Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
ATOVAQUONE; PROGUANIL HYDROCHLORIDE
GLAXO SMITH KLINE (ISRAEL) LTD
P01BB51
FILM COATED TABLETS
ATOVAQUONE 250 MG; PROGUANIL HYDROCHLORIDE 100 MG
PER OS
Required
GLAXO WELLCOME SA, SPAIN
PROGUANIL, COMBINATIONS
PROGUANIL, COMBINATIONS
Prevention of malaria: For the prophylaxis of P.falciparum malaria, including in areas where chloroquine resistance has been reported. Treatment of malaria: For the treatment of acute, uncomplicated P.flaciparum malaria. Malarone has been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance.
2023-05-31
[לוגו מדינת ישראל] [http://www.gov.il/] [http://www.gov.il/] [לוגו משרד הבריאות] [לוגו משרד הבריאות] [*5400] [http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx] [http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx] הציבור הרחב עסקים ומוסדות עובדים בבריאות חפש מידע תפריט * [סגירה] סגור * דף הבית [http://www.health.gov.il/] * אודות * אודות המשרד [http://www.health.gov.il/About/Pages/about_us.aspx] * תוכנית עבודה [http://www.health.gov.il/About/Pages/Agenda.aspx] * תקציב המשרד [http://www.health.gov.il/About/Pages/budget.aspx] * תרשים מבנה ארגוני [http://www.health.gov.il/About/Pages/OrganizationalStructureDiagram.aspx] * בעלי תפקידים [http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx] * יחידות המשרד [http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] * לשכות הבריאות [http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx?tab=3] * אמנת שירות [http://www.health.gov.il/About/sla/Pages/default.aspx] * אותות ופרסים [http://www.health.gov.il/About/Awards/Pages/mifal.aspx] * פרוייקטים תשתיתיים [http://www.health.gov.il/About/projects/shared_medical_info/Pages/default.aspx] * דרושים [http://www.health.gov.il/About/Careers/Pages/default.aspx] * מנכ"לי משרד הבריאות לדורותיהם [http://www.health.gov.il/About/Pages/GeneralManegerHistory.aspx] * יחידות המשרד * יחידות המשרד [http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] * לשכות הבריאות [http://www.health.gov.il/UnitsOffice/LB/Pages/default.aspx] * וועדות ומועצות [http://www.health.gov.il/Services/Committee/Pages/CommitteeList.aspx] * נושאים * בריאות הנפש [http://www.health.gov.il/Subjects/mental_health/Pages/default.aspx] * בריאות הסביבה [http://www.health.gov.il/Subjects/Environmental_Health/ Belgenin tamamını okuyun
1 1. NAME OF THE MEDICINAL PRODUCT MALARONE TABLETS FOR ADULTS MALARONE PAEDIATRIC TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Malarone tablet for adults contains 250 mg atovaquone and 100 mg proguanil hydrochloride. Each Malarone _ _ paediatric tablets contains 62.5 mg atovaquone and 25 mg proguanil hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet. Malarone tablets for adults – Round, biconvex, pink tablets engraved ‘GX CM3’ on one side. Malarone _ _ paediatric tablets – Round, biconvex, pink tablets engraved ‘GX CG7’ on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PREVENTION OF MALARIA Malarone is indicated for the prophylaxis of _Plasmodium falciparum_ malaria, including in areas where chloroquine resistance has been reported. TREATMENT OF MALARIA Malarone is indicated for the treatment of acute, uncomplicated _P. falciparum_ malaria. Malarone has been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within 1 hour after dosing, a repeat dose should be taken. Malarone Paediatric Tablets: Malarone may be crushed and mixed with condensed milk just prior to administration to patients who may have difficulty swallowing tablets. Malarone Tablets for adults: There is no data regarding crush/divide/chew PREVENTION OF MALARIA 2 Start prophylactic treatment with Malarone 1 or 2 days before entering a malaria-endemic area and continue daily during the stay and for 7 days after return. Adults: One tablet of Malarone Tablets For Adults ( 250 mg atovaquone/100 mg proguanil hydrochloride) per day. Paediatric Patients: The dosage for prevention of malaria in paediatric patients is based upon body weight (Table 1). TABLE 1. DOSAGE FOR PREVENTION OF MALARI Belgenin tamamını okuyun