- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The main component of allergens consists of polypeptides and proteins, which are broken down in the digestive tract and in tissues. It is not expected that a substantial portion of the allergens will reach the bloodstream. Therefore, pharmacokinetic studies have not been performed. [SmPC]
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
On-label
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Available formulations
Lyophilisaat, oraal 12 SQ-HDM
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Dosages
| Moderate to serious allergic rhinitis caused by dust mites |
|---|
|
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
The following side effects were observed more frequently in studies involving children compared to studies involving adults and adolescents:
Very common (≥1/10): Abdominal pain, diarrhea, dysgeusia, glossodynia, mouth ulcers, nausea, pharyngeal edema, and tongue edema.
The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Adult Side Effects
Lokale allergische reacties treden op, vooral in de eerste paar dagen, meestal binnen 5 minuten na inname, en nemen af na enkele minuten tot uren. Deze reacties verdwijnen bij voortzetting van de behandeling (na 1–3 maanden).
Zeer vaak (> 10%): nasofaryngitis, keelirritatie, gezwollen lippen, oedeem en/of jeuk in de mond. Jeukende oren.
Vaak (1-10%): astma, dyspneu, dysfonie. Orofaryngeale pijn, faryngeaal oedeem. Rinitis, sinusitis, faryngitis, bronchitis. Jeukende ogen. Jeukende lippen, jeukende tong, oedeem van de tong, glossitis, glossodynie, pijn in de mond, mondzweren, onaangenaam gevoel in de mond, erytheem van het mondslijmvlies, stomatitis, dysfagie, orale paresthesie, misselijkheid, braken, buikpijn, diarree, dyspepsie, gastro-oesofageale refluxziekte. Onaangenaam gevoel op de borst, vermoeidheid. Jeuk op de huid, urticaria.
Soms (0,1-1%): anafylactische reactie. Hartkloppingen. Duizeligheid, paresthesie. Verstopte neus, rinorroe, niezen, onaangenaam gevoel in de neus, neusoedeem. Beklemd gevoel in de keel, faryngeaal erytheem, hypertrofie van de tonsillen. Laryngitis. Blaarvorming van het mondslijmvlies, droge mond, pijnlijke lippen, lipzweren, speekselkliervergroting, hypersecretie van speeksel, oesofageale irritatie. Onaangenaam gevoel van de oren. Erytheem op de huid. Allergische conjunctivitis. Malaise.
Zelden (0,01-0,1%): angio-oedeem. Laryngeaal/tracheaal oedeem. Neusobstructie.
Verder is gemeld: eosinofiele oesofagitis.
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications in adults
- actieve of onvoldoende onder controle gebrachte aandoeningen die het immuunsysteem beïnvloeden (bv. maligniteiten, auto-immuunziekten of immunodeficiëntie);
- ontstekingen in de mondholte met ernstige klachten zoals lichen planus, ulceraties of mycosis;
- een FEV1 < 70% van de voorspelde waarde bij aanvang van de behandeling, ondanks adequate behandeling hiervoor
- ernstige verergering van astma in de laatste drie maanden;
- ten tijde van een acute luchtweginfectie bij astma-patiënten (dan de behandeling uitstellen tot de infectie over is).
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions
No information available on specific warnings and precautions in children.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Allergen extracts | ||
|---|---|---|
| V01AA02 | ||
| v01aa | ||
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References
- ALK-Abelló A/S, SmPC Acarizax (RVG 118889) 12-05-2023, www.geneesmiddeleninformatiebank.nl
- Stallergenes, SmPC Actair (RVG 126703) 12-01-2023, www.geneesmiddeleninformatiebank.nl
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Changes
Changes
