BONDRONAT ibandronic acid 6mg/6mL (as sodium) injection vial

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

ibandronate sodium, Quantity: 1.125 mg/mL (Equivalent: ibandronic acid, Qty 1 mg/mL)

Dostopno od:

Atnahs Pharma Australia Pty Ltd

Farmacevtska oblika:

Injection, concentrated

Sestava:

Excipient Ingredients: sodium chloride; glacial acetic acid; sodium acetate; water for injections

Pot uporabe:

Intravenous

Enote v paketu:

1 vial

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Indicated for the treatment of: Tumor-induced hypercalcaemia with or without metastases. Metastatic bone disease in patients with breast cancer.

Povzetek izdelek:

Visual Identification: Clear, colourless solution practically free from visible particles.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Status dovoljenje:

Registered

Datum dovoljenje:

2004-04-13

Navodilo za uporabo

BONDRONAT
®
pronounced "bon-droh-nat"
_contains the active ingredient ibandronic acid_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BONDRONAT.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using
BONDRONAT against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT BONDRONAT IS
USED FOR
BONDRONAT contains the active
ingredient ibandronic acid. It belongs
to a group of medicines called
bisphosphonates.
In patients with breast cancer,
BONDRONAT is used to slow down
the attachment, spread and growth of
cancer cells within the bone, known
as metastatic bone disease.
BONDRONAT works by stopping
the breakdown of bone.
BONDRONAT injection can also be
used to lower very high levels of
calcium in the blood. High levels of
calcium can occur in the presence of
a tumour. This is known as
hypercalcaemia of malignancy.
Your doctor may have prescribed
BONDRONAT for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY BONDRONAT HAS
BEEN PRESCRIBED FOR YOU.
BONDRONAT is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE OR ARE
GIVEN BONDRONAT
DO NOT TAKE OR RECEIVE
BONDRONAT IF:
1.
YOU HAVE LOW LEVELS OF CALCIUM
IN YOUR BLOOD (CALLED
HYPOCALCAEMIA)
2.
YOU HAVE HAD AN ALLERGIC
REACTION TO IBANDRONIC ACID, OR
TO ANY OTHER BISPHOSPHONATE
MEDICINE OR TO ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET
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.
3.
THE PACKAGE IS TORN OR SHOWS
SIGNS OF TAMPERING
4.
THE EXPIRY DATE (EXP) PRINTED
ON THE PACK HAS PASSED.
If you ta

Lastnosti izdelka

1
AUSTRALIAN PRODUCT INFORMATION - BONDRONAT
®
(IBANDRONIC ACID)
1. NAME OF THE MEDICINE
Ibandronic acid (as the monosodium salt monohydrate)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
BONDRONAT is available as a concentrated injection for intravenous
(IV) infusion containing 6 mg
ibandronic acid (as the monosodium salt monohydrate 6.75 mg).
BONDRONAT is also available as film-coated tablets containing 50 mg
ibandronic acid (as the monosodium
salt monohydrate 56.25 mg).The tablets also contain lactose.
Ibandronate sodium is a white to off-white powder and is freely
soluble in water.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
BONDRONAT is a sterile, clear and colourless concentrated injection
for intravenous (IV) infusion.
BONDRONAT 50 mg tablets are white to off-white, oblong, film-coated
tablets, engraved with “IT” on one
side and “L2” on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BONDRONAT Injection and Tablets are indicated for the treatment of
metastatic bone disease in patients
with breast cancer.
BONDRONAT Injection is indicated for the treatment of tumour-induced
hypercalcaemia with or without
metastases.
4.2 DOSE AND METHOD OF ADMINISTRATION
TREATMENT OF METASTATIC BONE DISEASE
BONDRONAT is intended for long-term administration unless clinically
inappropriate.
_INTRAVENOUS _
The recommended dose is 6 mg IV given every 4 weeks. The dose should
be infused over 1 - 2 hours. For
infusion, the contents of the vial should be added to 500 mL isotonic
sodium chloride solution (or 500 mL 5%
glucose solution).
_ORAL _
The recommended oral dose is one 50 mg film-coated tablet once daily.
BONDRONAT should be taken 30 minutes before the first food or drink of
the day (other than plain water) or
any other oral medication or supplement (including calcium).
•
Tablets should be swallowed whole with a full glass of plain water
(180 - 240 mL) while the patient is
standing or sitting in an upright position.
•
Patients should not chew or s