NEOTIGASON CAPSULE 25 mg

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

ACITRETIN

Tilgængelig fra:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

ATC-kode:

D05BB02

Dosering:

25 mg

Lægemiddelform:

CAPSULE

Sammensætning:

ACITRETIN 25 mg

Indgivelsesvej:

ORAL

Recept type:

Prescription Only

Fremstillet af:

DSM Nutritional Products France (Intermediate DP manufacturer)

Autorisation status:

ACTIVE

Autorisation dato:

1995-10-16

Indlægsseddel

2
10.09.2020
BH
19.10.2020
BH
125 x 315 mm
IL/Cenexi (Osny)
8
10.09.2020
15.09.2020
1. Profile
2.
3.
1. Black
2. PMS 485
3.
4.
5.
6.
AAAM4035 - Acitretine All strengths, PIL, Singapore
SUPPLIER INSTRUCTIONS Artwork, text and content must NOT be altered.
The only exceptions to this are: bleeds, chokes, spreads or
other adjustments required for print reproduction purposes only. If
you have any difficulties please conact the Teva Artwork Team. We
must receive a copy of the 3rd Party Vendros Proof before final
approval can be made.
RETINOID FOR ORAL TREATMENT OF SEVERE CASES OF
PSORIASIS AND DISORDERS OF KERATINIZATION
COMPOSITION
Active ingredient: acitretin.
Capsules 10 mg and 25 mg.
Excipient: antioxidant, sodium ascorbate.
The 10 mg capsules have a brown cap and a white
body with “10”, both printed in black. The 25 mg
capsules have a brown cap and a yellow body with
“25”, both printed in black.
PROPERTIES AND EFFECTS
Acitretin, the active ingredient of Neotigason, is
a synthetic aromatic analogue of retinoic acid.
In preclinical investigations of the tolerability of
acitretin, no relevant mutagenic or carcinogenic
effects were found, nor was there any evidence
of direct liver toxicity. Acitretin was found to
be highly teratogenic in animals. Clinical trials
confirmed that, in psoriasis and disorders
of keratinization, acitretin brought about
normalization of epidermal cell proliferation,
differentiation and cornification, while the side
effects were, in general, tolerable. The effect of
Neotigason is purely symptomatic; the mechanism
of action is as yet largely unknown.
PHARMACOKINETICS
_Absorption_
Acitretin reaches peak plasma concentration 1–4
hours after ingestion of the drug. Bioavailability
of orally administered acitretin is best when the
drug is taken together with food. Bioavailability
of a single dose is approximately 60%, but this
may vary considerably from one patient to another
(36–95%).
_Distribution_
Acitretin is highly lipophilic and penetrates readily
into body tissues. Protein bindin

Produktets egenskaber

2
7.05.2019
SS
13.05.2019
SS
125 x 315 mm
IL/Cenexi (Osny)
7
7.05.2019
10.05.2019
1. Profile
2.
3.
1. Black
2. PMS 485
3.
4.
5.
6.
AAAL3636 - Acitretine All strengths -, PIL, Singapore
SUPPLIER INSTRUCTIONS Artwork, text and content must NOT be altered.
The only exceptions to this are: bleeds,
chokes, spreads or other adjustments required for print reproduction
purposes only. If you have any difficulties
please conact the Teva Artwork Team. We must receive a copy of the 3rd
Party Vendros Proof before final approval
can be made.
RETINOID FOR ORAL TREATMENT OF SEVERE CASES OF
PSORIASIS AND DISORDERS OF KERATINIZATION
COMPOSITION
Active ingredient: acitretin.
Capsules 10 mg and 25 mg.
Excipient: antioxidant, sodium ascorbate.
The 10 mg capsules have a brown cap and a white
body with “10”, both printed in black. The 25 mg
capsules have a brown cap and a yellow body with
“25”, both printed in black.
PROPERTIES AND EFFECTS
Acitretin, the active ingredient of Neotigason, is
a synthetic aromatic analogue of retinoic acid.
In preclinical investigations of the tolerability of
acitretin, no relevant mutagenic or carcinogenic
effects were found, nor was there any evidence of
direct liver toxicity. Acitretin was found to be highly
teratogenic in animals. Clinical trials confirmed
that, in psoriasis and disorders of keratinization,
acitretin brought about normalization of epidermal
cell proliferation, differentiation and cornification,
while the side effects were, in general, tolerable.
The effect of Neotigason is purely symptomatic; the
mechanism of action is as yet largely unknown.
PHARMACOKINETICS
_Absorption_
Acitretin reaches peak plasma concentration 1–4
hours after ingestion of the drug. Bioavailability of
orally administered acitretin is best when the drug
is taken together with food. Bioavailability of a
single dose is approximately 60%, but this may vary
considerably from one patient to another (36–95%).
_Distribution_
Acitretin is highly lipophilic and penetrates readily
into body tissues. Protein bindin