Tag bydureon-instructions-gratis-dokumen

(Exenatide Extended-release) for Injectable Suspension Fact Sheet

(Exenatide Extended-release) for Injectable Suspension Fact Sheet

BYDUREON has two dosage forms: BYDUREON single-dose tray containing 2-mg vial and BYDUREON Pen single-dose 2-mg pen. BYDUREON 2 mg is administered via subcutaneous injection once every seven days (weekly). BYDUREON can be administered any time of day, with or without meals, and should be administered immediately after the dose is prepared.1 To ...

HIGHLIGHTS OF PRESCRIBING INFORMATION ). BYDUREON

HIGHLIGHTS OF PRESCRIBING INFORMATION ). BYDUREON

BYDUREON exenatide extended-release for injectable suspension is available as: • BYDUREON single-dose tray which contains one vial of 2 mg exenatide, one vial connector, one prefilled diluent syringe, and two needles (one provided as a spare). • BYDUREON Pen. Each singledose pen contains 2 mg

The Pharmaceutical Technology Specialists

The Pharmaceutical Technology Specialists

• Bydureon is an exenatide microsphere formulation • Vial and syringe, pen, suspension in auto-injector Bydureon (EU 2011 US 2012) Once weekly SC injection 2 mg per week dose Bydureon Pen (US 2014) Once weekly SC injection 2 mg per week dose Bydureon Bcise (US 2017) Once weekly SC MS suspension 2 mg per

Reference ID: 4242569 - Food and Drug Administration

Reference ID: 4242569 - Food and Drug Administration

BYDUREON is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. • The concurrent use of BYDUREON with prandial insulin has not been studied. • BYDUREON is an extended-release formulation of exenatide. BYDUREON should not be used withFile Size: 790KB

Product Information BYDUREON

Product Information BYDUREON

BYDUREON is an extended release microspheres formulation of exenatide. BYDUREON is supplied in a single dose kit containing a vial of powder, a prefilled syringe of diluent, a vial connector and two needles (one spare). BYDUREON is a sterile, white to off-white powder in a glass vial. The act

Introduction to Life Cycle Options (peptides) Formulation .

Introduction to Life Cycle Options (peptides) Formulation .

• Bydureon was launched in a vial and syringe • Importance of device was recognized too late • Bydureon dual chamber pen was difficult and took too long • At launch, inferior to other weekly GLP-1 products on the market • Bydureon

Benefits of early integration of Human Factors: A BYDUREON .

Benefits of early integration of Human Factors: A BYDUREON .

Bydureon® Pen Bydureon® BCise. HFE Approach for BCise - Outline • Focus of the development => improved usability • Users involved through-out • Target patient population: type II diabetics, adults ... Reduced Size Hidden needle Integrated needle Combin

Glucagon-Like Peptide (GLP-1) Receptor Agonists Clinical Edit Criteria

Glucagon-Like Peptide (GLP-1) Receptor Agonists Clinical Edit Criteria

bydureon 2 mg vial 31304 bydureon 2 mg pen inject 36352 bydureon bcise 2 mg autoinject 44039 byetta 5 mcg dose pen inj 24613 byetta 10 mcg dose pen inj 24614 ozempic 0.25-0.5 mg dose pen 44163 ozempic 1 mg dose pen 44164 soliqua 100 unit-33 mcg/ml pen 42676 trulicity 0.75 mg/0.5 ml pen 37169

in this issue from the editor J - diaTribe

in this issue from the editor J - diaTribe

Bydureon is the third GLP-1 receptor agonist to reach the US market, after Byetta in 2005 and Victoza in 2010. While Bydureon and Byetta share the same active ingredient (ex-enatide), Byetta is typically injected twice a day whereas Bydureon uses "microspheres" that degrade slowly in the body allowing for once-weekly dosing. In addition to ...

Application of Quantitative Clinical Pharmacology in the . - PQRI

Application of Quantitative Clinical Pharmacology in the . - PQRI

BYDUREON BCISE. EXENATIDE: Improve glycemic control in type II diabetes. Weekly: 0. BYDUREON...BYDUREON PEN: EXENATIDE SYNTHETIC. Improve glycemic control in type II diabetes: Weekly. 0: YUTIQ. FLUOCINOLONE ACETONIDE: Chronic noninfectious uveitis affecting the posterior segment of the eye

Product Information Name of The Medicine

Product Information Name of The Medicine

BYDUREON is supplied in either a single dose kit containing a vial of powder, a pre-filled syringe of diluent, a vial connector and two needles (one spare) or in a single dose dual-chamber pen containing the powder and solvent. BYDUREON is a sterile, white to off-white powder in a glass vial. The active ingredient in BYDUREON is exenatide.

Reference ID: 4170292 - Food and Drug Administration

Reference ID: 4170292 - Food and Drug Administration

If a dose is missed and the next regularly scheduled dose is due 1 or 2 days later, do not administer the missed dose and instead resume BYDUREON BCISE with the next regular ly scheduled dose. 2.3 Administration Instructions • BYDUREON BCISE is intended for patient self-administration. Prior to initiation, train patients on

LONG-ACTING INJECTABLES AND IMPLANTABLES WORKSHOP

LONG-ACTING INJECTABLES AND IMPLANTABLES WORKSHOP

2 mg per week dose Bydureon Pen Approved US 2014 Once weekly SC injection 2 mg per week dose Bydureon BCise Approved US 2017 Once weekly SC injection 2 mg per week dose Vial and syringe presentation discontinued Jan 2016 with pen launch Exenatide (39 a.a. peptide) first GLP-

Management of Type 2 Diabetes: Non-insulin and Insulin .

Management of Type 2 Diabetes: Non-insulin and Insulin .

60,120 mg Pen: 3ml (300 Units) Vial: 10ml (1000 Units) Januvia 25,50,100 mg Onglyza 2.5, 5 mg Tradjenta 5 mg Nesina 6.25,12.5,25 mg Byetta 5,10mcg Victoza 0.6, 1.2, 1.8 mg Adlyxin 10, 20mcg Bydureon or Bydureon Bcise 2 mg Trulicity 0.75, 1.5 mg Ozempic 0.25, 0.5, 1.0 mg Invokana 100, 300 mg Farxiga 5, 10 mg J

 -Quantity per Dispensing Level Limits/Allowances

-Quantity per Dispensing Level Limits/Allowances

10 mg/mL nasal spray (2.5 mL device) 2 devices ; 6 devices . Butrans ; All patch strengths 4 patches ; 12 patches . Bydureon ; 2 mg vial 4 single dose trays ; 12 single dose trays . Bydureon Pen ;

GENERAL AUTHORIZATION/QUANTITY LIMIT EXCEPTION .

GENERAL AUTHORIZATION/QUANTITY LIMIT EXCEPTION .

Bydureon (exenatide ER) 2 mg/vial in single dose tray; 4 trays/carton 1 carton (4 trays/4 doses) per 28 days Bydureon (exenatide ER) 2 mg/pen; 4 trays/carton 1 carton (4 doses) per 28 days Byetta (exenatide) 5 mcg/

727 Quality Care Dosing Guidelines Drug List

727 Quality Care Dosing Guidelines Drug List

Amerge™ 1, 2.5 mg 9 tablets ... Bydureon® (ST) 2mg vial/pen 4 vials/pens . ... Policy 621A Quality Care Dosing (QCD) Guidelines Link Drug Product Maximum Quantity Per RX 7 Bydureon BCise® (ST) 2mg autoinjector 4 pens Byetta® (ST) 5mcg 1.

Approved Product Monograph

Approved Product Monograph

BYDUREON BCise should not be used in combination with other GLP-1 agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors, as these have similar mechanisms of action and have not been studied together. The concurrent use of BYDUREON BCise with insulin has not been studied and is not recommended. BY