Disodium Pamidronate 3 Mg/Ml Concentrate For Solution For Infusion.
Out of date information, search anotherDISODIUM PAMIDRONATE 3 mg/ml CONCENTRATE FOR SOLUTION FOR
INFUSION
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking 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.
What is in this leaflet:
1. What Disodium Pamidronate is and what it is used for
2. What you need to know before you receive Pamidronate Disodium Teva
3. How to receive Pamidronate Disodium Teva
4. Possible side effects
5. How to store Pamidronate Disodium Teva
6. Contents of the pack and other information
1. What Disodium Pamidronate is and what it is used for
The active ingredient in Disodium Pamidronate 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 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 receive Pamidronate Disodium Teva Do NOT receive Disodium Pamidronate 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 start to receive this medicine if you:
• are on a low sodium diet
• are taking any other medicines to lower calcium in your blood
• have fits
• have had thyroid surgery
• have a reduced number of red blood cells (anaemia), white blood cells (leukopenia) or platelets (thrombocytopenia)
• have kidney problems, or kidney impairment
• have heart problems
• have any liver problems
• have calcium or vitamin D deficiency
• have had any problems with your teeth or jaw
• have a feverish illness e.g. flu or something similar.
Other special warnings
• Visiting the dentist:
There is a risk of having jaw bone problems associated with this medicine, therefore it is important to tell your dentist that you are receiving Disodium Pamidronate before you have any dental treatment or surgery.
You should try and go to the dentist before you start your treatment with Pamidronate Sodium Teva, also tell your doctor if you need to have any dental treatment.
The dentist should avoid invasive dental procedures during treatment with Pamidronate Disodium Teva. Make sure you are careful with your dental hygiene and visit your dentist for regular checkups.
• There is a risk of fracture of the thigh bone (femur), particularly in patients receiving longterm 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 Pamidronate Disodium 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 Pamidronate Disodium Teva.
Children and adolescents
Disodium Pamidronate is not suitable for treatingchildren.
Other medicines and Pamidronate Disodium Teva
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. Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
• If you are pregnant or are planning to become pregnant, your doctor should not prescribe Disodium Pamidronate to you except in cases of life-threatening hypercalcaemia..
• Breast-feeding during treatment with Disodium Pamidronate is not recommended.
Driving and using machines
• Disodium Pamidronate may cause sleepiness or dizziness. If you are affected, DO NOT drive or operate machinery.
Disodium Pamidronate contains sodium
This medicinal product contains less than 1 mmol sodium (15 mg) per maximum dose (90 mg), i.e. essentially ‘sodium- free.’
3. How to receive Pamidronate Disodium Teva
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.
The recommended dose is:
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 Pamidronate Disodium Teva.
If you receive more Disodium Pamidronate 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 either been given it or have taken it too often, also tell your doctor or nurse straight away.
If you do not receive Pamidronate Disodium 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 have not received 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 have cause side effects, although not everybody gets them.
The side effects are usually mild and disappear as treatment continues.
Tell your doctor immediately if the following happens:
• 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).
This is a serious side effect, likely to affect up to 1 in 100 people. You may need urgent medical attention.
A very common side effect is 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.
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.
The following side effects have been reported at the approximate rates shown:
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 lymphocytes (a type of white blood cell), 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).
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
• pain or inflammation of the teeth, jaw or bones (osteonecrosis), particularly associated with dental procedures.
• 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)
• reduction in the number of white blood cells, which makes infections more likely
• high potassium and high sodium levels in the blood.
Not known (frequency cannot be estimated from the available data)
• Inflammation of the eye socket
Disodium Pamidronate 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 contains:
• The active substance is disodium pamidronate. 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 and Manufacturer
Marketing Authorisation Holder: TEVA UK Limited, Eastbourne, BN22 9AG.
Manufacturer: Pharmachemie B.V., Haarlem, The Netherlands
This leaflet was last revised: March 2014
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 24 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