NUR-ISTERATE INJECTION

מדינה: דרום אפריקה

שפה: אנגלית

מקור: South African Health Products Regulatory Authority (SAHPRA)

זמין מ:

Bayer (Pty) Ltd û Isando

כמות:

See ingredients

טופס פרצבטיות:

INJECTION

הרכב:

EACH 1 ml SOLUTION CONTAINS NORETHISTERONE ENANTHATE 200 mg

מצב אישור:

Registered

תאריך אישור:

1977-10-09

עלון מידע

APPLICANT/PHRC:
Bayer (Pty) Ltd
DOSAGE FORM:
Solution for injection
STRENGTH:
Norethisterone enantate 200 mg/mL
PRODUCT PROPRIETARY NAME:
NUR-ISTERATE
CCPI7.1/04.2016/SA3.0/04.2022
Page 1 of 8
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S4
NUR-ISTERATE 200 MG/ML OILY SOLUTION FOR INJECTION
NORETHISTERONE ENANTATE
SUGAR FREE.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN NUR-ISTERATE.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
WHAT IS IN THIS LEAFLET
1.
What NUR-ISTERATE is and what it is used for
2.
What you need to know before you are given NUR-ISTERATE
3.
How to use NUR-ISTERATE
4.
Possible side effects
5.
How to store NUR-ISTERATE
6.
Contents of the pack and other information
1.
WHAT NUR-ISTERATE IS AND WHAT IT IS USED FOR
NUR-ISTERATE is a hormonal contraceptive for intramuscular injection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NUR-ISTERATE
DO NOT USE NUR-ISTERATE
Do not use NUR-ISTERATE if you have any of the conditions listed
below. If any of these apply to
you, tell your Healthcare Provider before using NUR-ISTERATE.
•
If you are pregnant or think you might be pregnant.
•
If you are suffering from or have a history of a thromboembolic
disorder in your veins.
Thrombosis is the formation of a blood clot. This may occur for
example in the blood vessels of
the legs (deep vein thrombosis) and the lungs (pulmonary embolism).
See also the section
“NUR-ISTERATE and thrombosis”.
•
If you have or have had a severe arterial, including cardiovascular,
disease such as heart attack,
stroke or ischaemic heart disease (angina pectoris). See also the
section “NUR-ISTERATE and
thrombosis”.
•
If you suffer from increased blood pressure requiring treatment.
•
If you suffer or have suffered from a severe liver disease (as long as
your liver function values
have not returned to normal). Symptoms of a liver disease may be, for
instance, yellowing of the
skin and/or itching of the whole body.
•
If you

מאפייני מוצר

APPLICANT/PHRC:
Bayer (Pty) Ltd
DOSAGE FORM:
Solution for injection
STRENGTH:
Norethisterone enantate 200 mg/mL
PRODUCT PROPRIETARY NAME:
NUR-ISTERATE
CCDS7/04.2016/SA3.0/04.2022
Page 1 of 10
SCHEDULING STATUS:
S4
1.
NAME OF THE MEDICINE
NUR-ISTERATE 200 mg/ml oily solution for intramuscular injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains norethisterone enantate (17

-ethinyl-17

-heptanoyloxy-4-estrene-3-one) 200 mg.
Excipient with known effect:
333,8 mg benzyl benzoate in 1 ml ampoule.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oily solution for intramuscular injection
Clear, yellowish, oily solution
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Hormonal contraception
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_How to start NUR-ISTERATE _
_No preceding hormonal contraceptive use _
NUR-ISTERATE should be administered within the first 5 days of the
woman’s natural cycle, i.e. the first
5 days of the menstrual bleeding.
_Changing from a combined oral contraceptive _
The woman should start with NUR-ISTERATE immediately on the day after
the last active tablet of her
previous combined oral contraceptive. When starting later she should
be advised to additionally use a
barrier method for the first 7 days after injection.
_Changing from a progestogen-only method (minipill, injection,
implant) or from a progestogen-releasing _
_intrauterine device _
The woman may switch any day from the minipill without break (from an
implant or an intrauterine system
on the day of its removal, from another injectable when the next
injection would be due), but should in all
of these cases be advised to additionally use a barrier method for the
first 7 days after injection.
APPLICANT/PHRC:
Bayer (Pty) Ltd
DOSAGE FORM:
Solution for injection
STRENGTH:
Norethisterone enantate 200 mg/mL
PRODUCT PROPRIETARY NAME:
NUR-ISTERATE
CCDS7/04.2016/SA3.0/04.2022
Page 2 of 10
_Following abortion or delivery _
NUR-ISTERATE may be used immediately after delivery or abortion as
long as