País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
KETOTIFEN FUMARATE
HOVID BERHAD
KETOTIFEN FUMARATE
100 ml; 1000 ml; 3600 ml
HOVID BERHAD
08 March 2023 _ _ _ _ Head of Generic Section Centre of Product Evaluation and Cosmetic National Pharmaceutical Regulatory Agency (NPRA) Ministry of Health Malaysia Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia. RE : LETTER OF COMMITMENT TO SUBMIT PIL & RIMUP PRODUCT NAME : KETOTIFEN SYRUP MAL NO. : MAL19940059AZ Dear Sir/Madam, We hereby commit that we will submit the PIL and RiMUP to pharmacovigilance unit review and to update QUEST3+ via variation after the PIL & RiMUP had been approved by pharmacovigilance unit. Thank you. Yours Sincerely CHONG YEN LENG (MS) Regulatory Affairs Department HOVID Bhd. Llegiu el document complet
KETOTIFEN SYRUP DESCRIPTION Colourless, transparent liquid with strawberry flavour. COMPOSITION Each 5 ml contains: Ketotifen (as Fumarate) 1 mg/5 ml. PHARMACODYNAMICS Ketotifen is a histamine-H1 receptor antagonist. It diminishes or abolishes the main actions of histamine in the body by competitive, reversible blockade of histamine receptor sites. It can also inhibit bronchoconstriction by preventing release of mediators of the allergic response including histamine and slow reacting substance of anaphylaxis (SRS-A) from mast cells. PHARMACOKINETICS Ketotifen is readily absorbed from the gastrointestinal tract. It undergoes hepatic metabolism and is excreted in the urine and faeces. INDICATIONS Ketotifen is used for the prophylactic treatment of asthma. It is also used in allergic conditions such as rhinitis and conjunctivitis. CONTRAINDICATIONS Ketotifen should not be given to premature infants and neonates and also patients during acute attacks of asthma. Caution should be exercised when it is used in conditions such as narrow angle glaucoma, urinary retention and prostatic hypertrophy. PRECAUTIONS • Previous anti-asthmatic treatment should be continued for a minimum of two weeks after initiation of ketotifen treatment. • Ketotifen may suppress positive skin test results and should be stopped several days before the test. • Patients hypersensitive to anti-histamines may be hypersensitive to this medication also. • It may cause dizziness, sedation, mental confusion and hypotension in geriatric patients. • This medication may cause drowsiness. Patients affected should not drive or operate machinery. • Patients should be warned not to take charge of vehicles or machinery. PREGNANCY AND LACTATION Use of Ketotifen during pregnancy is not recommended. Ketotifen is excreted in breast-milk, use by nursing mothers is not recommended. MAIN SIDE/ADVERSE EFFECTS • Increased appetite and weight gain • Sedation • Tiredness • Gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation Llegiu el document complet