Zoledronic Acid Fresenius Kabi 4 mg / 5 ml concentrate for solution for infusion – patient leaflet, side effects, dosage

1. What Zoledronic acid

The active substance in Zoled belongs to a group of su Zoledronic acid works by slowing down the rate of bo

• To prevent bone c adult patients with bo from primary site to the
• To reduce the amo adult patients where it of a tumour. Tumours ca in such a way that the increased. This conditi hypercalcaemia (TIH).

2. What you need to Zoledronic acid

sed

acid

other information

is and what it is used for

ronic acid is zoledronic acid, which bstances called bisphosphonates. attaching itself to the bone and ne change. It is used:

omplications e.g. fractures, in ne metastases (spread of cancer bone).

unt of calcium in the blood in is too high due to the presence n accelerate normal bone change release of calcium from bone is on is known as tumour-induced

know before you are given

Follow carefully all instructi

Your doctor will carry ou treatment with Zoledronic to treatment at regular inte

You should not be give

• if you are allergic bisphosphonate (the which Zoledronic acid ingredients of this medi
• if you are breast-feedin

Warnings and precautio Talk to your doctor befor

• if you have or have had
• if you have or have had of the jaw, a feeling of of a tooth. Your doc examination before yo acid.

• if you are having de undergo dental surger being treated with Zole about your dental treat

  ons given to you by your doctor.

  t blood tests before you start acid and will check your response rvals.

  n Zoledronic acid

  to zoledronic acid, another group of substances to belongs), or any of the other cine (listed in section 6).

  g.

  ns e you are given Zoledronic acid a kidney problem.

  pain, swelling or numbness heaviness in the jaw or loosening tor may recommend a dental u start treatment with Zoledronic

  ntal treatment or are due to y, tell your dentist that you are dronic acid and inform your doctor ment.

While being treated with Zo good oral hygiene (including routine dental check-ups.

Contact your doctor an experience any problems as loose teeth, pain or s discharge, as these could osteonecrosis of the jaw.

Patients who are und radiotherapy, who are taki dental surgery, who do not have gum disease, who are treated with a bisphosphon disorders) may have a highe of the jaw.

Reduced levels of calcium sometimes leading to mu sensation, have been rep Zoledronic acid. Irregular seizures, spasm and twitch as secondary to severe hyp hypocalcaemia may be life-

ledronic acid you should maintain regular teeth brushing) and receive

d dentist immediately if you with your mouth or teeth such welling, non-healing of sores or be signs of a condition called

ergoing chemotherapy and/or ng steroids, who are undergoing receive routine dental care, who smokers, or who were previously ate (used to treat or prevent bone r risk of developing osteonecrosis

in the blood (hypocalcaemia), scle cramps, dry skin, burning orted in patients treated with heart beat (cardiac arrhythmia), ing (tetany) have been reported ocalcaemia. In some instances the threatening. If any of these apply

to you, tell your doctor strai hypocalcaemia, it must be c dose of Zoledronic acid. Yo and vitamin D supplements

Patients aged 65 years and Zoledronic acid can be g and over. There is no evid precautions are needed.

Children and adolescents Zoledronic acid is not reco adolescents below the age

Other medicines and Zo

Tell your doctor if you are ta take any other medicines. I tell your doctor if you are al

• Aminoglycosides (me infections), calcitonin ( post-menopausal oste loop diuretics (a type pressure or oedema

  ght away. If you have pre-existing orrected before initiating the first u will be given adequate calcium .

  over

  iven to people aged 65 years ence to suggest that any extra

  mmended for use in children and of 18 years.

  ledronic acid

  king, have recently taken or might t is especially important that you so taking:

  dicines used to treat severe a type of medicine used to treat oporosis and hypercalcaemia), of medicine to treat high blood ) or other calcium-lowering

  medicines, since the com bisphosphonates may cause blood to become too low.

  • Thalidomide (a medicine us of blood cancer involving medicines which may harm y
  • Medicines that also cont to treat osteoporosis and ot the bone, or any other combined effects of these me zoledronic acid are unknown.
  • Anti-angiogenic medicines ( the combination of these wit associated with an increased jaw (ONJ).

Pregnancy and breast-feedi

You should not be given Zoledro Tell your doctor if you are or think

You must not be given Zol breast-feeding.

bination of these with the calcium level in the ed to treat a certain type the bone) or any other our kidneys.

ain zoledronic acid used her non-cancer diseases of bisphosphonate, since the dicines taken together with

used to treat cancer), since h zoledronic acid has been risk of osteonecrosis of the ng nic acid if you are pregnant. that you may be pregnant.

edronic acid if you are

Ask your doctor for advice before you are pregnant or breast-feedin

Driving and using machines

There have been very rare cases o with the use of zoledronic acid. Yo when driving, using machinery or need full attention.

Zoledronic acid contains sod

This medicine contains less than dose, i.e. it is essentially “sodium

1. 3. How Zoledronic acid is us

Zoledronic acid must healthcare professionals tr bisphosphonates intravenou

Your doctor will recommend th before each treatment to help pr

Carefully follow all the other instr doctor, nurse or pharmacist.

taking any medicine while g.

f drowsiness and sleepiness u should therefore be careful performing other tasks that ium

1 mmol sodium (23 mg) per -free”.

ed only be given by ained in administering sly, i.e. through a vein.

at you drink enough water event dehydration.

uctions given to you by your

How much Zoledronic acid is

• The usual single dose given is
• If you have a kidney problem lower dose depending on t problem.

How often Zoledronic acid is

• If you are being treated fo complications due to bone m one infusion of Zoledronic aci
• If you are being treated to re in your blood, you will no infusion of Zoledronic acid.

How Zoledronic acid is given

Zoledronic acid is given as a drip should take at least 20 minutes as a single intravenous solution i

Patients whose blood calcium lev be prescribed calcium and vitami each day.

If you are given more Zoledron

If you have received doses highe you must be carefully monitored b

given

4 mg.

, your doctor will give you a he severity of your kidney given r the prevention of bone etastases, you will be given d every three to four weeks. duce the amount of calcium rmally only be given one

(infusion) into a vein which and should be administered n a separate infusion line.

els are not too high will also n D supplements to be taken ic acid than you should be r than those recommended, y your doctor. This is because you may develop serum electrolyte levels of calcium, phosphorus changes in kidney function, includi If your level of calcium falls too lo supplemental calcium by infusion.

If you have any further questions ask your doctor, pharmacist or nu

4. Possible side effects

Like all medicines, this medici although not everybody gets the are usually mild and will proba time.

Tell your doctor about any o side effects straight away:

Common (may affect up to 1

• Severe kidney impairment (w by your doctor with certain sp
• Low level of calcium in the bl

Uncommon (may affect up t

abnormalities (e.g. abnormal and magnesium) and/or ng severe kidney impairment. w, you may have to be given on the use of this medicine, rse.

ne can cause side effects, m. The most common ones bly disappear after a short f the following serious in 10 people):

ill normally be determined ecific blood tests).

ood.

o 1 in 100 people):

• Pain in the mouth, teeth an healing sores inside the numbness or a feeling of loosening of a tooth. Thes damage in the jaw (osteone dentist immediately if you while being treated with Zole treatment.
• Irregular heart rhythm (atrial patients receiving zoledroni osteoporosis. It is currently acid causes this irregular he report it to your doctor if you after you have received zoled
• Severe allergic reaction: sho mainly of the face and throat

Rare (may affect up to 1 in 1

• As a consequence of low cal beat (cardiac arrhythmia; sec
• A kidney function disorder ca normally be determined by yo tests).

Very rare (may affect u

• As a consequence of numbness and tetany (s
• Talk to your doctor if y the ear, and/or an ear bone damage in the ear
• Osteonecrosis has also with other bones than t Tell your doctor immedi such as new onset o stiffness while being Fresenius Kabi or after s

Not known: frequency c available data

• Inflammation of the ki signs and symptoms may urine, blood in the urine, na

Tell your doctor abou effects as soon as possi

Very common (may affec

• The solution containing Z 20 minute intravenous inf The hydration status of pa and following administrati that they are adequately hy
• Studies with glass bottles, made from polyvinylchlorid (prefilled with 0.9% w/v so glucose solution) showed n acid.

• Since no data are av Zoledronic acid with ot substances, Zoledronic acid medications/substances an a separate infusion line.

  oledronic acid is given as a single usion in a separate infusion line. tients must be assessed prior to on of Zoledronic acid to ensure drated.

  as well as several container types e, polyethylene and polypropylene dium chloride solution or 5% w/v

  o incompatibility with Zoledronic

  ailable on the compatibility of her intravenously administered must not be mixed with other d should always be given through

How to store Zoledronic aci

• Keep this medicine out of the si
• Do not use this medicine acid af the pack.
• The unopened vial does not r conditions.

• For storage conditions after di dilution”

  d ght and reach of children. ter the expiry date stated on equire any specific storage lution, see “Shelf life after

p to 1 in 10,000 people):

low calcium values: seizures, econdary to hypocalcaemia). ou have ear pain, discharge from infection. These could be signs of .

very rarely been seen occurring he jaws, especially the hip or thigh. ately if you experience symptoms r worsening of aches, pains or treated with Zoledronic acid topping treatment.

annot be estimated from the

dney (tubulointerstitial nephritis): include decreased volume of the usea, feeling generally unwell.

t any of the following side ble:

t more than 1 in 10 people):

• Low level of phosphate

Common (may affect up t

• Headache and a flu-li fatigue, weakness, drow or muscle ache. In mo required and the sympt (couple of hours or days
• Gastrointestinal reactio well as loss of appetite.
• Conjunctivitis
• Low level of red blood c

Uncommon (may affect u

• Hypersensitivity reactio
• Low blood pressure
• Chest pain
• Skin reactions (redness rash, itching
• High blood pressure
• Shortness of breath
• Dizziness
• Anxiety
• Sleep disturbances

• Taste disturbances

  in the blood.

  o 1 in 10 people):

  ke syndrome consisting of fever, siness, chills and bone, joint and/ st cases no specific treatment is oms disappear after a short time ).

  ns such as nausea and vomiting as

  ells (anaemia).

  p to 1 in 100 people):

  ns

  and swelling) at the infusion site,

• Trembling
• Tingling or numbness o
• Diarrhoea
• Constipation
• Abdominal pain
• Dry mouth
• Low counts of white blo
• Low level of magnesium doctor will monitor this
• Weight increase
• Increased sweating
• Sleepiness.
• Blurred vision, tearing o
• Sudden coldness with f
• Difficulty in breathing w
• Urticaria.

Rare (may affect up to 1 in

• Slow heart beat
• Confusion

• Unusual fracture of the on long-term treatme rarely. Contact your weakness or discomfort may be an early indica thigh bone.

  f the hands or feet

  od cells and blood platelets and potassium in the blood. Your and take any necessary measures

  f the eye, sensitivity to light. ainting, limpness or collapse. ith wheezing or coughing.

  1,000 people):

  thigh bone particularly in patients nt for osteoporosis may occur doctor if you experience pain, in your thigh, hip or groin as this tion of a possible fracture of the

• Interstitial lung disea around the air sacks of
• Flu-like symptoms inclu
• Painful redness and/or s

Very rare (may affect up t

• Fainting due to low blo
• Severe bone, joint a incapacitating

Reporting of side effec

If you get any side effects, includes any possible side e can also report side effects

For UK:

Yellow Card Scheme Webs or search for MHRA Yellow App Store

For IE:

HPRA Pharmacovigilance Website: www.hpra.ie

By reporting side effects

se (inflammation of the tissue the lungs)

ding arthritis and joint swelling. welling of the eye.

o 1 in 10,000 people):

od pressure

nd/or muscle pain, occasionally

ts

talk to your doctor or nurse. This ffects not listed in this leaflet. You directly via:

ite: www.mhra.gov.uk/yellowcard Card in the Google Play or Apple

you can help provide more

information on the safety o

1. 5. How to store Zoledro

Your doctor, pharmacist Zoledronic acid properly (se

6. Contents of the pack

What Zoledronic acid c

• The active substance of One vial contains 4 mg o
• The other ingredients ar for injections.

What Zoledronic acid lo pack

Zoledronic acid is supplie colourless plastic vial. Zoledronic acid is supplied a Not all pack sizes may be m

f this medicine.

nic acid

or nurse knows how to store e section 6).

and other information

ontains

Zoledronic acid is zoledronic acid. f zoledronic acid (as monohydrate). e: mannitol, sodium citrate, water

oks like and contents of the

d as a solution in a clear and

s packs containing 1, 4 or 10 vials. arketed.

Marketing Authorisation Hol For UK

Fresenius Kabi Limited

Cestrian Court,

Eastgate Way,

Manor Park,

Runcorn,

Cheshire,

WA7 1NT

UK

For IRL

Fresenius Kabi Deutschland GmbH Else-Kroener Strasse 1,

Bad Homburg v.d.H. 61352, Germany

Manufacturer

Fresenius Kabi Austria GmbH, Hafnerstrasse 36,

A-8055 Graz,

Austria

der

This medicinal product is aut States of the EEA under the

Austria Zoledronsäu Konzentrat Infusionslös

Belgium Zoledronine 4 mg/5 ml voor infusie

Bulgaria Zoledronic a концентрат

Czech Republic Zoledronic a

Denmark Zoledronsyr

Estonia Zoledronic a

Germany Zoledronsäu Konzentrat Infusionslös

Greece Zoledronic

horised in the Member following names:

re Fresenius Kabi 4 mg/5 ml zur Herstellung einer ung zuur Fresenius Kabi concentraat voor oplossing cid Fresenius Kabi 4 mg/5 ml за инфузионен разтвор cid Fresenius Kabi 4 mg/5 ml e Fresenius Kabi cid Fresenius Kabi 4 mg/5 ml re Fresenius Kabi 4 mg/5 ml zur Herstellung einer ung acid / Fresenius Kabi,

πυκνό διά έγχυση, 4 Finland Zoledronsyr infuusiokon

France Acide Zolé 4mg/5ml, sol

Hungary Zoledronsav koncentrátu

Ireland Zoledronic a for solution

Italy Acido zoledr Latvia Zoledronic a koncentrāts pagatavoša

Lithuania Zoledronic a koncentrata

Luxembourg Zoledronsäu Konzentrat Infusionslös

λυμα για διάλυμα προς mg/5ml a Fresenius Kabi 4 mg/5 ml sentraatti, liuosta varten dronique Fresenius Kabi ution à diluer pour perfusion

Fresenius Kabi 4 mg/5ml m oldatos infúzióhoz cid 4 mg/5 ml concentrate for infusion onico Fresenius Kabi cid Fresenius Kabi 4 mg/5 ml infūziju šķīduma nai cid Fresenius Kabi 4 mg/5 ml s infuziniam tirpalui re Fresenius Kabi 4 mg/5 ml zur Herstellung einer ung

The Netherlands Zoledroninez concentraat

Norway Zoledronsyr

Poland Zoledronic a

Portugal Ácido zoledr

Romania Acid zoledro concentrat p

Slovak Republic Zoledronic 4 mg/5ml

Slovenia Zoledronska 4 mg/5 ml infundiranje

Spain Ácido Zol 4 mg / 5 ml para perfusi

Sweden Zoledronsyr

United Kingdom Zoledronic a

uur FreseniusKabi 4 mg/5 ml voor oplossing voor infusie e Fresenius Kabi cid Fresenius Kabi ónico Fresenius Kabi nic Fresenius Kabi 4 mg/5 ml entru soluţie perfuzabilă acid Fresenius Kabi kislina Fresenius Kabi koncentrat za raztopino za edrónico Fresenius Kabi concentrado para solución ón a Fresenius Kabi cid 4 mg/5 ml concentrate for solution

This leaflet was last revised

for infusion in August 2024.