POR-8 FERRING ornipressin 5 I.U./mL injection ampoule

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

ornipressin, Quantity: 5 IU/mL

Tilgængelig fra:

Ferring Pharmaceuticals Pty Ltd

INN (International Name):

Ornipressin

Lægemiddelform:

Injection, solution

Sammensætning:

Excipient Ingredients: sodium acetate; glacial acetic acid; sodium chloride; water for injections

Indgivelsesvej:

Infiltration

Enheder i pakken:

5 x 1mL

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Local administration: to induce ischaemia and haemostasis at the site of an operation in various types of surgery where bleeding is a problem Plastic Surgery: Hair transplants, meloplasty, otoplasty, skin grafts, resection of tumours etc Obstetrics/Gynaecology: Vaginal repair, vaginal hysterectomy, cone biopsy of cervix, episiotomy, myomectomy. ENT Surgery: Tonsillectomy, submucous resection of septum, myringoplasty etc. Other types of surgery: Neurosurgery, orofacial surgery, surgery of head and neck, abdominal and rectal surgery, care of burns (excision of eschar).

Produkt oversigt:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Autorisation status:

Registered

Autorisation dato:

1991-08-21

Indlægsseddel

POR-8 FERRING
®
INJECTION
_Ornipressin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about POR-8 FERRING.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
Please read this leaflet before
treatment with POR-8 FERRING is
commenced.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using POR-8
FERRING against the benefits they
expect it will have for you.
If you have any concerns about using
this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT POR-8 FERRING
IS USED FOR
This medicine is used to help control
bleeding. It narrows blood vessels at
the site of an operation.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed it for
another reason.
There is no evidence that POR-8
FERRING medicine is addictive.
It is available only with a doctor's
prescription.
BEFORE YOU USE POR-8
FERRING
_WHEN YOU MUST NOT USE IT_
Do not use POR-8 FERRING if you
have/are:
•
coronary heart disease
•
very high blood pressure
•
epilepsy
•
advanced hardening of the
arteries
•
infection relating to pregnancy
•
pregnant
•
allergies to the contents of the
product
There are some anaesthetic
procedures where POR-8 FERRING
should not be used.
Your doctor has more information
about these.
Do not use this medicine after the
expiry date printed on the pack or if
the packaging is torn or shows signs
of tampering.
If it has expired or is damaged, return
it to your pharmacist for disposal.
_BEFORE YOU START TO USE IT_
Tell your doctor if you have or have
had any of the medical conditions
listed above or if you have a
condition in which a rise in blood
pressure may cause you to become
unwell.
Tell your doctor if you plan to
become pregnant
_USING OTHER MEDICINES_
Tell your doctor or pharmacist if you
are using any other medicines,
including any that yo

Produktets egenskaber

#1196-v5A
PRODUCT INFORMATION
POR-8 FERRING
®
Ornipressin
DESCRIPTION
POR-8 FERRING
®
is ornipressin (8-ornithine-vasopressin), a synthetic polypeptide
with a molecular weight of 1042.2. It is closely related to synthetic
vasopressin,
and differs from that substance only by the substitution of ornithine
for lysine in the
side chain. It is available in sealed 1mL ampoules each containing 5
IU. The
sterile solution is clear and pH is adjusted to 3.7.
POR-8 FERRING contains sodium acetate, sodium chloride, acetic acid
and water
for injections as excipients.
Cys-Try-Phe-Gln-Asn-Cys-Pro-Orn-Gly-NH
2
C
45
H
63
N
13
O
12
S
2
CAS No. 3397-23-7
PHARMACOLOGY
POR-8 FERRING
®
has a potent and specific constrictor effect on the
microcirculation and veins which is equal to, if not greater than,
that of
vasopressin. It has antidiuretic activity but this is weak by
comparison with
vasopressin.
Topical administration or infiltration leads within 10 minutes to
local ischaemia
which usually lasts for 1 to 2 hours, and is not followed by reactive
hyperaemia.
POR-8 FERRING
®
may be used with general anaesthetics which are usually not
compatible with adrenaline, eg halothane, without fear of
precipitating cardiac
arrhythmias.
#1196-v5A
INDICATIONS
LOCAL ADMINISTRATION: to induce ischaemia and haemostasis at the site
of an
operation in various types of surgery where bleeding is a problem.
PLASTIC SURGERY: Hair transplants, meloplasty, otoplasty, skin grafts,
resection of
tumours etc.
OBSTETRICS/GYNAECOLOGY: Vaginal repair, vaginal hysterectomy, cone
biopsy of
cervix, episiotomy, myomectomy.
ENT SURGERY: Tonsillectomy, submucous resection of septum,
myringoplasty etc.
OTHER TYPES OF SURGERY: Neurosurgery, orofacial surgery, surgery of
head and
neck, abdominal and rectal surgery, care of burns (excision of
eschar).
CONTRAINDICATIONS
Coronary heart disease, severe hypertension, toxaemia of pregnancy;
advanced
arteriosclerosis; epilepsy; as an adjunct to local anaesthetics
intended to be used
in regions of terminal arteries, e.g. finge