Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Grass allergen extract

Generic name
Grass allergen extract
Brand name
ATC Code
V01AA02

Pharmacokinetics in children

The main component of the allergens consists of polypeptides and proteins that are broken down in the digestive tract and tissues. It is not expected that a substantial fraction of the allergens will reach the bloodstream. No pharmacokinetic studies have therefore been carried out. [SmPC]

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Inhalation allergy to grass
  • Sublingual
    • ≥ 5 years


      • Grazax: 75,000 SQ-T/day in a single dose, sublingual
        Oralair: start on Day 1: 100 IR/day in a single dose; Day 2: 200 IR/day in a single dose; Day 3 and thereafter: 300 IR/day in a single dose.

      • Duration of treatment:

        Start treatment approx. 4 months before the grass pollen season starts, continue for 3 years. 

      • Directions for administration:

        Place the tablet under the tongue (with dry fingers); do not swallow for one minute and do not eat for the following five minutes. The first tablet should be taken under medical supervision; observe the patient for 30 minutes.

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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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

Grazax:

Occurring more commonly in children (1-10%): systemic allergic reactions (non-severe), coughing, conjunctival irritation, nasopharyngitis, redness of and the sensation of a lump in the throat, oedema in the mouth (very often), blisters on the lips, cheilitis, glossitis, salivary gland enlargement, reddening of the skin, earache and chest pain. Tonsillitis and bronchitis are also (often) reported in children.

Oralair:

Occurring more often in children: coughing, nasopharyngitis, oedema in the mouth (very often), oral allergy syndrome, cheilitis, glossitis, sensation of a lump in the throat, unpleasant sensation in the ear (often). Additionally, tonsillitis, bronchitis (often) and chest pain (sometimes) also occur.

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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 children

Severe or uncontrolled asthma (FEV1 < 80% of predicted value in children) despite appropriate treatment.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

In surgical procedures in the mouth, including extraction of teeth and/or molars, and in children losing their milk teeth, pause the treatment for seven days to let the oral cavity heal properly.  In asthmatic children with infections of the upper respiratory tract, pause the treatment until the infection is cured.

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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
V01AA03
v01aa

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References

  1. ALK-Abello A/S, SmPC Grazax (RVG 33788) 06-10-2017, www.geneesmiddeleninformatiebank.nl
  2. Stallergenes, SmPC Oralair (RVG 105376 en 105380) 10-07-2014, www.cbg-meb.nl
  3. ALK-Abello A/S, SmPC Grazax (RVG 33788) 19-12-2024, www.geneesmiddeleninformatiebank.nl
  4. Stallergenes, SmPC Oralair (RVG 105376 en 105380) 06-12-2023, www.geneesmiddelinformatiebank.nl

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Changes

Changes