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GEMCITABINE 10MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

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X

784345
120 594
Pantone 533
1430

RegII
120

297

ASSAASASSS

u0itb323.indd 2

07.05.2012 07:53:02

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gemcitabine 10mg/ml concentrate for solution for infusion
Gemcitabine

Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- 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.
In this leaflet:
1. What Gemcitabine is and what it is used for
2. Before you use Gemcitabine
3. How to use Gemcitabine
4. Possible side effects
5. How to store Gemcitabine
6. Further information
1. WHAT GEMCITABINE IS AND WHAT IT IS USED FOR
Gemcitabine belongs to a group of medicines called “cytotoxics”. These medicines
kill dividing cells, including cancer cells.
Gemcitabine may be given alone or in combination with other anti-cancer
medicines, depending on the type of cancer.
Gemcitabine is used either alone or in combination with other drugs in the
treatment of the following types of cancer:
- non-small cell lung cancer (NSCLC)
- pancreatic cancer
- breast cancer
- ovarian cancer
- bladder cancer
2. BEFORE YOU USE GEMCITABINE


You should not be given Gemcitabine:
- if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients
of this medicine.
- if you are breast-feeding.




Take special care with Gemcitabine:
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. 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.
Please tell your doctor if:
- you have, or have previously had liver disease, heart disease or problems with
your veins
- you have problems with your lungs or your kidneys
- you have recently had, or are going to have radiotherapy.
- you have been vaccinated recently (especially against yellow fever)
- you develop breathing difficulties or feel very weak and are very pale (may be
a sign of kidney failure).
- you are pregnant or planning to become pregnant



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.




Pregnancy and breast-feeding
If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use
of Gemcitabine should be avoided during pregnancy. Your doctor will discuss with
you the potential risk of taking Gemcitabine during pregnancy.
If you are breast‑feeding, tell your doctor.
You must discontinue breast‑feeding during Gemcitabine treatment.
Men are advised not to father a child during and up to 6 months following treatment
with Gemcitabine. 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.








Driving and using machines
Gemcitabine 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 Gemcitabine
treatment has not made you feel sleepy.




ASSAASASSS




Important information about some of the ingredients of Gemcitabine
Gemcitabine contains 1.07mg sodium per milliliter (0.05 mmol).This should be
taken into consideration by patients on a controlled sodium diet.

3. HOW TO USE GEMCITABINE
The usual dose of Gemcitabine is 1000‑1250mg 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 infusion depends on the type of
cancer that you are being treated for.
You will always receive Gemcitabine 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 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 infusion which soon passes, however uncommonly or
rarely there can be more severe lung problems).



Side effects with Gemcitabine may include:



Very common side effects
- Low haemoglobin level (anaemia)
- Low white blood cells
- Low platelet count
- Difficulty breathing
- Vomiting
- 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)
- Stroke
- Irregular heart beat (arrhythmia)
- Heart failure
- Serious liver damage, including liver failure and death



Rare side effects
- Heart attack (myocardial infarction)
- Low blood pressure
- Skin scaling, ulceration or blister formation
- Injection site reactions
- Gangrene of fingers or toes
- Radiation recall- (a skin rash like severe sunburn) which can occur on skin that
has previously been exposed to radiotherapy.
- Radiation toxicity- scarring of the air sacs of the lung associated with radiation
therapy
- Fluid in the lungs
- Acute Respiratory Distress Syndrome (severe lung inflammation causing
respiratory failure)
- Inflammation of the blood vessels
- Sloughing of skin and severe skin blistering
- Kidney failure
- Hemolytic uraemic syndrome (a disease characterized by haemolytic anaemia,
acute renal failure and a low platelet count)



Very rare side effects
- Increased platelet count
- Anaphylactic reaction (severe hypersensitivity / allergic reaction)
- Ischaemic colitis (inflammation of the lining of the large bowel, caused by
reduced blood supply)
Potentially life-threatening cutaneous reactions with widespread purpuric macules
and epidermal detachment (Toxic epidermal necrolysis, Stevens-Johnson
Syndrome)
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.

ASSAASASSS







784345–RegII

u0itb323.indd 3

07.05.2012 07:53:02



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
Keep out of the reach and sight of children.
Do not use Gemcitabine after the expiry date which is stated on the carton and
label after EXP. The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
If the solution appears discoloured or contains visible particles, it should be
discarded.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These measures
will help to protect the environment.
6. Further information




What Gemcitabine contains
The active substance is gemcitabine (as hydrochloride).
The other ingredients are: Sodium acetate trihydrate, sodium hydroxide, water for
injects.








What Gemcitabine looks like and contents of the pack
This medicinal product is a concentrate for solution for infusion.
1ml of each vial contains 10mg gemcitabine (as hydrochloride) as active ingredient.
Gemcitabine is a concentrate for solution for infusion and a clear, colourless or
almost colourless solution.
200mg vial: Each vial contains 200mg gemcitabine (as hydrochloride) in 20ml.
500mg vial: Each vial contains 500mg gemcitabine (as hydrochloride) in 50ml.
1000mg vial: Each vial contains 1000mg gemcitabine (as hydrochloride) in 100ml.
It is available in packs containing 1 vial, 5 vials or 10 vials with or without a protective
plastic overwrap (Onco-Safe). The Onco-Safe has no contact with the drug
product and increases safety during transport for medical and pharmaceutical
personnel.
Not all pack sizes may be marketed.



Marketing Authorisation Holder and Manufacturer






Marketing authorisation holder:
EBEWE Pharma Ges.m.b.H. Nfg. KG
4866 Unterach
Austria


Manufacturer:
EBEWE Pharma Ges.m.b.H. Nfg. KG
4866 Unterach
Austria

This leaflet was last approved in 04/2012

PL 14510/0059
----------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
Compatibility with other drugs has not been studied; therefore, it is not
recommended to mix Gemcitabine with other drugs.
Parenteral drugs should be inspected visually for particulate matter and
discolouration, prior to administration, whenever solution and container permit.
Transfer the required quantity of solution under aseptic conditions into a suitable
infusion bag or bottle. The solution may be administered as prepared or further
diluted with 0.9% sodium chloride solution or 5% glucose solution as appropriate.
Mix the liquids thoroughly by rotating by hand.
Handling
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 an isolator or a cytotoxic safety cabinet. Protective
clothing should be used as required (protective coat, gloves, mask, protective
goggles).
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.
Any unused product or waste material should be disposed of in accordance with
local requirements.










Shelf life
As packaged for sale:
30 months
Stability after first opening:
Chemical and physical stability has been demonstrated for 28 days at room
temperature (20°C to 25°C).
From a microbiological point of view, the product should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the
responsibility of the user.
Shelf life after dilution:
Chemical and physical in-use stability has been demonstrated for 28 days at 2 to
8°C and at room temperature (20°C to 25°C) in glucose 5 % or sodium chloride
0.9 % (0.1 mg/ml and 7.5mg/ml).
From a microbiological point of view, the product 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.

u0itb323.indd 4

07.05.2012 07:53:03

X

784346 RegII
148 594
148
Pantone 533
1431

297

ASSAASSAAA

bzxu0sxn.indd 2

07.05.2012 07:47:48

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gemcitabine 10mg/ml concentrate for solution for infusion

ASSAASSAAA

Gemcitabine

ASSAASSAAA

Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- 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.
In this leaflet:
1. What Gemcitabine is and what it is used for
2. Before you use Gemcitabine
3. How to use Gemcitabine
4. Possible side effects
5. How to store Gemcitabine
6. Further information
1. WHAT GEMCITABINE IS AND WHAT IT IS USED FOR
Gemcitabine belongs to a group of medicines called “cytotoxics”. These medicines kill dividing
cells, including cancer cells.
Gemcitabine may be given alone or in combination with other anti-cancer medicines, depending on
the type of cancer.
Gemcitabine is used either alone or in combination with other drugs in the treatment of the following
types of cancer:
- non-small cell lung cancer (NSCLC)
- pancreatic cancer
- breast cancer
- ovarian cancer
- bladder cancer
2. BEFORE YOU USE GEMCITABINE
You should not be given Gemcitabine:
- if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of this medicine.
- if you are breast-feeding.
Take special care with Gemcitabine:
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. 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.
Please tell your doctor if:
- you have, or have previously had liver disease, heart disease or problems with your veins
- you have problems with your lungs or your kidneys
- you have recently had, or are going to have radiotherapy.
- you have been vaccinated recently (especially against yellow fever)
- you develop breathing difficulties or feel very weak and are very pale (may be a sign of kidney
failure).
- you are pregnant or planning to become pregnant
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.
Pregnancy and breast-feeding
If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of Gemcitabine
should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking
Gemcitabine during pregnancy.
If you are breast‑feeding, tell your doctor.
You must discontinue breast‑feeding during Gemcitabine treatment.
Men are advised not to father a child during and up to 6 months following treatment with Gemcitabine.
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.
Driving and using machines
Gemcitabine 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 Gemcitabine treatment has not made you feel sleepy.
Important information about some of the ingredients of Gemcitabine
Gemcitabine contains 1.07mg sodium per milliliter (0.05 mmol).This should be taken into
consideration by patients on a controlled sodium diet.
3. HOW TO USE GEMCITABINE
The usual dose of Gemcitabine is 1000‑1250mg 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 infusion depends on the type of cancer that you are
being treated for.
You will always receive Gemcitabine 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 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
infusion which soon passes, however uncommonly or rarely there can be more severe lung
problems).
Side effects with Gemcitabine may include:
Very common side effects
- Low haemoglobin level (anaemia)
- Low white blood cells
- Low platelet count
- Difficulty breathing
- Vomiting
- 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)
- Stroke
- Irregular heart beat (arrhythmia)
- Heart failure
- Serious liver damage, including liver failure and death
Rare side effects
- Heart attack (myocardial infarction)
- Low blood pressure
- Skin scaling, ulceration or blister formation
- Injection site reactions
- Gangrene of fingers or toes
- Radiation recall- (a skin rash like severe sunburn) which can occur on skin that has previously
been exposed to radiotherapy.
- Radiation toxicity- scarring of the air sacs of the lung associated with radiation therapy
- Fluid in the lungs
- Acute Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure)
- Inflammation of the blood vessels
- Sloughing of skin and severe skin blistering
- Kidney failure
- Hemolytic uraemic syndrome (a disease characterized by haemolytic anaemia, acute renal
failure and a low platelet count)
Very rare side effects
- Increased platelet count
- Anaphylactic reaction (severe hypersensitivity / allergic reaction)
- Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced blood supply)
Potentially life-threatening cutaneous reactions with widespread purpuric macules and epidermal
detachment (Toxic epidermal necrolysis, Stevens-Johnson Syndrome).
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.

784346–RegII

bzxu0sxn.indd 3

07.05.2012 07:47:48

5. HOW TO STORE GEMCITABINE
Keep out of the reach and sight of children.
Do not use Gemcitabine after the expiry date which is stated on the carton and label after EXP. The
expiry date refers to the last day of that month.
Do not refrigerate or freeze.
If the solution appears discoloured or contains visible particles, it should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Gemcitabine contains
The active substance is gemcitabine (as hydrochloride).
The other ingredients are: Sodium acetate trihydrate, sodium hydroxide, water for injects.
What Gemcitabine looks like and contents of the pack
This medicinal product is a concentrate for solution for infusion.
1ml of each vial contains 10mg gemcitabine (as hydrochloride) as active ingredient.
Gemcitabine is a concentrate for solution for infusion and a clear, colourless or almost colourless
solution.
200mg vial: Each vial contains 200mg gemcitabine (as hydrochloride) in 20ml.
500mg vial: Each vial contains 500mg gemcitabine (as hydrochloride) in 50ml.
1000mg vial: Each vial contains 1000mg gemcitabine (as hydrochloride) in 100ml.
It is available in packs containing 1 vial, 5 vials or 10 vials with or without a protective plastic overwrap
(Onco-Safe). The Onco-Safe has no contact with the drug product and increases safety during
transport for medical and pharmaceutical personnel.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
EBEWE Pharma Ges.m.b.H. Nfg. KG
4866 Unterach
Austria

Manufacturer:
EBEWE Pharma Ges.m.b.H. Nfg. KG
4866 Unterach
Austria

This leaflet was last approved in 04/2012
PL 14510/0059
------------------------------------------------------------------------------------------------------------------ The following information is intended for medical or healthcare professionals only:
Compatibility with other drugs has not been studied; therefore, it is not recommended to mix
Gemcitabine with other drugs.
Parenteral drugs should be inspected visually for particulate matter and discolouration, prior to
administration, whenever solution and container permit.
Transfer the required quantity of solution under aseptic conditions into a suitable infusion bag or
bottle. The solution may be administered as prepared or further diluted with 0.9% sodium chloride
solution or 5% glucose solution as appropriate. Mix the liquids thoroughly by rotating by hand.
Handling
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 an isolator or a
cytotoxic safety cabinet. Protective clothing should be used as required (protective coat, gloves,
mask, protective goggles).
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.
Any unused product or waste material should be disposed of in accordance with local requirements.
Shelf life
As packaged for sale:
30 months
Stability after first opening:
Chemical and physical stability has been demonstrated for 28 days at room temperature (20°C to
25°C).
From a microbiological point of view, the product should be used immediately. If not used
immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Shelf life after dilution:
Chemical and physical in-use stability has been demonstrated for 28 days at 2 to 8°C and at room
temperature (20°C to 25°C) in glucose 5 % or sodium chloride 0.9 % (0.1 mg/ml and 7.5mg/ml).
From a microbiological point of view, the product 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.

bzxu0sxn.indd 4

07.05.2012 07:47:48

+ Expand Transcript

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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