natgillin/translations-raw huggingface dataset:
Udvalget konkluderede, at fordelene ved GANFORT er større end risiciene ved behandling af åbenvinklet glaukom eller okulær hypertension hos patienter, der ikke responderer tilstrækkeligt på topiske betablokkere eller prostaglandin- analoger.
They decided that GANFORT’ s benefits are greater than its risks for the treatment of open-angle glaucoma or ocular hypertension in patients who do not respond sufficiently to topical beta-blockers or prostaglandin analogues.
Udvalget anbefalede udstedelse af markedsføringstilladelse for GANFORT.
They recommended that GANFORT be given marketing authorisation.
Andre oplysninger om GANFORT:
Other information about GANFORT:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for GANFORT til Allergan Pharmaceuticals Ireland den 19. maj 2006.
The European Commission granted a marketing authorisation valid throughout the European Union for GANFORT to Allergan Pharmaceuticals Ireland on 19 May 2006.
Den europæiske offentlige vurderingsrapport (EPAR) for GANFORT kan ses i sin helhed her.
The full EPAR for GANFORT can be found here.
Dette sammendrag blev sidst ajourført i april 2006.
This summary was last updated in 04-2006.
EU/ 1/ 06/ 340/ 001
Package size
3 ml (300 µg/ ml + 5 mg/ ml) 3 flasker
Bottle (LDPE) 3 ml (300 µg/ ml + 5 mg/ ml) 1 bottle Bottle (LDPE) 3 ml (300 µg/ ml + 5 mg/ ml) 3 bottles
GANFORT 300 mikrogram/ ml + 5 mg/ ml øjendråber, opløsning
GANFORT 300 micrograms/ ml + 5 mg/ ml eye drops, solution
1 ml opløsning indeholder 0, 3 mg bimatoprost og 5 mg timolol (svarende til 6, 8 mg timololmaleat).
One ml of solution contains 0.3 mg of bimatoprost and 5 mg of timolol (as 6.8 mg of timolol maleate).
Lægemidlet indeholder benzalkoniumchlorid 0, 05 mg/ ml.
Contains benzalkonium chloride 0.05 mg/ ml.
Reduktion af det intraokulære tryk hos patienter med åbenvinklet glaukom eller okulær hypertension, som ikke responderer tilstrækkeligt på lokale betablokkere eller prostaglandinanaloger.
Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
Anbefalet dosering til voksne (inklusive ældre)
Recommended dosage in adults (including the elderly)
Den anbefalede dosis er 1 dråbe GANFORT i det eller de afficerede øjne 1 gang inddryppet om morgenen.
The recommended dose is one drop of GANFORT in the affected eye(s) once daily, administered in the morning.
Dosis må ikke overstige 1 dråbe i det/ de afficerede øje/ øjne dagligt.
The dose should not exceed one drop in the affected eye(s) daily.
Hvis flere lokalt virkende øjenlægemidler anvendes, bør inddrypning med dem ske med mindst 5 minutters mellemrum.
If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart.
Anvendelse til patienter med nedsat nyre - eller leverfunktion
Use in renal and hepatic impairment
GANFORT er ikke undersøgt hos patienter med nedsat lever - eller nyrefunktion.
GANFORT has not been studied in patients with hepatic or renal impairment.
Anvendelse til børn og unge (under 18 år)
Use in children and adolescents
GANFORT har kun været undersøgt hos voksne, og derfor kan anvendelse til små eller store børn ikke anbefales.
GANFORT has only been studied in adults and therefore its use is not recommended in children or adolescents.
Luftvejssygdomme inklusive reaktiv asthma bronchiale eller asthma bronchiale i anamnesen, alvorlig kronisk obstruktiv lungesygdom.
Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease.
Sinus bradykardi, 2. eller 3. grads atrioventrikulært blok, åbenbart hjertesvigt, kardiogent shock.
Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock.
Ligesom ved andre øjenmidler til lokalbehandling kan der forekomme systemisk absorption af GANFORT.
Like other topically applied ophthalmic agents, GANFORT may be absorbed systemically.
På grund af den beta- adrenerge komponent, timolol, kan der forekomme samme type kardiovaskulære og pulmonære bivirkninger, som ses ved systemiske betablokkere.
Due to the beta-adrenergic component, timolol, the same types of cardiovascular and pulmonary adverse reactions as seen with systemic beta-blockers may occur.
Hjertesvigt bør være velkontrolleret før indledning af behandling med GANFORT.
Cardiac failure should be adequately controlled before beginning GANFORT therapy.
Patienter med alvorlig hjertesygdom i anamnesen bør overvåges for tegn på hjertesvigt med måling af pulsfrekvens.
Patients with a history of severe cardiac disease should be watched for signs of cardiac failure and have their pulse rates checked.
Efter administration af timololmaleat er der rapporteret om hjerte - og åndedrætsreaktioner inklusive død på grund af bronkospasmer hos patienter med astma samt i sjældne tilfælde død i forbindelse med hjertesvigt.
Cardiac and respiratory reactions, including death due to bronchospasm in patients with asthma, and, rarely, death in association with cardiac failures have been reported following administration of timolol maleate.
Betablokkere kan også maskere tegn på hypertyreoidisme og medføre forværring af variant angina pectoris, alvorlige perifere og centrale kredsløbssygdomme og hypotension.
Beta-blockers may also mask the signs of hyperthyroidism and cause worsening of Prinzmetal angina, severe peripheral and central circulatory disorders and hypotension.
Adrenerge beta- receptorblokkere bør anvendes med forsigtighed til patienter, der lider af spontan hypoglykæmi, eller til diabetikere (især patienter med labil diabetes), da betablokkere kan maskere symptomer på akut hypoglykæmi.
Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) as beta-blockers may mask the signs and symptoms of acute hypoglycemia.
Under behandling med betablokkere kan patienter med atopi eller alvorlige anafylaktiske reaktioner på en række allergener i anamnesen udvise manglende respons på den sædvanlige dosis adrenalin til behandling af anafylaktiske reaktioner.
While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be unresponsive to the usual dose of adrenaline used to treat anaphylactic reactions.
Bimatoprost medførte ingen nedsættelse af leverfunktionen efter 24 måneders brug hos patienter med mild leversygdom eller abnorm alanin- aminotransferase (ALAT), aspartat- aminotransferase (ASAT) og/ eller bilirubin ved baseline.
In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/ or bilirubin at baseline, bimatoprost had no adverse reactions on liver function over 24 months.
Før behandlingen påbegyndes skal patienten oplyses om muligheden for vækst af øjenvipper, mørkfarvning af øjenlågshuden og øget irispigmentering, eftersom dette har været observeret ved behandling med bimatoprost og GANFORT.
Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation since these have been observed during treatment with bimatoprost and GANFORT.
Nogle af disse ændringer kan være permanente og kan føre til forskelle i øjnenes udseende, når kun det ene øje behandles.
Some of these changes may be permanent, and may lead to differences in appearance between the eyes if only one eye is treated.
Efter 12 måneders behandling med GANFORT var incidensen af irispigmentering 0, 2%.
After 12 months treatment with GANFORT, the incidence of iris pigmentation was 0.2%.
Efter 12 måneders behandling med bimatoprost øjendråber alene var incidensen 1, 5%, og den steg ikke efter 3 års behandling.
After 12 months treatment with bimatoprost eye drops alone, the incidence was 1.5% and did not increase following 3 years treatment.
Cystoidt makulaødem er forekommet med GANFORT.
Cystoid macular oedema has been reported with GANFORT.
GANFORT bør derfor anvendes med forsigtighed til patienter med kendt risiko for makulaødem (fx afakiske patienter, pseudofakiske patienter med rift i den bageste linsekapsel).
Therefore, GANFORT should be used with caution in patients with known risk factors for macular oedema (e. g. aphakic patients, pseudophakic patients with a torn posterior lens capsule).
Benzalkoniumchlorid kan misfarve bløde kontaktlinser og må ikke komme i kontakt med denne linsetype.
Contact with soft contact lenses must be avoided.
Benzalkoniumchlorid er blevet rapporteret at forårsage punktformet keratopati og/ eller toksisk ulcerøs keratopati.
Benzalkonium chloride has been reported to cause punctate keratopathy and/ or toxic ulcerative keratopathy.
3 4. 5 Interaktion med andre lægemidler og andre former for interaktion
3 4.5 Interaction with other medicinal products and other forms of interaction
Der er potentiale for additiv virkning, som fører til hypotension og/ eller markant bradykardi, når øjendråber med timolol administreres samtidig med perorale calciumantagonister, guanethidin eller betablokkere, antiarytmika, digitalisglykosider eller parasympatomimetika.
There is a potential for additive effects resulting in hypotension, and/ or marked bradycardia when eye drops containing timolol are administered concomitantly with oral calcium channel blockers, guanethidine, or beta-blocking agents, anti-arrhythmics, digitalis glycosides or parasympathomimetics.
4. 4).
Beta-blockers can mask the signs and symptoms of hypoglycaemia (see section 4.4).
Den hypertensive reaktion på pludselig seponering af clonidin kan blive potenseret ved anvendelse af betablokkere.
The hypertensive reaction to sudden withdrawal of clonidine can be potentiated when taking beta-blockers.
Graviditet Der foreligger ikke tilstrækkelige data fra anvendelse af GANFORT til gravide kvinder.
Pregnancy There are no adequate data from the use of GANFORT in pregnant women.
Bimatoprost Der foreligger ikke tilstrækkelige kliniske data om eksponering under graviditet.
Bimatoprost No adequate clinical data in exposed pregnancies are available.
5. 3).
Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3).
Timolol Epidemiologiske undersøgelser har ikke dokumenteret bivirkninger i form af misdannelser, men har påvist en risiko for intrauterin væksthæmning ved peroral administration af betablokkere.
Timolol Epidemiological studies have not revealed malformative effects but shown a risk for intra uterine growth retardation when beta-blockers are administered by the oral route.
Endvidere er der observeret symptomer på betablokade (fx bradykardi, hypotension, åndenød og hypoglykæmi) hos den nyfødte, når moderen har fået betablokkere frem til fødslen.
In addition, signs and symptoms of beta-blockade (e. g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery.
5. 3).
Animal studies with timolol have shown reproductive toxicity at doses significantly higher than would be used in clinical practice (see section 5.3).
GANFORT bør derfor ikke anvendes under graviditet, med mindre det er klart nødvendigt.
Consequently, GANFORT should not be used during pregnancy unless clearly necessary.
Amning Timolol udskilles i modermælk.
Lactation Timolol is excreted in breast milk.
Stoffet udskilles dog i rottemælk.
It is not known if bimatoprost is excreted in human breast milk but it is excreted in the milk of the lactating rat.
GANFORT har kun ubetydelig indflydelse på evnen til at føre bil eller betjene maskiner.
GANFORT has negligible influence on the ability to drive and use machines.
Ligesom med enhver øjenbehandling skal patienten, hvis synet bliver sløret efter administration, vente med at køre bil eller betjene maskiner, til synet er klart igen.
As with any ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.
I kliniske forsøg er der ikke observeret bivirkninger specifikt for GANFORT.
No adverse drug reactions (ADRs) specific for GANFORT have been observed in clinical studies.
Bivirkninger begrænser sig til de tidligere indberettede bivirkninger for bimatoprost og timolol.
The ADRs have been limited to those earlier reported for bimatoprost and timolol.
De fleste bivirkninger var okulære og af lettere grad, og ingen var alvorlige.
The majority of ADRs were ocular, mild in severity and none were serious.
26% af patienterne og førte til seponering hos 1, 5% af patienterne.
Based on 12-month clinical data, the most commonly reported ADR was conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in approximately 26% of patients and led to discontinuation in 1.5% of patients.
4 Følgende bivirkninger blev indberettet i kliniske forsøg med GANFORT (inden for hver angivelse af hyppighed angives bivirkningerne med faldende sværhedsgrad):
The following ADRs were reported during clinical trials with GANFORT (within each frequency grouping, undesirable effects are presented in order of decreasing seriousness):
Hovedpine
4 Nervous system disorders Uncommon (≥ 1/ 1000 to < 1/ 100): headache
Øjensygdomme Meget almindelige (≥1/ 10):
Eye disorders Very common (≥ 1/ 10): conjunctival hyperaemia, growth of eyelashes.
Almindelige (≥1/ 100 til < 1/ 10):
Common (≥ 1/ 100 to < 1/ 10): superficial punctuate keratitis, corneal erosion, burning sensation, eye pruritus, stinging sensation in the eye, foreign body sensation, eye dryness, eyelid erythema, eye pain, photophobia, eye discharge, visual disturbance, eyelid pruritus.
Usædvanlige (≥1/ 1000 til < 1/ 100):
Uncommon (≥ 1/ 1000 to < 1/ 100): iritis, eye irritation, conjunctival oedema, blepharitis, epiphora, eyelid oedema, eyelid pain, visual acuity worsened, asthenopia, trichiasis.
Cystoidt makulaødem.
Not known: cystoid macular oedema.
Rinit
Respiratory, thoracic and mediastinal disorders Uncommon (≥ 1/ 1000 to < 1/ 100): rhinitis
Hirsuitisme
Skin and subcutaneous tissue disorders Common (≥ 1/ 100 to < 1/ 10): blepharal pigmentation Uncommon (≥ 1/ 1000 to < 1/ 100): hirsutism
Andre bivirkninger, som er forekommet i forbindelse med en af komponenterne, og som muligvis også vil kunne forekomme med GANFORT:
Additional adverse events that have been seen with one of the components and may potentially occur also with GANFORT:
Bimatoprost Infektiøse og parasitære sygdomme:
Bimatoprost Infections and infestations: infection (primarily colds and upper respiratory symptoms).
Allergisk konjunktivitis, katarakt, mørkfarvning af øjenlåg, øget irispigmentering, blepharospasmus, øjenlågsretraktion, retinal blødning, uveitis.
Nervous system disorders: dizziness Eye disorders: allergic conjunctivitis, cataract, eyelash darkening, increased iris pigmentation, blepharospasm, eyelid retraction, retinal haemorrhage, uveitis.
Hypertension.
Vascular disorders: hypertension.
Asteni, perifert ødem.
General disorders and administration site condition: asthenia, peripheral oedema.
Unormale leverfunktionsprøver.
Investigations: liver function tests (LFT) abnormal.
Nedsat følsomhed i cornea, diplopi, ptose, koroidalløsning (efter tabekulektomi), refraktive forandringer (i visse tilfælde på grund af indstilling af behandling af miosis).
Timolol Psychiatric disorders: insomnia, nightmares, decreased libido Nervous system disorders: dizziness, memory loss, increase in signs and symptoms of myasthenia gravis, paresthaesia, cerebral ischaemia Eye disorders: decreased corneal sensitivity, diplopia, ptosis, choroidal detachment (following filtration surgery), refractive changes (due to withdrawal of miotic therapy in some cases), keratitis.
Sygdomme i det ydre og det indre øre:
Ear and labyrinth disorders: tinnitus.
Karsygdomme:
Cardiac disorders: heart block, cardiac arrest, arrhythmia, syncope, bradycardia, cardiac failure, congestive heart failure.
Sygdomme i åndedrætsorganer, brysthule og mediastinum:
Vascular disorders: hypotension, cerebrovascular accident, claudication, Raynaud’ s phenomenon, cold hands and feet, palpitation.
Gastrointestinale sygdomme:
Respiratory, thoracic and mediastinal disorders: bronchospasm (predominantly in patients with pre- existing bronchospastic disease) dyspnoea, cough.
Sygdomme i hud og subkutane væv:
Gastrointestinal disorders: nausea, diarrhoea, dyspepsia, dry mouth.
Alopeci, psoriasiformt udslæt eller forværring af psoriasis.
Skin and subcutaneous tissue disorders: alopecia, psoriasiform rash or exacerbation of psoriasis.
Sygdomme i bevægeapparatet og bindevæv:
Musculoskeletal and connective tissue disorders: systemic lupus erythematosus.
Systemisk lupus erythematosus Sygdomme i nyrer og urinveje:
Renal and urinary disorders:
Peyronies sygdom.
Peyronie’ s disease.
Ødem, brystsmerter, træthed.
General disorders and administration site conditions: oedema, chest pain, fatigue.
5 4. 9 Overdosering
4.9 Overdose
I 2- ugers perorale rotte - og museforsøg fremkaldte doser på op til 100 mg/ kg/ dag ikke toksicitet.
Bimatoprost If GANFORT is accidentally ingested, the following information may be useful: in two-week oral rat and mouse studies, doses of bimatoprost up to 100 mg/ kg/ day did not produce any toxicity.
Denne dosis udtrykt i mg/ m2 er mindst 70 gange højere end den ved et uheld indtagne dosis af 1 flaske GANFORT hos et barn, der vejer 10 kg.
This dose 5 expressed as mg/ m2 is at least 70-times higher than the accidental dose of one bottle of GANFORT in a 10 kg child.
Timolol Symptomer på systemisk overdosering af timolol er bradykardi, hypotension, bronkospasme, hovedpine, svimmelhed, kortåndethed og hjertestop.
Timolol Symptoms of systemic timolol overdose are: bradycardia, hypotension, bronchospasm, headache, dizziness, shortness of breath, and cardiac arrest.
Et forsøg med patienter viste, at timolol ikke var let dialyserbart.
A study of patients showed that timolol did not dialyse readily.
Øjenmidler – betablokerende midler – timolol, kombinationer, ATC- kode:
Ophthalmological – beta-blocking agents – timolol, combinations, ATC code:
S01ED51
S01ED 51
GANFORT indeholder to aktive stoffer: bimatoprost og timololmaleat.
GANFORT consists of two active substances: bimatoprost and timolol maleate.
Bimatoprost er meget virksomt til sænkning af det intraokulære tryk.
Bimatoprost is a potent ocular hypotensive agent.
Den virkningsmekanisme, hvorved bimatoprost nedsætter det intraokulære tryk hos mennesker, er ved at øge kammervandsafløbet gennem trabekelværket og øge det uveosclerale afløb.
The mechanism of action by which bimatoprost reduces intraocular pressure in man is by increasing aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral outflow.
Den nøjagtige virkemåde er ikke helt afklaret, men beror sandsynligvis på hæmning af den øgede cAMP- syntese, som skyldes endogen beta- adrenerg stimulation.
The precise mechanism of action is not clearly established, but inhibition of the increased cyclic AMP synthesis caused by endogenous beta-adrenergic stimulation is probable.
Kliniske virkninger:
Clinical effects:
GANFORTs IOT- sænkende virkning er ikke ringere end virkningen af samtidig behandling med bimatoprost (en gang daglig) og timolol (to gange daglig).
The IOP-lowering effect of GANFORT is non-inferior to that achieved by adjunctive therapy of bimatoprost (once daily) and timolol (twice daily).
Der foreligger ingen undersøgelser, hvor GANFORT administreres om aftenen.
There are no studies with evening dosing of GANFORT.
Det anbefales derfor at anvende GANFORT om morgenen for at sikre maksimal IOT- sænkende virkning på tidspunktet for fysiologisk stigning i IOT.
Morning dosing of GANFORT is therefore recommended to ensure maximal IOP-lowering effect at the time of the physiological IOP rise.
Hvis det er nødvendigt af hensyn til patientkompliance, kan anvendelse om aftenen dog overvejes.
However, if necessary for patient compliance, an evening dosing may be considered.
En daglig dosis timolol 0, 5% opnår hurtigt maksimal virkning, som falder sammen med tidspunktet for denne stigning, og bevarer en klinisk betydelig IOT- sænkning over 24 timer.
Once-daily dosing of timolol 0.5% has a rapid onset of maximal effect, corresponding with the time of this rise, and maintains clinically meaningful IOP-lowering over the 24-hour period.
Undersøgelser af bimatoprost viser, at IOT- kontrol er omtrent den samme uanset anvendelse om morgenen eller aftenen.
Bimatoprost studies show comparable IOP control regardless of morning or evening dosing.
Plasmakoncentrationer af bimatoprost og timolol blev bestemt i et crossover- forsøg med sammenligning af monoterapibehandling og GANFORTbehandling hos raske forsøgspersoner.
Plasma bimatoprost and timolol concentrations were determined in a crossover study comparing the monotherapy treatments to GANFORT treatment in healthy subjects.
I de to 12- måneders undersøgelser med måling af systemisk absorption sås ingen akkumulering af de enkelte komponenter.
6 In two 12-month studies where systemic absorption was measured, no accumulation was observed with either of the individual components.
Bimatoprost Bimatoprost gennemtrænger human cornea og sclera godt in vitro.
Bimatoprost penetrates the human cornea and sclera well in vitro.
Efter okulær administration er den systemiske eksponering for bimatoprost meget lave med ingen akkumulering over tiden.
After ocular administration, the systemic exposure of bimatoprost is very low with no accumulation over time.
Efter 1 daglig okulær administration af 1 dråbe 0, 03% bimatoprost i begge øjne i 2 uger toppede blodkoncentrationer inden for 10 minutter efter dosering og faldt til under den laveste påviselige grænse (0, 025 mg/ ml) inden for 1, 5 time efter applikation.
After once daily ocular administration of one drop of 0.03% bimatoprost to both eyes for two weeks, blood concentrations peaked within 10 minutes after dosing and declined to below the lower limit of detection (0.025 ng/ ml) within 1.5 hours after dosing.
0, 08 ng/ ml og 0, 09 ng• t/ ml, hvilket angiver, at en stabil lægemiddelkoncentration blev nået i løbet af den første uges okulære administration.
Mean Cmax and AUC 0-24hrs values were similar on days 7 and 14 at approximately 0.08 ng/ ml and 0.09 ng• hr/ ml respectively, indicating that a steady drug concentration was reached during the first week of ocular dosing.
Bimatoprost distribueres moderat i legemsvæv, og den systemiske distributionsvolumen hos mennesker ved stabil tilstand var 0, 67 l/ kg.
Bimatoprost is moderately distributed into body tissues and the systemic volume of distribution in humans at steady-state was 0.67 1/ kg.
Plasmaproteinbindingen af bimatoprost er ca.
In human blood, bimatoprost resides mainly in the plasma.
88%.
The plasma protein binding of bimatoprost is approximately 88%.
Bimatoprost er den vigtigste cirkulerende art i blodet, ved den systemiske cirkulation efter okulær administration.
Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation following ocular dosing.
Bimatoprost gennemgår oxydering, N- deethylering og glucuronisering for at danne en række forskellige metabolitter.
Bimatoprost then undergoes oxidation, N-deethylation and glucuronidation to form a diverse variety of metabolites.
Bimatoprost elimineres primært ved udskillelse gennem nyrerne, op til 67% af en intravenøs dosis administreret til raske frivillige forsøgspersoner blev udskilt i urinen, 25% af dosen blev udskilt via fæces.
Bimatoprost is eliminated primarily by renal excretion, up to 67% of an intravenous dose administered to healthy volunteers was excreted in the urine, 25% of the dose was excreted via the faeces.
45 minutter, den totale blod- clearance var 1, 5 l/ t/ kg.
The elimination half-life, determined after intravenous administration, was approximately 45 minutes; the total blood clearance was 1.5 1/ hr/ kg.
Egenskaber hos ældre patienter:
Characteristics in elderly patients: