Oraltek (allergen mixture)

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ORALTEK (Allergen Mixture) (ORALTEK® Polyvalent)

Composition:

Active substance: natural allergen extract;

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

• mixture of house dust mite allergens (Dermatophagoides pteronyssinus 50% / Dermatophagoides farinae 50%), or
• mixture of allergens of Holcus lanatus, Dactylis glomerata, Lolium perenne, Poa pratensis, Phleum pratense, Festuca pratensis, or
• mixture of allergens of Hordeum vulgare, Avena sativa, Secale cereale, Triticum aestivum, or
• mixture of allergens of Betula pendula 25%, Alnus glutinosa 25%, Corylus avellana 25%, Fraxinus excelsior 25%, or
• mixture of allergens of Betula pendula 50%, Phleum pratense 50%, or
• mixture of allergens of Phleum pratense 34%, Artemisia vulgaris 33%, Ambrosia artemisiifolia 33%, or
• mixture of allergens of Artemisia vulgaris 50%, Ambrosia artemisiifolia 50%, or
• mixture of mold allergens (Alternaria alternata 50%, Aspergillus fumigatus 50%), or
• mixture of mold allergens (Alternaria alternata 50%, Cladosporium herbarum 50%), or
• mixture of mold allergens (Alternaria alternata 34%, Aspergillus fumigatus 33%, Cladosporium herbarum 33%), or
• mixture of mold allergens (Alternaria alternata 25%, Aspergillus fumigatus 25%, Cladosporium herbarum 25%, Penicillium notatum 25%).

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

Pharmaceutical form. Sublingual spray.

Pharmacotherapeutic group. Various agents. Allergens, allergen extracts.
ATC code: V01AA20.

Pharmacological Properties

Pharmacodynamics

Mechanism of action. ORALTEC (Allergen mixture) 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 for patient treatment. The complete and detailed mechanism of action in terms of the clinical effect of specific immunotherapy is not fully known and has not been investigated. For immunotherapy to be effective and to elicit an immune response, the allergen extract must be taken up by dendritic cells present in the oral mucosa, as they are essential for the induction of a specific immune response.

Pharmacokinetics

With the route of administration described below, significant absorption of the medicinal product ORALTEC (Allergen mixture) into 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 the medicinal product ORALTEC (Allergen mixture) do not indicate any special risk associated with its use at therapeutic doses according to the instructions for medical use.

Clinical Characteristics

Indications

The medicinal product ORALTEC (Allergen Mixture) 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 for various allergens.

Immunotherapy can 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 in the oral cavity or wounds therein (see section "Special Warnings and Precautions for Use").

Pregnancy.

Special Safety Measures

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

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

Interaction with Other Medicinal Products and Other Types of Interactions

Do not use concomitantly with β-blockers.

Tolerance to the medicinal product ORALTEK (Allergen Mixture) 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 the medicinal product ORALTEK (Allergen Mixture) are lacking.

Special precautions for use

The medicinal product ORALTEK (Allergen mixture) must be prescribed exclusively by an allergist and administered under his/her supervision.

The medicinal product ORALTEK (Allergen mixture) contains substances which may cause allergic reactions, systemic and/or local adverse reactions in patients.

The time interval between administration of ORALTEK (Allergen mixture) spray and food (or drink) intake should be as long as possible in order to minimize contact and the influence of food products on the area of drug spray deposition. Teeth should not be brushed and the oral cavity should not be rinsed for at least 30 minutes before and after administration of ORALTEK (Allergen mixture). In case of inflammation, ulceration, or infection in the oral cavity, or following recent dental treatment including tooth extraction or any other intervention in the oral cavity, treatment initiation or continuation must be postponed until complete healing of the oral mucosa (see section "Contraindications").

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

Important information about excipients

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

Use during pregnancy or breastfeeding

Pregnancy

Currently, there are no reliable data on the use of ORALTEK (Allergen mixture) in pregnant women. Therefore, the medicinal product is contraindicated during pregnancy. If pregnancy occurs during ongoing 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 ORALTEK (Allergen mixture). Close monitoring of pregnant patients with bronchial asthma is recommended.

Breastfeeding

Clinical data on the use of ORALTEK (Allergen mixture) during breastfeeding are lacking. No effects on infants who are breastfed are expected.

Ability to influence reaction rate while driving or operating machinery

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

Method of Administration and Dosage

Dosage regimen

The medicinal product ORALTEC (Allergen mixture) is intended for administration by sublingual spray.

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 doses of the medicinal product ORALTEC (Allergen mixture) are recommended for children aged 5 years and older and for adults.

Method of administration:

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

After using the medicinal product, return the spray 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 to a patient during allergen-specific immunotherapy may lead to systemic and local adverse reactions (see section "Adverse Reactions").

Adverse Reactions

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

Patients taking ORALTEK (Allergen Mix) should primarily expect mild or moderate local allergic reactions (oral/oropharyngeal) in the oral cavity, at the site of administration of ORALTEK (Allergen Mix), which predominantly occur at the beginning of treatment. The use of ORALTEK (Allergen Mix) 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 during administration of the medicinal product may be required.

Patients with known risk factors should not initiate treatment with ORALTEK (Allergen Mix) (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 (≥ 1/10000 to < 1/1000), very rare (< 1/10000), 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, blistering of the oral mucosa, abdominal pain, taste disturbance.

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

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

If a patient experiences serious adverse reactions to treatment, consideration should be given to using antiallergic medicinal products.

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

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and their legal representatives are encouraged to report any suspected adverse reactions and lack of 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 of solution in a vial. 2 vials with a screw cap equipped with an integrated spray nozzle, in a white plastic box.

Prescription category. 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