Description
Latin name
Sibry Breathhaler
Packing
30 capsules complete with inhalation device (breather)
Pharmacological action
Siberian Breezhaler (glycopyrronium bromide) is a long-acting anticholinergic bronchodilator intended for the treatment of COPD.
According to research, glycopyrronium bromide effectively improves lung function, reduces the severity of symptoms of COPD and reduces the frequency of exacerbations.
Glycopyrronium bromide begins to act within 5 minutes after administration, well tolerated and provides a bronchodilation effect lasting 24 hours.
Indications
Supportive care for bronchial conduction disorders in patients with chronic obstructive pulmonary disease.
Contraindications
hypersensitivity to glycopyrronium bromide or any other components that are part of the preparation Sibri Brizkhaler
age up to 18 years old
concomitant use with inhaled drugs containing other m-anticholinergic glucose lactobacilli, the drug contains lactose).
Precautions
Angle-closure glaucoma, diseases associated with urinary retention, severe renal failure (GFR below 30 ml / min / 1.73 m2), including end-stage renal failure requiring hemodialysis (Sybri Breezhaler should be used only if expected benefit outweighs potential risk) unstable coronary heart disease (CHD), a history of myocardial infarction, heart rhythm disturbances, lengthening of the QTc interval (QT adjusted> 0.44 s).
Use during pregnancy and lactation
Preclinical studies have shown that the drug does not have a teratogenic effect after inhalation. Due to the lack of clinical data on the use of the drug Sibri Breezhaler in pregnant women, the drug can be used during pregnancy only if the intended benefit to the patient outweighs the potential risk to the fetus.
It is not known whether glycopyrronium bromide passes into breast milk in humans. The use of Sibri Breezhaler during breastfeeding should only be considered if the benefits to the mother outweigh any potential risk to the baby.
Neither reproductive toxicity studies nor other animal studies suggest that the drug may affect fertility in men or women.
Composition
1 capsule with powder for inhalation contains: active substances: glycopyrronium base 50 μg, which corresponds to the content of glycopyrronium bromide 63 μg,
excipients: lactose monohydrate – 24.9 mg, magnesium stearate – 0.037 mg.
capsule composition: hypromellose – 45. 59 mg, water – 2.7 mg, carrageenan – 0.42 mg, sodium chloride – 0.18 mg, dye sunny sunset yellow (E110) – 0.12 mg.
ink composition: shellac, dye iron oxide black, propylene glycol, sodium hydroxide.
Dosage and administration
For inhalation only!
Sibri Breezhaler is a capsule with powder for inhalation, which should be used only for inhalation through the mouth using a special device for inhalation Breezhaler, which is included in the package. The drug can not be taken orally. Capsules with powder for inhalation should be stored in a blister and removed immediately before use.
The recommended dose of Sibri Breezhaler is 50 mcg (contents of 1 capsule) once a day. Inhalation of the drug is carried out daily 1 time per day at the same time. In case of skipping inhalation, the next dose should be taken as soon as possible. Patients should be instructed not to take more than 1 dose of the drug (50 mcg) per day.
When prescribing Sibri Breezhaler, patients should be instructed on the proper use of the inhaler. Use in patients with renal failure
In patients with mild to moderate renal failure, the recommended dose of Sibri Breezhaler may be used. In patients with severe renal failure or end-stage renal disease requiring hemodialysis, Sibri Breezhaler should be used at the recommended dose only if the intended benefit outweighs the potential risk.
Use in patients with hepatic impairment
No specific clinical studies have been conducted in patients with hepatic impairment. The drug Sibri Breezhaler is excreted mainly by renal excretion, therefore, a significant increase in exposure in patients with liver failure is not expected. In patients with impaired liver function, the recommended dose of Sibri Breezhaler may be used.
Use in elderly patients
The drug Sibri Breezhaler can be used at the recommended dose in patients aged 75 years and older.
Directions for use
Each package of Sibri Brizkhaler contains: – One inhalation device – Brizkhaler
– Blisters with capsules with powder for inhalation
Capsules with powder for inhalation must not be taken orally!
The Brizkhaler inhaled device in the package is intended for use only with the capsules of the drug.
For inhalation capsules, contained in the package, only the inhalation device Breezhaler is used.
Do not use the capsule of the drug with any other inhalation device and, in turn, do not use the brihaler to inhale other drugs.
After 30 days of use, the breather should be discarded.
How to use an inhaler.
Remove the cover.
Open the Breezhaler.
To open the inhaler, grasp it firmly by its base and tilt the mouthpiece.
Prepare the capsule: Separate one blister from the blister pack by tearing it in perforation.
Take one blister and peel off the protective film to release the capsule.
Do not squeeze the capsule through the protective film.
Remove the capsule: The capsules should be stored in a blister and removed only immediately before use. Dry your hands and remove the capsule from the blister. Do not swallow the capsule.
Insert the capsule into the Breezhaler: Put the capsule in the capsule chamber.
Never place the capsule directly in the mouthpiece.
Close the Breezhaler: Close the inhaler tightly. When it closes to the end, a click should be heard.
Pierce the capsule: Hold the Breezhaler upright with the mouthpiece pointing up.
Press both buttons fully until the end. When piercing the capsule, a click should be heard.
Do not press the buttons to pierce the capsule more than once.
Release the Breezhaler inhaler buttons completely on both sides.
Breathe out: Before you insert the mouthpiece into your mouth, exhale completely.
Never blow the mouthpiece.
Inhale drug: – Hold the Breezhaler in your hand so that the buttons are left and right (and not top and bottom), as shown in the picture.
– Insert the mouthpiece of the Breezhaler inhaler into your mouth and squeeze your lips tightly around it.
– Take a quick, uniform, deepest breath. Do not press the buttons of the piercing device.
Note: When you inhale through an inhaler, you should hear a characteristic rattling sound created by rotating the capsule in the chamber and spraying the powder. You may feel the sweet taste of the drug in your mouth.
If you do not hear a rattling sound, this may mean that the capsule is stuck in the inhaler chamber.
In this case, open the inhaler and gently release the capsule by tapping the base of the device. To release the capsule, do not press the buttons to pierce the capsule. Repeat steps 9 and 10 if necessary.
Hold your breath: If you hear a characteristic sound when you inhale, hold your breath for as long as possible (so as not to feel discomfort), and at the same time, remove the mouthpiece from your mouth. Then exhale.
Open the Breezhaler and see if the powder remains in the capsule. If the powder remains in the capsule, close the Breezhaler and repeat steps 9-12. Most people can empty the capsule in one or two inhalations.
Some people have a cough for a short time after inhalation of the drug. If you are coughing, do not worry. If there is no powder left in the capsule, then you have received the full dose of the drug.
Take out the capsule: After you take the daily dose of the Sibri Breezhaler drug, deflecting the mouthpiece, take out the empty capsule, tapping the inhaler and throw it away. Close the mouthpiece of the inhaler Breezhaler and close the Breezhaler lid.
Do not store capsules in the Breezhaler inhaler.
Do not swallow capsules with inhalation powder.
Use only the blazhaler in the package.
Capsules should be stored in a blister pack and removed immediately before use.
Never place a capsule in the mouthpiece of a Breezhaler inhaler. Do not press the piercing device more than once.
Never blow into the mouthpiece of an inhaler Breezhaler.
Always roll the capsule before inhalation.
Do not wash Breezhaler. Keep it dry. See How to Clean the Breezhaler. Do not disassemble Breezhaler.
When starting a new drug package, always use the new Breezhaler in the package to inhale the capsules.
Do not store capsules in the Breezhaler inhaler.
Always store blister packs with capsules and Breezhaler in a dry place.
Additional Information
In very rare cases, a small amount of the contents of the capsules may be ingested. Do not worry if you inhale or swallow it.
Note that if you pierce a capsule more than once, the risk of breaking it increases.
How to Clean the Breezhaler
Clean the Breezhaler once a week. Wipe the mouthpiece inside and out with a clean, dry cloth. Never use water to clean the Breezhaler inhaler. Keep it dry.
Side effects
The safety profile of the drug Sibri Breezhaler is characterized by symptoms associated with m-choli blocking effect, including dry mouth (2.2%), while other gastrointestinal effects and signs of urinary retention were infrequent.
Adverse drug reactions (NLR) associated with local drug tolerance included pharyngeal irritation, nasopharyngitis, rhinitis, and sinusitis. In recommended doses, the Sibri Breezhaler drug does not affect blood pressure (BP) and heart rate.
The safety and tolerability of Sibri Breezhaler was studied in 1353 patients with COPD at a recommended dose of 50 mcg once a day. Of these, 842 patients were treated for at least 26 weeks and 351 for at least 52 weeks.
The following criteria were used to estimate the incidence of NLR: very often (> 1/10) often (> 1 / 100.1 / 1000.1 / 10000, 1/1000) very rarely (
Infectious and parasitic diseases: often – nasopharyngitis infrequently – rhinitis, cystitis.
Metabolism and nutritional disorders: infrequently – hyperglycemia.
Mental disorders: often – insomnia.
Disorders of the nervous system: often – headache infrequently – hypesthesia.
Heart disorders: infrequently – atrial fibrillation, palpitations.
Disorders of the respiratory system, chest and mediastinal organs: infrequently – congestion in the sinuses, productive cough, pharyngeal irritation, nosebleeds.
Disorders of the digestive system: often – dry mouth, gastroenteritis infrequently – dyspepsia, dental caries.
Disorders of the skin and subcutaneous tissue: infrequently – skin rash.
Disorders of the musculoskeletal and connective tissue: infrequently – pain in the limbs, pain of skeletal muscles of the chest.
Disorders of the kidneys and urinary tract: often – urinary tract infection infrequently – dysuria, urinary retention.
General disorders and disorders at the injection site: infrequently – fatigue, asthenia.
In a 12-month clinical study, the following additional adverse events were identified that were more common with Sibri Breezhaler compared with placebo: nasopharyngitis (9.0% versus 5.6%), vomiting (1.3% versus 0, 7%), muscle pain (1.1% versus 0.7%), neck pain (1.3% versus 0.7%), diabetes mellitus (0.8% versus 0%).
Special patient groups
In elderly patients over the age of 75 years, the incidence of urinary tract infections and headache was higher with Sibri Breezhater, than in the placebo group (3.0% versus 1.5% and 2.3% versus 0%, respectively).
If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.
Drug interaction
Simultaneous administration of glycopyrronium bromide and inhalation indacaterol, beta2-adrenoceptor agonist, adrenoceptor.
In clinical studies in healthy volunteers, cimetidine, an inhibitor of organic cation transporters affecting renal clearance of glycopyrronium bromide, increased the total exposure (AUC) of glycopyrronium bromide by 22% and decreased renal clearance by 23%. Based on these indicators, no clinically relevant interaction is assumed with the concurrent use of Sibri Brizhaler with cimetidio or other cation transporter inhibitors. In vitro studies have shown that the drug Sibri Brizhaler probably does not affect the metabolism of other drugs.
Inhibition or induction of glycopyrronium bromide metabolism does not lead to significant changes in systemic exposure of the drug.
overdose
There is no data on overdose with Sibri Brizhaler.
In patients with COPD, regular inhalation of Sibri Brizhaler at a total dose of 100 and 200 mcg once daily for 28 days was well tolerated. Acute intoxication with accidental ingestion of a capsule of the Sibri Brizhaler drug is unlikely due to the low bioavailability of glycopyrronium bromide when administered orally (about 5%).
The maximum blood plasma concentration and total systemic exposure after intravenous administration of 150 μg glycopyrronium bromide (equivalent to 120 μg glycopyrronium) in healthy volunteers were approximately 50 and 6 times higher, respectively, than the maximum blood plasma concentration and total systemic exposure, respectively. achieved with the use of the drug Sibri Brizhaler inhalation in the recommended doses (50 μg once daily). There were no signs of overdose.
Storage conditions
In a dry place at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Expiration
2 years.
Deystvuyuschee substances
Hlykopyrronyya bromide
Formulation
Formulation
powder for inhalation
Novartis Farma Stein AG, Switzerland
