Zoledronic acid 5mg100ml solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Zoledronic acid monohydrate

Available from:

Sun Pharmaceutical Industries Europe B.V.

ATC code:

M05BA08

INN (International Name):

Zoledronic acid monohydrate

Dosage:

50microgram/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 8718531942714

Patient Information leaflet

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V011
B. PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLEDRONIC ACID 5 MG SOLUTION FOR INFUSION
zoledronic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zoledronic acid 5 mg
is and what it is used for
2.
What you need to know before you are given Zoledronic acid 5 mg
3.
How Zoledronic acid 5 mg
is used
4.
Possible side effects
5.
How to store Zoledronic acid 5 mg
6.
Contents of the pack and other information
1.
WHAT ZOLEDRONIC ACID 5 MG IS AND WHAT IT IS USED FOR
Zoledronic acid 5 mg contains the active substance zoledronic acid. It
belongs to a group of medicines
called bisphosphonates and is used to treat:
-
post-menopausal women and adult men with osteoporosis or osteoporosis
caused by treatment
with corticosteroids used to treat inflammation
-
Paget’s disease of the bone in adults.
OSTEOPOROSIS
Osteoporosis is a disease that involves the thinning and weakening of
the bones and is common in
women after the menopause, but can also occur in men. At the
menopause, a woman’s ovaries stop
producing the female hormone oestrogen, which helps keep bones
healthy. Following the menopause
bone loss occurs; bones become weaker and break more easily.
Osteoporosis could also occur in men
and women because of the long term use of steroids, which can affect
the strength of bones. Many
patients with osteoporosis have no symptoms but they are still at risk
of breaking bones because
osteoporosis has made their bones weaker. Decreased circulating levels
of sex hormones, mainly
oestrogens converted from androgens, also play a role in the more
gradual bone loss observed in men.
In both women and men, Zoledronic acid 5 mg strengthe

Summary of Product characteristics

OBJECT 1
ZOLEDRONIC ACID 5 MG SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 14-Jun-2018 | Ranbaxy (UK)
Limited a Sun Pharmaceutical
Company
1. Name of the medicinal product
Zoledronic acid SUN 5 mg solution for infusion
2. Qualitative and quantitative composition
Each vial with 100 ml of solution contains 5 mg zoledronic acid (as
monohydrate).
Each ml of the solution contains 0.05 mg zoledronic acid anhydrous,
corresponding to 0.0533 mg
zoledronic acid monohydrate.
Excipients with known effect: Sodium. Each vial contains <1 mmol
sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion.
Clear and colourless solution with a pH between 6.00 to 7.00 and an
osmolarity between 260 to 340
mOsm/kg.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of osteoporosis
- in post-menopausal women
- in adult men
at increased risk of fracture, including those with a recent
low-trauma hip fracture.
Treatment of osteoporosis associated with long-term systemic
glucocorticoid therapy
- in post-menopausal women
- in adult men
at increased risk of fracture.
Treatment of Paget's disease of the bone in adults.
4.2 Posology and method of administration
Posology
Patients must be appropriately hydrated prior to administration of
zoledronic acid. This is especially
important for the elderly (≥65 years) and for patients receiving
diuretic therapy.
Adequate calcium and vitamin D intake are recommended in association
with zoledronic acid
administration.
_Osteoporosis _
For the treatment of post-menopausal osteoporosis, osteoporosis in men
and the treatment of osteoporosis
associated with long-term systemic glucocorticoid therapy, the
recommended dose is a single intravenous
infusion of 5 mg zoledronic acid administered once a year.
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established. The need for
continued treatment should be re-evaluated periodically based on the
benefits and potential risks of
zoledronic acid on an individual