3 mg / ml concentrate for solution for infusion Disodium
pamidronate
What Pamifos is and what it is used for
Pamifos is a drug that affects the building and breaking down of bones. The drug is provided in the form of a solution that can be given as a slow infusion (drip).
Pamifos is used for three reasons:
- The drug reduces the high level of calcium in the blood caused by cancer.
- It inhibits the breakdown of bones in patients whose breast cancer has spread to the skeleton.
- It is used in patients with advanced multiple myeloma ( tumor of bone marrow cells).
Disodium pamidronate contained in Pamifos may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you get Pamifos
Pamifos will not be used
- if you are allergic to disodium pamidronate, other medicines containing bisphosphonates, or any of the other ingredients of this medicine (listed in section 6).
- if you are breastfeeding.
Warnings and cautions
Talk to your doctor or pharmacist before receiving Pamifos
- if you are pregnant.
- if you have been prescribed a low-salt diet.
- if you have low blood cell counts ( red blood cells, white blood cells, or platelets ).
- if you have had thyroid surgery.
- if you have heart problems.
- if you have liver problems.
- if you have kidney disease.
- if you are taking other medicines that may affect your kidneys.
- if you are taking other similar medicines that lower your blood calcium level.
- 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 Pamifos.
- If you are undergoing dental treatment or undergoing dental surgery, inform your dentist that you are being treated with Pamifos and inform your doctor about your dental treatment.
While you are being treated with Pamifos, 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.
Patients undergoing chemotherapy and/or radiation therapy who are taking steroids, undergoing dental surgery, who are not receiving regular dental care, who have gum problems, who are smokers, or who have previously been treated with a bisphosphonate (used to treat or prevent bone diseases) may have a higher risk of developing osteonecrosis of the jaw.
Once you have started treatment with Pamifos, your doctor will check your serum electrolytes, calcium, and phosphate and ensure that you have a good fluid balance.
If you are pregnant, you may only be prescribed pamidronate if necessary.
Other medicines and Pamifos
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interfere with your treatment. Tell your doctor or pharmacist if you are taking any of the following:
- other drugs for high calcium levels such as calcitonin.
- other bisphosphonates.
- other drugs that can affect the kidneys (doctors or pharmacists know what these drugs are).
- thalidomide (used to treat certain types of cancer).
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.
Pregnancy
If you are pregnant or likely to become pregnant, tell your doctor before taking disodium pamidronate.
Breast-feeding
If you are breastfeeding, you must not be treated with disodium pamidronate.
Driving and using machines
Do not drive or use machines
- if you feel drowsy or dizzy after an infusion of Pamifos.
- if you experience a side effect that may affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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.
Pamifos 3 mg / ml contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free’.
How to get Pamifos
Method of administration and route of administration
Pamifos is a solution that must be diluted and given as a slow infusion via the drip.
You receive Pamifos in a reconstituted solution that is given very slowly into a vein via a drip ( intravenous infusion ). The doctor only uses freshly prepared and clear solutions and does not use the solution if it contains particles.
Disodium pamidronate is only given to adult patients over 18 years of age under the supervision of a physician with the ability and equipment to monitor the effect of the drug.
Dosage
The dose of medicine you receive depends on your state of health, the level of calcium in your blood, and how well your kidneys are functioning. The usual dose per course of treatment is between 15 mg and 90 mg. Your doctor will decide how many infusions you need, how often they will be given, and how long the treatment will last.
During the treatment, you may submit blood samples and any urine samples.
If you take more Pamifos than you should
Because you are receiving this medicine while you are in the hospital, it is unlikely that you will receive too little or too much of the medicine.
If you get paresthesia (numbness), tetany (muscle cramps especially in the jaws, arms, or legs), or low blood pressure (feeling dizzy) during treatment with Pamifos, tell your healthcare provider. You then get calcium in a vein, which counteracts the symptoms. However, these symptoms are unlikely to occur during an infusion.
If, after all, you have received a dose higher than the recommended one, you will be closely monitored by your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of the following side effects may be associated with your underlying illness.
- Very common (may affect more than 1 in 10 people) side effects are flu-like symptoms and mild fever (increase in body temperature of 1 2 ° C) that occur within the first 48 hours and usually last no longer than 24 hours. Acute “flu-like” reactions usually occur only with the first infusion of Pamifos.
Should these side effects occur, they usually disappear after you have been treated with Pamifos for a while and you can continue with the treatment. Tell your doctor if any side effect is bothersome or prolonged.
- No known frequency (can not be calculated from the available data): 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 Pamifos or after stopping treatment.
Cases of skeletal bone injury ( osteonecrosis ) – primarily in the jaw – have been reported mainly in cancer patients treated with bisphosphonates, e.g. Pamifos. Many of the patients had signs of local infection, such as bone marrow inflammation (osteomyelitis), and the majority of the reports refer to cancer patients after tooth extractions or other dental surgery. There are a large number of well-documented risk factors for osteonecroses of the jaw, such as cancer diagnosis, other concomitant treatments (eg chemotherapy, radiation therapy, corticosteroids ), and concomitant diseases (eg anemia, diseases that affect blood coagulation[coagulopathies], infection, existing diseases of the mouth). You should avoid dental surgery while you are being treated with Pamifos. If you have osteonecrosis of the jaw, dental surgery can make the disease worse. It is not known whether the risk of osteonecrosis of the jaw in patients requiring dental treatment is reduced if interruption of bisphosphonate treatment is discontinued.
If you suddenly develop a rash with itching, or swelling of the hands, feet, ankles, face, lips, mouth, or throat, have difficulty swallowing or breathing, this may be a severe allergic reaction.
If this happens, contact a doctor immediately.
Disodium pamidronate can affect the blood. Your doctor will check this through blood tests.
Irregular heart rhythm ( atrial fibrillation ) has been seen in patients treated with pamidronate but it is currently unknown if this is caused by pamidronate. You should contact your doctor if you experience irregular heartbeat during treatment with pamidronate.
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 common (may affect more than 1 user in 10):
- Low levels of calcium and phosphate in the blood.
- Fever and flu-like symptoms are sometimes accompanied by fatigue, chills, fatigue, and hot flashes.
Common (may affect up to 1 in 10 people):
- Low red blood cell count ( anemia ).
- Low platelet count ( thrombocytopenia ).
- A low number of lymphocytes (type of white blood cells ) in the blood.
- Low levels of potassium in the blood.
- Low magnesium in the blood.
- Symptoms are caused by low calcium in the blood (numbness, muscle cramps, or muscle spasms).
- Headache.
- Insomnia . _
- Sleepiness ( somnolence ).
- Conjunctivitis (red eyes)
- High blood pressure ( hypertension ).
- Gastrointestinal reactions such as nausea, vomiting, loss of appetite ( anorexia ), abdominal pain, diarrhea, constipation, and gastritis.
- Rash.
- Episodes of skeletal, joint, or muscle pain.
- Pain, skin rash and swelling at the infusion site, inflammation or blood clot in the arm vein, general body pain.
- High levels of creatinine in serum.
Uncommon (may affect up to 1 in 100 people):
- Hypersensitivity with wheezing ( bronchospasm ), difficulty breathing ( dyspnoea ), acute swelling of the eyelids, lips, and tongue ( angioneurotic edema ).
- Seizures.
- Restlessness ( agitation ).
- Dizziness.
- Numbness ( lethargy ).
- Inflammation of the grape membrane of the eye ( uveitis ).
- Low blood pressure ( hypotension ).
- Digestive problems.
- Skin itching.
- Muscle cramps.
- Reduction in the amount of urine produced ( kidney failure ).
- Abnormal liver and kidney values.
Rare (may affect up to 1 in 1,000 people):
- Unusual femoral fractures.
- A change in kidney function is called glomerulosclerosis, some of the symptoms of this condition can be fluid retention, nausea, and fatigue.
- Protein leakage in the urine is associated with swelling of the legs and abdomen ( nephrotic syndrome ).
Very rare (may affect up to 1 in 10,000 people):
- New episodes of the previous infection with cold sores or shingles.
- Decreased number of white blood cells in the blood ( leukopenia ).
- Anaphylactic shock (life-threatening allergy with immediate restlessness, dizziness or fainting, shortness of breath, drop in blood pressure, or itching ).
- Elevated potassium levels in the blood.
- High sodium levels in the blood ( hypernatremia ).
- Confusion (disorientation) due to high sodium in the blood.
- Confusion or visual hallucinations (see non-existent).
- Irritation/inflammation of the connective tissue between the tendon and conjunctiva of the eye causes pain and redness (episcleritis).
- Inflammation of the retina of the eye causes pain and redness (scleritis).
- The abnormal visual condition makes everything appear to have a yellow tone (xanthopsia).
- Impaired heart failure with difficulty breathing.
- Severe lung disease ( acute respiratory distress syndrome).
- Inflammation of the lungs (interstitial lung disease).
- Deterioration of existing kidney disease.
- Blood in the urine.
- Kidney inflammation.
- 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 the unknown number of users):
- Irregular heartbeat ( atrial fibrillation ).
- Inflammation of structures inside the eye socket ( inflammation of the orbit).
- 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 ).
How to store Pamifos
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the label on the vial and carton after “EXP”.
No special storage instructions.
Shelf life after dilution in 5% glucose solution or 0.9% sodium chloride solution: Chemical and physical in-use stability has been demonstrated during storage for 96 hours at 25 ° C.
From a microbiological point of view, the diluted solution should be used immediately. If the solution is not used immediately, the user is responsible for the storage time during use and conditions before use. The time should not normally exceed 24 hours at 2‑8 ° C unless dilution has been performed under controlled and validated aseptic conditions.
Contents of the pack and other information
Content declaration
- The active substance is disodium pamidronate (from the group bisphosphonates).
- The other ingredients are sodium hydroxide, hydrochloric acid, and water for injections.
What the medicine looks like and the contents of the pack
Pamifos are supplied in glass containers called vials.
One milliliter (ml) solution contains 3 milligrams (mg) of disodium pamidronate in the form of pamidronic acid 2,527 mg.
5 ml vial (available in packs of 1, 4, or 10 vials and as a multi-pack of 4 packs, each containing 1 vial ) contains 15 mg of disodium pamidronate.
10 ml vial (available in packs of 1, 4, or 10 vials and as multi-pack of 4 packs, each containing 1 vial ) contains 30 mg disodium pamidronate.
20 ml vial (available in packs of 1, 4, or 10 vials and as a multi-pack of 4 packs, each containing 1 vial ) contains 60 mg of disodium pamidronate.
30 ml vial (available in packs of 1, 4, or 10 vials and as a multi-pack of 4 packs, each containing 1 vial ) contains 90 mg of disodium pamidronate.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
medac
Society for clinical
Special preparations mbH
Theater. 6
22880 Wedel
Germany
This medicinal product is authorized under the European Economic Area under the names:
Denmark, Finland, Slovakia, Sweden, Germany:
Pamifos
France:
Pamidronate of sodium MYLAN
Netherlands:
Pamper
Poland:
Pamidronate medac
United Kingdom:
Medac Disodium Pamidronate
Czech Republic:
Pamidronate medac