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GEMCITABINE MEDAC 38 MG/ML POWDER FOR SOLUTION FOR INFUSION

Active substance(s): GEMCITABINE HYDROCHLORIDE / GEMCITABINE HYDROCHLORIDE / GEMCITABINE HYDROCHLORIDE

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Gemcitabine 38 mg/ml · 90710-VP1GB · AE · 03.15 · Pharma-Code: 750
Format: 592 x 150 mm · HKS 44 · Corrective action: KV01_jte_12.03.15_M / KV02_jte_13.03.15_M / KV03_uma_16.12.16 / KV04_uma_19.12.16

Package leaflet: Information for the user

Gemcitabine
38 mg/ml powder for solution for infusion
Gemcitabine
Read all of this leaflet carefully before you start receiving
this medicine because it contains important information
for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or
nurse.
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor or nurse.
This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Gemcitabine is and what it is used for
2. What you need to know before you are given Gemcitabine
3. How Gemcitabine is given
4. Possible side effects
5. How to store Gemcitabine
6. Contents of the pack and other 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. No
sufficient data are available about the safety and efficacy of
gemcitabine in children.
Gemcitabine 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. What you need to know before you are given
Gemcitabine
You should not be given Gemcitabine:
• if you are allergic to gemcitabine or any of the other
ingredients of this medicine (listed in section 6).
• if you are breast-feeding.
Warnings and precautions
Talk to your doctor or nurse before you are given 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 vascular disease.

• you have recently had, or are going to have radiotherapy.
• you have been vaccinated recently.
• you get symptoms during treatment with this medicine,
such as headache with confusion, seizures (fits) or
changes in vision. This could be a very rare nervous
system side effect named posterior reversible
encephalopathy syndrome.
• you develop breathing difficulties or feel very weak and are
very pale (may be a sign of kidney failure or problems with
your lungs).
• you develop generalised swelling, shortness of breath or
weight gain, this may be a sign of fluid leaking from your
small blood vessels into the tissue.

Children and adolescents
This medicine is not recommended for use in children
under 18 years of age due to insufficient data on safety and
efficacy.
Other medicines and Gemcitabine
Tell your doctor if you are taking, have recently taken or might
take any other medicines.
Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before
you are given this medicine.
The use of Gemcitabine should be avoided during pregnancy.
Your doctor will discuss with you the potential risk of taking
Gemcitabine during pregnancy.
Breast-feeding
If you are breast-feeding, tell your doctor.

You must discontinue breast-feeding during Gemcitabine
treatment.
Fertility
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.
Gemcitabine contains sodium
Gemcitabine contains 3.5 mg (< 1 mmol) of sodium in each
200 mg vial, 17.5 mg (< 1 mmol) sodium in each 1000 mg vial
and 26.3 mg (> 1 mmol) sodium in each 1500 mg vial. To be
taken into consideration by patients on a controlled sodium
diet.
3. How Gemcitabine is given
The usual dose of Gemcitabine 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 infusion

depends on the type of cancer that you are being treated for.
A hospital pharmacist or doctor will have dissolved the
Gemcitabine powder before it is given to you.
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.
You must contact your doctor immediately if you notice
any of the following:
• Temperature of 38ºC or greater, sweating or other signs
of infection (since you might have less white blood cells
than normal accompanied by fever also known as febrile
neutropenia) (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
[thrombocytopenia]) (very common).
• Difficulty breathing (dyspnoea) (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 [pulmonary
oedema/interstitial pneumonitis/adult respiratory distress
syndrome]).
• Shortness of breath, excessive tiredness, leg swelling
(heart failure) (uncommon).
• Extreme tiredness and weakness, small areas of bleeding

The following information is intended for healthcare
professionals only:
Special precautions for disposal and other handling
Reconstitution:
For single use only.
This medicinal product has only been shown to be
compatible with sodium chloride 9 mg/ml (0.9 %) solution
for injection. Accordingly, only this diluent should be
used for reconstitution. Compatibility with other active
substances has not been studied. Therefore, it is not
recommended to mix this medicinal product with other
active substances when reconstituted.
Reconstitution at concentrations greater than 38 mg/ml
may result in incomplete dissolution, and should be
avoided.
To reconstitute, slowly add the appropriate volume of
sodium chloride 9 mg/ml (0.9 %) solution for injection
(as stated in the table below) and shake to dissolve.
Presentation

200 mg

Presentation Reconstituted
Final
volume of
volume
concentration
sodium chloride
9 mg/ml (0.9 %)
solution for
injection to be
added
5 ml
5.26 ml
38 mg/ml

1,000 mg

25 ml

26.3 ml

38 mg/ml

1,500 mg

37.5 ml

39.5 ml

38 mg/ml

The appropriate amount of medicinal product may be
further diluted with sodium chloride 9 mg/ml (0.9 %)
solution for injection.
Parenteral medicinal products should be inspected
visually for particulate matter and discolouration, prior to
administration, whenever solution and container permit.
Any unused solution should be discarded as described
below.
Guidelines for the Safe Handling of Cytotoxic Medicinal
Products:
Local guidelines on safe preparation and handling of
cytotoxic medicinal products must be adhered to.
Cytotoxic preparations should not be handled by pregnant
staff. The preparation of injectable solutions of cytotoxic
agents must be carried out by trained specialist personnel
with knowledge of the medicines used. This should be
performed in a designated area. The work surface should
be covered with disposable plastic-backed absorbent
paper.
Suitable eye protection, disposable gloves, face mask and
disposable apron should be worn. Precautions should be
taken to avoid the medicinal product accidentally coming
into contact with the eyes. If accidental contamination
occurs, the eye should be washed with water thoroughly
and immediately.
Syringes and infusion sets should be assembled carefully
to avoid leakage (use of Luer lock fittings is recommended).
Large bore needles are recommended to minimise pressure
and the possible formation of aerosols. The latter may also
be reduced by the use of a venting needle.
Actual spillage or leakage should be mopped up wearing
protective gloves. Excreta and vomit must be handled with
care.

Gemcitabine 38 mg/ml · 90710-VP1GB · AE · 03.15 · Pharma-Code: 750
Format: 592 x 150 mm · HKS 44 · Corrective action: KV01_jte_12.03.15_M / KV02_jte_13.03.15_M / KV03_uma_16.12.16 / KV04_uma_19.12.16

Disposal:
Adequate care and precaution should be taken in the
disposal of items used to reconstitute this medicinal
product. Any unused dry product or contaminated
materials should be placed in a high-risk waste bag.
Sharp objects (needles, syringes, vials, etc.) should be
placed in a suitable rigid container. Personnel concerned
with the collection and disposal of this waste should be
aware of the hazard involved. Waste material should be
destroyed by incineration. Any unused product or waste
material should be disposed of in accordance with local
requirements.












in the skin (bruises), acute renal failure (low/no urine
output), and signs of infection (haemolytic uraemic
syndrome). It may be fatal (uncommon).
Paralysis of face and extremities (mostly unilateral), visual
disturbances, speech disorders, numbness (stroke)
(uncommon).
Yellowing of skin/whites of eyes, nausea, fatigue,
diarrhoea, mental disorientation (serious liver damage,
including liver failure) (uncommon).
Heart attack, severe chest pain (myocardial infarction)
(rare).
Severe hypersensitivity/allergic reaction with severe skin
rash including red itchy skin, swelling of the hands, feet,
ankles, face, lips, mouth or throat (which may cause
difficulty in swallowing or breathing), wheezing, fast
beating heart and you may feel you are going to faint
(anaphylactoid reaction) (very rare).
Generalised swelling, shortness of breath or weight gain,
as you might have fluid leakage from small blood vessels
into the tissues (capillary leak syndrome) (very rare).
Headache with changes in vision, confusion, seizures or
fits (posterior reversible encephalopathy syndrome) (very
rare).

Side effects with Gemcitabine may include:

90710-VP1GB
AE

Very common: may affect more than 1 in 10 people
• Tiredness, feeling faint, becoming easily breathless or if
you look pale (anaemia)
• Low white blood cells (leukopenia)
• Vomiting
• Nausea
• Allergic skin rash, frequently itchy
• Hair loss (alopecia)
• Liver problems: found through abnormal blood test results

• Blood in urine (haematuria)
• Abnormal urine tests: protein in urine (proteinuria)
• Flu-like symptoms including fever, the most common
symptoms are fever, headache, chills, muscle pain,
weakness and poor appetite. Cough, runny nose,
discomfort, sweating and sleeping difficulties have also
been reported.
• Swelling of ankles, fingers, feet, face (oedema)
Common: may affect up to 1 in 10 people
• Poor appetite (anorexia)
• Headache
• Insomnia
• Sleepiness
• Cough
• Runny nose (rhinitis)
• Constipation
• Diarrhoea
• Pain, redness, swelling or sores in the mouth (stomatitis)
• Itching
• Sweating
• Muscle pain (myalgia)
• Back pain
• Fever
• Weakness (asthenia)
• Chills
Uncommon: may affect up to 1 in 100 people
• Wheeze (bronchospasm)
• Abnormal chest X ray/scan (scarring of the lungs)
• Irregular heart beat (arrhythmia)
• Weakness, shortness of breath, confusion, lethargy
(kidney failure)
• Blood stream infection (sepsis)
• Low red blood cell and low platelet count, small areas of

bleeding in the skin and kidney failure
(thrombotic microangiopathy)

5. How to store Gemcitabine
Keep out of the sight and reach of children.

Rare: may affect up to 1 in 1,000 people
• Low blood pressure (hypotension)
• Severe skin reactions, including scaling and blister
formation
• Ulceration of the skin
• Vesicle and sore formation on the skin
• Scaling of the skin
• Injection site reactions – mainly mild in nature
• Problems with blood flow to the limbs. If it is severe and
lasts a long time, the hands or feet may become dead
and black (gangrene)
• Inflammation of blood vessels (peripheral vasculitis)
• Skin rash like severe sunburn which can occur on skin
that has previously been exposed to radiotherapy
(radiation recall)
• Scarring of the air sacs of the lung associated with
radiation therapy (radiation toxicity)
Very rare: may affect up to 1 in 10,000 people
• Increased platelet count (thrombocytosis)
• Severe rash with itching, blistering or peeling of the skin
(Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Inflammation of the lining of the large bowel, caused by
reduced blood supply (ischaemic colitis)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information
on the safety of this medicine.

Do not use this medicine after the expiry date which is stated
on the carton after EXP.
This medicinal product does not require any special storage
conditions.
Reconstituted solution:
The product should be used immediately. When prepared
as directed, chemical and physical in-use stability of
reconstituted solutions of gemcitabine were demonstrated
for 35 days at 25 °C. Further dilution by a healthcare provider
may be done. Solutions of reconstituted gemcitabine should
not be refrigerated, as crystallisation may occur.
This medicine is for single use only; any unused solution
should be discarded under the local requirements.
6. Contents of the pack and other information
What Gemcitabine contains
• The active substance is gemcitabine. Each vial contains
200, 1000 or 1500 mg of gemcitabine (as gemcitabine
hydrochloride).
• The other ingredients are mannitol (E421), sodium acetate,
hydrochloric acid and sodium hydroxide.
What Gemcitabine looks like and contents of the pack
Gemcitabine is a white to off-white powder, for solution for
infusion in a vial. Each vial contains 200, 1000 or 1500 mg of
gemcitabine. Each pack of Gemcitabine contains 1 vial.

Marketing Authorisation Holder and Manufacturer
medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Tel.:
+49 4103 8006-0
Fax:
+49 4103 8006-100
This medicinal product is authorised in the Member
States of the EEA under the following names:
Czech Republic
Gemcitabine medac 38 mg/ml
prášek pro infuzní roztok
Germany
Gemedac 38 mg/ml Pulver zur
Herstellung einer Infusionslösung
Lithuania
Gemcitabine medac 38 mg/ml
milteliai infuziniam tirpalui
Poland
Gemcitabine medac
Slovak Republic Gemcitabine medac 38 mg/ml
prášok na infúzny roztok
United Kingdom Gemcitabine 38 mg/ml
powder for solution for infusion

This leaflet was last revised in 03/2015.

90710-VP1GB
AE

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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