Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - bondronat

Document Subject

Generated Narrative: MedicinalProductDefinition mpf352e985084276fc8e67c6d45807c1bf

identifier: http://ema.europa.eu/identifier/EU/1/96/012/004

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Bondronat 2 mg concentrate for solution for infusion.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-f352e985084276fc8e67c6d45807c1bf

identifier: http://ema.europa.eu/identifier/EU/1/96/012/004

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - bondronat

Attesters

What is in this leaflet:

1. What Bondronat is and what it is used for
2. What you need to know before you receive Bondronat
3. How to receive Bondronat
4. Possible side effects
5. How to store Bondronat
6. Contents of the pack and other information

Bondronat contains the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates.

Bondronat is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called bone metastases ).

• It helps to prevent your bones from breaking (fractures)
• It helps to prevent other bone problems that may need surgery or radiotherapy.

Bondronat can also be prescribed if you have a raised calcium level in your blood due to a tumour.

Bondronat works by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker.

Do not receive Bondronat:

• if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are listed in section 6
• if you have, or have ever had low levels of calcium in your blood.

Do not receive this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before having Bondronat.

Warnings and precautions A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving Bondronat for cancer-related conditions. ONJ can also occur after stopping treatment.

It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.

Before receiving treatment, tell your doctor/nurse (health care professional) if:

• you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction
• you don t receive routine dental care or have not had a dental check up for a long time
• you are a smoker (as this may increase the risk of dental problems)
• you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
• you have cancer.

Your doctor may ask you to undergo a dental examination before starting treatment with Bondronat.

While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Bondronat.

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 osteonecrosis of the jaw.

Talk to your doctor, pharmacist or nurse before receiving Bondronat:

• if you are allergic to any other bisphosphonates
• if you have high or low levels of vitamin D, calcium or any other minerals
• if you have kidney problems
• if you have heart problems and the doctor recommended to limit your daily fluid intake.

Cases of serious, sometimes fatal allergic reaction have been reported in patients treated with intravenous ibandronic acid. If you experience one of the following symptoms, such as shortness of breath/difficulty breathing, tight feeling in throat, swelling of tongue, dizziness, feeling of loss of consciousness, redness or swelling of face, body rash, nausea and vomiting, you should immediately alert your doctor or nurse (see section 4).

Children and adolescents Bondronat should not be used in children and adolescents below the age of 18 years.

Other medicines and Bondronat Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Bondronat can affect the way some other medicines work. Also, some other medicines can affect the way Bondronat works.

In particular, tell your doctor or pharmacist if you are receiving a type of antibiotic injection called aminoglycoside such as gentamicin. This is because aminoglycosides and Bondronat can both lower the amount of calcium in your blood.

Pregnancy and breast-feeding Do not receive Bondronat if you are pregnant, planning to get pregnant or if you are breast-feeding. Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines You can drive and use machines as it s expected that Bondronat has no or negligible effect on your ability to drive and use machines. Talk to your doctor first if you want to drive, use machines or tools.

Bondronat contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially sodium free .

Receiving this medicine

• Bondronat is normally given by a doctor or other medical staff who have experience with the treatment of cancer
• it is given as an infusion into your vein.

Your doctor may do regular blood tests while you are receiving Bondronat. This is to check that you are being given the right amount of this medicine.

How much to receive Your doctor will work out how much Bondronat you will be given depending on your illness.
If you have breast cancer that has spread to your bones, then the recommended dose is 3 vials (6 mg) every 3-4 weeks, as an infusion in your vein over at least 15 minutes.

If you have a raised calcium level in your blood due to a tumour then the recommended dose is a single administration of 1 vial (2 mg) or 2 vials (4 mg), depending on the severity of your illness. The medicine should be administered as an infusion in your vein over two hours. A repeated dose may be considered in case of insufficient response or if your illness reappears.

Your doctor may adjust your dose and duration of intravenous infusion if you have kidney problems.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects although not everybody gets them.

Talk to a nurse or a doctor straight away if you notice any of the following serious side effects you may need urgent medical treatment:

Rare (may affect up to 1 in 1,000 people)

• persistent eye pain and inflammation
• new pain, weakness or discomfort in your thigh, hip or groin. You may have early signs of a possible unusual fracture of the thigh bone.

Very rare (may affect up to 1 in 10,000 people)

• pain or sore in your mouth or jaw. You may have early signs of severe jaw problems (necrosis (dead bone tissue) in the jaw bone)
• Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear
• itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may be having a serious, potentially life threatening allergic reaction (see section 2)
• severe adverse skin reactions.

Not known (frequency cannot be estimated from the available data)

• asthma attack.

Other possible side effects

Common (may affect up to 1 in 10 people)

• flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, fatigue, bone pain and aching muscles and joints. These symptoms usually disappear within a couple of hours or days. Talk to a nurse or doctor if any effects become troublesome or last more than a couple of days
• rise in body temperature
• stomach and tummy pain, indigestion, being sick, vomiting or having diarrhoea (loose bowels)
• low calcium or phosphate levels in your blood
• changes in blood test results such as Gamma GT or creatinine
• a heart rhythm problem called bundle branch block
• pain in your bone or muscles
• headache, feeling dizzy or feeling weak
• feeling thirsty, sore throat, changes in taste
• swollen legs or feet
• aching joints, arthritis, or other joint problems
• problems with your parathyroid gland
• bruising
• infections
• a problem with your eyes called cataracts
• skin problems
• tooth problems.

Uncommon (may affect less than 1 in 100 people)

• shaking or shivering
• your body temperature getting too low ( hypothermia )
• a condition affecting the blood vessels in your brain called cerebrovascular disorder (stroke
  or brain bleeding)
• heart and circulatory problems (including palpitations, heart attack, hypertension (high blood pressure) and varicose veins)
• changes in your blood cells ( anaemia )
• a high level of alkaline phosphatase in your blood
• fluid build up and swelling ( lymphoedema )
• fluid in your lungs
• stomach problems such as gastroenteritis or gastritis
• gallstones
• being unable to pass water (urine), cystitis (bladder inflammation)
• migraine
• pain in your nerves, damaged nerve root
• deafness
• increased sensitivity of sound, taste or touch or changes in smell
• difficulty swallowing
• mouth ulcers, swollen lips ( cheilitis ), oral thrush
• itching or tingling skin around your mouth
• pelvic pain, discharge, itching or pain in the vagina
• a skin growth called a benign skin neoplasm
• memory loss
• sleep problems, feeling anxious, emotional instability, or mood swings
• skin rash
• hair loss
• injury or pain at the injection site
• weight loss
• kidney cyst (fluid-filled sac in the kidney).

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

• 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 folding box and on the label after EXP. The expiry date refers to the last day of that month
• After dilution the infusion solution is stable for 24 hours at 2-8 C (in a refrigerator)
• Do not use this medicine if you notice that the solution is not clear or contains particles.

What Bondronat contains

• The active substance is ibandronic acid. One vial with 2 ml of a concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate)
• The other ingredients are sodium chloride, acetic acid, sodium acetate and water for injections.

What Bondronat looks like and contents of the pack Bondronat is a colourless, clear solution. Bondronat is supplied as packs containing 1 vial (2 ml type I glass vial with a bromobutyl rubber stopper).

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Atnahs Pharma Netherlands B.V. Copenhagen Towers,
restads Boulevard 108, 5.tv DK-2300 K benhavn S,
Denmark

Manufacturer

Atnahs Pharma Denmark ApS Copenhagen Towers,
restads Boulevard 108, 5.tv DK-2300 K benhavn S,
Denmark

Or

Universal Farma, S.L. C/ El Tejido 2 Azuqueca de Henares 19200 Guadalajara Spain

This leaflet was last revised in {MM/YYYY}

Detailed information on this medicine is available on the European Medicines Agency web site: