Syntometrine

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Ergometrine maleate 0.5 mg/mL; Oxytocin 5 IU/mL ((8.5 µg) added as 200 IU/mL solution.)

Sẵn có từ:

Max Health Limited

INN (Tên quốc tế):

Ergometrine maleate 0.5 mg/mL

Dạng dược phẩm:

Solution for injection

Thành phần:

Active: Ergometrine maleate 0.5 mg/mL Oxytocin 5 IU/mL ((8.5 µg) added as 200 IU/mL solution.) Excipient: Carbon dioxide Chlorobutanol hemihydrate Glacial acetic acid Maleic acid Sodium acetate trihydrate Sodium chloride Water for injection

Các đơn vị trong gói:

Ampoule, glass, 1mL, 5 dose units

Lớp học:

Prescription

Loại thuốc theo toa:

Prescription

Sản xuất bởi:

Teva Czech Industries s.r.o.

Chỉ dẫn điều trị:

Active management of the third stage of labour (as a means to promote separation of the placenta and to reduce blood loss).

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Ampoule, glass, 1mL - 5 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Ngày ủy quyền:

1969-12-31

Tờ rơi thông tin

SYNTOMETRINE
®
_Injection _
_5 IU synthetic oxytocin / 0.5mg ergometrine maleate _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Syntometrine®.
It does not contain all the available information. It does not take
the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on
the final page. Some more recent information on the
medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE INFORMATION ON THE
MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM
WWW.MEDSAFE.GOVT.NZ
.
Those updates may contain important information about the medicine and
its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the
risks of you having Syntometrine® against the benefits
they expect it will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT SYNTOMETRINE® IS USED FOR
Syntometrine® can be used during and immediately after delivery of a
baby to help the birth and to prevent or treat excessive
bleeding.
Syntometrine® works by stimulating the muscles of the uterus (womb)
to produce rhythmic contractions.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SYNTOMETRINE® HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for another purpose.
Syntometrine® is only available with a doctor's prescription.
It is not addictive.
BEFORE YOU ARE GIVEN SYNTOMETRINE®
_WHEN YOU MUST NOT BE GIVEN IT _
YOU MUST NOT BE GIVEN SYNTOMETRINE® IF YOU ARE ALLERGIC TO:
•
oxytocin
•
ergometrine
•
any of the other ingredients listed at the end of this leaflet.
•
Latex
Symptoms of an allergic reaction may include shortness of breath,
wheezing or difficulty breathing; swelling of the face,
lips, tongue or other parts of the body; rash, itching or hives on the
skin.
IF YOU THINK YOU MAY BE ALLERGIC T

Đặc tính sản phẩm

NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 1 of 11
1
PRODUCT NAME
SYNTOMETRINE
®
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Name and strength of the active substances:
Each 1 mL ampoule of injectable solution contains:
Synthetic Oxytocin 5 IU/mL ((8.5 µg) added as 200 IU/mL solution) and
Ergometrine maleate 0.5 mg/mL
Active ingredient
Oxytocin
Ergometrine maleate
Chemical name
l-cysteinyl-l-tyrosyl-l-isoleucyl-l-
glutamyl-l-asparaginyl-l-cysteinyl-l-
prolyl-l-leucylglycinamide cyclic
(1→6)-disulfide
6aR,9R)-N-[(S)-2-hydroxy-1-
methylethyl]-7-methyl-4,6,6a,7,8,9-
hexahydro-indolo[4,3-fg]quinoline-
9-carboxamide (Z)-butenedioate
CAS number
50-56-6
129-51-1
Molecular weight
1007
441.5
Molecular formula
C
43
H
66
N
12
O
12
S
2
C
19
H
23
N
3
O
2
.C
4
H
4
O
4
Chemical structures
Excipient(s) with known effect
For the full list of excipients, refer section 6.1.
3
PHARMACEUTICAL FORM
Solution for Injection
Description
SYNTOMETRINE® injection is a sterile, clear, colourless solution,
faintly bluish
fluorescent. It is buffered to pH 3.2.
The ampoules have two blue identification rings.
NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 2 of 11
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
•
Active management of the third stage of labour (as a means to promote
separation of the placenta and to reduce blood loss).
•
Prevention and treatment of postpartum haemorrhage associated with
uterine
atony.
4.2
Dose and method of administration
Active management of third stage of labour:
1 mL intramuscularly following delivery of the anterior shoulder, or
immediately after
delivery of the child. Expulsion of the placenta, which is normally
separated by the first
strong uterine contraction following the injection of Syntometrine®
should be assisted
by controlled cord traction.
Prevention and treatment of postpartum haemorrhage:
1 mL i.m. following expulsion of the placenta, or when bleeding
occurs.
If necessary, the injection of 1 mL may be repeated after an interval
of not less than 2
hours. The total dose given