Prostin F2 Alpha
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
15-07-2013
Summary of Product characteristics
(SPC)
04-07-2017
Active ingredient:
Dinoprost trometamol 6.71 mg/mL equivalent to to 5 mg/ml Dinoprost
Available from:
Pfizer New Zealand Limited
INN (International Name):
Dinoprost trometamol 6.71 mg/mL (equiv. to 5 mg/ml Dinoprost)
Dosage:
5 mg/mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Dinoprost trometamol 6.71 mg/mL equivalent to to 5 mg/ml Dinoprost
Units in package:
Ampoule, 1 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Pharmacia & Upjohn Company LLC
Therapeutic indications:
PROSTIN F2 ALPHA Sterile Solution is indicated for term induction of labour and for evacuation of a third trimester foetal death in utero. PROSTIN F2 ALPHA Sterile Solution is indicated for aborting a pregnancy between the 16th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period.
Product summary:
Package - Contents - Shelf Life: Ampoule, - 1 mL - 48 months from date of manufacture stored at or below 25°C
Authorization date:
1975-12-04
Patient Information leaflet
PROSTIN F
2
ALPHA
DINOPROST
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Prostin F
2
alpha.
It does not contain
all the available information. It does not take the place
of talking to your
doctor or pharmacist.
All medicines have risks and benefits
.
Your doctor or pharmacist has weighed the risks of you
being given Prostin F
2
alpha against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET. You may need to read it again.
WHAT PROSTIN F
2
ALPHA IS USED FOR
Prostin F
2
alpha contains 5 mg/mL of the active ingredient called
dinoprost. This is in the form
of dinoprost tromethamine, a type of dinoprost.
The active ingredient is also known as prostaglandin F
2
alpha. Prostaglandins occur naturally
in the body and are very important in spontaneous labour.
Prostin F
2
alpha is used to induce miscarriage. The medicine empties the
uterus by causing
contractions. These contractions may not happen until several
hours after administration.
Your doctor may have prescribed Prostin F
2
alpha for another reason. Ask your doctor if you
have any questions about why Prostin F
2
alpha has been prescribed for you.
Prostin F
2
alpha is a PRESCRIPTION ONLY MEDICINE that must be administered
by a
doctor. Never administer this medicine yourself.
BEFORE YOU ARE GIVEN PROSTIN F
2
ALPHA
Before you are given Prostin F
2
alpha you should tell your doctor if you have:
ever had a caesarean section or any other operation on
your uterus.
ever had a bad reaction to a prostaglandin treatment in the
past or to the inactive
ingredient benzyl alcohol.
heart, lung, kidney or liver problems.
had a previous difficult labour or delivery.
more tha
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Summary of Product characteristics
Version: pfdprofi11213
Supercedes: pfdprofi10802
Page 1 of 7
DATA SHEET
PROSTIN
® F2 ALPHA
DINOPROST TROMETHAMINE
5 MG/ML SOLUTION FOR INJECTION
PRESENTATION
Prostin F2 Alpha is a clear colourless sterile solution containing 5
mg/mL dinoprost (as 6.71
mg/mL dinoprost tromethamine) in 1mL ampoules.
USES
ACTIONS
Although the exact mode of action in pregnancy termination in humans
is not fully defined,
when Prostin F2 Alpha is administered by the intravenous or
intrauterine route it initiates
rhythmical uterine contractions which, if continued for a sufficient
time, are capable of
expelling the contents of the uterus.
Sensitivity of the pregnant uterus to prostaglandins is lower during
early and mid-pregnancy
than at term.
While Prostin F2 Alpha has been shown to be luteolytic in several
animal species, it is
unlikely that this is the principal mechanism involved when the drug
is utilized in therapeutic
termination of pregnancy in the human as described in this data sheet.
Prostin F2 Alpha is also capable of inducing contractions of the
smooth muscle of the
intestinal tract. This action may be the cause of the vomiting and
diarrhoea which are
associated with the use of Prostin F2 Alpha but this is yet to be
shown conclusively.
In some animals and in man, large doses of Prostin F2 Alpha can bring
about an increase in
blood pressure, probably due to its vasoconstrictive effects on
vascular smooth muscle. At
the doses recommended for the therapeutic termination of pregnancy, or
for induction of
labour, this effect has not been clinically significant.
INDICATIONS
Prostin F2 Alpha sterile Solution for Injection is indicated for term
induction of labour and
for evacuation of a third trimester foetal death _in utero_.
Version: pfdprofi11213
Supercedes: pfdprofi10802
Page 2 of 7
Prostin F2 Alpha sterile Solution for Injection is indicated for
aborting a pregnancy between
the 16th and 20th weeks of gestation as calculated from the first day
of the last normal
menstrual period.
DOSAGE AND ADMINISTRATION
(NOTE: At the present
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