GEMCITABINA 10 мг/мл Инфузионный раствор

Содержание инструкции

1. Gemcitabina SUN Pharma
   1. What is Gemcitabina SUN Pharma and what it is used for
   2. What you need to know before you are given Gemcitabina SUN Pharma
   3. How Gemcitabina SUN Pharma is administered
   4. Possible side effects
   5. How to store Gemcitabina SUN Pharma
   6. Package contents and other information

Gemcitabina SUN Pharma

10 mg/ml solution for infusion
Generic medicine
Read this leaflet carefully before you start to use this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Gemcitabina SUN Pharma is and what it is used for
• 2. What you need to know before you are given Gemcitabina SUN Pharma
• 3. How Gemcitabina SUN Pharma is given
• 4. Possible side effects
• 5. How to store Gemcitabina SUN Pharma
• 6. Contents of the pack and other information

1. What is Gemcitabina SUN Pharma and what it is used for

Gemcitabina SUN Pharma belongs to a group of medicines called "cytotoxic agents". These medicines
block cell division, including cancer cells.
Gemcitabina SUN Pharma can be administered alone or in combination with other anticancer
drugs, depending on the type of tumor.
Gemcitabina SUN Pharma is used in the treatment of the following types of cancer:

• non-small cell lung carcinoma (NSCLC), alone or in combination with cisplatin
• pancreatic carcinoma
• breast carcinoma, in combination with paclitaxel
• ovarian carcinoma, in combination with carboplatin
• bladder carcinoma, in combination with cisplatin

2. What you need to know before you are given Gemcitabina SUN Pharma

Gemcitabina SUN Pharma must not be given:

• if you are allergic to gemcitabine or to any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding. Warnings and precautionsBefore each infusion, blood samples will be taken to assess whether you have sufficient liver and kidney function. Before each infusion, blood samples will be taken to check that you have enough blood cells to receive Gemcitabina SUN Pharma. The doctor may decide to change the dose or delay treatment depending on your general condition and if the blood cell count (white blood cells and platelets) is found to be inadequate (too low). Periodically, blood samples will be taken to assess whether you have sufficient

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor for advice before using this medicine. The use of Gemcitabina
SUN Pharma during pregnancy should be avoided. The doctor will talk to you about the potential
risk of taking Gemcitabina SUN Pharma during pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding. Breastfeeding must be stopped during treatment with
Gemcitabina SUN Pharma.

Fertility
Men are advised not to father a child during treatment with Gemcitabina SUN Pharma
and for 6 months afterwards. If you wish to father a child during treatment or within 6 months afterwards,
ask your doctor or pharmacist for advice. You should inquire about the methods of sperm preservation
before starting therapy.

Driving and operating machinery
Gemcitabina SUN Pharma may cause drowsiness, especially if you have consumed alcohol. You must not
drive a vehicle or operate machinery until you are sure that treatment with Gemcitabina SUN
Pharma has not caused you drowsiness.

Gemcitabina SUN Pharma contains sodium
One ml of solution for infusion contains 4.575 mg of sodium.
This must be taken into consideration by patients with a low-sodium diet.
Gemcitabina SUN Pharma contains 549.00 mg (23.88 mmol) of sodium in each 120 ml infusion bag, 640.50 mg (27.86 mmol) of sodium in each 140 ml infusion bag, 732.00 mg
(31.84 mmol) of sodium in each 160 ml infusion bag, 777.75 mg (33.83 mmol) of sodium in
each 170 ml infusion bag, 823.50 mg (35.82 mmol) of sodium in each 180 ml infusion bag, 915.00 mg (39.80 mmol) of sodium in each 200 ml infusion bag, 1006.50 mg
(43.78 mmol) of sodium in each 220 ml infusion bag.

3. How Gemcitabina SUN Pharma is administered

The recommended dose of Gemcitabina SUN Pharma is generally 1,000-1,250 mg per square
meter of body surface area. Your height and weight will be measured to calculate your body
surface area. Your doctor will use this body surface area to calculate the right dose for you. This dose may
be adjusted or treatment may be delayed depending on your blood tests and your
overall condition.
How often you receive the Gemcitabina SUN Pharma infusion depends on the type of cancer for
which you are being treated.
You will always receive Gemcitabina SUN Pharma as an infusion into a vein. The infusion will last about 30 minutes.
If you have any questions about using this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You must contact your doctor immediately if you notice any of the following:
Extreme fatigue and weakness, purpura or small areas of bleeding under the skin (bruising),
acute kidney failure (poor urine production or no urine production) and signs of infection. These
may be characteristics of thrombotic microangiopathy (blood clots forming in small blood
vessels) and hemolytic uremic syndrome, which can be fatal.

Serious side effects
You should immediately contact your doctor if you notice any of the following serious side effects:
Very common:may affect more than 1 in 10 people

• allergic reaction: if you develop a skin rash or fever
• fatigue, feel faint, feel short of breath easily or are pale (as you may have less hemoglobin than normal)
• bleeding from the gums, nose or mouth or any bleeding that does not tend to stop, reddish or slightly pink urine, unexplained bruising (as you may have fewer platelets than normal).

Common:may affect up to 1 in 10 people

• temperature of 38°C or higher, sweating or other signs of infection (as you may have fewer white blood cells than normal with fever, also known as febrile neutropenia)
• pain, redness, swelling or sores in the mouth (stomatitis)
• allergic reaction: if you develop itching
• mild difficulty breathing (mild difficulty breathing is common immediately after infusion with Gemcitabina SUN Pharma and passes quickly). Uncommon:may affect up to 1 in 100 people
• difficulty breathing due to more serious lung problems (interstitial pneumonia, bronchospasm)
• irregular heartbeat (arrhythmia). Rare:may affect up to 1 in 1,000 people
• difficulty breathing due to more serious lung problems (pulmonary edema, syndrome of

respiratory distress of the adult)

• severe chest pain (myocardial infarction).

Very rare:may occur in less than 1 in 10,000 people

• severe hypersensitivity/allergic reaction with severe skin rash including the appearance of red streaks on the skin, swelling of the hands, feet, ankles, face, lips, mouth or throat (which can cause difficulty swallowing or breathing), wheezing, rapid heartbeat and feeling like you are going to faint (anaphylactic reaction)
• generalised swelling, shortness of breath or weight gain, as you may have leakage of fluid from small blood vessels into tissues (capillary leak syndrome)
• headache with vision disturbances, confusion, seizures or convulsions (reversible posterior encephalopathy syndrome)
• severe skin rash with itching, with the appearance of blisters or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects
Tell your doctor as soon as possible if you notice any of the following side effects:
Very common:may affect more than 1 in 10 people

• low number of white blood cells
• difficulty breathing
• vomiting
• nausea
• hair loss
• liver problems: detected by abnormal blood test results
• blood in urine
• abnormal urine tests: protein in urine
• flu-like symptoms including fever
• swelling of the ankles, hands, feet and face (edema). Common:may affect up to 1 in 10 people
• poor appetite (anorexia)
• headache
• insomnia
• drowsiness
• cough
• runny nose
• constipation
• diarrhoea
• itching
• sweating
• muscle pain
• back pain
• fever
• weakness
• chills
• infections. Uncommon:may affect up to 1 in 100 people
• scarring of air sacs in the lung (interstitial pneumonitis)
• wheezing (bronchospasm)
• scarring of the lungs (altered chest X-ray/scan)
• heart failure
• kidney failure
• serious liver damage, including liver failure
• stroke (cerebrovascular accident). Rare:may affect up to 1 in 1,000 people
• low blood pressure
• skin peeling, ulceration or blistering rash
• shedding of skin and severe blistering of the skin
• reactions at the injection site
• skin rash similar to a severe sunburn that can occur in areas of skin previously exposed to radiation therapy (radiation recall phenomena)
• fluid in the lungs
• scarring of air sacs in the lung associated with radiation therapy (radiation toxicity)
• gangrene of the fingers of the hands or feet
• inflammation of blood vessels (peripheral vasculitis).

Very rare:may occur in less than 1 in 10,000 people

• increased number of platelets
• inflammation of the lining of the colon, caused by reduced blood supply (ischemic colitis)
• blood clots forming in small blood vessels (thrombotic microangiopathy). Not known (frequency cannot be estimated from available data):
• sepsis: when bacteria and their toxins circulate in the blood and begin to damage organs
• redness of the skin with swelling (pseudocellulitis). Low levels of hemoglobin (anemia), white blood cells and platelets will need to be detected with a blood test.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Gemcitabina SUN Pharma

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 on the
outer packaging. The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions. Do not refrigerate or
freeze

After opening the infusion bag:
From a microbiological point of view, the solution must be used immediately. If it is not used
immediately, the storage time during use and the conditions prior to use are the responsibility
of the user.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Gemcitabina SUN Pharma 10 mg /ml solution for infusion contains

• The active ingredient is: gemcitabine (as hydrochloride).
• The other ingredients are: sodium chloride, water for injections, sodium hydroxide and/or hydrochloric acid (to adjust the pH). Each infusion bag of 120 ml contains 1200 mg of gemcitabine (as hydrochloride) Each infusion bag of 140 ml contains 1400 mg of gemcitabine (as hydrochloride) Each infusion bag of 160 ml contains 1600 mg of gemcitabine (as hydrochloride) Each infusion bag of 170 ml contains 1700 mg of gemcitabine (as hydrochloride) Each infusion bag of 180 ml contains 1800 mg of gemcitabine (as hydrochloride) Each infusion bag of 200 ml contains 2000 mg of gemcitabine (as hydrochloride) Each infusion bag of 220 ml contains 2200 mg of gemcitabine (as hydrochloride) One ml of solution for infusion contains 10 mg of gemcitabine. One ml of solution for infusion contains 4.575 mg of sodium.

Description of the appearance of Gemcitabina SUN Pharma solution for infusion and contents of the pack
Gemcitabina SUN Pharma solution for infusion is a clear, colorless, sterile solution, free from
visible particles.
Gemcitabina SUN Pharma solution for infusion is packaged in cardboard boxes each
containing 1, 5 or 10 single-use infusion bags of 120 ml, 140 ml, 160 ml, 170 ml, 180 ml, 200 ml
or 220 ml, respectively.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Representative for Italy:
Ranbaxy Italia S.p.A. – Viale Giulio Richard, 1 – 20143 Milano

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
Belgium: Gemcitabine SUN 10 mg/ml oplossing voor infusie
Gemcitabine SUN 10 mg/ml solution pour perfusion
Gemcitabin SUN 10 mg/ml Infusionslösung
Denmark: Gemcitabin SUN 10 mg/ml infusionsvæske, opløsning
Finland: Gemcitabin SUN 10 mg/ml infuusioneste, liuos
France: Gemcitabine SUN 10 mg/ml solution pour perfusion
Germany: Gemcitabin SUN 10 mg/ml Infusionslösung
Italy: Gemcitabina SUN Pharma
Norway: Gemcitabin SUN 10 mg/ml infusjonsvæske, oppløsning
Netherlands: Gemcitabine SUN 1200/1400/1600/1700/1800/2000/2200 mg oplossing voor
infusie
Poland: Gemcitabine SUN
Czech Republic: Gemcitabin SUN 10 mg/ml infuzní roztok
Romania: Gemcitabina SUN 10 mg/ml soluţie perfuzabilă
United Kingdom: Gemcitabine 10 mg/ml solution for infusion
Slovakia: Gemcitabín SUN 10 mg/ml infúzny roztok
Spain: Gemcitabina SUN 10 mg/ml solución para perfusión
Sweden: Gemcitabin SUN 10 mg/ml infusionsvätska, lösning

The following information is intended exclusively for healthcare professionals
Instructions for use, handling and disposal
Handling

• Calculate the dose and decide which size of Gemcitabina SUN Pharma infusion bags is needed. If the required dose cannot be obtained with the available pack sizes, the use of an alternative gemcitabine product is recommended, including gemcitabine as a concentrate or gemcitabine as a powder for solution for infusion.
• Check the product packaging for any damage. Do not use if there are signs of tampering.
• Apply a patient-specific label to the packaging.

Removal from the packaging and inspection of the infusion bag

• Tear the packaging at the notch. Do not use if the packaging has been previously opened or damaged.
• Remove the infusion bag from the packaging.
• Use only if the infusion bags and seal are intact.
• Before administration, check for any small leaks by firmly squeezing the bag. If leaks are detected, discard the bag and solution as sterility may be compromised.
• Parenteral medicines should be visually inspected before administration for the presence of particles and discoloration. Do not use if particles are observed. Administration
• Break the seal of the Minitulipe cap by applying pressure on one side with your hand.
• Using aseptic technique, connect the sterile administration set.
• Refer to the instructions 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 for use and must not be mixed with other medicines.
• After opening the infusion bag:From a microbiological point of view, the solution must be used immediately. If not used immediately, the storage time during use and the conditions prior to use are the responsibility of the user.
• Gemcitabine solution for infusion is for single use only.

Personnel must be equipped with appropriate material for handling, in particular long-sleeved gowns, protective masks, headgear, protective goggles, sterile disposable gloves, protective covers for the work area, containers and bags for waste collection.
Pregnant women should be warned to avoid handling cytotoxic agents.
If the preparation comes into contact with the eyes, it may cause severe irritation. The eyes should be
washed immediately and thoroughly with water. If irritation persists, a
doctor should be consulted. If the solution comes into contact with the skin, wash thoroughly with water. The
secretions and vomit must be handled with caution.
Disposal
Unused medicine and waste derived from such medicine must be disposed of in accordance with
local regulations for cytotoxic medicinal products.