LEVEMIR® Insulin Detemir

Indication : Treatment of diabetes mellitus Levemir® is a soluble, basal insulin analogue with a prolonged duration of effect (up to 24 hours). Each pre-filled Levemir® pen contains 300 U of insulin detemir in 3 ml solution for injection. Levemir® is for subcutaneous administration only. (abdominal wall, the thigh, upper arm, deltoid and gluteal region) Indication : Treatment of diabetes mellitus Can be used in pregnant women and children ≥ 2 years Contraindication : Hypersensitivity to the active substance or to any of the excipients Levemir®. Indonesia Prescribing Information. 2017 Hanya bisa diberikan secara SUBKUTAN Bisa diberikan pada pasien hamil dan anak lebih dari 2 tahun

Storage : Store in refrigerator (2˚-8˚C) Storage : Store in refrigerator (2˚-8˚C). Keep away from the cooling element. Do not freeze. Keep the pen cap on FlexPen® in order to protect from light. Levemir® must be protected from excessive heat and light. After first opening or carried as a spare: Do not refrigerate. Store below 30°C. The in-use shelf life is 6 weeks. Levemir®. Indonesia Prescribing Information. 2017

How to Titrate Basal Insulin Levemir® Dose Titration Guidelines: 3-0-3 Algorithm Simple Dose titration with Levemir ® Mean 3-day FPG (mg/dL) FPG>110 mg/dL + 3 U FPG 80-110 mg/dL FPG <80 mg/dL - 3 U Start with Levemir® 10 U or 0.1-0.2 U per Kg body weight Patients who experienced hypoglycemia reduced their daily dose by 3 units Levemir® Penyuntikan dimulai dari 10 unit atau 0.1-0.2 U/kgBB, 1 kali/hari (Suntikkan pada waktu yang sama setiap harinya) Pantau gula darah puasa selama 3 hari dan diambil nilai rata rata. Titrasi dengan metode 3-0-3. Apabila : Rata-rata FPG selama 3 hari dose adjustment >110 mg/dL +3U 80-110 mg/dL <80 mg/dL -3U   Apabila sudah mencapai target gula darah puasa, maka pertahankan dosis. Jika pasien menunjukkan gejala hipoglikemi / GD<70 mg/dL, atasi penyebabnya. Tanpa menunggu nilai rata – rata gula darah puasa, turunkan dosis 3 unit segera. Pertahankan dosis hingga 3 bulan. Kemudian cek HbA1c. Bila HbA1c mencapai target, pertahankan dosis. Namun, bila HbA1c tidak mencapai target (>7%): FPG tidak mencapai target, titrasi kembali dosis insulin basal. FPG mencapai target, pertimbangkan penambahan dengan Bolus Insulin. Blonde L et al. Diabetes Obes Metab. 2009; 11(6):623-631. Levemir Indonesia Prescribing Information 2017

Significant improvement (p<0.001) Summary of A1chieve study in Indonesia Insulin naïve participants initiated on IDet (Indonesia) Baseline HbA1c Δ HbA1c Efficacy Safety Other Δ FPG Δ PPG Hypoglycaemia Weight IDet 9.5% ↓2.2% ↓101 mg/dL ↓115 mg/dL 1.0* Significant improvement (p<0.001) *p<0.001 Salah satu hasilnya adalah penggunaan Levimir di Indonesia pada subjek penelitian insulin naïve. Dimana hasilnya dapat terlihat disini terjadi penurunan HbA1C rata-rata sebesar 2.2%, dengan angka angka hypoglikemia yang rendah dan peningkatan BB yang sedikit. Soewondo P, et al. Clinical experience with insulin detemir: Results from the Indonesian cohort of the international A1chieve study. Diabetes Research and Clinical Practice 2013; 100(S1): S47–S53

NovoRapid® Insulin Aspart

NovoRapid® is a rapid-acting insulin analogue. Each pre-filled NovoRapid® pen contains 300 U of insulin Aspart in 3 ml solution for injection. NovoRapid® is for subcutaneous administration (abdominal wall, the thigh, upper arm, deltoid and gluteal region), insulin infusion and intravenously Indication : Treatment of diabetes mellitus Can be used in Adult T1DM, Adult T2DM, Children ≥ 2 years old, Pregnancy & lactation Contraindication : Hypoglycaemia. Hypersensitivity to the active substance or to any of the excipients NovoRapid®. Indonesia Prescribing Information. 2016

NovoRapid® must be protected from excessive heat and light. Special population : Elderly patients, Patients with renal/ hepatic impairment Storage Before opening: Store in a refrigerator (2°C – 8°C). Keep away from the cooling element. During use or when carried as a spare: Do not refrigerate. Store below 30°C. Use within 4 weeks. Do not freeze. Keep the pen cap on NovoRapid® FlexPen® in order to protect from light. NovoRapid® must be protected from excessive heat and light. NovoRapid®. Indonesia Prescribing Information. 2016

NovoRapid® is approved in various population Adult T1DM Adult T2DM Children ≥ 2 years old Pregnancy & lactation Elderly patients Patients using insulin pump Patients with renal/ hepatic impairment Hospitalised patients NovoRapid. Indonesia Prescribing Information. 2016

Strategies for dose intensification Straight to three bolus doses Sequential addition of bolus doses Fix the FPG first using basal insulin (dose optimisation) Goal: FPG 70-130 mg/dl (3.9-7.2 mmol/l) Consider adding bolus insulin when : A1C>7% and FPG at goal or basal insulin dose > 0.5 U/kg Fix the FPG first using basal insulin (dose optimisation) Goal: FPG 70-130 mg/dl (3.9-7.2 mmol/l) Consider adding bolus insulin when : A1C>7% and FPG at goal or basal insulin dose > 0.5 U/kg Add bolus 2U at each meal Titrate to next pre-prandial goals ( and bedtime) daily If subsequent pre-meal sugars are: <70mg/dl -1U 70-130mg/dl 0 >130mg/dl +1U Discontinue SU on addition of bolus insulin Patients need to monitor up to 4x per day Add bolus 4U at largest meal Titrate to next pre-prandial (or bedtime) goal daily If subsequent pre-meal sugars are: <70mg/dl -1U 70-130mg/dl 0 >130mg/dl +1U Discontinue SU on addition of bolus insulin Patients may need monitor up to 4x per day Id A1C>7% after 3 months despite titrating bolus dose, or bolus dose s are more than 30 U per meal : Resume titration of basal insulin and/or consider performing a 7 point profile Id A1C>7% after 3 months despite titrating bolus dose, or bolus dose is more than 30 U per meal : Add 2nd bolus of 4U at 2nd largest meal and titrate as before. Repeat for 3rd bolus dose at final meal of the day Pfutzner A, Forst T. Intensification with prandial insulin. Int J Clin Pract 2009; 63 (Suppl. 164): 11–14

Biphasic Insulin Aspart 30 NovoMix® 30 Biphasic Insulin Aspart 30

Indication : Treatment of diabetes mellitus NovoMix®30 dosing is individual and determined in accordance with the needs of the patient. Each pre-filled NovoMix®30 pen contains 300 U of insulin Aspart /protamine-crystallised insulin aspart in 3 ml solution for injection. NovoMix®30 is for subcutaneous administration only. (abdominal wall, the thigh, upper arm, deltoid and gluteal region) Indication : Treatment of diabetes mellitus Contraindication : Hypersensitivity to the active substance or to any of the excipients. During episodes of hypoglycaemia. NovoMix®. Indonesia Prescribing Information. 2016

Keep the pen cap on FlexPen® in order to protect from light. Special population : Elderly, Renal and hepatic impairment, and children and adolescents ≥ 10yrs Storage NovoMix® 30 FlexPen® that is being used or carried as a spare is not to be kept in the refrigerator. It can be kept at room temperature (below 30°C) for up to 4 weeks. Keep the pen cap on FlexPen® in order to protect from light. NovoMix®. Indonesia Prescribing Information. 2016

Switching from basal insulin OD or BID to BIAsp 30 BID 1:1 total dose transfer to BIAsp 30 Split the dose 50:50 pre-breakfast and pre-dinner Titrate the dose preferably once a week Discontinue sulphonylureas Continue metformin Consider discontinuing TZDs as per local guidelines and practice Administer BIAsp 30 just before meals BIAsp, biphasic insulin aspart; BID, twice daily; OD, once daily; TZDs, thiazolidinediones Unnikrishnan et al. Int J Clin Pract 2009;63:1571–7

Teknik Injeksi Insulin

Materi presentasi Pengenalan FlexPen® Jarum NovoTwist® Teknik Injeksi Insulin

Bagian Flexpen® device

Flexpen® Device 1 pen : 3 ml ~ 300 U Warna yang kontras, mudah dibedakan Tactile pada push button 1 klik = 1 Unit Pen sekali pakai, praktis untuk pasien Dosis yang lebih akurat dibanding pen insulin lainnya1 1. Asakura T et al.2008. Cur. Med. Res. and Opin. 2008;24(5):1429-34

Materi presentasi Pengenalan FlexPen® Jarum NovoTwist® Teknik Injeksi Insulin

Didesain untuk kemudahan Pasien berhak mendapat jarum yang baik pada saat inisiasi insulin Dokter setuju bahwa yang paling penting dari jarum adalah kenyamanannya NovoTwist® Didesain untuk kemudahan

NovoTwist® portfolio Panjang Diameter No Reg : AKL 20902412159 5 mm 32G (0.32 mm) No Reg : AKL 20902412159 Tersedia dalam kemasan dus isi 100 buah Jarum insulin sekali pakai Kompatibel digunakan dengan Levemir®, NovoRapid®, NovoMix® FlexPen® dan pena Victoza®

Kelebihan NovoTwist® – Just Twist Lebih mudah – Pemasangan jarum yang lebih sederhana menjadikan penyuntikkan lebih mudah Nyeri yang minimal – Jarum yang tipis seperti NovoTwist® meminimalkan rasa nyeri saat penyuntikan References: 2. Arendt-Nielsen L et al. Pain following controlled cutaneous insertion of needles with different diameters. Somatosensory and Motor Research 2006; 23 (1-2); 37-43.

Jarum Insulin Sekali Pakai Single use, Selalu gunakan jarum baru Penggunaan individual Risiko penggunaan jarum berkali-kali: Kontaminasi yang menyebabkan infeksi area penyuntikan Jarum menjadi tumpul sehingga timbul nyeri saat penyuntikan Jarum mengalami penyumbatan, dosis menjadi tidak akurat Jarum mudah patah, risiko tertinggal di area penyuntikan 5 mm, 32G

NovoTwist® – untuk semua kebutuhan Ingat! Selalu gunakan jarum baru Jarum NovoTwist® cocok untuk semua usia dan ukuran tubuh DEWASA DEWASA ANAK-ANAK Cara mencubit kulit: Cubit kulit dengan jempol dan telunjuk. Tahan selama 5-10 detik setelah menyuntik dan sebelum mencabut jarum Kurus Normal dan Obesitas Kurus, normal, obesitas Jarum 32G 5 mm Kulit dicubit Kulit dicubit Gitte Ehlers, Diabetes Nurse, Kalundborg Hospital, Denmark. April 2007.

Materi presentasi Pengenalan FlexPen® Jarum NovoTwist® Teknik Injeksi Insulin

Area Penyuntikan dan Rotasinya Keterangan A1&A2: Lengan atas B : Perut C : Bokong D : Paha atas

Teknik Injeksi dengan Flexpen® Bentuk Sediaan : - Premix : Suspensi (Keruh) - Insulin Basal dan Prandial : Solusio (Jernih) Gulung Pena Insulin diantara kedua telapak tangan sampai dengan 10 x (posisi horizontal) Gerakkan pena insulin keatas dan ke bawah sebanyak 10 x &

Teknik Injeksi dengan Flexpen®

Teknik Injeksi dengan Flexpen®

Putar dosis sesuai rekomendasi dokter Teknik Injeksi dengan Flexpen® Putar dosis sesuai rekomendasi dokter

Teknik Injeksi dengan Flexpen® Posisi tegak lurus 90°, tekan sampai kembali ke angka 0 Setelah disuntikkan, tahan hingga hitungan 10

Penyimpanan Insulin yang belum digunakan harus disimpan dalam suhu 20 – 80 C Insulin akan stabil sampai dengan masa kadaluarsa yang tercantum pada FlexPen® Insulin yang sudah digunakan dapat disimpan pada suhu kamar (< 300 C) dan akan stabil sampai dengan 6 minggu (Levemir®) sedangkan NovoMix® dan NovoRapid® 4 minggu. Berlaku untuk Flexpen® maupun vial. Hindari terpapar cahaya matahari langsung Referensi: Novo Nordisk FlexPen. Indonesia Package Insert

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