国家: 新加坡
语言: 英文
来源: HSA (Health Sciences Authority)
ACITRETIN
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
D05BB02
10 mg
CAPSULE
ACITRETIN 10 mg
ORAL
Prescription Only
DSM Nutritional Products France (Intermediate DP manufacturer)
ACTIVE
1995-10-16
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 阅读完整的文件
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 阅读完整的文件