Pays: Israël
Langue: anglais
Source: Ministry of Health
ABACAVIR AS SULFATE
GLAXO SMITH KLINE (ISRAEL) LTD
J05AF06
FILM COATED TABLETS
ABACAVIR AS SULFATE 300 MG
PER OS
Required
GLAXO SMITH KLINE PHARMACEUTICALS S.A., POLAND
ABACAVIR
ABACAVIR
Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected .28/10/2018 בקשה לשינוי משטר מינון
2013-11-30
לפוטמל הרהזא סיטרכ – בושח תוילבט )abacavir sulfate( ןגאיז )lamivudine/ dolutegravir/ abacavir( קמוירט תוילבט ןמזה לכ ךתיא הז סיטרכ אש םילפוטמהמ קלח ,ריוקבא םיליכמ קמוירט /ןגאיזו תויה תושיגר תבוגת חתפל םייושע קמוירט /ןגאיז םיחקולה תויהל הלוכי וז הבוגת .)הרומח תיגרלא הבוגת( רתי .ךישממ קמוירט /ןגאיזב לופיטה םא םייח תנכסמ ךילע םאה תוצעייתהל דימ ךלש אפורל הנפ :םא קמוירט /ןגאיז תחקל קיספהל וא רועב החירפ חתפמ התא )1 תוחפל ךותמ רתוי וא דחא ןימסת חתפמ התא )2 תואבה תוצובקה ןיבמ 2 םוח - לועיש וא ןורג באכ ,המישנ רצוק - ןטב באכ וא לושלש וא האקה וא הליחב - תיללכ ילוח תשגרה וא םיבאכ וא השק תופייע - IMPORTANT – PATIENT ALERT CARD Ziagen (abacavir sulfate) Tablets Triumeq (lamivudine/ dolutegravir/ abacavir) Tablets Carry this card with you at all times Since Ziagen/ Triumeq contain abacavir, some patients taking Ziagen/ Triumeq may develop a hypersensitivity reaction (serious allergic reaction). This reaction CAN BE LIFE-THREATENING if treatment with Ziagen/ Triumeq is continued. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE ON WHETHER YOU SHOULD STOP TAKING ZIAGEN/ TRIUMEQ IF: 1) YOU GET A SKIN RASH OR 2) YOU GET ONE OR MORE SYMPTOMS FROM AT LEAST 2 OF THE FOLLOWING GROUPS - fever - shortness of breath, sore throat or cough - nausea or vomiting or diarrhoea or abdominal pain - severe tiredness or achiness or generally feeling ill A. Card v4B 20376 جلاعتملل ريذحت ةقاطب ـ ماه صارقأ )abacavir sulfate( نچايز (lamivudine/ dolutegravir/ abacavir( ك ِ مويرت صارقأ تقولا لاوط كعم ةقاطبلا هذه لمحإ نيجلاعتملا ضعب نإف ،ريڤاكابأ ىلع ك ِ Lire le document complet
Page 1 of 20 ZIAGEN TABLETS 1. NAME OF THE MEDICINAL PRODUCT Ziagen tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of abacavir (as sulfate). For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablets) The scored tablets are yellow, biconvex, capsule shaped and are engraved with ‘GX 623’ on both sides. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection. The demonstration of the benefit of Ziagen is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy (see section 5.1). Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin(see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ziagen should be prescribed by physicians experienced in the management of HIV infection. Ziagen can be taken with or without food. To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing. Ziagen is also available as an oral solution for use in children over three months of age and weighing less than 14 kg and for those patients for whom the tablets are inappropriate. Page 2 of 20 Alternatively, for patients who are unable to swallow tablets, the tablet(s) may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2). _Adults, adolescents and children (weighing at least 25 kg): _ The recommended dose of Ziagen is 600 mg daily. This may be administered as either 300 mg (one tablet) twice daily or 600 mg (two tablets) once daily (see sections 4.4 and 5.1). _Children (weighing less than 25 kg): _ Dosi Lire le document complet