Instructions Alkoid (mixture of allergen extracts of honey grass, yarrow and others) MG01 suspension for subcutaneous administration 2000 and 10,000 TO/ml vial A+B 2.5 ml No. 2
Composition
active ingredients: 1 ml of solution contains 2000 TO (vial A for initial treatment) or 10,000 TO (vial B for initial/maintenance treatment) of one of the mixtures of glutaraldehyde-polymerized allergen extracts:
a mixture of house dust mite allergens (Dermatophagoides pteronyssinus 50%, Dermatophagoides farinae 50%),
or a mixture of allergens of woolly honey grass, common sedge, perennial fenugreek, meadow timothy, meadow fescue, meadow fescue (Holcus lanatus, Dactylis glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis),
or a mixture of allergens of common barley, oat, rye, common wheat (Hordeum vulgare, Avena sativa, Secale cereale, Triticum aestivum),
or a mixture of allergens of hanging birch, black alder, common ash, common hazel (Betula pendula 25%, Alnus glutinosa 25%, Fraxinus excelsior 25%, Corylus avellana 25%),
or a mixture of allergens of timothy grass, pendulous birch (Phleum pratense 50%, Betula pendula 50%),
or a mixture of allergens of timothy grass, ragweed, common wormwood (Phleum pratense 34%, Ambrosia artemisiifolia 33%, Artemisia vulgaris 33%),
or a mixture of ragweed and common wormwood allergens (Ambrosia artemisiifolia 50%, Artemisia vulgaris 50%).
Excipients: phenol, sodium chloride, aluminum hydroxide gel, water for injection.
Therapeutic efficacy is expressed in therapeutic units (TU).
Dosage form
Suspension for subcutaneous administration.
Pharmacotherapeutic group
Allergens, allergen extracts.
ATX code V01A A.
Pharmacological properties
Immunological and biological properties.
Subcutaneous immunotherapy (SIT) increases tolerance to an allergen through immunological mechanisms. This method of allergen-specific therapy sustainably reduces the level of immunoglobulin E (IgE) in human serum, and also prevents seasonal increases in IgE levels, which occur due to the natural increase in the number of certain allergens at certain times of the year.
During therapy, allergens are administered subcutaneously and adsorbed by dendritic cells, which subsequently transfer the antigen to T-lymphocytes, and thus trigger immune reactions to form tolerance to the allergen. The effect of the drug is manifested by an early increase in the level of antigen-specific immunoglobulin G (IgG) and inhibition of the production of seasonal IgE. Subsequently, there is a constant increase in the level of antigen-specific IgG with IgE-blocking properties.
PIT also inhibits the development of both the early and late phases of the immediate allergic reaction.
Pharmacodynamics.
Mechanism of action. ALKSOID (mixture of polymerized allergen extracts) 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 task 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. Treatment with the drug ALKSOID (mixture of polymerized allergen extracts) 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 observation has not been established.
Pharmacokinetics.
With the indicated method of administration of the medicinal product ALKSOID (mixture of polymerized allergen extracts), no significant absorption into the cardiovascular system is expected. Therefore, animal pharmacokinetic studies and clinical studies of the pharmacokinetic profile and metabolism have not been conducted.
Preclinical safety
Preclinical studies of the medicinal product do not indicate the existence of a special risk when using the medicinal product in therapeutic doses according to the instructions for medical use.
Indication
For allergen-specific immunotherapy in the treatment of allergic rhinitis, rhinoconjunctivitis.
Immunotherapy can be performed on adults and children aged 5 and over.
Contraindication
Hypersensitivity to the components of the drug (see the "Composition" section).
Concomitant use of β-blockers. Physical activity immediately after administration of the drug dose.
Elevated body temperature (over 38.5 °C).
Infectious diseases (viral hepatitis, tuberculosis).
Patients with acquired immunodeficiency syndrome (AIDS).
Exacerbation of bronchial asthma 3 days before dosing.
It is contraindicated to start and continue treatment with ALKSOID (a mixture of polymerized allergen extracts) in patients with active autoimmune diseases or patients who do not respond to treatment.
Due to the high risk of neoplasia exacerbation, it is contraindicated to start or continue treatment with the drug ALKSOID (a mixture of polymerized allergen extracts) in patients with malignant neoplasms.
Pregnancy period.
Special safety precautions
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 the drug ALKSOID (mixture of polymerized allergen extracts).
Application features
The drug ALKSOID (a mixture of polymerized allergen extracts) is prescribed exclusively by an allergist and administered under his supervision (self-administration of the drug to patients is strictly prohibited).
On an individual basis, treatment with the drug ALKSOID (a mixture of polymerized allergen extracts) is possible for patients with early stage HIV infection when CD4+>200/μl. In this case, careful monitoring of viral load and CD4+ lymphocyte count is required.
The drug ALKSOID (a mixture of polymerized allergen extracts) may be used with caution in patients with autoimmune diseases in remission.
This medicinal product contains less than 1 mmol (23 mg) sodium/dose, i.e. essentially sodium-free.
The suspension contains an appropriate concentration of a mixture of polymerized allergen extract adsorbed on aluminum hydroxide gel suspended in isotonic physiological 4% phenol solution.
Use during pregnancy or breastfeeding
Pregnancy
Currently, there are no reliable data on the use of the drug ALKSOID (mixture of polymerized allergen extracts) 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, in particular her pulmonary function and reactions to previous use of the drug ALKSOID (mixture of polymerized allergen extracts). Careful monitoring of the condition of pregnant patients with bronchial asthma is recommended.
Breast-feeding
There are no clinical data on the use of the drug ALKSOID (mixture of polymerized allergen extracts) 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
Dosage regimen
Suspension for subcutaneous administration. Injections should only be performed by a healthcare professional. Below are approximate treatment regimens. A more precise regimen is prescribed by a doctor.
Initial treatment
For treatment, 1 vial of A and/or 1 or 2 vials of B are required. Treatment is started with the solution from vial A (2000 TO/ml) (if available). First, a dose of 0.2 ml is administered and a second dose of 0.5 ml is administered a week later. After a dose of 0.5 ml (maximum dose) from vial A (concentration 2000 TO/ml), treatment is continued a week later with the solution from vial B (concentration 10,000 TO/ml); first, a dose of 0.2 ml is administered from this vial and a week later 0.5 ml. After a dose of 0.5 ml (maximum dose) from vial B (concentration 10,000 TO/ml), the solution from this vial is then administered once a month in a dose of 0.5 ml until the solution in the vial is used up.
Table 1
Initial treatment regimen
| Bottle | Volume of one injection | Interval | Date | Note |
AND 2000 TO/ml | 0.2 ml | | | |
| 7 days | | | |
| 0.5 ml | | | | |
IN 10,000 TO/ml | | 7 days | | |
| 0.2 ml | | | | |
| 7 days | | | |
| 0.5 ml | | | | |
| 30 days | | | |
| 0.5 ml | | | | |
| 30 days | | The need for supportive treatment | |
| 0.5 ml | | | | |
Supportive treatment
Treatment requires 1 or 2 vials of B. Treatment begins with a dose of 0.5 ml from vial B once a month. A total of 5 doses from this vial are administered.
Table 2
Maintenance treatment regimen
| Bottle | Volume of one injection | Interval | Date | Note |
IN 10,000 TO/ml | 0.5 ml | | | |
| 30 days | | | |
| 0.5 ml | | | | |
| 30 days | | | |
| 0.5 ml | | | | |
| 30 days | | | |
| 0.5 ml | | | | |
| 30 days | | The need for supportive treatment | |
| 0.5 ml | | | | |
| 30 days | | | |
Children.
The same doses of the drug ALKSOID (a mixture of polymerized allergen extracts) are recommended for children aged 5 years and older and adults.
Method of application
The drug ALKSOID (a mixture of polymerized allergen extracts) is intended for use in a medical facility.
Treatment with the drug ALKSOID (a mixture of polymerized allergen extracts) is carried out only in a medical institution equipped with emergency medical care in the event of anaphylactic shock, in particular, the availability of adrenaline and cardiopulmonary resuscitation is ensured.
The procedure for using the drug from vials:
- ensure a high level of asepsis when working with vials;
- for manipulations, use 1 ml syringes (for insulin) with 5/10 or 6/10 needles 1 cm long;
- Shake the bottle slowly to ensure that the medicine becomes homogeneous;
- disinfect the rubber cap of the vial with alcohol and insert the needle;
- before administering the drug, disinfect the injection site with alcohol - the deltoid area of the outer surface of the arm, pinch the skin so that blood does not get into the syringe;
- After administering the drug, do not wipe the area of skin where the injection was made.
The patient is left in the medical facility for at least 30 minutes after the injection, so that in case of undesirable side reactions, he can immediately be provided with the necessary medical care.
Children.
Used for children aged 5 and over.
Overdose
Exceeding the dose of allergens administered to a patient during allergen-specific immunotherapy may lead to general and local adverse reactions (see the section "Adverse reactions").
Side effects
When using the drug ALKSOID (a mixture of polymerized allergen extracts), both local and systemic adverse reactions may occur.
Local reactions occur frequently
Manifested as redness, pain and/or swelling at the injection site. Usually occur within the first 30 minutes (immediate reactions) and/or with a delay of 30 minutes to 72 hours (delayed reactions).
Mild local reactions (immediate or delayed) in the form of redness or swelling, the diameter of which does not exceed 5–6 cm, are normal.
Moderate immediate reactions in the form of redness or swelling, 6–12 cm in diameter, may require treatment with antihistamines.
Serious immediate reactions in the form of redness or swelling, more than 12 cm in diameter, require treatment with antihistamines and observation of the patient for 60 minutes.
Delayed moderate or severe local reactions are usually harmless and are treated with ice packs and/or topical corticosteroids.
Moderate systemic reactions occur infrequently.
Eye and nasal irritation, sneezing, urticaria, angioedema, occurring 15 minutes to 4–6 hours after subcutaneous injection. Treatment with oral or intramuscular antihistamines is recommended, especially in the case of urticaria or angioedema. Intravenous corticosteroids (40 mg prednisolone) may be used. This treatment may be repeated if necessary. Bronchodilators should be used if bronchospasm (of any severity) occurs. The patient is advised accordingly.
Severe systemic reactions occur very rarely.
Appear 30 minutes after injection
May manifest as bronchial asthma (respiratory failure), urticaria/angioedema or anaphylactic shock.
When treating patient-threatening conditions, approved protocols for the treatment of systemic allergic reactions should be followed.
Very rarely, asthma (breathing difficulties) requiring treatment with corticosteroids and bronchodilators has been reported.
All side effects should be reported to the doctor.
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
2.5 ml per bottle.
Primary packaging: a type I clear glass vial with a butyl rubber stopper, closed with a silver (vials A 2000 TO for initial treatment) or blue (vials B 10000 TO for maintenance treatment) cap.
Secondary packaging: 2 vials sealed with a silver cap (vials A 2000 TO for initial treatment) and blue (vials B 10000 TO for maintenance treatment) or 1 vial sealed with a blue cap (vials B 10000 TO for maintenance treatment), in a white box made of impact-resistant plastic filled with foamed material, in which the vials with the drug are placed.
Vacation category
According to the recipe.
Producer
IMMUNOTEK, S.L.
Location of the manufacturer and address of its place of business.
Calle Punto Mobi, 5, Alcala de Henares, 28805 Madrid, Spain.
