Retaane

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

Anecortave acetate

Φύλλο οδηγιών χρήσης

 
Ret AUN CMI (021105) 

1
RETAANE

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Anecortave acetate  

Alcon Laboratories (Aust) Pty Ltd 

CONSUMER MEDICINE INFORMATION 

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WHAT IS IN THIS LEAFLET 

This leaflet answers some common 
questions about RETAANE. It does 
not contain all the available 
information. It does not take the 
place of talking to your doctor. 

All medicines have risks and 
benefits. Your doctor has weighed 
the risks of you receiving RETAANE 
against the benefits they expect it 
will have for you. 

IF YOU HAVE ANY CONCERNS ABOUT 
THIS MEDICINE ASK YOUR DOCTOR. 

KEEP THIS LEAFLET. 
You may need to read it again.

WHAT RETAANE IS USED 
FOR 

RETAANE is used to treat a condition 
where abnormal blood vessels 
grow in the back of your eye 
causing loss of central vision and 
impairment of your sight. This 
condition is known as exudative or 
“wet” age-related macular 
degeneration or AMD. 

AMD causes damage to the 
macula, the central zone of the 
retina.  The retina is the light 
sensitive layer at the back of the 
eye. The macula is a very 
specialised region of the retina 
responsible for our ability to see 
detail, perceive colors and perform 
other activities that require focused, 
straight-ahead vision.  

The most common cause of 
irreversible vision loss in people 
over the age of 50 is degeneration 
of the macula (AMD) caused by 
abnormal blood vessel growth.  

_HOW IT WORKS _

RETAANE works by stopping or 
slowing down the growth of 
abnormal blood vessels in your 
eye._ _

ASK YOUR DOCTOR IF YOU HAVE ANY 
QUESTIONS ABOUT WHY YOU WILL BE 
RECEIVING THIS MEDICINE. 

This medicine is not addictive. 

BEFORE YOU ARE GIVEN 
RETAANE 

_WHEN YOU MUST NOT BE GIVEN IT _

YOU MUST NOT BE GIVEN RETAANE IF 
YOU HAVE AN ALLERGY TO: 

• 
Anecortave acetate or any of the 
ingredients listed at the e

Αρχείο Π.Χ.Π.

Retaane PI (091205) 

1 
PRODUCT INFORMATION 

RETAANE
® 
15 MG 
(ANECORTAVE ACETATE) 
DEPOT SUSPENSION 

NAME OF THE DRUG 
Retaane (anecortave acetate, depot suspension) contains the
angiostatic cortisene, 
anecortave acetate
.
 The chemical structure of anecortave acetate is; 

CH
3
H
OH
H
O
CH
3
O
O
O
CH
3

CHEMICAL NAME: 4,
9(11)-Pregnadien-17a,21-diol-3,20-dione-21-acetate 
MOLECULAR FORMULA: C
23
H
30
O
5

MOLECULAR WEIGHT: 386.49 
CAS NUMBER: 7753-60-8 

DESCRIPTION 
Retaane depot is a white to off-white suspension administered as a
posterior juxtascleral 
depot injection. 

Retaane depot is supplied as a sterile, unpreserved, pyrogen free,
single-dose aqueous 
suspension, that has a buffered pH of approximately 7.0 – 7.8 and
an osmolality of 
approximately 290 mOsm/kg.  

Active ingredient: anecortave acetate 15 mg/0.5 mL.  
Excipients: sodium phosphate – monobasic; sodium
phosphate – dibasic dodecahydrate; 
tyloxapol; sodium chloride and water for injection. Hydrochloric acid
and/or sodium 
hydroxide may be used for pH adjustment. 

PHARMACOLOGY 
Anecortave acetate is a synthetic analogue of cortisol that
is devoid of glucocorticoid 
activity. _In vivo_ anecortave acetate is rapidly hydrolysed by
plasma esterases to the 
pharmacologically active metabolite, anecortave desacetate [4,
9(11)-Pregnadien-17a,21-
diol-3,20-dione].  

Retaane PI (091205) 

2 
Anecortave acetate and anecortave desacetate have been shown to be
effective inhibitors 
of pathological blood vessel growth in the eye (ocular
neovascularisation). The anti-
angiogenic activity of both anecortave acetate and anecortave
desacetate has been 
demonstrated in a wide variety of animal models independent of the
inciting cause of 
neovascularisation. 

PHARMACODYNAMICS_ _
_In vitro_ and _in vivo_ studies demonstrate that the
anti-angiogenic activity of anecortave 
acetate is multifactorial. Anecortave acetate and anecortave
desacetate may inhibit