natgillin/translations-raw huggingface dataset:
Svimmelhed, kvalme, kløende røde udbrud i huden (udslæt), sortfarvning af neglene (melanonychia), hårtab.
Dizziness, nausea, itching red eruption of the skin (rash), black nails (melanonychia), hair loss.
Sjældne bivirkninger (opstår for mindre end 1 ud af 1000 personer, men for mere end 1 ud af 10. 000 personer):
Rare side effects (occurring in less than 1 in 1,000 people, but more than 1 in 10,000):
Bensår, ændret leverfunktion.
Wounds on the legs (leg ulcers), modification of liver function,
Meget sjældne bivirkninger eller bivirkninger af ukendt hyppighed Mangel på spermatozoer eller nedsat mængde spermatozoer i sæden (azoospermia eller oligozoospermia).
Very rare side effects or unknown frequency Absence or low amount of sperm in the semen (azoospermia or oligospermia).
Enkelte tilfælde af ondartet sygdom i blodlegemerne (leukæmi), hudkræft hos ældre patienter, virusinfektion med parvovirus B19, blødning, forstyrrelser i mave- tarmkanalen, hudtørhed, feber, udeblevne menstruationscyklusser (amenorré) samt vægtøgning.
Isolated cases of malignant disease of blood cells (leukaemia), skin cancer in elderly patients, viral infection with Parvovirus B19, bleeding, gastrointestinal disturbances, vomiting, skin dryness, fever, absence of menstrual cycles (amenorrhoea), and weight gain.
SÅDAN OPBEVARER DE SIKLOS
HOW TO STORE SIKLOS
Brug ikke Siklos efter den udløbsdato, der står på pakningen og blisterkortene.
Do not use Siklos after the expiry date which is stated on the carton and the blisters.
Ubrugte, brudte tabletter skal lægges tilbage i blisterkortet, og blisterkortet skal lægges tilbage i sin pakning.
Unused broken tablets must be replaced in the blister and the blister itself must be put back in its box.
Siklos indeholder
What Siklos contains
Aktivt stof: hydroxycarbamid.
22 The active substance is hydroxycarbamide.
Hver filmovertrukket tablet indeholder 1000 mg hydroxycarbamid.
Each film-coated tablet contains 1000 mg hydroxycarbamide.
Øvrige indholdsstoffer. natriumstearylfumarat, silicificeret mikrokrystallinsk cellulose og methacrylatcopolymer.
The other ingredients are sodium stearyl fumarate and silicified microcrystalline cellulose and methacrylate copolymer.
Siklos ’ udseende og pakningsstørrelse
What Siklos looks like and contents of the pack
Siklos 1000 mg filmovertrukne tabletter er råhvide, kapselformede tabletter med tre delekærver på begge sider.
Siklos 1000 mg film-coated tablets are off-white, capsule-shaped tablets marked with three score lines on both sides.
Siklos leveres i blisterkort, der er pakket i kartoner med 30 tabletter.
Siklos is supplied in blisters packed in cartons containing 30 tablets.
Indehaveren af markedsføringstilladelsen Addmedica 84 rue d' Amsterdam 75009 Paris Frankrig
Marketing Authorisation Holder Addmedica 84 rue d'Amsterdam 75009 Paris France
Fremstiller Laboratoire Elaïapharm 2881 Route des Crêtes Z. I.
Manufacturer Laboratoire Elaïapharm 2881 Route des Crêtes Z. I.
Les Bouillides - Sophia Antipolis 06560 Valbonne Frankrig
Les Bouillides - Sophia Antipolis 06560 Valbonne France
Denne indlægsseddel blev senest godkendt den
This leaflet was last approved in ….
De kan finde yderligere information om Siklos på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu Der er også links til websites om sjældne sygdomme og hvordan de behandles.
There are also links to other websites about rare diseases and treatments.
BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET SOM SKAL IMPLEMENTERES AF MEDLEMSSTATERNE
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET SOM SKAL RETTES MOD MEDLEMSSTATERNE
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED TO THE MEMBER STATES
Denne informationspakke indeholder følgende: • Behandlingsvejledning for læger • Patientinformationspakke
The Member States shall ensure that the MAH, prior to launch, provides all physicians who are expected to prescribe Siklos with a physician information pack containing the following: • Treatment guide for physicians • Patient information pack
Behandlingsvejledningen for læger skal indeholde følgende nøgleelementer: • Produktresuméet • Behovet for regelmæssige blodtællinger og dosisjustering • Behovet for antikonception • Risikoen for kvindens og mandens fertilitet samt den potentielle risiko for fosteret og i forbindelse med amning • Kontrol af behandlede børns vækst • Håndtering af brudte tabletter • Administration af uønskede lægemiddelbivirkninger
The treatment guide for physicians should contain the following key elements: • The Summary of Product Characteristics • Need for periodic blood counts and dose adjustment • Need for contraception • Risk to male and female fertility, potential risk to foetus and breast feeding • Growth follow-up of treated children • Handling of broken tablets • Management of adverse drug reactions
Patientinformationspakken skal indeholde følgende nøgleelementer: • Indlægssedlen • Håndtering af brudte tabletter • Behovet for regelmæssige blodtællinger • Information om kriser og infektioner • Behovet for antikonception • Risikoen for kvindens og mandens fertilitet samt den potentielle risiko for fosteret og i forbindelse med amning • Vigtige tegn og symptomer på alvorlige bivirkninger • Hvornår der er behov for øjeblikkelig lægehjælp • Information til forældre om kontrol af behandlede børns vækst
The patient information pack should contain the following key elements: • Package leaflet • Handling of broken tablets • Need for periodic blood counts • Information on crisis or infections • Need for contraception • Risk to male and female fertility, potential risk to foetus and breast feeding • Key signs and symptoms of serious adverse reactions • When to seek urgent attention from the health care provider • Information on growth follow-up of treated children for their parents
Brochuren med informationer bør indeholde følgende nøgleelementer: • information om, at anvendelse af epoetin alfaprodukter kan forårsage immunogenicitet, hvilket i sjældne tilfælde kan føre til sygdommen Pure Red Cell Aplasia (PRCA) • information om, at der, som det er tilfældet med andre epoetin produkter, er øget risiko for immunogenicitet ved kronisk nyresygdom (CKD), ved subkutan (sc) indgivelse. • information om, at der ikke findes tilstrækkelig data om Silapo til at kunne fastslå størrelse af den øgede risiko for immunogenicitet ved subkutan anvendelse. • Subkutan indgivelse frarådes til patienter med CKD. • Tab af effekt eller andre symptomer på udvikling af immunogenicitet skal undersøges. • Ethvert mistænkt tilfælde af sygdommen Pure Red Cell Aplasia (PRCA) eller udvikling af immunogenicitet skal rapporteres til indehaveren af markedsføringstilladelsen
The educational leaflet shall contain the following key elements: • That the use of epoetin alfa products can cause immunogenicity which in rare cases may lead to Pure Red Cell Aplasia (PRCA) • That with other epoetin products, the risk of immunogenicity in Chronic Renal Failure (CRF) is increased with the subcutaneous route. • There is insufficient data on Silapo/ Retacrit to know the size of any increased immunogenicity risk with subcutaneous use • Therefore, the sc route is not recommended for patients with CRF • Loss of efficacy or other symptoms of the development of immunogenicity should be investigated • Any suspected case of Pure Red Cell Aplasia or development of immunogenicity should be reported to the MAH
Silapo leveres i fyldte injektionssprøjter, der indeholder mellem 1 000 og 40 000 internationale enheder (IU) af det aktive stof epoetin zeta.
It is available in pre-filled syringes containing between 1,000 and 40,000 international units (IU) of the active substance, epoetin zeta.
Silapo er et biosimilært lægemiddel.
Silapo is a ‘ biosimilar’ medicine.
Det betyder, at Silapo svarer til et biologisk lægemiddel, der allerede er godkendt i EU og indeholder et lignende aktivt stof (dette kaldes referencelægemidlet).
This means that Silapo is similar to a biological medicine that is already authorised in the European Union (EU) and contains a similar active substance (also known as the ‘ reference medicine’).
Referencelægemidlet for Silapo er EPREX/ ERYPO, som indeholder epoetin alfa.
The reference medicine for Silapo is EPREX/ ERYPO, which contains epoetin alfa.
Silapo anvendes til at stimulere produktionen af røde blodlegemer i følgende situationer: • til behandling af anæmi (mangel på røde blodlegemer) hos patienter med kronisk nyresvigt (langvarig, fremadskridende nedsættelse af nyrefunktionen) eller andre nyresygdomme, • til behandling af anæmi og til at mindske behovet for blodtransfusioner hos voksne patienter, der får kemoterapi for visse kræftformer, • til at øge den mængde af blod, som kan tages fra patienter med let anæmi før et kirurgisk indgreb, således at de kan donere blod til eget brug under eller efter indgrebet.
Silapo is used to stimulate red blood cell production in the following situations: • to treat anaemia (low red blood cell counts) caused by chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems, • to treat anaemia and reduce the need for blood transfusions in adults receiving chemotherapy for certain types of cancer, • to increase the amount of blood that patients with moderate anaemia can donate before surgery, so that their own blood can be given back to them during or after surgery.
Behandling med Silapo skal påbegyndes under opsyn af en læge med erfaring i behandling af de sygdomme, lægemidlet er beregnet til.
Treatment with Silapo must be initiated under the supervision of doctors who have experience in the management of patients with the conditions that the medicine is used for.
Til patienter med nyreproblemer og patienter, som skal opereres, skal Silapo gives ved indsprøjtning i en blodåre, mens patienter i kemoterapi skal have det indsprøjtet under huden.
For patients with kidney problems or about to undergo surgery, Silapo must be injected intravenously (into a vein), while patients receiving chemotherapy receive it subcutaneously (under the skin).
Dosisstørrelsen, dosishyppigheden og behandlingens varighed afhænger af, hvilken tilstand der behandles, og justeres alt efter, hvordan patienten reagerer på behandlingen.
The dose, the frequency of injection and how long it is used for depend on why Silapo is being used, and are adjusted according to the patient’ s response.
Det aktive stof i Silapo, epoetin zeta, er en kopi af det menneskelige erytropoietin og har nøjagtigt samme stimulerende virkning på produktionen af røde blodlegemer som det naturlige hormon.
The active substance in Silapo, epoetin zeta, is a copy of human erythropoietin and works in exactly the same way as the natural hormone to stimulate red blood cell production.
Det produceres af en celle, der har fået indsat et gen (dna), som gør den i stand til at producere erytropoietin.
The active substance in Silapo, epoetin zeta, is produced by ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce erythropoietin.
Forsøgsmodeller og undersøgelser hos mennesker har vist, at Silapo er sammenligneligt med referencelægemidlet EPREX/ ERYPO.
Silapo was studied to show that it is comparable with the reference medicine, EPREX/ ERYPO, in experimental models and in humans.
Det blev her givet ved indsprøjtning i en blodåre.
Silapo, injected intravenously, was compared with the reference medicine in two main studies involving 922 patients who had anaemia associated with chronic renal failure requiring haemodialysis (a blood clearance technique).
I den første undersøgelse sammenlignedes Silapos og EPREX/ ERYPO’ s evne til at øge antallet af røde blodlegemer hos 609 patienter over en periode på 24 uger.
The first study compared the effects of Silapo with those of EPREX/ ERYPO in correcting red blood cell counts in 609 patients over 24 weeks.
I den anden undersøgelse sammenlignedes Silapos og EPREX/ ERYPO’ s evne til at fastholde antallet af røde blodlegemer hos 313 patienter.
The second study compared the effects of Silapo with those of EPREX/ ERYPO in maintaining red blood cell counts in 313 patients.
Alle patienterne i den anden undersøgelse var blevet behandlet med EPREX/ ERYPO i mindst tre måneder, inden de skiftede over til Silapo eller fortsatte behandlingen med EPREX/ ERYPO i 12 uger.
All of the patients in the second study had been receiving treatment with EPREX/ ERYPO for at least three months before they were either switched to Silapo or remained on EPREX/ ERYPO for 12 weeks.
Firmaet forelagde desuden resultaterne af en undersøgelse af virkningen af Silapo indgivet ved indsprøjtning under huden hos 261 kræftpatienter, der var i kemoterapi.
The company also presented the results of a study looking at the effects of Silapo injected subcutaneously in 261 cancer patients taking chemotherapy.
Silapo var lige så effektivt som EPREX/ ERYPO til at øge antallet af røde blodlegemer og holde det oppe.
Silapo was as effective as EPREX/ ERYPO in correcting and maintaining red blood cell counts.
11, 4 g/ dl) som ved behandling med EPREX/ ERYPO.
In the study of patients already being treated with an epoetin, haemoglobin levels were maintained to the same extent when the patients were receiving Silapo and when they were receiving EPREX/ ERYPO, at around 11.4 g/ dl.
Undersøgelsen af patienter i kemoterapi viste, at Silapo også var effektivt, når det blev givet ved indsprøjtning under huden, og at det gav de samme forbedringer i hæmoglobinniveauet som dem, der er beskrevet i den videnskabelige litteratur for andre epoetiner.
The study in patients receiving chemotherapy showed that Silapo was also effective when it was injected subcutaneously, with similar improvements in haemoglobin levels as those reported in the scientific literature for other epoetins.
Den mest almindelige bivirkning ved Silapo er øget blodtryk, hvilket også gælder for andre lægemidler, der indeholder epoetin.
As with other medicines containing an epoetin, the most common side effect with Silapo is an increase in blood pressure, which can sometimes lead to symptoms of encephalopathy (brain problems) such as sudden, stabbing migraine-like headache and confusion.
Dette kan nogle gange medføre symptomer på hjernesygdom som f. eks. pludselig, borende, migrænelignende hovedpine og omtågethed.
Silapo can also lead to skin rash and flu-like symptoms.
Silapo kan desuden give hududslæt og influenzalignende symptomer.
For the full list of all side effects reported with Silapo, see the Package Leaflet.
Den fuldstændige liste over de indberettede bivirkninger for Silapo fremgår af indlægssedlen.
Silapo should not be used in people who may be hypersensitive (allergic) to epoetin zeta or any of the other ingredients.
Silapo bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for epoetin zeta eller andre af indholdsstofferne.
Silapo is not recommended for subcutaneous injection in the treatment of kidney problems because further studies are needed to make sure that this does not cause allergic reactions.
Det bør desuden ikke anvendes til følgende grupper: • patienter, der har fået aplastisk anæmi (nedsat eller ophørt produktion af røde blodlegemer) efter behandling med erytropoietin af enhver art, • patienter med for højt blodtryk, der ikke er velreguleret, • patienter, der skal have foretaget kirurgiske indgreb, og som har svære hjerte- karproblemer, herunder nyligt hjerteanfald eller slagtilfælde, • patienter, der ikke må få blodfortyndende medicin.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Silapo has been shown to have a comparable quality, safety and efficacy profile to
Hvorfor blev Silapo godkendt?
EPREX/ ERYPO.
Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at det i overensstemmelse med EU - kravene er påvist, at Silapos kvalitet, sikkerhed og virkning svarer til EPREX/ ERYPO’ s.
Therefore, the CHMP’ s view was that, as for EPREX/ ERYPO, the benefit outweighs the identified risks.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Silapo.
The Committee recommended that Silapo be given marketing authorisation.
Hvilke foranstaltninger træffes der for at sikre en risikofri anvendelse af Silapo?
Which measures are being taken to ensure the safe use of Silapo?
Det firma, der fremstiller Silapo, skal udarbejde informationspakke til sundhedspersonalet i alle EU - medlemsstater, herunder sikkerhedsinformation om lægemidlet.
The company that makes Silapo will provide information packs for healthcare workers in all Member States, including information on the safety of the medicine.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Silapo til STADA Arzneimittel AG den 18. december 2007.
The European Commission granted a marketing authorisation valid throughout the EU for Silapo to STADA Arzneimittel AG on 18 December 2007.
Silapo 1000 IU/ 0, 3 ml injektionsvæske, opløsning i en fyldt injektionssprøjte
Silapo 1000 IU/ 0.3ml solution for injection in pre-filled syringe
4. 4). − Behandling af anæmi og reduktion af transfusionsbehov hos voksne patienter i kemoterapi for massive tumorer, malignt lymfom eller multipelt myelom og med risiko ved transfusion vurderet ud fra patientens almentilstand (fx kardiovaskulær tilstand, præeksisterende anæmi ved kemoterapistart). − Silapo kan anvendes til at øge udbyttet af autologt blod fra patienterne i et prædonationsprogram.
− Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: o Treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis (See section 4.4). o Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis (See section 4.4). − Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e. g. cardiovascular status, pre-existing anaemia at the start of chemotherapy). − Silapo can be used to increase the yield of autologous blood from patients in a predonation programme.
2 − Behandling af symptomatisk anæmi hos voksne og pædiatriske patienter med kronisk nyreinsufficiens
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patientsIn patients with chronic renal failure the medicinal product has to be administered intravenously (see section 4.4)
Det er nødvendigt, at en læge bedømmer den individuelle patients kliniske forløb og tilstand.
2 Anemia symptoms and sequaelea may vary with age, gender and overall burden of disesase; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
På grund af variabilitet hos den enkelte patient kan der af og til observeres individuelle hæmoglobinværdier for en patient, som ligger over og under det ønskede hæmoglobinniveau.
Silapo should be administered intravenously in order to increase haemoglobin to not greater than 12 g/ dL (7.5 mmol/ L) Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Patienterne bør monitoreres nøje for at sikre, at den lavest godkendte dosis af Silapo anvendes til at sørge for tilstrækkelig kontrol af de anæmiske symptomer.
Patients should be monitored closely to ensure that the lowest approved dose of Silapo is used to provide adequate control of the symptoms of anemia.
3 Dosis (IU/ kg 3 gange ugentligt)
Dose (IU/ kg given 3x week)
Voksne patienter i peritonealdialyse Behandlingen inddeles i to faser:
3 Adult patients on peritoneal dialysis The treatment is divided into two stages:
2.
Correction phase:
Vedligeholdelses - fasen:
Starting dose of 50 IU/ kg 2 times per week by the intravenous route.
Der startes med 50 IU/ kg 2 gange om ugen, intravenøst.
Maintenance phase:
Silapo skal indgives subkutant til patienter med anæmi (f. eks. hæmoglobinkoncentration ≤ 10 g/ dl (6, 2 mmol/ l).
Silapo should be administered by the subcutaneous route to patients with anaemia (e. g. haemoglobin concentration ≤ 10 g/ dl (6.2 mmol/ l).
Der bør fortsættes med Silapo- terapi indtil 1 måned efter kemoterapiens ophør.
Silapo therapy should continue until one month after the end of chemotherapy.
4 med en initialdosis på 450 IU/ kg subkutant 1 gang ugentligt.
Alternatively, Silapo can be administered at an initial dose of 450 IU/ kg subcutaneously once weekly.
Hvis hæmoglobinet er steget med mindst 1 g/ dl (0, 62 mmol/ l), eller reticulocyttællingen er steget til ≥ 40. 000 celler/ µl over baseline efter 4 ugers behandling, bør der fortsættes med dosis på 150 IU/ kg 3 gange om ugen eller 450 IU/ kg 1 gang ugentligt.
If the haemoglobin has increased by at least 1 g/ dl (0.62 mmol/ l) or the reticulocyte count has increased ≥ 40,000 cells/ µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/ kg 3 times per week or 450 IU/ kg once weekly.
Når først behandlingsmålet for den enkelte patient er opnået, bør dosis reduceres med 25- 50% for at fastholde hæmoglobin på det niveau.
4 Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to maintain haemoglobin at that level.
25- 50%.
Dose adjustment At a rate of rise in haemoglobin of > 2 g/ dl (> 1.25 mmol/ l) per month the Silapo dose should be reduced by about 25-50%.
Hvis hæmoglobinniveauet overstiger 12 g/ dl (7, 5 mmol/ l), ophøres der med terapi, indtil niveauet er faldet til 12 g/ dl (7, 5 mmol/ l) eller derunder, hvorefter Silapo- terapien genoptages med en dosis, som er 25% under den tidligere dosis.
If haemoglobin level exceeds 12 g/ dl (7.5 mmol/ l), discontinue therapy until it falls to 12 g/ dl (7.5 mmol/ l) or lower and then reinstitute Silapo therapy at a dose 25% below the previous dose.
Let anæmiske patienter (hæmatokrit 33- 39%), som kræver en forudgående behandling med ≥ 4 enheder blod, skal behandles med Silapo med en dosis på 600 IU/ kg legemsvægt 2 gange ugentligt i 3 uger forud for operationen.
Mildly anaemic patients (haematocrit of 33-39%) requiring predeposit of ≥ 4 units of blood should be treated with Silapo at a dose of 600 IU/ kg body weight 2 times weekly for 3 weeks prior to surgery.
6 muligt, gerne flere uger før den autologe prædonation påbegyndes, således, at der opbygges store jerndepoter, før Silapo- behandling påbegyndes.
Iron supplementation should be started as soon as possible, even several weeks prior to initiating the autologous predeposit, in order to achieve high iron stores prior to starting Silapo therapy.
Indgivelsesmåde
5 Method of administration
Silapo bør ikke administreres ved intravenøs infusion.
Silapo should not be administered by intravenous infusion.
6. 2).
Silapo must not be mixed with other medicinal products (see section 6.2).
Til patienter med kronisk nyresvigt må Silapo ikke gives subkutant.
In chronic renal failure patients Silapo has not to be administered subcutaneously.