SYNTOMETRINE INJECTION

Quốc gia: Nam Phi

Ngôn ngữ: Tiếng Anh

Nguồn: South African Health Products Regulatory Authority (SAHPRA)

Sẵn có từ:

Adcock Ingram Critical Care (Pty) Ltd

Liều dùng:

See ingredients

Dạng dược phẩm:

INJECTION

Thành phần:

EACH 1,0 ml SOLUTION CONTAINS ERGOMETRINE MALEATE 0,5 mg OXYTOCIN (SYNTHETIC) 5,0 iu

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2003-06-03

Tờ rơi thông tin

Adcock Ingram Critical Care (Pty) Ltd
Syntometrine
H1966
Page 1 of 8
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS S4
SYNTOMETRINE, INJECTION
Ergometrine maleate and Oxytocin
Sugar free
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN SYNTOMETRINE
•
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.
WHAT IS IN THIS LEAFLET
1. What SYNTOMETRINE is and what it is used for
2. What you need to know before you are treated with SYNTOMETRINE
3. How to receive SYNTOMETRINE
4. Possible side effects
5. How to store SYNTOMETRINE
6. Contents of the pack and other information
1. WHAT SYNTOMETRINE IS AND WHAT IT IS USED FOR
DURING LABOUR:
Active management of the third stage of labour (as a means to promote
childbirth and to reduce blood loss).
AFTER LABOUR:
Adcock Ingram Critical Care (Pty) Ltd
Syntometrine
H1966
Page 2 of 8
Prevention and treatment of bleeding after delivery of the baby.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE TREATED WITH SYNTOMETRINE
YOU SHOULD NOT BE ADMINISTERED SYNTOMETRINE IF:
•
You are allergic to ergometrine maleate or oxytocin or to any other
ingredients of SYNTOMETRINE (listed in section 6)
•
You are not in labour or are in the first or second stages of labour
•
You have ineffective contractions
•
You have had a previous caesarean section
•
You have impaired kidney or liver function
•
You have high blood pressure that may or may not result in fits
•
The foetus is in distress
•
You have porphyria (metabolic disease affecting porphyrin
metabolism)
•
You have occlusive vascular disease (blockage or narrowing of an
artery resulting in pain usually in the legs)
•
You have sepsis (a condition that may occur after an infection and
results in fever, difficulty breathing, low blood pressure, fast heart
rate
and mental confusion)
•
You have any heart conditions
WARNINGS AND PRECAUTIONS
Tell your doctor or healthcare professional before being given the
injection if:
•
If

Đặc tính sản phẩm

Adcock Ingram Critical Care (Pty) Ltd
Syntometrine
H1966
Page 1 of 15
PROFESIONAL INFORMATION
SCHEDULING STATUS S4
1. NAME OF THE MEDICINE
SYNTOMETRINE Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
1
ml
ampoule
contains:
5.I.U.
synthetic
oxytocin
and
0,5
mg
ergometrine maleate.
_ _
Excipient(s) with known effect:_ _
Sugar content: Sugar free
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Injection
A clear, colourless solution with a faint bluish fluorescence
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.
Adcock Ingram Critical Care (Pty) Ltd
Syntometrine
H1966
Page 2 of 15
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ACTIVE MANAGEMENT OF THIRD STAGE OF LABOUR _
1
ml
SYNTOMETRINE
should
be
injected
intramuscularly
(BUT
NOT
INTRAVENOUSLY), after delivery of the shoulder, or at the latest,
immediately
after delivery of the child. Expulsion of the placenta, which is
normally
separated by the first strong uterine contraction, should be assisted
by
controlled cord traction.
_ _
_PREVENTION AND TREATMENT OF POSTPARTUM HAEMORRHAGE _
Following expulsion of the placenta, 1 ml intramuscularly, or
intravenously if
bleeding is heavy.
Intravenous injections should be given slowly.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in
section 6.1;
Pregnancy and labour (induction of labour, first stage of labour,
second stage
of labour prior to the delivery of the anterior shoulder) due to the
risk of
uterine hypertonus and associated foetal complications (see section
4.6
Fertility, pregnancy and lactation);
Primary or secondary uterine inertia;
Predisposition to uterine rupture as in patients of high parity or
with a uterine
scar from previous caesarean section;
Impaired renal or hepatic function;
Severe toxaemia of Human Reproduction;
Placent