FISONS PROTAMINE SULFATE 50mg/5mL injection ampoule

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

Protamine sulfate, Quantity: 10 mg/mL

Dostupno od:

Sanofi-Aventis Australia Pty Ltd

Farmaceutski oblik:

Injection, solution

Sastav:

Excipient Ingredients: sodium chloride; water for injections; hydrochloric acid; sodium hydroxide

Administracija rute:

Intravenous

Jedinice u paketu:

10x5mL

Tip recepta:

Not scheduled. Not considered by committee

Terapijske indikacije:

INDICATIONS AS AT 1 JANUARY 1991: To counteract the Anticoagulant effect of Heparin.

Proizvod sažetak:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Registered

Datum autorizacije:

1991-10-21

Uputa o lijeku

PROTAMINE SULFATE
®
_Injection 1%_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PROTAMINE
SULFATE. 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 giving you
PROTAMINE SULFATE against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT PROTAMINE
SULFATE IS USED FOR
The active ingredient of
PROTAMINE SULFATE is the
protein protamine sulfate. Protamine
sulfate is used in hospitals to
counteract the effect of heparin given
before and after surgery and after
dialysis. Heparin is used to prevent
blood clots from forming. Protamine
sulfate is given when there is
excessive bleeding from heparin
administration.
Your doctor may have prescribed
PROTAMINE SULFATE for
another reason. Ask your doctor if
you have any questions about why
PROTAMINE SULFATE has been
prescribed for you.
This medicine is available only with
a doctor's prescription.
PROTAMINE SULFATE is not
recommended for use in children.
BEFORE YOU ARE GIVEN
PROTAMINE
SULFATE
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT RECEIVE
PROTAMINE SULFATE IF YOU
HAVE A SEVERE ALLERGY TO
PROTAMINE SULFATE OR AN
ALLERGY TO ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS LEAFLET
UNDER PRODUCT DESCRIPTION.
YOUR DOCTOR, NURSE AND PHARMACIST
WILL ENSURE THAT YOU ARE NOT GIVEN
PROTAMINE SULFATE AFTER THE
EXPIRY DATE (EXP) PRINTED ON THE
PACK.
If you are given this medicine after
the expiry date has passed, it may not
work as well.
YOUR DOCTOR, NURSE AND PHARMACIST
WILL ENSURE THAT YOU ARE NOT GIVEN
PROTAMINE SULFATE IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START BEING GIVEN
PROTAMINE SULFATE, CONTACT
YOUR DOCTOR OR PHARMACIST.
_BEFORE YOU ARE GIVEN IT_
TELL Y

Svojstava lijeka

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AUSTRALIAN PRODUCT INFORMATION – FISONS PROTAMINE
SULFATE INJECTION B.P (PROTAMINE SULFATE )
1
NAME OF THE MEDICINE
Fisons Protamine Sulfate solution for injection.
2 AND 3
QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
A sterile, pyrogen-free, clear, colourless 1% solution of Protamine
Sulfate (Salmine) in
Sodium Chloride Intravenous Infusion B.P. (0.9% w/v) adjusted to a pH
of 2.5 to 3.5 and
supplied in 5mL glass ampoules.
For the full list of excipients, see Section 6.1 List of excipients.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Protamine is a basic protein which combines with heparin to form a
stable, inactive complex.
It is used to counteract the anticoagulant effect of heparin; before
surgery; after renal dialysis;
after open-heart surgery; if excessive bleeding occurs and when an
overdose has
inadvertently been given.
4.2
DOSE AND METHOD OF ADMINISTRATION
Fisons Protamine Sulfate Injection should be administered by slow
intravenous injection over
a period of about 10 minutes. The dose is dependent on the amount of
heparin to be
neutralised. 1mg of Fisons Protamine Sulfate will usually neutralise
at least 100 international
units of mucous heparin or 80 units of lung heparin. Since heparin is
being continuously
excreted, the dose of Fisons Protamine Sulfate should be reduced if
more than 15 minutes
have elapsed since the heparin injection. Ideally, the dose required
to neutralise the action of
heparin should be calculated from the results of determinations of the
amount required to
produce an acceptable blood clotting time in the patient. In gross
excess, protamine itself
acts as an anticoagulant.
4.3
CONTRAINDICATIONS
Hypersensitivity to protamine (including protamine contained in
insulin NPH [Neutral
Protamine Hagedorn]) or to any excipients.
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Page 2 of 7
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Too rapid administration of protamine sulfate may cause severe
hypotension and
anaphylacto