Gemcitabine 10 Mg/Ml Solution For Infusion

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Gemcitabine 10 mg/ml, solution for infusion

gemcitabine

The following information is intended for healthcare professionals only

Instructions for use, handling and disposal

Handling

- Calculate the dose, and decide which size of the Gemcitabine infusion bags is needed. If the required dose cannot be achieved with the available presentations, use of an alternative gemcitabine product, including gemcitabine as a concentrate or gemcitabine as powder for solution for infusion, is recommended.

- Inspect the product pack for any damage. Do not use if there are signs of tampering.

- Apply patient-specific label on the overwrap.

Removal of infusion baa from overwrap and infusion baa inspection

- Tear overwrap at notch. Do not use if overwrap has been previously opened or damaged.

- Remove infusion bag from overwrap.

- Use only if infusion bag and seal are intact. Prior to administration check for minute leaks by squeezing bag firmly. If leaks are found, discard the bag and solution as sterility may be impaired.

- Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.

Administration

- Break the Minitulipe stopper seal by applying pressure on one side with hand.

- Using aseptic technique, attach sterile administration set.

- Refer to directions for use accompanying the administration set.

Precautions

- Do not use in series connection.

- Do not introduce additives into the infusion bag.

- The solution for infusion is ready to use and and must not be mixed with other medicinal products.

- After opening the infusion baa:

From a microbiological point of view, the solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

- Gemcitabine solution for infusion is for single use only.

Personnel must be provided with appropriate handling materials, notably long sleeved gowns, protection masks, caps, protective goggles, sterile single-use gloves, protective covers for the work area and collection bags for waste.

Cytotoxic preparations should not be handled by pregnant staff.

If the product comes into contact with the eyes, severe irritation may result. In such an event, the eyes should be washed thoroughly and immediately. Consult a doctor if irritation persists. If the solution should come into contact with skin, rinse the affected area thoroughly with water. Excreta and vomit must be handled with care.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic agents.

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5. How to store Gemcitabine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the infusion bag and the outer packaging after EXP The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions. Do not refrigerate or freeze.

After opening the infusion bag:

From a microbiological point of view, the solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Do notthrow away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Gemcitabine solution for infusion contains

- The active substance is: gemcitabine (as hydrochloride)

- The other ingredients are: sodium chloride, waterfor injection, sodium hydroxide and/or hydrochloric acid (for pH adjustment).

One 120 ml infusion bag contains 1200 mg gemcitabine (as hydrochloride).

One 160 ml infusion bag contains 1600 mg gemcitabine (as hydrochloride).

One 170 ml infusion bag contains 1700 mg gemcitabine (as hydrochloride).

One 180 ml infusion bag contains 1800 mg gemcitabine (as hydrochloride).

One 200 ml infusion bag contains 2000 mg gemcitabine (as hydrochloride).

One 220 ml infusion bag contains 2200 mg gemcitabine (as hydrochloride).

One ml of the solution for infusion contains 10 mg gemcitabine.

One ml of the solution for infusion contains 4.575 mg sodium.

What Gemcitabine solution for infusion looks like and contents of the pack

Gemcitabine solution for infusion is a clear, colourless, sterile solution free from visible particulate matter.

Gemcitabine solution for infusion is supplied in carton boxes each containing 1,5 or 10 single-dose infusion bags of 120 ml, 160 ml, 170 ml, 180 ml, 200 ml or 220 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceutical Industries Europe BV Polarisavenue 87 2132 JH Hoofddorp The Netherlands

This leaflet was last revised in October 2015

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