FrancophonIA/ELRC3.0 huggingface dataset:
English: Gabapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults.
Danish: Gabapentin er indiceret til behandling af perifere neuropatiske smerter såsom smertefuld diabetisk neuropati og post-herpetisk neuralgi, hos voksne.
English: Specialist advice should be given to women who are likely to become pregnant or who are of childbearing potential and the need for antiepileptic treatment should be reviewed when a woman is planning to become pregnant.
Danish: Nødvendigheden af antiepileptisk behandling bør revurderes, når en kvinde planlægger at blive gravid.
English: Grounds for amendments of the Summaries of Products Characteristics, labelling and Package leaflet
Danish: Begrundelser for ændringer af produktresuméer, etikettering og indlægsseddel
English: No systematic studies in patients 65 years or older have been conducted with gabapentin.
Danish: Gabapentin er ikke undersøgt systematisk til behandling af patienter på 65 år eller derover.
English: If you take more [Neurontin and associated names] than you should Call your doctor or go to the nearest hospital emergency unit immediately.
Danish: Hvis De tager mere [Neurontin og ledsagende navne] end De bør Kontakt straks lægen, skadestuen eller apoteket.
English: vomiting, nausea, dental abnormalities, gingivitis, diarrhea, abdominal pain, dyspepsia, constipation, dry mouth or throat, flatulence
Danish: opkastning, kvalme, tandmisdannelser, gingivitis, diarré, abdominalsmerter, dyspepsi, obstipation, tørhed i mund eller hals, flatulens
English: 300 mg (N = 7)
Danish: Farmakokinetisk parameter 300 mg (N = 7)
English: withdrawal reactions (mostly anxiety, insomnia, nausea, pains, sweating), chest pain.
Danish: seponeringssymptomer (oftest angst, søvnløshed, kvalme, smerter, svedtendens), brystsmerter.
English: Treatment of peripheral neuropathic pain
Danish: Behandling af perifere neuropatiske smerter
English: Following oral administration, peak plasma gabapentin concentrations are observed within 2 to 3 hours.
Danish: Gabapentins maksimale plasmakoncentration opnås inden for 2-3 timer efter oral administration.
English: • Decrease in white blood cells, increase in weight
Danish: • Fald i antal hvide blodlegemer, vægtøgning
English: The adverse reactions observed during clinical studies conducted in epilepsy (adjunctive and monotherapy) and neuropathic pain have been provided in a single list below by class and frequency (very common (> 1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100) and rare (>1/10,000; <1/1,000).
Danish: (meget almindelig (≥1/10), almindelig (≥1/100, <1/10), ikke almindelig (≥1/1000 og <1/100), sjælden (≥1/10.000 og <1/1000).
English: • Hallucinations
Danish: • Halluciationer
English: Driving and using machines [Neurontin and associated names] may produce dizziness, drowsiness and tiredness.
Danish: [Neurontin og ledsagende navne] kan give bivirkninger i form af svimmelhed, døsighed og træthed.
English: Pain sensations may be described as hot, burning, throbbing, shooting, stabbing, sharp, cramping, aching, tingling, numbness, pins and needles etc.
Danish: Smertefornemmelsen kan beskrives som varm, brændende, dunkende, jagende, skærende, skarp, krampagtig, smertende, snurrende, følelsesløs, prikkende og stikkende osv.
English: • Difficulty breathing, bronchitis, sore throat, cough, dry nose
Danish: • Vejrtrækningsbesvær, bronkitis, øm hals, hoste, tørre næseslimhinder
English: No effects were observed in pregnant mice given 500 mg/kg/day (approximately 1/2 of the daily human dose on a mg/m2 basis).
Danish: Der ses ingen effekt hos drægtige mus ved doser på 500 mg/kg/dag (ca. halvdelen af den daglige dosis til mennesker omregnet til mg/m2).
English: Teratogenesis
Danish: Teratogenicitet
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg hard capsule contains 100 mg of gabapentin.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 hård kapsel på 100 mg indeholder 100 mg gabapentin.
English: − if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of [Neurontin and associated names].
Danish: De bør ikke tage [Neurontin og ledsagende navne] - hvis De er allergisk (overfølsom) over for gabapentin eller et af de øvrige indholdsstoffer i
English: Regarding the indication in pain, the review of the previously available information and the review of the results of the newly conducted multicenter, placebo-controlled clinical study supports the use of Neurontin for the treatment of post-herpetic neuralgia and painful diabetic peripheral neuropathy.
Danish: Hvad angår indikationen smerter, underbygges anvendelsen af Neurontin til behandling af postherpetisk neuralgi og smertefuld diabetisk perifer neuropati dels af en gennemgang af de allerede forliggende oplysninger, dels af resultaterne af den nylig gennemførte placebokontrollerede kliniske multicenterundersøgelse.
English: leucopenia
Danish: leukopeni
English: HOW TO STORE [NEURONTIN AND ASSOCIATED NAMES] Keep out of the reach and sight of children.
Danish: HVORDAN DE OPBEVARER [NEURONTIN OG LEDSAGENDE NAVNE] Opbevares utilgængeligt for børn.
English: You should take [Neurontin and associated names] in addition to your current treatment unless told otherwise.
Danish: De skal tage [Neurontin og ledsagende navne] sammen med Deres nuværende behandling, medmindre lægen har fortalt Dem noget andet.
English: Gabapentin is excreted in human milk.
Danish: Gabapentin udskilles i modermælk.
English: Take special care with [Neurontin and associated names]
Danish: Vær særlig forsigtig med at anvende [Neurontin og ledsagende navne]
English: visual disturbances such as amblyopia, diplopia Ear and Labyrinth disorders Common:
Danish: synsforstyrrelser, som f.eks. amblyopi, diplopi Sygdomme i det ydre og det indre øre Almindelig:
English: HOW TO TAKE [NEURONTIN AND ASSOCIATED NAMES]
Danish: HVORDAN DE TAGER [NEURONTIN OG LEDSAGENDE NAVNE]
English: Each capsule, hard contains either 100 mg, 300 mg or 400 mg gabapentin.
Danish: 1 hård kapsel indeholder 100 mg, 300 mg eller 400 mg gabapentin.
English: Elimination pharmacokinetics (pharmacokinetic parameters which do not include F such as CLr and T1/2), are best described by linear pharmacokinetics.
Danish: Eliminationsfarmakokinetik (farmakokinetiske parametre, som ikke omfatter F, som f.eks. CLr og
English: Dosage adjustment is recommended in patients with compromised renal function as described in Table 2 and/or those undergoing haemodialysis.
Danish: Dosisjustering anbefales hos patienter med nedsat nyrefunktion, og/eller som er i hæmodialysebehandling.
English: • Accidental injury, fracture, abrasion
Danish: • Hændeligt uheld, knoglebrud, hudafskrabning
English: Pfizer Limited Ramsgate Road, Sandwich Kent, CT13 9NJ, UK
Danish: Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ, Storbritannien
English: Peripheral Neuropathic Pain:
Danish: Perifere neurogene smerter:
English: Neurontin and associated names 600 mg film-coated tablet Neurontin and associated names 800 mg film-coated tablet
Danish: Neurontin og ledsagende navne 600 mg filmovertrukne tabletter Neurontin og ledsagende navne 800 mg filmovertrukne tabletter
English: Eye disorders Common:
Danish: Øjensygdomme Almindelig:
English: Ramsgate Road Sandwich, Kent CT13 9NJ, UK
Danish: Ramsgate Road Sandwich, Kent CT13 9NJ, Storbritannien
English: − The other ingredients in [Neurontin and associated names] tablets are:
Danish: - De øvrige indholdsstoffer i [Neurontin og ledsagende navne] kapsler er: - De øvrige indholdsstoffer i [Neurontin og ledsagende navne] filmovertrukne tabletter er: [Udfyldes nationalt]
English: Common side-effects which may affect more than 1 person in 100 are listed below:
Danish: Almindelige bivirkninger, det forekommer hos mellem 1 og 10 ud af 100 patienter, er nævnt nedenfor:
English: Each 100 mg hard capsule contains 13 mg lactose (as monohydrate).
Danish: 1 hård kapsel på 100 mg indeholder 13 mg lactose (som monohydrat).
English: No definite conclusion can be made as to whether gabapentin is associated with an increased risk of congenital malformations when taken during pregnancy, because of epilepsy itself and the presence of concomitant antiepileptic medicinal products during each reported pregnancy.
Danish: Det kan ikke med sikkerhed konkluderes, om gabapentin er forbundet med en øget risiko for medfødte misdannelser, når det anvendes under graviditet.
English: Gabapentin steady-state pharmacokinetics are similar for healthy subjects and patients with epilepsy receiving these antiepileptic agents.
Danish: Gabapentins steady state farmakokinetik hos patienter med epilepsi i behandling med disse antiepileptika afviger ikke fra farmakokinetikken hos raske personer.
English: dyspnoea, bronchitis, pharyngitis, cough, rhinitis Gastrointestinal disorders Common:
Danish: dyspnø, bronkitis, pharyngitis, hoste, rhinitis
English: Use in patients undergoing haemodialysis
Danish: Patienter i hæmodialysebehandling
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 100 mg hard capsule contains 100 mg of gabapentin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hård kapsel på 100 mg indeholder 100 mg gabapentin.
English: Each 400 mg hard capsule contains 54 mg lactose (as monohydrate).
Danish: 1 hård kapsel på 400 mg indeholder 54 mg lactose (som monohydrat).
English: CT13 9NJ, UK
Danish: Kent, CT 13 9NJ Storbritannien
English: peripheral or generalized oedema, abnormal gait, asthenia, pain, malaise, flu syndrome
Danish: perifere eller generaliserede ødemer, gangforstyrrelser, asteni, smerter, utilpashed, influenzalignende symptomer
English: United Kingdom Pfizer Ltd. Ramsgate Road Sandwich
Danish: Pfizer Europe MA EEIG Ramsgate Road, Sandwich
English: When in the judgment of the clinician there is a need for dose reduction, discontinuation, or substitution with an alternative medication, this should be done gradually over a minimum of one week.
Danish: Det er op til den behandlende læge at vurdere, om det er nødvendigt at reducere dosis, seponere eller substituere behandlingen med et andet lægemiddel.
English: Each 300 mg hard capsule contains 41 mg lactose (as monohydrate).
Danish: 1 hård kapsel på 300 mg indeholder 41 mg lactose (som monohydrat).
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities
Danish: 6.1 Fortegnelse over hjælpestoffer [Udfyldes nationalt]
English: accidental injury, fracture, abrasion
Danish: Hændeligt uheld, fraktur, abrasio
English: These doses are approximately 1 to 5 times the human dose of 3600 mg on a mg/m2 basis.
Danish: Disse doser svarer til ca. 1-5 gange dosis til mennesker på 3600 mg omregnet til mg/m2 på basis af kroppens overfladeareal).
English: A statistically significant increase in the incidence of pancreatic acinar cell tumors was found only in male rats at the highest dose.
Danish: Hos hanrotter, der fik den højeste dosis, fandt man en statistisk signifikant stigning i forekomsten af acinære celletumorer i pankreas.
English: Neurontin and associated names 100 mg hard capsule
Danish: Neurontin og ledsagende navne 100 mg hårde kapsler
English: Rare side-effects which may affect less than 1 person in 1000 are listed below:
Danish: Sjældne bivirkninger, det forekommer hos mellem 1 og 10 ud af 10.000 patienter, er nævnt nedenfor:
English: hypertension, vasodilatation Respiratory, thoracic and mediastinal disorders Common:
Danish: Sygdomme i åndedrætsorganer, brysthule og mediastinum Almindelig:
English: Ramsgate Road, Sandwich Kent, CT 13 9NJ UK
Danish: Ramsgate Road, Sandwich Kent, CT13 9NJ, Storbritannien
English: Multiple antiepileptic drug therapy may be associated with a higher risk of congenital malformations than monotherapy, therefore it is important that monotherapy is practised whenever possible.
Danish: Behandling med flere antiepileptika er forbundet med en øget risiko for medfødte misdannelser end ved monoterapi.
English: Dosage adjustment in patients with compromised renal function or undergoing haemodialysis is recommended (see section 4.2).
Danish: Dosisjustering anbefales hos patienter med nedsat nyrefunktion samt hos patienter i behandling med hæmodialyse (se pkt.
English: The therapeutic indication of gabapentin as adjunctive epilepsy therapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above is well established.
Danish: Den terapeutiske indikation for gabapentin, supplerende behandling af partiel epilepsi, med eller uden sekundære, generaliserede anfald, hos voksne og unge over 12 år, er veldokumenteret.
English: Luxembourg Pfizer S.A.. Boulevard de la Plaine 17 B-1050
Danish: Pfizer S.A. Boulevard de la Plaine, 17
English: Each 800 mg film-coated tablet contains 800 mg of gabapentin.
Danish: 1 filmovertrukken tablet på 800 mg indeholder 800 mg gabapentin.
English: Each 400 mg hard capsule contains 400 mg of gabapentin.
Danish: 1 hård kapsel på 400 mg indeholder 400 mg gabapentin.
English: Each 300 mg hard capsule contains 300 mg of gabapentin.
Danish: 1 hård kapsel på 300 mg indeholder 300 mg gabapentin.
English: Neurontin and associated names 400 mg hard capsule
Danish: Neurontin og ledsagende navne 400 mg hårde kapsler
English: Neurontin and associated names 300 mg hard capsule
Danish: Neurontin og ledsagende navne 300 mg hårde kapsler
English: Each 600 mg film-coated tablet contains 600 mg of gabapentin.
Danish: 1 filmovertrukken tablet på 600 mg indeholder 600 mg gabapentin.
English: There have been no studies specifically looking at the use of gabapentin in pregnant women, but other medications used to treat seizures have reported an increased risk of harm to the foetus, particularly when more than one seizure medication is taken at the same time.
Danish: Anden medicin mod behandling af anfald har vist en øget risiko for at skade fosteret, især hvis der tages mere end en type medicin mod anfald på samme tid.
English: Additionally, in clinical studies in children, aggressive behaviour and hyperkinesias were reported commonly.
Danish: Derudover er aggressiv opførsel og hyperkinesi rapporteret som almindelig i kliniske undersøgelser hos børn.
English: On dialysis-free days, there should be no treatment with gabapentin.
Danish: På dage, hvor patienten ikke er i hæmodialysebehandling, bør gabapentin ikke anvendes.
English: Neurontin and associated names 100 mg hard capsules Neurontin and associated names 300 mg hard capsules Neurontin and associated names 400 mg hard capsules Neurontin and associated names 600 mg film-coated tablets Neurontin and associated names 800 mg film-coated tablets [See Annex I - To be completed nationally] Gabapentin
Danish: Neurontin og ledsagende navne 100 mg hårde kapsler Neurontin og ledsagende navne 300 mg hårde kapsler Neurontin og ledsagende navne 400 mg hårde kapsler Neurontin og ledsagende navne 600 mg filmovertrukne tabletter Neurontin og ledsagende navne 800 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt] Gabapentin
English: Each film-coated tablet contains either 600 mg or 800 mg gabapentin.
Danish: 1 filmovertrukken tablet indeholder 600 mg eller 800 mg gabapentin.
English: Pneumonia, respiratory infection, urinary tract infection, infection, otitis media Blood and the lymphatic system disorders Common:
Danish: pneumoni, luftvejsinfektion, urinvejsinfektion, infektion, otitis media
English: Neurontin and associated names 100 mg hard capsule Neurontin and associated names 300 mg hard capsule Neurontin and associated names 400 mg hard capsule Neurontin and associated names 600 mg film-coated tablet Neurontin and associated names 800 mg film-coated tablet Gabapentin [See Annex I - To be completed nationally]
Danish: Neurontin og ledsagende navne 100 mg hårde kapsler Neurontin og ledsagende navne 300 mg hårde kapsler Neurontin og ledsagende navne 400 mg hårde kapsler Neurontin og ledsagende navne 600 mg filmovertrukne tabletter Neurontin og ledsagende navne 800 mg filmovertrukne tabletter Gabapentin [Se bilag I - Udfyldes nationalt]
English: Peripheral neuropathic pain
Danish: Perifere neurogene smerter
English: Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1).
Danish: Gabapentin er indiceret til supplerende behandling af partiel epilepsi, med eller uden sekundære, generaliserede anfald, hos voksne og børn over 6 år (se afsnit 5.1).
English: • Adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain
Danish: • Bivirkninger, der skyldes pludselig stop i behandling med gabapentin (angst, søvnforstyrrelser,
English: palpitations
Danish: palpitationer
English: stomach pain, indigestion, constipation, dry mouth or throat, flatulence
Danish: fordøjelsesbesvær, forstoppelse, tør mund eller hals, luft i tarmen
English: These doses are approximately 1/4 to 8 times the daily human dose of 3600 mg on a mg/m2 basis.
Danish: Disse doser svarer til ca. 0,25-8 gange den daglige dosis til mennesker på 3600 mg omregnet til mg/m2 på basis af kroppens overfladeareal).
English: Gabapentin did not induce structural chromosome aberrations in mammalian cells in vitro or in vivo, and did not induce micronucleus formation in the bone marrow of hamsters.
Danish: Gabapentin har ikke fremkaldt mikronucleusdannelse i knoglemarven hos hamstere.
English: • Vomiting (being sick), nausea (feeling sick), problems with teeth, inflamed gums, diarrhoea,
Danish: • Opkastning, kvalme, tandproblemer, tandkødsbetændelse, diarré, mavesmerter,
English: Always take [Neurontin and associated names] exactly as your doctor has told you.
Danish: [Neurontin og ledsagende navne] bør altid tages i nøje overensstemmelse med Deres læges instruktioner.
English: Vascular disorder Common:
Danish: Gastrointestinale sygdomme Almindelig:
English: • High blood pressure, flushing or dilation of blood vessels
Danish: • Højt blodtryk, pludselig varmefølelse som skyldes udvidelse af blodkar i huden
English: Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above.
Danish: Gabapentin er som monoterapi indiceret til behandling af partiel epilepsi, med eller uden sekundære, generaliserede anfald hos voksne og unge på 12 år og derover.
English: • Swelling in the legs and arms or swelling that may involve the face, trunk and limbs, difficulty with walking, weakness, pain, feeling unwell, flu-like symptoms
Danish: • Hævede ben og arme eller hævelser i ansigtet, kroppen og lemmer, gangforstyrrelser, svaghed,
English: Blood glucose fluctuations in patients with diabetes, elevated liver function tests Injury and poisoning
Danish: Svingende blodsukkerniveau hos diabetikere, forhøjede levertal Skader, forgiftninger og komplikationer ved medicinske procedurer Almindelig:
English: The total daily dose should be divided in three single doses, the maximum time interval between the doses should not exceed 12 hours to prevent breakthrough convulsions.
Danish: For at undgå nye anfald bør der ikke gå mere end 12 timer mellem doserne.
English: Furthermore, attempts to withdraw concomitant anti-epileptics in treatment refractory patients on more than one anti-epileptic, in order to reach gabapentin monotherapy is not recommended as a low success rate is expected, as with other anti-epileptics.
Danish: Desuden kan det ikke anbefales, at man skifter til monoterapi med gabapentin ved at seponere sideløbende antiepileptika hos behandlingsrefraktære patienter i behandling med flere antiepileptika, da der som for andre antiepileptika må forventes en lav responsrate.
English: It is usually given in 3 divided doses, by taking the capsule(s) or tablet(s) each day, usually once in the morning, once in the afternoon and once in the evening.
Danish: Dosis skal fordeles på i alt 3 doser dagligt: 1 dosis om morgenen, 1 dosis om eftermiddagen og 1 dosis om aftenen.
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Danish: - Ønsker De mere information, så kontakt læge eller apotek.
English: Slower titration of gabapentin dosage may be appropriate for individual patients.
Danish: Hos nogle patienter kan det være nødvendigt med en langsommere titrering af gabapentindosis.
English: Thereafter, the dose may be increased stepwise up to a maximum of 3600 mg each day and your doctor will tell you to take this in 3 divided doses, i.e. once in the morning, once in the afternoon and once in the evening.
Danish: Denne dosis skal fordeles på i alt 3 doser dagligt: 1 dosis om morgenen, 1 dosis om eftermiddagen og 1 dosis om aftenen.
English: Mean %CV Mean %CV Mean %CV
Danish: 800 mg (N=14) gennemsnit %CV gennemsnit %CV gennemsnit %CV
English: “Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1).” An update of efficacy data in children has been made in section 5.1.
Danish: "Gabapentin er indiceret til supplerende behandling af partiel epilepsi, med eller uden generaliserede anfald, hos voksne og børn over 6 år (se afsnit 5.1)".
English: Additionally in clinical studies in children, aggressive behaviour and jerky movements were reported commonly.
Danish: Derudover er der set aggressiv opførsel og rykvise bevægelser i kliniske undersøgelser hos børn.
English: For all indications a titration scheme for the initiation of therapy is described in Table 1, which is recommended for adults and adolescents aged 12 years and above.
Danish: Denne behandlingsplan anbefales for voksne og unge på 12 år og derover.
English: • Inflammation of the pancreas
Danish: • Betændelse i bugspytkirtlen
English: Gabapentin is eliminated unchanged solely by renal excretion.
Danish: Gabapentin udskilles uomdannet gennem nyrerne.
English: If you are taking any medicines containing morphine, please tell your doctor or pharmacist as morphine may increase the effect of [Neurontin and associated names].
Danish: Morfin kan forstærke virkningen af [Neurontin og ledsagende navne].
English: Infections and infestations Very Common: Viral infection Common:
Danish: Almene lidelser og reaktioner på indgivelsesstedet Meget almindelig:
English: [Neurontin and associated names] may interfere with some laboratory tests, if you require a urine test tell your doctor or hospital that you are taking [Neurontin and associated names].
Danish: Oplys altid ved urinprøvekontrol, at De er i behandling med [Neurontin og ledsagende navne], da [Neurontin og ledsagende navne] kan påvirke visse laboratorieprøver.
English: WBC (white blood cell count) decreased, weight gain
Danish: nedsat antal hvide blodlegemer, vægtøgning,
English: What [Neurontin and associated names] looks like and contents of the pack
Danish: HVAD [NEURONTIN OG LEDSAGENDE NAVNE] ER, OG HVAD DET ANVENDES TIL
English: thrombocytopenia Immune system disorders Rare:
Danish: thrombocytopeni
English: Lithuania
Danish: Lithauen
English: BEFORE YOU TAKE [NEURONTIN AND ASSOCIATED NAMES]
Danish: HVAD DE SKAL GØRE, FØR DE BEGYNDER AT TAGE ANVENDE [NEURONTIN OG LEDSAGENDE NAVNE]
English: What [Neurontin and associated names] contains
Danish: [Neurontin og ledsagende navne].
English: No sudden discontinuation of antiepileptic therapy should be undertaken as this may lead to breakthrough seizures, which could have serious consequences for both mother and child. Developmental delay in children of mothers with epilepsy has been observed rarely.
Danish: Forsinket psykisk udvikling hos børn af mødre med epilepsi er set i sjældne tilfælde.
English: • Convulsions, jerky movements, difficulty with speaking, loss of memory, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation, difficulty with coordination, unusual eye movement, increased, decreased or absent reflexes
Danish: • Krampetrækninger, rykvise bevægelser, taleproblemer, hukommelsestab, rysten,
English: 11 December 2014
Danish: Den 11. december 2014
English: International non-proprietary name (INN): spiramycin
Danish: Internationalt fællesnavn (INN): spiramycin