MITOGUT 40 INJECTION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Dr ReddyÆs Laboratories (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

INJECTION

Composition:

EACH VIAL CONTAINS ESOMEPRAZOLE 40,0 mg

Authorization status:

Registered

Authorization date:

2020-02-10

Patient Information leaflet

_ _
APPLICANT/PHCR: DR REDDY’S LABORATORIES (PTY) LTD
PRODUCT PROPRIETARY NAME: MITOGUT 40
DOSAGE FORM AND STRENGTH: LYOPHILISED POWDER FOR SOLUTION FOR
INJECTION AND INFUSION, 40 MG/VIAL
____________________________________________________________________________________
_ _
Sign: HD Date: 08.01.2021
_PAGE 1 OF 10_
APPROVED CLEAN PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
MITOGUT 40, ESOMEPRAZOLE SODIUM EQUIVALENT TO ESOMEPRAZOLE 40 MG,
LYOPHILIZED
POWDER FOR SOLUTION FOR INJECTION AND INFUSION
Esomeprazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN MITOGUT 40

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor, pharmacist,
nurse or other
health care provider.

MITOGUT 40 has been prescribed for you personally and you should not
share
your medicine with other people. It may harm them, even if their
symptoms are the
same as yours.
WHAT IS IN THIS LEAFLET
1.
What MITOGUT 40 is and what it is used for
2.
What you need to know before you use MITOGUT 40
3.
How MITOGUT 40 is given to you
4.
Possible side effects
5.
How to store MITOGUT 40
6.
Contents of the pack and other information
1.
WHAT MITOGUT 40 IS AND WHAT IT IS USED FOR
The active substance is esomeprazole.
MITOGUT 40 is a prescription medicine called a proton pump inhibitor.
MITOGUT 40 reduces the amount of acid that your stomach produces.
_ _
APPLICANT/PHCR: DR REDDY’S LABORATORIES (PTY) LTD
PRODUCT PROPRIETARY NAME: MITOGUT 40
DOSAGE FORM AND STRENGTH: LYOPHILISED POWDER FOR SOLUTION FOR
INJECTION AND INFUSION, 40 MG/VIAL
____________________________________________________________________________________
_ _
Sign: HD Date: 08.01.2021
_PAGE 2 OF 10_
MITOGUT 40 is used for the short-term treatment of certain conditions
such as,
gastroesophageal reflux disease (GERD). - when you are unable to have
treatment by
mouth.
MITOGUT 40 is also used for the prevention of a stomach or duodenal
ulcer from bleeding
again after an endoscopy treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YO

Summary of Product characteristics

Date: 08/01/2021 Sign: HD 1 OF 16
APPLICANT/PHCR:
DR REDDY’S LABORATORIES (PTY) LTD
PRODUCT PROPRIETARY NAME: MITOGUT 40
DOSAGE FORM AND STRENGTH: LYOPHILISED POWDER FOR SOLUTION FOR
INJECTION AND INFUSION, 40 MG/VIAL
______________________________________________________________________________________________
APPROVED CLEAN PROFESSIONAL INFORMATION
SCHEDULING STATUS
1 NAME OF THE MEDICINE
MITOGUT 40 (Lyophilized powder for solution for injection and
infusion)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
MITOGUT 40:
Each vial contains esomeprazole sodium equivalent to esomeprazole 40
mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilized powder for solution for injection and infusion.
MITOGUT 40: A white to off-white cake or powder filled in 5 ml clear
glass USP type I vials
sealed with a bromobutyl rubber stopper and flip-off aluminium seal
with polypropylene green
button.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MITOGUT 40 is indicated for Gastroesophageal Reflux Disease as an
alternative where oral
therapy is not appropriate and for the shortest possible time.
GASTROESOPHAGEAL REFLUX DISEASE:
-
Treatment of erosive reflux oesophagitis
-
Long-term management of patients with healed oesophagitis to prevent
relapse
-
Treatment of severe symptoms of reflux disease
S4
Date: 08/01/2021 Sign: HD 2 OF 16
APPLICANT/PHCR:
DR REDDY’S LABORATORIES (PTY) LTD
PRODUCT PROPRIETARY NAME: MITOGUT 40
DOSAGE FORM AND STRENGTH: LYOPHILISED POWDER FOR SOLUTION FOR
INJECTION AND INFUSION, 40 MG/VIAL
______________________________________________________________________________________________
MITOGUT 40 is indicated for the short-term maintenance of haemostasis
and prevention of
rebleeding in patients following therapeutic endoscopy for acute
bleeding gastric or duodenal
ulcers.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS:
_GASTROESOPHAGEAL REFLUX DISEASE (GORD): _
Treatment with MITOGUT 40 can be given for up to 7 days as part of a
full treatment period
for the specified i