natgillin/translations-raw huggingface dataset:
Meget sjælden (forekommer hos op til 1 ud af 10.000 patienter): - Som en konsekvens af lave calcium-værdier: anfald, følelsesløshed og tetani (sekundære symptomer på hypokalcæmi).
Very rare (may affect up to 1 in 10,000 people): - As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Du bør ikke få Zoledronsyre Actavis, hvis du er gravid.
You should not be given Zoledronic acid Actavis if you are pregnant.
4.1 og 4.2, indgivet samtidig med almindeligt anvendte anticancerlægemidler, diuretika, antibiotika og analgesika uden tilsyneladende kliniske interaktioner.
In clinical studies, zoledronic acid, used as indicated in sections 4.1 and 4.2, has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Et hætteglas indeholder 5 ml opløsning.
One vial contains 5 ml of solution.
Patienter i behandling med Zoledronsyre Actavis bør få udleveret indlægssedlen og patienthuskekortet.
Patients treated with Zoledronic acid Actavis should be given the package leaflet and the patient reminder card.
Ikke almindelig (kan påvirke op til 1 ud af 100 patienter): - Smerter i munden, tænder og/eller kæberne, hævelse eller ikke helende sår inde i munden eller,
Uncommon (may affect up to 1 in 100 people): - Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Pakningstørrelser og yderligere oplysninger Zoledronsyre Actavis indeholder
Contents of the pack and other information What Zoledronic acid Actavis contains
Det skal du vide, før du får Zoledronsyre Actavis
What you need to know before you are given Zoledronic acid Actavis
Osteonekrose af kæberne (ONK) er blevet rapporteret med frekvensen ”ikke almindelig” i kliniske forsøg og efter markedsføring hos patienter behandlet med zoledronsyre.
Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid.
1Bivirkninger med frekvenser < 5% blev vurderet medicinsk, og det blev vist, at de er i overensstemmelse med den veletablerede sikkerhedsprofil for zoledronsyre som indikeret under pkt.
1Adverse events occurring with frequencies < 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid as indicated in sections 4.1 and 4.2 (see section 4.8)
I kliniske forsøg med zoledronsyre blev patienter med serum-kreatinin > 265 mikromol/l eller > 3,0 mg/dl ekskluderet.
In clinical trials with zoledronic acid, patients with serum creatinine > 265 micromol/l or > 3.0 mg/dl were excluded.
Før administration skal 5 ml koncentrat fra et hætteglas eller det påkrævede udtagende volumen af koncentratet fortyndes yderligere med 100 ml calciumfri infusionsvæske (0,9% w/v natriumklorideller 5% w/v glukoseopløsning).
Prior to administration, 5 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/v sodium chloride solution or 5% w/v glucose solution).
Denne bivirkning består af en række symptomer der inkluderer feber, myalgi, hovedpine, smerter i arme og ben, kvalme, opkastning, diarré, artralgi og artritis med efterfølgende hævede led .
This adverse drug reaction consists of a constellation of symptoms that includes fever, myalgia, headache, extremity pain, nausea, vomiting, diarrhoea, arthralgia and arthritis with subsequent joint swelling.
Asteni, perifere ødemer, reaktioner ved injektionsstedet (inklusive smerter, irritation, hævelse, induration), brystsmerter, vægtøgning, anafylaktisk reaktion/shock, urticaria
Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria Arthritis and joint swelling as a symptom of acute phase reaction
− Brug ikke Zoledronsyre Actavis efter den udløbsdato, der står på hætteglasset og pakningen, efter EXP.
- Do not use Zoledronic acid Actavis after the expiry date stated on the vial and carton after EXP. - This medicinal product does not require any specific storage conditions.
Sjælden (kan påvirke op til 1 ud 1000 patienter): - Som en konsekvens af lave calcium-værdier: uregelmæssig hjerterytme (hjertearytmi;
Rare (may affect up to 1 in 1,000 people): - As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Sjælden (kan påvirke op til 1 ud 1000 patienter): - Langsom hjerterytme.
Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
− Opløsningen indeholdende zoledronsyre indgives ved en enkelt intravenøs infusion over 15 minutter i en seperat infusionsslange.
- The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
Efter fortynding: Den kemiske og fysiske stabilitet under brug er undersøgt i 24 timer ved 2°C - 8°C og ved 25°C efter fortynding i 100 ml 0,9% w/v natriumkloridopløsning eller 100 ml 5% w/v glukoseopløsning.
After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C and at 25°C after dilution in 100 ml 0.9% w/v sodium chloride solution or 100 ml 5% w/v glucose.
− hvis du ammer.
- if you are breast-feeding.
Det er ikke nødvendigt at dosisjustere patienter med TIH og serum-kreatinin < 400 mikromol/l eller < 4,5 mg/dl (se afsnit 4.4).
No dose adjustment is necessary in TIH patients with serum creatinine < 400 micromol/l or < 4.5 mg/dl (see section 4.4).
Den udtagne mængde af koncentratet skal fortyndes yderligere i 100 ml sterilt 0,9% w/v natriumklorid- eller 5% w/v glukoseopløsning.
The withdrawn amount of concentrate must be further diluted in 100 ml of sterile 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Der er rapporteret forværring af nyrefunktion, progression til nyresvigt samt dialyse hos patienter efter initial dosis eller enkeltdosis af 4 mg zoledronsyre (se pkt.
Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid (see section 4.4).
Almindelig (kan påvirke op til 1 ud af 10 patienter): - Hovedpine og influenzalignende symptomer som feber, træthed, svaghed, døsighed,
Common (may affect up to 1 in 10 people): - Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
- Holdbarhed efter fortynding: Den kemiske og fysiske stabilitet under brug er undersøgt i 24 timer ved 2°C - 8°C og ved 25°C efter fortynding i 100 ml 0,9% w/v natriumkloridopløsning eller 100 ml 5% w/v glukoseopløsning.
- Shelf life after dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C and at 25°C after dilution in 100 ml 0.9% w/v sodium chloride solution or 100 ml 5% w/v glucose.
Når behandling med Zoledronsyre Actavis initieres hos patienter med multiple myelom eller knoglemetastatisk skade fra solide tumorer bør serum-kreatinin og kreatininclearence (CLcr) bestemmes.
Prevention of skeletal related events in patients with advanced malignancies involving bone: When initiating treatment with Zoledronic acid Actavis in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Anbefalet dosis af Zoledronsyre Actavis*
Zoledronic acid Actavis recommended dose*
Koncentrat til infusionsvæske, opløsning 1 x 5 ml hætteglas
Concentrate for solution for infusion 1 x 5 ml vial
Zoledronsyre Actavis koncentrat må ikke blandes med calcium eller anden divalent kationholdig infusionsopløsning såsom Ringer-lactatopløsning, og bør indgives som en enkelt intravenøs opløsning i en separat infusionsslange.
Zoledronic acid Actavis must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
For at forhindre eventuelle uforligeligheder skal Zoledronsyre Actavis 4 mg/5 ml koncentrat til infusionsvæske, opløsning, fortyndes med 0,9% w/v natriumklorid- eller 5% w/v glukoseopløsning.
To avoid potential incompatibilities, Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion is to be diluted with 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Bivirkninger i form af frakturer på lange knogler i de nedre ekstremiteter var rapporteret hos ca. 24% (femur) og 14% (tibia) af zoledronsyrebehandlede patienter vs. 12 % og 5% af pamidronatbehandlede patienter med svær osteogenesis imperfecta uanset sygdomstype og kausalitet.
Fracture adverse events of long bones in the lower extremities were reported in approximately 24% (femur) and 14% (tibia) of zoledronic acid-treated patients vs 12% and 5% of pamidronate-treated patients with severe osteogenesis imperfecta, regardless of disease type and causality but overall incidence of fractures was comparable for the zoledronic acid and pamidronate-treated patients: 43% (32/74) vs 41% (31/76).
Zoledronsyre Actavis 4 mg/5 ml sterilt koncentrat zoledronsyre
Zoledronic acid Actavis 4 mg/5 ml sterile concentrate zoledronic acid
Tabel 2: Effektresultater (patienter med prostatacancer i hormonbehandling) Enhver SRE (+TIH)
Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy)
Brug af anden medicin sammen med Zoledronsyre Actavis
Other medicines and Zoledronic acid Actavis
I kliniske forsøg blev patienter med serum-kreatinin > 400 mikromol/l eller > 4,5 mg/dl ekskluderet.
In the clinical studies, patients with serum creatinine > 400 micromol/l or > 4.5 mg/dl were excluded.
Der er andre lægemidler tilgængelige til osteoporose-indikationer og behandling af Pagets knoglesygdom, som indeholder zoledronsyre som det aktive indholdsstof.
Other products containing zoledronic acid as active substances are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Indlægsseddel: Information til brugeren Zoledronsyre Actavis 4 mg/5 ml koncentrat til infusionsvæske, opløsning zoledronsyre
Package leaflet: Information for the user Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ} Andre informationskilder
This leaflet was last revised in {month YYYY}.
4.1 og 4.2, er blevet forbundet med rapporter om nedsat nyrefunktion.
Zoledronic acid, used as indicated in sections 4.1 and 4.2, has been associated with reports of renal dysfunction.
Mens du er i behandling med Zoledronsyre Actavis, skal du holde en god mundhygiejne (inkl.
While being treated with Zoledronic acid Actavis, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Du må ikke få Zoledronsyre Actavis, hvis du ammer.
You must not be given Zoledronic acid Actavis if you are breast-feeding.
(< 1,4 mg/dl eller < 124 mikromol/l).
1.0 mg/dl or 88 micromol/l.
55,6% (p = 0,021)* 83,3% (p = 0,010)* 86,7% (p = 0,015)*
Zoledronic acid 8 mg (N=90) 55.6% (p=0.021)* 83.3% (p=0.010)* 86.7% (p=0.015)* Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
4.1 og 4.2), og reaktionen er også refereret til ved brug af termerne ”influenza-lignende symptomer” eller ”symptomer efter dosering”.
The onset time is ≤ 3 days post-zoledronic acid infusion (used as indicated in sections 4.1 and 4.2), and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
10 x 5 ml hætteglas
10 x 5 ml vials
For at undgå eventuelle uforligeligheder skal der som infusionsvæske til fortynding enten bruges 0,9% w/v natriumchlorid- eller 5% w/v glucoseopløsning.
To avoid potential incompatibilities, the infusion solution used for dilution must be either 0.9% w/v sodium chloride or 5% w/v glucose solution.
Forværring af nyrefunktion blev i kliniske studier defineret som følger: - Øgning på 0,5 mg/dl eller 44 mikromol/l hos patienter med normal serum-kreatinin ved baseline
In the clinical trials, renal deterioration was defined as follows: - For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 micromol/l), an increase of 0.5 mg/dl or 44 micromol/l; - For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 micromol/l), an increase of
Svimmelhed, paræstesier, dysgeusi, hypæstesi, hyperæstesi, tremor, somnolens Kramper, hypæstesi og tetani (sekundært til hypokalcæmi)
Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Den rekonstituerede Zoledronsyre Actavis opløsning må ikke blandes med calciumholdige eller andre divalente kationholdige opløsninger som lakteret Ringers væske.
Do not mix Zoledronic acid Actavis concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Actavis Italy S.p.A Via Pastiur.
Actavis Italy S.p.A Via Pasteur, 10 20014 Nerviano (MI) Italy
Hvor ofte skal du have Zoledronsyre Actavis
How often Zoledronic acid Actavis is given
Hvordan får du Zoledronsyre Actavis
How to store Zoledronic acid Actavis
− Spørg lægen, apoteket eller sygeplejersken, hvis der er mere, du vil vide.
- If you have any further questions, ask your doctor, pharmacist or nurse.
Før indgift af Zoledronsyre Actavis skal patienterne vurderes med henblik på at sikre, de er vel hydrerede.
Patients must be assessed prior to administration of Zoledronic acid Actavis to ensure that they are adequately hydrated.
4.1 og 4.2, er en akut fasereaktion almindeligvis blevet indrapporteret med symptomer som knoglesmerter, feber, træthed, artralgi, myalgi, stivhed og artritis med efterfølgende hævelse af led.
Within three days after zoledronic acid administration, used as indicated in sections 4.1 and 4.2, an acute phase reaction has commonly been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Zoledronsyre Actavis 4 mg/5 ml koncentrat til infusionsvæske, opløsning rekonstitueret yderligere i 100 ml (se pkt.
Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Det skal du vide, før du får Zoledronsyre Actavis Sådan bliver du behandlet med Zoledronsyre Actavis Bivirkninger
What Zoledronic acid Actavis is and what it is used for What you need to know before you are given Zoledronic acid Actavis How Zoledronic acid Actavis is used Possible side effects
Koncentrat til infusionsvæske, opløsning (sterilt koncentrat) Klart og farveløst koncentrat til infusionsvæske, opløsning.
Concentrate for solution for infusion (sterile concentrate).
Hvor meget Zoledronsyre Actavis skal du have
How much Zoledronic acid Actavis is given
Zoledronsyre Actavis 4 mg/5 ml koncentrat til infusionsvæske, opløsning
Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion
Instruktion i fremstilling af reducerede doser Zoledronsyre Actavis Udtag en passende volumen af koncentratet efter følgende:
Instructions for preparing reduced doses of Zoledronic acid Actavis Withdraw an appropriate volume of the concentrate needed, as follows: - 4.4 ml for 3.5 mg dose
− Opbevar Zoledronsyre Actavis utilgængeligt for børn.
- Keep Zoledronic acid Actavis out of the sight and reach of children.
Øgninger i serumkreatinin og serumurea, hypocalcæmi
Blood creatinine and blood urea increased, hypocalcaemia
Zoledronsyre Actavis 4 mg/5 ml koncentrat til infusionsvæske, opløsning zoledronsyre
Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Placebo Δ Zoledronic
Placebo Zoledronic acid
Hvordan skal Zoledronsyre Actavis opbevares
How Zoledronic acid Actavis is given
Nedsat nyrefunktion, osteonekrose af kæberne, akut fasereaktion, hypocalcæmi, atrieflimren, anafylaksi, interstitiel lungesygdom.
The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Der er kun begrænsede farmakokinetiske data vedrørende patienter med svær nyreinsufficiens
Only limited pharmacokinetic data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
Infusionen bør vare mindst 15 minutter og skal gives som en enkelt intravenøs infusion i en separat infusionsslange.
- Zoledronic acid Actavis is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
Zoledronsyre Actavis, anvendt som indikeret under pkt.
What Zoledronic acid Actavis is and what it is used for
Hvid du ønsker yderligere oplysninger om Zoledronsyre Actavis, skal du henvende dig til den lokale repræsentant:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel 1A Pharma til Acino Pharma GmbH den 28. juli 2009.
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel 1A Pharma to Acino Pharma GmbH on 28 July 2009.
Ved akut koronarsyndrom anvendes Clopidogrel 1A Pharma sammen med aspirin, og behandlingen indledes almindeligvis med en startdosis på fire 75 mg-tabletter.
In acute coronary syndrome, Clopidogrel 1A Pharma is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Standarddosis af Clopidogrel 1A Pharma er 75 mg en gang dagligt med eller uden et måltid.
The standard dose of Clopidogrel 1A Pharma is one 75 mg tablet once a day, taken with or without food.
Clopidogrel 1A Pharma anvendes til forebyggelse af aterotrombotiske hændelser hos voksne (problemer forårsaget af blodpropper og åreforkalkning).
Clopidogrel 1A Pharma is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Clopidogrel 1A Pharma kan anvendes til patienter, som har myokardieinfarkt med ”forhøjelse af STsegmentet” (ST-elevation), dvs. en unormal visning på elektrokardiogrammet (EKG), når lægen vurderer, at patienterne kan have gavn af denne behandling.
Clopidogrel 1A Pharma can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment.
Det betyder, at Clopidogrel 1A Pharma er identisk med et referencelægemiddel, der allerede er godkendt i Den Europæiske Union, kaldet Plavix.
This means that Clopidogrel 1A Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel 1A Pharma i overensstemmelse med EU-kravene har vist sig at være af sammenlignelig kvalitet og at være bioækvivalent med Plavix.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel 1A Pharma has been shown to have comparable quality and to be bioequivalent to Plavix.
• patienter med perifere kredsløbsforstyrrelser (problemer med blodgennemstrømningen i
• patients with peripheral arterial disease (problems with blood flow in the arteries);
Behandling med Clopidogrel 1A Pharma kan påbegyndes få dage efter anfaldet og indtil 35 dage efter,
Clopidogrel 1A Pharma can be started between a few days and 35 days after the attack;
Da Clopidogrel 1A Pharma er et generisk lægemiddel, der er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Clopidogrel 1A Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Clopidogrel 1A Pharma er et lægemiddel, der indeholder det aktive stof clopidogrel.
Clopidogrel 1A Pharma is a medicine that contains the active substance clopidogrel.
Da Clopidogrel 1A Pharma er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
Because Clopidogrel 1A Pharma is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Hvilken fordel og risiko er der forbundet med Clopidogrel 1A Pharma?
What are the benefit and risk of Clopidogrel 1A Pharma?
Den fuldstændige EPAR for Clopidogrel 1A Pharma findes her.
The full EPAR for Clopidogrel 1A Pharma can be found here.
Behandlingen med Clopidogrel 1A Pharma kan påbegyndes 7 dage efter slagtilfældet og indtil 6 måneder efter,
Clopidogrel 1A Pharma can be started between seven days and six months after
Det aktive stof i Clopidogrel 1A Pharma, clopidogrel, er et blodpladeaggregationshæmmende middel.
The active substance in Clopidogrel 1A Pharma, clopidogrel, is an inhibitor of platelet aggregation.
Det fås som Clopidogrel 1A er et ‘generisk lægemiddel'.
Clopidogrel 1A Pharma is a ‘generic medicine'.
Hvordan anvendes Clopidogrel 1A Pharma?
How is Clopidogrel 1A Pharma used?
Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel
The Committee recommended that Clopidogrel 1A Pharma be given marketing authorisation.
Clopidogrel 1A Pharma kan gives til
Clopidogrel 1A Pharma can be given to the following groups of patients:
Hvordan virker Clopidogrel 1A Pharma?
What is Clopidogrel 1A Pharma?
Resultaterne var heterogene og inkonsekvente.
Results are heterogeneous and inconsistent.
Tilgængelige data tyder faktisk på en sådan årsagssammenhæng.
Available data is in fact indicative of such causal relationship.
Dets virkning skyldes primært dens α1blokerende egenskaber.
Its effect results mainly from its α1-blocking properties.
Benefit/risk-forholdet
Benefit -risk balance
Det giver et fald i blodtrykket og en stigning i det perifere blodomløb.
It produces a decrease in blood pressure and an increase in peripheral blood flow.
Sådanne bivirkningers sværhedsgrad og deres mulige dødelige udfald understreges.
The seriousness of such adverse effects and their possible fatal outcome is underlined.
Derfor anbefaler CHMP i henhold til artikel 116 i direktiv 2001/83/EF følgende:
Therefore, in accordance with Article 116 of Directive 2001/83/EC, the CHMP recommends:
Underrapportering kan også mistænkes, fordi stoffet har været på markedet i lang tid, og fordi fibrose allerede er nævnt som en bivirkning i produktinformationen.
Under-reporting can also be suspected because the substance has been on the market for a long time and because fibrosis is already mentioned as an undesirable effect in the product information.
Begrundelser for ændring/suspendering af betingelserne for markedsføringstilladelserne
Grounds for the variation/suspension to the terms of the marketing authorisations
Samlet resumé af den videnskabelige vurdering af lægemidler, der indeholder dihydroergocristin (se bilag I).
Overall summary of the scientific evaluation of dihydroergocristine containing medicinal products (see Annex I)
I Europa fås dihydroergocristin også i kombination med etofyllinum.
In Europe, dihydroergocristine is also available in combination with etofyllinum.
Den 18. januar 2012 indbragte Frankrig en sag i henhold til artikel 31 i direktiv 2001/83/EF for følgende lægemidler, der indeholder ergotderivater: dihydroergocryptin/koffein, dihydroergocristin, dihydroergotamin, dihydroergotoxin og nicergolin.
On 18 January 2012, France triggered a referral under Article 31 of Directive 2001/83/EC for the following ergot derivatives containing medicinal products: dihydroergocryptine/caffeine, dihydroergocristine, dihydroergotamine, dihydroergotoxine and nicergoline.