SOOLANTRA CREAM 10MGG

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

IVERMECTIN

Saatavilla:

GALDERMA SINGAPORE PRIVATE LIMITED

ATC-koodi:

D11AX22

Lääkemuoto:

CREAM

Koostumus:

IVERMECTIN 10 mg/g

Antoreitti:

TOPICAL

Prescription tyyppi:

Prescription Only

Valmistaja:

LABORATOIRES GALDERMA

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2017-03-23

Valmisteyhteenveto

NOTICE RECTO 180x498,75
PLAN n° MT.09.DRA.2223.R01.2
®
10 MG/G CREAM
Ivermectin
TABLE 1 – ADVERSE REACTIONS
SYSTEM ORGAN CLASS
FREQUENCY
ADVERSE REACTIONS
Skin and
subcutaneous tissue
disorders
Common
Skin burning sensation
Uncommon
Skin irritation, pruritus, dry
skin, rosacea aggravation*
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.
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
ha