natgillin/translations-raw huggingface dataset:
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).
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).
Øget forekomst af hydroureter og/ eller hydronefrose ses hos rotter, der får 2000 mg/ kg/ dag i en fertilitetsundersøgelse og generel reproduktionsundersøgelse, 1500 mg/ kg/ dag i et teratologiforsøg og 500, 100 og 2000 mg/ kg/ dag i et perinatal - og postnatalforsøg.
An increased incidence of hydroureter and/ or hydronephrosis was observed in rats given 2000 mg/ kg/ day in a fertility and general reproduction study, 1500 mg/ kg/ day in a teratology study, and 500, 1000, and 2000 mg/ kg/ day in a perinatal and postnatal study.
Disse doser svarer til ca.
The significance of these findings is unknown, but they have been associated with delayed development.
1- 5 gange dosis til mennesker på 3600 mg omregnet til mg/ m2 på basis af kroppens overfladeareal).
These doses are also approximately 1 to 5 times the human dose of 3600 mg on a mg/ m2 basis.
Disse doser svarer til ca.
In a teratology study in rabbits, an increased incidence of post-implantation fetal loss, occurred in doses given 60, 300, and 1500 mg/ kg/ day during organogenesis.
0, 25– 8 gange den daglige dosis til mennesker på 3600 mg omregnet til mg/ m2 på basis af kroppens overfladeareal).
These doses are approximately 1/ 4 to 8 times the daily human dose of 3600 mg on a mg/ m2 basis.
37 6. 1 Fortegnelse over hjælpestoffer
6.1 List of excipients
Kapsler:
Capsules:
Findes også som en titreringspakning til behandling af neurogene smerter, som indeholder 40 x 300 mg kapsler og 10 x 600 mg tabletter.
36 Also supplied as a titration pack for treatment of neuropathic pain containing 40 x 300 mg capsules and 10 x 600 mg tablets.
38 ETIKETTERING
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
XX kapsler eller XX tabletter
XX capsules or XX tablets
42 INDLÆGSSEDDEL
42 PACKAGE LEAFLET:
43 INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
INFORMATION FOR THE USER
information, bør De fortælle det til Deres læge eller apotek.
It may harm them, even if their symptoms are the same as yours. − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Hvad [Neurontin og ledsagende navne] er, og hvad det anvendes til 2.
What [Neurontin and associated names] is and what it is used for 2.
Hvad De skal gøre, før De begynder at tage [Neurontin og ledsagende navne] 3.
Before you take [Neurontin and associated names] 3.
Hvordan De tager [Neurontin og ledsagende navne] 4.
How to take [Neurontin and associated names] 4.
Hvilke mulige bivirkninger [Neurontin og ledsagende navne] har 5.
Possible side effects 5.
Hvordan De opbevarer [Neurontin og ledsagende navne] 6.
How to store [Neurontin and associated names] 6.
HVAD [NEURONTIN OG LEDSAGENDE NAVNE] ER, OG HVAD DET ANVENDES TIL
WHAT [NEURONTIN AND ASSOCIATED NAMES] IS AND WHAT IT IS USED FOR
[Neurontin og ledsagende navne] anvendes til behandling af visse former for epilepsi (kramper, der i starten er begrænset til visse dele af hjernen, hvad enten kramperne spreder sig til andre dele af hjernen eller ej).
[Neurontin and associated names] is used to treat various forms of epilepsy (seizures that are initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not).
Perifere neurogene smerter:
Peripheral neuropathic pain:
[Neurontin og ledsagende navne] anvendes til behandling af langvarige smerter, som skyldes beskadigede nervebaner.
[Neurontin and associated names] is used to treat long lasting pain caused by damage to the nerves.
Flere forskellige sygdomme kan være årsag til disse perifere neurogene smerter (opstår hovedsageligt i arme og/ eller ben), f. eks. diabetes eller helvedesild.
A variety of different diseases can cause peripheral (primarily occurring in the legs and/ or arms) neuropathic pain, such as diabetes or shingles.
De bør ikke tage [Neurontin og ledsagende navne]
Do not take [Neurontin and associated names] − if you are allergic (hypersensitive) to gabapentin or any of the other ingredients of [Neurontin and associated names].
- hvis De får vedvarende mavesmerter, får kvalme eller kaster op, skal De straks kontakte lægen.
Take special care with [Neurontin and associated names] − if you suffer from kidney problems − if you develop signs such as persistent stomach pain, feeling sick and being sick contact your doctor immediately.
Det gælder også for medicin, som ikke er på recept.
43 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Ved for hurtigt ophør af behandlingen kan der opstå gennembrudsanfald, der kan være farlige for både mor og barn.
Do not suddenly discontinue taking this medicine as this may lead to breakthrough seizure, which could have serious consequences for you and your baby.
De bør derfor ikke tage [Neurontin og ledsagende navne], hvis De ammer.
Because the effect on the nursing infant is unknown, it is not recommended to breast-feed your baby while using [Neurontin and associated names].
45 [Neurontin og ledsagende navne] bør altid tages i nøje overensstemmelse med Deres læges instruktioner.
HOW TO TAKE [NEURONTIN AND ASSOCIATED NAMES] 44 Always take [Neurontin and associated names] exactly as your doctor has told you.
Hvis De er ældre (over 65 år), skal De tage [Neurontin og ledsagende navne] som normalt, medmindre De har nyreproblemer.
If you are an elderly patient (over 65 years of age), you should take [Neurontin and associated names] normally except if you have problems with your kidneys.
Deres læge kan have anvist en anden doseringsvejledning og/ eller dosis, hvis De har nyreproblemer.
Your doctor may prescribe a different dosing schedule and/ or dose if you have problems with your kidneys.
Startdosis er normalt 300- 900 mg dagligt.
The starting dose will generally be between 300 mg and 900 mg each day.
1 dosis om morgenen, 1 dosis om eftermiddagen og 1 dosis om aftenen.
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.
Tag det antal kapsler eller tabletter, som lægen har ordineret.
Take the number of capsules or tablets as instructed.
Behandlingen vil starte med en lav startdosis, som gradvist vil blive øget over en periode på cirka 3 dage.
The dose to be given to your child will be decided by your doctor as it is calculated against your child’ s weight.
Den normale dosis til kontrol af epilepsi er 25- 35 mg/ kg dagligt.
The treatment is started with a low initial dose which is gradually increased over a period of approximately 3 days.
Denne dosis skal fordeles på i alt 3 doser dagligt:
The usual dose to control epilepsy is 25-35 mg/ kg/ day.
1 dosis om morgenen, 1 dosis om eftermiddagen og 1 dosis om aftenen.
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.
Hvis De holder op med at tage [Neurontin og ledsagende navne] De må ikke stoppe med at tage [Neurontin og ledsagende navne], medmindre Deres læge har bedt Dem herom.
45 Do not stop taking [Neurontin and associated names] unless your doctor tells you to.
46 Spørg Deres læge eller apotek, hvis De har yderligere spørgsmål.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
HVILKE MULIGE BIVIRKNINGER [NEURONTIN OG LEDSAGENDE NAVNE] HAR
POSSIBLE SIDE EFFECTS
• Virusinfektion • Følelse af døsighed, svimmelhed, manglende koordination • Følelse af træthed, feber
• Viral infection • Feeling drowsy, dizziness, lack of coordination • Feeling tired, fever
• Lungebetændelse, luftvejsinfektion, urininfektion, infektion, betændelse i øret • Lavt antal hvide blodlegemer • Appetitmangel, øget appetit • Vrede over for andre, forvirring, humørsvingninger, depression, angst, nervøsitet, vanskelighed ved at tænke • Krampetrækninger, rykvise bevægelser, taleproblemer, hukommelsestab, rysten, søvnforstyrrelser, hovedpine, følsom hud, nedsat berøringsfølelse, koordinationsforstyrrelser, usædvanlige øjenbevægelser, forstærkede, nedsatte eller fraværende reflekser • Sløret syn, dobbeltsyn • Svimmelhed • Højt blodtryk, pludselig varmefølelse som skyldes udvidelse af blodkar i huden • Vejrtrækningsbesvær, bronkitis, øm hals, hoste, tørre næseslimhinder • Opkastning, kvalme, tandproblemer, tandkødsbetændelse, diarré, mavesmerter, fordøjelsesbesvær, forstoppelse, tør mund eller hals, luft i tarmen • Hævelser i ansigt, blå mærker, udslæt, kløe, bumser • Ledsmerter, muskelsmerter, rygsmerter, muskeltrækninger • Inkontinens • Rejsningsproblemer • Hævede ben og arme eller hævelser i ansigtet, kroppen og lemmer, gangforstyrrelser, svaghed, smerter, følelse af at være utilpas, influenzalignende symptomer • Fald i antal hvide blodlegemer, vægtøgning • Hændeligt uheld, knoglebrud, hudafskrabning
• Pneumonia, respiratory infection, urinary tract infection, infection, inflammation of the ear • Low white blood cell counts • Anorexia, increased appetite • Anger towards others, confusion, fluctuation in mood, depression, anxiety, nervousness, difficulty with thinking • 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 • Blurred vision, double vision • Vertigo • High blood pressure, flushing or dilation of blood vessels • Difficulty breathing, bronchitis, sore throat, cough, dry nose • Vomiting (being sick), nausea (feeling sick), problems with teeth, inflamed gums, diarrhoea, stomach pain, indigestion, constipation, dry mouth or throat, flatulence • Facial swelling, bruises, rash, itch, acne • Joint pain, muscle pain, back pain, twitching • Incontinence • Difficulties with erection • 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 • Decrease in white blood cells, increase in weight • Accidental injury, fracture, abrasion
Sjældne bivirkninger, det forekommer hos mellem 1 og 10 ud af 10. 000 patienter, er nævnt nedenfor:
Rare side-effects which may affect less than 1 person in 1000 are listed below:
• Nedsat antal blodplader (får blodet til at størkne) • Allergiske reaktioner som f. eks. nældefeber • Halluciationer • Problemer med abnorme bevægelser, såsom vridninger, rykvise bevægelser og stivhed • Ringen for ørerne • Hjertebanken • Betændelse i bugspytkirtlen • Leverbetændelse, gulfarvning af huden og øjnene • Alvorlige allergiske reaktioner, som straks kræver lægehjælp, opsvulming af læber og ansigt, hududslæt og rødme, hårtab
• Decreased platelets (blood clotting cells) • Allergic reaction such as hives • Hallucinations • Problems with abnormal movements such as writhing, jerking movements and stiffness • Ringing in the ears • Racing heartbeat • Inflammation of the pancreas • Inflammation of the liver, yellowing of the skin and eyes • Severe skin reactions that require immediate medical attention, swelling of the lips and face, skin rash and redness, hair loss • Acute kidney failure
47 • Akut nyresvigt • Bivirkninger, der skyldes pludselig stop i behandling med gabapentin (angst, søvnforstyrrelser, får kvalme, smerter, svedtendens), brystsmerter • Svingende blodsukkerniveau hos diabetikere, abnorme blodprøveresultater, som tyder på leverproblemer.
46 • Adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain • Blood glucose fluctuations in patients with diabetes, abnormal blood test results suggesting problems with the liver.
HVORDAN DE OPBEVARER [NEURONTIN OG LEDSAGENDE NAVNE]
HOW TO STORE [NEURONTIN AND ASSOCIATED NAMES]
Hvad [Neurontin og ledsagende navne] indeholder
What [Neurontin and associated names] contains
- Det aktive stof er gabapentin.
− The active substance is gabapentin.
1 hård kapsel indeholder 100 mg, 300 mg eller 400 mg
Each capsule, hard contains either 100 mg, 300 mg or 400 mg gabapentin.
- De øvrige indholdsstoffer i [Neurontin og ledsagende navne] kapsler er:
− The other ingredients in [Neurontin and associated names] capsules are:
- De øvrige indholdsstoffer i [Neurontin og ledsagende navne] filmovertrukne tabletter er:
− The other ingredients in [Neurontin and associated names] tablets are:
Produktets udseende og pakningstørrelse
What [Neurontin and associated names] looks like and contents of the pack
Hårde kapsler
Capsule, hard
Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne:
Austria
48 Østrig Belgien Cypern Tjekkiet Danmark Estonia Finland Frankrig Tyskland Grækenland Ungarn Island Irland Italien Letland Lithauen Luxemburg Malta Holland Norge Polen Portugal Slovakiet Slovenien Spanien Sverige Storbritannien
Czech Republic Neurontin Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy
Neurontin Neurontin Neurontin Neurontin Gabapentin ” Pfizer ” Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin
Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin Neurontin
London, den 4. august 2006 EMEA/ CHMP/ 142335/ 2006
London, 4 August 2006 EMEA/ CHMP/ 142335/ 2006
Neurontin og tilknyttede navne (se bilag I)
Neurontin and associated names (See Annex I)
Gabapentin er strukturelt knyttet til neurotransmitteren GABA (gamma- aminosmørsyre) og interagerer med GABA- synapser.
Gabapentin is structurally related to the neurotransmitter GABA (gamma- aminobutyric acid) and interacts with GABA synapses.
Den 2. september 2004 indbragte Italien (Agencizia Italiana del Farmaco) en sag for EMEA i henhold til artikel 30 i direktiv 2001/ 83/ EF med henblik på at harmonisere de nationalt godkendte produktresuméer, indlægssedler og etiketteringer for lægemidlet Neurontin og tilknyttede navne.
On 2nd September 2004, Italy (Agencizia Italiana del Farmaco) presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, in order to harmonise the nationally authorised summaries of product characteristics, PL and labelling of the medicinal product Neurontin and associated names.
Grundlaget for indbringelsen af sagen var, at der var afvigelser mellem de produktresuméer for Neurontin (og tilknyttede navne), der var godkendt i de forskellige EU- medlemsstater, Island og Norge, især med hensyn til indikationer, dosering, kontraindikationer, bivirkninger og de afsnit, som omhandler anbefalingerne om anvendelsen, som følge af divergerende nationale beslutninger.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Neurontin (and associated names) approved across EU Member States, Iceland and Norway, in particular with respect to indications, posology, contra-indications, undesirable effects and sections dealing with the recommendations for use due to divergent national decisions.
Indehaveren af markedsføringstilladelsen fremsendte yderligere oplysninger den 20. april 2005, den 20. december 2005, den 27. marts 2006 og den 9. maj 2006.
The Marketing Authorisation Holder provided supplementary information on 20 April 2005, 20 December 2005, 27 March 2006 and 9 May 2006.
På mødet den 29. maj – 1. juni 2006 var CHMP på baggrund af de samlede fremlagte oplysninger og den faglige drøftelse i udvalget af den opfattelse, at forslaget om harmonisering af produktresuméet, etiketteringen og indlægssedlen var acceptabelt, og at disse følgelig skulle ændres.
During its 29 May – 1 June 2006 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet was acceptable and that they should be amended.
Europa- Kommissionen traf en afgørelse den 4. august 2006.
A Decision was issued by the European Commission on 4 August 2006.
London, den 3. april 2006 EMEA/ CHMP/ 106563/ 2006
London, 03 April 2006 EMEA/ CHMP/ 106563/ 2006
21 FOR
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
Nifedipine Pharmamatch 30 og 60 mg
OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Nifedipine Pharmamatch 30 and 60 mg International Non-Proprietary Name (INN):
Nifedipine Pharmamatch, depottabletter 30 og 60 mg (nifedipin), er en calciumantagonist af 1, 4- dihydropyridintypen, som anvendes til symptomatisk behandling af kronisk, stabil angina pectoris som monoterapi eller kombineret med en beta- blokker samt til behandling af patienter med let til moderat essentiel hypertension.
Nifedipine Pharmamatch 30 and 60 mg prolonged release tablets (nifedipine) is 1,4 – dihydropyridine calcium antagonist used for symptomatic treatment of chronic stable angina pectoris as monotherapy or in combination with a beta-blocker and in the treatment of patients with light to moderate essential hypertension.
Forskellene i afsnit 4. 3 og 4. 6 blev anset for at give anledning til alvorlig betænkelighed vedrørende folkesundheden.
The differences in section 4.3 and 4.6 were considered to be of serious public health concern.
I afsnit 4. 3 og 4. 6 i produktresuméet for referenceproduktet i Det Forenede Kongerige angives, at produktet er kontraindiceret ved graviditet, for fødedygtige kvinder og for kvinder, der ammer.
Section 4.3 and 4.6 of the SPC of the reference product in the UK contains the information that the product is contraindicated in pregnancy, for women capable of child- bearing or for nursing mothers.
På mødet i januar 2006 fandt CHMP på baggrund af alle de forelagte oplysninger og den faglige drøftelse i udvalget, at benefit- risk forholdet er gunstigt for Nifedipine Pharmamatch, depottabletter, 30 og 60 mg, at de af Det Forenede Kongerige rejste indvendinger ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
During the January 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Nifedipine Pharmamatch retard 30 and 60 mg tablets, that the objections raised by United Kingdom should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Den endelige udtalelse blev omarbejdet til en beslutning af Europa- Kommissionen den 3. april 2006.
The final opinion was converted into a Decision by the European Commission on 03 April 2006.
1 Artikel 29, stk. 2 i direktiv 2001/ 83/ EF, som ændret.
1 Article 29(2) of Directive 2001/ 83/ EC, as amended.
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGER, INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
1/ 44 Indehaver af Medlemsstat
1/ 44
markedsføringstilladelse
Marketing Authorisation
Depottablet
prolonged-release tablets
Forenede Kongerige af Storbritannien og Nordirland
United Kingdom
2/ 44 BILAG II
2/ 44 ANNEX II
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEER, ETIKETTERING OG INDLÆGSSEDLER FREMLAGT AF EMEA
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
3/ 44 FAGLIGE KONKLUSIONER
3/ 44 SCIENTIFIC CONCLUSIONS
SAMLET RESUME AF DEN FAGLIGE VURDERING AF NIFEDIPINE PHARMAMATCH RETARD 30/ 60 mg og tilknyttede navne (se bilag I)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF NIFEDIPINE PHARMAMATCH RETARD 30/ 60 mg and associated names (See Annex I)
Det kan forekomme, at andre behandlingsalternativer ikke er egnede, eller at calciumantagonister godt kan administreres sammen med andre lægemidler efter nøje evaluering af benefit/ risk- forholdet.
There are situations when other treatment alternatives are not suitable or where calcium antagonists are appropriate to include in a combination of different drugs after careful benefit/ risk evaluation.
Det er et faktum, at der på EU- markedet findes nifedipine- produkter, som hverken er kontraindicerede under graviditet eller for kvinder i den fødedygtige alder.
It is a fact that there are nifedipine products on the EU market which are not contraindicated neither in pregnancy nor in women capable of child bearing.
Det konkluderes, at ansøgerens foreslåede advarsel til kvinder i den fødedygtige alder under afsnit 4. 6 ” Graviditet og amning ” er relevant og tilstrækkelig.
In conclusion, the warning related to women of childbearing potential proposed by the applicant in section 4.6 Pregnancy and lactation is relevant and sufficient.
Den foreslåede ordlyd i afsnit 4. 6. i produktresuméet om at undgå amning, når det skønnes nødvendigt, er derfor tilstrækkelig.
Thus, the proposed wording in section 4.6. of the SmPC to avoid breastfeeding during treatment when necessary, is sufficient.
Det konkluderes, at benefit/ risk- forholdet begunstiger den opfattelse, at nifedipine til kvinder i den fødedygtige alder eller til ammende kvinder ikke bør kontraindiceres.
In conclusion, the benefit/ risk ratio favours the opinion that the use of nifedipine should not be contraindicated for women capable of childbearing or for nursing women.
- formålet med henvisningen var at opnå enighed om, hvorvidt nifedipine bør kontraindiceres til
- The scope of the referral was to agree whether nifedipine should be contraindicated for
kvinder i den fødedygtige alder og til ammende kvinder, og at ændre produktresuméet på grundlag af de foreliggende oplysninger om sikkerhed,
women capable of childbearing or for nursing women and to amend the Summary of Products Characteristics in view of the available safety data
- det af ansøgeren foreslåede produktresumé, etikettering og indlægsseddel er blevet vurderet på
- The Summary of Products Characteristic, labelling and package leaflet proposed by the
grundlag af den forelagte dokumentation, den faglige drøftelse i udvalget og den foreslåede ordlyd i den ajourførte udgave af Guideline on Summary of Product Characteristics fra oktober 2005 og de seneste QRD- modeller (version 7),
applicant has been assessed based on the documentation submitted, the scientific discussion within the Committee and the new wording proposed in the updated Guideline on SPC dated October 2005 and the latest QRD templates version 7
Produktresumé, etikettering og indlægsseddel fremgår af bilag III.
The CHMP has recommended the granting of the Marketing Authorisation(s) for which the Summaries of Product Characteristics, labelling and package leaflet are set out in Annex III for Nifedipinr Pharmamatch Retard 30/ 60 mg and associated names (see Annex I).
4/ 44 BILAG III
4/ 44 ANNEX III
PRODUKTRESUME
5/ 44 SUMMARY OF PRODUCT CHARACTERISTICS
Nifedipine Pharmamatch retard 30 mg depottabletter
Nifedipine Pharmamatch retard 30 mg prolonged-release tablets
Hver depottablet indeholder 30 mg nifedipin.
Each prolonged release tablet contains 30 mg nifedipine.
Rød jernoxid (E172):.
Red iron oxide (E172):
farvestof farvestof
colouring aid
En liste over alle hjælpestoffer
For a full list of excipients,
er anført under pkt.
see section 6.1.
4. 1 Terapeutiske indikationer Symptomatisk behandling af kronisk stabil angina pectoris som eneste behandling eller sammen med en beta- blokker.
4.1 Therapeutic indications Symptomatic treatment of chronic stable angina pectoris as monotherapy or in combination with a beta-blocker.