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Gemcitabine (DBL) TM

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.

Active ingredients: vorasidenib

Brand name

(ARTG)

: DBL GEMCITABINE INJECTION gemcitabine (as hydrochloride) 200mg/5.3mL solution for Injection vial

Download the Consumer Medicine Information Leaflet

Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website

What this medicine is used for

(ARTG)

DBL Gemcitabine Injection is indicated: 1. For treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). 2. For treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. 3. For treatment of patients with FU refractory pancreatic cancer. 4. Alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. 5. In combination with paclitaxel, for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated. 6. In combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

How to use this medicine

(ARTG)

This medicine contains one component only.

Component :

  • Injection, solution
  • Intravenous
  • A clear, colourless or light straw-coloured solution in a clear glass vial

Storage conditions

(ARTG)

  • Store at 2 to 8 degrees Celsius
  • Do not Freeze
  • Refrigerate
  • Shelf lifetime is 24 Months.

Do I need a prescription ?

(ARTG)

These medicine packs are available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.

  • Single pack

Pregnant or planning a pregnancy ?

(AHT)

For the active ingredient vorasidenib

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

Reporting side effects

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

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