Novartis

Infusion solution 5 mg 
(Clear, colorless solution)

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Aclasta is and what it is used for 
2. What you need to know before you take Aclasta 
3. How to use Aclasta 
4. Possible side effects 
5. How to store Aclasta 6. Contents of the pack 
and other information

1. What Aclasta is and what it is used for

Aclasta contains the active substance zoledronic acid. Aclasta belongs to a group of medicines called bisphosphonates and is used to treat osteoporosis in postmenopausal women and in adult men with osteoporosis or osteoporosis caused by treatment with corticosteroids used to treat inflammation and Paget’s disease in adults.

Osteoporosis

Osteoporosis is a disease that consists of thinning and weakening of the bone tissue and is common in women after menopause, but can also occur in men. In menopause woman’s ovaries stop producing the female hormone et estrogen, which helps to keep bones healthy. After menopause, there is a loss of bone tissue, which means that the skeleton is weakened and broken more easily. Osteoporosis can also occur in men and women due to long-term use of corticosteroids, which can affect the strength of the skeleton. Many patients with osteoporosis have no symptoms, but they are still at risk of skeletal fractures, due to osteoporosis made the skeleton weaker. Decreased circulating levels of sex hormones, mainly estrogen converted from androgens, also play a role in the more gradual bone loss observed in men. In both women and men, Aclasta strengthens the skeleton and therefore there is less risk of it breaking. Aclasta is also used for patients who have recently broken their hip in a minor accident such as a fall and therefore have a national for subsequent bone fractures.

Paget’s disease

Normally, old bone tissue is replaced with new. This process is called remodeling. In Paget’s disease, this remodeling is too fast and new bone tissue is formed in a disordered manner, making it weaker than normal. If the disease is not treated, the bones can deform and cause pain and possibly break. Aclasta works by restoring the bone remodeling process to normal, ensuring the formation of normal bone tissue and thus rebuilding the strength of the bone tissue.

2. What you need to know before you receive Aclasta

Do not use Aclasta

Carefully follow all instructions given to you by your doctor, pharmacist, or nurse before receiving Aclasta.

Aclasta should not be used:

  • if you are allergic to zoledronic acid, other bisphosphonates, or any of the other ingredients of this medicine (listed in section 6).
  • if you have hypocalcemia (your blood calcium level is too low).
  • if you have severe kidney disease.
  • if you are pregnant.
  • if you are breast-feeding.

Warnings and cautions

Talk to your doctor before receiving Aclasta:

  • if you are being treated with a medicine containing zoledronic acid, which is also the active substance in Aclasta (zoledronic acid is used in adult patients with certain cancers to prevent bone complications or to reduce the amount of calcium).
  • if you have or have had any kidney disease.
  • if you can not take daily calcium supplements.
  • if you have had surgery to remove any or all of the parathyroid glands in your throat.
  • if you have removed parts of your small intestine.

Following the marketing authorization, a side effect called osteonecrosis of the jaw (ONJ) ​​(bone damage in the jaw) has been reported in patients treated with Aclasta (zoledronic acid) for osteoporosis. ONJ can also occur after the end of treatment.

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

Before receiving Aclasta treatment, talk to your doctor, pharmacist, or nurse

  • you have any problems with your mouth or teeth such as poor dental health, gum problems, or a planned tooth extraction;
  • you do not receive regular dental care or have not had a dental examination for a long time;
  • you are a smoker (because it can increase the risk of dental problems);
  • you have previously been treated with a bisphosphonate (used to treat or prevent bone diseases);
  • you are taking medicines called corticosteroids (such as prednisolone or dexamethasone);
  • you have cancer.

Your doctor may ask you to have a dental examination before starting treatment with Aclasta.

While you are being treated with Aclasta, you should maintain good oral hygiene (including regular toothbrushing) and have regular dental check-ups. If you wear dentures, you should make sure that they fit snugly. If you are having dental treatment or are about to undergo dental surgery (eg extracting a tooth), inform your doctor about your dental care and tell your dentist that you are being treated with Aclasta. Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or wounds that do not heal or fluid, as these may be signs of osteonecrosis of the jaw.

Monitoring of renal function

Your doctor should take a blood test to check your kidney function (creatinine levels) before each dose of Aclasta. It is important that you drink at least 2 glasses of liquid (such as water), a few hours before you receive Aclasta, as directed by your healthcare professional.

Children and young people

Aclasta is not recommended for people under 18 years of age.

Other medicines and Aclasta

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

It is important that your doctor knows all the medicines you are taking, especially if you are taking any medicines that may be harmful to your kidneys (eg aminoglycosides ) or diuretics (” diuretics “) which may cause dehydration.

Pregnancy and breastfeeding

Aclasta should not be given to you if you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby.

Ask your doctor, pharmacist, or nurse for advice before taking this medicine.

Driving and using machines

If you feel dizzy while being treated with Aclasta, do not drive or use machines until you feel better.

Aclasta contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 100 ml vial of Aclasta, ie essentially ‘sodium-free’. essentially “sodium-free”.

How to use Aclasta

Carefully follow all instructions given to you by your doctor or nurse. If you are not sure, talk to your doctor or nurse.

Osteoporosis

The usual dose is 5 mg given as an infusion into a vein at one time per year by your doctor or nurse. Infusion one takes at least 15 minutes.

In case you have recently broken your hip, it is recommended that Aclasta be given two or more weeks after your hip surgery.

It is important to take calcium and vitamin D supplements (eg in tablet form) according to the instructions given to you by your doctor.

In osteoporosis, Aclasta works for one year. Your doctor will tell you when to return for your next dose.

Paget’s disease

For the treatment of Paget’s disease: Aclasta should only be prescribed by doctors who have experience in the treatment of Paget’s disease.

The usual dose is 5 mg, which is given as a first infusion into a vein by your doctor or nurse. Infusion one takes at least 15 minutes. Aclasta may last for more than a year and your doctor will tell you if you need to be treated again.

Your doctor may recommend that you take calcium and vitamin D supplements (eg tablets) for at least the first ten days after receiving Aclasta. It is important that you follow this advice carefully so that the level of calcium in the blood does not become too low during the period after infusion one. Your doctor will inform you about the symptoms associated with hypocalcemia.

Aclasta with food and drink

Make sure you drink enough fluids (at least one or two glasses) before and after treatment with Aclasta as directed by your doctor. This helps prevent dehydration. You can eat normally on the day you are treated with Aclasta. This is especially important in patients taking diuretics (” diuretics “) and in elderly patients (65 years or older).

If you miss a dose of Aclasta

Contact your doctor or hospital as soon as possible to book a new appointment.

If you stop using Aclasta

If you are considering stopping treatment with Aclasta, go to your next scheduled visit and discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with Aclasta.

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

4. Possible side effects

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

Side effects associated with the first infusion are very common (occurring in 30% of patients), but are less common with subsequent infusions. Most of the side effects, such as fever and chills, muscle and joint pain, and headaches appear within the first three days after a dose of Aclasta. The symptoms are usually mild to moderate and disappear within three days. Your doctor may recommend a mild painkiller such as ibuprofen or paracetamol to reduce the side effects. The likelihood of experiencing these side effects decreases with continued treatment with Aclasta.

Some side effects can be serious

Common (may affect up to 1 in 10 people)

Irregular heart rhythm ( atrial fibrillation ) has been noted in patients treated with Aclasta for postmenopausal osteoporosis. It is currently unclear if Aclasta causes the irregular heartbeat, but you should report to your doctor if you experience such symptoms after being treated with Aclasta.

Uncommon (may affect up to 1 in 100 people)

Swelling, redness, pain, and itching in the eyes or photosensitivity.

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

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)

Pain in the mouth and/or jaw, swelling or sores that do not heal in 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 Aclasta or after stopping treatment.

Renal impairment (eg decreased urine output) may occur. Your doctor should take a blood test to check your kidney function (creatinine levels) before each dose of Aclasta. It is important that you drink at least 2 glasses of liquid (such as water), a few hours before you receive Aclasta, as directed by your healthcare professional.

If you experience any of the above side effects then you should contact your doctor immediately.

Aclasta can cause other side effects that are

Very common (may affect more than 1 user in 10)

Fever

Common (may affect up to 1 in 10 people)

Headache, dizziness, nausea, vomiting, diarrhea, muscle aches, pain in the bones and/or joints, back, arm, or leg pain, flu-like symptoms (eg fatigue, chills, joint and muscle pain), chills, feeling tired, and disinterest, weakness, pain, malaise, swelling and/or pain at the infusion site.

In patients with Paget’s disease, symptoms due to low levels of calcium in the blood, such as muscle spasms or numbness or a stinging sensation, especially around the mouth, have been reported.

Uncommon (may affect up to 1 in 100 people)

Influenza, upper respiratory infections, decreased red blood cells, loss of appetite, insomnia, drowsiness, which can include reduced alertness and attention, needle sticks or numbness, extreme fatigue, tremor, temporary loss of consciousness, an eye infection or irritation or inflammation with pain and redness, vertigo, increase in blood pressure et, flushing, coughing, shortness of breath, indigestion, abdominal pain, constipation, dry mouth, heartburn, rash, sweating, itching, red skin, neck pain, stiffness in muscles, skeleton and/or joints, joint swelling, muscle spasms, shoulder pain, chest and chest pain, joint inflammation, muscle weakness, abnormal laboratory results regarding kidney function, frequent urination, swelling and swelling of the hands, swelling of the hands, , thirst, toothache, taste disorders.

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

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. Low levels of phosphate in the blood.

Has been reported (occurs in an unknown number of users)

Severe allergic reactions including dizziness and difficulty breathing, swelling mainly in the face and throat, decreased blood pressure, dehydration secondary to acute phase reactions (symptoms such as fever, vomiting, and diarrhea which occurred after dosing ).

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Aclasta

Your doctor, pharmacist, or nurse knows how to store Aclasta correctly.

  • 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 after EXP.
  • The unopened vial does not require any special storage instructions.
  • After opening, the solution should be used immediately to prevent bacteria from coming into contact with the solution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. Normally this time should not exceed 24 hours at 2 ° C – 8 ° C. Allow the cooled solution to reach room temperature before administration.

6. Contents of the packaging and other information

Content declaration

  • The active substance is zoledronic acid. Each vial of 100 ml contains 5 mg of zoledronic acid (as monohydrate). One ml of solution contains 0.05 mg of anhydrous zoledronic acid (as monohydrate).
  • The other ingredients are mannitol, sodium citrate, and water for injections.

What the medicine looks like and the contents of the pack

Aclasta is a clear and colorless solution. It is supplied in a 100 ml plastic bottle as a reconstituted infusion solution. Aclasta is supplied in packs, one vial or multiple packs consisting of five packs, one vial each. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 LithuaniaSIA Novartis Baltics Lithuanian branches.Tel: +370 5 269 16 50
BulgariaNovartis Bulgaria EOODTel: +359 2 489 98 28 Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11
Czech RepublicNovartis sroTel: +420 225 775 111 HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00
DenmarkSandoz A / STel: +45 63 95 10 00 MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
GermanyNovartis Pharma GmbHTel: +49 911 273 0 The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111
EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 NorwaySandoz A / STel: +45 63 95 10 00
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 AustriaNovartis Pharma GmbHTel: +43 1 86 6570
SpainBEXAL PHARMACEUTICALS, SATel: +34 900 456 856 PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
FranceSandozTel: +33 800 45 57 99 PortugalNovartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600
CroatiaNovartis Hrvatska dooTel. +385 1 6274 220 RomaniaSandoz SRLTel: +40 21 40751 60
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439
ItalyNovartis Farma SpATel: +39 02 96 54 1 Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
ΚύπροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690
LatviaSIA Novartis BalticsTel: +371 67 887 070 United KingdomNovartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370

This leaflet was last modified in:

2020-03-26

Other sources of information

Further information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

INFORMATION FOR NURSING STAFF

The following information is intended for healthcare professionals only (see section 3):

Preparation and administration of Aclasta

  • Aclasta 5 mg infusion solution is reconstituted.

For single use only. Any unused solution should be discarded. Only clear solutions without particles and discoloration should be used. Aclasta must not be mixed or administered intravenously with any other medicinal product and must be administered via a separate ventilated infusion channel at a constant infusion rate. The infusion time must not be less than 15 minutes. Aclasta must not come into contact with calcium-containing solutions. If the solution is cooled, it should be allowed to warm to room temperature before administration. Preparation of infusion should be performed under aseptic conditions. Infusion one should be administered according to current medical practice.

Storage of Aclasta

  • Keep out of sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP.
  • The unopened vial does not require any special storage instructions.
  • After opening, the solution should be used immediately to avoid microbiological contamination.
  • 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 ° C – 8 ° C. Allow the cooled solution to reach room temperature before administration

Muhammad Nadeem

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