Country: Сингапур
Језик: Енглески
Извор: HSA (Health Sciences Authority)
Clozapine base
MYLAN PHARMACEUTICALS PTE. LTD.
N05AH02
100 mg
TABLET, FILM COATED
Clozapine base 100 mg
ORAL
Prescription Only
MADAUS GmbH
ACTIVE
1992-11-06
CLOZARIL CAN CAUSE AGRANULOCYTOSIS. ITS USE SHOULD BE LIMITED TO PATIENTS: • WHO ARE NON-RESPONSIVE TO OR INTOLERANT OF CLASSICAL ANTIPSYCHOTIC AGENTS • WHO HAVE INITIALLY NORMAL LEUKOCYTE FINDINGS (WHITE BLOOD CELL COUNT (WBC) ≥ 3500/MM 3 ( ≥ 3.5 X 10 9 /L), AND ABSOLUTE NEUTROPHIL COUNTS (ANC) ≥ 2000/MM 3 ( ≥ 2.0 X 10 9 /L)), • AND IN WHOM REGULAR WHITE BLOOD CELL COUNTS AND ABSOLUTE NEUTROPHIL COUNTS CAN BE PERFORMED AS FOLLOWS: WEEKLY DURING THE FIRST 18 WEEKS OF THERAPY, AND AT LEAST EVERY 4 WEEKS THEREAFTER THROUGHOUT TREATMENT. MONITORING MUST CONTINUE THROUGHOUT TREATMENT AND FOR 4 WEEKS AFTER COMPLETE DISCONTINUATION OF CLOZARIL (SEE SECTION WARNINGS AND PRECAUTIONS). PRESCRIBING PHYSICIANS SHOULD COMPLY FULLY WITH THE REQUIRED SAFETY MEASURES. AT EACH CONSULTATION, A PATIENT RECEIVING CLOZARIL SHOULD BE REMINDED TO CONTACT THE TREATING PHYSICIAN IMMEDIATELY IF ANY KIND OF INFECTION BEGINS TO DEVELOP. PARTICULAR ATTENTION SHOULD BE PAID TO FLU-LIKE COMPLAINTS SUCH AS FEVER OR SORE THROAT AND TO OTHER EVIDENCE OF INFECTION, WHICH MAY BE INDICATIVE OF NEUTROPENIA (SEE SECTION WARNINGS AND PRECAUTIONS). CLOZARIL MUST BE DISPENSED UNDER STRICT MEDICAL SUPERVISION IN ACCORDANCE WITH OFFICIAL RECOMMENDATIONS (SEE SECTION WARNINGS AND PRECAUTIONS). MYOCARDITIS CLOZAPINE IS ASSOCIATED WITH AN INCREASED RISK OF MYOCARDITIS WHICH HAS, IN RARE CASES, BEEN FATAL. THE INCREASED RISK OF MYOCARDITIS IS GREATEST IN THE FIRST 2 MONTHS OF TREATMENT. FATAL CASES OF CARDIOMYOPATHY HAVE ALSO BEEN REPORTED RARELY. MYOCARDITIS OR CARDIOMYOPATHY SHOULD BE SUSPECTED IN PATIENTS WHO EXPERIENCE PERSISTANT TACHYCARDIA AT REST, ESPECIALLY IN THE FIRST 2 MONTHS OF TREATMENT, AND/OR PALPITATIONS, ARRHYTHMIAS, CHEST PAIN AND OTHER SIGNS AND SYMPTOMS OF HEART FAILURE (EG. UNEXPLAINED FATIGUE, DYSPNOEA, TACHYPNOEA) OR SYMPTOMS THAT MIMIC MYOCARDIAL INFARCTION. IF MYOCARDITIS OR CARDIOMYOPATHY ARE SUSPECTED, CLOZARIL TREATMENT SHOULD BE PROMPTLY STOPPED AND THE PATIENT IMMEDIATELY REFERRED TO A CARDIOLOGIST. PATIENTS WHO DEV Прочитајте комплетан документ
Live Text: Production Site: Singapore Comp. No. New: 708732 N/A 172 x 600 mm WZ_468_BPZ_172x600_Kennzeich_ IMA_C80 Comp. No. Old: Printing Colours: Technical Colours: PANTONE Black C Format/Dimension: Tech. Drawing No.: Min. Font Size Text: Braille: N/A ! PLEASE TURN OVERPRINTING ON ! PR: 2590585 Comp. Description: Clozaril 25mg & 100mg PI Revised ACC: NA Cutting Font Type: Proof No.: Arul Date: 02 28 Sep 2022 No / Both Yes / Pharmacode Clozaril can cause agranulocytosis. Its use should be limited to patients: • with schizophrenia who are non-responsive to or intolerant of classical antipsychotic agents. • who have initially normal leukocyte findings (white blood cell count (WBC) ≥ 3500/mm 3 (≥3.5 x 10 9 /L), and absolute neutrophil counts (ANC) ≥ 2000/mm 3 (≥2.10 x 10 9 /L). • and in whom regular white blood cell counts and absolute neutrophil counts can be performed as follows: weekly during the first 18 weeks of therapy, and at least every 4 weeks thereafter throughout treatment. Monitoring must continue throughout treatment and for 4 weeks after complete discontinua- tion of Clozaril (see section WARNINGS AND PRECAUTIONS). Prescribing physicians should comply fully with the required safety measures. At each consultation, a patient receiving Clozaril should be reminded to contact the treating physician immediately if any kind of infection begins to develop. Particular attention should be paid to flu-like complaints such as fever or sore throat and to other evidence of infection, which may be indicative of neutropenia (see section WARNINGS AND PRECAUTIONS). Clozaril must be dispensed under strict medical supervision in accordance with official recommendations (see section WARNINGS AND PRECAUTIONS). Myocarditis Clozapine is associated with an increased risk of myocarditis which has, in rare cases, been fatal. The increased risk of myocarditis is greatest in the first 2 months of treatment. Fatal cases of cardiomyopathy have also been reported rarely. Myocarditis or cardiomyopathy should be suspecte Прочитајте комплетан документ