3 mg / ml, 6 mg / ml and 9 mg / ml concentrate for solution for infusion pamidronate
disodium
What Pamidronate disodium Pfizer is and what it is used for
Pamidronate disodium Pfizer belongs to a group of medicines called bisphosphonates. The medicinal effect is that they bind to bone and counteract the breakdown of bone.
The drug is used against elevated calcium levels in the blood that are caused by tumors and to prevent the bone-degrading effect of certain types of tumors, including in patients with breast cancer or multiple myeloma. Talk to your doctor if you are wondering why you have been given this medicine.
What you need to know before you use Pfizer Pamidronate Disodium
Do not use Pamidizer disodium disodium
- if you are allergic to pamidronate disodium or any of the other ingredients of this medicine (listed in section 6) or other bisphosphonates (the group of medicines to which Pamidronate disodium Pfizer belongs)
Warnings and cautions
Talk to your doctor or nurse before using Pfizer Pamidronate Disodium
- if you have or have ever had thyroid problems
- if you suffer from any kidney disease
- if you suffer from any heart problems
- if you have blood disorders ( anemia ( anemia ), leukopenia (low levels of white blood cells ), or thrombocytopenia (low levels of platelets ))
- Pamidronate disodium Pfizer may cause eye irritation
- Pfizer pamidronate disodium is not recommended for use in children
- if you have or have had pain, swelling, or numbness in the jaw, a feeling of heaviness, or that any tooth has come loose. Your doctor may recommend that you have a dental examination before starting treatment with Pamidronate disodium Pfizer.
- If you are undergoing dental treatment or undergoing dental surgery, inform your dentist that you are being treated with Pamidronate disodium Pfizer and inform your doctor about your dental treatment.
While you are being treated with Pfidronate disodium Pfizer, you should maintain good oral hygiene (including regular toothbrushing) and have regular 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, wounds that do not heal, or fluids, as this may be a sign of a condition called osteonecrosis of the jaw (bone damage in the jaw ).
Patients undergoing chemotherapy and/or radiation therapy, taking steroids, undergoing dental surgery, not receiving regular dental care, having gum problems, smoking, or being previously treated with a bisphosphonate (used to treat or prevent bone diseases) may be at higher risk of developing osteonecrosis of the jaw.
When you are being treated with Pamidronate disodium Pfizer, your doctor will prescribe regular tests to check your treatment.
Children and young people
There is no clinical experience in children and adolescents (<18 years old).
Other medicines and Pfizer’s Pamidronate disodium
- Pamidronate disodium Pfizer should not be used at the same time as other bisphosphonates (the group to which Pfizer belongs to Pamidron disodium) or other drugs that lower calcium levels.
- Other medicines that affect the kidneys (your doctor or nurse knows which ones they are).
- Thalidomide (used to treat multiple myeloma ).
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, 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 Pfidronate disodium Pfizer during pregnancy. Animal studies have shown harmful effects on the fetus (skeletal changes). The potential risk to humans is unknown. Pamidronate treatment is not recommended during pregnancy unless necessary.
Breast-feeding is not recommended when you are being treated with Pamidronate disodium Pfizer.
Driving and using machines
If you feel drowsy or dizzy after being treated with pamidronate disodium, do not drive or use machines that require sharpened attention until these effects have stopped.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Pamidronate disodium Pfizer contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per maximum dose (90 mg), ie essentially ‘sodium-free’. However, if a saline solution (9 mg/ml sodium chloride solution) is used to dilute Pfizer Pamidronate disodium before administration, the sodium dose will be higher.
How to use Pfizer Pamidronate disodium
Pamidronate disodium Pfizer is given very slowly into a vein ( intravenous infusion ), never as a rapid injection. Your doctor will decide what is the right dose for you. The infusion time can be up to several hours depending on dose one. Your doctor will decide how many infusions you need and how often to give them.
The recommended dose per course of 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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are decreased calcium levels in the blood, flu-like symptoms, and fever (body temperature rises by 1-2 ° C) which occur when treatment is started and can last for 48 hours.
Some patients notice increased leg pain shortly after starting treatment. This usually improves after a few days. If not, tell your doctor.
Healthcare professionals can stop administering Pamidronate disodium Pfizer immediately if you experience symptoms of angioedema, such as the swollen face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing (uncommon side effects: may affect up to 1 in 100 people).
Tell your doctor immediately if you notice any of the following side effects from anaphylactic shock (severe allergic reaction ):
- a feeling of pressure over the chest, difficulty breathing, extensive rash, hives, swelling of the skin and mucous membranes, sudden drop in blood pressure. (Very rare side effects that may affect up to 1 in 10,000 people).
Other side effects that may occur:
Very common (may affect more than 1 user in 10):
- Fever and flu-like symptoms, sometimes accompanied by malaise, stiffness, fatigue, and sudden feeling of heat.
- Decreased levels of calcium and phosphate in the blood.
Common (may affect up to 1 in 10 people):
- Decreased white blood cell count (lymphocytopenia),
- anemia decreased platelet count ( thrombocytopenia ),
- decreased levels of potassium and magnesium in the blood,
- headache,
- insomnia,
- drowsiness,
- nausea,
- vomiting,
- diarrhea, constipation, abdominal pain, loss of appetite,
- transient leg pain, joint pain, muscle aches, muscle cramps, general aches, pains,
- redness or swelling at the infusion site,
- tenderness or pain in the veins, possibly concomitantly with a local blood clot,
- high blood pressure,
- tingling in the hands and feet,
- numbness,
- inflammation of the conjunctiva of the eye ( conjunctivitis ), skin rash,
- increased serum creatinine ( a blood test that measures kidney function).
Uncommon (may affect up to 1 in 100 people):
- Allergic reaction,
- respiratory cramps,
- seizures,
- indignation,
- dizziness,
- mental lethargy ( lethargy ),
- inflammation of the eye which causes pain and redness,
- low blood pressure,
- upset stomach, indigestion,
- itching,
- muscle cramps,
- bone tissue death ( osteonecrosis ),
- abnormal liver function tests,
- increased level of urea in blood/serum,
- acute renal failure.
Rare (may affect up to 1 in 1,000 people):
- Kidney problems
- Unusual femoral fractures, especially in patients receiving long-term treatment for osteoporosis, may occur in rare cases.
Contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin as this may be an early sign of a possible femoral fracture.
Very rare (may affect up to 1 in 10,000 people):
- Flushing cold sores/blisters or shingles (reactivation of the herpes virus ),
- decreased white blood cell count ( leukopenia ),
- increased levels of potassium and sodium in the blood,
- confusion,
- heart failure,
- breathing difficulties,
- lung disease,
- kidney problems (usually in patients with a history of kidney problems),
- blood in the urine,
- visual hallucinations (seeing things that do not exist),
- visual disturbances/eye pain,
- pneumonia that can cause coughing, difficulty breathing, and rumbling sounds in the chest,
- anaphylactic shock (severe allergic reaction ).
- Talk to a doctor if you have ear pain, discharge from the ear, and / or an ear infection. This may be a sign of a bone injury in the ear.
Has been reported (occurs in an unknown number of users)
- Irregular heart rhythm ( atrial fibrillation ) has been seen in patients receiving pamidronate. It is currently unclear whether pamidronate causes irregular heartbeat. You should tell your doctor if you experience irregular heartbeat during treatment with pamidronate.
- Redness in the area around the eyes.
- Idiopathic (benign) intracranial hypertension ( pseudotumor cerebri ), is a disorder associated with the nervous system.
- Pain in the mouth, teeth, and/or jaw, swelling or sores that do not heal on the inside of the mouth or jaw, warts, numbness, or a feeling of heaviness in the jaw or tooth loss. This may be a sign of bone damage in the jaw ( osteonecrosis ). Tell your doctor and dentist immediately if you experience such symptoms while you are being treated with Pamidronate disodium Pfizer or after stopping treatment.
How to store Pamidronate disodium Pfizer
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 carton and bottle label after EXP: The expiration date is the last day of that month.
Do not store above 25 ° C.
After dilution, the drug should be used immediately. If the diluted medicine can not be used immediately, it can be stored for a maximum of 24 hours at 2 ° C-8 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is pamidronate disodium. Each milliliter (ml) 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 the medicine looks like and the contents of the pack
Pamidronate disodium Pfizer concentrates for solution for infusion (sterile concentrate) is a clear, colorless solution.
Pamidizer Pamidronate disodium 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.
Pamidizer disodium Pfizer 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 Authorization Holder and Manufacturer
Marketing Authorisation Holder
Pfizer AB
191 90 Sollentuna
Phone: 08-550 520 00
Email: eumedinfo@pfizer.com
Manufacturer:
Pfizer Service Company BVBA, Hoge Wei 10, 1930 Zaventem, Belgium