Active ingredients: Salbutamol, Ipratropium bromide
BREVA & reg: 0.375% + 0.075% Solution to be nebulised or oral solution
Breva package inserts are available for the packs:- BREVA & reg: 0.375% + 0.075% Solution to be nebulized or oral solution
- BREVA® dosed aerosol
Why is Breva used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Combination with bronchodilating activity of a selective beta2-adrenergic receptor agonist and an anticholinergic.
THERAPEUTIC INDICATIONS
Bronchial asthma.
Obstructive bronchopathy with asthmatic component.
When it is indicated to associate an anticholinergic to the beta-adrenergic.
Contraindications When Breva should not be used
Known hypersensitivity to the components.
Severe heart disease.
Glaucoma.
Prostatic hypertrophy; urinary retention or intestinal obstruction syndromes
Precautions for use What you need to know before taking Breva
Sympathomimetic agents should be used with great caution in patients who may be particularly susceptible to their effects.
Even severe hypokalaemia may follow therapy with beta2-agonists, especially in the case of parenteral administration and by nebulization. This effect can be enhanced by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended, in such situations, to regularly check serum potassium levels.
SPECIAL GROUPS OF PATIENTS
In patients with diseases such as coronary heart disease, arrhythmias, arterial hypertension and in patients with glaucoma, hyperthyroidism, pheochromocytoma, diabetes and prostatic hypertrophy, the product should only be used in case of absolute necessity.
PARADOX REACTIONS
As with other drugs administered by inhalation, paradoxical bronchospasm may occur, with increased wheezing immediately after inhalation.
Interactions Which drugs or foods can change the effect of Breva
As a rule, beta2-agonist drugs and non-selective beta-blocking drugs, such as propranolol, should not be prescribed at the same time.
Warnings It is important to know that:
Tell your doctor if you have heart disease or angina before starting therapy with a medicinal product containing salbutamol.
USE DURING PREGNANCY AND BREASTFEEDING
Its use during pregnancy and breastfeeding is not recommended.
For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Dosage and method of use How to use Breva: Dosage
One drop of Breva (0.05 mL) contains:
Salbutamol 187.5 µg
Ipratropium bromide 37.5 µg
Respiratory use
Adults
For inhalation with electric nebulizers, for outpatient or home use, dilute with distilled water or sterile physiological solution:
5 drops to 2 mL duration: 10-15 minutes, to be repeated 2-3 times a day
For inhalation with electric respirators (Intermittent Positive Pressure Breathing), for hospital use, dilute with distilled water or sterile physiological solution:
2 drops to 1 mL 6 inspirations
or 2 drops at 5 mL duration: 2 minutes
or 1 drop at 5 mL lasting 10 minutes
Children
Proportionally reduced doses, also depending on the symptoms.
Oral use
We recommend the use of Breva solution to be nebulized or oral solution diluted with plain water or sugared water.
Adults
10 drops 3-4 times a day.
Children
In the opinion of the Doctor and indicatively:
Infants from 1 to 3 months: 1-3 drops 2-3 times a day
Infants from 3 to 12 months: 2-4 drops 2-3 times a day
Children from 1 to 3 years: 3-5 drops 2-3 times a day
Children from 3 to 6 years: 4-6 drops 2-3 times a day
Children from 6 to 12 years: 5-7 drops 2-3 times a day
INSTRUCTIONS FOR USE
To prevent the bottle from being easily opened, a dropper was used to open which requires a movement that is not instinctive but rational.
To open the bottle it is necessary to exert a pressure on the dropper ring nut and a counterclockwise twist at the same time.
To close the bottle, screw the ring nut clockwise as usual. Breva's solution can be straw yellow in color.
Side Effects What are the side effects of Breva
In case of overdose or in particularly sensitive subjects, muscle tremors and an increase in heart rate may occur transiently. These phenomena resolve spontaneously shortly after administration. Headache, tension, peripheral vasodilation may occur rarely for high doses; dry mouth, visual accommodation disturbances, dizziness, somnolence. Rarely hypersensitivity reactions have been reported.
Very rarely, some patients may experience chest pain (due to heart problems such as angina). Tell your doctor as soon as possible, avoiding stopping therapy unless advised to do so.
THE PATIENT IS INVITED TO COMMUNICATE ANY UNDESIRABLE EFFECT OTHER THAN THOSE INDICATED ABOVE TO THEIR DOCTOR OR PHARMACIST.
Expiry and Retention
See the expiration date printed on the package.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date indicated on the package.
Breva solution should be used within 3 months after first opening.
Store at a temperature not exceeding 25 ° C
Do not disperse the bottle in the environment after use.
COMPOSITION
100 ml of solution contain:
Active principles:
Salbutamol sulfate equivalent to 375 mg of Salbutamol Ipratropium
bromide monohydrate equivalent to 75 mg of Ipratropium bromide.
Excipients:
Methyl p-hydroxybenzoate.
Ethyl p-hydroxybenzoate
Butyl p-hydroxybenzoate.
Sodium chloride.
1N sulfuric acid
Purified water.
PHARMACEUTICAL FORM AND CONTENT
Nebulizer solution or oral solution
15 ml amber bottle
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
BREVA
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
For excipients see 6.1.
03.0 PHARMACEUTICAL FORM
Dosed aerosol.
Nebulizer solution or oral solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of bronchial asthma and obstructive bronchopathy with asthmatic component; when it is indicated to associate an anticholinergic to the beta-adrenergic.
04.2 Posology and method of administration
Breva dosed aerosol
Each spray of Breva delivers:
Salbutamol 75 mcg
Ipratropium bromide 15 mcg
The recommended dosage is as follows:
Adults:
2 sprays, 3 - 6 times a day
Children:
1 - 2 sprays, 2 - 4 times a day.
Administration to the child should be carried out under the supervision of an adult.
N.B. The instructions for use are detailed in the package leaflet, accompanied by figures.
Breva nebuliser solution or oral solution One drop of Breva (0.05 mL) contains:
Salbutamol 187.5 mcg
Ipratropium bromide 37.5 mcg
Respiratory use:
Adults:
For inhalation with electric nebulizers, for outpatient or home use, dilute with distilled water or sterile physiological solution:
5 drops to 2 mL duration: 10 - 15 minutes, to be repeated 2-3 times a day.
For inhalation with electric respirators (Intermittent Positive Pressure Breathing), for hospital use, dilute with distilled water or sterile physiological solution:
2 drops to 1 mL 6 inspirations
or 2 drops at 5 mL duration: 2 minutes
or 1 drop at 5 mL duration: 10 minutes
Children:
Proportionally reduced doses, also depending on the symptoms.
Oral use:
We recommend the use of Breva solution diluted with plain water or sugared water.
Adults:
10 drops, 3-4 times a day
Children:
In the opinion of the Doctor and indicatively:
Infants from 1 to 3 months: 1 - 3 drops 2 - 3 times a day
Infants from 3 to 12 months: 2 - 4 drops 2 - 3 times a day
Children from 1 to 3 years: 3 - 5 drops 2 - 3 times a day
Children from 3 to 6 years: 4 - 6 drops 2 - 3 times a day
Children from 6 to 12 years: 5 - 7 drops 2 - 3 times a day.
04.3 Contraindications
Known hypersensitivity to the components. Severe heart disease. Glaucoma. Prostatic hypertrophy. Syndromes of urinary retention and intestinal obstruction.
04.4 Special warnings and appropriate precautions for use
Sympathomimetic agents should be used with great caution in patients who may be particularly susceptible to their effects.
In patients with diseases such as coronary heart disease, arrhythmias, arterial hypertension and in patients with glaucoma, hyperthyroidism, pheochromocytoma, diabetes and prostatic hypertrophy, the product should only be used in case of absolute necessity.
Even severe hypokalaemia may follow therapy with beta2-agonists, especially in the case of parenteral administration and by nebulization. This effect can be enhanced by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended, in such situations, to regularly check serum potassium levels.
There is evidence from post-marketing data and published literature of rare cases of myocardial ischaemia associated with the use of salbutamol. Patients with pre-existing severe heart disease (eg, ischemic heart disease, tachyarrhythmia, or severe heart failure) who receive salbutamol for respiratory disease , they should be advised to tell their doctor if chest pain or symptoms of worsening heart disease occur.
It is good that the Doctor invites the patient to:
Carefully read the leaflet;
keep the medicine out of the reach of children;
to keep in mind the following:
Breva dosed aerosol:
Shake the bottle well before use.
The mouthpiece and valve should always be kept clean, frequently washing the mouthpiece with lukewarm water.
To clean, remove the can from the inhaler, wash the mouthpiece with warm water, dry and put the can back into the clean mouthpiece.
The appliance must always be protected from dust, kept away from heat sources and, even if empty, must not be thrown into the fire.
Do not dispose of the bottle in the environment after use.
Short nebuliser solution or oral solution:
Breva's solution can be straw yellow in color.
To prevent the bottle from being easily opened, a dropper was used to open it, not an instinctive, but a rational movement.
To open the bottle it is necessary to exert a pressure on the dropper ring nut and a counterclockwise twist at the same time. To close the bottle, the ring nut must be screwed clockwise as usual.
Do not dispose of the bottle in the environment after use.
04.5 Interactions with other medicinal products and other forms of interaction
As a rule, beta2-agonist drugs and non-selective beta-blocking drugs, such as propranolol, should not be prescribed at the same time.
04.6 Pregnancy and lactation
The use of the product during pregnancy and breastfeeding is not recommended.
04.7 Effects on ability to drive and use machines
You don't notice.
04.8 Undesirable effects
In the case of overdose or in particularly sensitive subjects, muscle tremors and an increase in heart rate may occur transiently. These phenomena resolve spontaneously shortly after administration. Headache, tension, peripheral vasodilation may occur rarely for high doses; dry mouth, visual accommodation disturbances, dizziness, drowsiness.
Hypersensitivity reactions have rarely been reported.
As with other drugs administered by inhalation, paradoxical bronchospasm may occur, with increased wheezing immediately after inhalation.
Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystole), myocardial ischaemia have been reported very rarely.
04.9 Overdose
In the event of an overdose, muscle tremors and an increase in heart rate may occur transiently (see also section 4.8)
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: R03AK04
Two active ingredients are associated in Breva which perform anti-bronchospastic activity with different mechanisms, namely: a beta2-stimulant, such as Salbutamol, and an anticholinergic, such as Ipratropium bromide.
Breva's mechanism of adrenergic-antivagal action allows to intervene directly on the pathogenetic moment of both spastic and hypersecretive bronchostruction allowing, on the one hand, a reactivation of the adrenergic receptors and, on the other, a reduction of the cholinergic potential.
The synergistic bronchial antispasmodic action of the preparation is determined by the specificity and by the different mechanism of action of the two components which would have an effect on the cyclic nucleotides of the smooth muscle cell: AMP and cyclic GMP, responsible for bronchial dynamics.
05.2 Pharmacokinetic properties
Kinetic studies show that salbutamol is rapidly absorbed from the gastrointestinal tract and gradually by inhalation, is excreted primarily via the urine, partly as unchanged salbutamol, partly as glucuronide or sulfate conjugate, and that Ipratropium bromide is absorbed to an extent modest both by oral and inhalant administration, it is partially metabolized and is excreted by both the renal and faecal routes.
05.3 Preclinical safety data
Breva has very low acute, subacute and chronic toxicity in the most common laboratory animals, therefore it is well tolerated for the administration routes used in human clinics even for high doses and much higher than those recommended or in any case achievable in clinical practice.
By way of example, the LD50 intravenously in the rat of a solution consisting of 5 parts of Salbutamol + 1 part of Ipratropium bromide, is 34.85 mg / kg of Salbutamol + 6.97 mg / kg of Ipratropium bromide.
Parenteral administration of 750 mcg / kg of Salbutamol + 150 mcg / kg of Ipratropium bromide involves only modest toxic depressive symptoms.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Breva dosed aerosol: oleic acid, trichlorofluoromethane, dichlorodifluoromethane.
Short nebuliser solution or oral solution: methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, purified water.
06.2 Incompatibility
Not known.
06.3 Period of validity
Breva dosed aerosol: 36 months
Short nebuliser solution or oral solution: 36 months
The expiry date indicated refers to the product in intact packaging, correctly stored.
06.4 Special precautions for storage
Breva dosed aerosol:
Keep the appliance away from heat sources and never throw it on the fire, even when it is empty.
Store at a temperature not exceeding 25 ° C
Short nebuliser solution or oral solution:
Store at a temperature not exceeding 25 ° C
06.5 Nature of the immediate packaging and contents of the package
Breva dosed aerosol:
Aluminum bottle for 200 puffs, equipped with dosing valve and inhaler mouthpiece, packaged, together with the package leaflet, in cardboard boxes.
Short nebuliser solution or oral solution:
15 mL polyethylene bottle, closed with a screw cap with a difficult-to-open dropper and packaged, together with the package leaflet, in cardboard boxes.
06.6 Instructions for use and handling
Breva dosed aerosol:
The instructions for use, accompanied by figures, are given in the Il ustrative sheet.
Short nebuliser solution or oral solution:
To open the bottle it is necessary to exert a pressure on the dropper ring nut and a counterclockwise twist at the same time.
To close the bottle, the ring nut must be screwed clockwise as usual.
For all packs:
Do not use the medicine after the expiry date stated on the package.
07.0 MARKETING AUTHORIZATION HOLDER
Valeas s.p.a. - Chemical and Pharmaceutical Industry - Via Vallisneri, 10 - Milan.
08.0 MARKETING AUTHORIZATION NUMBER
Breva dosed aerosol:
A.I.C. No. 024154054
Breva mg 375 + mg 75/100 ml solution for nebulisation or oral solution
A.I.C. No. 024154066
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
01/05/2005
10.0 DATE OF REVISION OF THE TEXT
01/05/2007
