FORTUM 1g powder for injection vial

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

ceftazidime pentahydrate, Quantity: 1.164 g (Equivalent: ceftazidime, Qty 1 g)

Disponível em:

Aspen Pharmacare Australia Pty Ltd

Forma farmacêutica:

Injection, powder for

Composição:

Excipient Ingredients: sodium carbonate

Via de administração:

Intramuscular, Intravenous

Unidades em pacote:

1 vial X 1g, 5 vials x 1g

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Fortum is indicated for the treatment of single and mixed infections caused by susceptible aerobic organisms with suspected or documented resistance to other antimicrobials , but not to ceftazidime, and as an alternative to aminoglycosides in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other pseudomonal antibiotics cannot be used. Indications include: Severe infections in general: for example septicaemia, including neonatal sepsis, bacteraemia, and in patients in intensive care units with specific problems, e.g., infected burns. Respiratory tract infections: for example, pneumonia, bronchopneumonia, infected pleurisy, infected bronchiectasis and bronchitis. Severe ear, nose and throat infections: for example, otitis media, mastoiditis. Urinary tract infections: for example, acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only), and infections associated with bladder and renal stones. Skin and soft tissue infections: for example, erys

Resumo do produto:

Visual Identification: White to cream powder; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status de autorização:

Registered

Data de autorização:

1991-08-13

Folheto informativo - Bula

CARDIZEM® CD CAPSULES AND CARDIZEM® TABLETS
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CARDIZEM?
Cardizem CD capsules or Cardizem tablets both contain an active
ingredient diltiazem hydrochloride. Cardizem tablets are used to
prevent angina. Cardizem CD capsules are used to prevent angina or to
treat hypertension (high blood pressure).
For more information, see Section 1. Why am I using Cardizem? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CARDIZEM?
Do not use if you have ever had an allergic reaction to Cardizem CD
capsules or Cardizem tablets or any of the ingredients listed at
the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Cardizem? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cardizem and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE CARDIZEM?
•
Cardizem CD capsules can be taken once a day, preferably at the same
time every day.
•
Cardizem tablets can be taken three or four times a day.
•
Swallow the capsules or the tablets with a glass of water. Do not chew
them.
•
Your doctor will tell you how often and how much Cardizem CD or
Cardizem tablets to take.
More instructions can be found in Section 4. How do I use Cardizem? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CARDIZEM?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Cardizem CD or Cardizem tablets.
•
If you are taking these medicines for angina, tell your doctor if you
continue to have angina attacks or if
they become more frequent.
•

Características técnicas

cardizem-ccdsv13-piv17-11mar20
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION – CARDIZEM
®
(DILTIAZEM HYDROCHLORIDE)
1
NAME OF THE MEDICINE
CARDIZEM (diltiazem hydrochloride) 60 mg film coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of CARDIZEM contains 60 mg diltiazem hydrochloride.
Diltiazem hydrochloride is a white to off-white crystalline powder
with a bitter taste. It is
freely soluble in water, methanol, and chloroform.
Excipients with known effect: lactose monohydrate and methyl
hydroxybenzoate.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Film coated tablet
CARDIZEM 60 mg tablets are clear coated, light yellow, round double
(13/32” or 1.03 cm)
convex tablets with characteristic direct compression speckle. The
word “Marion” is
engraved on one side while the other side is scored and engraved with
1772.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Patients with moderate to severe angina pectoris due to
atherosclerotic coronary artery
disease or coronary artery spasm (vasospastic angina).
4.2
DOSE AND METHOD OF ADMINISTRATION
For oral administration.
ANGINA
Dosage must be adjusted to each patient's needs. Starting with 30 mg
four times daily, before
meals and at bedtime, dosage should be increased gradually (given in
divided doses three or
four times daily) at one to two day intervals until optimum response
is obtained. Although
individual patients may respond to any dosage level, the average
optimum dosage range
appears to be 180 to 240 mg/day. The maximum recommended dose is 360
mg daily. There
cardizem-ccdsv13-piv17-11mar20
Page 2 of 18
are no available data concerning dosage requirements in patients with
impaired renal or
hepatic function. If the drug must be used in such patients, titration
should be carried out
with particular caution.
USE IN THE ELDERLY
Pharmacokinetics of diltiazem in elderly patients has not been fully
elucidated. Preliminary
results in elderly patients (over 65 years old) suggest that a lower
dosage mig