Երկիր: Մալայզիա
Լեզու: անգլերեն
Աղբյուրը: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CETIRIZINE HYDROCHLORIDE
World Medicare Supplies Sdn Bhd
CETIRIZINE HYDROCHLORIDE
120 ml
SUNWARD PHARMACEUTICAL SDN. BHD.
MEDIZINE SYRUP 5MG/5ML Cetirizine hydrochloride (5mg/5ml) _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Medizine Syrup is used for 2. How Medizine Syrup works 3. Before you use Medizine Syrup 4. How to use Medizine Syrup 5. While you are using it 6. Side effects 7. Storage & disposal of Medizine Syrup 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT MEDIZINE SYRUP IS USED FOR Medizine Syrup is used to treat adults and children aged 2 and over who have hay fever (seasonal allergic rhinitis), year round allergies such as dust or pet allergies (perennial allergic rhinitis) and urticaria (swelling, redness and itchiness of the skin). HOW MEDIZINE SYRUP WORKS The active ingredient this medicine is cetiriz- ine. 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 MEDIZINE SYRUP _- When you must not use it _ Do not use Medizine Syrup if you: are hypersensitive to cetirizine, hydroxyz- ine, piperazine or any other ingredients listed at the end of the leaflet. have severe kidney failure (creatinine clear- ance less than 10ml/min). _Children_ Medizine Syrup is not recommended to be use for children under 2 years of age. _ _ _- Before you start to use it _ Tell your doctor before taking this medicine if you have: moderate or severe kidney problem. have difficulty in urination. fits. convulsion. _Pregnancy and breastfeeding _ You should check with your doctor if you are or think you may be pregnant, planning to become pregnant or if you are breastfeeding. It is not recommended for pregnant women and nursing mothers unless the expected benefit outweighs any potential risks. There is inadequate evidence of safety in human pregnancy or fertility. Safety during pregnancy has not been established. Caution should be taken when breastfeeding as cetiriz- ine found excreted in breast milk. _- Taki Կարդացեք ամբողջական փաստաթուղթը
Each 5ml contains : 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: INDICATIONS: SIDE EFFECTS / ADVERSE REACTIONS: PRECAUTIONS/WARNINGS: USE IN PREGNANCY & LACTATION: MEDIZINE SYRUP 5MG/5ML Adults and children of 2 years and above: symptomatic treatment of seasonal allergic rhinitis, perennial allergic rhinitis and urticaria of allergic origin. Activities Requiring Mental Alertness: In clinical trials the occurrence of somnolence has been reported in some patients taking Cetirizine: due caution should therefore be exercised when driving a car or operating potentially dangerous machinery. Dosage adjustment is necessary in patients with moderate or severe renal impairment (see section Recommended Dose). Caution should be taken in patients with predisposition factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention.Caution in epileptic patients and patients at risk of convulsions is recommended. For patients w Կարդացեք ամբողջական փաստաթուղթը