Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
oxytocin, Quantity: 5 IU/mL
Viatris Pty Ltd
Injection, solution
Excipient Ingredients: glacial acetic acid; chlorobutanol hemihydrate; water for injections; sodium acetate trihydrate; ethanol
Intravenous, Intramuscular, Intramural
5 x 1 mL
Medicine Registered
(S4) Prescription Only Medicine
Induction of labour; inadequate uterine effort; management of third stage of labour; post-partum haemorrhage.
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
Registered
1991-08-21
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 Leggi il documento completo
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 Leggi il documento completo
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 Leggi il documento completo
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 Leggi il documento completo