תאריך December 22, 2013 שם תכשיר באנגלית ומספר הרישום veregen 10% ointment : 148 40 33422 00




Дата канвертавання22.04.2016
Памер61.03 Kb.

הודעה על החמרה ( מידע בטיחות)

(מעודכן 05.2013)



תאריך __________December 22, 2013 ____

שם תכשיר באנגלית ומספר הרישום

VEREGEN 10% ointment : 148 40 33422 00_

שם בעל הרישום _אביק שיווק בע"מ ת.ד. 8077 נתניה___

בעלון לרופא

טופס זה מיועד לפרוט ההחמרות בלבד !





ההחמרות המבוקשות


פרק בעלון



טקסט נוכחי


טקסט חדש

Composition

1 g of the ointment contains 100 mg of polyphenon E extract (as dry extract), refined from Camellia sinensis (L.) O. Kuntze folium (green tea leaf) (45-56:1), corresponding to: 55-72 mg of (-)-epigallocatechin gallate.

First extraction solvent: water



1 g of the ointment contains 100 mg of extract (as dry extract, refined) from Camellia sinensis (L.) O. Kuntze, folium (green tea leaf) (24-56:1), corresponding to: 55-72 mg of (-)-epigallocatechin gallate.

First extraction solvent: water
1 g of the ointment contains 100 mg of polyphenon E extract (as dry extract), refined from Camellia sinensis (L.) O. Kuntze folium (green tea leaf) (45-56:1), corresponding to: 55-72 mg of (-)-epigallocatechin gallate.

First extraction solvent: water



Indication








contraindications






Posology, dosage & administration

Posology for adults

Up to 250 mg Veregen ointment in total, corresponding to about 0.5 cm of ointment strand (max. total single dose) to be applied three times per day to all external genital and perianal warts warts


Geriatric population

An insufficient number of geriatric patients was treated with Veregen ointment to determine whether they respond differently from younger subjects.

Method of administration

A small amount of Veregen should be applied to each wart using the fingers, dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts (max. 250 mg in total).




Posology for adults

Up to 250 mg Veregen ointment in total, corresponding to about 0.5 cm of ointment strand (max. total single dose) to be applied three times per day to all external genital and perianal warts warts (750 mg total daily dose)..


Older people Geriatric population

An insufficient number of older people geriatric patients were was treated with Veregen ointment to determine whether they respond differently from younger subjects.


Patients with hepatic impairment

Patients with severe liver dysfunction (e.g. clinically relevant elevation of liver enzymes, increase of bilirubin, increase of INR) should not use Veregen due to insufficient safety data.
Method of administration

A small amount of Veregen should be applied to each wart using the fingers, dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts (max. 250 mg in total for all warts/single dose).






Special Warnings and Special Precautions for Use

The effectiveness and safety in patients taking immunomodulatory medicines have not been established. Those patients should not use Veregen ointment.
The safety and effectiveness for treatment beyond 16 weeks or for multiple treatment courses have not been established.
Patients with hepatitis B/C or other pre-existing liver disease (elevation of liver enzymes) should not use Veregen due to insufficient safety data.


The effectiveness and safety in patients taking immunomodulatory medicines have not been investigated established. Those patients should not use Veregen ointment.
The safety and effectiveness for treatment beyond 16 weeks or for multiple treatment courses have not been established.
Patients with severe liver dysfunction (e.g. clinically relevant elevation of liver enzymes, increase of bilirubin, increase of INR) should not use Veregen due to insufficient safety data.
Patients with hepatitis B/C or other pre-existing liver disease (elevation of liver enzymes) should not use Veregen due to insufficient safety data.


Interaction with Other Medicaments and Other Forms of Interaction




Concomitant intake of high-dosed oral green tea extract preparations (food supplements) should be avoided (see section 4.8).


Fertility, pregnancy and Lactation

Pregnancy

There are no or limited amount of data from the use of Veregen in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).

Veregen is not recommended during pregnancy and in women of childbearing potential not using contraception (see also section 4.4).
Breast-feeding

It is unknown whether Veregen or its metabolites are excreted in human milk. A risk to the suckling child cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Veregen therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.


Pregnancy

There are no or limited amount of data from the use of Veregen in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).

Veregen is not recommended during pregnancy and in women of childbearing potential not using contraception (see also section 4.4).

As a precautionary measure, it is preferable to avoid the use of Veregen during pregnancy, although systemic exposure to epigallocatechin gallate is expected to be low following dermal application of Veregen.
Breast-feeding

It is unknown whether Veregen or its metabolites are excreted in human milk. A risk to the suckling child cannot be excluded.


No effects on the breastfed newborn / infant are anticipated since systemic exposure to epigallocatechin gallate is expected to be low following dermal application of Veregen.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Veregen therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.




preclinical safety data

No effects on fertility were observed in male rats after dermal and in female rats after vaginal application Embryofoetal development was not affected after vaginal application in rats or after subcutaneous administration in rabbits After oral administration effects on the ventricular system of the brain were noted in single foetuses of all treated groups of both species, but considering that exposure occurs via dermal application, the clinical relevance is unknown. In rats reduced foetal body weights were seen even in foetuses from dams not showing signs of maternotoxicity. In a pre- and postnatal development study in rats using vaginal administration of Veregen 15% adverse effects (maternotoxicity including stillbirths) were observed.



No effects on fertility were observed in male rats after dermal (safety margin of 728 based on mean Cmax) and in female rats after vaginal application (safety margin of 127 based on mean Cmax). Embryofoetal development was not affected after vaginal application in rats (safety margin of 127 based on mean Cmax) or after subcutaneous administration in rabbits (safety margin of 223 based on mean Cmax), respectively). After oral administration (no kinetic data available) effects on the ventricular system of the brain were noted in single foetuses of all treated groups of both species, but considering that exposure occurs via dermal application, the clinical relevance is unknown. In rats reduced foetal body weights were seen even in foetuses from dams not showing signs of maternotoxicity. In a pre- and postnatal development study in rats using vaginal administration of Veregen 15% adverse effects (maternotoxicity including stillbirths) were observed.
No systemic exposure data are available from this preclinical reproduction toxicity study, but based on toxicokinetic data from an intravaginal combined mating performance and embryo toxicity study in rats conducted with comparable dose levels, a safety margin of 69 (based on mean Cmax) could be established.


Adverse events




Class attribution effect

Literature data describe cases of hepatotoxicity following oral intake of high-doses of green tea extracts. Clinical studies, postmarketing surveillance data and nonclinical studies with Veregen did not reveal any adverse effect on liver function. However, to improve the product safety database for Veregen, any signs of liver dysfunction during the treatment with Veregen should be reported to the marketing authorisation holder.
Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal products is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.


Pharmacodynamic and pharmacokinetic properties

Pharmacokinetic properties

The pharmacokinetics of topically applied extract from green tea leaves have not been sufficiently characterized at this time.




Pharmacokinetic properties

Based on consistent data obtained in exposure studies (topical application of Veregen 15% and green tea beverage) it can be expected that systemic exposure of catechines following dermal application of Veregen does not exceed systemic exposure evident from oral green tea consumption.

After dermal application of 750 mg Veregen 15% (containing 72 mg of epigallocatechin gallate (EGCg), the major catechin of Veregen) the cmax lies in the area of 7 ng/ml for EGCg in plasma, with 7.34 ng/ml as highest value measured. This finding was restricted to single patients only. Therefore there seems no indication for systematic systemic exposure of catechines after topically applied Veregen that would exceed systemic exposure evident from oral green tea consumption established as worldwide consumed beverage. The cmax reported for EGCg in the literature following oral administration of green tea beverages are all consistently well above the sporadic concentrations measured in patients in the exposure studies (based on intake EGCg> 50 mg: 1 cup of tea ca. 50 – 200 mg EGCg).
The pharmacokinetics of topically applied extract from green tea leaves have not been sufficiently characterized at this time.


בעלון לצרכן





ההחמרות המבוקשות


פרק בעלון



טקסט נוכחי


טקסט חדש

הרכב

Polyphenon® E



[(Dry extract refined from Camellia sinensis (L.) O.Kuntze (green tea leaf) (45-56:1), corresponding to: 55-72% of (-)-epigallocatechin gallate (EGCg) 10% w/w

1g of the ointment contains

100 mg of extract (as dry extract, refined) from Camellia sinensis (L.) O. Kuntze folium (green tea leaf) (24:56:1), corresponding to: 55-72 mg of (-)-epigallocatechin gallate.

First extraction solvent: water
Polyphenon® E

[(Dry extract refined from Camellia sinensis (L.)

O.Kuntze (green tea leaf) (45-56:1),

corresponding to: 55-72% of

(-)-epigallocatechin gallate (EGCg) 10% w/w

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