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GEMCITABINE NIDDA 38MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Gemcitabine NIDDA 38 mg/ml Concentrate for Solution for Infusion
Gemcitabine
Read all of this leaflet carefully before you start receiving this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor, nurse or pharmacist.

In this leaflet:
1. What Gemcitabine NIDDA is and what it is used for
2. Before you are given Gemcitabine NIDDA
3. How Gemcitabine NIDDA is given
4. Possible side effects
5. How to store Gemcitabine NIDDA
6. Further information

1. WHAT Gemcitabine NIDDA IS AND WHAT IT IS USED FOR
Gemcitabine NIDDA belongs to a group of medicines called “cytotoxics”. These medicines kill
dividing cells, including cancer cells.
Gemcitabine NIDDA may be given alone or in combination with other anti-cancer medicines,
depending on the type of cancer.
Gemcitabine NIDDA is used in the treatment of the following types of cancer:
• non-small cell lung cancer (NSCLC), alone or together with cisplatin.
• pancreatic cancer.
• breast cancer, together with paclitaxel.
• ovarian cancer, together with carboplatin.
• bladder cancer, together with cisplatin.

2. BEFORE YOU ARE GIVEN Gemcitabine NIDDA
You should not be given Gemcitabine NIDDA:
• if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of Gemcitabine
NIDDA.
• if you are breast-feeding.
Take special care with Gemcitabine NIDDA
Before the first infusion you will have samples of your blood taken to evaluate if you have sufficient
kidney and liver function. Before each infusion you will have samples of your blood taken to evaluate
if you have enough blood cells to receive Gemcitabine NIDDA. Your doctor may decide to change the
dose or delay treating you depending on your general condition and if your blood cell counts are too
low. Periodically you will have samples of your blood taken to evaluate your kidney and liver
function.
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Please tell your doctor if:
• you have, or have previously had liver disease, heart disease or vascular disease.
• you have recently had, or are going to have radiotherapy.
• you have been vaccinated recently.
• you develop breathing difficulties or feel very weak and are very pale (may be a sign of kidney
failure).
• you are suffering from alcoholism, as this medicinal product contains ethanol (alcohol).
• you are suffering from epilepsy, as this medicinal product contains ethanol (alcohol).
Men are advised not to father a child during and up to 6 months following treatment with Gemcitabine
NIDDA. If you would like to father a child during the treatment or in the 6 months following
treatment, seek advice from your doctor or pharmacist. You may want to seek counselling on sperm
storage before starting your therapy.

Taking other medicines
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other
medicines, including vaccinations and medicines obtained without a prescription.
The amount of alcohol in this medicinal product may alter the effects of other medicines.

Pregnancy and breast-feeding
If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of Gemcitabine
NIDDA should be avoided during pregnancy. Your doctor will discuss with you the potential risk of
taking Gemcitabine NIDDA during pregnancy.
If you are breast-feeding, tell your doctor.
You must discontinue breast-feeding during Gemcitabine NIDDA treatment.

Driving and using machines
Gemcitabine NIDDA may make you feel sleepy, particularly if you have consumed any alcohol. Do
not drive a car or use machinery until you are sure that treatment with Gemcitabine NIDDA has not
made you feel sleepy.
The amount of alcohol in this medicine may impair your ability to drive or use machines.

Important information about some of the ingredients of Gemcitabine NIDDA
This medicine contains 50 vol% ethanol (alcohol), i.e. up to 21 g per 2 g dose, equivalent to 525 ml
beer or 220 ml wine per dose
• Harmful for those suffering from alcoholism.
• To be taken into account in pregnant womenand high-risk groups such as patients with liver
disease, or epilepsy.
• The amount of alcohol in this medicinal product may alter the effects of other medicines.
• The amount of alcohol in this medicinal product may impair your ability to drive or use machines.
This medicine contains 175 mg (7.6 mmol) of sodium per 2 g dose. To be taken into consideration by
patients on a controlled sodium diet.

3. HOW Gemcitabine NIDDA IS GIVEN
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The usual dose of Gemcitabine NIDDA is 1000-1250 mg for every square metre of your body’s
surface area. Your height and weight are measured to work out the surface area of your body. Your
doctor will use this body surface area to work out the right dose for you. This dosage may be adjusted,
or treatment may be delayed depending on your blood cell counts and on your general condition.
How frequently you receive your Gemcitabine NIDDA infusion depends on the type of cancer that
you are being treated for.
A hospital pharmacist or doctor will have diluted the Gemcitabine NIDDA concentrate before it is
given to you.
You will always receive Gemcitabine NIDDA by infusion into one of your veins. The infusion will
last approximately 30 minutes.
If you have further questions on the use of this product ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Gemcitabine NIDDA can cause side effects, although not everybody gets them.
Frequencies of the observed side effects are defined as:
• very common: affects more than 1 user in 10
• common: affects 1 to 10 users in 100
• uncommon: affects 1 to 10 users in 1,000
• rare: affects 1 to 10 users in 10,000
• very rare: affects less than 1 user in 10,000
• not known: frequency can’t be estimated from the available data
You must contact your doctor immediately if you notice any of the following:
• Fever or infection (common): if you have a temperature of 38ºC or greater, sweating or other signs
of infection (since you might have less white blood cells than normal which is very common).
• Irregular heart rate (arrhythmia) (frequency not known).
• Pain, redness, swelling or sores in your mouth (common).
• Allergic reactions: if you develop skin rash (very common) / itching (common), or fever (very
common).
• Tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less
haemoglobin than normal which is very common).
• Bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish
urine, unexpected bruising (since you might have less platelets than normal which is very
common).
• Difficulty breathing (it is very common to have mild breathing difficulty soon after the
Gemcitabine NIDDA infusion which soon passes, however uncommonly or rarely there can be
more severe lung problems).
Side effects with Gemcitabine NIDDA may include:
Very common side effects
Low haemoglobin level (anaemia)
Low white blood cells
Low platelet count
Difficulty breathing
Vomiting
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Nausea
Skin rash: allergic skin rash, frequently itchy
Hair loss
Liver problems: found through abnormal blood test results
Blood in urine
Abnormal urine tests: protein in urine
Flu-like symptoms including fever
Oedema (swelling of ankles, fingers, feet, face)
Common side effects
Fever accompanied by low white blood cell count (febrile neutropaenia)
Anorexia (poor appetite)
Headache
Insomnia
Sleepiness
Cough
Runny nose
Constipation
Diarrhoea
Pain, redness, swelling or sores in the mouth
Itching
Sweating
Muscle pain
Back pain
Fever
Weakness
Chills
Uncommon side effects
Interstitial pneumonitis (scarring of the air sacs of the lung)
Spasm of the airways (wheeze)
Abnormal chest X ray/scan (scarring of the lungs)
Rare side effects
Heart attack (myocardial infarction)
Low blood pressure
Skin scaling, ulceration or blister formation
Injection site reactions
Very rare side effects
Increased platelet count
Anaphylactic reaction (severe hypersensitivity/allergic reaction)
Sloughing of skin and severe skin blistering
Side effects with frequency not known
Irregular heart beat (arrhythmia)
Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure)
Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been
exposed to radiotherapy.
Fluid in the lungs
Radiation toxicity: scarring of the air sacs of the lung associated with radiation therapy
Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced blood supply)
Heart failure
Kidney failure
Gangrene of fingers or toes
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Serious liver damage, including liver failure
Stroke
You might have any of these symptoms and/or conditions. You must tell your doctor as soon as
possible when you start experiencing any of these side effects.
If you are concerned about any side effects, talk to your doctor.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet,
please tell your doctor.

5. HOW TO STORE Gemcitabine NIDDA
Keep out of the reach and sight of children.
Do not use after the expiry date (EXP) which is stated on the carton.
This medicinal product does not require any special storage conditions.
After first opening:
Chemical and physical in-use stability has been demonstrated for 3 days at 25°C.
From a microbiological point of view, once opened, the product may be stored for a maximum of 28
days at 25°C. Other in-use storage times and conditions are the responsibility of the user.
Solution for infusion:
Chemical and physical in-use stability after dilution in 0.9% sodium chloride solution has been
demonstrated for 3 days at 2°C to 8°C or at 30°C.
From a microbiological point of view, the solution for infusion should be used immediately. If not
used immediately, in-use storage times and conditions prior to use are the responsibility of the user
and would normally not be longer than 24 hours at 2°C to 8°C unless dilution has taken place in
controlled and validated aseptic conditions.
This medicine will be prepared and administered to you by healthcare staff. Any unused medicine
must be disposed of by the healthcare staff.

6. FURTHER INFORMATION
What Gemcitabine NIDDA contains
The active substance is gemcitabine.
Each ml of the concentrate for solution for infusion contains 38 mg gemcitabine (as gemcitabine
hydrochloride).
Each vial contains either 200 mg, 1000 mg, 1500 mg or 2000 mg gemcitabine (as gemcitabine
hydrochloride).
The other ingredients are ethanol 96%, sodium hydroxide (for pH adjustment), hydrochloric acid (for
pH adjustment) and water for injections.

What Gemcitabine NIDDA looks like and contents of the pack
This medicine is a concentrate for solution for infusion.
The concentrate is a clear, colourless to slightly yellow solution. It is filled in clear glass vials sealed
with rubber stoppers and aluminium flip-off caps.

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Each vial of 5.26 ml contains 200 mg gemcitabine.
Each vial of 26.3 ml contains 1000 mg gemcitabine.
Each vial of 39.5 ml contains 1500 mg gemcitabine.
Each vial of 52.6 ml, contains 2000 mg gemcitabine.
Each pack contains 1 vial.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
< To be completed nationally >

Manufacturer
cell pharm GmbH
Feodor-Lynen-Str. 35
30625 Hannover
Germany

This leaftlet was last approved in <02/2010>
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany
Gemcitabine NIDDA 38 mg/ml Konzentrat zur Herstellung einer Infusionslösung
United Kingdom
Gemcitabine NIDDA 38 mg/ml Concentrate for Solution for Infusion

The following information is intended for medical or healthcare professionals only:
Instructions for use, handling and disposal
1. Use aseptic techniques during preparation of gemcitabine for intravenous infusion administration.
2. Calculate the dose and the number of Gemcitabine NIDDA vials needed.
3. Gemcitabine NIDDA concentrate for solution for infusion is a clear, colourless to slightly yellow
solution with a concentration of 38 mg/ml gemcitabine. The concentrate should be diluted with
sterile sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative.
4. Parenteral medicinal products should be inspected visually for particulate matter and discolouration
prior to administration. If particulate matter is observed, do not administer.
5. Chemical and physical in-use stability after first opening of the vial has been demonstrated for 3
days at 25°C. From a microbiological point of view, once opened, the product may be stored for a
maximum of 28 days at 25°C. Other in-use storage times and conditions are the responsibility of
the user.
6. Chemical and physical in-use stability of the solution for infusion has been demonstrated for 3 days
at 2°C to 8°C or at 30°C. From a microbiological point of view, the solution for infusion should be
used immediately. If not used immediately, in-use storage times and conditions prior to use are the
responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless
dilution has taken place in controlled and validated aseptic conditions.
7. Gemcitabine infusion solutions are for single use only. Any unused product or waste material
should be disposed of in accordance with local requirements.
Preparation and administration precautions
The normal safety precautions for cytostatic agents must be observed when preparing and disposing of
the infusion solution. Handling of the solution for infusion should be done in a safety box and

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protective coats and gloves should be used. If no safety box is available, the equipment should be
supplemented with a mask and protective glasses.
If the preparation comes into contact with the eyes, this may cause serious irritation. The eyes should
be rinsed immediately and thoroughly with water. If there is lasting irritation, a doctor should be
consulted. If the solution is spilled on the skin, rinse thoroughly with water.
Disposal
Any unused product should be disposed of in accordance with local requirements.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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