Instructions Oraltec (Monoalergen) W302 sublingual spray 30,000 IU with wormwood allergen extract bottle 9 ml No. 2
Composition
active ingredient: natural allergen extract;
1 ml of solution in each of the individual vials contains 30,000 TO of one of the natural allergen extracts:
ragweed (Ambrosia artemisiifolia 100%) or
common wormwood (Artemisia vulgaris 100%), or
Pendulous birch (Betula pendula 100%), or
Alternaria alternata mold fungi 100%, or
mold fungi Cladosporium herbarum 100%, or
mold fungi Aspergillus fumigatus 100%, or
mold fungi Candida albicans 100%, or
cat dander (Cat dander 100%), or
dog hair (Dog dander 100%);
Excipients: glycerin 50%, pineapple essence, sodium chloride, water for injection.
Therapeutic efficacy is expressed in therapeutic units (TU).
Dosage form
Sublingual spray
Pharmacotherapeutic group
Other medicines. Allergens, allergen extracts.
ATX code V01A A.
Pharmacological properties
Other medicines. Allergens, allergen extracts.
ATX code V01A A.
Pharmacodynamics.
Mechanism of action. ORALTEC (Monoallergen) is used to treat patients with specific IgE-mediated allergic reactions to various allergens with symptoms such as rhinitis and rhinoconjunctivitis. The target of the pharmacodynamic effect is the immune system. The goal is to modify the immune response to the allergens with which the patient is treated. The complete and detailed mechanism of action from the point of view of the clinical effect of specific immunotherapy is not known for certain and has not been studied. The use of the drug ORALTEC (Monoallergen) causes a systemic competitive antibody response to various allergens, which is accompanied by a gradual increase in the production of specific IgG over 2 years of treatment or more. The clinical significance of this phenomenon has not been established.
Pharmacokinetics.
With the indicated route of administration, no significant absorption and systemic effects of the drug ORALTEC (Monoalergen) are expected. Therefore, animal pharmacokinetic studies and clinical studies of the pharmacokinetic profile and metabolism of this drug have not been conducted.
Preclinical safety
Preclinical studies of the drug ORALTEC (Monoalergen) do not indicate the existence of a special risk when used in therapeutic doses according to the instructions for medical use.
Indication
Immunotherapy of respiratory allergies in patients with clinical symptoms and positive skin prick tests and/or positive specific IgE tests to various allergens.
Immunotherapy can be performed on adults and children aged 2 years and older.
Contraindication
Hypersensitivity to any of the excipients of the medicinal product (see section "Composition"). Simultaneous use of β-blockers. Physical exertion immediately after applying a dose of the spray. Elevated body temperature (over 38.5 °C). Infectious diseases (viral hepatitis, tuberculosis). Acquired immunodeficiency syndrome (AIDS). Patients with autoimmune diseases in active form or who do not respond to treatment. Malignant neoplasms. Exacerbation of bronchial asthma 3 days before the dose. Pregnancy.
Special safety precautions
There is no need for special precautions and precautions when using allergen preparations.
Any unused 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 simultaneously with β-blockers.
There are no data on the possible risks of concomitant immunotherapy with other allergens during treatment with ORALTEC (Monoalergen).
Application features
The drug ORALTEC (Monoalergen) is prescribed exclusively by an allergist and is used under his supervision.
Allergen immunotherapy with ORALTEC (Monoallergen) is contraindicated in patients with acquired immunodeficiency syndrome (AIDS). On an individual basis, treatment with ORALTEC (Monoallergen) is possible in patients with early stage HIV infection when CD4+>200/μl. In this case, careful monitoring of viral load and CD4+ lymphocyte count is required.
Also, patients with active autoimmune diseases or those that do not respond to treatment should not start or continue treatment with ORALTEC (Monoallergen). ORALTEC (Monoallergen) spray should be used with caution in patients with autoimmune diseases in remission.
Due to the high risk of neoplasia exacerbation, treatment with ORALTEC (Monoalergen) should not be initiated or continued in patients with malignant neoplasms.
ORALTEC (Monoallergen) contains substances that may cause allergic reactions, systemic and/or local undesirable side effects in patients.
Excipients.
This medicinal product contains 1 mmol (23 mg) sodium per dose, i.e. essentially sodium-free. Caution should be exercised when administering this medicinal product to patients on a controlled sodium diet.
The medicine contains 50% glycerin, which may cause headache, digestive tract irritation, and diarrhea.
Use during pregnancy or breastfeeding
Pregnancy
Currently, there are no reliable data on the use of the drug ORALTEC (Monoalergen) in pregnant women. Therefore, the drug is contraindicated during pregnancy. If pregnancy occurs during treatment, the decision to discontinue the drug is made based on the results of a complete assessment of the patient's general condition, including her pulmonary function and reactions to previous doses of the drug ORALTEC (Monoalergen). Careful monitoring of the condition of pregnant patients with bronchial asthma is recommended.
Breast-feeding
There are no clinical data on the use of ORALTEC (Monoalergen) during breastfeeding. No effects on breastfed infants are expected.
Ability to influence reaction speed when driving vehicles or other mechanisms
Allergen preparations do not affect the ability to drive or use other mechanisms.
Method of administration and doses
ORALTEC (Monoalergen) is intended for use by spraying under the tongue and on the back of the tongue.
The recommended dose is 2 sprays per day.
The duration of treatment is approximately 1.5–3 months. These are approximate values and may vary in practice.
The use of ORALTEC (Monoallergen) spray should be spaced as far apart as possible from food (drinks) intake to minimize contact and exposure of food products to the spray area. Do not brush your teeth or rinse your mouth for at least 30 minutes before and after applying ORALTEC (Monoallergen).
Children.
The same doses of the drug ORALTEC (Monoalergen) are recommended for children aged 2 years and older and adults.
Method of application:
- remove the seal of the bottle to be used;
- before use, move the bottle pipette to the side and perform 3–4 sprays to properly fill the dispenser;
- turn the rotating nozzle, directing it under the tongue, so that when spraying, the drug gets under the tongue and onto its back;
- spray the drug;
- Hold the solution under your tongue without swallowing for about 1 minute. Then you can swallow.
After taking the medicine, return the pipette to its original position, which will lock the spray button. Place the bottle in the original packaging.
Children.
Used for children aged 2 years and over.
Overdose
Exceeding the dose of allergens administered to a patient during allergen-specific immunotherapy may lead to systemic and local adverse reactions (see the section "Adverse reactions").
Side effects
When using the drug ORALTEC (Monoalergen), both local and systemic adverse reactions may occur.
Local reactions
Allergic reactions in the oral cavity: itching in the oral cavity, swelling, discomfort in the oral cavity and throat, impaired salivary gland function (increased salivation or dry mouth).
Very rarely, asthma (breathing difficulties) requiring treatment with corticosteroids and bronchodilators has been reported.
Reporting of suspected adverse reactions
Once a medicinal product has been authorised, it is essential to report suspected adverse reactions. This allows for continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any adverse reactions via the national reporting system.
Expiration date
3 years.
Storage conditions
Store in original packaging in a dark place.
Store in a refrigerator (2–8°C). Do not freeze.
Keep out of reach of children.
Packaging
9 ml of solution in a bottle. 2 bottles with a swivel nozzle equipped with a built-in sprayer in a white plastic box.
Vacation category
According to the recipe.
Producer
INMUNOTEK, S.L./INMUNOTEK, SL
Address
Calle Punto Mobi, 5, Alcala de Henares, 28805 Madrid, Spain
Calle Punto Mobi ,5, Alcala de Henares, 28805 Madrid, Spain.
