البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
SELUMETINIB AS HYD-SULFATE
ASTRAZENECA (ISRAEL) LTD
L01EE04
HARD CAPSULE
SELUMETINIB AS HYD-SULFATE 10 MG
PER OS
Required
ASTRA ZENECA UK LIMITED
SELUMETINIB
Koselugo is indicated for the treatment of pediatric patients 2 years of age and older withneurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
2021-06-29
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS( - 1986 This medicine is dispensed with a doctor’s prescription only KOSELUGO™ 10 MG HARD CAPSULES Each hard capsule contains: Selumetinib )as hyd-sulfate( 10 mg KOSELUGO™ 25 MG HARD CAPSULES Each hard capsule contains: Selumetinib )as hyd-sulfate( 25 mg For inactive ingredients in the medicine - please see section 6 “Further Information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you/your child. Do not pass it on to others. It may harm them, even if it seems to you that their ailment is similar. 1. WHAT THE MEDICINE INTENDED FOR? Koselugo is indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 )NF1( who have symptomatic, inoperable plexiform neurofibromas )PN(. THERAPEUTIC GROUP Koselugo is protein Kinase inhibitor. 2. BEFORE USING THE MEDICINE: DO NOT USE THE MEDICINE IF: You or your child are/is sensitive )allergic( to the active ingredient Selumetinib or to any of the other ingredients of this medicine )see section 6(. SPECIAL WARNINGS REGARDING USE OF KOSELUGO BEFORE TREATMENT WITH KOSELUGO, TELL THE DOCTOR IF: you or your child suffers from heart problems )see section 4 "Side effects"(. you or your child suffers from eye problems such as: blurred vision, sensitivity to light, cataracts or increased intraocular pressure )see section 4 "Side effects"(. you or your child suffers from gastrointestinal problems such as diarrhea )see section 4 "Side effects"(. you or your child suffers from skin problems such as rash )see section 4 "Side effects"(. you or your child suffers from muscle pain )which can be caused by increase creatinine phosphokinase enzyme( )see section 4 "Side effects"(. you or your child suffers from an increased risk of bleeding . you are pregnant or plannin اقرأ الوثيقة كاملة
1 1 NAME OF THE MEDICINAL PRODUCT Koselugo 10 mg Koselugo 25 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Selumetinib (As Hyd-Sulfate) 10 mg/capsule Selumetinib (As Hyd-Sulfate) 25 mg/capsule 3 PHARMACEUTICAL FORM Hard Capsules 4 THERAPEUTIC INDICATIONS KOSELUGO is indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). 5 DOSAGE AND ADMINISTRATION 5.1 RECOMMENDED DOSAGE The recommended dosage of KOSELUGO is 25 mg/m 2 orally twice daily (approximately every 12 hours) until disease progression or unacceptable toxicity. Take KOSELUGO on an empty stomach. Do not consume food 2 hours before each dose or 1 hour after each dose _[see Clinical Pharmacology (11)]_ . The recommended dose of KOSELUGO based on body surface area (BSA) is shown in Table 1. TABLE 1 RECOMMENDED DOSAGE BASED ON BODY SURFACE AREA BODY SURFACE AREA* RECOMMENDED DOSAGE 0.55 – 0.69 m 2 20 mg in the morning and 10 mg in the evening 0.70 – 0.89 m 2 20 mg twice daily 0.90 – 1.09 m 2 25 mg twice daily 1.10 – 1.29 m 2 30 mg twice daily 1.30 – 1.49 m 2 35 mg twice daily 1.50 – 1.69 m 2 40 mg twice daily 1.70 – 1.89 m 2 45 mg twice daily ≥ 1.90 m 2 50 mg twice daily * The recommended dosage for patients with a BSA less than 0.55m 2 has not been established. Swallow KOSELUGO capsules whole with water. Do not chew, dissolve or open capsule. Do not administer to patients who are unable to swallow a whole capsule. Do not take a missed dose of KOSELUGO unless it is more than 6 hours until the next scheduled dose. If vomiting occurs after KOSELUGO administration, do not take an additional dose, but continue with the next scheduled dose. 5.2 DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS 2 The recommended dose reductions for adverse reactions are provided in Table 2. TABLE 2 RECOMMENDED DOSE REDUCTIONS FOR KOSELUGO FOR ADVERSE REACTIONS * Permanently discontinue KOSELUGO in patients unable to tolerate KOSELUGO after two dose reductions اقرأ الوثيقة كاملة