GEMSOL 40 мг/мл Концентрат для инфузионного раствора

Содержание инструкции

1. Gemsol 40 mg/ml concentrate for solution for infusion
   1. What is Gemsol and what is it used for
   2. What you need to know before using Gemsol
   3. How to use Gemsol
   4. Possible side effects
   5. How to store Gemsol
   6. Contents of the pack and other information

Gemsol 40 mg/ml concentrate for solution for infusion

Gemcitabine

Read this leaflet carefully before using 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.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

• 1. What Gemsol is and what it is used for
• 2. What you need to know before using Gemsol
• 3. How to use Gemsol
• 4. Possible side effects
• 5. How to store Gemsol
• 6. Contents of the pack and other information

1. What is Gemsol and what is it used for

Gemsol belongs to a group of medicines called “cytotoxics”. These drugs kill the
cells that are dividing, including cancer cells.
Gemsol can be given alone or in combination with other anticancer medicines,
depending on the type of cancer.
Gemsol is used for the treatment of the following types of cancer:

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

2. What you need to know before using Gemsol

Do not use Gemsol:

• if you are allergic to gemcitabine or any of the other ingredients of this medicine (listed in section 6)
• if you are breastfeeding.

Warnings and precautions
Before the first infusion, blood tests will be performed to check if your
liver and kidneys are functioning well enough for this medicine to be
administered to you. Before each infusion, blood tests will be performed to
check that you have enough cells in your blood to receive Gemsol. The doctor may
decide to change the dose or delay treatment depending on your
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general condition and if the blood count (white blood cells and platelets) is too low. Periodically
blood tests will be performed to assess how well your kidneys and
liver are functioning.
Talk to your doctor, pharmacist or nurse before using Gemsol if:

• you have or have had liver, heart or vascular diseases
• you have problems with your lungs or kidneys because it may not be suitable for treatment with Gemsol
• you have recently undergone or are about to undergo radiotherapy, as early or late radiation reactions may occur with the use of Gemsol
• you have recently been vaccinated (especially against yellow fever), as this may cause adverse effects with the use of Gemsol
• you develop difficulty breathing or feel very weak and are very pale as this may be a sign of kidney failure or lung problems
• you experience generalized swelling, shortness of breath or weight gain as these may be signs related to the leakage of fluid from blood vessels into the tissue
• you experience symptoms such as headache with confusion, seizures (fits) or changes in vision. This could be a very rare side effect of the nervous system called posterior reversible encephalopathy syndrome
• you are pregnant or planning a pregnancy
• you experience pain at the infusion site or any other symptom associated with extravasation (reactions at the injection site such as swelling, redness or localized heat). If you experience symptoms such as headache with confusion, seizures (fits) or changes in vision during treatment with this medicine, seek medical attention immediately. This could be a very rare side effect of the nervous system called posterior reversible encephalopathy syndrome.

Children and adolescents
This medicine is not recommended for use in children under 18 years of age due to
lack of data regarding efficacy and safety.

Other medicines and Gemsol
Tell your doctor or hospital pharmacist if you are taking or have recently taken or
may take any other medicines, including those obtained without a prescription and
vaccinations.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding with breast milk, ask your doctor for advice before taking this medicine.
Pregnancy
If you are pregnant or planning a pregnancy, tell your doctor. The use of
Gemsol should be avoided during pregnancy. The doctor will discuss with you the potential
risk associated with the use of Gemsol during pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding.
Breastfeeding should be discontinued during therapy with Gemsol.
Fertility
Men are advised not to father a child during treatment with Gemsol and for 6
months afterwards. If you wish to father a child during treatment or within 6 months afterwards,
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ask your doctor or pharmacist for advice. It may be advisable to consult about
methods of sperm preservation before starting therapy.

Driving and operating machinery
Gemsol may cause drowsiness, especially when combined with alcohol. Do not drive
vehicles or operate machinery until you are sure that treatment with Gemsol does not
cause you drowsiness.

3. How to use Gemsol

The normal dosage of Gemsol ranges from 1000 to 1250 mg per each square meter of your body surface area. To calculate the body surface area, your weight and height will be measured. The doctor will use this data to calculate the most suitable dosage. This dosage may be adjusted or treatment delayed, depending on your blood count and your general condition. The frequency with which you will receive the Gemsol infusion depends on the type of tumor for which you are being treated. You will always receive Gemsol only after dilution, by infusion into a vein. The infusion will last approximately 30 minutes. If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you notice any of the following symptoms contact your doctor immediately:

• bleeding from gums, nose or mouth or any bleeding that does not stop, reddish or pinkish urine, unusual bruising (you may have fewer platelets than normal, a very common situation)
• fatigue, feeling faint, shortness of breath or paleness (you may have fewer red blood cells than normal, a very common situation)
• mild to moderate skin rashes (very common)/itching (common) or fever (very common) (allergic reactions)
• a temperature of 38°C or higher, sweating or other signs of infection (you may have fewer white blood cells than normal, accompanied by fever a common condition known as febrile neutropenia) (common)
• pain, redness, swelling or ulcers in the mouth (stomatitis) (common)
• irregular heartbeat (arrhythmia) (uncommon)
• extreme fatigue and weakness, purpura or small areas of bleeding under the skin (bruising), acute kidney failure (decreased urine production or no urine) and signs of infection. This can be fatal (uncommon)
• difficulty breathing (mild difficulty breathing is very common immediately after the infusion of Gemsol, which however passes quickly, although more serious lung problems can occur, although not commonly or rarely).
• severe chest pain (myocardial infarction) (rare)
• severe hypersensitivity/allergic reactions associated with the development of severe skin rashes including itchy red skin, swelling of the hands, feet, ankles, face,

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of the lips, mouth or throat (which can cause difficulty swallowing or breathing), wheezing, increased heartbeat and may feel faint
(anaphylactic reaction) (very rare).

• widespread swelling, shortness of breath or weight gain, this may be a sign of leakage of fluid from small blood vessels into tissues (capillary leak syndrome) (very rare)
• headache with changes in vision, confusion, seizures (reversible posterior encephalopathy syndrome) (very rare)
• severe skin rash with itching, blistering and peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare)
• extreme fatigue and weakness, purpura or small areas of bleeding under the skin (bruising), acute kidney failure (decreased urine production or no urine) 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.

Other side effects with Gemsol may include the following
Very common side effects(may affect more than 1 in 10 people)

• Low white blood cell count
• Vomiting
• Nausea
• Hair loss
• Liver problems, detected by abnormal blood test results
• Blood in urine
• Abnormal urine test results: protein in urine
• Flu-like symptoms, including fever
• Swelling of ankles, fingers, feet and face (edema)

Common side effects(may affect up to 1 in 10 people)

• Loss of appetite (anorexia)
• Headache
• Difficulty sleeping
• Drowsiness
• Cough
• Runny nose
• Constipation
• Diarrhea
• Itching
• Sweating
• Muscle pain
• Back pain
• Fever
• Weakness
• Chills
• Increased liver values (bilirubin)
• Infections

Uncommon side effects(may affect up to 1 in 100 people)

• Scarring of the air sacs in the lung (interstitial pneumonia)
• Dyspnea (bronchospasm)

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• Scarring of the lungs (abnormal chest X-rays/scans)
• Stroke
• Heart failure
• Kidney failure
• Severe liver damage, including liver failure and death

Rare side effects(may affect up to 1 in 1000 people)

• Low blood pressure
• Peeling, ulceration or blistering of the skin
• Detachment of the skin and severe blistering under the skin
• Reactions at the injection site
• Severe inflammation of the lungs that can cause respiratory failure (acute respiratory distress syndrome)
• Skin rash similar to a severe sunburn that can occur on previously irradiated skin (radiation recall phenomenon)
• Fluid in the lungs
• Scarring of the air sacs in the lungs associated with radiation therapy (radiation toxicity)
• Gangrene of the fingers of the hands or feet
• Inflammation of blood vessels
• Increased liver values (GGT)

Very rare side effects(may affect up to 1 in 10,000 people)

• Increased platelet count
• Inflammation of the lining of the large intestine, caused by reduced blood supply (ischemic colitis)
• Thrombotic microangiopathy: blood clots forming in small blood vessels

Not known (frequency cannot be estimated from available data)

• sepsis: when bacteria and their toxins circulate in the blood and begin to damage organs
• Pseudocellulitis: redness of the skin with swelling

Low level of hemoglobin (anemia), low lymphocyte count and change in platelet count on blood tests.
Any or more of these symptoms and/or conditions may occur. When you begin to experience
any of these side effects, you should inform your doctor as soon as possible.
If any side effect bothers you, consult your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly through the national reporting
system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you
can help provide more information on the safety of this medicine.

5. How to store Gemsol

Keep this medicine out of sight and reach of children.
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Do not use Gemsol after the expiry date, which is stated on the packaging and label, after
the wording EXP. The expiry date refers to the last day of the month.
The hospital pharmacy must store Gemsol vials at 2-8°C. Do not freeze.
If stored below 2 ° C, the solution may form precipitates.
If the solution appears discolored or contains visible particles, it must be discarded.
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. Contents of the pack and other information

What Gemsol contains
The active substance is gemcitabine (as hydrochloride).
Each ml of concentrate for solution for infusion contains 40 mg of gemcitabine (as
hydrochloride)
Each vial of 5 ml contains 200 mg of gemcitabine (as hydrochloride)
Each vial of 25 ml contains 1000 mg of gemcitabine (as hydrochloride)
Each vial of 50 ml contains 2000 mg of gemcitabine (as hydrochloride)
The other ingredients are: water for injections and dilute hydrochloric acid (for the adjustment of
pH).

Description of the appearance of Gemsol and contents of the pack
This medicinal product is a concentrate for solution for infusion.
The concentrate is a clear solution, from colourless to pale yellow, in glass vials
colourless (type I) closed with grey rubber stoppers in accordance with Ph.Eur (type I). The vials are
sealed with or without a protective plastic wrapper (Onco-Safe). “Onco-Safe” does not come into
contact with the medicinal product and guarantees additional protection for transport, which increases
safety for medical and pharmaceutical personnel.
Packs:
200mg/5ml: 1 vial, 5 vials, 10 vials
1000mg/25ml: 1 vial
2000 mg/50ml: 1 vial
Not all pack sizes may be marketed

Marketing Authorisation Holder
Sandoz Spa
Largo U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturer
EBEWE Pharma Ges.m.b.H. Nfg. KG
4866 Unterach
Austria
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This medicinal product has been authorised in the member states of the EEA with the following
denominations:
Austria Gemsol 40 mg/ml Konzentrat zur
Herstellung einer Infusionslösung
Belgium Gemcitabin Sandoz 40 mg/ml concentrate
for solution for infusion
Bulgaria ГЕМСОЛ 40 MG/ML КОНЦЕНТРАТ ЗА
ИНФУЗИОНЕН РАЗТВОР
Cyprus Gemsol 40 mg/ml Πυκνό dιάλυµa γιa
paρasκeυή dιaλύµatος pρος έγχυση
Czech
Republic
Gemcitabin Ebewe 40mg/ml
Denmark Gemcitabin “Sandoz”
Estonia Gemsol 40 mg/ml
Finland Gemcitabin Sandoz 40 mg/ml
infuusiokonsentraatti, liuosta varten
France GEMCITABINE SANDOZ 40 mg/ml solution à
diluer pour perfusion
Greece GEMLIQUID 40 mg/ml πυκνό διάλυµα για
παρασκευή διαλύματος προς έγχυση
Italy GEMSOL
Lithuania Gemsol 40 mg/ml koncentratas infuziniam
tirpalui
Luxembourg Gemcitabin Sandoz 40mg/ml solution à
diluer pour perfusion
Latvia Gemsol 40 mg/ml koncentrāts infūziju
šķīduma pagatavošanai
Netherlands Gemcitabine Sandoz 40mg/ml, concentraat
voor oplossing voor infusie
Norway Gemcitabin Sandoz 40mg/ml konsentrat til
infusjonsvæske, oppløsning
Poland GEMSOL 40 MG/ML, KONCENTRAT DO
SPORZĄDZANIA ROZTWORU DO INFUZJI
Romania Gemsol 40 mg/ml concentrat pentru soluţie
perfuzabilă
Sweden Gemcitabin Sandoz 40 mg/ml koncentrat till
infusionsvätska, lösning
Slovenia Gemcitabin Ebewe 40 mg/ml koncentrat za
raztopino za infundiranje
Slovak
Republic
Gemliquid 40 mg/ml
----------------------------------------------------------------------------------------------------------The
following information is intended exclusively for healthcare professionals:
Compatibility with other medicinal products has not been studied, it is therefore recommended not to mix
Gemsol with other medicinal products.
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Parenteral medicinal products should be visually inspected before
administration for the presence of suspended particles and discoloration, when the solution and
container permit.
Transfer aseptically the required amount of solution into a suitable bag or bottle
for infusion. The solution must be further diluted with 0.9% sodium chloride solution or 5% glucose solution, as appropriate. Mix the
liquids thoroughly by manual rotation.
Handling
During the preparation and disposal of the infusion solution, normal safety precautions for
cytostatic agents must be observed. Handling of the
infusion solution must be carried out in an isolator or in a cytotoxic safety
cabinet. Protective clothing must be used as needed (protective gown, gloves, mask, protective
glasses).
If the preparation comes into contact with the eyes, it can cause serious irritation. The eyes
must be rinsed immediately and thoroughly with water. If the irritation
persists, a doctor should be consulted. If the solution is spilled on the skin, wash
thoroughly with water.
Remaining medicinal product, as well as all materials that have been used for the
reconstitution, dilution and administration, must be destroyed according to
standard hospital procedures applicable to cytotoxic drugs and in accordance with local regulations
regarding the disposal of hazardous waste.
Shelf life

Intact vials:2 years
Stability after first opening
Chemical and physical stability has been demonstrated for 28 days at 2-8°C and at room temperature
(15-25°C).
From a microbiological point of view, this product must be used immediately,
otherwise the time and conditions of storage are the responsibility of the user
and generally do not exceed 24 hours at 2-8°C, unless the opening has taken place
under controlled and validated aseptic conditions.
Shelf life after dilution
Chemical and physical stability in use has been demonstrated for 28 days at 2-8°C and at room
temperature in a 5% glucose solution or 0.9% sodium chloride solution (1.0 mg/ml, 7.0
mg/ml and 25 mg/ml).
From a microbiological point of view, this product must be used immediately,
otherwise the time and conditions of storage in use are the responsibility
of the user and generally do not exceed 24 hours at 2-8°C, unless the dilution has
taken place under controlled and validated aseptic conditions.
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