Document: Pamidronatdinatrium Hospira concentrate for solution for infusion ENG PL change

• Pamidronatdinatrium Hospira concentrate for solution for infusion PL
• Pamidronatdinatrium Hospira concentrate for solution for infusion ENG PL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Pamidronatdinatrium Hospira 3 mg/ml concentrate for solution for infusion,

Pamidronatdinatrium Hospira 6 mg/ml concentrate for solution for infusion,

Pamidronatdinatrium Hospira 9 mg/ml concentrate for solution for infusion

pamidronat disodium

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.

• 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.

What is in this leaflet:

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

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

3. How to use Pamidronatdinatrium Hospira

4. Possible side effects

Pamidronatdinatrium Hospira is member of the group of substances called bisphosphonates. The medicinal action of pamidronate is that it binds to bone and reduces destruction of bone.

The medicine is used to help lower high levels of calcium in the blood caused by tumours, and reduce bone loss, which may occur in patients with certain types of cancer, for example breast cancer or multiple myeloma. If you are unsure, why you are being given this medicine, ask your doctor.

Do not use Pamidronatdinatrium Hospira

Warnings and precautions

Talk to your doctor or nurse before using Pamidronatdinatrium Hospira

• If you have you ever had thyroid problems

• If you suffer from any kidney disease

• If you suffer from any heart problems

• If you have blood diseases (anaemia, leukopenia (low white cell count) and thrombocytopenia (low platelet count)

- if you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or

loosening of a tooth. Your doctor may recommend a dental examination before you start treatment with Pamidronatdinatrium Hospira.

- if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Pamidronatdinatrium Hospira and inform your doctor about your dental treatment.

While being treated with Pamidronatdinatrium Hospira, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.

Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of a condition called osteonecrosis of the jaw.

Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids, who are undergoing dental surgery, who do not receive routine dental care, who have gum disease, who are smokers, or who were previously treated with a bisphosphonate (used to treat or prevent bone disorders) may have a higher risk of developing osteonecrosis of the jaw.

When you are being treated with Pamidronatdinatrium Hospira, your doctor will check your response to the treatment at regular intervals.

Children and adolescents

There is no clinical experience in the paediatric and adolescent (<18 years old) population.

Other Medicines and Pamidronatdinatrium Hospira

• Pamidronatdinatrium Hospira should not be used with other bisphosphonate medicines (the group to which Pamidronatdinatrium Hospira belongs) or any other medicine that lowers your levels of calcium

• Other medicines that affect your kidneys (your doctor or nurse will know which ones these are)

• Thalidomide (used in the treatment of multiple myeloma)

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and Breast-feeding and Fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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

Breast-feeding is not recommended whilst being treated with Pamidronatdinatrium Hospira concentrate for solution for infusion.

Driving and using machines

If you feel sleepy or dizzy after being treated with pamidronate disodium, do not drive or use machines that need your full attention until these effects wear off.

Pamidronatdinatrium Hospira contains sodium:

Pamidronatdinatrium Hospira contains less than 1 mmol sodium (23 mg) per maximum dose (90 mg) i.e. it is essentially "sodium-free".

Pamidronatdinatrium Hospira is given by very slow intravenous infusion (in a vein), never as a rapid injection. Your doctor will decide on a correct dose for you. The infusion will last from one to several hours depending on the dose. Your doctor will decide how many infusions you need and how often they will be given.

The recommended dose for each treatment is between 15 mg and 90 mg.

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

4. Possible side effects

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

The most common side effects are decreased calcium levels in blood, flu-like symptoms and fever (an increase in body temperature of 1-2C) which occurs at the start of treatment and may last up to 48 hours.

Some patients notice an increase in bone pain soon after starting treatment. This usually improves after a few days. If it does not, tell your doctor.

Your healthcare professional may stop administering Pamidronatdinatrium Hospira immediately if you experience symptoms of angioedema, such as swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties in breathing(uncommon: may affect up to 1 in 100 people).

Tell your doctor immediately if you notice any of these side effects of an anaphylactic shock (severe allergic reaction):

Other side effects that may occur:

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

• Fever and influenza-like symptoms, sometimes accompanied by feeling ill, stiffness, tiredness and hot flushes.

• Decrease in the levels of calcium and phosphatase in the blood.

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

• Decreased number of white blood cells (lymphocytopenia),

• anaemia, reduced number of platelets in the blood (thrombocytopenia),

• reduced level of potassium and magnesium in the blood,

• headache,

• sleeplessness,

• drowsiness,

• feeling sick,

• vomiting,

• diarrhoea,

• constipation, stomach pain, loss of appetite,

• transient bone pain, joint pain, muscle pain, muscle spasms, generalised pain, pain,

• redness, or swelling at the injection site,

• tender or painful veins, sometimes at the same time as a local clot of blood,

• high blood pressure,

• tingling sensation in hands and feet,

• numbness,

• conjunctivitis, skin rash,

• increase in serum creatinine (a blood test to measure kidney function)..

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

• Allergic reaction,

• bronchospasm,

• seizures (fits),

• agitation,

• dizziness,

• lethargy,

• inflammation of the eye which causes pain and redness,

• low blood pressure,

• upset stomach, indigestion,

• itching,

• muscle cramps,

• death of bone tissue (osteonecrosis),

• abnormal liver function tests,

• increase in blood/serum urea,

• acute renal failure.

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

• Kidney problems

• Unusual fracture of the thigh bone, particularly in patients on long-term treatment for osteoporosis, may occur rarely.

Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.

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

• Flare up of cold sores/blisters or shingles (reactivation of Herpes virus),

• decreased number of white blood cells (leucopenia),

• increase in levels of potassium and sodium in the blood,

• confusion,

• heart failure,

• respiratory problems,

• lung disease,

• problem with kidneys (usually in patients with previous kidney problem),

• blood in the urine,

• visual hallucinations (seeing things that are not there),

• problems with vision/ eye pain,

• inflammation of the lungs which may cause coughing, breathing difficulties and wheezing,

• anaphylactic shock (severe allergic reaction)

• talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.

Not known: frequency cannot be estimated from the available data

• Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving pamidronate. It is currently unclear whether pamidronate causes this irregular heart rhythm. You should report to your doctor if you experience irregular heart rhythm during treatment with pamidronate.

• Redness around the eye area.

• Pseudotumor cerebri, a disorder associated with nervous system.

• Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw (osteonecrosis). Tell your doctor and dentist immediately if you experience such symptoms while being treated with Pamidronatdinatrium Hospira or after stopping treatment.

Reporting of side effects

If you getany side effects, talk toyourdoctororpharmacist.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Pamidronatdinatrium Hospira

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

Do not use Pamidronatdinatrium Hospira after the expiry date which is stated on the label and carton after EXP:The expiry date refers to the last day of that month.

Do not store above 25C.

After dilution the product should be used immediately. If the diluted product is not used immediately, in-use storage times should not be longer than 24 hours at 2-8°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.These measures will help to protect the environment.

6. Contents of the pack and other information

What Pamidronatdinatrium Hospira contains

• The active substance is pamidronate disodium. Each millilitre (ml) of solution contains 3 mg, 6 mg or 9 mg of pamidronate disodium.

• The other ingredients are mannitol, phosphoric acid, sodium hydroxide and Water for Injections.

What Pamidronatdinatrium Hospira looks like and contents of the pack

Pamidronatdinatrium Hospira concentrate for solution for infusion (sterile concentrate), is a clear colourless solution.

Pamidronatdinatrium Hospira 3 mg/ml:

5 ml clear glass vials in packs of 5 vials or 4 x (5 x 5 ml) vials. 10 ml clear glass vials in packs of 1 vial or 4 x (1 x 10 ml) vials.

Pamidronatdinatrium Hospira 6 mg/ml and 9 mg/ml:

10 ml clear glass vials in packs of 1 vial or 4 x (1 x 10 ml) vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Hospira UK Limited
Horizon

Honey Lane

Hurley

Maidenhead

SL6 6RJ

United Kingdom

Manufacturer:

Hospira UK Limited, Horizon, Honey Lane, Hurley Maidenhead, SL6 6RJ, , United Kingdom

Hospira Benelux BVBA, Stallestraat 63, 1180 Brussels, Belgium.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: Hospira Nordic AB, P.O.Box 34116, SE-100 26 Stockholm, Sweden

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria	Pamidronat Dinatrium Hospira		Italy	Pamidronato disodico Hospira
Belgium	Pamidronaatdinatrium Hospira		Lithuania	Pamidronate Disodium Hospira
Denmark	Pamidronatdinatrium Hospira		Luxembourg	Pamidronate disodique Hospira
Finland	Pamidronatdinatrium Hospira		Netherlands	Pamidronaatdinatrium Hospira
France	Pamidronate de sodium Hospira		Norway	Pamidronatdinatrium Hospira
Germany	Pamidronat Hospira		Poland	Pamisol
Greece	Pamidronate Disodium Hospira		Portugal	Pamidran
Hungary	Pamidronate Hospira		Spain	Pamidronato Hospira
Iceland	Pamidronatdinatrium Hospira		Sweden	Pamidronatdinatrium Hospira

This leaflet was last revised 2016-05-13.

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The following information is intended for medical or healthcare professionals only:

Administration:

For intravenous use as infusion only. Pamidronate disodium must never be given 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 90 mg/250 ml. Only clear solutions practically free from particles should be used. For single use only. Any unused solution should be discarded.

Incompatibilities:

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

Storage and shelf -life:

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