Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
dasabuvir,ombitasvir,paritaprevir,Ribavirin,Ritonavir
Abbvie Pty Ltd
dasabuvir,ombitasvir,paritaprevir,Ribavirin,Ritonavir
VIEKIRA PAK-RBV _A combination therapy containing paritaprevir, ritonavir, ombitasvir, dasabuvir and ribavirin_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Viekira Pak-RBV. 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 or pharmacist has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT VIEKIRA PAK-RBV IS USED FOR Viekira Pak-RBV is used to treat chronic (lasting a long time) hepatitis C infection in adults including those with cirrhosis (scarring of the liver). Hepatitis C is a liver disease caused by a virus which infects and damages liver cells. This treatment consists of 3 different types of tablets. These must be taken according to the instructions given by your doctor. Viekira Pak-RBV works by lowering the amount of hepatitis C virus in your body. It removes the virus from your blood over a period of time. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. BEFORE YOU TAKE VIEKIRA PAK-RBV _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE VIEKIRA PAK-RBV IF YOU ARE PREGNANT OR YOUR FEMALE PARTNER IS PREGNANT (IF YOU ARE MALE). RIBAVIRIN MAY CAUSE BIRTH DEFECTS AND/OR DEATH OF AN UNBORN BABY. EXTREME CARE MUST BE TAKEN TO AVOID PREGNANCY DURING TREATMENT AND FOR 6 MONTHS AFTER COMPLETION OF TREATMENT WITH RIBAVIRIN. TWO RELIABLE FORMS OF CONTRACEPTION MUST BE USED DURING THIS TIME. DO NOT TAKE VIEKIRA PAK-RBV IF YOU HAVE AN ALLERGY TO: • ANY MEDICINE CONTAINING PARITAPREVIR, RITONAVIR, OMBITASVIR, DASABUVIR OR RIBAVIRIN; OR • ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some symptoms of an allergic reaction includ Read the complete document
VIEKIRA PAK-RBV Version 08 9 November 2017 1 of 59 PRODUCT INFORMATION VIEKIRA PAK-RBV COMBINATION THERAPY PACK NAME OF THE MEDICINE VIEKIRA PAK-RBV is a composite pack containing paritaprevir/ritonavir/ombitasvir 75/50/12.5 mg tablets, dasabuvir 250 mg tablets and 200 mg, 400 mg or 600 mg ribavirin tablets. Refer to DOSAGE AND ADMINISTRATION for populations requiring ribavirin. CHEMICAL STRUCTURE AND DESCRIPTION OF EACH ACTIVE PHARMACEUTICAL INGREDIENT PARITAPREVIR Paritaprevir drug substance is manufactured as a dihydrate; however, it is dehydrated during the drug product manufacturing process and is amorphous and anhydrous in the final product. Paritaprevir dihydrate is chemically designated (2_R_,6_S_,12_Z_,13a_S_,14a_R_,16a_S_)-_N_- (Cyclopropylsulfonyl)- 6-{[(5-methylpyrazin-2-yl)carbonyl]amino}-5,16-dioxo-2-(phenanthridin-6-yloxy)- 1,2,3,6,7,8,9,10,11,13a,14,15,16,16atetradecahydrocyclopropa[_e_]pyrrolo[1,2-_a_][1,4] diazacyclopentadecine-14a(5_H_)-carboxamide dihydrate. The molecular formula is C 40 H 43 N 7 O 7 S•2H 2 O (dihydrate) and the molecular weight for the drug substance is 801.91 (dihydrate). Paritaprevir dihydrate has the following structural formula: CAS Number: 1456607-71-8 Paritaprevir dihydrate is a white to off-white powder with very low water solubility. Paritaprevir dihydrate has a pKa of 4.6 at 25°C. RITONAVIR Ritonavir is chemically designated as [5_S_-(5_R_*,8_R_*,10_R_*,11_R_*)]10-Hydroxy-2-methyl-5-(1- methyethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmehyl)-2,4,7,12- tetraazatridecan-13-oic acid,5-thiazolylmethyl ester. The molecular formula is C 37 H 48 N 6 O 5 S 2 and the molecular weight is 720.95. VIEKIRA PAK-RBV Version 08 9 November 2017 2 of 59 Ritonavir has the following structural formula: CAS Number: 155213-67-5 Ritonavir is a white to light tan powder practically insoluble in water and freely soluble in methanol and ethanol. Ritonavir has a pKa of 2.8. OMBITASVIR Ombitasvir drug substance is manufactured as a hydrate; however, it is dehydrated dur Read the complete document