GNH USA

Europe — EMA

Itulazax (Betula Verrucosa (108))

GNH USA supplies Itulazax (Betula verrucosa), an allergen extract for allergic rhinitis caused by birch pollen. Request a quote for global supply.

Betula Verrucosa (108)

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What is Betula Verrucosa (108)?

Betula verrucosa, the active ingredient in Itulazax, is an allergen extract presented as a sublingual preparation for sublingual use. It is indicated for the treatment of allergic rhinitis caused by birch pollen in individuals with IgE‑mediated sensitivity.

GNH USA supplies Itulazax as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company ensures quality compliance with EU standards and provides reliable distribution to healthcare providers across multiple regions.

What is Betula Verrucosa (108) used for?

Itulazax is used in allergen immunotherapy to address birch‑pollen‑induced allergic rhinitis.

- Allergic rhinitis (birch pollen): reduces nasal congestion, sneezing and itching. - Seasonal allergic rhinitis (birch): improves tolerance and decreases medication reliance. - IgE‑mediated birch pollen allergy: induces long‑term immunologic tolerance.

What are the side effects of Betula Verrucosa (108)?

Sublingual exposure to Betula verrucosa extract may cause local and systemic reactions.

Common Side Effects: - Oral itching or mild burning sensation. - Throat irritation or mild soreness. - Slight swelling of the lips or tongue. - Transient nasal congestion. - Mild headache. - Temporary increase in sneezing.

Serious or Rare Side Effects: - Anaphylaxis or severe systemic allergic reaction. - Angioedema involving the face, lips or airway. - Severe bronchospasm or respiratory distress.

What precautions apply to Betula Verrucosa (108)?

Before initiating therapy, clinicians should evaluate patient suitability and monitor for reactions.

- Allergy assessment: confirm IgE‑mediated birch pollen sensitivity. - Asthma control: avoid use in patients with uncontrolled asthma. - Local reaction monitoring: observe for persistent oral or throat irritation. - Systemic reaction protocol: discontinue and seek emergency care if systemic symptoms develop. - Concomitant immunotherapy: avoid simultaneous use of other allergen extracts without specialist guidance. - Store at room temperature: keep in the original packaging, protect from moisture and direct sunlight.

What does Betula Verrucosa (108) interact with?

Betula verrucosa extract may interact with certain medications that affect immune or allergic responses.

Major Interactions (Avoid): - Beta‑blockers: may mask signs of anaphylaxis and complicate emergency treatment. - ACE inhibitors: increase risk of angioedema during systemic reactions.

Moderate Interactions (Monitor Closely): - Immunosuppressants (e.g., corticosteroids, methotrexate): may reduce efficacy of immunotherapy. - Antihistamines: may blunt local reaction signs, requiring careful monitoring. - NSAIDs: can exacerbate gastrointestinal irritation when combined with oral extracts.

Frequently asked questions

What is Itulazax used for?+
Itulazax is prescribed for allergen immunotherapy in patients with allergic rhinitis caused by Betula verrucosa, commonly known as birch pollen. The sublingual formulation aims to reduce nasal symptoms, sneezing, and itching by gradually inducing immune tolerance to the specific birch pollen allergen.
How does Betula verrucosa work in Itulazax?+
Betula verrucosa extract contains purified birch pollen proteins. Repeated sublingual exposure modulates the immune system, shifting the response from an IgE‑driven allergic pathway toward a regulatory T‑cell and IgG4‑dominant profile. This reduces hypersensitivity and alleviates clinical symptoms over time.
What is the usual dose of Itulazax?+
The dosing regimen for Itulazax is individualized and determined by the prescribing healthcare professional. The prescriber selects the initial dose, escalation schedule, and maintenance level based on the patient’s sensitivity, age, and clinical response.
Is Itulazax safe during pregnancy or breastfeeding?+
Safety data for Itulazax in pregnancy and lactation are limited. Because the risk cannot be fully assessed, it should only be used if the potential benefit justifies the potential risk to the fetus or infant, and only under medical supervision.
How do I order Itulazax from GNH USA?+
To order Itulazax, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain if needed), and necessary import documentation.
How does Itulazax compare with other birch pollen immunotherapies?+
Itulazax delivers the birch pollen allergen via a sublingual route, which is non‑invasive compared with subcutaneous injections. This method often results in fewer systemic reactions and allows self‑administration at home, while still achieving comparable long‑term tolerance when used according to a prescribed schedule.
How should Itulazax be stored and handled?+
Itulazax should be stored at room temperature, below 25 °C, in its original packaging. Protect the product from moisture, direct sunlight, and extreme temperature fluctuations. Do not refrigerate unless specifically instructed by the manufacturer.
How is Itulazax administered?+
Itulazax is administered sublingually. The patient places the prescribed dose under the tongue, holds it for the recommended time (usually 1–2 minutes), and then swallows. Administration should be performed on an empty stomach, and patients should avoid eating or drinking for a short period afterward as advised by their clinician.
What are the most serious risks to watch for with Itulazax?+
The most serious risks include systemic allergic reactions such as anaphylaxis, angioedema, and severe bronchospasm. Patients should be educated to recognize early signs of systemic involvement and seek immediate medical attention if symptoms such as difficulty breathing, swelling of the face or throat, or rapid onset of hives occur.
Who should not use Itulazax?+
Itulazax is contraindicated in individuals with a history of severe systemic reactions to birch pollen extracts, uncontrolled asthma, or those receiving beta‑blocker therapy that could mask anaphylaxis. It should also be avoided in patients with known hypersensitivity to any component of the formulation.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.
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Product details

Drug
Betula Verrucosa (108)
Route
Sublingual Use
Manufacturer
Alk-Abello A/S
Origin
EU

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