Ivermectine Sigillata 3 mg tabletten

Riik: Holland

keel: hollandi

Allikas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Toimeaine:

IVERMECTINE 3 mg/stuk

INN (Rahvusvaheline Nimetus):

IVERMECTINE 3 mg/stuk

Ravimvorm:

Tablet

Koostis:

BUTYLHYDROXYANISOL (E 320) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CITROENZUUR 0-WATER (E 330) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD, BUTYLHYDROXYANISOL (E 320) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CITROENZUUR 0-WATER (E 330) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD

Manustamisviis:

Oraal gebruik

Loa andmise kuupäev:

2022-04-12

Infovoldik

_CIS [Specialist Field Identification Code]: 6 000 000 0 _
_M000/1000/003 _
_ _
1
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
Ivermectine Sigillata 3 mg tabletten
IVERMECTINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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
1. What {(INVENTED) NAME} is and what it is used for
2. What you need to know before you take {(INVENTED) NAME}
3. How to take {(INVENTED) NAME}
4. Possible side effects
5. How to store {(INVENTED) NAME}
6. Contents of the pack and other information
1.
WHAT {(INVENTED) NAME} IS AND WHAT IT IS USED FOR
{(INVENTED) NAME} contains a medicine called ivermectin. This is a
type of medicine which is used for
infections caused by some parasites.
It is used to treat:
•
an infection in your gut called gastrointestinal strongyloidiasis
(anguillulosis). This is caused by a type
of round worm called _“Strongyloides stercoralis”_.
•
an infection of your blood called
microfilaremia due to “lymphatic filariasis”. This is caused by an
immature worm called “_Wuchereria bancrofti”._ {(INVENTED) NAME}
does not work against adult
worms, only against immature worms.
•
skin mites
(
scabies). This is when tiny mites burrow under your skin. This can
cause severe itching.
{(INVENTED) NAME} should only be taken when your doctor has proven or
thinks you have scabies.
{(INVENTED) NAME} WILL NOT STOP YOU FROM GETTING ONE OF THESE
INFECTIONS. It does not work against adult
worms. {(INVENTED) NAME} should only be taken when your doctor has
proven or thinks you have a parasite
infection.
2.
WHAT YOU NEE

Toote omadused

SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAAM VAN HET GENEESMIDDEL
IVERMECTINE SIGILLATA 3 MG TABLETTEN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3 mg ivermectin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Tablets are uncoated, round, 5.5 mm diameter, white marked with "A
300" on one side. 4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
•
Treatment of gastrointestinal strongyloidiasis (anguillulosis).
•
Treatment of proven or suspected microfilaremia in patients with
lymphatic filariasis caused by
_Wuchereria bancrofti_.
•
Treatment of human sarcoptic scabies. Treatment is justified when the
diagnosis of scabies has
been established clinically and/or by parasitological examination.
Without formal diagnosis treatment is
not justified in case of pruritus.
Official guidelines should be taken into consideration. Official
guidelines will normally include WHO
and public health authorities’ guidelines.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Treatment of gastrointestinal strongyloidiasis _
The recommended dosage is one single oral dose of 200 micrograms of
ivermectin per kg of body
weight.
For guidance, the dose, as determined by the patient’s weight, is as
follows:
BODY WEIGHT (KG)
DOSE NUMBER OF 3 MG TABLETS
15 to 24
one
25 to 35
two
36 to 50
three
51 to 65
four
66 to 79
five
≥ 80
six
_Treatment of microfilaremia caused by Wuchereria bancrofti _
The recommended dosage for mass distribution for the treatment of
microfilaremia caused by
_Wuchereria bancrofti_ is a single oral dose once every 6 months
designed to provide approximately 150
to 200 µg/kg of body weight. In endemic areas where treatment can
only be administered once every
12 months, the recommended dosage is 300 to 400 µg/kg of body weight
to maintain adequate
suppression of microfilaremia in treated patients.
For guidance, the dose, as determined by the patient’s weight, is as
follows:
BODY WEIGHT
(KG)
DOSE WHEN GIVEN ONCE EVERY 6
MONTHS
NUMBER OF 3 MG TABLETS
DOSE