open intermediates (B and C) and then to the two-ring opened form (ADR-925) which has a structure similar to EDTA and is a strong chelator of iron and divalent cations as calcium ions.
Den initiale eliminationshalveringstid (alfa) er 0, 18- 1 timer (median 0, 34 timer) og den terminale eliminationshalveringstid 1, 9- 9, 1 timer (median 2, 8 timer).
Initial elimination half lives (alpha) are 0.18-1 h (median 0.34 h) and terminal elimination half lives 1.9-9.1 h (median 2.8 h).
Den samlede genfindelse af uændret dexrazoxan i urin er 34% - 60%.
Total urinary recovery of unchanged dexrazoxane is 34%-60%.
Metabolitternes farmakokinetik stammer fra et enkelt forsøg med fem patienter.
The pharmacokinetics of the metabolites is derived from a single study with five patients.
Den gennemsnitlige eliminationshalveringstid for metabolit B med én åben ring og metabolit C er henholdsvis 0, 9- 3, 9 timer (n = 5) og 0, 5- 0, 8 timer (n = 3).
The mean elimination half-lives of the one-ring opened metabolite B and metabolite C are 0.9-3.9 h (n=5) and 0.5-0.8 h (n=3), respectively.
Eliminationshalveringstiden for metabolitten ADR- 925 med to åbne ringe er ikke angivet i litteraturen.
The elimination half-life of the two-ring opened metabolite ADR-925 is not given in literature.
Det er rapporteret, at ADR- 925 øges 3 gange inden for 15 minutter efter infusion af 1. 500 mg/ m2 og forbliver relativt konstant på et niveau i 4 timer, hvorefter det mindskes til cirka halvdelen efter 24 timer.
ADR-925 is reported to increase three-fold within 15 min after infusion of 1500 mg/ m2 and remain relatively constant on a plateau for 4 hours and then decreased to about half at 24 h.
Clearance kan reduceres hos patienter med lav kreatininclearance.
Clearance may be reduced in patients with low creatinine clearance.
In vitro- forsøg med dexrazoxan ved test i humane mikrosomer har vist høj stabilitet ved dexrazoxan, hvilket indikerer, at væsentlig metabolisme via cytokrom P450 er usandsynlig.
In vitro studies on dexrazoxane when tested in human microsomes have shown high stability of dexrazoxane indicating that major metabolism via cytochrome P450 is unlikely
Inter - og intraindividuel farmakokinetisk variabilitet er ikke blevet undersøgt systematisk.
Inter- and intraindividual pharmacokinetic variabilities have not been studied systematically.
På basis af et begrænset antal patienter blev den interindividuelle variabilitet, beregnet som variationskoefficienten (CV%), vurderet til at være cirka 30% for de vigtigste farmakokinetiske parametre.
Based on a limited number of patients, interindividual variability calculated as the coefficient of variation (CV%), was estimated to be approximately 30% for the main pharmacokinetic parameters.
Imidlertid er razoxan (den racemiske blanding af dexrazoxan og levrazoxan) rapporteret til at være forbundet med udviklingen af sekundære maligniteter hos mus (lymfoide neoplasmer) og rotter (svulst i uterus) efter indgivelse over en længere periode.
The carcinogenic potential of dexrazoxane has not been investigated, however, razoxane, (the racemic mixture of dexrazoxane and levrazoxane), has been reported to be associated with the development of secondary malignancies in mice (lymphoid neoplasms) and rats (uterine carcinomas) after administration for a prolonged period of time.
8 Forsøg med gentagen dosistoksicitet har vist, at de primære målorganer var væv med hurtig celledeling: knoglemarv, lymfevæv, testikler og mave- tarm- kanal.
Repeat-dose toxicity studies have shown that primary target organs were tissues that undergo rapid cell division: bone marrow, lymphoid tissue, testes and digestive tract.
Den tilsyneladende effekt var større ved kronisk end ved akut indgivelse.
The apparent effects were greater during chronic administration than acute.
DMSO bør derfor ikke anvendes hos patienter, der behandles med dexrazoxan for at forhindre ekstravasation af antracyklin.
When mice with experimental daunorubicin extravasation were treated with dexrazoxane systemically combined with topical treatment with DMSO on the daunorubicin-affected skin area, 67% of the mice developed small skin wounds, whereas dexrazoxane treatment alone completely prevented the daunorubicin induced skin necrosis in another group of mice, Thus, DMSO should not be used in patients treated with dexrazoxane to prevent anthracycline extravasation.
Savene- pulver Saltsyre
Savene powder Hydrochloric acid
Savene- opløsningsvæske Natriumklorid Kaliumklorid Magnesiumklorid- hexahydrat Natriumacetat- trihydrat Natriumgluconat Natriumhydroxid Vand til injektion
8 Savene diluent Sodium chloride Potassium chloride Magnesium chloride hexahydrate Sodium acetate trihydrate Sodium gluconate Sodium hydroxide Water for injections
Hætteglas og poser:
Vials and bags:
Efter rekonstituering og fortynding:
After reconstitution and dilution:
Kemisk og fysisk brugsstabilitet er påvist i 4 timer, når det opbevares ved 2- 8°C.
Chemical and physical in-use stability has been demonstrated for 4 hours when stored at 2 to 8°C.
Opbevaringstiden er normalt ikke længere end 4 timer ved 2- 8°C.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 4 hours at 2 to 8°C.
Opbevar hætteglas og poser i den ydre karton for at beskytte mod lys.
Keep the vials and bags in the outer carton in order to protect from light.
9 Savene- pulver:
Savene powder:
Ravgult hætteglas (type I) med gummiprop af klorbutyl og en flip- off hætte eller en hætte, der kan rives af.
Amber coloured glass type I vial with rubber stopper made of chlorobutyl and a flip- off or tear off cap.
Poser består af polyolefin/ polyamid co- ekstruderet plast, pakket i en beskyttende yderpose af polyamid/ polypropylen.
Bags made of polyolefin/ polyamide co-extruded plastic and over wrapped with a protective plastic bag composed of polyamide/ polypropylene.
Hvert hætteglas indeholder 500 mg dexrazoxan og 3 poser med 500 ml Savene- opløsningsvæske.
Savene is available in a box consisting of 10 vials of Savene powder containing 500 mg dexrazoxane and 3 bags of 500 ml Savene diluent.
Inden infusion skal Savene- pulveret rekonstitueres med 25 ml sterilt vand for at opnå en koncentration på 20 mg dexrazoxan pr. ml sterilt vand.
Before infusion, Savene powder must be reconstituted with 25 ml sterile water to give a concentration of 20 mg dexrazoxane per ml sterile water.
Den rekonstituerede opløsning er let gul.
The reconstituted solution is slightly yellow.
Den rekonstituerede opløsning skal herefter fortyndes i 500 ml Savene- opløsningsvæske.
The reconstituted solution should then be diluted in 500 ml Savene diluent.
Der skal udvises forsigtighed ved håndtering og forberedelse af den rekonstituerede opløsning, og de normale procedurer for korrekt håndtering af cytotoksiske lægemidler skal anvendes.
Caution must be exercised when handling and preparing the reconstituted solution and the normal procedures for proper handling of cytotoxic medicinal products should be adopted.
Hvis pulveret eller opløsningen kommer i kontakt med huden eller slimhinderne, skylles straks grundigt med vand.
If the powder or solution contacts the skin or mucous membranes, wash immediately and thoroughly with water.
TopoTarget A/ S Fruebjergvej 3 DK- 2100 København Ø Danmark
TopoTarget A/ S Fruebjergvej 3 DK – 2100 Copenhagen Denmark
DATO FOR ÆNDRING AF TEKST
DATE OF REVISION OF THE TEXT
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. eu. int /
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. eu. int/
Indehaveren af markedsføringstilladelsen skal sikre, at lægemiddelovervågningssystemet er implementeret og fungerer, inden produktet sættes på markedet, og så længe det markedsførte produkt anvendes.
• OTHER CONDITIONS The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
14 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske (Pakning med 10 hætteglas og 3 poser med opløsningsvæske)
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box (Pack of 10 vials and 3 bags of diluent)
Dexrazoxan.
Savene 20 mg/ ml powder for concentrate and diluent for solution for infusion Dexrazoxane
Hver ml indeholder 20 mg dexrazoxan efter rekonstituering med 25 ml vand til injektion.
Each vial contains 500 mg dexrazoxane (as hydrochloride) Each ml contains 20 mg of dexrazoxane after reconstitution with 25 ml of water for injections
Natriumklorid Kaliumklorid Magnesiumklorid- hexahydrat Natriumacetat- trihydrat Natriumgluconat Natriumhydroxid Vand til injektion
Sodium chloride Potassium chloride Magnesium chloride hexahydrate Sodium acetate trihydrate Sodium gluconate Sodium hydroxide Water for injections
3 poser med 500 ml opløsningsvæske.
Powder for concentrate and diluent for solution for infusion 10 vials of 500 mg dexrazoxane 3 bags of 500 ml diluent
Læs indlægssedlen inden brug.
Intravenous use after reconstitution and dilution Read the package leaflet before use
Savene skal indgives under tilsyn af en læge, der har erfaring med anvendelse af cytotoksiske stoffer.
To be administered under the supervision of a physician experienced in the use of cytotoxic agents
UDLØBSDATO
EXP {MM/ YYYY}
15 EXP {MM/ ÅÅÅÅ}
15 9.
Opbevar hætteglas og poser i den ydre karton for at beskytte mod lys.
Store below 25°C Reconstituted and diluted solution may be stored at 2 to 8°C for 4 hours Keep vials and bags in the outer carton in order to protect from light
Indeholder cytostatika.
Contains cytostatics.
Nødhjælpssæt til ekstravasation af antracyklin.
Emergency kit for Anthracycline Extravasation
Der foreligger ingen information i braille- skrift.
No information in Braille is available.
Savene- pulver Dexrazoxan Pulver til koncentrat Intravenøs anvendelse efter rekonstituering og fortynding.
Savene powder Dexrazoxane Powder for concentrate Intravenous use after reconstitution and dilution
Infusionspose
Infusion bag
Savene- opløsningsvæske
Savene diluent
Opløsningsvæske til infusionsvæske, 500 ml
Diluent for solution for infusion 500 ml
Opbevar i den ydre karton for at beskytte mod lys.
Keep in the outer carton in order to protect from light
18 Indeholder cytostatika efter rekonstituering og fortynding.
18 11.
Der foreligger ingen information i Braille- skrift.
No information in Braille is available
20 INDLÆGSSEDDEL
20 PACKAGE LEAFLET:
Savene 20 mg/ ml pulver til koncentrat og opløsningsvæske til infusionsvæske
Savene 20 mg/ ml powder for concentrate and diluent for solution for infusion
Læs hele denne indlægsseddel omhyggeligt, inden De begynder at anvende dette lægemiddel.
Read all of this leaflet carefully before you start using this medicine
Hvad Savene er, og hvad det anvendes til 2.
What Savene is and what it is used for 2.
Hvad skal De gøre, før De begynder at anvende Savene 3.
Before you are given Savene 3.
Hvordan De anvender Savene 4.
How to use Savene 4.
Hvilke mulige bivirkninger Savene har 5 Hvordan De opbevarer Savene 6.
Possible side effects 5 How to store Savene 6.
HVAD SAVENE ER, OG HVAD DET ANVENDES TIL
WHAT SAVENE IS AND WHAT IT IS USED FOR
Savene er et afgiftningsmiddel til behandling mod cancer.
Savene is a detoxifying agent for anti-cancer treatment.
De fleste lægemidler mod cancer indgives intravenøst.
Most anti-cancer medicines are administered intravenously.
Lejlighedsvis sker der et uheld, og lægemidlet indgives uden for venen og ind i det omgivende væv.
Occasionally an accident occurs and the medicine is infused outside the vein and into the surrounding tissue.
Savene anvendes som en modgift til at behandle ekstravasationer, der er forårsaget af den gruppe cancerlægemidler, som kaldes antracykliner.
Savene is used as an antidote to treat extravasations caused by the group of anti-cancer medicines called anthracyclines.
HVAD SKAL DE GØRE, FØR DE BEGYNDER AT TAGE SAVENE
BEFORE YOU ARE GIVEN SAVENE
De bør ikke anvende Savene:
Savene will not be used:
- Hvis De er allergisk (overfølsom) over for dexrazoxan eller et af de øvrige indholdsstoffer i Savene
- If you are allergic (hypersensitive) to dexrazoxane or any of the other ingredients of Savene
- Hvis De planlægger at blive gravid og ikke anvender en tilstrækkelig præventionsmetode
- If you are planning to become pregnant and do not use adequate contraceptive measures
- Hvis De ammer
- If you are breast-feeding
- Hvis De får vaccine mod gul feber
- If you are given yellow fever vaccine
Vær særligt forsigtig med at anvende Savene
Special care with Savene should be taken
- Savene skal kun gives til Dem, hvis De har haft en ekstravasation i forbindelse med kemoterapi,
- Savene should only be given to you if you have had an extravasation in connection with
som indeholder antracyklin.
anthracycline-containing chemotherapy.
- Under behandlingen med Savene skal De have taget blodprøver regelmæssigt for at kontrollere
- During treatment with Savene you will have blood tests taken regularly to check your blood
Deres blodlegemer.
cells.
- Hvis De har nedsat leverfunktion, holder lægen øje med Deres leverfunktion under behandlingen.
- If you have liver dysfunction your doctor will monitor your liver function during treatment
- Hvis De har nedsat nyrefunktion, holder lægen øje med tegn på ændringer i Deres blodlegemer.
- If you have kidney dysfunction your doctor will monitor for signs of changes to your blood
- Mænd, der er i behandling med dexrazoxan, skal bruge prævention under behandling og i op til tre
- Men being treated with dexrazoxane are advised not to father a child during and up to three
måneder efter, at behandlingen er afsluttet.
months after treatment.
- Kvinder i den fødedygtige alder skal bruge prævention under behandlingen.
- Women of childbearing potential must use contraceptive measures during treatment.
- Hvis De får levende, svækkede vacciner eller fenytoin (lægemiddel mod epilepsi).
- If you receive live attenuated vaccines or phenytoin (anti-epileptic medicines).
- Savene må ikke anvendes til børn.
- Savene should not be administered to children.
Anvendelse af anden medicin Savene bør ikke blandes med andre lægemidler under infusionen.
Taking other medicines Savene should not be mixed with any other medicines during the infusion.