Pamidronate Disodium 9 Mg/Ml Concentrate For Solution For Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER PAMIDRONATE DISODIUM 3 mg/ ml, 6 mg/ ml & 9 mg/ ml CONCENTRATE FOR SOLUTION FOR INFUSION )
(Pamidronate disodium)
Read all of this leaflet carefully before you start using this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Pamidronate is and what it is used for
2. Before you use Pamidronate
3. How to use Pamidronate
4. Possible side effects
5. How to store Pamidronate
6. Further information
1. WHAT PAMIDRONATE IS AND WHAT IT IS USED FOR
The name of your medicine is Pamidronate Disodium 3 mg/ ml, 6 mg/ ml or 9 mg/ ml Concentrate For Solution For Infusion which is to be given as a slow injection via a drip. Throughout the rest of the leaflet it will be referred to as Pamidronate.
The active ingredient in Pamidronate is called pamidronate disodium. This is one of a group of medicines called biphosphonates which can help to regulate the amount of calcium in the blood.
High blood calcium levels (hypercalcaemia) occur in a number of conditions, including some types of cancer. Often, hypercalcaemia is caused by the release of calcium from bones. Pamidronate sticks to bones and helps to reduce the release of calcium into the blood. If untreated, hypercalcaemia can cause symptoms such as nausea, tiredness and confusion.
Pamidronate is used to treat high blood calcium levels caused by some cancers. In some patients with cancer, it is also used to treat bone disease and to help relieve bone pain.
Pamidronate is also used to treat Paget’s disease.
2. BEFORE YOU USE PAMIDRONATE Do not use Pamidronate
- if you have shown signs of hypersensitivity (severe) allergy to Pamidronate on previous occasions
- if you are pregnant or breastfeeding Take special care with Pamidronate
- if you have kidney problems
- if you have heart problems
- if you have thyroid problems
- if you have low levels of blood cells (red blood cells, white blood cells or platelets)
- if you suffer from calcium or vitamin D deficiency
- if you are taking other similar medicines that reduce the levels of calcium
- if you had or have pain, swelling or numbness of the jaw or a “heavy jaw feeling” or loosening of a tooth It is important to tell the doctor about any of your medical conditions, whether they are included in the above lists or not. Please tell your doctor if you are taking, or have recently taken, any other medicines, including ones that are not prescribed for you.
Please tell your doctor if you need to undergo an examination of your bones, as Pamidronate could interfere with the examination.
If you go into hospital, let the medical staff know you are taking Pamidronate.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, especially, if you are using other drugs known as biphosphonates.
Pregnancy and breast-feeding Pregnancy
Pamidronate should not be used during pregnancy at any stage, unless you have life-threatening high amount of calcium in the blood, which cannot be controlled by any other means.
If pregnancy occurs during treatment, contact your doctor for genetic counselling.
Women of childbearing potential
Women of child-bearing potential should use effective contraception during treatment and up to 3 months after treatment.
Breastfeeding
Breast feeding must be discontinued before starting treatment with Pamidronate.
Fertility
Men being treated with Pamidronate are advised not to father a child during and up to 3 months after treatment. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or use machines:
• if you feel drowsy or dizzy
• if you experience any effect which may impair your ability to drive or use machines.
Important Information about Pamidronate
If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Pamidronate.
3. HOW PAMIDRONATE IS USED
Your doctor will have decided on the right dose depending on your condition.
A doctor or nurse will prepare the injection by diluting this solution with a special infusion fluid. The made-up solution must be stored in a refrigerator and used within 24 hours.
Pamidronate is given by very slow injection into a vein (intravenous infusion). The infusion will take 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
Dosage guidelines are as follows:
For hypercalcaemia
15-90 mg given as a single or several infusions.
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. For Paget’s disease
180 mg given as either 30 mg once a week for 6 weeks, or 60 mg every other week for 6 weeks.
Your doctor may also give you a test dose of 30 mg to see how you respond to the treatment.
Your doctor may also have prescribed treatment with Calcium and Vitamin D at the same time as Pamidronate. What if you have had too much Pamidronate? (Overdose)
If you think you have either been given or have taken too much Pamidronate tell your doctor or nurse straight away.
What if you miss a dose of Pamidronate?
If you miss one of your appointments, please let your doctor or nurse know immediately.
4. POSSIBLE SIDE EFFECTS
Like all medicines, pamidronate can cause side effects, although not everybody gets them.
If any of the following happen, tell the doctor immediately:
• severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.
These are very serious side effects. You may need urgent medical attention. All of these very serious side effects are rare.
The most common effects are flu-like symptoms and a mild fever (increase in body temperature) which occurs at the start of treatment and may last for 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.
Other side effects:
Please tell your doctor if any of the following gets serious or lasts longer than a few days:
Very Common (affects more than 1 in 10 people)
- Changes in blood test results (including low potassium, low phosphate, low magnesium and raised serum creatinine levels or, very rarely, raised potassium or sodium levels).
Common (affects less than 1 in 10 people)
- pain, redness or swelling at the injection site
- joint muscle pain or generalised pain
- nausea, vomiting, headache sleeplessness, tiredness
- eye irritations
- skin rash or unexplained bruising/increased bleeding
- loss of appetite, stomach pain, gastritis, constipation or diarrhoea
- tingling in hands and feet and muscle spasms (symptoms of low level of calcium)
- high blood pressure
- low level of white blood cells (leucopenia) or red blood cells (anaemia)
Uncommon (affects less than 1 in 100 people)
- muscle cramps or spasms
- dizziness, confusion, agitation, seizures
- problems with vision, painful red eyes
- low blood pressure
- itching
- indigestion
- deterioration of kidney function (e.g. unexpected change in the amount of urine produced and/or its appearance), abnormal liver function tests or increases in serum urea
- problems with teeth or jaw
Rare (affects less than 1 in 1,000 people)
- A change in kidney function known as glomerulosclerosis. Some of the symptoms of this condition may be, fluid retention, nausea and fatigue. Tell your doctor if you suspect that you might have these symptoms.
- 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 (affects less than 1 in 10,000 people)
- cardiac effects which may include a difficulty in breathing and fluid retention
- confusion or hallucinations (seeing things or hearing things that are not there)
- worsening of an existing kidney problem e.g. blood in urine
- flare up of cold sores or shingles
Pamidronate may affect your blood (the number of particular cells and the chemistry of the blood). Your doctor will monitor for this with blood tests.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE PAMIDRONATE
Keep out of the reach and sight of children.
This medicine should not be used after the expiry date which is stated on the vial label and carton after “EXP”. The expiry date refers to the last day of that month.
Your medication should not be stored above 25°C. The vials should be kept in the original package in order to protect from light.
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.
6. FURTHER INFORMATION What Pamidronate contains
Each ml contains 3 mg or 6 mg or 9 mg of the active ingredient pamidronate disodium anhydrous.
The other ingredients are mannitol, phosphoric acid and water for injections.
The 3mg/ml strength of Pamidronate contains 3.97mg/ml of pamidronate disodium pentahydrate, which is equivalent to 3mg/ml of pamidronate disodium anhydrous
The 6mg/ml strength of Pamidronate contains 7.93mg/ml of pamidronate disodium pentahydrate, which is equivalent to 6mg/ml of pamidronate disodium anhydrous
The 9mg/ml strength of Pamidronate contains 11.90mg/ml of pamidronate disodium pentahydrate, which is equivalent to 9mg/ml of pamidronate disodium anhydrous
This leaflet does not contain the complete information on Pamidronate. If you have any questions, or are not sure about anything, ask your doctor or pharmacist.
What Pamidronate looks like and contents of the pack
Pamidronate 3 mg/ ml or 6 mg/ ml or 9 mg/ ml is a clear colourless solution in glass vials with rubber stoppers sealed with colour coded aluminium flip-off, tear-off seals.
Pamidronate 3 mg/ ml or 6 mg/ ml or 9 mg/ ml is produced in 10 ml vials. They are available in single packs.
Marketing Authorisation Holder
APTIL Pharma Limited,
9th floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL.
Manufacturer:
APC Pharmaceuticals & Chemicals (Europe) Limited,
9th floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL.
This leaflet was last amended 05/2012. ^
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