Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Pegfilgrastim, Quantity: 6 mg
Amgen Australia Pty Ltd
Pegfilgrastim
Injection, solution
Excipient Ingredients: sodium; polysorbate 20; acetate; sorbitol; water for injections
Subcutaneous
1 prefilled syringe with automatic needle guard
(S4) Prescription Only Medicine
For the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.
Visual Identification: clear, colourless liquid; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2010-05-26
NEULASTA® 1 NEULASTA ® _pegfilgrastim (rbe) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET WHAT NEULASTA IS USED FOR ............. 1 How it works ............................. 1 BEFORE YOU USE IT ............................ 1 When you must not use it .......... 1 Before you start to use it ............ 2 Taking other medicines .............. 2 HOW TO USE IT................................... 2 HOW TO INJECT NEULASTA USING A PRE- FILLED SYRINGE WITH AN AUTOMATIC NEEDLE GUARD ................................... 2 Important ................................... 2 Before you use Neulasta pre- filled syringe with automatic needle guard, read this important information: ............................... 2 Guide to parts ............................. 2 Things to do before you inject ... 2 Where to inject ........................... 3 How to inject ............................. 3 How to remove detachable label 3 Disposing ................................... 4 FURTHER INFORMATION ON USE .......... 4 How much to inject .................... 4 When to inject ............................ 4 If you forget your injection ........ 4 If you inject too much (overdose) ................................................... 4 WHILE YOU ARE USING IT ................... 4 Things you must do ................... 4 Things you must not do ............. 4 SIDE EFFECTS ...................................... 4 AFTER USING IT .................................. 5 Storage ....................................... 5 Disposal ..................................... 5 PRODUCT DESCRIPTION ....................... 5 What it looks like ...................... 5 Ingredients ................................. 5 Sponsor ...................................... 5 This leaflet answers some common questions about Neulasta. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines have risks and benefits. Your doctor has prescribed Neulasta after considering its likely benefit to y Read the complete document
NEULASTA ® (PEGFILGRASTIM) - SOLUTION FOR INJECTION - PRODUCT INFORMATION PAGE 1 OF 18 AUSTRALIAN PI - NEULASTA ® (PEGFILGRASTIM) 1 NAME OF THE MEDICINE Neulasta ® is the Amgen Inc. trademark for pegfilgrastim (rbe), a long-acting form of recombinant human granulocyte colony-stimulating factor (G-CSF). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Neulasta is composed of filgrastim (recombinant methionyl human G-CSF, tradename NEUPOGEN) with a 20,000 dalton polyethylene glycol (PEG) molecule covalently bound to the N-terminal methionine residue. Filgrastim is a 175 amino acid protein manufactured by recombinant DNA technology. Filgrastim is produced by _Escherichia coli_ (_E coli_) bacteria into which has been inserted the human G-CSF gene. Filgrastim is unglycosylated and contains an N-terminal methionine necessary for expression in _E coli_. Neulasta has a total molecular weight of 39,000 daltons. Each single-use pre-filled syringe with automatic needle guard of Neulasta contains 6 mg of pegfilgrastim (based on protein mass only). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Neulasta is a sterile, clear, colourless, preservative-free liquid for subcutaneous (SC) administration. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Neulasta is indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE (DOSE AND INTERVAL) The recommended dosage of Neulasta is a single SC injection of 6 mg administered once per chemotherapy cycle. Neulasta should be administered approximately 24 hours after the administration of cytotoxic chemotherapy. In clinical studies, Neulasta has been safely NEULASTA ® (PEGFILGRASTIM) - SOLUTION FOR INJECTION - PRODUCT INFORMATION PAGE 2 OF 18 administered 14 days before chemotherapy (see Section 4.4 Special warnings and precautions for use). METHOD OF ADMINISTRATION Read the complete document