PAMIDRONATE HOSPIRA 6 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Pamidronate Hospira 3 mg/ml concentrate for solution for infusion

Pamidronate Hospira 6 mg/ml concentrate for solution for infusion

Pamidronate Hospira 9 mg/ml concentrate for solution for infusion

Disodium pamidronate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Pamidronate Hospira belongs to a group of medicines called bisphosphonates. The mechanism of action of pamidronate is that it binds to bone and reduces bone destruction.

This medicine is used to help decrease the levels of calcium in the blood caused by tumors, reduce the loss of bone that may occur in patients with certain types of cancer, such as breast cancer or multiple myeloma. If you are not sure why you are being given this medicine, ask your doctor.

2. What you need to know before you use Pamidronate Hospira

Do not use Pamidronate Hospira:

• If you are allergic to disodium pamidronate or any of the other ingredients of this medicine (see section 6) or to other bisphosphonates (the group to which Pamidronate Hospira belongs).

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting treatment with Pamidronate Hospira

• If you have or have ever had thyroid problems.
• If you have kidney disease.
• If you have heart problems.
• If you have blood disorders (anemia, leukopenia (low white blood cell count) and thrombocytopenia (low platelet count).
• Pamidronate Hospira may cause eye irritation.
• Pamidronate Hospira is not recommended for use in children.

• If you have or have had pain, swelling, or numbness of the jaw, a feeling of heaviness in the jaw, or a tooth has come loose. Your doctor may recommend that you have a dental check-up before starting treatment with Pamidronate Hospira.
• If you are receiving dental treatment or are going to have dental surgery, inform your dentist that you are being treated with Pamidronate Hospira and inform your doctor about your dental treatment.

While you are being treated with Pamidronate Hospira, you should maintain good oral hygiene (including regular brushing of your teeth) and attend regular dental check-ups.

Contact your doctor and dentist immediately if you experience any oral or dental problems, such as a loose tooth, pain, or swelling, ulcers that do not heal, or discharge, as these could be signs of jawbone necrosis.

Patients who are receiving chemotherapy and/or radiotherapy, are taking steroids, are undergoing dental procedures, do not receive regular dental care, have gum disease, are smokers, or have received treatment with a bisphosphonate (used to treat or prevent bone disorders) may have a higher risk of developing jawbone necrosis.

While you are being treated with Pamidronate Hospira, your doctor will check your response to treatment at regular intervals.

Children and adolescents

There are no clinical data in the pediatric and adolescent population (under 18 years of age)

Using Pamidronate Hospira with other medicines

• Pamidronate Hospira should not be used with other bisphosphonates (the group to which Pamidronate Hospira belongs) or with other medicines that lower calcium levels.
• Other medicines that affect your kidneys (your doctor or nurse will know which ones)
• Talidomide (used in the treatment of multiple myeloma)

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding, and fertility

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.

There are no clinical data on the use of Pamidronate Hospira concentrate for solution for infusion during pregnancy. Animal studies have shown harmful effects on the offspring (skeletal abnormalities). The potential risk to humans is unknown.

If you are pregnant, you should not be treated with pamidronate unless it is absolutely necessary.

Breastfeeding is not recommended while being treated with Pamidronate Hospira concentrate for solution for infusion.

Driving and using machines

If you feel drowsy or dizzy after being treated with disodium pamidronate, do not drive or operate machinery that requires special attention until the effects have disappeared.

Pamidronate Hospira contains sodium:

This medicine contains less than 1 mmol of sodium (23 mg) per maximum dose (90 mg); it is essentially "sodium-free".

However, if a saline solution (0.9% w/v sodium chloride solution) is used for dilution of Pamidronate Hospira before administration, the sodium dose received would be higher.

3. How to use Pamidronate Hospira

Pamidronate Hospira will be administered to you by slow intravenous infusion (into a vein), never by rapid injection. Your doctor will decide the correct dose according to your condition. The infusion may take from one to several hours, depending on the dose. The doctor will decide how many infusions you need and how often they should be given.

The recommended dose per treatment course is between 15 mg and 90 mg.

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

4. Possible side effects

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

The most common side effects are a decrease in blood calcium levels, flu-like symptoms, and fever (a rise in body temperature of 1°C - 2°C) that appears at the start of treatment and may last for about 48 hours.

Some patients feel more bone pain when starting treatment. This usually improves after a few days. If it does not improve, tell your doctor.

Your doctor may immediately stop the administration of Pamidronate Hospira if you experience symptoms of angioedema, such as swelling of the face, tongue, or pharynx, difficulty swallowing, urticaria, and breathing difficulties (uncommon: may affect up to 1 in 100 people).

If you experience any of the following side effects, symptoms of anaphylactic shock (severe allergic reaction), call your doctor immediately:

• Chest tightness, breathing difficulties, widespread rash, urticaria, skin and mucous membrane swelling, sudden drop in blood pressure. (Uncommon side effect that may affect up to 1 in 10,000 people).

Other side effects that may occur are:

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

• Fever and flu-like symptoms, some of which are accompanied by a feeling of being unwell, stiffness, fatigue, and a feeling of suffocation.
• Decrease in blood calcium and phosphatase levels.

Common (may affect up to 1 in 10 people):

• Decrease in white blood cell count (lymphocytopenia),
• Anemia, reduction in platelet count (thrombocytopenia),
• Decrease in potassium and magnesium levels in the blood,
• Headache,
• Insomnia,
• Numbness,
• Feeling unwell,
• Vomiting,
• Diarrhea,
• Constipation, stomach pain, loss of appetite,
• Transient bone pain, joint pain, muscle pain, muscle spasms, generalized pain, pain,
• Redness or inflammation at the injection site,
• Sensitive or painful veins, sometimes with local blood spots,
• High blood pressure,
• Feeling of tingling in hands and feet,
• Numbness,
• Conjunctivitis, skin rash,
• Increased serum creatinine (blood test to measure kidney function).

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

• Allergic reaction,
• Bronchospasm,
• Seizures (convulsions),
• Agitation,
• Dizziness,
• Lethargy,
• Eye inflammation that can cause pain and redness,
• Low blood pressure,
• Feeling of fullness in the stomach, indigestion,
• Itching,
• Muscle cramps,
• Bone tissue death (osteonecrosis),
• Abnormal liver function,
• Increased serum and blood urea,
• Acute kidney failure.

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

• Kidney problems
• Atypical fractures of the thigh bone, which can occur rarely, especially in patients on long-term treatment for osteoporosis.

Tell your doctorif you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early signs of a possible fracture of the femur.

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

• Appearance of burns, ulcers, and herpes (reactivation of the Herpes virus)
• Decrease in white blood cell count (leukopenia),
• Increased levels of potassium and sodium in the blood,
• Confusion,
• Heart failure,
• Breathing difficulties,
• Lung disease,
• Kidney problems (especially in patients with pre-existing kidney problems),
• Blood in the urine,
• Visual hallucinations (seeing things that are not there),
• Vision problems / eye pain,
• Lung inflammation that can cause cough, breathing difficulties, and wheezing,
• Anaphylactic shock (severe allergic reaction).
• Tell your doctor if you experience ear pain, ear discharge, and/or ear infection. This may indicate damage to the ear.

Frequency not known: frequency cannot be estimated from the available data

• Irregular heart rhythm (atrial fibrillation) has been observed in patients who received pamidronate. It is not clear whether pamidronate causes this irregular heart rhythm. You should tell your doctorif you experience an irregular heart rhythm during treatment with pamidronate.
• Redness around the eye area.
• Pseudotumor cerebri, a disorder associated with the nervous system.
• Pain in the mouth, teeth, and/or jaw, swelling or ulcers that do not heal within the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or a tooth coming loose. These could be signs of bone damage in the jaw (osteonecrosis). Tell your doctor and dentist immediately if you experience these symptoms while being treated with Pamidronate Hospira or after stopping treatment.

Reporting of side effects

If you experience 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 via the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pamidronate Hospira

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 carton after EXP. The expiry date refers to the last day of the month shown.

Do not store above 25°C.

The diluted product should be used immediately. If not used immediately, storage times and conditions are the responsibility of the user and should not normally exceed 24 hours at 2-8°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pamidronate Hospira

• The active substance is disodium pamidronate. Each milliliter (ml) of solution contains 3 mg, 6 mg, or 9 mg of disodium pamidronate.
• The other ingredients are: mannitol, phosphoric acid, sodium hydroxide, and water for injections.

Appearance and packaging

Pamidronate Hospira concentrate for solution for infusion (sterile concentrate) is a clear and colorless solution.

Pamidronate Hospira 3 mg/ml

Transparent vials of 5 ml, which are presented in packs of 5 vials or 4 vials (5 x 5 ml).

Transparent vials of 10 ml, which are presented in packs of 1 vial or 4 vials (1 x 10 ml).

Pamidronate Hospira 6 mg/ml and 9 mg/ml

Transparent vials of 10 ml, which are presented in packs of 1 vial or 4 vials (1 x 10 ml).

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer, S.L.

Avenida de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Manufacturer

Pfizer Service Company BV

Hoge Wei 10

1930 Zaventem

Belgium

This medicine is authorized in the Member States of the European Economic Area under the following names:

This leaflet was last revised in 06/2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals

Administration:

For intravenous administration only as an infusion. Disodium pamidronate should never be administered as a bolus injection. The solution should be diluted before use and should be infused slowly. The concentration of disodium pamidronate in the infusion solution should not exceed 90 mg/250 ml. Only clear solutions free of particles should be used. For single use only. Discard any unused portion of the solution.

Incompatibilities:

Pamidronate forms complexes with divalent cations and should not be added to intravenous solutions containing calcium.

Storage and shelf-life:

Chemical and physical stability has been demonstrated in sodium chloride 0.9% and glucose 5% for 24 hours when stored at 2-8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions are the responsibility of the user and normally should not exceed 24 hours at 2-8°C.