SYNTOCINON oxytocin 5 IU/1 mL injection ampoule

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

oxytocin, Quantity: 5 IU/mL

Saatavilla:

Viatris Pty Ltd

Lääkemuoto:

Injection, solution

Koostumus:

Excipient Ingredients: glacial acetic acid; chlorobutanol hemihydrate; water for injections; sodium acetate trihydrate; ethanol

Antoreitti:

Intravenous, Intramuscular, Intramural

Kpl paketissa:

5 x 1 mL

luokka:

Medicine Registered

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

Induction of labour; inadequate uterine effort; management of third stage of labour; post-partum haemorrhage.

Tuoteyhteenveto:

Visual Identification: A 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

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

1991-08-21

Pakkausseloste

SYNTOCINON
®
_synthetic oxytocin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Syntocinon.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. Some more recent
information on the medicine may be
available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Syntocinon
against the benefits they expect it to
provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT SYNTOCINON IS
USED FOR
Syntocinon can be used to bring on
(induce) labour. It can also be used
during and immediately after
delivery to help the birth and to
prevent or treat excessive bleeding.
Syntocinon is a man-made chemical
that is identical to a natural hormone
called oxytocin. It works by
stimulating the muscles of the uterus
(womb) to produce rhythmic
contractions.
Syntocinon is not suitable in all
situations - for example, if the baby
or placenta are in the wrong position
or if you have had a previous
caesarean section or other surgery
involving the uterus. Your doctor can
give you more information on the
suitability of Syntocinon in your
particular case.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SYNTOCINON
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
Syntocinon is only available with a
doctor's prescription. It is not
addictive.
BEFORE YOU HAVE
SYNTOCINON
_WHEN YOU MUST NOT HAVE IT_
YOU MUST NOT HAVE SYNTOCINON IF:
•
your doctor thinks that inducing
or enhancing contractions for
normal labour and vaginal
delivery would be unsuitable for
you or

Pakkausseloste

SANDIMMUN
®
_cyclosporin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sandimmun.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Sandimmun
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SANDIMMUN IS
USED FOR
Sandimmun is used for people who
have had a kidney, heart or liver
transplant, to prevent the body from
rejecting the new organ. It does this
by blocking the development of
special cells which would normally
attack the transplanted tissue.
Sandimmun is also used to treat
several other conditions which are
thought to be caused by a problem
with the immune system:
•
a kidney disease, called nephrotic
syndrome
•
severe cases of rheumatoid
arthritis (a disease, affecting the
joints with pain and swelling)
•
severe cases of :
-
psoriasis (a skin disease with
thickened patches of red skin,
often with silvery scales)
-
atopic dermatitis (skin allergies)
Sandimmun contains the active
ingredient, cyclosporin. It belongs to
a group of medicines called immuno-
suppressive agents. These medicines
help to control your body's immune
system.
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.
Sandimmun i

Valmisteyhteenveto

1
_Syntocinon PI _
_ Version 1.0 _
_Page 1 of 13 _
SYNTOCINON
®
INJECTION
(SYNTHETIC OXYTOCIN)
NAME OF THE MEDICINE
Oxytocin BAN, INN. The active substance of Syntocinon is a synthetic
nonapeptide identical
with oxytocin, a hormone released by the posterior lobe of the
pituitary. Being wholly
synthetic, it does not contain vasopressin and has a constant and
reliable effect.
DESCRIPTION
Oxytocin injection is a sterile aqueous solution containing synthetic
oxytocin. The solution is
clear and colourless.
Syntocinon is available in ampoules containing 5 IU in 1 mL and 10 IU
in 1 mL.
Excipients: sodium acetate, glacial acetic acid, chlorobutanol
hemihydrate, ethanol, water for
injections.
PHARMACOLOGY
PHARMACODYNAMICS
Oxytocin stimulates the smooth muscle of the uterus, producing
rhythmic contractions,
particularly towards the end of pregnancy, during labour, after
delivery and in the
puerperium, i.e. at times when the number of specific oxytocin
receptors in the myometrium
is increased. When given by low-dose intravenous infusion, Syntocinon
elicits rhythmic
uterine contractions that are indistinguishable in frequency, force
and duration from those
observed during spontaneous labour. At higher infusion dosages, or
when given by single
injection, the drug is capable of causing sustained tetanic uterine
contractions. Upon
discontinuation of the infusion or following a substantial reduction
in the infusion rate (e.g. in
the event of over stimulation), uterine activity declines rapidly but
may continue at an
adequate lower level.
Oxytocin also causes contraction of the myo-epithelial cells
surrounding the mammary
alveoli. It therefore facilitates lactation in women experiencing
difficulty in breast feeding.
Synthetic oxytocin has only very slight pressor and anti-diuretic
activity (absence of vasopressin).
Another pharmacological effect observed with high doses of oxytocin,
particularly when
administered by rapid intravenous bolus injection, is a transient
direct relaxing effect on
2
_Syntocinon PI _
_ Version 1.0 _
_Pa

Valmisteyhteenveto

1
SANDIMMUN
®
(CYCLOSPORIN)
Immunosuppressive agent
DESCRIPTION
Cyclosporin (BAN, AAN), ciclosporin (prop. INN), cyclosporine (USAN),
also known as
Cyclosporin A. A cyclic polypeptide consisting of 11 amino acids. It
is produced as a
metabolite by the fungus species
_Beauveria nivea_
(formerly
_Tolypocladium inflatum Gams_
).
Chemical Name:
Cyclo[[(2
_S_
,3
_R_
,4
_R_
,6
_E_
)-3-hydroxy-4-methyl-2-(methylamino)oct-6-
enoyl]-
_L_
-2-aminobutanoyl-
_N_
-methylglycyl-
_N_
-methyl-
_L_
-leucyl-
_L_
-valyl-
_N_
-methyl-l-leucyl-
_L_
-alanyl-
_D_
-alanyl-
_N_
-methyl-
_L_
-leucyl-
_N_
-methyl-
_L_
-
leucyl-
_N_
-methyl-
_L_
-valyl]
Chemical formula:
C
62
H
111
N
11
O
12
Chemical structure:
N
C H
C O
N
C H
C
N
C H
C O
N
C H
C
N
C H
2
C H
C H
N
C O
C H
O C
N
C O
C O
C H
N
O
H
N
C
C H
N
O
H
O
H
C O
C H
C O
N
C H
2
C H
C H
3
C H
3
C H
3
C H
C H
3
C H
3
C H
3
C H
C H
C H
3
H O
C H
2
C
H
C
H
C H
3
C H
2
C H
3
C H
3
C H
2
C H
C H
3
C H
3
C H
C H
3
C H
3
C H
3
C H
2
C H
C H
3
C H
3
C H
3
H
C H
3
C H
2
C H
C H
3
C H
3
C H
3
C H
3
C H
3
L
L
L
L
L
L
L
L
L
D
(R )
(R )
Molecular Weight: 1202.635
CAS Number:
59865-13-3
Cyclosporin is poorly soluble in water (0.004% w/w) and n-hexane, but
is very soluble in
other organic solvents and in lipids.
EXCIPIENTS
Sandimmun capsules and oral solution contain maize oil, ethanol (see
PRECAUTIONS), and
inter-esterified maize oil.
Sandimmun soft gelatin capsule shells contain gelatin, glycerol,
titanium dioxide, iron oxide
red CI77491 (25 and 100 mg capsules only), iron oxide yellow CI 77492
(50 mg capsules),
and Anidrisorb 85/70 (sorbitol syrup).
Sandimmun concentrate for intravenous infusion contains castor oil –
polyoxyethylated,
macrogolglycerol
ricinoleate
(Cremophor
®
EL)
65
%,
and
ethanol
26
%
w/v
(see
PRECAUTIONS).
2
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: immunosuppressive agents, calcineurin
inhibitors
ATC Code: L04A D01
Cyclosporin is a potent immunosuppressive agent which prevents or
delays rejection of solid
organ allografts or xenografts in various ani