Valsts: Jaunzēlande
Valoda: angļu
Klimata pārmaiņas: Medsafe (Medicines Safety Authority)
Enfuvirtide 108mg (includes overage 20%)
Roche Products (NZ) Ltd
Enfuvirtide 108 mg (includes overage 20%)
90 mg/mL
Injection with diluent
Active: Enfuvirtide 108mg (includes overage 20%) Excipient: Hydrochloric acid Mannitol Sodium carbonate Sodium hydroxide Water for injection
Combination pack, 60xfuzeon, 60xdiluent + 60x1mL and 60x3 mL syringes, 60 dose units
Prescription
Prescription
Corden Pharma Colorado Inc
FUZEON (enfuvirtide) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in antiretroviral experienced patients with treatment failure due to intolerance to previous antiretroviral agents or with evidence of HIV-1 replication despite ongoing therapy. Evidence to support this indication is based on surrogate endpoints (change in viral load and CD4 count) in controlled studies following 48 weeks of treatment (see Clinical Trials).
Package - Contents - Shelf Life: Combination pack, 60xfuzeon, 60xdiluent + 60x1mL and 60x3 mL syringes - 60 dose units - 48 months from date of manufacture stored at or below 30°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Diluent, type I - 2 mL - 48 months from date of manufacture stored at or below 30°C - Vial, glass, Fuzeon powder, type I - 3 mL - 48 months from date of manufacture stored at or below 30°C
2003-09-15
R Fuzeon ® CMI 110811 1 of 11 DS 110610 CONSUMER MEDICINE INFORMATION FUZEON ® ENFUVIRTIDE POWDER FOR INJECTION 108 MG WHAT IS IN THIS LEAFLET This leaflet answers some common questions about FUZEON. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using FUZEON against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT FUZEON IS USED FOR FUZEON is used for the treatment of HIV (Human Immunodeficiency Virus), the virus which causes AIDS. FUZEON belongs to a group of medicines called anti-HIV medicines. FUZEON is the first in a new class of medicines called HIV fusion inhibitors. It works by blocking the entry of HIV into cells that the virus attacks (called CD4 or T cells) in your blood. FUZEON is used in combination with other anti-HIV medicines to treat people with HIV. FUZEON has been shown to reduce the amount of HIV in the blood (“viral load”) and increase the number of CD4 cells. Reducing the amount of HIV in the blood reduces the risk of death or infections which are due to your low immunity (called opportunistic infections). You should always report any changes in your condition to your doctor to ensure that any opportunistic infections are treated promptly. Your doctor, however, may have prescribed FUZEON for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY FUZEON HAS BEEN PRESCRIBED FOR YOU. FUZEON does not cure HIV infection or AIDS. FUZEON does not reduce the risk of passing HIV to other people through unprotected sexual contact, sharing needles, or contaminated blood. R Fuzeon ® CMI 1108 Izlasiet visu dokumentu
R _ _ Fuzeon ® DS 110610 1 of 18 T2009-101 DATA SHEET FUZEON ® _Enfuvirtide _ CAS Registry Number: 159519-65-0 O N H N H O NH 2 N H N H O NH O N H N H O O O H N H O N H O O OH N H O NH 2 N H O NH N H O N H O OH N H O N H O N H O N H O O N H 2 N H O NH O O O H N H O O OH NH O N H 2 N H O O N H 2 NH O O N H 2 N H O O H N H O O H N H O O H N H O N H O N H O NH N N H O O H N H O N H O N H O O OH N H O O OH N H O O H N H O O NH 2 N H O O N H 2 N H O NH 2 O O H O O NH 2 O The empirical formula of enfuvirtide is C 204 H 301 N 51 O 64 , and the molecular weight is 4,492. It has the following primary amino acid sequence: Ac-Tyr-Thr-Ser-Leu-Ile-His-Ser-Leu-Ile-Glu-Glu-Ser-Gln-Asn-Gln-Gln-Glu-Lys-Asn-Glu-Gln-Glu-Leu- Leu-Glu-Leu-Asp-Lys-Trp-Ala-Ser-Leu-Trp-Asn-Trp-Phe-NH 2 DESCRIPTION FUZEON (enfuvirtide) is derived from a naturally occurring motif, amino acid residues (643-678) within the gp41 transmembrane glycoprotein of human immunodeficiency virus type 1 strain LAI (HIV-1 LAI ). Enfuvirtide is a linear 36-amino acid synthetic peptide, composed of naturally occurring L-amino acid residues. FUZEON is a white to off-white lyophilised powder. Each vial contains 108 mg enfuvirtide. Reconstituted FUZEON solution contains 90mg/mL of enfuvirtide. FUZEON also contains sodium carbonate (anhydrous), mannitol, sodium hydroxide and hydrochloric acid. R _ _ Fuzeon ® DS 110610 2 of 18 T2009-101 _ _ _ _ PHARMACOLOGY _MECHANISM OF ACTION _ Enfuvirtide is a member of the therapeutic class called fusion inhibitors. It is an inhibitor of the structural rearrangement of HIV-1 gp41 that functions by specifically binding to this virus protein extracellularly and thereby blocking the virus from entering the cell. The antiviral activity of enfuvirtide results from its association with a heptad-repeat motif, HR1, within native gp41 on the viral surface. _ _ _MICROBIOLOGY _ ANTIVIRAL A Izlasiet visu dokumentu