Gemcitabine Aurovitas Spain 1000 mg concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Gemcitabine Aurovitas Spain 1,000 mg concentrate for solution for infusion

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Gemcitabine Aurovitas Spain is and what it is used for

Gemcitabine Aurovitas Spain belongs to a group of medicines called "cytotoxic agents". These medicines destroy cells that are dividing, including cancer cells.

Gemcitabine may be given alone or in combination with other anticancer medicines, depending on the type of cancer.

Gemcitabine is used to treat 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 starting to use Gemcitabine Aurovitas Spain

Do not use Gemcitabine Aurovitas Spain

• 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 precautions

Before the first infusion, blood samples will be taken to check whether your liver and kidneys are functioning well enough for you to receive this medicine. Likewise, before each infusion, blood samples will be taken to check whether you have enough red blood cells to receive gemcitabine. Your doctor may decide to adjust the dose or delay treatment depending on your general condition and if your blood cell counts are too low. Blood samples will be taken periodically to monitor how well your kidneys and liver are working.

Consult your doctor, nurse, or hospital pharmacist before starting to use this medicine.

If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking gemcitabine.

If you have or have previously had liver, heart, blood vessel disease, or kidney problems, consult your doctor or hospital pharmacist, as you may not be able to receive gemcitabine.

Inform your doctor if you have recently received, or are scheduled to receive, radiotherapy, as gemcitabine may cause an early or delayed radiation reaction.

Inform your doctor if you have recently been vaccinated, as this may cause adverse effects when combined with gemcitabine.

If during treatment with this medicine you experience symptoms such as headache with confusion, seizures, or changes in vision, consult your doctor immediately. This could be a very rare nervous system adverse reaction called reversible posterior encephalopathy syndrome.

Inform your doctor if you develop difficulty breathing or feel very weak and look very pale, as this may be a sign of kidney failure or lung problems.

Inform your doctor if you experience generalized swelling, shortness of breath, or weight gain, as these may be signs of fluid leakage from your smallest blood vessels into your tissues.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis (AGEP), have been reported in association with gemcitabine treatment. Seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Children and adolescents

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

Other medicines and Gemcitabine Aurovitas Spain

Inform your doctor or hospital pharmacist if you are taking, have recently taken, or might need to take any other medicines, including vaccines and over-the-counter medicines, or if you have received or are scheduled to receive radiotherapy.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Gemcitabine use during pregnancy should be avoided. Your doctor will discuss with you the potential risks of using gemcitabine during pregnancy. Women of childbearing potential must use an effective method of contraception during treatment with gemcitabine and for 6 months after the last dose.

Breastfeeding

Inform your doctor if you are breastfeeding.

You must stop breastfeeding during treatment with gemcitabine.

Fertility

Men are advised not to father a child during treatment with gemcitabine and for 3 months after treatment ends. If you wish to father a child during treatment or within 3 months after treatment, seek advice from your doctor or pharmacist. You may request information about sperm preservation before starting treatment.

Driving and use of machines

Gemcitabine may cause drowsiness.

Do not drive or operate machinery until you are sure that treatment with gemcitabine does not cause drowsiness.

3. How to use Gemcitabina Aurovitas Spain

The recommended dose of gemcitabine is 1,000–1,250 mg per square meter of your 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 determine the correct dose for you. This dose may be adjusted or the treatment may be delayed depending on your general health and your blood cell counts.

The frequency with which you receive your gemcitabine infusion depends on the type of cancer for which you are being treated.

A hospital pharmacist or a doctor will have diluted the Gemcitabina Aurovitas Spain concentrate before administration.

You will always receive this medicine as an intravenous infusion into one of your veins. The infusion will last approximately 30 minutes.

Use of this medicine is not recommended in children under 18 years of age.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

You must contact your doctor immediately if you notice any of the following effects:

• Bleeding from gums, nose or mouth, or any bleeding that does not stop, red or pink urine, unexpected bruising (because you may have lower than normal platelet counts, which is very common).
• Tiredness, feeling faint, shortness of breath, or paleness (because you may have lower than normal hemoglobin levels, which is very common).
• Allergic reactions: mild or moderate skin rash (very common), itching (common), or fever (very common).
• Temperature of 38°C or higher, sweating, or other signs of infection (because you may have lower than normal white blood cell counts accompanied by fever, also known as febrile neutropenia) (common).
• Pain, redness, swelling, or sores in the mouth (stomatitis) (common).
• Irregular heartbeat (arrhythmia) (uncommon).
• Severe weakness and fatigue, purpura or small areas of bleeding under the skin (bruising), acute kidney failure (low urine output or no urine output), and signs of infection (hemolytic uremic syndrome). This may be fatal (uncommon).
• Difficulty breathing (it is common to experience mild shortness of breath shortly after gemcitabine infusion, which quickly resolves; however, more serious lung problems may occur uncommonly or rarely).
• Severe chest pain (myocardial infarction) (rare).
• Severe allergic/hypersensitivity reaction, with severe skin rash including redness and itching of the skin, swelling of hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing), wheezing, rapid heartbeat (tachycardia), and feeling faint (anaphylactic reaction) (very rare).
• Generalized swelling, shortness of breath, or weight gain, because you may have leakage of fluid from your smallest blood vessels into your tissues (capillary leak syndrome) (very rare).
• Headache with changes in vision, confusion, seizures or epileptic fits (reversible posterior encephalopathy syndrome) (very rare).
• Severe rash with itching, blistering or peeling of the skin, often accompanied by flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare).
• Extreme tiredness and weakness, purpura or small areas of bleeding under the skin (bruising), acute kidney injury (low urine output or no urine output), and signs of infection. These may be signs of thrombotic microangiopathy (clotting in small blood vessels) and hemolytic uremic syndrome, which may be fatal.
• Generalized red, scaly rash with inflamed bumps under the skin (including skin folds, trunk, and upper limbs), and blisters accompanied by fever (Acute Generalized Exanthematous Pustulosis [AGEP]) (frequency not known).

Other adverse effects with gemcitabine may include:

Very common adverse effects (may affect more than 1 in 10 people)

Low white blood cell count

Shortness of breath

Vomiting

Nausea

Hair loss

Liver problems: detected through abnormal blood test results

Blood in urine

Abnormal urine tests: protein in urine

Pseudoinfluenza syndrome including fever

Swelling of ankles, fingers, feet, face (edema)

Low hemoglobin levels (anemia)

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

Loss of appetite (anorexia)

Headache

Insomnia

Drowsiness

Cough

Stuffy nose

Constipation

Diarrhea

Itching

Sweating

Muscle pain

Back pain

Fever

Weakness

Chills

Infections

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

Hardening of the walls of lung alveoli (interstitial pneumonitis)

Wheezing (spasm of the airways)

Hardening of the lung walls (abnormal chest X-ray/scan)

Heart failure

Kidney failure

Severe liver damage, including liver failure, which could potentially be fatal

Stroke (cerebral infarction)

Rare adverse effects (may affect up to 1 in 1,000 people)

Low blood pressure

Skin peeling, ulceration, or blistering

Severe skin peeling and blistering

Injection site reactions

Severe lung inflammation causing respiratory failure (adult respiratory distress syndrome)

Sunburn-like skin rash, which may occur in skin previously exposed to radiotherapy (late skin toxicity)

Fluid in the lungs

Hardening of the walls of lung alveoli associated with radiotherapy (radiation-associated toxicity)

Gangrene of fingers or toes

Inflammation of blood vessels (peripheral vasculitis)

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

Increased platelet count

Inflammation of the lining of the large intestine due to reduced blood supply (ischemic colitis)

Blood tests may reveal low hemoglobin levels (anemia), low white blood cell count, and low platelet count.

Thrombotic microangiopathy: blood clots forming in small blood vessels.

Frequency not known (cannot be estimated from available data)

Sepsis: when bacteria and their toxins circulate in your blood and begin to damage organs.

Pseudocellulitis: redness of the skin with swelling.

You may experience any of these symptoms and/or conditions. You should inform your doctor as soon as possible if you develop any of these adverse effects.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gemcitabine Aurovitas Spain

Keep this medicine out of the sight and reach of children.

Unopened container

Store in a refrigerator (between 2°C and 8°C).

After first opening:

Physical and chemical stability in use has been demonstrated for 28 days at 25°C.

From a microbiological standpoint, unless the opening method prevents the risk of microbiological contamination, the product should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user.

Infusion solution:

Chemical and physical stability in use has been demonstrated for 28 days at 2°C–8°C and at approximately 25°C after dilution in 0.9% sodium chloride solution to a final concentration within the range of 2 to 25 mg/ml (2.0 mg/ml, 12 mg/ml, and 25 mg/ml). Diluted solutions are stable when stored in PVC or PE infusion bags.

From a microbiological standpoint, the infusion solution should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2°C–8°C, unless dilution has taken place under controlled, validated aseptic conditions.

Do not use this medicine after the expiry date stated on the vial and the outer carton after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if particles are observed.

6. Contents of the container and other information

Composition of Gemcitabina Aurovitas Spain

• The active substance is gemcitabine (as gemcitabine hydrochloride). Each ml of concentrate for infusion solution contains 40 mg of gemcitabine (as gemcitabine hydrochloride).

Each 25 ml vial contains 1,000 mg of gemcitabine (as gemcitabine hydrochloride).

• The other components are hydrochloric acid (E-507) for pH adjustment and water for injections.

Appearance of the product and contents of the container

Gemcitabina Aurovitas Spain concentrate for infusion solution is a clear, colourless or pale yellow solution.

Gemcitabina Aurovitas Spain is supplied in a colourless type I glass vial with a rubber stopper and sealed with an aluminium cap and a polypropylene disc. The vial may be packaged with or without a protective plastic overwrap.

Pack size

1 vial of 25 ml

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana, FRN 1914
Malta

Manufacturer

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Or

Generis Farmacêutica, S.A.
Rua João de Deus, nº 19, Venda Nova
2700-487 Amadora
Portugal

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

Date of the most recent review of this leaflet: December 2023

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only:

Instructions for use

Gemcitabina Aurovitas Spain 1,000 mg concentrate for infusion solution

Cytotoxic

Handling

Standard safety precautions for cytotoxic agents should be observed when preparing or disposing of the infusion solution. Pregnant healthcare personnel should not handle this product. The solution should be manipulated in a safety cabinet and protective gowns and gloves should be worn. If a safety cabinet is not available, protective equipment should also include a face mask and safety goggles.

If the product comes into contact with the eyes, severe irritation may occur. Immediately rinse the eyes thoroughly with plenty of water. Consult a physician if irritation persists. If the solution contacts the skin, wash the affected area thoroughly with copious amounts of water.

Dilution instructions

The only approved diluent for Gemcitabina Aurovitas Spain concentrate for infusion solution is 9 mg/ml (0.9%) sodium chloride injection solution (without preservatives).

• Use aseptic techniques during dilution of gemcitabine for intravenous infusion administration.

• The diluted solution is a clear, colourless or pale yellow solution.

• Parenteral medicinal products should be visually inspected for particulate matter and discoloration prior to administration. If particles are observed, the solution must not be administered.

• Disposal of unused medicine and all materials that have come into contact with it must be carried out in accordance with local regulations.

Storage conditions

After first opening:

Physical and chemical stability in use has been demonstrated for 28 days at 25°C.

From a microbiological standpoint, unless the opening procedure prevents microbiological contamination, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user.

Infusion solution:

Chemical and physical stability in use has been demonstrated for 28 days at 2°C–8°C and at approximately 25°C after dilution in 0.9% sodium chloride solution to a final concentration within the range of 2 to 25 mg/ml (2.0 mg/ml, 12 mg/ml and 25 mg/ml). The pH of the diluted solution ranges from 2 to 3 and osmolarity is approximately 285 mOsm/kg. Diluted solutions are stable when stored in PVC or PE infusion bags.

From a microbiological standpoint, the infusion solution should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2°C–8°C, unless dilution has been carried out under controlled and validated aseptic conditions.