natgillin/translations-raw huggingface dataset:
I Sverige registreres brug af lægemidler ved den første graviditetskonsultation, der for mindst 90% af de gravide finder sted inden uge 14 i graviditeten.
In Sweden, drug use is recorded at the first antenatal care visit, which for at least 90% of pregnant women is made before week 14 of pregnancy.
Medicinanvendelsen registreres således prospektivt i forhold til med graviditetsresultatet.
Thus, drug use is recorded prospectively to pregnancy outcome.
CPMP fandt, at eventuelle bias, der er fundet i Medicinska födelseregistret, herunder misklassifikationer, ville give risikoestimatet en bias i retning mod 1 eller være uden indflydelse.
The CPMP considered that possible biases that have been identified in the SMBR, including misclassifications, would bias the risk estimate towards 1 or not affect it.
Graviditetsresultat hos kvinder, der har taget loratadin CPMP behandlede de spontane indberetninger efter markedsføringen om anvendelsen af loratadin under graviditet.
Outcome of pregnancies in women taking loratadine The CPMP considered the spontaneous post-marketing reports of loratadine use during pregnancy.
250 tilfælde, hvor loratadin er anvendt under graviditeten.
Approximately 250 cases of loratadine use during pregnancy have been reported.
I disse indberetninger indgår de 15 tilfælde af hypospadi fra Medicinska födelseregistret samt 8 spontane indberetninger, der er modtaget efter indledning af artikel 31- proceduren for indbragte sager.
These reports include the 15 hypospadias cases from the SMBR, and 8 spontaneous reports that were received following the initiation of the Article 31 referral procedure.
Hvis spontan indberetning giver pålidelige oplysninger, skulle man have forventet et antal
Hence, the data presented show that hypospadias have not been spontaneously reported as an adverse drug reaction.
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Prækliniske undersøgelser Udvikling af genitalia externa masculina og vigtigheden af androgener CPMP konkluderede, at antiandrogen aktivitet er på nuværende tidspunkt den eneste kendte ikke - genetiske mekanisme for fremkaldelse af hypospadi.
Preclinical studies External Male Genitalia Development and Importance of Androgens The CPMP concluded that antiandrogenic activity is the only currently known non-genetic mechanism for induction of hypospadias.
SAMLET KONKLUSION VEDRØRENDE BENEFIT/ RISK- FORHOLDET
OVERALL CONCLUSION ON BENEFIT/ RISK
CPMP konkluderede, at de foreliggende data om loratadin ikke tyder på, at stoffet har hverken genotoksisk eller antiandrogent potentiale.
The CPMP concluded that, the available data for loratadine does not indicate that the compound has either genotoxic or antiandrogenic potential.
CPMP konkluderede, at Medicinska födelseregistret giver et robust signal om, at eksponering for loratadin under graviditeten øger risikoen for hypospadi.
The CPMP concluded that the SMBR provides a robust signal that loratadine exposure during pregnancy increases the risk of hypospadia.
Signalets opståen kan ikke med rimelighed forklares med de bias- faktorer, der er blevet identificeret i Medicinska födelseregistret, herunder misklassifikationer.
Reasonable biases that have been identified in the SMBR, including misclassifications, cannot explain the occurrence of the signal.
De prækliniske data taler mod en egentlig lægemiddelbetinget virkning.
The preclinical data argue against a true drug effect.
De foreliggende oplysninger giver derfor hverken grundlag for at bekræfte eller udelukke en kausal sammenhæng.
Thus, based on the available data, a causal relationship can neither be confirmed nor excluded.
Som sikkerhedsforanstaltning anbefalede CPMP, at produktresuméet for lægemidler indeholdende loratadin skulle ændres, så det indeholdt en angivelse af, at det ikke anbefales at anvende loratadin under graviditet.
As a precautionary measure the CPMP recommended, that the SPC for loratadine containing medicinal products should be amended to state that the use of loratadine during pregnancy is not recommended.
Fordi pseudoephedrin formindsker blodgennemstrømningen i moderens uterus, er kombinationen af loratadin og pseudoephedrin kontraindiceret under graviditet.
Because pseudoephedrine decreases maternal uterine blood flow the use of the combination of loratadine and pseudoephedrine is contraindicated during pregnancy.
Der mangler data til dokumentation herfor ved normal forskriftsmæssig brug
Data to substantiate these concerns were lacking in normal condition of use, in the context of what is required in Article 116 of Directive 2001/ 83/ EC, as amended and CPMP agreed to introduce adequate warnings and precautions in the SPC, this included limiting the indication to seasonal rhinitis to reduce the duration of treatment.
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CPMP fandt derfor, at benefit/ risk- forholdet for lægemidler indeholdende en kombination af loratadin og pseudoephedrin forbliver uændret for indikationen “ symptomatisk behandling af sæsonbetinget allergisk rhinitis, når denne ledsages af nasal kongestion ”, og anbefalede opretholdelse af markedsføringstilladelserne i overensstemmelse med produktresuméet i bilag III til CPMP’ s udtalelse med vægt på følgende:
Therefore the CPMP considered that the benefit/ risk balance of the combination of loratadine and pseudoephedrine containing medicinal products remains unchanged for the indication “ symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion” and recommended the maintenance of the Marketing Authorisations according to the Summary of Product Characteristics as set out in Annex III of the CPMP Opinion with emphasis to the following:
Det er ikke påvist, at det er sikkert at anvende {SÆRNAVN} under graviditet.
The safe use of {INVENTED NAME} during pregnancy has not been established.
Brugen af pseudoephedrin formindsker blodgennemstrømningen i moderens uterus.
The use of pseudoephedrine decreases maternal uterine blood flow.
Brugen af {SÆRNAVN} er kontraindiceret under graviditet. ”
The use of {INVENTED NAME} is contraindicated during pregnancy .”
- Udvalget konkluderede, at Medicinska födelseregistret giver et robust signal om, at eksponering
- The Committee concluded that the SMBR provides a robust signal that loratadine exposure during
for loratadin under graviditeten øger risikoen for hypospadi.
pregnancy increases the risk of hypospadia.
Endvidere konkluderede udvalget, at kombinationen af loratadin og pseudoephedrin er kontraindiceret under graviditet, fordi pseudoephedrin formindsker blodgennemstrømningen i moderens uterus.
As a precautionary measure the CPMP recommended, that the SPC for loratadine containing medicinal products should be amended to state that the use of loratadine during pregnancy is not recommended; furthermore the Committee concluded that because pseudoephedrine decreases maternal uterine blood flow the use of the combination of loratadine and pseudoephedrine is contraindicated during pregnancy;
- CPMP behandlede problemerne med hensyn til sikkerhed og hensigtsmæssig anvendelse af
- The CPMP addressed the concerns regarding the safe and appropriate use of the combination of
kombinationen af loratadin og pseudoephedrin i lyset af den kendte farmakodynamiske effekt af pseudoephedrin på hjertet samt problemet med hensyn til pseudoephedrin i forbindelse med afhængighed og misbrug.
loratadine and pseudoephedrine in the light of the known pharmacodynamic effect of pseudoephedrine on the heart, and the concern for pseudoephedrine related to dependency and addiction.
- Udvalget var af den opfattelse, at lægemidler indeholdende en kombination af loratadin og
- The Committee considered that the combination of loratadine and pseudoephedrine containing
pseudoephedrin er effektive til lindring af symptomer forbundet med sæsonbetinget allergisk rhinitis ledsaget af nasal kongestion.
medicinal products are effective in the relief of symptoms associated with seasonal allergic rhinitis accompanied with nasal congestion.
- Udvalget var følgelig af den opfattelse, at benefit/ risk- forholdet for lægemidler indeholdende en
- The Committee, as a consequence considered that the benefit/ risk balance of the combination of
kombination af loratadin og pseudoephedrin forbliver uændret til lindring af symptomer forbundet med sæsonbetinget allergisk rhinitis ledsaget af nasal congestion.
loratadine and pseudoephedrine containing medicinal products remains unchanged in the relief of symptoms associated with Seasonal Allergic Rhinitis accompanied by nasal congestion.
anbefalede CPMP derfor opretholdelse af markedsføringstilladelserne for lægemidler indeholdende en kombination af loratadin og pseudoephedrin, som er anført i bilag I som ændret i overensstemmelse med produktresuméet i bilag III.
As a consequence, the CPMP recommended the maintenance of the Marketing Authorisations for the combination of loratadine and pseudoephedrine containing medicinal products referred in Annex I as amended in accordance with the SPC set out in Annex III.
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Dette er det SPC, der var bilag til Europa- Kommissionens beslutning vedrørende denne artikel 31 arbitreringssag vedrørende lægemidler indeholdende Loratadin og Pseudoephedrin.
This SPC is the one that was annexed to the Commission Decision on this Article 31 referral for loratadine and pseudoephedrine containing medicinal products.
CPMP/ 4060/ 03 1.
CPMP/ 4060/ 03 1.
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{SÆRNAVN} 5 mg/ 120 mg {lægemiddelform} {SÆRNAVN} 10 mg/ 240 mg {lægemiddelform}
{INVENTED NAME} 5 mg/ 120 mg {pharmaceutical form} {INVENTED NAME} 10 mg/ 240 mg {pharmaceutical form}
< Hver {lægemiddelform} indeholder 5 mg loratadin og 120 mg pseudoephedrinsulfat. > < Hver {lægemiddelform} indeholder 10 mg loratadin og 240 mg pseudoephedrinsulfat. >
< Each {pharmaceutical form} contains 5 mg loratadine and 120 mg pseudoephedrine sulphate > < Each {pharmaceutical form} contains 10 mg loratadine and 240 mg pseudoephedrine sulphate >
< Overtrukket tablet > < Tabletter med modificeret udløsning > < Depottabletter >
< Coated tablet > < Modified-release tablet > < Prolonged-release tablet >
{SÆRNAVN} {lægemiddelform} er indiceret til symptomatisk behandling af sæsonbetinget allergisk rhinitis med samtidig nasal kongestion.
{INVENTED NAME} {pharmaceutical form} is indicated for the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.
Voksne og børn på 12 år eller derover: < [For produkter indeholdende 10 mg/ 240 mg] En {SÆRNAVN} {lægemiddelform} en gang daglig med et glas vand.
Adults and children 12 years of age and over: < [For products containing 10 mg/ 240 mg] One {INVENTED NAME} {pharmaceutical form} once daily with a glass of water.
{Lægemiddelform} skal sluges hel (uden at knuse, brække eller tygge den).
The {pharmaceutical form} must be swallowed entirely (without crushing, breaking or chewing it).
{Lægemiddelform} kan tages uafhængigt af måltider. >
The {pharmaceutical form} may be taken without regard to mealtime. >
< [For produkter indeholdende 5 mg/ 120 mg] En {SÆRNAVN} {lægemiddelform} to gange daglig med et glas vand.
< [For products containing 5 mg/ 120 mg] One {INVENTED NAME} {pharmaceutical form} twice daily with a glass of water.
Må ikke administreres til børn under 12 år, da sikkerhed og effekt endnu ikke er dokumenteret for denne population.
Not to be administered to children under the age of 12 years, as the safety and efficacy in this population has not been established yet.
Behandlingsvarigheden bør holdes så kort som mulig og bør ikke fortsættes efter symptomerne er forsvundet.
The duration of treatment should be kept as short as possible and should not be continued after the symptoms have disappeared.
Det er anbefalelsesværdigt at begrænse behandlingen til omkring 10 dage, da aktiviteten af pseudoephedrin aftager med tiden ved kronisk administration.
It is advisable to limit treatment to about 10 days, as during chronic administration the activity of pseudo-ephedrine diminishes with time.
4. 4).
After improvement of the congestive condition of the mucosae of the upper airway, treatment may be maintained with an antihistamine alone, if necessary.
CPMP/ 4060/ 03 4. 3 Kontraindikationer
CPMP/ 4060/ 03
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Da {SÆRNAVN} indeholder pseudoephedrin er det ligeledes kontraindiceret hos patienter der er i behandling med monoaminoxidase (MAO) hæmmere eller ved seponering hermed indenfor de seneste 2 uger, og hos patienter med:
The combination product should not be administered to patients above 60 years of age or patients with impaired renal or hepatic function (see section 4.4).
- snævervinkel glaucom,
4.3 Contraindications
- kardiovaskulære sygdomme som iskæmisk hjertesygdom, tachycardi og alvorlig hypertension,
{INVENTED NAME} {pharmaceutical form} is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to either of its components, to any of the excipients or to adrenergic agents.
hjerneblødning på grund af den alfa- mimetiske aktivitet af vasokonstriktoren, i kombination med vasokonstriktorer som bromocriptin, pergolid, lisurid, cabergolin, ergotamin, dihydroergotamin eller andre dekongestanter anvendt som nasale dekongestanter, enten administreret oralt eller nasalt (phenylpropanolamin, phenylephrin, ephedrin...).
As {INVENTED NAME} contains pseudo-ephedrine it is also contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitor therapy or during the 2 weeks following the stopping of such treatment, and in patients with: − narrow-angle glaucoma, − urinary retention, − cardiovascular diseases such as ischaemic heart disease, tachyarrhythmia and severe hypertension − hyperthyroidism − a history of haemorhagic stroke or with risk factors which could increase the risk of haemorhagic stroke, due to the alpha-mimetic activity of the vasoconstrictor, in combination with vasoconstrictors such as bromocriptine, pergolide, lisuride, cabergoline, ergotamine, dihydroergotamine or any other decongestant drug used as nasal decongestant, either by oral route or by nasal route (phenylpropanolamine, phenylephrine, ephedrine…).
< [Indsættes/ slettes nationalt efter behov] Patienter, der har haft besvær med at synke tabletter eller som har kendt øvre gastrointestinal forsnævring eller abnorm spiserørsperistaltik, må ikke anvende dette produkt. >
< [To be included/deleted nationally as appropriate] Patients who have had difficulty in swallowing tablets or who have known upper gastrointestinal narrowing or abnormal oesophageal peristalsis must not use this product. >
4. 6).
{INVENTED NAME} {pharmaceutical form} must not be used during pregnancy (see section 4.6).
4. 2).
Do not exceed the recommended dosage and the duration of treatment (see 4.2).
Patienter på 60 år eller derover har større sandsynlighed for at opleve bivirkninger ved sympatomimetiske lægemidler.
Patients of 60 years or older are more likely to experience adverse reactions to sympathomimetic medications.
Sikkerhed og effekt af kombinationen er ikke undersøgt i denne population og der er ikke tilstrækkelig dokumentation til at give passende dosis rekommandationer.
The safety and efficacy of the combination have not been established in this population, and there are insufficient data to give adequate dose recommendations.
Kombinationsproduktet bør ikke anvendes af patienter over 60 år.
The combination product should not be used in patients above 60 years of age.
Sikkerhed og effekt af kombinationen er ikke blevet undersøgt hos patienter med nedsat nyre - eller leverfunktion, og der er ikke tilstrækkelig dokumentation til at give passende dosis rekommandationer.
The safety and efficacy of the combination have not been established in patients with impaired renal or hepatic function, and there are insufficient data to give adequate dose recommendations.
Kombinationsproduktet bør ikke anvendes af patienter med nedsat nyre - eller leverfunktion.
The combination product should not be used in patients with impaired renal or hepatic function.
Patienter bør informeres om at behandlingen bør afbrydes i tilfælde af hypertension, tachycardi, palpitationer eller hjertearytmier, kvalme eller andre neurologiske tegn (så som hovedpine eller forværret hovedpine).
Patients should be informed that the treatment should be discontinued in case of hypertension, tachycardia, palpitations or cardiac arrhythmias, nausea or any other neurologic sign (such as headache or increased headache).
Stimulation af centralnervesystemet med kramper eller kardiovaskulær kollaps med deraf følgende hypotension kan forårsages af sympatomimetiske aminer.
Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines.
4. 9).
These effects may be more likely to occur in children, the elderly, or in cases of overdose (see Section 4.9).
Forsigtighed tilrådes hos digitalispatienter, patienter med hjertearytmier, hypertension, myokardieinfarkt i anamnesen, diabetes mellitus, blærehalsobstruktion eller bronkospasme i anamnesen.
Caution should be exercised in patients receiving digitalis, those with cardiac arrhythmias, hypertension, a history of myocardial infarction, diabetes mellitus, bladder neck obstruction, or positive anamnesis of bronchospasm.
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Som med andre CNS - stimulerende midler er der risiko for misbrug af pseudoephedrin.
As with other CNS stimulants, pseudo-ephedrine sulphate carries the risk of abuse.
Øgede doser kan ultimativt medføre toksicitet.
Increased doses may ultimately produce toxicity.
Vedvarende brug kan medføre toleranceudvikling og hermed øget risiko for overdosering.
Continuous use can lead to tolerance resulting in an increased risk of overdosing.
Depression kan følge en umiddelbar seponering.
Depression may follow rapid withdrawal.
Perioperativ akut hypertension kan forekomme hvis flygtige halogenerede anæstetika anvendes under behandling med indirekte sympatomimetiske midler.
Perioperative acute hypertension can occur if volatile halogenated anaesthetics are used during treatment with indirect sympathomimetic agents.
Derfor er det ønskeligt, hvis der er planlagt operation, at seponere behandlingen 24 timer før anæstesi.
Therefore, if surgery is scheduled, it is preferable to discontinue treatment 24 hours before anaesthesia.
Atleter bør informeres om, at behandling med pseudoephedrin kan give en positiv dopingtest.
Athletes should be informed that treatment with pseudoephedrine could lead to positive dope-tests.
Administreret samtidig med alkohol har loratadin ingen potenserende effekt, målt ved psychomotoriske udførelsesstudier.
When administered concomitantly with alcohol loratadine has no potentiating effects as measured by psychomotor performance studies.
Samtidig anvendelse af monoaminoxidase hæmmere og sympatomimetika kan medføre alvorlige hypertensionsreaktioner.
Concurrent administration of monoamine oxidase inhibitors and sympathomimetic drugs can cause critical hypertension reactions.
Sympatomimetika reducerer den antihypertensive effekt af α- methyldopa, mecamylamin, reserpin, veratrumalkaloider og guanethidin.
Sympathomimetic drugs reduce the antihypertensive effect of α -methyldopa, mecamylamine, reserpine, veratrum alkaloids, and guanethidine.
De følgende kombinationer rekommanderes ikke:
The following combinations are not recommended:
Bromocriptin, cabergolin, lisurid, pergolid: risiko for vasokonstriktion og øget blodtryk.
Bromocriptine, cabergoline, lisuride, pergolide: risk of vasoconstriction and increase in blood pressure.
Dihydroergotamin, ergotamin, methylergometrin, (dopaminerge vasokonstriktorer): risiko for vasokonstriktion og øget blodtryk.
Dihydroergotamine, ergotamine, methylergometrine (dopaminergic vasoconstricteurs): risk of vasoconstriction and increase in blood pressure.
Linezolid: risiko for vasokonstriktion og øget blodtryk.
Linezolide: risk of vasoconstriction and increase in blood pressure.
Andre vasokonstriktorer anvendt oralt eller nasalt som nasale dekongestanter, (phenylpropanolamin, phenylephrin, ephedrin...): risiko for vasokonstriktion.
Other vasoconstrictors used as nasal decongestant, by oral or nasal route, (phenylpropanolamine, phenylephrine, ephedrine…): risk of vasoconstriction.
Anvendelse af pseudoephedrin mindsker blodgennemstrømningen i moderens livmoder.
Antacids increase the rate of pseudoephedrine sulphate absorption, kaolin decreases it.
CPMP/ 4060/ 03 4. 8 Bivirkninger
CPMP/ 4060/ 03 4.6 Pregnancy and lactation
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< [For produkter indeholdende 10 mg/ 240 mg]
4.7 Effects on ability to drive and use machines
Bivirkninger rapporteret under kliniske studier hyppigere end for placebo for 10 mg/ 240 mg {lægemiddelform} meget almindelig (> 1/ 10); almindelig (> 1/ 100, < 1/ 10); usædvanlig (> 1/ 1000, < 1/ 100); sjælden (> 1/ 10000, < 1/ 1000); meget sjælden (< 1/ 10000) Psykiske lidelser Almindelig:
< [For products containing 10 mg/240 mg] Adverse reactions reported during clinical trials in excess of placebo for 10 mg/240 mg {Pharmaceutical form} very common (> 1/ 10); common (> 1/ 100 ,< 1/10); uncommon (> 1/1000 ,< 1/100); rare (> 1/10,000, < 1/ 1000); very rare (< 1/10 ,000)
Sygdomme i nervesystemet (perifere og centrale)
Nervous system disorders (Peripheral and Central)
Anorexi, nervøsitet, søvnighed, søvnløshed
Anorexia, nervousness, somnolence, insomnia
Sygdomme i det autonome nervesystem
Autonomic Nervous system disorders
Svimmelhed, hyperkinesi
Dizziness, hyperkenesia
Tachycardi, palpitation
Tachycardia, palpitation
Rhinitis, epistaxis
Rhinitis, epistaxis
Kroppen som helhed – Almene lidelser
Body as a whole-General disorders
> < [For produkter indeholdende 5 mg/ 120 mg]
CPMP/ 4060/ 03 < [For products containing 5 mg/ 120 mg]
Bivirkninger rapporteret under kliniske studier hyppigere end for placebo for 5 mg/ 120 mg {lægemiddelform} meget almindelig (> 1/ 10); almindelig (> 1/ 100, < 1/ 10); usædvanlig (> 1/ 1000, < 1/ 100); sjælden (> 1/ 10000, < 1/ 1000); meget sjælden (< 1/ 10000) Stofskiftesygdomme og ernæringsbetingede sygdomme Almindelig:
Adverse reactions reported during clinical trials in excess of placebo for 5 mg/ 120 mg {Pharmaceutical form} very common (> 1/ 10); common (> 1/ 100 ,< 1/10); uncommon (> 1/1000 ,< 1/100); rare (> 1/10,000, < 1/ 1000); very rare (< 1/10 ,000) Metabolic and Nutrition Disorders Common:
Nervøsitet, søvnighed, depression, opstemthed, anorexi
Nervousness, somnolence, depression, agitation, anorexia
Sygdomme i det autonome nervesystem
Autonomic Nervous System Disorders
Forvirring, tremor Svimmelhed
Confusion, tremor Dizziness
Almindelig:
Very Common:
Øget svedtendens, hedestigning, smagsforstyrrelser Mundtørhed
Increased sweating, hot flushes, taste perversion Dry mouth
Sygdomme i det ydre og det indre øre
Ear and Labyrinth Disorders
Unormal tåreflåd
Abnormal lacrimation
Palpitation Tachycardi
Palpitation Tachycardia
Epistaxis Pharyngitis, rhinitis,
Epistaxis Pharyngitis, rhinitis
Urineringsfrekvens og forstyrrelser
post-marketing period are listed in the
CPMP/ 4060/ 03 Sygdomme i hud og subkutane væv
CPMP/ 4060/ 03
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Andre bivirkninger, der kun blev rapporteret for loratadin i kliniske studier og efter markedsføring, omfatter øget appetit, udslæt og gastritis.
Other adverse reactions that were only reported for loratadine in clinical trials and during the post marketing period include increased appetite, rash and gastritis.
Symptomer på overdosering har for det meste sympatomimetisk karakter undtagen let sedation, som kan forårsages af loratadin i doser, der er mange gange højere end den rekommanderede dosis.
Symptoms of overdose are mostly of a sympathomimetic nature, except for slight sedation that can be caused by loratadine at doses many times higher than the recommended dose.
Symptomer kan variere fra CNS- depression (sedation, apnoea, nedsat mental årvågenhed, cyanose, koma, kardiovaskulær kollaps) til CNS- stimulation (søvnløshed, hallucination, rysten, kramper) med muligt fatalt udfald.
Symptoms may vary from CNS depression (sedation, apnoea, diminished mental alertness, cyanosis, coma, cardiovascular collapse) to CNS stimulation (insomnia, hallucination, tremors, convulsions) with possible fatal outcome.