Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CETIRIZINE DIHYDROCHLORIDE
SUNWARD PHARMACEUTICAL SDN. BHD.
CETIRIZINE DIHYDROCHLORIDE
3.8 L; 3.6 L; 1 L; 120 ml; 100 ml; 60 ml; 120 ml; 60 ml; 100 ml
SUNWARD PHARMACEUTICAL SDN. BHD.
SUNIZINE SYRUP ® Cetirizine hydrochloride (5mg/5ml) _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Sunizine Syrup is used for 2. How Sunizine Syrup works 3. Before you use Sunizine Syrup 4. How to use Sunizine Syrup 5. While you are using it 6. Side effects 7. Storage & disposal of Sunizine Syrup 8. Product description 9. Manufacturer and Product Registration Holder 10.Date of revision WHAT SUNIZINE SYRUP IS USED FOR Sunizine Syrup is used for the symptomatic treatment of seasonal rhinitis (inflammation of the mucous membrane inside the nose), perennial (throughout the year) allergic rhinitis and urticaria (a red, raised, itchy rash) of allergic origin in adults and children of 3 years or above. HOW SUNIZINE SYRUP WORKS The active ingredient this medicine is cetirizine. It belongs to a group of medicines called ‘antihistamines. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. BEFORE YOU USE SUNIZINE SYRUP _- When you must not use it _ Do not use Sunizine Syrup if you: are hypersensitive to cetirizine or any other ingredients in this product. Pregnancy and breastfeeding Tell your doctor if you are pregnant, planning to become pregnant or breastfeeding. Cetirizine should not be used during the first 3 months of pregnancy. Cetirizine is contra- indicated during breast-feeding as it is excreted in breast milk. _ _ _- Before you start to use it _ Inform your doctor if you have any kidney problem before taking Sunizine Syrup. _- Taking other medicines _ There are no known interactions with other drugs. Nevertheless, cetirizine should be used with caution if sedatives are also being taken. HOW TO USE SUNIZINE SYRUP _- How much to use_ You should take Sunizine Syrup exactly as advised by your doctor or pharmacist. The amount you take each day will depend on your condition. Do not take more or less than what your doctor prescribes. Adults: 10ml (10mg) syrup once daily. Children 6- 12 years of age: 10ml (10mg) syrup onc Pročitajte cijeli dokument
Each 5ml cantains : Cetirizine HCl 5mg PHARMACOLOGY: In experimental animals, cetirizine has been shown to be an anti-H1 agent devoid of any significant anticholinergic or antiserotonin effects. At pharmacological active doses, it induces neither sedation nor behavioural changes. This may be explained by the fact that cetirizine does not cross the blood-brain barrier. It was shown in human pharmacology studies that cetirizine will inhibit certain effects produced by exogenous histamine. This activity appears rapidly. Cetirizine also inhibits the effects produced by endogenous histamine released in vivo by an agent eg 48/80. Finally, it inhibits the cutaneous reaction induced by VIP (Vasoactive Intestinal Polypeptide) and substance P, neuropeptides that are believed to take part in the allergic reaction. Cetirizine markedly reduces bronchial hyper-reactivity to histamine in the asthmatic patient. It also reduces the allergic reaction induced by specific allergens. These effects are obtained without central effects being demonstrated either by psychometric test or by a quantified EEG. PHARMACOKINETICS: Peak blood levels of the order of 0.3 mg/ml are reached between 30 and 60 minutes after administration of a 10 mg dose of cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately 9 hours. Cetirizine is strongly bound to plasma proteins. INDICATIONS: Adults and children of 3 years or above: Symptomatic treatment of seasonal rhinitis, perennial allergic rhinitis and urticaria of allergic origin. SIDE EFFECTS / ADVERSE REACTIONS: There have been occasional reports of mild and transient subjective side effects such as headache, dizziness, drowsiness, agitation, dry mouth and gastrointestinal discomfort. In objective tests of psychomotor function, the incidence of sedation with cetirizine was similar to that of placebo. Occasionally, symptoms of hypersensitivity have been reported Pročitajte cijeli dokument