Země: Tanzanie
Jazyk: angličtina
Zdroj: Tanzania Medicinces & Medical Devices Authority
Loratidine , Pseudoephedrine
SPIMACO ADDWAEIH, KINGDOM OF SAUDI ARABIA
Systemic nasal decongstants
Loratidine + Pseudoephedrine
5/60
Syrup
Spimaco Addwaeih, KINGDOM OF SAUDI ARABIA
Physical description: A colourless to yellowish syrup with a characteristic strawberry odour and taste, free from foreign matter; Local technical representative: Wide Spectrum (T) Limited (5975)
Registered/Compliant
2021-11-26
SUMMARY OF PRODUCT CHARACTERISTICS (SPC) 1. NAME OF THE MEDICINAL PRODUCT Lorinase 2. QUALITATIVE AND QUANTITATIVE COMPOSITION FOR LORINASE SYRUP: Active ingredients: Loratadine Micronized USP 5 mg and Pseudoephedrine sulfate 60 mg. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM A colourless to yellowish syrup with a characteristic strawberry odour and taste, free from foreign matter. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Lorinase syrup is indicated for the symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion. 4.2. Posology and method of administration Adults and children 6-12 years of age (body weight > 30 Kg): 5 ml syrup (one tea spoonful) twice a day (every 12 hours). Do not give to children below 6 years of age. 4.3. Contraindications - Hypersensitivity to the active substance or to any of the excipients. Since Lorinase syrup containing pseudoephedrine, it is also contraindicated in patients receiving monoamine oxidase enzyme (MAO) inhibitors or within 14 days after discontinuation of MAO inhibitors in patients with narrow-angle glaucoma, urinary retention, cardiovascular diseases, such as for example. Coronary ischemia, tachyarrhythmia and severe hypertension, or hyperthyroidism. Lorinase syrup should not be given to children under the age of 6 years. 4.4. Special warnings and precautions for use In patients taking digitalis, patients with cardiac arrhythmias, hypertension, myocardial infarction, diabetes, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy or bladder neck obstruction, or bronchospasm in patients with a history of caution. Special caution is required in patients aged 60 years or more, it is for people in this age group are more likely adverse reactions to sympathomimetics. In this case, the dose should be reduced. The dose should be reduced in the case of severe renal insufficiency. Caution should be exercised in patients treated with other sympathomimetic agents, including decongestants, drugs t Přečtěte si celý dokument