Ofost 10 IU/ml concentrate for solution for infusion or solution for intramuscular injection

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Oxytocin

Доступна з:

AS Grindeks

Код атс:

H01BB02

ІПН (Міжнародна Ім'я):

Oxytocin

Дозування:

10 international unit(s)/millilitre

Фармацевтична форма:

Solution for injection/infusion

Терапевтична области:

oxytocin

Статус Авторизація:

Marketed

Дата Авторизація:

2020-12-11

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
OFOST 5 IU/ML CONCENTRATE FOR SOLUTION FOR INFUSION OR SOLUTION FOR
INTRAMUSCULAR INJECTION
OFOST 10 IU/ML CONCENTRATE FOR SOLUTION FOR INFUSION OR SOLUTION FOR
INTRAMUSCULAR INJECTION
oxytocin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects serious, talk to your doctor or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ofost is and what it is used for
2.
What you need to know before you receive Ofost
3.
How to use Ofost
4.
Possible side effects
5.
How to store Ofost
6.
Contents of the pack and other information
1.
WHAT OFOST IS AND WHAT IT IS USED FOR
Each Ofost ampoule contains oxytocin 8.3 micrograms (equivalent to 5
IU) or 16.7 micrograms (equivalent
to 10 IU) in 1 ml solution. Oxytocin is a hormone that contracts the
smooth muscles in the womb.
OFOST IS USED:
-
to start or help contractions during childbirth (labour);
-
during caesarean section;
-
to prevent and control bleeding after delivery of your baby;
-
to help in the management of a miscarriage.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE OFOST
YOU MUST NOT RECEIVE OFOST
-
if you are allergic to oxytocin or any of the other ingredients of
this medicine (listed in section 6);
-
if your doctor thinks that to start or increase contractions of the
womb would be unsuitable for
you, for example:
•
where there are obstructions that may prevent delivery;
•
where contractions of the womb are unusually strong;
•
where your baby may be short of oxygen.
-
Where labour or vaginal delivery is not advisable, for example:
•
if your baby’s head is too large to fit through your pel

Характеристики продукта

Health Products Regulatory Authority
01 February 2023
CRN00C1WV
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ofost 10 IU/ml concentrate for solution for infusion or solution for
intramuscular injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 16.7 microgram oxytocin (10 IU).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion (Injection/Infusion).
Colourless, clear liquid, free from visible particles.
pH of solutions 3.5-4.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Antepartum
-Induction of labour for medical reasons, e.g. in case of post-term
gestation, premature rupture of the membranes,
pregnancy-induced hypertension (pre-eclampsia);
-stimulation of labour in hypotonic uterine inertia;
-in early stages of pregnancy as an adjunctive therapy for the
management of incomplete, inevitable, or missed abortion.
Postpartum
-During caesarean section, following delivery of the child;
-prevention and treatment of postpartum uterine atony and haemorrhage.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_INDUCTION OR ENHANCEMENT OF LABOUR_:
Oxytocin should not be started for 6 hours following administration of
vaginal prostaglandins. Ofost should be administered as
an intravenous (i.v.) drip infusion or, preferably, by means of a
variable-speed infusion pump. For drip infusion it is
recommended that 5 IU of Ofost be added to 500 ml of a physiological
electrolyte solution (such as sodium chloride 0.9%). For
patients in whom infusion of sodium chloride must be avoided, 5%
dextrose solution may be used as the diluent (see
section 4.4 Special warnings and precautions for use). To ensure even
mixing, the bottle or bag must be turned upside down
several times before use.
The initial infusion rate should be set at 1 to 4 milliunits/minute (2
to 8 drops/minute). It may be gradually increased at
intervals not shorter than 20 minutes and increments of not more than
1-2 milliunits/minute, until a contraction p