CHARACTERISTICSSalbutamol Aerosol is a kind of white suspension mixed with just right quantity of propellant and kept in a pressurised canister with a metered valve system.INDICATIONSBronchial asthma, bronchitis with gasp as the main symptom, and bronchospasm related to emphysema.ADVERSE REACTIONXerostomia, cough, vomiting. Dizziness and palpitation.CONTRAINDICATIONS1. Salbutamol Aerosol is absolutely contraindicated in patients with hyperthyroidism.2. Patients suffering from hypertension or cardiopulmonary insufficiency should use the medicine with caution.STORAGE It should be stored hermetically at a dark cool place.MANUFACTURER Jewim Pharmaceutical (Shandong) Co., Ltd.anti-asthmatic

BECLOMETHASONE DIPROPIONATE INHALER BPCHARACTERISTICSThis product is a kind of white or slight yellow suspension mixed with just right quantity of propellant and kept in a pressurised canister with a metered valve system.INDICATIONSIt is indicated for bronchial asthma which does not respond to adrenocortical hormones or other drugs.DOSAGE AND ADMINSTRATIONAdult: 1-2 doses each time.1-3 times a day.Children: 1/2 the adult dose or follow the physician’s directions.OVERDOSAGE When used at excessive doses, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear.PRESENTATION200metered doses per canister, contains 250mcg Beclomethasone dipropionate BP per actuation.anti-asthmatic

Ipratropium Bromide Aerosol :for treatment of bronchospasm associated with moderate to severe chronic obstruction airway disease.Indications: It is indicated as bronchodilator for treatment of bronchospasm associated with moderate to severe chronic obstruction airway disease.Dosage and administration:It is for oral inhalation use only.Adults: Two inhalations four times a day. The dose may be increased as required up to a limit of 12 inhalations in 24 hours. Children: Not recommended for children under 12 years of age. Patients should be advised to consult a doctor or the nearest hospital immediately in the case of acute or rapidly worsening dyspnoea (difficulty in breathing) if additional inhalations do not produce an adequate improvement. Contraindications: It is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine or its derivatives.PRESENTATION20mcg per actuation, 200 actuations per bottle.MANUFACTURER Jewim Pharmaceutical (Shandong) Co., Ltd.　for treatment of bronchospasm

Budesonide Aerosol: For the maintenance treatment of bronchial asthma and asthmatic chronic bronchitis. CHARACTERISTICSBudesonide Aerosol is a kind of slightly yellow to offwhite suspension mixed with just right quantity of propellant and kept in a pressurised canister with a metered valve system.DOSAGE AND ADMINISTRATION Adult: 1dose each time. 2-4 times a day. Children: 1/2 of the adult dose or follow the physician’s directions. ADVERSE REACTIONFever, sinusitis, pain, pharyngitis, bronchospasm, bronchitis and headache. CONTRAINDICATIONS It is contraindicated as the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to budesonide or any of the ingredients of this preparation contraindicates the use of budesonide aerosol. PRESENTATION200doses,each dose contains 200mcg of Budesonide BP.STORAGE: Store below 30℃.Protect from frost.

1. NAME OF THE MEDICINAL PRODUCTBudenisone Budesonide-R Aerosol 2. QUALITATIVE AND QUANTITATIVE COMPOSITIONEach metered dose (ex-valve)/actuation contains Budesonide-R 100 micrograms. 3. ContraindicationsHistory of hypersensitivity to budesonide R or any of the excipients. Active pulmonary tuberculosis. Special care is needed in patients with quiescent pulmonary tuberculosis and with fungal and viral infections in the airways.Budesonide R has also been shown to decrease airway reactivity to histamine and methacholine in hyperreactive patients. 4.HPA axis function Studies in healthy volunteers with inhaled budesonide R (administered as a dry powder via Turbohaler) have shown dose-related effects on plasma and urinary cortisol. At recommended doses Pulmicort Turbohaler causes less effect on adrenal function than prednisolone 10 mg, as shown by ACTH tests.

1. NAME OF THE MEDICINAL PRODUCTCilclesonide  Aerosol2. QUALITATIVE AND QUANTITATIVE COMPOSITIONactuation (delivered dose from the mouthpiece) contains 80 micrograms of ciclesonide. .3. PHARMACEUTICAL FORMPressurised inhalation, solution Clear and colourless4. CLINICAL PARTICULARS4.1 Therapeutic indicationsTreatment to control persistent asthma in adults and adolescents (12 years and older).4.2 Posology and method of administrationThe medicinal product is for inhalation use only. Dosing recommendation for adults and adolescents: The recommended dose of Alvesco is 160 micrograms once daily, which leads to asthma control in the majority of patients. However in severe asthmatics, a 12 week study has shown that a dose of 640 micrograms/day (given 320 micrograms twice daily) has demonstrated a reduction in the frequency of exacerbations but without an improvement in lung function (see section 5.1). Dose reduction to 80 micrograms once daily may be an effective maintenance dose for some patients. Alvesco should preferably be administered in the evening although morning dosing of Alvesco has also been shown to be effective. The final decision on evening or morning dosing should be left to the discretion of the physician. Symptoms start to improve with Alvesco within 24 hours of treatment. Once control is achieved, the dose of Alvesco should be individualised and titrated tothe minimum dose needed to maintain good asthma control. Patients with severe asthma are at risk of acute attacks and should have regular assessments of their asthma control including pulmonary function tests. Increasing use of short-acting bronchodilators to relieve asthma symptoms indicates deterioration of asthma control. If patients find that short-acting relief bronchodilator treatment becomes less effective, or they need more inhalations than usual, medical attention must be sought. In this situation, patients should be reassessed and consideration given to the need for increased anti-inflammatory treatment therapy (e.g. a higher dose of Alvesco for a short period [see section 5.1] or a course of oral corticosteroids). Severe asthma exacerbations should be managed the usual way. To address specific patient needs, such as finding it difficult to press the inhaler and breathe in at the same time, Alvesco can be used with the AeroChamber Plus spacer device. Specific patient groups:There is no need to adjust the dose in elderly patients or those with hepatic or renal impairment. To date, there are insufficient data available in the treatment of children under 12 years of age with ciclesonide. Instructions for use / handling:The patient needs to be instructed how to use the inhaler correctly. If the inhaler is new or has not been used for one week or more, three puffs should be released into the air. No shaking is necessary as this is a solution aerosol. During inhalation, the patient should preferably sit or stand, and the inhaler should be held upright with the thumb on the base, below the mouthpiece. Instruct the patient to remove the mouthpiece cover, place the inhaler into their mouth, close their lips around the mouthpiece, and breathe in slowly and deeply. While breathing in through the mouth, the top of the inhaler should be pressed down. Then, patients should remove the inhaler from their mouth, and hold their breath for about 10 seconds, or as long as is comfortable. The patient is not to breathe out into the inhaler. Finally, patients should breathe out slowly and replace the mouthpiece cover. The mouthpiece should be cleaned with a dry tissue or cloth weekly. The inhaler should not be washed or put in water. For detailed instructions see Patient Information Leaflet.4.3 ContraindicationsHypersensitivity to ciclesonide or any of the excipients.4.4 Interaction with other medicinal products and other forms of interactionIn vitro data indicate that CYP3A4 is the major enzyme involved in the metabolism of the active metabolite of ciclesonide M1 in man. In a drug-drug interaction study at steady state with ciclesonide and ketoconazole as a potent CYP3A4 inhibitor, the exposure to the active metabolite M1 increased approximately 3.5fold, whereas the exposure to ciclesonide was not affected. Therefore the concomitant administration of potent inhibitors of CYP 3A4 (e.g. ketoconazole, itraconazole and ritonavir or nelfinavir) should be avoided unless the benefit outweighs the increased risk of systemic side effects of corticosteroids4.5 Pregnancy and lactationThere are no adequate and well-controlled studies in pregnant women. In animal studies glucocorticoids have been shown to induce malformations (see section 5.3). This is not likely to be relevant for humans given recommended inhalation doses. As with other glucocorticoids, ciclesonide should only be used during pregnancy if the potential benefit to the mother justifies the potential risk to the fetus. The lowest effective dose of ciclesonide needed to maintain adequate asthma control should be used. Infants born of mothers who received corticosteroids during pregnancy are to be observed carefully for hypoadrenalism. It is unknown whether inhaled ciclesonide is excreted in human breast milk. Administration of ciclesonide to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.4.6 Effects on ability to drive and use machinesInhaled ciclesonide has no or negligible influence on the ability to drive and use machines.4.7OverdoseAcute:Inhalation by healthy volunteers of a single dose of 2880 micrograms of ciclesonide was well tolerated. The potential for acute toxic effects following overdose of inhaled ciclesonide is low. After acute overdosage no specific treatment is necessary. Chronic:After prolonged administration of 1280 micrograms of ciclesonide, no clinical signs of adrenal suppression were observed. However, if higher than recommended dosage is continued over prolonged periods, some degree of adrenal suppression cannot be excluded. Monitoring of adrenal reserve may be necessary.5. PHARMACOLOGICAL PROPERTIES5.1 Pharmacodynamic propertiesPharmacotherapeutic group: Other drugs for obstructive airway diseases, Inhalants, Glucocorticoids, ATC Code: R03B A08 Ciclesonide exhibits low binding affinity to the glucocorticoid-receptor. Once orally inhaled, ciclesonide is enzymatically converted in the lungs to the principal metabolite (C21-des-methylpropionyl-ciclesonide) which has a pronounced anti-inflammatory activity and is thus considered as the active metabolite. In four clinical trials, ciclesonide has been shown to reduce airway hyperresponsiveness to adenosine monophosphate in hyperreactive patients with maximal effect observed at the dose of 640 micrograms. In another trial, pretreatment with ciclesonide for seven days significantly attenuated the early and late phase reactions following inhaled allergen challenge. Inhaled ciclesonide treatment was also shown to attenuate the increase in inflammatory cells (total eosinophils) and inflammatory mediators in induced sputum. A controlled study compared 24hour plasma cortisol AUC in 26 adult asthmatic patients following 7 days of treatment. Compared to placebo, treatment with ciclesonide 320, 640, and 1,280 micrograms/day did not statistically significantly lower the 24hour time averages of plasma cortisol (AUC(0-24)/24 hours) nor was a dose-dependent effect seen. In a clinical trial involving 164 adult male and female asthmatic patients, ciclesonide was given at doses of 320 micrograms or 640 micrograms/day over 12 weeks. After stimulation with 1 and 250 micrograms cosyntropin, no significant changes in plasma cortisol levels were observed versus placebo. Double-blind placebo-controlled trials of 12weeks duration in adults and adolescents have shown that treatment with ciclesonide resulted in improved lung function as measured by FEV1 and peak expiratory flow, improved asthma symptom control, and decreased need for inhaled beta2 agonist. In a 12week study of 680 severe asthmatics, previously treated with 5001,000 micrograms fluticasone propionate per day or equivalent, 87.3% and 93.3% of patients remained exacerbation-free during treatment with 160 or 640 micrograms of ciclesonide, respectively. At the end of the 12 week study period, the results showed a statistically significant difference between the doses of 160 micrograms and 640 micrograms/day ciclesonide with regard to the occurrence of anexacerbation after the first day of the study: 43 patients/339 (= 12.7%) in the 160 micrograms/day group and 23 patients/341 (6.7%) in the 640 micrograms/day group (Hazard ratio=0.526; p= 0.0134). Both ciclesonide doses resulted in comparable FEV1 values at 12 weeks. Treatment-related adverse events wereseen in 3.8% and 5% of patients treated with 160 or 640 micrograms per day of ciclesonide respectively. No study was performed to compare 160 micrograms, 320 micrograms and 640 micrograms daily dose in patients with severe asthma.5.2 Pharmacokinetic propertiesCiclesonide is presented in HFA134a propellant and ethanol as a solution aerosol, which demonstrates a linear relationship between different doses, puff strengths and systemic exposure. Absorption:Studies with oral and intravenous dosing of radiolabeled ciclesonide have shown an incomplete extent of oral absorption (24.5%). The oral bioavailability of both ciclesonide and the active metabolite is negligible (

1. NAME OF THE MEDICINAL PRODUCTFluticasone 50 micrograms Fluticasone 125 micrograms Fluticasone 250 micrograms 2. QUALITATIVE AND QUANTITATIVE COMPOSITIONFluticasone 50 micrograms , Fluticasone 125 micrograms and Fluticasone 250 micrograms are pressurised inhalation, delivering either 50, 125 or 250 micrograms of fluticasone propionate per actuation, respectively. 3. PHARMACEUTICAL FORMPressurised inhalation 4.3 ContraindicationsHypersensitivity to any ingredient of the preparation. 4.7 OverdoseAcute : Inhalation of the drug in doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not necessitate emergency action being taken. In these patients treatment with fluticasone propionate by inhalation should be continued at a dose sufficient to control asthma adrenal function recovers in a few days and can be verified by measuring plasma cortisol. Chronic : refer to section 4.4: risk of adrenal suppression. Monitoring of adrenal reserve may be indicated. Treatment with inhaled fluticasone propionate should be continued at a dose sufficient to control asthma.

Name: Sodium Cromoglicate Aerosol (Suspension)Characteristics:This colourless or yellowish suspension with added q.s. of propellant is contained under pressure in hermetically sealed container with a quantitative valve system. Pharmacological action:This product, a chromone type medicament, effectively suppresses immediately allergic type reactions mainly by stabilizing the surface of mast cells and thus blocking the release of anaphylactic factors. In addition, it directly inhibits certain reflexes related to bronchospasm and turns off nonspecific bronchial hyperreactivity. Indications:It is used to prevent and treat allergic asthma. Dosage:1-2 actuations corresponding to 5 to 10mg Sodium Cromoglicate, 3-4 times a day or as directed by the physician. Presentation:112 metered actuations per canister, each containing 5mg Sodium Cromoglicate BP per actuation. Storage:Store below 30℃. Protect from frost. MANUFACTURERJewim Pharmaceutical (Shandong) Co., Ltd. It is used to prevent and treat allergic asthma.

Name: Salbutamol + Ipratropium Bromide Aerosol 100mcg/20mcg/doseQualitative and quantitative composition: 100 micrograms Salbutamol (as sulphate) BP per actuation and 20 micrograms Ipratropium Bromide BP per actuation with a specially designed actuator. Each canister provides 200 inhalations. Pharmaceutical form: Pressurised metered-dose aerosol. Indications: It is indicated as bronchodilator for prevention and treatment of bronchospasm associated with moderate to severe chronic obstructive airway disease. Overdosage: The preferred antidote for overdosage is a cardioselective beta-blocking agent, but beta-blocking drugs should be used with caution in patients with a history of bronchospasm. Acute overdosage by inhalation is unlikely since ipratropium bromide is not well absorbed systemically after aerosol or oral administration. Storage: It should be stored below 30℃protect from direct sunlight, heat and frost. The canister should not be broken, punctured or burn, even when empty. Manufacture: Jewim Pharmaceutical(Shandong)Co., Ltd. It is indicated as bronchodilator for prevention and treatment of bronchospasm associated with moderate to severe chronic obstructive airway disease.

1.Composition Aerovent InhalerEach actuation delivers: Beclomethasone Dipropionate BP 50 mcg Salbutamol Sulphate BP equivalent to Salbutamol 100 mcg Suspended in propellant HFA 134a q.s. contains absolute alcohol. 2. Description Aerovent is a combination of salbutamol and beclomethasone dipropionate. Salbutamol is a betaadrenergic stimulant that has a highly selective action on the receptors in bronchial muscle, resulting in bronchodilation. Beclomethasone dipropionate is a synthetic glucocorticoid with a potent anti-inflammatory activity and weak mineralocorticoid activity. This association of salbutamol and eclomethasone dipropionate is specially provided for those patients who require regular doses of both drugs for treatment of their obstructive airways disease. 3. Indications Aerovent is indicated in the treatment of asthma, once the need for inhaled corticosteroid and bronchodilator therapy has been established. 4.Aerovent Inhaler 5.Pack of 120 metered doses The association of salbutamol BP and beclomethasone dipropionate BP is specially provided for those patients who require regular doses of both drugs for reversible airways obstruction. Salbutamol is a selective beta-2 adrenoceptors agonist. At therapeutic