Hemabate 250micrograms/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Carboprost trometamol

Available from:

Pfizer Ltd

ATC code:

G02AD04

INN (International Name):

Carboprost trometamol

Dosage:

250microgram/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07010100; GTIN: 5012882002220

Patient Information leaflet

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HEMABATE
® STERILE SOLUTION FOR INJECTION
Carboprost tromethamine 250 mcg/ml
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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.
If you get any side effects, talk to your doctor or nurse. This
includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Hemabate Sterile Solution is and what it is used for
2.
What you need to know before you are given Hemabate Sterile Solution
3.
How you are given Hemabate Sterile Solution
4.
Possible side effects
5.
How to store Hemabate Sterile Solution
6.
Contents of the pack and other information
1.
WHAT HEMABATE STERILE SOLUTION IS AND WHAT IT IS USED FOR
Therapeutic group
*
•
Hemabate belongs to a group of medicines called prostaglandins.
Prostaglandins are produced naturally in your body and are very
important for
a variety of activities, including childbirth. After childbirth they
make the
womb contract and to help it stay contracted, which stops heavy
bleeding from
the womb. Hemabate given after childbirth increases the contraction of
your
womb which helps to control bleeding after delivery.
Therapeutic indications
•
Hemabate is a sterile solution for injection. It is available in
ampoules and
contains 250mcg of the active ingredient, carboprost, per ml of
solution.
•
Hemabate is used to stop excessive bleeding in women who have just
given
birth, when bleeding is due to the womb failing to return to its
normal size.
*
A therapeutic group is one in which a drug is classified depending on
its actions and
the part(s) of the body it affects.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HEMABATE STERILE
SOLUTION
™
DO NOT TAKE HEMABATE:
Page 2 of 11
HEMABATE IS NOT SUITABLE FOR ALL WOMEN. YOUR DOCTOR MAY DECIDE TO GIVE
YOU A
DIFFERENT MEDICINE IF ANY OF THESE APPLY TO YOU.
YOU SHOULD NOT BE GIVEN HEMA

Summary of Product characteristics

OBJECT 1
HEMABATE STERILE SOLUTION
Summary of Product Characteristics Updated 10-Oct-2013 | Pfizer
Limited
1. Name of the medicinal product
Hemabate Sterile Solution
2. Qualitative and quantitative composition
Each 1 ml contains carboprost tromethamine equivalent to carboprost
250 micrograms.
Excipient(s) with known effect
Hemabate sterile solution also contains 8.1-10.4 mg/ml benzyl alcohol
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Colourless, sterile, aqueous solution for intramuscular injection.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of post-partum haemorrhage due to uterine atony and
refractory to conventional methods of
treatment with oxytocic agents and ergometrine used either alone or in
combination.
Conventional therapy should usually consist of 0.5 - 1 mg ergometrine
with up to 50 units of oxytocin
infused intravenously over periods of time from 20 minutes to 12
hours. The dosage and duration of
administration should reflect the seriousness of the clinical
situation.
4.2 Posology and method of administration
Parenteral drug products should be inspected visually for particulate
matter and discoloration prior to
administration whenever solution and container permit.
An initial dose of 250 micrograms (1.0 ml) of Hemabate should be
administered as a deep intramuscular
injection.
If necessary, further doses of 250 micrograms may be administered at
intervals of approximately 1.5
hours. In severe cases the interval between doses may be reduced at
the discretion of the attending
physician, but it should not be less than 15 minutes. The total dose
of Hemabate should not exceed 2 mg
(8 doses).
_Elderly_:
Not applicable
_Children_:
Not applicable
4.3 Contraindications
1. Hemabate should not be used where the patient is sensitive to
carboprost tromethamine or any of the
excipients.
2. Acute pelvic inflammatory disease.
3. Patients with known active cardiac, pulmonary, renal, or hepatic
disease.
4. Hemabate is contra-indicated in pregnancy.