Prospect: 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

Pamidronate disodium

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

• Keep this prospect. You may have to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

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

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

3.How to use Pamidronate Hospira

4.Possible adverse effects

5.Storage of Pamidronate Hospira

6.Contents of the package and additional information

Pamidronato Hospira belongs to a group of medications called bisphosphonates. The mechanism of action of pamidronato is that it binds to bone and reduces bone destruction.

This medication is used to help decrease calcium levels in the blood caused by tumors, reduce bone loss that may occur in patients with certain types of cancer, for example, breast cancer or multiple myeloma. If you are unsure why you are being administered this medication, ask your doctor.

No use Pamidronato Hospira:

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

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to use Pamidronato Hospira

• If you have or have had any thyroid problems.
• If you have any kidney disease.
• If you have any heart problems.
• If you have blood disorders (anemia, leukopenia (low white blood cell count) and thrombocytopenia (low platelet count).
• Pamidronato Hospira may cause eye irritation.
• Do not recommend the use of Pamidronato Hospira in children.

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

While receiving treatment with Pamidronato Hospira, you must maintain good oral hygiene (including regular brushing of teeth) and attend periodic dental check-ups.

Contact your doctor and dentist immediately if you experience any oral or dental problems, such as a loose tooth, pain, swelling, ulcers that do not heal, or suppurations, as they may be signs of jaw osteonecrosis.

Patients receiving chemotherapy and/or radiation therapy, taking steroids, undergoing dental interventions, not receiving regular dental care, having 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 jaw osteonecrosis.

While receiving treatment with Pamidronato Hospira, your doctor will check your response to treatment at regular intervals.

Children and adolescents

No clinical data in pediatric and adolescent populations (under 18 years)

Use of Pamidronato Hospira with other medications

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

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

No clinical data on the use of Pamidronato Hospira concentrated solution for infusion during pregnancy. Animal studies have shown harmful effects on the offspring (skeletal alterations). The potential risk to humans is unknown.

If you are pregnant, you should not be treated with pamidronate, except in extreme cases.

Do not recommend breastfeeding while being treated with Pamidronato Hospira concentrated solution for infusion.

Driving and operating machinery

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

Pamidronato Hospira contains sodium:

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

However, if a saline solution (sodium chloride 0.9% w/v solution) is used to dilute Pamidronato Hospira before administration, the sodium dose received would be higher.

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

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most common side effects are a decrease in blood calcium levels, symptoms such as flu and fever (a body temperature increase of 1?C-2ºC) that appear at the beginning of treatment and can last for up to 48 hours.

Some patients feel more bone pain when starting treatment. Generally, this improves within a few days. If it does not improve, tell your doctor.

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

If you experience any of the following side effects, symptoms of an 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. (Side effectthat may affect up to 1in 10000people).

Other side effects that may occur are:

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

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

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

• Decrease in white blood cell count (lymphopenia),
• Anemia,reduction in platelet count in the blood (thrombocytopenia),
• Reduction in blood potassium and magnesium levels,
• Headache,
• Insomnia,
• Numbness,
• Feeling of nausea,
• Vomiting,
• Diarrhea,
• Constipation,abdominal 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, sometimesaccompanied by local skin bleeding,
• High blood pressure,
• Feeling of tingling inhandsand feet,
• Numbness,
• Conjunctivitis,skin rash,
• Increased serum creatinine (blood test to measure kidney function).

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

• Allergic reaction,
• Asthma,
• Seizures(tremors),
• Agitation,
• Dizziness,
• Letargy,
• Eye inflammationthat may cause painand redness,
• Low blood pressure,
• Feeling of full stomach, indigestion,
• Itching,
• Muscle cramps,
• Death of bone tissue(osteonecrosis),
• Altered liver function,
• Increased urea serum and blood,
• Acute renal failure.

Rare (may affect up to 1 in 1000people):

• Renal problems
• Atypical femoral fractures, which may occur in rare cases, especially in patients undergoing prolonged treatment for osteoporosis.

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

Very rare (may affect up to 1 in 10000people):

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

Frequency not known:the 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 if pamidronate causes this irregular heart rhythm.Inform your doctorif you experience an irregular heart rhythm during treatment with pamidronate.
• Redness around the eye area.
• Pseudotumor cerebral, a disorder associated with the nervous system.
• Dental pain, teeth, and/or jaw, swelling or ulcers that do not heal within the mouth or jaw, abscesses, numbness or feeling of heaviness in the jaw, or loosening of a tooth. These may be signs of jaw bone damage (osteonecrosis). Inform your doctor and dentist immediately if you experience these symptoms while receiving treatment with Pamidronato Hospira or after stopping treatment

Reporting of 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

The diluted product must be used immediately. If not, storage times should not exceed 24 hours at a temperature of 2°C-8°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Pamidronate Hospira Composition

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

Appearance of the product and contents of the package

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

Pamidronate Hospira 3 mg/ml

Transparent 5 ml vials presented in packs of 5 vials or 4 vials (5×5 ml).

Transparent 10 ml vials presented in packs of 1 vial or 4 vials (1×10 ml).

Pamidronate Hospira 6 mg/ml and 9 mg/ml

Transparent 10 ml vials presented in packs of 1 vial or 4 vials (1×10 ml).

It may not be marketed in all package sizes.

Marketing Authorization Holder

Pfizer, S.L.

Avenida de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Pfizer Service Company BV

Hoge Wei 10

1930 Zaventem

Belgium

This medicine is authorized in the member states of the European Economic Area with the following names:

This leaflet was revised in 06/2024

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

This information is intended solely for healthcare professionals

Administration:

Only for intravenous administration as infusion. Pamidronate disodium should never be administered as a bolus injection. The solution must be diluted before use and must be infused slowly. The concentration of pamidronate disodium in the infusion solution should not exceed 90mg/250ml. Only transparent 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 expiration:

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