Soolantra 10 mg/g Kräm

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

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Bipacksedel Bipacksedel (PIL)

02-07-2019

Produktens egenskaper Produktens egenskaper (SPC)

16-02-2021

Aktiva substanser:
ivermektin
Tillgänglig från:
2care4 ApS,
ATC-kod:
D11AX22
INN (International namn):
ivermectin
Dos:
10 mg/g
Läkemedelsform:
Kräm
Sammansättning:
cetylalkohol Hjälpämne; ivermektin 10 mg Aktiv substans; stearylalkohol Hjälpämne; metylparahydroxibensoat Hjälpämne; propylparahydroxibensoat Hjälpämne; propylenglykol Hjälpämne; glycerol Hjälpämne
Receptbelagda typ:
Receptbelagt
Bemyndigande status:
Avregistrerad
Godkännandenummer:
56218
Tillstånd datum:
2017-06-14

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

28-06-2019

Produktens egenskaper Produktens egenskaper - engelska

02-07-2020

Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska

22-04-2015

Läs hela dokumentet

Package leaflet: Information for the patient

Soolantra 10 mg/g cream

ivermectin

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm

them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Soolantra is and what it is used for

What you need to know before you use Soolantra

How to use Soolantra

Possible side effects

How to store Soolantra

Contents of the pack and other information

1.

What Soolantra is and what it is used for

Soolantra contains the active substance ivermectin that belongs to a group of medicines called

avermectins. The cream is used on the skin to treat pimples and spots found with rosacea.

Soolantra should be used in adults only (18 years of age or older).

2.

What you need to know before you use Soolantra

Do not use Soolantra:

if you are allergic to ivermectin or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Soolantra.

At the start of the treatment, some patients may experience worsening of the symptoms of rosacea,

however this is uncommon and usually resolves within 1 week of the treatment.

Talk to your doctor

if this happens.

Other medicines and Soolantra

Other medicines may have an effect on Soolantra, you should therefore tell your doctor if you are

using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

Soolantra is not recommended during pregnancy.

If you are breast-feeding, you should not use this medicine, alternatively, you should stop breast-

feeding before start treatment with Soolantra. You should consult your doctor to help you decide

between using Soolantra and breast-feeding, taking into account the benefit of the treatment and the

benefit of breast-feeding.

Driving and using machines

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

Soolantra contains:

Cetyl

alcohol

stearyl

alcohol

which

cause

local

skin

reactions

(e.g.

contact

dermatitis),

Methyl parahydroxybenzoate (E218)

propyl parahydroxybenzote (E216)

which may

cause allergic reactions (possibly delayed),

Propylene glycol

which may cause skin irritation.

3.

How to use Soolantra

Always use this medicine exactly as your doctor has told you. Check with your doctor or

pharmacist if you are not sure.

Important:

Soolantra is intended for adults and only for use on the skin of the face. Do not use this

medicine on other parts of your body, especially not moist body surfaces, e.g. your eyes, your

mouth or any mucosa. Do not swallow.

The recommended dose is one application on facial skin per day. Apply a pea size amount of the

cream to each of the five areas of the face: forehead, chin, nose and each cheek. Then spread the

cream as a thin layer across the entire face.

Make sure to avoid the eyelids, lips and any mucosa such as inside the nose, the mouth and the

eyes. If you accidentally get cream in the eyes or near the eyes, eyelids, lips, mouth or mucosa

wash the area immediately with plenty of water.

Do not apply cosmetics (such as other facial creams or make-up) before the daily application of

Soolantra. These products can be used after the applied cream has dried.

Wash your hands immediately after applying the cream.

You should use Soolantra daily over the treatment course and the treatment course may be

repeated. Your doctor will tell you how long you will need to use Soolantra. The duration of

treatment can vary from person to person and depends on the severity of the skin disorder.

You may notice an improvement after 4 weeks of treatment. In case of no improvement after

3 months, you should discontinue Soolantra and consult your doctor

Hepatic impairment

If you have liver problems, please consult your doctor before using Soolantra.

Use in children and adolescents

Soolantra should not be used by children and adolescents.

How to open the tube with child-resistant cap

To avoid spilling, do not squeeze the tube while opening or closing.

Push down on the cap and turn counter clockwise (turn to the left). Then pull the cap off.

How to close the tube with a child-resistant cap

Push down and turn clockwise (turn to the right).

If you use more Soolantra than you should

If you use more than the daily recommended dose, please contact your doctor, who will advise you

on what action to take.

If you forget to use Soolantra

Do not use a double dose to make up for a forgotten dose.

If you stop using Soolantra

Pimples and spots will be reduced only after several applications of this medicine. It is important

that you continue using Soolantra as long as prescribed by your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Soolantra may cause the following side effects:

Common side effect (may affect up to 1 in 10 people):

Burning feeling of the skin

Uncommon side effects (may affect up to 1 in 100 people):

Irritation of the skin

Itching of the skin

Dry skin

Rosacea aggravation (please consult your doctor)

Not known side effect (frequency cannot be estimated from the available data):

Redness of the skin

Inflammation of the skin

Swelling of the face

Liver enzyme elevations (ALAT/ASAT)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet.

You can also report side effects directly via the national reporting

system listed in Appendix V. By reporting side effects you can help provide more information on

the safety of this medicine.

5.

How to store Soolantra

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and tube after EXP. The

expiry date refers to the last day of that month.

After first opening of the tube, use the product within 6 months.

This medicine does not require any special storage conditions.

Do not throw away unused Soolantra cream via wastewater or household waste. Ask your

pharmacist how to throw away medicines you no longer use. These measures will help protect the

environment.

6.

Contents of the pack and other information

What Soolantra contains

The active substance is ivermectin. One gram of cream contains 10 mg of ivermectin.

The other ingredients are glycerol, isopropyl palmitate, carbomer, dimeticone, disodium

edetate, citric acid monohydrate, cetyl alcohol, stearyl alcohol, macrogol cetostearyl ether,

sorbitan stearate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216),

phenoxyethanol, propylene glycol, oleyl alcohol, sodium hydroxide, purified water.

What Soolantra looks like and contents of the pack

Soolantra is a white to pale yellow cream. It is supplied in tubes containing 2, 15, 30, 45 or

60 grams of cream. The larger tubes have a child resistant closure whilst the 2 g tube does not.

Pack size of 1 tube.

Not all pack sizes may be marketed.

This medicinal product is authorised in the Member States of the EEA under the following name:

Austria, Germany, Portugal :

Soolantra 10 mg/g Creme

Belgium, Luxemburg:

Soolantra 10 mg/g crème

Soolantra 10 mg/g Creme

Bulgaria:

Soolantra 10 mg/g Крем

Cyprus, Greece:

Soolantra 10 mg/g Κρέμα

Czech Republic, Hungary, Slovakia :

Soolantra 10 mg/g krém

Denmark

Soolantra

Estonia :

Soolantra 10 mg/g kreem

Finland :

Soolantra 10 mg/g emulsiovoide

France, Netherlands:

Soolantra10 mg/g crème

Iceland, Norway, Poland:

Soolantra 10 mg/g krem

Ireland, United Kingdom:

Soolantra 10 mg/g cream

Italy:

Efacti 10 mg/g crema

Latvia:

Soolantra 10 mg/g krēms

Lithuania:

Soolantra 10 mg/g kremas

Malta:

Soolantra 10 mg/g krema

Romania:

Soolantra 10 mg/g Cremă

Spain :

Soolantra 10 mg/g crema

Sweden :

Soolantra 10 mg/g kräm

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This leaflet was last revised in 2019-06-28

Läs hela dokumentet

SUMMARY OF PRODUCT CHARACTERISTICS

NAME OF THE MEDICINAL PRODUCT

Soolantra 10 mg/g cream

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

One gram of cream contains 10 mg of ivermectin.

Excipient(s) with known effect:

One gram of cream contains 35 mg of cetyl alcohol, 25 mg of stearyl alcohol, 2 mg of methyl

parahydroxybenzoate (E218), 1 mg of propyl parahydroxybenzoate (E216) and 20 mg of propylene glycol.

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Cream.

White to pale yellow hydrophilic cream.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Soolantra is indicated for the topical treatment of inflammatory lesions of rosacea (papulopustular) in adult

patients.

4.2

Posology and method of administration

Posology

One application a day for up to 4 months. Soolantra should be applied daily over the treatment course. The

treatment course may be repeated. It can be applied as monotherapy or as part of combination treatment (see

section 5.1).

In case of no improvement after 3 months, the treatment should be discontinued.

Special population

Renal impairment

No dosage adjustment is necessary.

Hepatic impairment

Caution should be exercised in patients with severe hepatic impairment.

Elderly patients

No dosage adjustment is necessary in the geriatric population (see also section 4.8).

Paediatric population

The safety and efficacy of Soolantra in children and adolescents aged less than 18 years have not been

established. No data are available.

Method of administration

Cutaneous use only.

Cutaneous application of a pea-size amount of medicinal product to each of the five areas of the face:

forehead, chin, nose, and each cheek. The medicinal product should be spread as a thin layer across the entire

face, avoiding the eyes, lips and mucosa.

Soolantra should be applied only to the face.

Hands should be washed after applying the medicinal product.

Cosmetics may be applied after the medicinal product has dried.

4.3

Contraindications

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

4.4

Special warnings and precautions for use

Patients may experience transient aggravation of rosacea, which usually resolves within 1 week under

continuation of the treatment as might be expected due to a reaction to the dying Demodex mites.

In case of severe worsening with a strong dermal reaction, the treatment should be discontinued.

Soolantra has not been studied in patients with renal or hepatic impairment.

The medicinal product contains:

cetyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis),

methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic

reactions (possibly delayed),

and propylene glycol which may cause skin irritation.

4.5

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed (see section 5.2 for Biotransformation).

In vitro studies have shown that ivermectin is primarily metabolised by CYP3A4. Consequently, caution is

advised when ivermectin is administered concomitantly with potent CYP3A4 inhibitors as the plasma

exposure may be significantly increased.

4.6

Fertility, pregnancy and lactation

Pregnancy

There are no or a limited amount of data from the topical use of ivermectin in pregnant women. Oral

reproductive toxicity studies have shown that ivermectin is teratogenic in rats and rabbits (see section 5.3),

however due to the low systemic exposure following topical administration of the product at the proposed

posology, there is a low safety concern for a human foetus. Soolantra is not recommended during pregnancy.

Breast-feeding

Following oral administration, ivermectin is excreted in human milk in low concentrations. Excretion in

human milk following topical administration has not been evaluated. Available pharmacokinetic/

toxicological data in animals have also shown excretion of ivermectin in milk. A risk to a suckling child

cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain

from Soolantra therapy taking into account the benefit of breast-feeding for the child and the benefit of

therapy for the woman.

Fertility

No human data on the effect of ivermectin on fertility are available. In rats, there was no effect on mating or

fertility with ivermectin treatment.

4.7

Effects on ability to drive and use machines

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

4.8

Undesirable effects

Summary of the safety profile

The most commonly reported adverse reactions are skin burning sensation, skin irritation, pruritus and dry

skin, all occurring in 1% or less of patients treated with the medicinal product in clinical trials.

They are typically mild to moderate in severity, and usually decrease when treatment is continued.

No meaningful differences in the safety profile were observed between subjects 18 to 65 years and subjects

≥65 years of age.

Tabulated list of adverse reactions

The adverse reactions are classified by System Organ Class and frequency, using the following convention:

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) and were reported

with Soolantra in clinical studies (see Table 1).

Table 1 – Adverse reactions

System Organ Class

Frequency

Adverse reactions

Common

Skin burning sensation

Uncommon

Skin irritation, pruritus, dry skin

Rosacea aggravation*

Skin and subcutaneous

tissue disorders

Not known

Erythema

Dermatitis contact (allergic or irritant)

Swelling face

Investigations

Not known

Transaminases increased*

* Adverse reaction reported from post-marketing data.

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. Healthcare professionals are asked

to report any suspected adverse reactions via the national reporting system listed in Appendix V.

4.9

Overdose

There are no reports of overdosage with Soolantra.

In accidental or significant exposure to unknown quantities of veterinary formulations of ivermectin in

humans, either by ingestion, inhalation, injection, or exposure to body surfaces, the following adverse effects

have been reported most frequently: rash, oedema, headache, dizziness, asthenia, nausea, vomiting, and

diarrhoea. Other adverse effects that have been reported include: seizure, ataxia, dyspnea, abdominal pain,

paresthesia, urticaria, and contact dermatitis.

In case of accidental ingestion, supportive therapy, if indicated, should include parenteral fluids and

electrolytes, respiratory support (oxygen and mechanical ventilation if necessary) and pressor agents if

clinically significant hypotension is present. Induction of emesis and/or gastric lavage as soon as possible,

followed by purgatives and other routine anti-poison measures, may be indicated if needed to prevent

absorption of ingested material.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Other dermatological preparations, other dermatologicals, ATC code: D11AX22

Mechanism of action

Ivermectin is a member of the avermectin class. Avermectin has anti-inflammatory effects by inhibiting

lipopolysaccharide-induced production of inflammatory cytokines. Anti-inflammatory properties of

cutaneous ivermectin have been observed in animal models of skin inflammation. Ivermectin also causes

death of parasites, primarily through binding selectively and with high affinity to glutamate-gated chloride

channels, which occur in invertebrate nerve and muscle cells. The mechanism of action of Soolantra in

treating the inflammatory lesions of rosacea is not known but may be linked to anti-inflammatory effects of

ivermectin as well as causing the death of Demodex mites that have been reported to be a factor in

inflammation of the skin.

Clinical efficacy and safety

Soolantra applied once daily at bedtime was evaluated in the treatment of inflammatory lesions of rosacea in

two randomised, double-blind, vehicle-controlled clinical studies, which were identical in design. The

studies were conducted in 1371 subjects aged 18 years and older who were treated once daily for 12 weeks

with either Soolantra or vehicle.

Overall, 96% of subjects were Caucasian and 67% were female. Using the 5-point Investigator Global

Assessment (IGA) scale, 79% of subjects were scored as moderate (IGA=3) and 21% scored as severe

(IGA= 4) at baseline.

The co-primary efficacy endpoints in both clinical studies were the success rate based on the IGA outcome

(percentage of subjects “clear” and “almost clear” at Week 12 of the study) and absolute change from

baseline in inflammatory lesion counts. The IGA scale is based on the following definitions:

Table 2: Investigator Global Assessment (IGA) scale

Grade

Score

Clinical Description

Clear

No inflammatory lesions present, no erythema

Almost Clear

Very few small papules/pustules, very mild erythema

present

Mild

Few small papules/pustules, mild erythema

Moderate

Several small or large papules/pustules, moderate erythema

Severe

Numerous small and/or large papules/pustules, severe

erythema

The results from both clinical studies demonstrated that Soolantra applied once daily for 12 weeks was

statistically superior to vehicle cream in terms of IGA success rate and absolute change in inflammatory

lesion counts (p<0.001, see table 3 and Figure 1, Figure 2, Figure 3 and Figure 4).

The following table and figures present efficacy outcomes from both studies.

Table 3: Efficacy Results

Study 1

Study 2

Soolantra

(N=451)

Vehicle

(N=232)

Soolantra

(N=459)

Vehicle

(N=229)

Investigator Global

Assessment

Number (%) of Subjects

Clear or Almost Clear in

the IGA at Week 12

(38.4)

(11.6)

(40.1)

(18.8)

Inflammatory Lesions

Mean Inflammatory Lesion

Count

at Baseline

31.0

30.5

33.3

32.2

Mean Inflammatory Lesion

Count

at Week 12

10.6

18.5

11.0

18.8

Mean Absolute Change

(%Change) in

Inflammatory Lesion

Count

from Baseline at Week 12

-20.5

(-64.9)

-12.0

(-41.6)

-22.2

(-65.7)

-13.4

(-43.4)

Figures 1 and 2: IGA Success Rates Over Time in weeks

Study 1

Study 2

Figures 3 and 4: Mean Absolute Change in Inflammatory Lesion Counts from Baseline Over Time in

weeks

Study 1

Study 2

Soolantra was statistically superior to vehicle cream on the co-primary efficacy endpoints with a time to

onset of efficacy of 4 weeks of treatment (p<0.05).

IGA was assessed during the 40-week extension of the two clinical studies and the percentages of subjects

treated with Soolantra achieving an IGA score of 0 or 1 continued to increase up to Week 52. The Success

Rate (IGA=0 or 1) at Week 52 was 71% and 76% in Studies 1 and 2, respectively.

The efficacy and safety of the medicinal product in the treatment of inflammatory lesions of rosacea were

also evaluated in a randomised, investigator-blinded, active-controlled clinical study. The study was

conducted in 962 subjects aged 18 years and older who were treated for 16 weeks with either Soolantra once

daily or Metronidazole 7.5 mg/g cream twice daily. In this study, 99.7% of subjects were Caucasian and

65.2% were female; on the IGA scale, 83.3% of subjects were scored as moderate (IGA=3) and 16.7%

scored as severe (IGA=4) at baseline (see figure 5).

The results of the study demonstrated that Soolantra was statistically superior to Metronidazole 7.5 mg/g

cream on the primary efficacy endpoint (Mean Percent Change in Inflammatory Lesion Counts) with a

reduction of 83.0% and 73.7% from baseline after 16 weeks of treatment for the ivermectin and

metronidazole groups respectively (p<0.001). The superiority of Soolantra at Week 16 was confirmed on

Success Rate based on IGA and Absolute Change in Inflammatory Lesion Counts (secondary endpoints

(p<0.001).

Figure 5:

Mean percent change over time in weeks

Approximately 300 subjects aged 65 years and older were treated over all clinical trials with the medicinal

product. No meaningful differences in the efficacy and safety profile were observed between elderly subjects

and subjects 18 to 65 years of age.

The safety profile, as described in section 4.8 remained stable over conditions of long-term use as observed

in long-term treatments up to one year.

Treatment with ivermectin plus 40 mg doxycycline modified release capsules

The ANSWER study evaluated the relative efficacy of Soolantra (IVM) in combination with doxycycline 40

mg modified release capsules (DMR) vs IVM plus placebo for DMR (PBO) in the treatment of severe

rosacea. It was a 12-week, randomized, investigator-blind, controlled, parallel-group study of 273 male and

female subjects aged ≥18 years with 20-70 inflammatory lesions (papules and pustules) on the face and a

Baseline Investigator’s Global Assessment score (IGA) of 4.

The primary efficacy endpoint was the percentage change from Baseline in inflammatory lesion counts at

Week 12. A significantly greater mean percentage reduction in inflammatory lesion count was seen for IVM

+ DMR compared to IVM + PBO (mean±standard deviation: -80.29 ± 21.65 % vs -73.56 ± 30.52%;

p=0.032).

Paediatric population

The European Medicines Agency has waived the obligation to submit the results of studies with Soolantra in

all subsets of the paediatric population in papulopustular rosacea (see section 4.2 for information on

paediatric use).

5.2

Pharmacokinetic properties

Absorption

The absorption of ivermectin from Soolantra was evaluated in a clinical trial in adult subjects with severe

papulopustular rosacea under maximal use conditions. At steady state (after 2 weeks of treatment), the

highest mean (± standard deviation) plasma concentrations of ivermectin peaked within 10 ±8 hours post-

dose (C

: 2.1 ± 1.0 ng/mL range: 0.7 - 4.0 ng/mL) and the highest mean (± standard deviation) AUC

0-24hr

was 36± 16 ng.hr/mL (range: 14-75ng.hr/mL). Ivermectin systemic exposure levels reached a plateau by two

weeks of treatment (steady state conditions). In the longer treatment durations of the Phase 3 studies,

ivermectin systemic exposure levels were similar to those observed after two weeks of treatment. At steady

state conditions, the ivermectin systemic exposure levels (AUC

0-24hr

:36 ±16 ng.hr/mL) were lower than those

obtained following a single 6-mg oral dose of ivermectin in healthy volunteers (AUC

0- 24hr

:134 ± 66

ng.hr/mL).

Distribution

An in vitro study demonstrated that ivermectin is greater than 99% bound to plasma proteins and is bound

primarily to human serum albumin. No significant binding of ivermectin to erythrocytes was observed.

Biotransformation

In vitro studies using human hepatic microsomes and recombinant CYP450 enzymes have shown that

ivermectin is primarily metabolized by CYP3A4.

In vitro studies show that ivermectin does not inhibit the CYP450 isoenzymes 1A2, 2A6, 2B6, 2C8, 2C9,

2C19, 2D6, 3A4, 4A11 or 2E1. Ivermectin does not induce CYP450 enzyme expression (1A2, 2B6, 2C9 or

3A4) in cultured human hepatocytes.

Two major metabolites of ivermectin were identified in a maximal use clinical pharmacokinetic study and

assessed during Phase 2 clinical studies (3’’-O-demethyl ivermectin and 4a-hydroxy ivermectin). Similar to

the parent compound, metabolites reached steady state conditions by 2 weeks of treatment, with no evidence

of accumulation up to 12 weeks. Furthermore, the metabolites systemic exposures (estimated with C

AUC) obtained at steady state were much lower than those observed following oral administration of

ivermectin.

Elimination

The terminal half-life averaged 6 days (mean: 145 hours, range 92-238 hours) in patients receiving a once

daily cutaneous application of the medicinal product for 28 days, in the maximal use clinical

pharmacokinetic study. Elimination is absorption-dependent following topical treatment with Soolantra.

Pharmacokinetics of ivermectin have not been studied in patients with renal and hepatic impairment.

5.3

Preclinical safety data

Repeat-dose studies up to 9 months via dermal application of ivermectin 10 mg/g cream in minipigs have not

shown toxic effects or local toxicity at systemic exposure levels comparable to clinical exposure.

Ivermectin is not genotoxic in a battery of in vitro and in vivo tests. A 2-year carcinogenicity study via dermal

application of ivermectin 10 mg/g cream in mice did not show any increased tumour incidence.

Reproductive toxicity studies after oral administration of ivermectin showed teratogenic effects in rats (cleft

palates) and rabbits (carpal flexures) at high doses (exposure margin to the NOAEL at least 70-fold

compared to the clinical exposure).

The neonatal toxicity in oral rat studies was not related to in utero exposure but to postnatal exposure through

maternal milk which resulted in high levels of ivermectin in the brain and in plasma of offspring.

Ivermectin 10 mg/g cream has evidence of being skin irritant, sensitizing and photosensitising in Guinea pigs,

but is not phototoxic.

Environmental Risk Assessment (ERA)

Ivermectin is very toxic for invertebrates and a risk has been identified for the aquatic, sediment and the

terrestrial compartment. Care should be taken in order to prevent environmental contamination, in particular

in the aquatic media.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Glycerol

Isopropyl palmitate

Carbomer

Dimeticone

Disodium edetate

Citric acid monohydrate

Cetyl alcohol

Stearyl alcohol

Macrogol cetostearyl ether

Sorbitan stearate

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Phenoxyethanol

Propylene glycol

Oleyl alcohol

Sodium hydroxide

Purified water

6.2

Incompatibilities

Not applicable

6.3

Shelf life

2 years

After first opening: use within 6 months.

6.4

Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5

Nature and contents of container

Polyethylene (PE)/Aluminium (Al)/ Polyethylene (PE) laminated plastic white tubes with:

A white high density polyethylene (HDPE) head and polypropylene (PP) child resistant closure for

the 15 g, 30 g, 45 g or 60 g tubes

A polypropylene (PP) white cap for the 2 g tubes (non child resistant closure)

Pack sizes: 1 tube of 2 g, 15 g, 30 g, 45 g or 60 g.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal

Mitigation measures should be taken in order to prevent or reduce contamination, in particular the aquatic

media.

Any unused medicinal product or waste material should be disposed of in accordance with local

requirements.

7.

MARKETING AUTHORISATION HOLDER

[To be completed nationally]

8.

MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally]

9.

DATE OF FIRST AUTHORISATION

Date of first authorisation: {DD month YYYY}

[To be completed nationally]

10.

DATE OF REVISION OF THE TEXT

2020-06-12

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