Klenil UDV suspension for inhalation 0.8 mg / ml, 2 ml No. 20

Bronchial asthma.

Inhalation The drug is not intended for injection. ClenilЃ UDV must be applied using a special inhaler (compressor nebulizer) equipped with a mouthpiece and a special mask. The dose of the drug is selected individually.
Adults: 800 mcg (1 single-dose ampoule for one nebulization procedure) 1-2 times a day.
Children from 6 years old : 400 mcg (half of a single-dose ampoule for one nebulization procedure) 1-2 times a day. The single-dose ampoule has a half-dose mark.

Directions for the use of KlenilaЃ UDV with a nebulizer:
Use a single-dose ampoule in accordance with the following instructions:

1. Bend the single-dose ampoule in two directions

2. Separate the single-dose ampoule from the strip at the top, then in the central part

3. Shake the single-dose ampoule vigorously until a homogeneous suspension is formed, until completely dispersed.

4. Open the single-dose ampoule by turning the cap as shown in the figure

5. Gently squeeze the contents of a single-dose ampoule in the prescribed dose into the nebulizer chamber

6. If half dose is used, the ampoule can be closed with the back of the cap as shown in the figure.

Unused suspension should be disposed of.

2 ml of suspension contains:
Active substance:
beclomethasone dipropionate 800 mcg.
Excipients:
sodium chloride, polysorbate 20, sorbitan laurate, purified water.

Hypersensitivity to the components of the drug, children under 6 years of age, tuberculosis infection of the respiratory system. Pregnancy (I trimester) and lactation.

With care:
Liver cirrhosis, glaucoma, hypothyroidism, systemic infections (bacterial, fungal, parasitic), viral respiratory infections, osteoporosis.

Trade name
KlenilЃ UDV

International non-proprietary or group name
Beclomethasone

Dosage form:

suspension for inhalation

Composition:

2 ml of suspension contains:
Active substance:
beclomethasone dipropionate 800 mcg.
Excipients:
sodium chloride, polysorbate 20, sorbitan laurate, purified water.

Description:
White, opalescent, homogeneous or slightly sedimented suspension, breakable when shaken in a hermetically sealed plastic ampoule.

Pharmacotherapeutic group:

Topical glucocorticosteroid

Pharmacological properties:

ClenilЃ UDV contains beclomethasone, a cortisone derivative, as an active ingredient . Beclomethasone is an inhaled glucorticosteroid (GCS), in recommended doses has an anti-inflammatory effect, reduces the severity of symptoms of bronchial asthma and the frequency of exacerbations of the disease, while having a lower frequency of side effects than systemic GCS.
Under the influence of beclomethasone, the number of mast cells in the bronchial mucosa decreases, epithelial edema, mucus secretion by the bronchial glands, bronchial hyperreactivity, marginal accumulation of neutrophils, inflammatory exudate and cytokine production decrease, macrophage migration is inhibited, the intensity of infiltration and granulation processes decreases, and function indicators improveexternal respiration. Restores the patient's reaction to bronchodilators, allowing to reduce the frequency of their use.
Does not possess mineralocorticoid activity. In therapeutic doses, it has an active local effect without the development of side effects characteristic of systemic corticosteroids.

Pharmacokinetics: Pharmacokinetic
studies of beclomethasone have shown that after inhalation of a high dose, only 20-25% of the drug is absorbed.
Inhaled beclomethasone is rapidly absorbed by the lungs; its absorption is preceded by an intensive conversion of beclomethasone into its active metabolite beclomethasone-17-monopropionate (B-17-MP). The systemic bioavailability of B-17-MP is provided by 36% due to the lungs, as well as due to the absorption of the swallowed part of the inhalation dose by the organs of the gastrointestinal tract (GIT). Absolute bioavailability after inhalation is about 2% and 62% of the nominal dose in relation to unchanged beclomethasone and B-17-MP, respectively. Communication with plasma proteins - 87%. Beclomethasone is characterized by a very high rate of clearance (150 l / h and 120 l / h, respectively) from the systemic circulation due to the action of esterase, which is present in most tissues. The main metabolic product of beclomethasone is the active metabolite B-17-MP.Less active metabolites are beclomethasone-21-monopropionate (B-21-MP) and beclomethasone, which are also formed as a result of metabolism, but their role in the systemic effects of beclomethasone is very insignificant. The main part of beclomethasoneexcreted with feces in the form of polar metabolites. Approximately 12% of the administered dose is excreted in the urine in the form of free and conjugated polar metabolites. The half-life (T1 / 2) of beclomethasone and B-17-MP is 0.5 and 2.7 hours, respectively.

Indications:

Bronchial asthma.

Contraindications:

Hypersensitivity to the components of the drug, children under 6 years of age, tuberculosis infection of the respiratory system. Pregnancy (I trimester) and lactation.

With care:
Liver cirrhosis, glaucoma, hypothyroidism, systemic infections (bacterial, fungal, parasitic), viral respiratory infections, osteoporosis.

Pregnancy and lactation:
It is not recommended to use ClenilЃ UDV in the first 3 months of pregnancy, and in its subsequent periods (II and III trimesters), the drug should be used only in cases where the benefits of using the drug for the mother outweigh the potential risk to the fetus. It is recommended to prescribe the minimum dose that provides effective control of the symptoms of bronchial asthma. It is not recommended to use ClenilЃ UDV during lactation.

Method of administration and dosage:
Inhalation. The drug is not intended for injection. ClenilЃ UDV must be applied using a special inhaler (compressor nebulizer) equipped with a mouthpiece and a special mask. The dose of the drug is selected individually.
Adults: 800 mcg (1 single-dose ampoule for one nebulization procedure) 1-2 times a day.
Children from 6 years old : 400 mcg (half of a single-dose ampoule for one nebulization procedure) 1-2 times a day. The single-dose ampoule has a half-dose mark.

Directions for the use of KlenilaЃ UDV with a nebulizer:
Use a single-dose ampoule in accordance with the following instructions:

1. Bend the single-dose ampoule in two directions

2. Separate the single-dose ampoule from the strip at the top, then in the central part

3. Shake the single-dose ampoule vigorously until a homogeneous suspension is formed, until completely dispersed.

4. Open the single-dose ampoule by turning the cap as shown in the figure

5. Gently squeeze the contents of a single-dose ampoule in the prescribed dose into the nebulizer chamber

6. If half dose is used, the ampoule can be closed with the back of the cap as shown in the figure.

Unused suspension should be disposed of.

Note
After each inhalation, rinse your mouth with water. If using a mask, make sure the mask is snug against the face when inhaling. Wash face after inhalation.

Side effect:

Hoarseness, throat irritation, coughing, sneezing; candidiasis of the oral cavity and upper respiratory tract (with prolonged use and / or when used in high doses), which passes with local antifungal therapy without stopping treatment.
In some cases, paradoxical bronchospasm may occur (it is stopped by the administration of inhaled bronchodilators), eosinophilic pneumonia; allergic reactions (rash, urticaria, itching, erythema; swelling of the eyes, face, lips, pharynx).
In rare cases, symptoms may occur caused by the systemic effects of beclomethasone, incl. adrenal insufficiency, Itsenko-Cushing's syndrome, growth retardation in children and adults, decreased bone mineral density, anxiety, sleep disturbances, hyperactivity and irritability mainly in children, headaches, dizziness, cataracts, increased intraocular pressure, leukocytosis, lymphopenia, eosinopenia.

Overdose:

With a single inhalation of doses exceeding the average therapeutic values, a slight decrease in the function of the hypothalamic-pituitary-adrenal system is possible, which does not require any emergency measures, and treatment should be continued. The function of the hypothalamic-pituitary-adrenal system is restored in 1-2 days. With prolonged use of the drug in doses significantly exceeding the recommended ones, a systemic glucocorticosteroid effect may develop in the form of hypercortisolism and suppression of adrenal function. In this case, treatment should be interrupted and measures should be taken to reduce the symptoms of adrenal cortex suppression with appropriate therapy.

Interaction with other medicinal products:
No significant interactions of inhaled GCS with other medicinal products have been identified.
Beclomethasone restores the patient's response to beta-adrenergic agonists, making it possible to reduce the frequency of their use. Phenobarbital, phenytoin, rifampicin and other inducers of liver microsomal enzymes reduce the effectiveness. Methandienone, estrogens, beta2-adrenergic agonists, theophylline and oral corticosteroids enhance the effect. Increases the effect of beta-adrenergic agonists.

Special instructions:

Beclomethasone is not intended for the relief of acute attacks of bronchial asthma.
After the appointment of inhaled GCS, some patients may develop candidiasis of the oral cavity or pharynx. In patients with anamnestic or laboratory data on a previous infection, this complication develops quickly. It is advisable to rinse the mouth and pharynx after inhalation (prevention of candidiasis), and when the initial signs of fungal infection of the oral mucosa appear, the use of nystatin, fluconazole, amphotericin B, without interrupting treatment with beclomethasone. Washing after inhalation can prevent damage to the skin of the eyelids and nose.
Paranasal sinus or nasal cavity infections should be treated with appropriate medications, however, they are not specific contraindications to the use of ClenilaЃ UDV.
Due to the possible risk of weakening the function of the adrenal glands, special attention should be paid to patients who are transferred from oral corticosteroids to taking ClenilЃ UDV. In such patients, special precautions should be taken to reduce the dose of systemic corticosteroids and to control the hypothalamic-pituitary-adrenal function. In stressful situations, these patients may show signs and symptoms of adrenal insufficiency. Such patients should have a supply of GCS and a warning card with them, which should indicate that in stressful situations (such as trauma, surgery, etc.) they need additional systemic administration of GCS (after eliminating the stressful situation, the dose steroids can be reduced again).Sometimes the transfer from taking systemic corticosteroids to inhalation can lead to the manifestation of previously suppressed forms of allergy, for example, allergic rhinitis or eczema.
When switching from oral corticosteroids to ClenilЃ UDV, symptoms such as muscle pain or joint pain may occur. In such cases, a temporary increase in the dose of oral corticosteroids may be required. In rare cases, symptoms such as fatigue, headache, nausea and vomiting may occur, indicating systemic insufficiency of GCS. Store upright as shown on the package. Single-dose vials can be stored for 3 months outside the protective bag, protected from light.
It is recommended to be careful when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Release form:

Suspension for inhalation 800 mcg / 2ml.
2 ml in a hermetically sealed plastic ampoule. A strip of 5 ampoules is placed in an aluminum strip. 4 strips with instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature not exceeding 25 ? —, in the original packaging to protect from light, away from heating devices. Keep out of the reach of children.

Shelf life:

2 years. Do not use after the date indicated on the package.

Terms of dispensing from pharmacies:

On prescription.