natgillin/translations-raw huggingface dataset:
Patienter, der lider af phenylketonuri, bør være opmærksomme på, at hver 4 mg tyggetablet indeholder phenylalanin i en mængde svarende til 0, 674 mg phenylalanin pr. dosis.
Patients with phenylketonuria should take into account that each 4 mg chewable tablet contains phenylalanine in an amount equivalent to 0.674 mg phenylalanine per dose.
Montelukast forventes ikke at påvirke patientens evne til at køre bil eller betjene maskiner.
Montelukast is not expected to affect a patient’ s ability to drive a car or operate machinery.
1750 pædiatriske astmapatienter i alderen 6- 14 år, og • 4 mg tyggetabletter hos 851 pædiatriske patienter i alderen 2- 5 år.
10 mg film-coated tablets in approximately 4000 adult patients 15 years of age and older 5 mg chewable tablets in approximately 1750 paediatric patients 6 to 14 years of age, and 4 mg chewable tablets in 851 paediatric patients 2 to 5 years of age.
Følgende lægemiddelrelaterede bivirkninger i kliniske undersøgelser er rapporteret som almindelige (≥1/ 100 til < 1/ 10) hos astmapatienter behandlet med montelukast og med en højere incidens end hos patienter behandlet med placebo.
29 The following drug-related adverse reactions in clinical studies were reported commonly (≥ 1/ 100 to < 1/ 10) in patients treated with montelukast and at a greater incidence than in patients treated with placebo:
Pædiatriske
Paediatric Patients
Voksne
Adult Patients
patienter
6 to 14 years old
patienter 6- 14 år
2 to 5 years old
patienter 2- 5 år
Body System Class
15 år og ældre
15 years and older
(Én 8- ugers
(one 8-week study;
(Én 12- ugers
(one 12-week study;
(To 12- ugers
(two 12-week studies;
undersøgelse; n=201)
n=201)
undersøgelse; n=461)
n=461)
SYSTEMORGANKLASSE undersøgelser; n=795)
n=795)
(To 56 ugers
(two 56 week studies; n=615)
Almene symptomer og reaktioner på
Nervous system
admini -
disorders
Tørst
headache
strationsstedet
headache
Abdominalsmerter
disorders General disorders and
Abdominalsmerter
abdominal pain
Hovedpine
administration site conditions
Hovedpine
thirst
Psykiske forstyrrelser:
Immune system disorders: hypersensitivity reactions including anaphylaxis, hepatic eosinophilic infiltration.
Abnorme drømme inklusive mareridt, hallucinationer, søvnløshed, psykomotorisk hyperaktivitet (inklusive irritabilitet, rastløshed, ophidselse med aggressivadfærd, tremor), depression, i meget sjældne tilfælde selvmordstanker og - adfærd (suicidal adfærd).
Psychiatric disorders: dream abnormalities including nightmares, hallucinations, insomnia, psychomotor hyperactivity (including irritability, restlessness, agitation including aggressive behaviour, and tremor), depression, suicidal thinking and behaviour (suicidality) in very rare cases.
61 mg/ kg for et 42 måneder
These include reports in adults and children with a dose as high as 1000 mg 30 (approximately 61 mg/ kg in a 42 month old child).
I undersøgelser hos voksne viste montelukast 10 mg, en gang dagligt, sammenlignet med placebo, signifikant forbedring i morgen FEV1 (10, 4% versus 2, 7% ændring fra baseline), morgenekspiratorisk peak flow hastighed (PEFR) (24, 5 l/ min versus 3, 3 l/ min ændring fra baseline) og signifikant fald i total brug af β- agonist (- 26, 1% versus - 4, 6% ændring fra baseline).
In studies in adults, montelukast, 10 mg once daily, compared with placebo, demonstrated significant improvements in morning FEV1 (10.4% vs 2.7% change from baseline), AM peak expiratory flow rate (PEFR) (24.5 L/ min vs 3.3 L/ min change from baseline), and significant decrease in total β -agonist use (-26.1% vs -4.6% change from baseline).
Undersøgelser hos voksne viste montelukasts evne til at supplere den kliniske effekt af inhalationskortikosteroider (% - ændring fra baseline for inhalationsbeclomethason plus montelukast versus beclomethason, henholdsvis for FEV1:
Studies in adults demonstrated the ability of montelukast to add to the clinical effect of inhaled corticosteroid (% change from baseline for inhaled beclomethasone plus montelukast vs beclomethasone, respectively for FEV1:
Montelukast forbedrede signifikant dagsymptomer (herunder hoste, hivende vejrtrækning, åndedrætsbesvær og 30 indskrænket aktivitet) samt natlige symptomer i forhold til placebo.
Montelukast improved daytime symptoms (including coughing, wheezing, trouble breathing and activity limitation) and nighttime symptoms compared with placebo.
Montelukast nedsatte ligeledes p. n. brug af β- agonist og akut kortikosteroidbehandling til forværret astma i forhold til placebo.
Montelukast also decreased "as-needed" β -agonist use and
Patienter, der fik montelukast, havde flere dage uden astma end de patienter, der fik placebo.
Patients receiving montelukast had more days without asthma than those receiving placebo.
En 12- ugers undersøgelse hos voksne viste signifikant reduktion i anstrengelsesudløst bronkokonstriktion (maksimalt fald i FEV1 22, 33% for montelukast versus 32, 40% for placebo; tid til restitution til inden for 5% af baseline FEV1 44, 22 min versus 60, 64 min).
Significant reduction of exercise-induced bronchoconstriction (EIB) was demonstrated in a 12-week study in adults (maximal fall in FEV1 22.33% for montelukast vs 32.40% for placebo; time to recovery to within 5% of baseline FEV1 44.22 min vs 60.64 min).
Reduktion i anstrengelsesudløst bronkokonstriktion 31 blev også vist i en korttidsundersøgelse hos børn i alderen 6- 14 år (maksimalt fald i FEV1 18, 27% versus 26, 11%; tid til restitution til inden for 5% af baseline FEV1 17, 76 min versus 27, 98 min).
Reduction in EIB was also demonstrated in a short term study in paediatric patients 6 to 14 years of age (maximal fall in FEV1 18.27% vs 26.11%; time to recovery to within 5% of baseline FEV1 17.76 min vs 27.98 min).
Effekten i begge undersøgelser blev vist i slutningen af doseringsintervallet ved en dosis en gang dagligt.
The effect in both studies was demonstrated at the end of the once-daily dosing interval.
Distribution:
Distribution.
Biotransformation:
Biotransformation.
32 Ved høje doser af montelukast (20 og 60 gange den anbefalede voksendosis) sås fald i plasmateofyllinkoncentrationen.
With high doses of montelukast (20- and 60-fold the recommended adult dose), a decrease in plasma theophylline concentration was observed.
I undersøgelser med kaniner sås højere forekomst af ukomplet ossifikation sammenlignet med kontrolgruppen ved systemisk påvirkning > 24 gange større end den kliniske, systemiske påvirkning set ved klinisk dosis.
In studies in rabbits, a higher incidence of incomplete 33 ossification, compared with concurrent control animals, was seen at systemic exposure > 24-fold the clinical systemic exposure seen at the clinical dose.
Der sås ingen dødsfald efter oral enkeltadministration af montelukastnatrium i doser op til 5000 mg/ kg hos mus og rotter (henholdsvis 15. 000 mg/ m2 og 30. 000 mg/ m2 hos mus og rotter), den maksimale testede dosis.
No deaths occurred following a single oral administration of montelukast sodium at doses up to 5000 mg/ kg in mice and rats (15,000 mg/ m2 and 30,000 mg/ m2 in mice and rats, respectively), the maximum dose tested.
Mannitol Mikrokrystallinsk cellulose Hydroxypropylcellulose (E463) Rød jernoxid (E172) Croscarmellosenatrium Kirsebæraroma Aspartam (E951) Magnesiumstearat.
Mannitol Microcrystalline cellulose Hyprolose (E 463) Red ferric oxide (E 172) Croscarmellose sodium Cherry flavour Aspartame (E 951) Magnesium stearate
33 Pakket i polyamid/ PVC/ aluminium blisterpakning.
Packaged in polyamide/ PVC/ aluminum blister package in:.
Blister i pakker med 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 og 200 tabletter.
7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 and 200 tablets.
Blister (unit doser) i pakker med 49, 50 og 56 tabletter.
49, 50 and 56 tablets.
[Udfyldes nationalt]
34 [TO BE COMPLETED NATIONALLY]
ETIKETTERING
35 LABELLING
SINGULAIR 4 mg granulat – Ydre karton
SINGULAIR 4 mg Granules– Outer Carton
SINGULAIR 4 mg granulat montelukast Til børn fra 6 måneder til 5 år.
SINGULAIR 4 mg granules montelukast For children 6 months to 5 years of age
Granulat 7 x 1 brev 20 x 1 brev 28 x 1 brev 30 x 1 brev
Granules 7 x 1 sachet 20 x 1 sachet 28 x 1 sachet 30 x 1 sachet
Opbevares i den originale yderpakning for at beskytte mod lys/ fugt.
Store in the original package in order to protect from light and moisture.
37 [Udfyldes nationalt]
37 10.
SINGULAIR 4 mg granulat
SINGULAIR 4 mg granules
SINGULAIR 4 mg granulat – Brev
SINGULAIR 4 mg Granules - Sachet
SINGULAIR 4 mg granulat montelukast
SINGULAIR 4 mg granules montelukast
[Udfyldes nationalt]
{Name of the Marketing Authorisation Holder} [To be completed nationally]
SINGULAIR 4 mg tabletter – Ydre karton
SINGULAIR 4 mg Tablets – Outer Carton
SINGULAIR 4 mg tyggetabletter montelukast Til børn fra 2 til 5 år.
SINGULAIR 4 mg chewable tablets montelukast For children 2 to 5 years of age
En tyggetablet indeholder montelukastnatrium svarende til 4 mg montelukast.
One chewable tablet contains montelukast sodium, which is equivalent to 4 mg montelukast.
Indeholder aspartam (E951).
Contains aspartame (E 951).
7, 10, 14, 20, 28, 30, 49, 50, 56, 98, 100, 140, 200 tyggetabletter
7, 10, 14, 20, 28, 30, 49, 50, 56, 98, 100, 140, 200 chewable tablets.
40 [Udfyldes nationalt]
40 10.
SINGULAIR 4 mg tabletter – Blister
SINGULAIR 4 mg tablets - Blister
SINGULAIR 4 mg tyggetablet
SINGULAIR 4 mg chewable tablet
montelukast
montelukast
42 INDLÆGSSEDDEL
42 PACKAGE LEAFLET
Læs denne indlægsseddel grundigt, inden Deres barn begynder at tage medicinen.
Read all of this leaflet carefully before your child starts taking this medicine. • Keep this leaflet.
- Spørg lægen eller på apoteket, hvis der er mere, De vil vide.
You may need to read it again. • If you have any further questions, please ask your doctor or pharmacist. • This medicine has been prescribed for your child.
- Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller Deres barn får bivirkninger,
It may harm them, even if their symptoms are the same as your child’ s. • 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.
SINGULAIRs virkning og hvad De skal bruge det til 2.
What SINGULAIR is and what it is used for 2.
Det skal De vide, før Deres barn begynder at tage SINGULAIR 3.
Before SINGULAIR is taken 3.
Sådan skal Deres barn tage SINGULAIR 4.
How to take SINGULAIR 4.
Sådan opbevarer De SINGULAIR 6.
How to store SINGULAIR 6.
SINGULAIR er en leukotrienreceptor- antagonist, der blokerer visse stoffer (leukotriener) i kroppen.
SINGULAIR is a leukotriene receptor antagonist that blocks substances called leukotrienes.
Lægen har foreskrevet SINGULAIR til behandling af Deres barns astma og til at forhindre astmasymptomer om dagen og om natten.
Your doctor has prescribed SINGULAIR to treat your child’ s asthma, preventing asthma symptoms during the day and night.
• SINGULAIR er til behandling af patienter i alderen 6 måneder- 5 år, der ikke er tilstrækkeligt behandlet med deres nuværende medicin, og som har brug for yderligere behandling. • SINGULAIR kan også anvendes som behandling i stedet for kortikosteroider som inhalation til patienter i alderen 2- 5 år, som ikke for nylig har taget kortikosteroidtabletter mod deres astma, og som har vist, at de ikke er i stand til at anvende kortikosteroider som inhalation. • SINGULAIR hjælper også til at forebygge forsnævring af luftvejene ved fysisk aktivitet hos patienter i alderen 2 år og ældre.
• SINGULAIR is used for the treatment of 6 months to 5 year old patients who are not adequately controlled on their medication and need additional therapy. • SINGULAIR may also be used as an alternative treatment to inhaled corticosteroids for 2 to 5 year old patients who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids. • SINGULAIR also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.
Særlige kendetegn for astma er: • Forsnævring af luftvejene som gør vejrtrækningen besværlig.
Asthma includes: • difficulty breathing because of narrowed airways.
Denne forsnævring kan ændres som reaktion på forskellige forhold. • Følsomme luftveje som reagerer på mange ting, for eksempel cigaretrøg, pollen, kold luft eller fysisk aktivitet. • Betændelse i luftvejene; det vil sige, der opstår hævelse af luftvejene.
This narrowing of airways worsens and improves in response to various conditions. • sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise. • swelling (inflammation) in the lining of the airways.
44 Symptomer på astma er:
44 2.
DET SKAL DE VIDE, FØR DERES BARN BEGYNDER AT TAGE SINGULAIR
BEFORE SINGULAIR IS TAKEN
Fortæl Deres læge om alle helbredsproblemer, som De har nu eller har haft.
Tell your doctor about any medical problems or allergies your child has now or has had.
Giv ikke SINGULAIR til Deres barn
Do not give SINGULAIR to your child if he/ she
• Hvis Deres barn er allergisk (overfølsom) over for montelukast eller et af de øvrige indholdsstoffer i SINGULAIR (se 6.
• is allergic (hypersensitive) to montelukast or any of the other ingredients of SINGULAIR (see 6.
• Fortæl det straks til lægen, hvis Deres barns astma eller vejrtrækning bliver værre.
• If your child’ s asthma or breathing gets worse, tell your doctor immediately.
• SINGULAIR- tabletter er ikke beregnet til behandling af akutte astmaanfald.
• Oral SINGULAIR is not meant to treat acute asthma attacks.
De skal altid have Deres barns inhalationsmedicin til astmaanfald med Dem.
Always have your child’ s inhaled rescue medicine for asthma attacks with you.
• Hvis Deres barn er i behandling med astmamedicin, bør De kontakte lægen, hvis barnet udvikler en kombination af influenzalignende symptomer, stikkende og prikkende eller sovende fornemmelser i arme eller ben og/ eller udslæt.
• If your child is on anti-asthma medicines, be aware that if the he/ she develops a combination of symptoms such as flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/ or rash, you should consult your doctor.
• Deres barn bør ikke tage acetylsalicylsyre (aspirin), hvis astmaen bliver værre af aspirin eller anden nonsteroid anti- inflammatorisk medicin (visse former for smertestillende medicin).
• Your child should not take acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/ her asthma worse.
Fortæl det til lægen hvis Deres barn tager følgende medicin, før De begynder at give SINGULAIR:
Please tell your doctor or pharmacist if your child is taking or has recently taken other medicines, including those obtained without a prescription.
phenobarbital (mod epilepsi) phenytoin (mod epilepsi) rifampicin (mod tuberkulose og andre infektioner)
Tell your doctor if your child is taking the following medicines before starting SINGULAIR: • phenobarbital (used for treatment of epilepsy) • phenytoin (used for treatment of epilepsy) • rifampicin (used to treat tuberculosis and some other infections)
Brug af SINGULAIR sammen med mad og drikke
Taking SINGULAIR with food and drink
Følgende information er dog relevant for det aktive stof, montelukast.
This subsection is not applicable for the SINGULAIR 4 mg granules since they are intended for use in children 6 months to 5 years of age, however the following information is relevant to the active ingredient, montelukast.
45 Graviditet Hvis De er gravid eller planlægger at blive gravid, bør De kontakte lægen, før de tager SINGULAIR.
45 Use in pregnancy
Amning Man ved ikke, om SINGULAIR udskilles i modermælk.
It is not known if SINGULAIR appears in breast milk.
Hvis De ammer eller planlægger at amme, bør De kontakte lægen, før De tager SINGULAIR.
You should consult your doctor before taking SINGULAIR if you are breast-feeding or intend to breast-feed.
Der er i meget sjældne tilfælde set bivirkninger (såsom svimmelhed og døsighed) med SINGULAIR, som kan påvirke evnen til at køre bil eller betjene maskiner.
Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with SINGULAIR may affect some patients’ ability to drive or operate machinery.
SÅDAN SKAL DERES BARN TAGE SINGULAIR
HOW TO TAKE SINGULAIR
• Denne medicin bør gives til et barn under opsyn af en voksen person. • Deres barn skal tage SINGULAIR hver aften. • Deres barn skal også tage granulatet, selvom barnet ikke har symptomer eller hvis han/ hun har et akut astmaanfald. • Barnet skal altid tage granulatet efter lægens anvisning.
Your child should take SINGULAIR every evening. • It should be taken even when your child has no symptoms or if he/ she has an acute asthma attack. • Always have your child take SINGULAIR as your doctor has told you.
Er De i tvivl så spørg barnets læge eller apoteket. • Tag granulatet gennem munden.
You should check with your child’ s doctor or pharmacist if you are not sure. • To be taken by mouth
Børn (6 måneder til 5 år):
For children 6 months to 5 years of age:
Ét brev SINGULAIR 4 mg granulat, der skal tages gennem munden hver aften.
One sachet of SINGULAIR 4 mg granules to be taken by mouth each evening.
Til børn i alderen 2- 5 år fås SINGULAIR 4 mg tyggetabletter og SINGULAIR 4 mg granulat.
For children 2 to 5 years old, SINGULAIR 4 mg chewable tablets and SINGULAIR 4 mg granules are available.
SINGULAIR 4 mg granulat bør normalt ikke anvendes til børn under 6 måneder.
The SINGULAIR 4 mg granules formulation is not recommended below 6 months of age.
Sådan giver De SINGULAIR til Deres barn • Åben ikke brevet med granulatet, før De er klar til at bruge det
How should I give SINGULAIR granules to my child?
• De kan give SINGULAIR enten: • Direkte i munden • ELLER blandet med en skefuld koldt eller tempereret, blødt mad (f. eks. æblemos, is,
• Do not open the sachet until ready to use.
gulerødder og
• SINGULAIR granules can be given either:
ris).
o o OR
• Man skal sikre sig, at barnet straks får hele skefulden af granulat/ madblandingen (inden for 15 minutter).
46 • Be sure the child is given the entire spoonful of the granule/ food mixture immediately (within 15 minutes).
Gem aldrig en blanding af mad og granulat til senere brug.
Never store any granule/ food mixture for use at a later time.
46 • SINGULAIR granulat kan tages uden hensyn til tidspunktet for indtagelse af mad.
• SINGULAIR granules can be taken without regard to the timing of food intake.
Hvis Deres barn har taget for meget SINGULAIR Kontakt straks barnets læge for at få rådgivning.
If your child takes more SINGULAIR than he/ she should
I de fleste tilfælde med overdosering er der ikke indberettet bivirkninger.
Contact your child’ s doctor immediately for advice.
De mest almindelige symptomer set i forbindelse med overdosering hos voksne og børn er:
There were no side effects reported in the majority of overdose reports.
Mavesmerter, søvnighed, tørst, hovedpine, opkastning og hyperaktivitet.
The most frequently occurring symptoms reported with overdose in adults and children included abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity.
Hvis De har glemt at give SINGULAIR til Deres barn Giv SINGULAIR, som lægen har foreskrevet.
Try to give SINGULAIR as prescribed.
Hvis De har glemt at give Deres barn en dosis, skal De blot genoptage behandlingen og fortsætte med én tablet én gang dagligt.
However, if your child misses a dose, just resume the usual schedule of one sachet once daily.
Hvis Deres barn holder op med at tage SINGULAIR
If your child stops taking SINGULAIR
SINGULAIR kan kun behandle Deres barns astma, hvis barnet fortsætter med at tage det.
SINGULAIR can treat your child's asthma only if he/ she continues taking it.
Det er vigtigt, at barnet fortsætter med at tage SINGULAIR, så længe lægen foreskriver det for at bevare kontrollen med astmaen.
It will help control your child’ s asthma.
Spørg barnets læge eller apoteket, hvis der er noget, De er i tvivl om eller føler Dem usikker på.
If you have any further questions on the use of this product, ask your child’ s doctor or pharmacist.
Derudover er følgende bivirkninger set i kliniske undersøgelser med SINGULAIR 10 mg filmovertrukne tabletter og 5 mg eller 4 mg tyggetabletter:
In clinical studies with SINGULAIR 4 mg granules, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 paediatric patients treated) thought to be related to SINGULAIR were: • diarrhoea • hyperactivity • asthma • scaly and itchy skin • rash Additionally, the following side effects were reported in clinical studies with either SINGULAIR 10 mg film-coated tablets, 5 mg or 4 mg chewable tablets: • abdominal pain • headache • thirst These were usually mild and occurred at a greater frequency in patients treated with SINGULAIR than placebo (a pill containing no medication).
47 ændret drømmemønster med mareridt, søvnløshed, stikkende og prikkende fornemmelser/ følelsesløshed, kramper • Utilpashed, led - eller muskelsmerter, muskelkramper, tør mund, kvalme, opkastning, fordøjelsesbesvær, diarré, leverbetændelse • Øget blødningstendens, blå mærker, knuderosen (ømme, røde knuder under huden oftest på skinnebenene), hjertebanken. • Hævelser.
47 Additionally, while the medicine has been on the market, the following have been reported: • allergic reactions including rash, swelling of the face, lips, tongue, and/ or throat which may cause difficulty in breathing or swallowing, itching, and hives; • tiredness, restlessness, agitation including aggressive behaviour, irritability, tremor, depression, suicidal thoughts and actions (in very rare cases), dizziness, drowsiness, hallucinations, dream abnormalities, including nightmares and trouble sleeping, pins and needles/ numbness, seizure; • feeling unwell, joint or muscle pain, muscle cramps, dry mouth, nausea, vomiting, indigestion, diarrhoea, hepatitis; • increased bleeding tendency, bruising, tender red lumps under the skin most commonly on your shins (erythema nodosum), palpitations; • swelling.
Hos astmatiske patienter, der er behandlet med montelukast, er der set meget sjældne tilfælde af en kombination af allergiske symptomer med influenzalignende sygdom, stikkende og prikkende fornemmelse eller følelsesløshed i arme og ben, og / eller udslæt (Churg- Strauss syndrom).
In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/ or rash (Churg-Strauss syndrome) have been reported.
Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your child’ s doctor or pharmacist.
• Brug ikke SINGULAIR efter den udløbsdato, der står på pakningen.
• Do not use this medicine after the date shown by the six numbers following EXP on the sachet.
Udløbsdatoen er den sidste dag i den nævnte måned.
This medicine expires at the end of the month shown.
SINGULAIR indeholder:
What SINGULAIR contains
Montelukast.
• The active substance is montelukast.
Hver pose granulat indeholder montelukastnatrium, som svarer til 4 mg montelukast.
Each sachet of granules contains montelukast sodium which corresponds to 4 mg of montelukast. • The other ingredients are:
Mannitol, hydroxypropylcellulose (E463), og magnesiumstearat.
Mannitol, hyprolose (E 463), and magnesium stearate.
SINGULAIRs udseende og pakningsstørrelser
What SINGULAIR looks like and contents of the pack
SINGULAIR 4 mg granulat er hvidt.
4 mg SINGULAIR granules are white granules.
Findes i æsker med 7, 20, 28 og 30 breve.
Cartons of 7, 20, 28 and 30 sachets.
Indehaver af markedsføringstilladelse og Fremstiller Danmark
Marketing Authorization Holder and Manufacturer
Repræsentant i
Information is given by
[Udfyldes nationalt] nationalt]
{To be completed nationally}
[Udfyldes
{To be completed nationally}
48 Dette lægemiddel er godkendt i EØS medlemslande under følgende navne:
48 This medicinal product is authorized in the Member States of the EEA under the following names: