Prospect: information for the user

Gemcitabina Hospira 200mg concentrate for solution for infusion

gemcitabina

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

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

1.What is Gemcitabina Hospira and for what it is used

2.What you need to know before starting to use Gemcitabina Hospira

3.How to use Gemcitabina Hospira

4.Possible adverse effects

5.Storage of Gemcitabina Hospira

6.Contents of the package and additional information

Gemcitabina Hospira (gemcitabina) – ATC codeL01BC05.

Gemcitabina Hospira belongs to a group of medicines called “cytotoxics”, which are medicines for treating cancer. These medicines destroy cells that divide, including cancer cells.

Gemcitabina may be administered alone or in combination with other antineoplastics (for example, cisplatin, paclitaxel, carboplatin), depending on the type of cancer you have.

Gemcitabina Hospira is used in the treatment of the following types of cancer:

• one type of lung cancer callednon-small cell lung cancer (NSCLC), it is administered alone or with cisplatin,
• pancreatic cancer,
• breast cancer, it is administered with paclitaxel,
• ovarian cancer, it is administered with carboplatin,
• bladder cancer, it is administered with cisplatin.

No use gemcitabina if:

• he is allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• is breastfeeding.

Warnings and precautions

Before the first infusion, blood samples will be taken to check if the liver and kidneys are functioning properly.

Before each infusion, blood samples will also be taken to check if there are enough blood cells to receive the gemcitabina treatment.

Depending on your overall health and blood test results, your doctor may decide to change the dose or postpone the gemcitabina treatment if your blood cell count is too low.

Blood samples will be taken periodically to evaluate the liver and kidney function.

Consult your doctor or nurse before receiving gemcitabina if:

• has ever developed severe skin rash or skin peeling, blisters, and/or mouth sores after using gemcitabina.
• has or has had liver, heart, or vascular diseases.
• has received radiation therapy in the last few days or is about to receive it.
• has recently been vaccinated.
• has difficulty breathing or feels extremely weak and pale (may be a sign of kidney failure).

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized pustular psoriasis (PEGA), have been reported in association with gemcitabina treatment. Seek medical attention immediately if you observe any symptoms related to these severe skin reactions described in section 4.

Children and adolescents

This medication is not recommended for children under 18 years of age due to a lack of safety and efficacy data.

Other medications and gemcitabina

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use other medications, including vaccines.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or plan to become pregnant, consult your doctor.Gemcitabina use should be avoided during pregnancy.Women of childbearing age should use effective contraceptive methods during gemcitabina treatment and for 6 months after the last dose.

Your doctor will inform you about the possible risks of using gemcitabina during pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding.

You should stop breastfeeding during gemcitabina treatment.

Fertility

If you are a man, you should avoid fathering children during gemcitabina treatment and for 3 months after the treatment ends.Men are recommended to use effective contraceptive methods during gemcitabina treatment and for 3 months after the last dose.If you want to father a child during treatment or in the 3 months following treatment, consult your doctor or pharmacist.You may want to learn about sperm preservation before starting treatment.

Driving and operating machinery

Gemcitabina treatment may cause drowsiness, especially if you have consumed alcohol.You should not drive or operate machinery until you are sure that gemcitabina treatment has not caused drowsiness or dizziness.

Gemcitabina Hospira contains sodium

Gemcitabina Hospira 200 mg concentrate for solution for infusion

This medication contains less than 1 mmol of sodium (23 mg) per vial; it is essentially “sodium-free”.

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The doctor will calculate the initial dose of gemcitabina and it will depend on the type of cancer you have and your body surface area in square meters (m2).

Your height and weight will be measured to calculate your body surface area. Your doctor will use this information to calculate the appropriate dose.The usual dose is between 1000mg/m2and 1250mg/m2.

This dose may be adjusted or delayed depending on the results of blood tests, your overall health status, and any adverse reactions you experience.

The frequency at which you will receive a dose of gemcitabina by infusion will depend on the type of cancer you are being treated for.

Gemcitabina will be administered to you always as an infusion (a slow injection through a drip) in one of your veins. The infusion will last approximately 30minutes.

Since you will receive gemcitabina under the supervision of a doctor, it is unlikely that you will receive an incorrect dose. However, if you have any doubts about the dose you receive or if you have any other questions about the use of this medication, speak with your doctor, pharmacist, or nurse.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Contact your doctor immediately if you notice any of the following symptoms:

• Bleeding gums, nose, or mouth, or any bleeding that does not stop, pink or red urine, unexpected bruises (since you may have fewer platelets than normal, which is very common).
• Fatigue, feeling of dizziness, easily getting winded, or if you are pale (since you may have lower than normal hemoglobin, which is very common).
• Mild or moderate skin rash (very common) / itching (common), or fever (very common); (allergic reactions).
• Temperature of 38°C or higher, sweating, or other signs of infection (since you may have fewer white blood cells than normal, accompanied by fever, also known as neutropenic fever) (common).
• Pain, redness, swelling, or sores in the mouth (stomatitis) (common).
• Irregular heart rate (arrhythmia) (rare).

Extreme fatigue and weakness, purple spots or small areas of bleeding on the skin (bruises), acute kidney failure (low or no urine production), and signs of infection.These may be signs of microangiopathic thrombosis (clots that form in small blood vessels) (very rare) and hemolytic uremic syndrome (rare), which can be fatal.

• Difficulty breathing (it is very common to have mild difficulty breathing immediately after gemcitabine infusion, which passes quickly, however, it can rarely or occasionally have more serious lung problems).
• Severe chest pain (myocardial infarction) (rare).
• Severe allergic reaction / anaphylaxis with severe skin rash including itching and redness on the skin, swelling of hands, feet, ankles, face, lips, mouth, and throat (which can cause difficulty swallowing or breathing), wheezing, rapid heartbeat, and may feel like you are going to faint (anaphylactic reaction) (very rare).
• Generalized swelling, difficulty breathing, or weight gain, as you may experience fluid extravasation from small blood vessels to tissues (capillary leak syndrome) (very rare).
• Headache with changes in vision, confusion, seizures, or attacks (posterior reversible encephalopathy syndrome) (very rare).
• Severe rash with itching, blisters, or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare).
• Generalized red and scaly rash with inflamed skin lumps under the skin, including skin folds, trunk, and upper limbs, and blisters accompanied by fever (Generalized Acute Pustular Exanthema [GPEA]) (unknown frequency).

Other side effects of Gemcitabine Hospira may include:

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

• Low white blood cell count
• Difficulty breathing
• Vomiting
• Nausea
• Hair loss
• Liver problems: detected through abnormal blood test results
• Blood in the urine
• Abnormal urine test results: protein in the urine
• Symptoms of a flu-like illness, including fever
• Swelling of ankles, fingers, feet, face (edema)

Common:(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

Rare:(may affect up to 1 in 100 people)

• Interstitial lung disease (hardening of the walls of the alveoli)

• Wheezing (bronchospasm)
• Abnormal chest X-ray / examination (pulmonary fibrosis)
• Heart failure
• Kidney failure
• Severe liver damage, including liver failure
• Stroke (ictus)

Rare:(may affect up to 1 in 10,000 people)

• Low blood pressure.
• Peeling of the skin, ulceration, or blistering.
• Severe skin peeling and blistering.
• Reactions at the injection site.
• Severe lung inflammation that causes respiratory failure (adult respiratory distress syndrome).
• Severe sunburn-like rash that can occur in skin that has been previously exposed to radiation (radiation-associated cutaneous toxicity).
• Liquid in the lungs.
• Hardening of the walls of the alveoli associated with radiation (radiation-associated toxicity).
• Finger or hand gangrene.
• Peripheral vasculitis (inflammation of blood vessels).

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

• Increased platelet count
• Inflammation of the large intestine caused by reduced blood supply (ischemic colitis)
• May be detected through blood tests low hemoglobin levels, white blood cell count, and platelet count.
• Clots that form in small blood vessels (microangiopathic thrombosis)

Unknown:(cannot be estimated from available data).

• A condition in which eosinophils, a type of cell that is usually found in the blood, accumulate in the lungs (eosinophilic pneumonia)

• Redness of the skin with swelling(pseudocelulitis)
• When a bacterium and its toxins circulate in your blood and start to damage your organs (sepsis)

You may experience any of these side effects and/or conditions. Inform your doctor as soon as possible if you start experiencing any of these side effects.

Talk to your doctor if you are concerned about any of the side effects.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: http;//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Healthcare professionals will conserve and administer gemcitabina and follow these guidelines:

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the vial and on the box after the expiration date (EXP). The expiration date is the last day of the month indicated.
• Store in refrigerator (2°C-8°C).
• This medication is for single use only; unused medication will be disposed of according to local regulations.

Composition of Gemcitabina Hospira:

• The active substance of Gemcitabina Hospira is gemcitabine (as hydrochloride).The solution has a concentration of 38mg/mL, which means that each milliliter of the solution contains 38 milligrams of gemcitabine (as hydrochloride).

• The other components of this medication are: water for injection, hydrochloric acid (to adjust the pH) and sodium hydroxide (to adjust the pH).

Appearance of the product and contents of the package

• Gemcitabina Hospira is a transparent, colorless or pale yellow solution

• Gemcitabina Hospira is presented in glass vials

• Three sizes of glass vials are marketed, which contain:

200mg of gemcitabine (as hydrochloride) in 5.3mL of solution

1000mg of gemcitabine (as hydrochloride) in 26.3mL of solution

2000mg of gemcitabine (as hydrochloride) in 52.6mL of solution

• Each vial is packaged in an individual outer packaging

Marketing Authorization Holder:

Pfizer, S.L.

Avenida de Europa 20B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing::

Pfizer Service Company BV

Hoge Wei 10

1930, Zaventem

Belgium

Last review date of thisleaflet:April 2024.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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The following information is intended only for healthcare professionals:

Instructions for use, handling and disposal

Use

• Consult the Technical Dossier to calculate the dose and the number of vials required.

• The solution must be diluted: A diluent authorized for the gemcitabine concentrate solution for infusion is sodium chloride 9mg/mL (0.9%) injection (without preservative). Follow aseptic technique during the dilution of Gemcitabina concentrate before administration.

• Before administration, parenteral medications must be visually inspected for the presence of particles or discoloration. If particles are observed, do not administer it.

• After dilution, the chemical and physical stability has been demonstrated for:

From a microbiological point of view, the product should be used immediately. If not, the storage times during use and the conditions before use are the responsibility of the user andshould not exceed more than 24hours at 2°Cto 8°C, unless the dilution has taken place in controlled and validated aseptic conditions.

Handling

• Standard precautions for cytostatics should be taken into account when preparing and disposing of the infusion solution. The handling of the infusion solution should be carried out in a safety cabinet and with gloves and protective overalls on. If a safety cabinet is not available, a mask and protective glasses will be added to the equipment.

• If the prepared solution comes into contact with the eyes, it could cause severe irritation. The eyes should be thoroughly flushed with water immediately. If irritation persists, a doctor should be consulted. If the solution is spilled on the skin, it should be thoroughly flushed with water.

Disposal

Gemcitabina Hospira is for single use only. The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations for cytotoxic agents.