Arrow - Etidronate

国家: 新西兰

语言: 英文

来源: Medsafe (Medicines Safety Authority)

有效成分:

Disodium etidronate 200mg

可用日期:

Teva Pharma (New Zealand) Limited

INN（国际名称）:

Disodium etidronate 200 mg

剂量:

200 mg

药物剂型:

Tablet

组成:

Active: Disodium etidronate 200mg Excipient: Magnesium stearate Maize starch Microcrystalline cellulose Pregelatinised maize starch Purified water

每包单位数:

Blister pack, PVC/PE/PVDC/aluminium foil, 100 tablets, 100 tablets

类:

Prescription

处方类型:

Prescription

厂商:

Medichem SA

產品總結:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC/aluminium foil - 100 tablets - 3 years from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with PP closure - 100 tablets - 3 years from date of manufacture stored at or below 25°C

授权日期:

2006-08-18

资料单张

ARROW - ETIDRONATE
Disodium etidronate 200 mg Tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ARROW -
ETIDRONATE.
It does not contain all of the available information. It does not take
the place of
talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the
risks of
you taking ARROW - ETIDRONATE against the benefits they expect it will
have for you.
If you have any concerns about taking this medicine, talk to your
doctor or
pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
WHAT ARROW - ETIDRONATE IS USED FOR
Disodium etidronate, the active ingredient in ARROW - ETIDRONATE
Tablets, belongs to a group of medicines called bisphosphonates.
Bisphosphonates can be used to help bone diseases such as osteoporosis
and Paget's disease.
Your doctor may prescribe ARROW - ETIDRONATE to prevent and treat
abnormal deposition of calcium in the bone. This condition may happen
following spinal cord injury or total hip replacement.
As part of the treatment, your doctor will give you calcium to take
after
completing the course of ARROW - ETIDRONATE.
Your doctor may have prescribed ARROW - ETIDRONATE for another
reason. Ask your doctor if you have any questions about why ARROW -
ETIDRONATE has been prescribed for you.
ARROW - ETIDRONATE SHOULD NOT BE GIVEN TO CHILDREN.
There is no experience with the use of ARROW - ETIDRONATE in children.
There is no evidence that ARROW - ETIDRONATE Tablets is additive.
ARROW - ETIDRONATE is available only with a doctor's prescription.
BEFORE YOU TAKE ARROW - ETIDRONATE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ARROW - ETIDRONATE IF YOU ARE ALLERGIC TO MEDICINES
CONTAINING ETIDRONATE, BISPHOSPHONATES OR 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.
DO NOT TAKE ARRO

产品特点

Version 1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Arrow – Etidronate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of disodium etidronate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Off-white rectangular tablet marked “ED 2” on one side and '
' on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OSTEOPOROSIS
Etidronate is indicated for the treatment of osteoporosis in both men
and women. This includes the
prevention and treatment of corticosteroid induced osteoporosis and
the prevention and treatment of
osteoporosis in postmenopausal women.
PAGET'S DISEASE
Etidronate is indicated for the treatment of symptomatic Paget's
disease of bone (osteitis deformans)
when other therapy is considered inappropriate or cannot be tolerated.
Effectiveness has been
demonstrated primarily in patients with polyostotic Paget's disease
with symptoms of pain and with
clinically significant elevations of urinary hydroxyproline and serum
alkaline phosphatase. In patients
treated with etidronate at the dose of 5 mg/kg/day, the elevated
urinary hydroxyproline and serum
alkaline phosphatase decreased by 30% or more in about 4 out of 5
patients. Hydroxyproline either
returned to normal or was decreased by at least 50% in about 3 out of
5 patients and alkaline
phosphatase in about one-half of the patients.
In controlled studies, approximately 3 out of 5 patients experienced
decreased pain and/or improved
mobility. Two out of 5 patients in the placebo group showed similar
subjective improvement.
Objective measurements in etidronate-treated patients have shown
reductions of elevated cardiac
output in about 2 out of 3 patients. Reductions in elevated skin
temperature over Pagetic lesions have
also been measured. The number of treated patients in these categories
is still too small to predict with
certainty how likely such a result will be in any given patient.
Objective evidence of hearing
improvement has not been demonstrated.
The majority of patients with loca