Disodium Pamidronate 3 Mg/Ml Concentrate For Solution For Infusion.
Package leaflet: Information for the user Disodium Pamidronate Teva 3 mg/ml concentrate for solution for infusion
Read all of this leaflet carefully before you are given 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 nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Disodium Pamidronate Teva is and what it is used for
2. What you need to know before you are given Disodium Pamidronate Teva
3. How Disodium Pamidronate Teva is given
4. Possible side effects
5. How to store Pamidronate Disodium Teva
6. Contents of the pack and other information
1. What Disodium Pamidronate Teva is and what it is used for
The active ingredient in Disodium Pamidronate Teva is called pamidronate disodium. Disodium Pamidronate belongs to a group of medicines called the bisphosphonates which can help to regulate the amount of calcium in the blood.
Disodium Pamidronate Teva is used to:
• reduce high levels of calcium in the blood caused by cancers
• reduce bone loss in patients with breast cancer that has spread to the bones
• reduce bone loss and fractures in patients with multiple myeloma (a tumour of bone marrow cells).
2. What you need to know before you are given Pamidronate Disodium Teva You must not be given Disodium Pamidronate Teva:
• if you are allergic to pamidronate disodium, any other bisphosphonates e.g. alendronic acid, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or nurse before you are given Pamidronate Disodium Teva:
• if you are on a low sodium diet
• if you are taking any other medicines to lower calcium in your blood
• if you have fits
• if you have had thyroid surgery
• if you have a reduced number of red blood cells (anaemia), white blood cells (leukopenia) or platelets (thrombocytopenia)
• if you have kidney problems, or kidney impairment
• if you have heart problems
• if you have any liver problems
• if you have calcium or vitamin D deficiency
• if you have a feverish illness e.g. flu or something similar.
• if you had or have 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 Disodium Pamidronate Teva.
If you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Disodium Pamidronate Teva and inform your doctor about your dental treatment.
While being treated with Disodium Pamidronate Teva, 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.
There is a risk of fracture of the thigh bone (femur), particularly in patients receiving long-term treatment for osteoporosis (see section 4 Possible side effects).
You must make sure that you do not become dehydrated while you are being treated with Disodium Pamidronate Teva. Talk to your doctor to make sure you are aware how much you must drink.
Your doctor will want to check your progress by carrying out a number of tests e.g. blood tests and kidney function tests. Remind your doctor that you are taking Disodium Pamidronate before they do any tests. The results may be affected by Disodium Pamidronate Teva.
Children and adolescents
Disodium Pamidronate Teva is not suitable for treating children.
Other medicines and Pamidronate Disodium Teva
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. In particular, tell your doctor or nurse if you are taking any of the following:
• any other bisphosphonate medicines e.g. alendronic acid or risendronate sodium
• any medicines that reduce levels of calcium such as calcitonin
• any other medicines that can affect the kidneys
• thalidomide (used to treat some cancers) as the risk of kidney problems may be increased. Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine.
• If you are pregnant or are planning to become pregnant, you should not be given Disodium Pamidronate Teva except in cases of life-threatening hypercalcaemia..
• Breast-feeding during treatment with Disodium Pamidronate Teva is not recommended.
Driving and using machines
• Disodium Pamidronate Teva may cause sleepiness or dizziness. If you are affected, DO NOT drive or operate machinery.
Disodium Pamidronate Teva contains sodium
Disodium Pamidronate Teva contains less than 1 mmol sodium (15 mg) per maximum dose (90 mg), i.e. essentially ‘sodium- free.’
3. How Disodium Pamidronate Teva is given
The medicine will be given to you very slowly into a vein via a drip (intravenous infusion). Your medicine will be administered by a doctor or nurse, who will prepare the infusion. The infusion will take from one to several hours depending on the dose.
Your doctor will decide how many infusions you will need and how often they will be given. During treatment you will have blood tests and may be asked to provide urine samples. Recommended dose:
The dose given to you will depend upon your medical condition, the levels of calcium in your blood and how well your kidneys are working.
For hypercalcaemia: 15-90 mg given as a single or several infusions over 2-4 days.
For bone diseases and bone pain: 90 mg every 4 weeks. In some patients the dose may be given every 3 weeks at the same time as chemotherapy.
Your doctor may also have prescribed treatment with Calcium and Vitamin D at the same time as Disodium Pamidronate Teva.
If you are given more Disodium Pamidronate Teva than you should
As this medicine will be given to you by a doctor or nurse whilst you are in hospital it is unlikely that you will be given too little or too much. If nevertheless you have received doses higher than those recommended you will be carefully monitored by your doctor or nurse. If you think you have been given too much Disodium Pamidronate Teva, tell your doctor or nurse straight away.
If you are not given Disodium Pamidronate Teva
As this medicine will be given to you whilst you are in hospital it is unlikely that you will miss a dose. If nevertheless you are not given your dose or think you may have missed a dose, you should ask your doctor or nurse immediately.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects are usually mild and disappear as treatment continues.
Serious side effects:
Tell your doctor immediately if the following happens:
Very common: may affect more than 1 in 10 people
• flu-like symptoms and a mild fever (increase in body temperature) which occurs within the first 48 hours of treatment and usually lasts no more than 24 hours. If these symptoms last for longer, tell your doctor.
Uncommon: may affect up to 1 in 100 people
• an allergic reaction causing a sudden itchy rash (hives), wheezing and coughing, swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing).
Rare: may affect up to 1 in 1,000 people
• 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.
Some patients notice an increase in bone pain soon after starting treatment. This usually
improves after a few days, but if it does not, tell your doctor.
Very common: may affect more than 1 in 10 people
• fever, shivering, tiredness and flushing
• changes in blood test results (including low calcium and low phosphate levels).
Common: may affect up to 1 in 10 people
• pain, redness or swelling at the infusion site, including inflammation of a vein which can sometimes lead to a blood clot
• skin rash, unusual bleeding or unexplained bruising
• joint, muscle, bone or generalised pain
• feeling sick or being sick, loss of appetite, stomach pain, inflammation of the stomach lining (gastritis) which may cause pain and sickness, constipation or diarrhoea
• headache, tiredness, difficulty sleeping
• conjunctivitis
• low calcium levels in the blood, leading to muscle cramps/spasms and pins and needles (tingling/numbness in the hands and feet)
• high blood pressure
• reduction in the number of white blood cell (leucopenia, lymphocytopenia), which makes infections more likely
• reduction in red blood cells (anaemia) which can cause weakness or breathlessness
• changes in blood test results (including low magnesium, low potassium and increased blood creatinine levels).
• Irregular heart rhythm
Uncommon: may affect up to 1 in 100 people
• muscle cramps
• agitation, dizziness or lack of energy, fits
• problems with vision, inflammation of the eye
• low blood pressure
• indigestion
• itching
• kidney failure
• allergic reaction which causes difficulty in breathing, dizziness, or swelling to the face or throat.
• abnormal liver function tests
• increase of urea levels in blood
Rare: may affect up to 1 in 1,000 people
• kidney function problems which can cause symptoms of fluid retention, feeling sick and tiredness
• protein in urine.
Very rare: may affect up to 1 in 10,000 people
• heart and respiratory problems which may include difficulty in breathing, fluid retention or chest pain, lung disease
• inflammation of the kidneys, kidney problems and deterioration of pre-existing kidney disease e.g. blood in urine, unexpected change in the amount of urine produced
• flare up of cold sores or shingles
• confusion or visual hallucinations (seeing things or hearing things that are not there)
• yellow tint to vision, eye inflammation problems
• water retention in the lung (pulmonary oedema)
• deterioration of pre-existing heart disease with shortness of breath
• anaphylactic shock (serious allergic reaction which causes difficulty in breathing, dizziness)
• high potassium and high sodium levels in the blood
• 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)
• Inflammation of the eye socket
• Severe and occasionally incapacitating bone, joint, and/or muscle pain, atypical subtrochanteric and diaphyseal femoral fractures.
• 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 Dosodium Pamidronate Teva or after stopping treatment.
Disodium Pamidronate Teva may affect your blood (the number of particular cells and the chemistry of the blood). Your doctor will monitor you for this with blood tests.
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 tell your doctor if you experience irregular heart rhythm during treatment with pamidronate.
Reporting of side effects
If you get 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Pamidronate Disodium Teva
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 vial and outer packaging after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
6. Contents of the pack and other information
What Disodium Pamidronate Teva contains:
• The active substance is disodium pamidronate. Each ml concentrate for solution for infusion contains 3 mg pamidronate disodium as pamidronic acid 2.527 mg. One vial contains 15 mg, 30 mg, 60 mg or 90 mg disodium pamidronate.
• The other ingredients are sodium hydroxide, hydrochloric acid, and water for injections.
What Disodium Pamidronate looks like and contents of the pack:
• Each vial contains 15, 30, 60 or 90 mg of disodium pamidronate as a colourless liquid.
• Each vial is available in packs of 1, 4 or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Marketing Authorisation Holder: TEVA UK Limited, Eastbourne, BN22 9AG.
Manufacturer
Manufacturer: Pharmachemie B.V., Haarlem, The Netherlands
This leaflet was last revised: April 2016 PL 00289/0854
The following information is intended for healthcare professionals only Further to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here.
Incompatibilities
Pamidronate will form complexes with divalent cations and should not be added to calcium-containing intravenous solutions.
Instructions for use and handling
Must be diluted prior to administration.
The concentration of pamidronate disodium in the infusion solution should not exceed 90 mg/250 ml.
Do not use solution if particles are present.
Any portion of the contents remaining after use should be discarded.
In-use storage precautions
Following dilution in 0.9% sodium chloride and 5% glucose infusion solutions, chemical and physical in-use stability has been demonstrated for 96 hours at temperatures not exceeding 25°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 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.