Oraltek (monoallergen)

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ORALTEK (Monoallergen) (ORALTEK® Monovalent)

Composition:

Active substance: natural allergen extract;

1 ml of solution in each individual vial contains 30,000 TU of one of the following natural allergen extracts:

Ambrosia artemisiifolia (Ragweed) 100%, or
Artemisia vulgaris (Mugwort) 100%, or
Betula pendula (Silver birch) 100%, or
Alternaria alternata (mold) 100%, or
Cladosporium herbarum (mold) 100%, or
Aspergillus fumigatus (mold) 100%, or
Candida albicans (yeast) 100%, or
Cat dander (Cat danger) 100%, or
Dog dander (Dog danger) 100%;

Excipients: glycerol 50%, pineapple essence, sodium chloride, water for injections.
Concentration is expressed in therapeutic units (TU).

Pharmaceutical form. Sublingual spray.

Pharmacotherapeutic group. Various agents. Allergens, allergen extracts.
ATC code: V01A A.

Pharmacological Properties

Pharmacodynamics

Mechanism of action. ORALTEK (Monoallergen) is used for the treatment of patients with specific IgE-mediated allergic reactions to various allergens, presenting with symptoms such as rhinitis and rhinoconjunctivitis. The target of pharmacodynamic action is the immune system. The aim of treatment is to induce an immune response against the allergens used to treat the patient. The complete and detailed mechanism of action in terms of the clinical effect of specific immunotherapy is not fully understood and has not been thoroughly investigated. For immunotherapy to be effective and elicit an immune response, the allergen extract must be taken up by dendritic cells present in the oral mucosa, as these cells are essential for inducing a specific immune response.

Pharmacokinetics

With the administration route described below, significant absorption of ORALTEK (Monoallergen) into the systemic circulation is not expected. Therefore, no pharmacokinetic studies in animals or clinical studies on the pharmacokinetic profile and metabolism have been conducted.

Preclinical safety data

Preclinical studies of ORALTEK (Monoallergen) do not indicate any particular risk associated with its use at therapeutic doses according to the instructions for medical use.

Clinical characteristics

Indications

ORALTEC (Monoallergen) is indicated for immunotherapy of respiratory allergies in patients with clinical symptoms and positive skin allergy tests (prick test) and/or positive specific IgE tests to various allergens.

Immunotherapy may be administered to adults and children aged 5 years and older.

Contraindications

Hypersensitivity to any of the excipients of the medicinal product (see section "Composition"). Concomitant use of β-blockers.

Elevated body temperature (above 38.5 °C).

Active infectious diseases (viral hepatitis, tuberculosis, pneumonia, mononucleosis, etc.).

Acquired immunodeficiency syndrome (AIDS).

Autoimmune diseases in the active phase or lack of response to treatment.

Malignant neoplasms.

Poorly controlled or partially controlled bronchial asthma.

Severe and acute inflammatory processes or wounds in the oral cavity (see section "Special precautions").

Pregnancy.

Special precautions

There are no special warnings or precautions required for the use of allergen preparations.

Any unused medicinal product or waste material must be disposed of in accordance with local requirements.

Interaction with other medicinal products and other forms of interaction

Do not use concurrently with β-blockers.

Tolerance to ORALTEC (Monoallergen) may be increased when used concomitantly with medicinal products for symptomatic treatment of allergy (antihistamines, corticosteroids, etc.). This should be taken into account when discontinuing such medicinal products.

Data on possible risks of concomitant immunotherapy with other allergens during the use of ORALTEC (Monoallergen) are lacking.

Special precautions for use

The medicinal product ORALTEC (Monoallergen) must be prescribed exclusively by an allergist and used under his/her supervision.

The medicinal product ORALTEC (Monoallergen) contains substances that may cause allergic reactions, systemic and/or local adverse reactions in patients.

The time interval between administration of ORALTEC (Monoallergen) spray and food (or drink) intake should be as long as possible to minimize contact and the impact of food products on the area of drug application. Teeth should not be brushed and the oral cavity should not be rinsed at least 30 minutes before and after administration of ORALTEC (Monoallergen). If there is inflammation, ulceration, or infection in the oral cavity, or following recent dental treatment including tooth extraction or any other intervention in the oral cavity, initiation or continuation of treatment should be postponed until complete healing of the oral cavity (see section "Contraindications").

It is recommended to avoid any intense physical exertion for 1–2 hours after administration of a dose of the medicinal product.

Important information on excipients

This medicinal product contains less than 1 mmol (23 mg) of sodium per 1 ml, i.e. practically sodium-free.

Use during pregnancy or breastfeeding

Pregnancy

Currently, there are no reliable data on the use of ORALTEC (Monoallergen) in pregnant women. Therefore, the medicinal product is contraindicated during pregnancy. If pregnancy occurs during treatment, the decision to discontinue the medicinal product should be based on a complete assessment of the patient's overall condition, including pulmonary function and reactions to previous administrations of ORALTEC (Monoallergen). Close monitoring of pregnant patients with bronchial asthma is recommended.

Breastfeeding

Clinical data on the use of ORALTEC (Monoallergen) during breastfeeding are lacking. No effect on breastfed infants is expected.

Ability to influence the speed of reactions when driving or operating machinery

The effect of allergen preparations on the ability to drive or operate machinery is absent or negligible.

Administration and Dosage

Dosage regimen

The medicinal product ORALTEC (Monoallergen) is intended for sublingual spray administration.

The recommended dose is 2 sprays per day.

Duration of treatment – approximately 1.5–3 months. These are approximate values and may vary in practice.

Paediatric patients

The same dosage of the medicinal product ORALTEC (Monoallergen) is recommended for children aged 5 years and older and adults.

Method of administration:

• remove the seal from the bottle to be used;
• prior to use, turn the nozzle with rotating tip to the side (CAUTION! DO NOT LIFT THE NOZZLE FORWARD); perform 3–4 sprays to properly prime the dispenser (only during the first use of the bottle);
• direct the nozzle with rotating tip under the tongue so that the spray reaches under the tongue and onto its dorsal surface;
• administer the spray;
• hold the solution under the tongue for approximately 1–2 minutes, then swallow.

After using the medicinal product, return the nozzle with rotating tip to its original position to lock the spray button. Place the bottle back into its original packaging.

Children

The medicinal product can be used in children aged 5 years and older.

Overdose

Exceeding the dose of allergens administered during allergen-specific immunotherapy may lead to systemic and local adverse reactions in the patient (see section "Adverse Reactions").

Side effects

Most adverse reactions associated with the use of ORALTEK (Monoallergen) are very rare. They may be local (at the site of administration) or systemic.

Patients receiving ORALTEK (Monoallergen) should primarily expect mild or moderate local allergic reactions (oral/oropharyngeal) in the oral cavity, at the site of administration of ORALTEK (Monoallergen), which predominantly occur at the beginning of treatment. The use of ORALTEK (Monoallergen) is also associated with symptoms affecting the lower gastrointestinal tract. Most reactions are transient and resolve spontaneously.

The presence of the listed adverse effects does not necessarily mean that treatment must be interrupted or postponed, but monitoring of drug administration may be required.

Patients with known risk factors should not initiate treatment with ORALTEK (Monoallergen) (see section "Contraindications").

Possible adverse reactions

Information on the adverse reactions listed below was obtained from clinical trial data, spontaneous reports, and medical literature.

All adverse reactions are listed by system organ class and frequency of occurrence: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000), frequency not known (cannot be estimated from available data).

Immune system disorders: very rare – anaphylactic reaction**, hypersensitivity.

Psychiatric disorders: very rare – behavioral disorders.

Respiratory, thoracic and mediastinal disorders: very rare – bronchospasm, nocturnal asthma, dyspnea, facial, eye, lip, tongue or throat swelling, upper respiratory tract infection.

Gastrointestinal disorders: common – oral pruritus; very rare – dysphagia, oral numbness, oral mucosal blistering, abdominal pain, taste disturbance.

Skin and subcutaneous tissue disorders: very rare – eczema, rash, pruritic rash, urticaria.

General disorders and administration site conditions: very rare – increased fatigue, swelling, fever, facial swelling, pain.

If a patient experiences serious adverse reactions to treatment, consideration should be given to the use of antiallergic medications.

**Severe systemic reactions are included in the term anaphylaxis and may lead to anaphylactic shock. In the event of an anaphylactic reaction, adrenaline should be administered intramuscularly at a dose of 0.01 mg/kg, up to a maximum of 0.5 mg (1/1000 solution). Administration may be repeated every 5–15 minutes.

Reporting of suspected adverse reactions

Reporting of adverse reactions after drug registration is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and their legal representatives should report all suspected adverse reactions and lack of drug efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life

3 years.

Storage conditions

Store in the original packaging in a dark place.

Store in a refrigerator (at 2–8 °C).

Keep out of reach of children.

Packaging

9 mL solution in a vial. 2 vials with a twist nozzle equipped with an integrated spray device, in a white plastic box.

Prescription status: Prescription only.

Manufacturer

INMUNOTEK, S.L./INMUNOTEK, S.L.

Manufacturer's address and place of business

Calle Punto Mobi, 5, Alcalá de Henares, 28805 Madrid, Spain