DAIVOBET

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
BETAMETHASONE AS DIPROPIONATE; CALCIPOTRIOL AS HYDRATE
Available from:
DEXCEL LTD, ISRAEL
ATC code:
D05AX52
Pharmaceutical form:
OINTMENT
Composition:
BETAMETHASONE AS DIPROPIONATE 0.5 MG/G; CALCIPOTRIOL AS HYDRATE 50 MCG/G
Administration route:
DERMAL
Prescription type:
Required
Manufactured by:
LEO PHARMA A/S , DENMARK
Therapeutic group:
CALCIPOTRIOL, COMBINATIONS
Therapeutic area:
CALCIPOTRIOL, COMBINATIONS
Therapeutic indications:
Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy.
Authorization number:
127 60 30600 00
Authorization date:
2013-01-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

23-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

10-09-2020

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

Daivobet

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One gram of ointment contains 50 micrograms of calcipotriol (as hydrate) and 0.5 mg of

betamethasone (as dipropionate).

Excipient with known effects:

Butylhydroxytoluene (E321) 50 micrograms/g ointment

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Ointment.

Off-white to yellow.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy.

4.2 Posology and method of administration

Posology

Daivobet ointment should be applied to the affected area once daily.

The recommended treatment period is 4 weeks. There is experience with

repeated courses of Daivobet up to 52 weeks. If it is necessary to continue or

restart treatment after 4 weeks, treatment should be continued after medical

review and under regular medical supervision.

When using calcipotriol containing medicinal products, the maximum daily dose should not

exceed 15 g. The body surface area treated with calcipotriol containing medicinal products

should not exceed 30% (see section 4.4).

Special populations

Renal and hepatic impairment

The safety and efficacy of Daivobet ointment in patients with severe renal insufficiency or

severe hepatic disorders have not been evaluated.

Paediatric population

The safety and efficacy of Daivobet ointment in children below 18 years have not been

established. Currently available data in children aged 12 to 17 years are described in

section 4.8 and 5.1 but no recommendation on a posology can be made.

Method of administration

Daivobet ointment should be applied to the affected area. In order to achieve optimal effect,

it is not recommended to take a shower or bath immediately after application of Daivobet

ointment.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Daivobet ointment is contraindicated in erythrodermic, exfoliative and pustular psoriasis.

Due to the content of calcipotriol, Daivobet ointment is contra-indicated in patients with

known disorders of calcium metabolism (see section 4.4).

Due to the content of corticosteroid, Daivobet ointment is contraindicated in the following

conditions: Viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin

infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral

dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris,

acne rosacea, rosacea, ulcers and wounds (see section 4.4).

4.4 Special warnings and precautions for use

Effects on endocrine system

Daivobet ointment contains a potent group III steroid and concurrent treatment with other

steroids must be avoided. Adverse reactions found in connection with systemic

corticosteroid treatment, such as adrenocortical suppression or impact on the metabolic

control of diabetes mellitus may occur also during topical corticosteroid treatment due to

systemic absorption.

Application under occlusive dressings should be avoided since it increases the systemic

absorption of corticosteroids. Application on large areas of damaged skin or on mucous

membranes or in skin folds should be avoided since it increases the systemic absorption of

corticosteroids (see section 4.8).

In a study in patients with both extensive scalp and extensive body psoriasis using a

combination of high doses of Daivobet gel (scalp application) and high doses of Daivobet

ointment (body application), 5 of 32 patients showed a borderline decrease in cortisol

response to adrenocorticotropic hormone (ACTH) challenge after 4 weeks of treatment

(see section 5.1).

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient

presents with symptoms such as blurred vision or other visual disturbances, the patient

should be considered for a referral to an ophthalmologist for evaluation of possible causes

which may include cataract, glaucoma or rare diseases such as central serous

chorioretinopathy (CSCR) which have been reported after use of systemic and topical

corticosteroids.

Effects on calcium metabolism

Due to the content of calcipotriol, hypercalcaemia may occur if the maximum daily dose

(15 g) is exceeded. Serum calcium is normalised when treatment is discontinued. The risk

of hypercalcaemia is minimal when the recommendations relevant to calcipotriol are

followed. Treatment of more than 30% of the body surface should be avoided (see section

4.2).

Local adverse reactions

Daivobet ointment contains a potent group III-steroid and concurrent treatment with other

steroids on the same treatment area must be avoided. Skin of the face and genitals are

very sensitive to corticosteroids. The medicinal product should not be used in these areas.

The patient must be instructed in correct use of the medicinal product to avoid application

and accidental transfer to the face, mouth and eyes. Hands must be washed after each

application to avoid accidental transfer to these areas.

Concomitant skin infections

When lesions become secondarily infected, they should be treated with antimicrobiological

therapy. However, if infection worsens, treatment with corticosteroids should be stopped

(see section 4.3).

Discontinuation of treatment

When treating psoriasis with topical corticosteroids there may be a risk of generalised

pustular psoriasis or of rebound effects when discontinuing treatment. Medical supervision

should therefore continue in the post-treatment period.

Long-term use

With long-term use there is an increased risk of local and systemic corticosteroid adverse

reactions. The treatment should be discontinued in case of adverse reactions related to

long-term use of corticosteroid (see section 4.8).

Unevaluated use

There is no experience with the use of Daivobet ointment in guttate psoriasis.

Concurrent treatment and UV exposure

There is limited experience for the use of this medicinal product on the scalp. Daivobet

ointment for body psoriasis lesions has been used in combination with Daivobet gel for

scalp psoriasis lesions, but there is limited experience of combination of Daivobet with

other topical anti-psoriatic products at the same treatment area, other anti-psoriatic

medicinal products administered systemically or with phototherapy.

During Daivobet ointment treatment, physicians are recommended to advise patients to

limit or avoid excessive exposure to either natural or artificial sunlight. Topical calcipotriol

should be used with UVR only if the physician and patient consider that the potential

benefits outweigh the potential risks (see section 5.3).

Adverse reactions to excipients

Daivobet ointment contains butylhydroxytoluene (E321) as an excipient, which may cause

local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous

membranes.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed with Daivobet.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of Daivobet ointment in pregnant women. Studies

in animals with glucocorticoids have shown reproductive toxicity (see section 5.3), but a

number of epidemiological studies (less than 300 pregnancy outcomes)

have not revealed

congenital anomalies among infants born to women treated with corticosteroids during

pregnancy. The potential risk for humans is uncertain. Therefore, during pregnancy,

Daivobet ointment should only be used when the potential benefit justifies the potential risk.

Breast-feeding

Betamethasone passes into breast milk but risk of an adverse effect on the infant seems

unlikely with therapeutic doses. There are no data on the excretion of calcipotriol in breast

milk. Caution should be exercised when prescribing Daivobet ointment to women who

breast-feed. The patient should be instructed not to use Daivobet ointment on the breast

when breast-feeding.

Fertility

Studies in rats with oral doses of calcipotriol or betamethasone dipropionate demonstrated

no impairment of male and female fertility (see section 5.3).

4.7 Effects on ability to drive and use machines

Daivobet has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

The estimation of the frequency of adverse reactions is based on a pooled analysis of data

from clinical studies including post-authorisation safety studies and spontaneous reporting.

The most frequently reported adverse reactions during treatment are various skin reactions,

like pruritus and skin exfoliation.

Pustular psoriasis and hypercalcaemia have been reported.

Adverse reactions are listed by MedDRA SOC and the individual adverse reactions are

listed starting with the most frequently reported. Within each frequency grouping, adverse

reactions are presented in the order of decreasing seriousness.

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

Infections and infestations

Uncommon ≥1/1,000 to <1/100

Skin infection*

Folliculitis

Rare (≥1/10,000 to <1/1,000)

Furuncle

Immune system disorders

Rare (≥1/10,000 to <1/1,000)

Hypersensitivity

Metabolism and nutrition disorders

Rare (≥1/10,000 to <1/1,000)

Hypercalcaemia

Eye disorders

Not known

Vision, blurred****

Skin and subcutaneous tissue disorders

Common (≥1/100 to <1/10)

Skin exfoliation

Pruritus

Uncommon (≥1/1,000 to <1/100)

Skin atrophy

Exacerbation of psoriasis

Dermatitis

Erythema

Rash**

Purpura or ecchymosis

Skin burning sensation

Skin irritation

Rare (≥1/10,000 to <1/1,000)

Pustular psoriasis

Skin striae

Photosensitivity reaction

Acne

Dry skin

General disorders and administration site conditions

Uncommon (≥1/1,000 to <1/100)

Application site pigmentation changes

Application site pain***

Rare (≥1/10,000 to <1/1,000)

Rebound effect

*Skin infections including bacterial, fungal and viral skin infections have been reported.

**Various types of rash reactions such as rash exfoliative and rash pustular have been

reported.

***Application site burning is included in application site pain.

****See section 4.4.

Paediatric population

In an uncontrolled open study, 33 adolescents aged 12-17 years with psoriasis vulgaris

were treated with Daivobet ointment for 4 weeks to a maximum of 56 g per week. No new

adverse events were observed and no concerns regarding systemic corticosteroid effect

were identified. The size of this study does however not allow firm conclusions regarding

the safety profile of Daivobet ointment in children and adolescents.

The following adverse reactions are considered to be related to the pharmacological

classes of calcipotriol and betamethasone, respectively:

Calcipotriol

Adverse reactions include application site reactions, pruritus, skin irritation, burning and

stinging sensation, dry skin, erythema, rash, dermatitis, eczema, psoriasis aggravated,

photosensitivity and hypersensitivity reactions including very rare cases of angioedema and

facial oedema.

Systemic effects after topical use may appear very rarely causing hypercalcaemia or

hypercalciuria (see section 4.4).

Betamethasone (as dipropionate)

Local reactions can occur after topical use, especially during prolonged application,

including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis,

allergic contact dermatitis, depigmentation and colloid milia.

When treating psoriasis with topical corticosteroids there may be a risk of generalised

pustular psoriasis.

Systemic reactions due to topical use of corticosteroids are rare in adults, however they

can be severe. Adrenocortical suppression, cataract, infections, impact on the metabolic

control of diabetes mellitus and increase of intra-ocular pressure can occur, especially after

long term treatment. Systemic reactions occur more frequently when applied under

occlusion (plastic, skin folds), when applied on large areas and during long term treatment

(see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal

product.

Any suspected adverse events should be reported to the Ministry of Health according to the

National Regulation by using an online form

https://sideeffects.health.gov.il

4.9 Overdose

Use above the recommended dose may cause elevated serum calcium which subsides

when treatment is discontinued. The symptoms of hypercalcaemia include polyuria,

constipation, muscle weakness, confusion and coma.

Excessive prolonged use of topical corticosteroids may suppress the pituitary-adrenal

functions resulting in secondary adrenal insufficiency which is usually reversible. In such

cases symptomatic treatment is indicated.

In case of chronic toxicity the corticosteroid treatment must be discontinued gradually.

It has been reported that due to misuse one patient with extensive erythrodermic psoriasis

treated with 240 g of Daivobet ointment weekly (corresponding to a daily dose of

approximately 34 g) for 5 months (maximum recommended dose 15 g daily) developed

Cushing’s syndrome during treatment and then pustular psoriasis after abruptly stopping

treatment.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antipsoriatics. Other antipsoriatics for topical use, Calcipotriol,

combinations.

ATC Code: D05AX52

Calcipotriol is a vitamin D analogue. In vitro data suggests that calcipotriol induces

differentiation and suppresses proliferation of keratinocytes. This is the proposed basis for

its effect in psoriasis.

Like other topical corticosteroids, betamethasone dipropionate has anti-inflammatory,

antipruritic, vasoconstrictive and immunosuppressive properties, however, without curing

the underlying condition. Through occlusion the effect can be enhanced due to increased

penetration of the stratum corneum. The incidence of adverse events will increase because

of this. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is

unclear.

A safety study in 634 psoriasis patients has investigated repeated courses of Daivobet

ointment used once daily as required, either alone or alternating with Daivonex, for up to 52

weeks, compared with Daivonex used alone for 48 weeks after an initial course of Daivobet

ointment. Adverse drug reactions were reported by 21.7 % of the patients in the Daivobet

ointment group, 29.6 % in the Daivobet ointment/Daivonex alternating group and 37.9 % in

the Daivonex group. The adverse drug reactions that were reported by more than 2 % of

the patients in the Daivobet ointment group were pruritus (5.8 %) and psoriasis (5.3 %).

Adverse events of concern possibly related to long-term corticosteroid use (e.g. skin

atrophy, folliculitis, depigmentation, furuncle and purpura) were reported by 4.8 % of the

patients in the Daivobet ointment group, 2.8 % in the Daivobet ointment/Daivonex

alternating group and 2.9 % in the Daivonex group.

Adrenal response to ACTH was determined by measuring serum cortisol levels in patients

with both extensive scalp and body psoriasis, using up to 106 g per week combined

Daivobet gel and Daivobet ointment. A borderline decrease in cortisol response at 30

minutes post ACTH challenge was seen in 5 of 32 patients (15.6 %) after 4 weeks of

treatment and in 2 of 11 patients (18.2 %) who continued treatment until 8 weeks. In all

cases, the serum cortisol levels were normal at 60 minutes post ACTH challenge. There

was no evidence of change of calcium metabolism observed in these patients. With regard

to HPA suppression, therefore, this study shows some evidence that very high doses of

Daivobet gel and ointment may have a weak effect on the HPA axis.

Paediatric population

The adrenal response to ACTH challenge was measured in an uncontrolled 4-week study

in 33 adolescents aged 12-17 years with body psoriasis who used up to 56 g per week of

Daivobet ointment. No cases of HPA axis suppression were reported. No hypercalcaemia

was reported but one patient had a possible treatment related increase in urinary calcium.

5.2 Pharmacokinetic properties

Clinical studies with radiolabelled ointment indicate that the systemic absorption of

calcipotriol and betamethasone from Daivobet ointment is less than 1 % of the dose (2.5 g)

when applied to normal skin 625 cm

) for 12 hours. Application to psoriasis plaques and

under occlusive dressings may increase the absorption of topical corticosteroids.

Absorption through damaged skin is approx. 24 %.

Following systemic exposure, both active ingredients – calcipotriol and betamethasone

dipropionate – are rapidly and extensively metabolised. Protein binding is approx. 64 %.

Plasma elimination half-life after intravenous application is 5-6 hours. Due to the formation

of a depot in the skin elimination after dermal application is in order of days.

Betamethasone is metabolised especially in the liver, but also in the kidneys to glucuronide

and sulfate esters. The main route of excretion of calcipotriol is via faeces (rats and

minipigs) and for betamethasone dipropionate it is via urine (rats and mice). In rats, tissue

distribution studies with radiolabelled calcipotriol and betamethasone dipropionate,

respectively, showed that the kidney and liver had the highest level of radioactivity.

Calcipotriol and betamethasone dipropionate were below the lower limit of quantification in

all blood samples of 34 patients treated for 4 or 8 weeks with both Daivobet gel and

Daivobet ointment for extensive psoriasis involving the body and scalp. One metabolite of

calcipotriol and one metabolite of betamethasone dipropionate were quantifiable in some of

the patients.

5.3 Preclinical safety data

Studies of corticosteroids in animals have shown reproductive toxicity (cleft palate, skeletal

malformations). In reproduction toxicity studies with long-term oral administration of

corticosteroids to rats, prolonged gestation and prolonged and difficult labour were

detected. Moreover, reduction in offspring survival, body weight and body weight gain was

observed. There was no impairment of fertility. The relevance for humans is unknown.

A dermal carcinogenicity study with calcipotriol in mice and an oral carcinogenicity study in

rats revealed no special risk to humans.

Photo(co)carcinogenicity studies in mice suggest that calcipotriol may enhance the effect of

UVR to induce skin tumours.

A dermal carcinogenicity study in mice and an oral carcinogenicity study in rats revealed no

special risk of betamethasone dipropionate to humans. No photocarcinogenicity study has

been performed with betamethasone dipropionate.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

White soft paraffin

Polyoxypropylene stearyl ether

Liquid paraffin

All-rac-α-tocopherol

Butylhydroxytoluene (E321)

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other

medicinal products.

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials.

After first opening: 1 year for 15g, 30g, 60g, 100g and 120g tubes or 7 days for 3g tube.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Aluminium/epoxyphenol tubes with polyethylene screw cap.

Tube sizes: 3, 15, 30, 60, 100 and 120 g.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. MARKETING AUTHORIZATION HOLDER

Dexcel Ltd.

1 Dexcel St., Or Akiva, 3060000, Israel

8. MARKETING AUTHORISATION NUMBER

30600

This leaflet format has been determined by the Ministry of Health and the content has been

checked and approved in April 2017, and updated according to the guidelines of the

Ministry of Health in March 2020

העדוה

לע

הרמחה

(

עדימ

ןולעב )תוחיטב

ל

אפור

ןכדועמ(

05.2013

ךיראת

03/05/2015

םש

רישכת

תילגנאב

רפסמו

םושירה

(

127-60-30600-00

D

aivobet ointment

(

םש

לעב

םושירה

.

Dexcel Ltd

ספוט

הז

דעוימ

טורפל

תורמחהה

דבלב

תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט

Indication

contraindications

Hypersensitivity to the active

substances or to any of the excipients.

Daivobet ointment is contraindicated

in erythrodermic, exfoliative and

pustular psoriasis.

Due to the content of calcipotriol

Daivobet ointment is contra-indicated

in patients with known disorders of

calcium metabolism.

Due to the content of corticosteroid

Daivobet ointment is contraindicated

in the following conditions: Viral (e.g.

herpes or varicella) lesions of the skin,

fungal or bacterial skin infections,

parasitic infections, skin

manifestations in relation to

tuberculosis or syphilis, perioral

dermatitis, atrophic skin, striae

atrophicae, fragility of skin veins,

ichthyosis, acne vulgaris, acne rosacea,

rosacea, ulcers, wounds, perianal and

genital pruritus.

Hypersensitivity to the active substances or to

any of the excipients listed in section 6.1.

Daivobet ointment is contraindicated in

erythrodermic, exfoliative and pustular psoriasis.

Due to the content of calcipotriol, Daivobet

ointment is contra-indicated in patients with

known disorders of calcium metabolism (see

section 4.4).

Due to the content of corticosteroid, Daivobet

ointment is contraindicated in the following

conditions: Viral (e.g. herpes or varicella) lesions

of the skin, fungal or bacterial skin infections,

parasitic infections, skin manifestations in

relation to tuberculosis or syphilis, perioral

dermatitis, atrophic skin, striae atrophicae,

fragility of skin veins, ichthyosis, acne vulgaris,

acne rosacea, rosacea, ulcers, and wounds (see

section 4.4)., perianal and genital pruritus.

Special warnings

and special

precautions for

use

Local adverse reactions

Skin of the face and genitals are very

sensitive to corticosteroids. The

medicinal product should not be used

in these areas. The patient must be

instructed in correct use of the

medicinal product to avoid application

and accidental transfer to the face,

mouth and eyes. Hands must be

washed after each application to avoid

accidental transfer to these areas.

Local adverse reactions

Daivobet ointment contains a potent group III-

steroid and concurrent treatment with other

steroids on the same treatment area must be

avoided. Skin of the face and genitals are very

sensitive to corticosteroids. The medicinal

product should not be used in these areas. The

patient must be instructed in correct use of the

medicinal product to avoid application and

accidental transfer to the face, mouth and eyes.

Hands must be washed after each application to

Concurrent treatment and UV

exposure

There is no experience for the use

of this medicinal product on the

scalp. Daivobet ointment for body

psoriasis lesions has been used in

combination with Daivobet gel for

scalp psoriasis lesions, but there is

no experience of combination of

Daivobet with other topical anti-

psoriatic products at the same

treatment area, other anti-psoriatic

medicinal products administered

systemically or with phototherapy.

avoid accidental transfer to these areas.

Concurrent treatment and UV exposure

There is no experience for the use of this

medicinal product on the scalp. There is limited

experience for the use of this medicinal product

on the scalp. Daivobet ointment for body

psoriasis lesions has been used in combination

with Daivobet gel for scalp psoriasis lesions, but

there is no limited experience of combination of

Daivobet with other topical anti-psoriatic

products at the same treatment area, other anti-

psoriatic medicinal products administered

systemically or with phototherapy.

Fertility,

pregnancy and

lactation

Pregnancy

There are no adequate data from the

use of Daivobet ointment in pregnant

women. Studies in animals with

glucocorticoids have shown

reproductive toxicity (see section 5.3),

but a number of epidemiological

studies have not revealed congenital

anomalies among infants born to

women treated with corticosteroids

during pregnancy. The potential risk

for humans is uncertain. Therefore,

during pregnancy, Daivobet ointment

should only be used when the potential

benefit justifies the potential risk.

Pregnancy

There are no adequate data from the use of

Daivobet ointment in pregnant women. Studies in

animals with glucocorticoids have shown

reproductive toxicity (see section 5.3), but a

number of epidemiological studies (less than 300

pregnancy outcomes) have not revealed

congenital anomalies among infants born to

women treated with corticosteroids during

pregnancy. The potential risk for humans is

uncertain. Therefore, during pregnancy, Daivobet

ointment should only be used when the potential

benefit justifies the potential risk.

Undesirable effect

The trial program for Daivobet

ointment has so far included more than

2,500 patients and has shown that

approximately 10% of patients can be

expected to experience a non-serious

undesirable effect.

Skin and subcutaneous tissue

disorders

Common:

Pruritus

Rash

Burning sensation of

skin

Uncommon:

Exacerbation of

psoriasis

Skin pain or irritation

Dermatitis

Erythema

Folliculitis

Application site

The trial program for Daivobet ointment has so

far included more than 2,500 patients and has

shown that approximately 10% of patients can be

expected to experience a non-serious undesirable

effect.

The most frequently reported adverse reaction

during treatment are various skin reactions, like

pruritus, and skin exfoliation.

Pustular psoriasis and hypercalcamemia have

been reported.

Infections and infestations

Uncommon

≥1/1,000 to

<1/100

Skin infection*

Folliculitis

Rare (≥1/10,000

to <1/1,000)

Furuncle

Immune system disorders

pigmentation changes

Rare

Pustular psoriasis

General disorders and administration

site conditions

Not known

Rebound effect

included in section 4.4

Rare ≥1/10,000

to <1/1,000

Hypersensitivity

Metabolism and nutrition disorders

Rare (≥1/10,000

to <1/1,000)

Hypercalcaemia

Skin and subcutaneous tissue disorders

Common ≥1/100

to < 1/10

Skin exfoliation

Pruritus

Uncommon

≥1/1,000 to

<1/100

Skin atrophy

Exacebation of psoriasis

Dermatitis

Erythema

Rash**

Purpura or ecchymosis

Skin burning sensation

Skin irritation

Rare ≥1/10,000

to <1/1,000

Skin striae

Photosensitivity reaction

Acne

Dry skin

General disorders and administration site

conditions

Uncommon

≥1/1,000 to

<1/100

Application site pigmentation

changes

Application site pain***

Rare ≥1/10,000

to <1/1,000

Rebound effect

*Skin infections including bacterial, fungal and

viral skin infections have been reported.

** Various types of rash reactions such as rash

exfoliative and rash pustular have been reported

***Application site burning is included in

application site pain.

Overdose

Use above the recommended dose may

cause elevated serum calcium which

should rapidly subside when treatment

is discontinued

Use above the recommended dose may cause

elevated serum calcium subsides when treatment

is discontinued. The symptoms of hypercalcaemia

include polyuria, constipation, muscle weakness,

confusion and coma.

Preclinical safety

data

Photo(co)carcinogenicity studies in

mice suggest that calcipotriol may

enhance the effect of UVR to induce

skin tumours

No carcinogenicity or

photocarcinogenicity studies have been

performed with betamethasone

dipropionate.

Photo(co)carcinogenicity studies in mice suggest

that calcipotriol may enhance the effect of UVR

to induce skin tumours.

A dermal carcinogenicity study in mice and an

oral carcinogenicity study in rats

revealed no special risk of betamethasone

dipropionate to humans. No carcinogenicity or

photocarcinogenicity study has been performed

with betamethasone dipropionate.

העדוה

לע

הרמחה

(

עדימ

ןולעב )תוחיטב

ןכרצל

ןכדועמ(

05.2013

ךיראת

03/05/2015

םש

רישכת

תילגנאב

רפסמו

םושירה

(

127-60-30600-00

D

aivobet ointment

(

םש

לעב

םושירה

.

Dexcel Ltd

ספוט

הז

דעוימ

טורפל

תורמחהה

דבלב

תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט תויוותה יתמ

ןיא שמתשהל רישכתב

?

ךניה

שיגר

םירמוחל

םיליעפה

וא

לכל דחא

םיביכרמהמ

םיפסונה

רשא הליכמ הפורתה

ןיא

שמתשהל

החשמב

לע

רוע

קד

םידירו

םיקוזינה

תולקב

ינמיס

החיתמ

הנקא

םיביכ

וא

םיעצפ

רועב

רוע

קודס

תיזזח הדורו

האיצזור

תאטבתמה

הארמב לש רוע

םינפ

םדמדא

קומסו

ביבס

הפה

ימוהיז

רוע

םילאריו

ימוהיז

רוע םייתירטיפ

תוילאירטקב

וא

תויליפט

תועפות

רוע תורושקה

תפחשל

תבגע

וא

סיזויטכיא

ichthyosis

םירקמב

לש

דרג

ירבאב ןימה

וא

יפב

תעבטה

ךניה

לבוס

תויעבמ

תומרב

ןדיס ףוגב

שי

ךל

גוס

רחא

לש

תחפס

התא

שיגר

םירמוחל )יגרלא(

םיליעפה

וא לכל

דחא

םיביכרמהמ

םיפסונה

רשא הליכמ

הפורתה

האר(

ףיעס

ןיא

שמתשהל

החשמב

לע

רוע

םידירו ,קד םיקוזינה

ינמיס ,תולקב

,הנקא ,החיתמ םיביכ

וא

םיעצפ

רוע ,רועב

,קודס תיזזח הדורו

תאטבתמה )האיצזור(

הארמב

לש רוע

םינפ

םדמדא

קומסו

ביבס

הפה

ימוהיז

רוע

,םילאריו ימוהיז

רוע תירטיפ םיי תוילאירטקב ,

וא

,תויליפט תועפות

רוע

תורושקה

,תפחשל תבגע

וא סיזויטכיא

ichthyosis

םירקמב

לש

דרג ירבאב

ןימה

וא

יפב

תעבטה

ךניה

לבוס

תויעבמ

תומרב

ןדיס

ףוגב

תחפס לש רחא גוס ךל שי

,תימרדורתירא תיתסרומ וא תיביטאילופסקא .)תירלוטסופ( ןיא שמתשהל הפורתב ילבמ ץעוויהל אפורב

ינפל תלחתה לופיטה

:

םא

ךניה

לבוס

תרכוסמ

שומיש םידיאורטסב

לולע

עיפשהל

לע

ןוזיא תומר

רכוס

םדב

םא

ךניה

לבוס

הלחממ

הרומח

לש דבכה

וא

תוילכה

םא

שי

ךל

םוהיז

לש

רועה

ןכתי אפורהש

הרוי

ךל

לע

תקספה

לופיטה

םא

שי

ךל

גוס

םיוסמ

לש תחפס

הטטוג

סיזאירוספ

ךניה

לבוס

תרכוסמ

שומיש( םידיאורטסב

לולע

עיפשהל

לע

ןוזיא תומר

רכוס

)םדב

ךניה

לבוס

הלחממ

הרומח

לש

דבכה

וא .תוילכה

שי

ךל

םוהיז

לש

ןכתי .רועה

אפורהש הרוי

ךל

לע

תקספה

.לופיטה

שי

ךל

גוס

םיוסמ

לש

תחפס

הטטוג סיזאירוספ

תשמתשה

הפורתב

וז

ךשמל

ןמז

בר ךתנווכבו

קיספהל

שי(

ןוכיס סיזאירוספהש

רימחי

וא

ץרפתי הקספהב

תימואתפ

לש

.)םידיאורטס

ךניה

שיגר

ןוזמל

והשלכ

וא

הפורתל יהשלכ

תורהזא תודחוימ תועגונה שומישל :הפורתב

םא

ךניה

שיגר

ןוזמל

והשלכ

וא הפורתל

יהשלכ

ךילע

עידוהל

לע

ךכ אפורל

ינפל

תליטנ

הפורתה

ןיא

שמתשהל

הפורתב

וז

לע

יחטש רוע

םיבחרנ

לע

םינפה

לע

ירבא

ןימה

ילפקב

רוע

ןוגכ העשפמ

יתב

יחש

תחתמ

םיידשל

וא לע

המקר

תיריר

שי

אורקל

ןויעב

תא תורהזאה

תורושקה ןפואל

שומישה

ףיעסב

"

דציכ

שמתשת הפורתב

."?

ןיא

שמתשהל

תחתמ

םידגבל

םימטוא וא

תוסכל

תא

רוזיאה

רחאל

תחירמ החשמה

שי

ענמיהל

הייהשמ

תכשוממ

שמשב

שומיש

ךשוממ

םוירלוסב

וא

לכב

הרוצ תרחא

לש

לופיט

רואב

ןיא

שמתשהל

הפורתב

וז

לע

םירוזא

םיבחרנ לש

רוע

,םוגפ ילפקב

רוע

ןוגכ(

,העשפמ יתב

יחש

תחתמ

וא )םיידשל

לע

המקר

תיריר רחאמ

הזו

ריבגמ

תא

הגיפסה

לש .םידיאורטסה שי

אורקל

ןויעב

תא

תורהזאה תורושקה

ןפואל

שומישה

ףיעסב

דציכ" שמתשת

"?הפורתב

ןיא

שמתשהל

לע

םינפה

וא

לע

ירבא

,ןימה רחאמ

םירוזאו

הלא

םישיגר

דואמ .םידיאורטסל

ןיא

שמתשהל

תחתמ

םידגבל

םימטוא

תושובחת

וא

תוסכל

תא

רוזאה

רחא תחירמ

החשמה

רחאמ

הזו

ריבגמ

תא הגיפסה

לש

.םידיאורטס

שי

ענמיהל

הייהשמ

תכשוממ

שומיש ,שמשב ךשוממ

םוירלוסב

וא

לכב

הרוצ

תרחא

לש לופיט

.רואב

שי

ענמיהל

שומישמ

לע

רתוי

ףוגהמ

וא

רתוי

םרג

םויל

דציכ שמתשת :הפורתב

...

םא

תשמתשה

תומכב

הלודג

רתוי ץלמומהמ

וא

לע

חטש

ףוג

בחרנ

רתוי שי

תונפל

אפורל

.

שומיש

רתי וא

הפוקתל

תכשוממ

לולע

םורגל תויעבל

תומרב

ןדיסה

םדב

רשא

רזוח תומרל

תוילאמרונ

רחאל

תקספה לופיטה

ןכתי

אפורהש

ךרטצי

ךתונפהל תוקידבל

םד

ידכב

לולשל

בצמ

הז

שומיש

רתי

וא

הפוקתל תכשוממ

לולע

םג

םורגל

תויעבל דוקפתב

תטולב

תרתוי הילכה

הכומסה

הילכל

תרציימו םינומרוה

...

םא

תשמתשה

תומכב

הלודג

רתוי

ץלמומהמ וא

לע

חטש

ףוג

בחרנ

רתוי

שי

תונפל

אפורל

.

שומיש

רתי

וא

הפוקתל

תכשוממ

לולע

םורגל תויעבל

תומרב

ןדיסה

םדב

רשא

רזוח

תומרל וילאמרונ

רחאל

תקספה

ןכתי .לופיטה

אפורהש ךרטצי

ךתונפהל

תוקידבל

םד

ידכב

לולשל

בצמ .הז

שומיש

רתי

וא

הפוקתל

תכשוממ

לולע

םג םורגל

תויעבל

דוקפתב

תטולב

תרתוי

הילכה הכומסה(

הילכל

תרציימו

.)םינומרוה

...

תועפות יאוול ומכ

לכב

הפורת

שומישה

טבוביידב לולע

םורגל

תועפותל

יאוול

קלחב םישמתשמהמ

לא

להבית

ארקמל תמישר

תועפות

יאוולה

ןכתיי

אלו לובסת

ףאמ

תחא

ןהמ

שי

קיספהל

תא

שומיש

תונפלו

דימ רדחל

ןוימ

םא

ךנה

שח

ב

:

הבוגת

תיגרלא

הלוכיה

אטבתהל תוחיפנב

םינפב

םיידיב

םיילגרב

הפב וא

ןורגב

יישקו

המישנ

שי

קיספהל

תא

שומיש

תונפלו

דימ אפורל

םא

ךנה

שח

ב

:

תעפוה

תחפס

תיתסרומ

pustular

psoriasis

רוזיא

םודא

םע

תוילגומ תובהבהצ

ךרדב

ללכ עיפומ

םיידיב

םיילגרבו

שי

תונפל

אפורל

םדקהב

ירשפאה םא

התא

שח

ב

:

הרמחה

בצמב

סיזארוספה

תחפס

העיגפ

תוליעפב

תטולב

תרתוי שי

קיספהל

תא

ה

שומיש

תונפלו

דימ

אפורל םא

ךנה

שח

ב

:

הבוגת

תיגרלא

הלוכיה

אטבתהל

תוחיפנב הקומע

םינפב

וא

יקלחב

ףוג

םירחא

ומכ הפב ,םיילגרב ,םיידיב

וא

ןורגב

יישקו

.המישנ

תעפוה

תחפס

תיתסרומ

pustular psoriasis

רוזא

םודא

םע

תויתלגומ

הבהבהצ

ךרדב

ללכ םיידיב

וא

תופכב

.)םיילגרה שי

תונפל

אפורל

םדקהב

ירשפאה

תעפוהב תועפותה

:תואבה

תועפות

יאוול

ןניאש

תוחיכש

תועפות

תועיפומש

ב

1-10

םישמתשמ

ךותמ

1000

)

הרמחה בצמב

סיזאירוספה

,)תחפס( תקלד

וא תוחיפנ

יקיקזב

רעישה

.)סיטילוקילופ(

העיגפ

תוליעפב

תטולב

תרתוי

הילכה תאטבתמ(

ןואכיד ,תופייעב

,)הדרחו הילע

ץחלב

ךות

יניע

אטבתמ(

באכב תוימומדא ,םייניע

העיגפ ,ןיעב

היארב

וא הילכה

אטבתמ

תופייעב

ןואכיד הדרחו

המר

ההובג

לש

ןדיס

ןתשב

וא םדב

אטבתמ

באכב

תומצעב

תוריצע

הדירי

ןובאתב

הליחב

תואקה

העפות

וז

תירוק

ךרדב

ללכ בקע

שומיש

תומכב

החשמ

הלודג

ידימ תפלוחו

םע

תקספה

לופיטה טבוביידב

הילע

ץחלב

ךות יניע

אטבתמ

באכב

םייניע

תוימומדא ןיעב

העיגפ

היארב

וא

היאר תלפרועמ

טקרטק

אטבתמ

היארב תלפרועמ

ישוק

היארב

הלילב

תושיגרו רואל

תוחתפתה

םימוהיז וא

ימוהיז

רוע

לודליד

רועה

תעפוה

ילכ םד

םייחטש

וא

ינמיס

החיתמ

םייוניש תחימצב

רעישה

החירפ המודא

ביבס

הפה

החירפ

רועב הוולמה

תקלדב

וא

תוחיפנ

תוטילב תוירוע

תומוח

תוקירבמ

תואלמה לזונב

תרהבה

עבצ רועה

היצטנמגיפד

העיגפ

ןוזיאב ילובטמ

לש

תרכוס

תולולע

תויהל תודונת

תומרב רכוסה

ףוגב

תועפות

יאוול

תופסונ

:

תועיפומ םיתיעל

תובורק

דוריג

החירפ

הבירצ

תועיפומ

םיתיעל

תוקוחר

יוריג

ימוקמ וא

באכ

ירוע

החירפ

רועב

הוולמ תקלדב

סיטיטמרד

תוימומדא תירוע

תמרגנה

תובחרתהמ

ילכ

םד םינטק

רועב

תקלד

וא

תוחיפנ

יקיקזב רעישה

יוניש

עבצ

רועה

רוזאב תחירמ

החשמה

תועפות

יאוול

תוחיכשב

אל

העודי

רוע שבי

תושיגר

רועה

רואל

תאטבתמה החירפב

המזקא

הרמחה לש

תחפסה

רחאל

תקספה

שומיש הפורתב

םא

תחא

תועפותמ

יאוולה

הרימחמ

וא רשאכ

התא

לבוס

תעפותמ

יאוול

אלש הרכזוה

ןולעב

ךילע ץעייתהל

םע

אפורה

היאר

;)תלפרועמ

טקרטק

אטבתמ( היארב

ישוק ,תלפרועמ

היארב

הלילב תושיגרו

;)רואל

תוחתפתה

םימוהיז

וא ימוהיז

;רוע

העיגפ

ןוזיאב

ילובטמה

לש תרכוס

תולולע(

תויהל

תודונת

תומרב רכוסה

.)ףוגב

ריבס

רתוי

תועפותש

ולא ורקי

רחאל

שומיש

שומיש ,ךשוממ םילפקב

רועב

לשמל(

תיב ,העשפמ

יחש וא

תחתמ

שומיש )הזחל

םירוזאב

םיסוכמ וא

שומיש

ירוזאב

רוע

םיבחרנ

.

המר

ההובג

לש

ןדיס

ןתשב

וא

םדב תאטבתמ

ןתמב

ןתש

רבגומ

באכב תומצעב

,תוריצע

הדירי

תוליחב ,ןובאתב תואקהו

תשלוח

םירירש

לובלב

תמדרתו

העפות

וז

תירוק

ךרדב

ללכ

בקע

שומיש תומכב

החשמ

הלודג

ידימ

תפלוח

םע תקספה

לופיטה

;)טבוביידב

תועפות

תועיפומה

רחאל

שומיש

:ךשוממ לוליד

,רועה

תעפוה

ילכ

םד

םייחטש

וא ינמיס

ייוניש ;החיתמ

תחימצב

;רעישה החירפ

המודא

ביבס

החירפ ;הפה

רועב הוולמה

תקלדב

וא

תוחיפנ

תוטילב תובוהז

תואלמה

ל'גב

colloid milia

תרהבה

עבצ

רועה

)היצטנמגיפד(

תועפות

יאוול

תופסונ

:

תועפות

יאוול

תוחיכש

תועפות( תועיפומש

ב

1-10

םישמתשמ

ךותמ

100

:)

דוריג

הבירצ ,החירפ

ףוליק

רוע

תועפות

יאוול

ןניאש

תוחיכש תועפות(

תועיפומש

ב

1-10

םישמתשמ

ךותמ

1000

:)

יוריג

ימוקמ וא

באכ

החירפ ,ירוע

םע

תקלד

לש

רועה תוימומדא ,)סיטיטמרד(

רועה

האצותכ תובחרתהמ

ילכמ

םד

םינטק

,)המתירא( יוניש

עבצ

רועה

רוזאב

תחירמ

החשמה

,החירפ

יוריג

תשוחת ,םייניעב

הריעב ץוצקעו

,רועב

תעפוה

ימתכ

רוע

םימודא וא

םילוגס

הרופרופ(

וא

)סיזומיכא

.

תועפות

יאוול

תורידנ

תועפות( תועיפומש

ב

1-10

םישמתשמ

ךותמ

10,000

:)

םימוהיז

םייתיירטפ

וא

םיילאירטקב יקיקזב

המר ,הרעשה

ההובג

לש

ןדיס םדב

תובוגת ,)הימצלקרפיה(

,תויגרלא ינמיס

תושיגר ,החיתמ

רועה

רואל תאטבתמה

שבוי ,הנקא ,החירפב

,רועב טקפא

הרמחה -דנואביר

לש

תחפסה רחאל

תקספה

שומישה

.הפורתב

תועפות

יאוול

תוחיכשב

אל

:העודי .המזקא

Similar products

Search alerts related to this product

View documents history

Share this information