Aquaear Ear Drops solution bottle

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

isopropyl alcohol, Quantity: 634 mg/mL; glacial acetic acid, Quantity: 17.3 mg/mL

から入手可能:

Haleon Australia Pty Ltd

医薬品形態:

Ear Drops, solution

構図:

Excipient Ingredients: purified water

投与経路:

Otic

パッケージ内のユニット:

35mL

クラス:

Medicine Registered

処方タイプ:

Not scheduled. Not considered by committee

適応症:

Helps prevent and helps treat swimmer's ear the painful ear infection that often occurs when water is trapped in the ear canal after swimming, bathing, surfing or diving. Aquaear dries up moisture and retards the growth of bacteria. Aquaear also helps relieve the painful inflammation caused by swimmer's ear.

製品概要:

Visual Identification: A clear, colourless liquid with a distinctive odour of isopropyl acohol and pungency of acetic acid; free from suspended matter or haze..; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

認証ステータス:

Registered

承認日:

1991-08-30

製品の特徴

1
AUSTRALIAN PRODUCT INFORMATION – SANDIMMUN (CICLOSPORIN)
1
NAME OF THE MEDICINE
ciclosporin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CAPSULES
Each Sandimmun 25 mg capsule contains 25 mg ciclosporin
Each Sandimmun 50 mg capsule contains 50 mg ciclosporin
Each Sandimmun 100 mg capsule contains 100 mg ciclosporin
CONCENTRATE FOR INTRAVENOUS INFUSION
Sandimmun concentrate for intravenous infusion contains 250 mg/5 mL or
50 mg/1 mL of
ciclosporin
EXCIPIENTS WITH KNOWN EFFECT:
Alcohol (as ethanol 34% v/v in the concentrates for intravenous
infusion and ethanol 12.8% v/v in
the capsules)
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CAPSULES
25 mg:
Pink oval soft gelatin capsule, approx. 11.3 mm (length) and 7.4 mm
(diameter)
50 mg:
Corn yellow, oblong, soft, gelatin capsule, approx 19.9 mm (length)
and 7.5mm
(diameter)
100 mg:
Dusty rose oblong soft gelatin capsule, approx. 24.9 mm (length) and
8.7 mm
(diameter)
CONCENTRATE FOR INTRAVENOUS INFUSION
250 mg/5 mL: Clear brown-yellow, oily solution
50 mg/1 mL:
Clear brown-yellow, oily solution
2
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Sandimmun is indicated:
•
As an immunosuppressive agent for the prevention of graft rejection
following kidney, liver and
heart allogeneic transplantation.
•
For induction and/or maintenance of remission in the nephrotic
syndrome. Ciclosporin is not a
first-line agent. Its use should be restricted to occasions when
steroids and cytostatic drugs have
failed,
or
are
not
tolerated, or
are
considered
inappropriate,
and
when
renal
function
is
unimpaired (see Section 4.4 Special Warnings and Precautions for Use).
•
For the treatment of severe, active rheumatoid arthritis in patients
for whom classical slow-acting
antirheumatic agents (including methotrexate) are inappropriate or
ineffective.
•
In patients with severe psoriasis in whom conventional therapy is
ineffective or inappropriate and
the disease has caused a significant interference with quality of
life.
•
For
the
treat