RHINOCORT AQUA Nasal spray

គុណភាពព្យាបាល៖

- ប្រើសម្រាប់ព្យាបាលជម្ងឺរលាកច្រមុះ តាមរដូវឬជាប្រចាំ

- ប្រើសម្រាប់ព្យាបាលឬបង្ការឬសដូងច្រមុះ(Nasal Polyps) ក្រោយការវះកាត់សាច់ច្រមុះ(Polypectomy)។

កម្រិតនិងរបៀបប្រើ៖

រលាកច្រមុះនិងNasal Polyps (ឬសដូងច្រមុះ):

- ចំពោះមនុស្សពេញវ័យ និង កុមារអាយុលើសពី6ឆ្នាំ កម្រិតប្រើដំបូងគឺ256μg/1ថ្ងៃ ដោយបាញ់ចូលក្នុងរន្ធច្រមុះទាំងសងខាង ម្ខាង128μg (2x64μg)នៅពេលព្រឹក។

- គេអាចចែករំលែក256μg បាញ់ជា2ដងក្នុង1ថ្ងៃ ពេលព្រឹកនិងពេលល្ងាច ដោយបាញ់ក្នុងរន្ធច្រមុះម្ខាងៗ64μg នៅពេលជំងឺធូរស្រាល ហើយគេអាចបន្ថយកម្រិតប្រើត្រឹមតែ32μg ក្នុងរន្ធច្រមុះម្ខាងនិងបាញ់តែរ1ថ្ងៃ1ដង។

- អាការៈនឹងធូរស្រាលក្រោយការបាញ់បាន5-7ម៉ោង ហើយជាសះស្បើយក្នុងរយៈពេល2-3ថ្ងៃ យ៉ាងយូរណាស់2សប្ដាហ៍។

របៀបប្រើ៖

- បញ្ចេញខ្យល់ពីច្រមុះ

- ក្រឡុកបំពង់ទឹកថ្នាំSpray

- ដោះគំរបការពារពណ៌ត្នោតចេញពីបំពង់

- ហើយកាន់បំពង់ទឹកSpray ដូចការបង្ហាញក្នុងរូបភាព

- បញ្ចូលចុងបំពង់ទឹកSprayទៅក្នុងរន្ធច្រមុះ ហើយសង្កត់Pumpតាមកំរិតណែនាំ(1-2) បន្ទាប់មក បញ្ចូលក្នុងរន្ធច្រមុះម្ខាងទៀត(ធ្វើដូចលើកមុន)

- បាញ់រួចហើយបិទគំរបការពារវិញ

- ចូរកុំបាញ់លើសពីកំរិតណែនាំ។

កំណត់សំគាល់: ក្នុងការប្រើដំបូងបង្អស់ គេត្រូវក្រឡុកបំពង់Spray បន្ទាប់មក គេត្រូវសង្កត់Pumpជាច្រើនដងចោល(5-10ដង) ដើម្បីបញ្ចូលខ្យល់។ នៅពេលប្រើលើកក្រោយគេពុំចាំបាច់ធ្វើដូច្នេះទេ គឺធ្វើតាមការណែនាំខាងលើបានហើយ។

Therapeutic indications:

Seasonal and perennial allergic rhinitis, and vasomotor rhinitis.

Preventively against nasal polyps after polypectomy.

Symptomatic treatment in nasal polyposis.

Posology and method of administration:

The posology must be adjusted individually.

Rhinitis Adults and children from 6 years of age: The recommended initial dose is 256 micrograms daily. The dose can be administered once daily in the morning, or divided into two administrations, morning and evening. This implies 128 micrograms (2 x 64 micrograms) into each nostril in the morning or 64 micrograms into each nostril morning and evening.

No further effect has been shown for daily doses higher than 256 micrograms.

For elderly patients the posology is the same as for adults.

When the desired effect has been obtained, the dose is reduced to the lowest amount necessary for control of the symptoms. Clinical trails show that a dose of 32 micrograms into each nostril in the morning may be sufficient for some patients.

Symptomatic relief occurs in some patients within only 5-7 hours after the start of treatment. The full effect is only obtained after a few days of treatment (in rare cases not until after 2 weeks). Treatment of seasonal rhinitis should therefore, if possible, start before exposure to the allergens.

In cases of severe nasal congestion, the adjunct of a vasoconstrictor may be required.

Supplementary treatment may sometimes be necessary in order to counteract any ocular symptoms caused by the allergy.

Symptomatic treatment and prevention of nasal polyps

The recommended dose is 256 micrograms daily. The dose can be administered once daily in the morning or divided into two administrations morning and evening. After the desired clinical effect is obtained the maintenance dose should be tapered to the smallest amount necessary to control the symptoms.

Instructions for correct use of Rhinocort Aqua:

It is important to instruct the patient to carefully read: “Instructions for use and handling, and disposal”

ហាមប្រើចំពោះអ្នកធ្លាប់មានប្រតិកម្មជាមួយសារធាតុផ្សំណាមួយនៃឱសថនេះ។

Earlier hypersensitivity to budesonide or to any of the excipients.

Local irritation, epistaxis, slight haemorrhagic nasal secretion, Nasal septum, perforation, ulceration of mucous membranes, Angioedema, urticaria, dermatitis, rash, pruritus, Anaphylactic reaction.

Oral ketoconazole 200 mg once daily increased the plasma concentrations of oral budesonide (3 mg in a single dose) on average six-fold when administered simultaneously. When ketoconazole was administered 12 hours after budesonide the concentration increased on average three-fold. Information on this interaction is lacking for nasal budesonide, but greatly increased plasma levels are expected there too. Since there is an absence of data to permit dosage recommendations for nasal administration, the combination should be avoided. If this is not possible, the interval between administration of ketoconazole and budesonide should be as long as possible. A reduction of the budesonide dose must also be considered. Other potent inhibitors of CYP3A4 probably also cause a marked increase in the plasma levels of budesonide.

• គួរជៀសវាងប្រើចំពោះស្ត្រីមានផ្ទៃពោះ

• ចំពោះស្ត្រីបំបៅកូនគេមិនដឹងថាឱសថនេះជ្រាបចូលក្នុងទឹកដោះម្តាយឬទេ។

Pregnancy

Data from more than 2000 pregnancies do not indicate any increased risk of malformations in general for Rhinocort Aqua treatment. Compared to expected incidence, a small increase in the occurrence of minor heart malformations has been detected in children where the mother has been exposed to Rhinocort Aqua in early pregnancy, however a relationship to the exposure is not likely.

During pregnancy, the aim must be the lowest effective dose and the shortest treatment period of Rhinocort Aqua.

Lactation

Budesonide is excreted in breast milk. However, at therapeutic doses of Rhinocort Aqua no effects on the suckling child are anticipated. Rhinocort Aqua can be used during breast-feeding.

ប្រុងប្រយ័ត្នចំពោះ៖

- ការប្រើឱសថនេះរយៈពេលយូរនិងក្នុងកម្រិតខ្ពស់ អាចបណ្ដាលអោយមានប្រតិកម្មSystemicនៃGlucocorticoides ដូចជា Hypercortisolism, adrenal suppression និងពន្យារដល់ការលូតលាស់របស់កុមារ។

- ត្រូវប្រុងប្រយ័ត្នក្នុងការប្រើឱសថនេះ ចំពោះអ្នកមានជំងឺផ្សិតក្នុងច្រមុះឬHerpesឬធ្លាប់មានប្រតិកម្មSystemic បណ្ដាលមកពីការប្រើឱសថនេះ(Rhinocort) អ្នកមានជំងឺមុខងារថ្លើមខ្សោយខ្លាំង អ្នកមានជំងឺរបេងសួត ។ល។

- ត្រូវប្រុងប្រយ័ត្នកុំអោយឱសថនេះបាញ់ចូលក្នុងភ្នែក។ បើបាញ់ចូលក្នុងភ្នែកត្រូវលាងទឹកភ្លាម។

- គួរជៀសវាងប្រើចំពោះស្ត្រីមានផ្ទៃពោះ

- ចំពោះស្ត្រីបំបៅកូន គេមិនដឹងថាឱសថនេះជ្រាបចូលក្នុងទឹកដោះម្ដាយឬទេ។

During long-term treatment with high doses, systemic effects of glucocorticoids such as hypercortisolism, adrenal suppression and/or delayed growth in children can occur.

Long-term effects of nasal steroids in children have not been established. Treatment with cortisone-containing medicinal products can lead to slower growth. Regular monitoring of growth is recommended in children and adolescents receiving long-term treatment with corticosteroids, irrespective of the administration form. If delayed growth is suspected, this must be investigated. The benefits of glucocorticosteroid treatment must be placed in relation to possible risks of inhibition of growth.

Caution must be observed when treating patients with nasal fungal or herpes infections.

Caution is necessary in the treatment of patients transferred from systemically acting glucocorticosteroids to Rhinocort Aqua where disturbances in the hypothalamic-pituitary-adrenal axis is suspected. In these patients the dose of systemic steroid should be cautiously reduced, and tests of hypothalamic-pituitary-adrenocortical function should be considered. They may also require the addition of systemic steroids in connection with periods of stress, e.g. surgery,

trauma, etc.

Severely reduced liver function affects the pharmacokinetics of orally administered budesonide, resulting in a lower elimination rate and increased systemic availability.

Account may need to be taken of possible systemic effects.

Special vigilance may be needed in patients with pulmonary tuberculosis.

Rhinocort Aqua should not come into contact with the eyes. If Rhinocort Aqua comes into contact with the eyes, rinse immediately with water.

Concomitant treatment with ketoconazole or other potent CYP3A4 inhibitors should be avoided. If this is not possible, the interval between administrations of the medications should be as long as possible (see Interactions with other medicinal products and other forms of interaction).