GNH USA

Europe — EMA

Itulazax

GNH USA supplies Itulazax (Betula verrucosa), an allergen extract for allergic rhinitis and conjunctivitis caused by birch pollen. Request a quote for 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 and allergic conjunctivitis caused by birch pollen in sensitised individuals.

GNH USA supplies Itulazax as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company follows stringent quality standards and provides regulatory documentation for export to EU and other markets. Customers benefit from reliable lead times and dedicated technical support throughout the procurement process.

What is Betula Verrucosa (108) used for?

Itulazax is used in allergen immunotherapy targeting birch pollen–induced respiratory allergy. - Allergic rhinitis due to birch pollen: reduces nasal congestion, sneezing and itching. - Allergic conjunctivitis due to birch pollen: alleviates ocular redness, tearing and itching. - Seasonal birch pollen allergy: improves overall tolerance and may decrease the need for rescue antihistamines.

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

Sublingual administration of Itulazax may be associated with local and systemic adverse reactions.

Common Side Effects: - Mild oral itching or tingling: transient sensation on the tongue or palate. - Transient throat irritation: mild discomfort that resolves without treatment. - Nasal congestion: temporary increase in nasal blockage. - Mild headache: occasional tension‑type headache.

Serious or Rare Side Effects: - Anaphylaxis: severe systemic allergic reaction requiring immediate medical attention. - Angioedema: swelling of lips, tongue or airway that may compromise breathing. - Severe asthma exacerbation: sudden worsening of bronchospasm in asthmatic patients.

What precautions apply to Betula Verrucosa (108)?

Prior to prescribing Itulazax, clinicians should consider several safety and handling precautions. - Allergy testing: confirm sensitisation to Betula verrucosa before initiation. - Medical history: assess for uncontrolled asthma or severe cardiovascular disease. - Concurrent immunotherapy: avoid simultaneous use of other allergen extracts without specialist guidance. - Pregnancy and lactation: use only if potential benefit justifies potential risk, as data are limited. - Monitoring: observe patients for at least 30 minutes after the first dose for systemic reactions. - Store at ambient temperature: keep below 25 °C, in original container, protected from moisture and direct sunlight.

What does Betula Verrucosa (108) interact with?

Itulazax may interact with medications that influence immune response or increase the risk of allergic reactions.

Major Interactions (Avoid): - Beta‑blockers: may mask symptoms of anaphylaxis and complicate emergency treatment. - ACE inhibitors: can potentiate angioedema risk when combined with allergen exposure.

Moderate Interactions (Monitor Closely): - Antihistamines: may reduce perceived efficacy of sublingual immunotherapy; timing adjustments may be needed. - Corticosteroids: systemic steroids can alter immune modulation; monitor clinical response. - Other allergen extracts: concurrent use may increase cumulative allergen load; coordinate with allergist.

Frequently asked questions

What is Itulazax used for?+
Itulazax is a prescription allergen extract indicated for the treatment of allergic rhinitis and allergic conjunctivitis that are triggered by birch pollen exposure. It is used in patients with documented sensitisation to Betula verrucosa to reduce seasonal symptoms and improve quality of life.
How does Betula verrucosa work in Itulazax?+
Betula verrucosa extract in Itulazax provides controlled sublingual exposure to birch pollen proteins. This repeated exposure shifts the immune response from an IgE‑driven allergy toward IgG4 production and activates regulatory T‑cells, promoting long‑term tolerance and decreasing inflammatory reactions when natural pollen is encountered.
What is the usual dose of Itulazax?+
The dosing regimen for Itulazax is determined by the prescribing physician based on individual sensitivity, age, and clinical response. The product is administered sublingually under medical supervision, and the prescriber will establish the appropriate concentration and schedule for each patient.
Is Itulazax safe during pregnancy or breastfeeding?+
Safety data for Itulazax in pregnancy and lactation are limited. It should only be used when the potential therapeutic benefit outweighs any possible risk to the fetus or infant, and the decision should be made in consultation with a qualified healthcare professional.
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 supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and the necessary import documentation.
How does Itulazax compare with other birch pollen immunotherapy options?+
Itulazax is a sublingual formulation, which avoids injections and can be self‑administered under supervision. Compared with subcutaneous birch pollen extracts, it offers a more convenient route, a lower risk of systemic reactions, and similar efficacy in inducing tolerance when used according to recommended protocols.
What are the storage and handling requirements for Itulazax?+
Itulazax should be stored at ambient temperature, preferably below 25 °C, in its original packaging. Protect the product from moisture, direct sunlight and extreme temperature fluctuations to maintain potency throughout its shelf life.
How is Itulazax administered?+
Itulazax is administered as a sublingual preparation. The patient places the prescribed dose under the tongue and holds it for the recommended time, usually a few minutes, before swallowing. Administration is performed under medical guidance, especially during the initial dose escalation phase.
What are the most serious risks associated with Itulazax?+
The most serious risks include systemic allergic reactions such as anaphylaxis, angioedema affecting the airway, and severe asthma exacerbations. Patients should be observed after the first dose and instructed to seek immediate medical care if they experience any signs of a severe reaction.
Who should not use Itulazax?+
Itulazax is contraindicated in individuals with a known hypersensitivity to Betula verrucosa or any component of the formulation. Patients with uncontrolled asthma, severe cardiovascular disease, or those receiving beta‑blockers without specialist oversight should avoid use until evaluated by an allergist.
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.

Product details

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

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