Aclasta

Main information

  • Trade name:
  • Aclasta 5 mg/100mL Solution for infusion
  • Dosage:
  • 5 mg/100mL
  • Pharmaceutical form:
  • Solution for infusion
  • Units in package:
  • Bottle, plastic, 100 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Novartis Pharma AG

Documents

Localization

  • Available in:
  • Aclasta 5 mg/100mL Solution for infusion
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • · Treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures and to increase bone mineral density. · Prevention of postmenopausal osteoporosis.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 11849
  • Authorization date:
  • 11-10-2004
  • Last update:
  • 27-09-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Aclasta

ACLASTA

Zoledronic acid

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Aclasta.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

The information in this leaflet was

last updated on the date listed on the

final page. More recent information

on the medicine may be available.

You should ensure that you speak

to your pharmacist or doctor to

obtain the most up-to-date

information on the medicine. You

can also download the most up-to-

date leaflet from

www.medsafe.govt.nz

Those updates may contain important

information about the medicine and

its use of which you should be aware.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you having Aclasta

against the benefits they expect it

will have for you.

If you have any concerns about

having this medicine, ask your

doctor or pharmacist.

Keep this leaflet.

You may need to read it again.

What Aclasta is used

for

The active ingredient in Aclasta is

zoledronic acid, which belongs to a

group of medicines called

bisphosphonates.

Aclasta is used to treat osteoporosis

in postmenopausal women and in

men, to prevent additional fractures

in men or women who have recently

had a hip fracture, or to treat or

prevent osteoporosis in men and

women caused by treatment with

steroid medicines such as prednisone.

Aclasta is also used to treat Paget’s

disease of bone.

Osteoporosis is a disease which

causes bones to become less dense,

gradually making them weaker, more

brittle and likely to break. This is

common in women after menopause,

when a woman’s ovaries stop

producing the female hormone,

oestrogen, which keeps bones

healthy. It also occurs in men and

women with increasing age. Broken

bones may result from injury or

simple falls. Breaks may occur

during normal everyday activity,

such as lifting, or from minor injury

that would not ordinarily fracture

normal bone. Fractures in people

with osteoporosis usually occur at the

hip, spine or wrist. These can lead

not only to pain, but also to

considerable deformity and

disability, such as stooped posture

from curvature of the spine, and loss

of mobility.

Paget’s disease is a chronic disorder

which may affect various bones of

the skeleton. Bone is a living tissue

and, just like other parts of the body,

it is constantly being renewed. This

process is called bone remodelling.

In Paget’s disease, the bone material

breaks down more quickly than

usual, and new bone material grows

more quickly than usual and in a

disordered way. The new bone that is

formed may be thicker but weaker

than normal, which can cause pain

and may lead to fractures (broken

bones).

How does it work

Aclasta works by slowing down bone

resorption, which allows the bone-

forming cells time to rebuild normal

bone. This allows bone remodelling

to go back to normal and protects the

bones from being weakened.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

Aclasta is only available with a

doctor’s prescription. It is not

addictive.

There is not enough information to

recommend the use of this medicine

for children or adolescents.

Before you have

Aclasta

When you must not have it

You must not have Aclasta if you

have an allergy to:

zoledronic acid (the active

ingredient in Aclasta) or any of

the other ingredients listed at the

end of this leaflet

any other bisphosphonate

medicine such as alendronate

(e.g. Fosamax) or risedronate

(e.g. Actonel).

Some of the symptoms of an allergic

reaction may include shortness of

breath, wheezing or difficulty

breathing; swelling of the face, lips,

tongue or other parts of the body;

rash, itching or hives on the skin.

Aclasta

If you are not sure whether you are

allergic to other bisphosphonate

medicines, talk to your doctor.

Other bisphosphonate medicines

have been shown to cause breathing

difficulties in people with asthma

who are allergic to aspirin.

Do not have Aclasta if you have

low levels of calcium in your blood.

Your doctor may do a blood test to

check your calcium levels before you

have Aclasta.

Do not have Aclasta if you are

pregnant.

There is no information on use of this

medicine in pregnancy.

Do not breast-feed while you are

having treatment with Aclasta.

It is not known if the active

ingredient, zoledronic acid, passes

into the breast milk and could affect

your baby.

Do not have Aclasta after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If it has expired or is damaged, return

it to your pharmacist.

If you are not sure whether you

should be given this medicine, talk

to your doctor.

Before you have it

Tell your doctor if you have been

or are being treated with:

Zometa

which contains the same

active ingredient as in Aclasta

another bisphosphonate medicine

prior to Aclasta

diuretic therapy (commonly

called ‘fluid tablets’)

Tell your doctor if:

you have a kidney problem. This

medicine is not suitable for some

people with a kidney problem.

you have a calcium deficiency or

a vitamin D deficiency

you are unable to take daily

calcium or vitamin D

supplements

you have had some or all of your

parathyroid or thyroid glands in

your neck surgically removed

you have had sections of your

intestine removed

you have or have had pain,

swelling or numbness of the jaw

or loosening of a tooth or any

other oral issues

you had or have joint stiffness,

aches and pains and difficulty in

movement (especially of the hip,

thigh, knee or upper arm)

you are under dental treatment or

will undergo dental surgery. Your

doctor will check your oral health

before you start treatment with

Aclasta. It is important to have

good dental hygiene, routine

dental care and regular dental

check-ups. Discuss with your

doctor any planned dental surgery

such as a tooth extraction. Tell

your dentist that you are being

treated with Aclasta.

you have or have had uveitis or

iritis (inflammatory conditions of

the eye).

Taking other medicines

Tell your doctor, nurse or

pharmacist if you are taking any

other medicines, including

medicines that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

Some medicines and Aclasta can

interfere with each other. These

include:

medicines that may affect your

kidneys such as fluid tablets

aminoglycoside medicines used

to treat severe infections.

You may need to take different

amounts of these medicines or you

may need to take different medicines.

Your doctor or pharmacist has more

information.

How Aclasta is given

Follow all directions given to you

by your doctor, nurse and

pharmacist carefully.

These directions may differ from the

information contained in this leaflet.

If you do not understand the

instructions, ask your doctor,

nurse or pharmacist for help

before treatment starts.

Make sure you drink enough fluids

before and after the treatment with

Aclasta as directed by your doctor.

Two glasses of fluid (such as water)

before and after the infusion are

usually enough. This will help to

prevent dehydration.

You may eat normally on the day

you are treated with Aclasta.

How it will be given

Aclasta will be given to you by

infusion into a vein by your doctor or

nurse once a year. The infusion will

take at least 15 minutes.

How much is given

A 100mL infusion will last at least

15 minutes.

How long treatment will last

For osteoporosis, each dose of

Aclasta lasts one year. Your

doctor will check your condition

and may prescribe further annual

doses.

For Paget’s disease, each dose of

Aclasta may work for longer than

one year. Your doctor will let you

know if you need to be treated

again.

If you have too much

(overdose)

Immediately telephone your doctor

or Poisons and Hazardous

Chemicals National Information

Centre, Dunedin (telephone 0800

POISON or 0800 764 766), or go to

Accident and Emergency at your

nearest hospital if you think that

an overdose has happened. Do this

even if there are no signs of

discomfort or poisoning.

Tell your doctor if you have any of

the following symptoms:

muscle spasms

numbness or tingling sensation,

especially around the mouth

shortness of breath.

Aclasta

These symptoms may mean the level

of calcium in your blood has fallen

too far.

While you are being

given Aclasta

Things you must do

If you get a headache, fever or

other flu-like symptoms in the first

three days after you are given

Aclasta, take paracetamol if your

doctor has told you to.

Some people get short-lasting flu-like

symptoms after having Aclasta.

Paracetamol can provide some relief.

Take calcium and vitamin D

supplements if your doctor has told

you to.

Most people with osteoporosis do

not get enough calcium and

vitamin D in their diet and

supplements are needed to help

strengthen your bones.

If you are being treated with

Aclasta for Paget’s disease, your

doctor should advise corrective

treatment for a vitamin D

deficiency and that you take

calcium and vitamin D

supplements for at least the first

ten days after you have Aclasta to

reduce the risk of low calcium

levels in your blood.

Keep all of your doctor’s

appointments so that your progress

can be checked.

Your doctor may want you to have

X-rays, bone density scans or blood

tests from time to time to make sure

Aclasta is working and to prevent

unwanted side effects from

happening.

Tell your doctor immediately if

you become pregnant while having

treatment with this medicine.

Your doctor can discuss with you the

risks of having it while you are

pregnant.

Tell your doctor and dentist

immediately about any dental

symptoms you get while you are

being treated with Aclasta. This

may include persistent pain,

swelling, loosening of a tooth

and/or non-healing sores or

discharge (pus or oozing).

A dental condition called jaw

osteonecrosis has been reported,

primarily in patients being treated

with this type of medicine for other

illnesses.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are being treated with Aclasta.

Tell any other doctor, dentist or

pharmacist who treats you that

you are having Aclasta.

Things to be careful of

Be careful driving or operating

machinery until you know how

Aclasta affects you.

Aclasta has no known effect on the

ability to drive or use machines but,

as a general precaution, if you are

travelling home by car after the

infusion, arrange to have someone

else drive.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are

having Aclasta.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

Do not be alarmed by the following

list of side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

short-lasting fever, sometimes

with flu-like symptoms,

headache, chills, pain or aching

in the muscles or joints. Take

paracetamol if your doctor has

told you to. Paracetamol can

provide some relief.

redness, swelling or pain where

the needle for the infusion was

inserted

upset stomach, abdominal pain,

loss of appetite or other eating

disorder, thirst or heartburn

nausea, vomiting, diarrhoea,

with possible dehydration

constipation

dry mouth, toothache or sore

throat

lack of energy, tiredness and

lack of interest, weakness,

dizziness, low blood pressure

pain in your back, neck,

shoulders, arms, legs or chest

muscles, swollen or stiff joints,

muscle stiffness, weakness or

spasm, tingling or numbness of

your hands or feet

swollen fingers or lower legs due

to fluid build-up

swollen, red, painful or itchy

eyes or sensitivity of the eyes to

light

pink eye (conjunctivitis)

palpitations (feeling of fast,

forceful and/or irregular

heartbeat), which may be

accompanied by dizziness and

breathlessness

excessive sweating

difficulty sleeping.

Contact your doctor if you

experience pain, weakness or

discomfort in your thigh, hip or

groin as this may be an early

indication of a possible fracture of

the thigh bone.

Unusual fracture of the thigh bone

particularly in patients on long-term

treatment for osteoporosis may

occur.

Aclasta

Tell your doctor and dentist

immediately about any dental

symptoms you get after you have

Aclasta. This may include:

pain in the mouth, teeth and jaw,

swelling of sores inside the

mouth, numbness or a feeling of

heaviness in the jaw, or loosening

of a tooth. These could be signs

of bone damage in the jaw

(osteonecrosis).

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital if you notice

any of the following after you have

Aclasta:

signs of allergy such as rash,

itching or hives on the skin;

swelling of the face, throat, lips,

tongue or other part of the body;

shortness of breath, difficulty

breathing or swallowing;

tightness of the chest.

signs that the level of calcium in

your blood may have fallen too

far, such as muscle spasms,

numbness or tingling sensation,

especially around the mouth,

shortness of breath

signs that the level of

phosphorus in your blood may

have fallen too far, such as

muscle problems and weakness,

confusion, irritation, and

delirium

signs that your kidneys may not

be working properly, such as

decreased urine output.

The above side effects may be

serious. You may need urgent

medical attention.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Other side effects not listed above

may also occur in some people.

Some of these (e.g. effects on kidney

function and on the level of calcium

in the blood) can only be found by

laboratory testing.

After having Aclasta

Storage

It is unlikely you will have to store

Aclasta at home.

If you do have to store it:

Store the medicine in a cool dry

place at room temperature

Do not store Aclasta or any other

medicine in the bathroom or near

a sink

Do not leave it in the car or on a

window sill.

Heat and dampness can destroy some

medicines.

Keep the medicine where young

children cannot reach it.

A locked cupboard at least one-and-

a-half metres above the floor is a

good place to store medicines.

Each Aclasta vial is to be used for

one injection only and then

discarded.

Disposal

If you no longer need Aclasta or it

has passed its expiry date, return

any unused medicine to your

pharmacist.

Product description

What it looks like

Aclasta solution for infusion is

supplied in a transparent plastic vial

containing 100mL of a clear,

colourless solution. Aclasta is

supplied as packs containing one

vial.

Ingredients

Each vial of Aclasta contains 5mg of

zoledronic acid. Each vial also

contains:

mannitol

sodium citrate

water for injections.

Sponsor

Aclasta is supplied in New Zealand

Novartis New Zealand Limited

109 Carlton Gore Road

Newmarket

Auckland 1023

PO Box 99102

Newmarket

Auckland 1149

Telephone 0800 354 335

Web site: www.novartis.com.au

Date of preparation

This leaflet was prepared in

December 2016 .

= Registered trademark

Internal Document Code

(acl090117cNZ.doc) based on Data

sheet (acl090117iNZ.doc)

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Mycophenolate mofetil, mycophenolic acid : List of nationally authorised medicinal products - PSUSA/00010550/201805

Mycophenolate mofetil, mycophenolic acid : List of nationally authorised medicinal products - PSUSA/00010550/201805

Mycophenolate mofetil, mycophenolic acid : List of nationally authorised medicinal products - PSUSA/00010550/201805

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid

Europe - EMA - European Medicines Agency

26-11-2018


Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6488 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6486 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6466 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

4-6-2018

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Active substance: chenodeoxycholic acid) - Centralised - Yearly update - Commission Decision (2018)3627 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

8-3-2018

Mycophenolate mofetil, mycophenolic acid

Mycophenolate mofetil, mycophenolic acid

Mycophenolate mofetil, mycophenolic acid (Active substance: mycophenolate mofetil or mycophenolic acid) - Centralised - Art 28 - (PSUR - Commission Decision (2018)1540 of Thu, 08 Mar 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10550/201705

Europe -DG Health and Food Safety

5-2-2018

Oxybee (Dany Bienenwohl GmbH)

Oxybee (Dany Bienenwohl GmbH)

Oxybee (Active substance: oxalic acid dihydrate) - New authorisation - Commission Decision (2018)684 of Mon, 05 Feb 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4296

Europe -DG Health and Food Safety