국가: 네덜란드
언어: 네덜란드어
출처: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TEMOZOLOMIDE 20 mg/stuk
Lotus Support Services S.R.L. 47 Theodor Pallady Boulevard, 2nd Office, Entrance B, 1st Floor, 3rd District 032 258 BOEKARES
L01AX03
TEMOZOLOMIDE 20 mg/stuk
Capsule, hard
AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 0-WATER ; NATRIUMZETMEELGLYCOLAAT ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171) ; WIJNSTEENZUUR, (L (+) Vorm) (E 334) ; ZWARTE INKT, AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 0-WATER ; NATRIUMZETMEELGLYCOLAAT (E468) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171) ; WIJNSTEENZUUR, (L (+) Vorm) (E 334) ; ZWARTE INKT,
Oraal gebruik
Temozolomide
Hulpstoffen: AMMONIA (E 527); GELATINE (E 441); IJZEROXIDE GEEL (E 172); IJZEROXIDE ZWART (E 172); KALIUMHYDROXIDE (E 525); LACTOSE 0-WATER; NATRIUMZETMEELGLYCOLAAT (E468); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); SILICIUMDIOXIDE (E 551); STEARINEZUUR (E 570); TITAANDIOXIDE (E 171); WIJNSTEENZUUR, (L (+) Vorm) (E 334); ZWARTE INKT;
1900-01-01
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Temozolomide Lotus 20 mg, capsules, hard Temozolomide Lotus 100 mg, capsules, hard Temozolomide Lotus 140 mg, capsules, hard Temozolomide Lotus 180 mg, capsules, hard Temozolomide Lotus 250 mg, capsules, hard Temozolomide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Temozolomide Lotus is and what it is used for 2. What you need to know before you take Temozolomide Lotus 3. How to take Temozolomide Lotus 4. Possible side effects 5. How to store Temozolomide Lotus 6. Contents of the pack and other information 1. WHAT TEMOZOLOMIDE LOTUS IS AND WHAT IT IS USED FOR Temozolomide Lotus contains a medicine called temozolomide. This medicine is an antitumour agent. Temozolomide is used for the treatment of specific forms of brain tumours: - in adults with newly-diagnosed glioblastoma multiforme. Temozolomide is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment). - in children 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Temozolomide is used in these tumours if they return or get worse after standard treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEMOZOLOMIDE LOTUS DO NOT TAKE TEMOZOLOMIDE - if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6). - if you have had an allergic reaction to dacarbazine (an anticancer medicine so 전체 문서 읽기
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Temozolomide Lotus 20 mg, capsules, hard Temozolomide Lotus 100 mg, capsules, hard Temozolomide Lotus 140 mg, capsules, hard Temozolomide Lotus 180 mg, capsules, hard Temozolomide Lotus 250 mg, capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 20 mg temozolomide Each hard capsule contains 100 mg temozolomide Each hard capsule contains 140 mg temozolomide Each hard capsule contains 180 mg temozolomide Each hard capsule contains 250 mg temozolomide. Excipient with known effect: Each 20 mg hard capsule contains 182.2 mg of anhydrous lactose. Each 100 mg hard capsule contains 85.7 mg of anhydrous lactose. Each 140 mg hard capsule contains 119.98 mg of anhydrous lactose. Each 180 mg hard capsule contains 154.26 mg of anhydrous lactose. Each 250 mg hard capsule contains 214.25 mg of anhydrous lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. _ _ Temozolomide 20 mg Capsule is rich yellow opaque/ white opaque, No. 2 capsules, imprinted with “LP” in black ink on the rich yellow opaque cap and “605” in black ink on the white opaque body of the capsules, and filled with white to off-white powder. Temozolomide 100 mg Capsule is pink opaque/ white opaque, No. 2 capsules, imprinted with “LP” in black ink on the rich pink opaque cap and “606” in black ink on the white opaque body of the capsules, and filled with white to pink powder. _ _ Temozolomide 140 mg Capsule is powder blue opaque/ white opaque, No. 1 capsules, imprinted with “LP” in black ink on the powder blue opaque cap and “607” in black ink on the white opaque body of the capsules, and filled with white to pink powder. Temozolomide 180 mg Capsule is Swedish orange opaque/ white opaque, No. 0 capsules, imprinted with “LP” in black ink on the Swedish orange opaque cap and “608” in black ink on the white opaque body of the capsules, and filled with white to pink powder. Temozolomide 250 전체 문서 읽기