VERMOX SUSPENSION

Држава: Јужноафричка Република

Језик: Енглески

Извор: South African Health Products Regulatory Authority (SAHPRA)

Доступно од:

Johnson & Johnson (Pty) Ltd û East London

Дозирање:

See ingredients

Фармацеутски облик:

SUSPENSION

Састав:

EACH 5 ML SUSPENSION CONTAINS MEBENDAZOLE 100 MG

Статус ауторизације:

Registered

Датум одобрења:

1978-02-02

Информативни летак

Johnson & Johnson (Pty) Ltd
VERMOX
® SUSPENSION
Each 5 mL suspension contains:
100 mg mebendazole
DATE OF CLINICAL APPROVAL: 09 December 2021
Page 1 of 9
VERMOX
® SUSPENSION
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S1
VERMOX
® SUSPENSION
MEBENDAZOLE
CONTAINS SUGAR (100 MG SUCROSE PER ML).
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
VERMOX
®
suspension is available without a doctor’s prescription, for you to
treat a mild illness.
Nevertheless, you still need to take VERMOX
®
suspension carefully to get the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Ask you pharmacist if you need more information or advice.
•
You must see a doctor if your symptoms worsen or do not improve.
WHAT IS IN THIS LEAFLET
1.
What VERMOX
®
suspension is and what it is used for.
2.
What you need to know before you take VERMOX
®
suspension.
3.
How to take VERMOX
®
suspension.
4.
Possible side effects.
5.
How to store VERMOX
®
suspension.
6.
Contents of the pack and other information.
1.
WHAT VERMOX
® SUSPENSION IS AND WHAT IT IS USED FOR
VERMOX
®
suspension belongs to a group of medicines known as anthelmintics. It
is used to treat
worm infections of the gut, such as:
Johnson & Johnson (Pty) Ltd
VERMOX
® SUSPENSION
Each 5 mL suspension contains:
100 mg mebendazole
DATE OF CLINICAL APPROVAL: 09 December 2021
Page 2 of 9
-
Pinworm (_Enterobius vermicularis_);
-
Whipworm (_Trichuris trichiura_);
-
Roundworm (_Ascaris lumbricoides_);
-
Hookworm (_Ancylostoma duodenale_; _Necator americanus_);
-
Threadworm (_Strongyloides stercoralis_);
-
Tapeworm (_Taenia_ spp.);
-
_Moniliformis moniliformis;_
-
_Ternidens deminutus._
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VERMOX
® SUSPENSION
DO NOT TAKE VERMOX
® SUSPENSION:
•
If
you are hypersensitive (allergic) to mebendazole or any of the other
ingredients of
VERMOX
®
suspension (see section 6).
•
If you are pregnant (see PREGNANCY, BREASTFEEDING AND FERTILITY).
•
If you are taking metronidazole (antib

Карактеристике производа

Johnson & Johnson (Pty) Ltd
VERMOX
® SUSPENSION
Each 5 mL suspension contains:
100 mg mebendazole
DATE OF CLINICAL APPROVAL: 09 December 2021
Page 1 of 12
PROFESSIONAL INFORMATION FOR VERMOX
® SUSPENSION
SCHEDULING STATUS
S1
1.
NAME OF THE MEDICINE
VERMOX
®
suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each medicine measure (5 mL) contains 100 mg mebendazole._ _
_ _
_Excipients with known effect: _
Preservatives:
Methylparaben 0,18 % _m/v_
Propylparaben 0,02 % _m/v_
Contains sugar (100 mg sucrose per mL).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension.
Banana-flavoured beige suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VERMOX
®
suspension is indicated for the treatment of single and mixed helminth
gastrointestinal
infestations caused by:
-
NEMATODES SUCH AS:
Johnson & Johnson (Pty) Ltd
VERMOX
® SUSPENSION
Each 5 mL suspension contains:
100 mg mebendazole
DATE OF CLINICAL APPROVAL: 09 December 2021
Page 2 of 12
-
_Trichuris trichiura_
(whipworm)
-
_Ancylostoma duodenale_
(hookworm)
-
_Necator americanus_
(hookworm)
-
_Ascaris lumbricoides_
(large roundworm)
-
_Ternidens deminutus_
-
_Enterobius vermicularis_
(pinworm)
-
_Strongyloides stercoralis_
(threadworm)
-
CESTODES SUCH AS:
-
_Taenia_ spp.
(tapeworm)
-
Infestations by _Moniliformis moniliformis_
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
WHIPWORM; HOOKWORM; LARGE ROUNDWORM; PINWORM; _TERNIDENS DEMINUTUS_;
INFESTATIONS BY
_MONILIFORMIS MONILIFORMIS_: One medicine measure (5 mL) twice daily
(morning and evening) for
three consecutive days. This standard dosage applies to adults,
children and infants over the age
of 1 year.
WHIPWORM; HOOKWORM; LARGE ROUNDWORM AND PINWORM: 25 mL given as a
single dose.
This dosage applies only to adults and children older than 1 year.
TAPEWORM (_TAENIA _SPP.): One medicine measure (5 mL) twice daily
(morning and evening) for
six consecutive days. This standard dosage applies to adults, children
and infants.
THREADWORM (_STRONGYLOIDES STERCORALIS_):
ADULTS: Two