STROMECTOL ivermectin 3mg tablet blister pack

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

ivermectin, Quantity: 3 mg

Pieejams no:

Merck Sharp & Dohme (Australia) Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

Ivermectin

Zāļu forma:

Tablet, uncoated

Kompozīcija:

Excipient Ingredients: microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; butylated hydroxyanisole; citric acid

Ievadīšanas:

Oral

Vienības iepakojumā:

4 tablets

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

STROMECTOL (ivermectin) is indicated for the treatment of: a) Onchocerciasis and intestinal strongyloidiasis (anguillulosis). b) Crusted scabies in conjunction with topical therapy c) Human sarcoptic scabies when prior topical treatment has failed or is contraindicated. Treatment is only 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 alone.?

Produktu pārskats:

Visual Identification: White, round, flat uncoated tablets with bevelled edge; unscored on one side and engraved with MSD and 32 on the other.; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Autorizācija statuss:

Licence status A

Autorizācija datums:

2011-05-13

Lietošanas instrukcija

STROMECTOL
®
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING STROMECTOL?
STROMECTOL contains the active ingredient ivermectin. STROMECTOL is
used to treat river blindness (onchocerciasis),
threadworm involving the intestines (intestinal strongyloidiasis) and
scabies which is caused by the Sarcoptes scabiei mite.
For more information, see Section 1. Why am I using STROMECTOL? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE STROMECTOL?
Do not use if you have ever had an allergic reaction to Ivermectin or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
STROMECTOL? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with STROMECTOL and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE STROMECTOL?
Your doctor will tell you how many tablets you need to take. The dose
depends on your infection and your weight or height. Take
STROMECTOL as a single dose with a full glass of water.
More instructions can be found in Section 4. How do I use STROMECTOL?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING STROMECTOL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
STROMECTOL. Visit your doctor
if scheduled, to check the progress of your infection. This is to help
make sure that the infection has
cleared up completely
THINGS YOU
SHOULD NOT DO
•
Do not give STROMECTOL to anyone else, even if they have the same
condition as you.
DRIVING
OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how STROMECTOL affects you
LOOKING AFTER
YOUR

Produkta apraksts

_Copyright © (2021) Merck & Co., Inc., Kenilworth, NJ, USA, and its
affiliates. All rights reserved. _
S-IPC-MK0933-T-032021
AUSTRALIAN PRODUCT INFORMATION
STROMECTOL BLISTER PACK
(IVERMECTIN)
TABLETS
1
NAME OF THE MEDICINE
Ivermectin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ivermectin 3 mg tablets.
Ivermectin
is
derived
from
the
avermectins,
a
class
of
highly
active
broad-spectrum
antiparasitic agents isolated from fermentation broths of
_Streptomyces avermitilis_.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
STROMECTOL (ivermectin) is available as white, round, flat tablets
with a bevelled edge,
engraved with ‘MSD’ on one side and ‘32’ on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
STROMECTOL (ivermectin) is indicated for the treatment of:
a)
onchocerciasis and intestinal strongyloidiasis (anguillulosis).
b)
crusted scabies in conjunction with topical therapy.
c)
human sarcoptic scabies when prior topical treatment has failed or is
contraindicated.
Treatment is only 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 alone.
4.2
DOSE AND METHOD OF ADMINISTRATION
STROMECTOL is available as white tablets each containing 3 mg
ivermectin. Treatment is
administered as a single oral dose given with water.
The dose is determined by the patient's weight as shown below.
STRONGYLOIDIASIS
The dosage aims to provide approximately 200 µg ivermectin/kg body
weight.
Table 1
Dosage in Strongyloidiasis
Body Weight (Kg):
Dose (Number of 3 mg tablets):
15-24
One
25-35
Two
S-IPC-MK0933-T-032021
36-50
Three
51-65
Four
66-79
Five
> 80
Approx 200

g/kg
In general, additional doses are not necessary, however, a follow-up
examination of stool to
verify efficacy should be performed.
ONCHOCERCIASIS
The dosage aims to provide approximately 150 µg ivermectin/kg body
weight.
Table 2
Dosage in Onchocerciasis:
Body Weight (Kg):
Do