CEFTRIAXONE-AFT ceftriaxone (as sodium) 500 mg powder for injection vial

Main information

  • Trade name:
  • CEFTRIAXONE-AFT ceftriaxone (as sodium) 500 mg powder for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEFTRIAXONE-AFT ceftriaxone (as sodium) 500 mg powder for injection vial
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 185099
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

185099

CEFTRIAXONE-AFT ceftriaxone (as sodium) 500 mg powder for injection vial

ARTG entry for

Medicine Registered

Sponsor

AFT Pharmaceuticals Pty Ltd

Postal Address

PO Box 748,North Ryde,Sydney, NSW, 1670

Australia

ARTG Start Date

20/02/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. CEFTRIAXONE-AFT ceftriaxone (as sodium) 500 mg powder for injection vial

Product Type

Single Medicine Product

Effective date

7/02/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For the treatment of the following infections when caused by susceptible aerobic organisms:

= Lower Respiratory Tract Infections caused by S. pneumoniae, Streptococcus species (excluding enterococci), methicillin sensitive S. aureus, H.

influenzae, H. parainfluenzae, Klebsiella species (including K. pneumoniae), E. coli, E. aerogenes, Proteus mirabilis and Serratia marcescens.

= Skin And Skin Structure Infections caused by methicillin sensitive S. aureus, methicillin sensitive S. epidermidis, Streptococcus Group B,

Streptococcus Group G, Streptococcus pyogenes, Streptococcus viridans, Streptococcus species (excluding enterococci), Peptostreptococcus species,

E. coli, E. cloacae, Klebsiella species (including K. pneumoniae, K. oxytoca), Proteus mirabilis, Morganella morganii, Serratia marcescens.

= Urinary Tract Infections (complicated and uncomplicated) caused by E. coli, Proteus mirabilis, Proteus vulgaris, M. morganii and Klebsiella species

(including K. pneumoniae).

= Uncomplicated Gonorrhoea (cervical/urethral and rectal) caused by Neisseria gonorrhoea, including both penicillinase and non penicillinase producing

strains.

= Bacterial Septicemia caused by S. pneumoniae, E. coli and H. influenzae.

= Bone Infections caused by methicillin sensitive S. aureus, methicillin sensitive S. epidermidis, Streptococcus Group B, S. pneumoniae, Streptococcus

species (excluding enterococci), E. coli, Enterobacter species, P. mirabilis and K. pneumoniae.

= Joint Infections caused by methicillin sensitive S. aureus, S. pneumoniae, Streptococcus species (excluding enterococci), E. coli, P. mirabilis, K.

pneumoniae and Enterobacter species.

= Meningitis: The initial treatment, as a single agent, of meningitis in children and immunocompetent adults when presumed or proven to be caused by

Haemophilus influenzae type b, Neisseria meningitidis, Streptococcus pneumoniae or Enterobacteriaceae pending culture and sensitivity results.

= Surgical Prophylaxis: The preoperative administration of a single 1 g dose of ceftriaxone may reduce the incidence of post-operative infections in

patients undergoing vaginal or abdominal hysterectomy or cholecystectomy in high risk patients, surgical procedures which are classified as

contaminated or potentially contaminated and patients undergoing coronary artery bypass surgery.

= Although ceftriaxone has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no

placebo-controlled trials have been conducted.

= Susceptibility Testing: Before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism

and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

36 Months

Store below 25

degrees Celsius

Restricted flow insert

Protect from Light

Vial

Glass Type II Clear

36 Months

Store below 25

degrees Celsius

Restricted flow insert

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

5 vials

(S4) Prescription Only Medicine

10 vials

(S4) Prescription Only Medicine

1 vial

(S4) Prescription Only Medicine

Components

1. CEFTRIAXONE-AFT ceftriaxone (as sodium) 500 mg powder for injection vial

Dosage Form

Injection, powder for

Public Summary

Page 1 of

Produced at 29.11.2017 at 03:51:31 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Route of Administration

Intravenous

Intramuscular

Visual Identification

Almost white or yellowish crystalline powder

Active Ingredients

ceftriaxone sodium

539 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 29.11.2017 at 03:51:31 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Ceftriaxone-AFT

Ceftriaxone sodium equivalent to Ceftriaxone 500 mg, 1 g and 2 g, powder for

injection

What is in this leaflet

This leaflet answers some common questions about Ceftriaxone-AFT.

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 will have considered risks of you

being given Ceftriaxone-AFT against the benefits they expect it will have for you..

If you have any concerns or questions about being given this medicine, ask

your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What Ceftriaxone-AFT is used for

Ceftriaxone-AFT is an antibiotic used to treat infections in different parts of the body

caused by bacteria. Ceftriaxone-AFT is also used to prevent infections before, during

and after surgery. It will not work against infections caused by viruses such as colds

and flus.

Ceftriaxone-AFT belongs to a group of antibiotics called cephalosporins. They work

by killing the bacteria that are causing your infection or by stopping the bacteria from

growing.

If you are not sure if you are uncertain why Ceftriaxone-AFT has been

prescribed for you, talk to your doctor. They may have prescribed it for another

reason.

Before you are given Ceftriaxone-AFT

When you must not be given it

You must not use Ceftriaxone-AFT if you:

Have had an allergic reaction to Ceftriaxone-AFT or any other cephalosporin

antibiotic

Have had an allergic reaction to any penicillin

Symptoms of allergic reactions include severe skin rash, itching, hives, dry skin,

swelling of the face, lips, mouth, throat which may cause difficulty in swallowing or

breathing, swelling of the hands, feet or ankles.

You may have an increased risk of being allergic to Ceftriaxone-AFT if you are

allergic to penicillins.

Ceftriaxone-AFT should not be given to newborn infants if they need or are expected

to need treatment with calcium containing intravenous solutions including intravenous

nutrition.

Ceftriaxone-AFT should not be given to preterm newborns or newborns with certain

liver disorders.

If you are uncertain if Ceftriaxone-AFTshould be given to you, talk to your

doctor.

Before you are given Ceftriaxone-AFT

You must tell your doctor if:

You have had any type of allergic reaction to any cephalosporin or penicillin

medicines

You have had an allergy or over-reaction to lignocaine or other anaesthetic

medicines (these substances may be used to dissolve Ceftroaxone-AFT

before administration)

You have any allergies to any other medicines or other substances e.g. foods,

preservatives, dyes

You have any other medical conditions including kidney disease, bowel

problems (e.g. inflammation of the large bowel), diarrhoea associated with

previous use of antibiotics or a previous intestinal infection with a bacteria

called Clostridium difficile.

You are pregnant or intending to become pregnant

You are breast feeding or intending to breast feed

If you have not told your doctor about any of the above you must tell them before you

are given Ceftriaxone-AFT.

Other Medicines

You must tell your doctor if you are taking any other medicines including any you

may buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and Ceftriaxone-AFT may interfere with each other. These

include:

chloramphenicol, vancomycin, aminoglycosides (medicines to treat

infections),

fluconazole (a medicine used to treat fungal infections)

amsacrine (a medicine used to treat cancer).

These medicines may be affected by Ceftriaxone-AFT or may affect how well it

works. You may need to take different amounts of your medicines. Your doctor will

advise you.

Some antibiotics decrease the effectiveness of some contraceptive pills. Talk to your

doctor about the need for additional contraception while using Ceftriaxone-AFT.

Your doctor or pharmacist will have more information on medicines to be careful with

or avoid while being given Ceftriaxone-AFT.

How Ceftriaxone-AFT is given

Ceftriaxone-AFT will be given by either a doctor or nurse.

Ceftriaxone-AFT can be given as either:

As a slow injection into a vein

As an injection into a large muscle

Ceftriaxone-AFT should not be mixed or administered with calcium-containing

solutions even via different infusion lines.

Your doctor will decide what dose and for how long you will receive Ceftriaxone-AFT.

It will depend on your infection and other factors such as your weight. For most

infections Ceftriaxone-ADR is usually given once a day. The length of treatments is

usually 4-14 days.

Sometimes only a single dose of Ceftriaxone-AFT is required for the treatment and

prevention of certain infections.

If too much Ceftriaxone-AFT is given you may experience symptoms such as skin

reactins, chills, diarrhoea, stomach upsets, headache or dizziness.

While you are using Ceftriaxone-AFT

If the symptoms of your infection do not improve within a few days or if they

become worse, tell your doctor.

If you get severe diarrhoea tell your doctor, nurse or pharmacist immediately

even if occurs several weeks after Ceftriaxone-AFT has been stopped.

Diarrhoea may mean you have a serious condition affecting your bowel. You may

need urgent medical attention. Do not take any medicine to stop the diarrhoea

without first checking with your doctor.

Tell you doctor if you get a sore or white furry mouth or tongue or if you get vaginal

itching or discharge. You may have a fungal infection called thrush. Sometimes the

use of Ceftriaxone-AFT may allow fungi to grow and the above symptoms to occur.

Ceftriaxone-AFT will not work against fungi.

Tell your doctor if you become pregnant while using Ceftriaxone-AFT.

If you test your urine for sugar, make sure your doctor knows which type of test you

use as Ceftriaxone-AFT may affect the test results.

If you are having any blood tests tell who ever is doing the tests that you are taking

Ceftriaxone-AFT as Ceftriaxone-AFT may affect the results of some blood tests.

Complete blood counts should be done at regular intervals as Ceftriaxone-AFT may

affect the results of some blood tests.

Tell all doctors, dentists and pharmacists who are treating you that you are

using ceftriaxone-AFT.

You must not:

Give Ceftriaxone to anyone else even if the seem to have the same condition

as you

Use Ceftriaxone-ADR to treat other complaints unless your doctor says to

Be careful of driving or operating machinery until you know how Ceftriaxone-

AFT affects you. Ceftriaxone-AFT generally does not cause any problems with you

ability to drive or operate machinery. However Ceftriaxone-AFT may cause dizziness

in some people.

Side effects

Tell your doctor, nurse or pharmacist as soon as possible if you do not feel

well while you are using Ceftriaxone-AFT.

Ceftriaxone-AFT helps most people with infections but it may have unwanted side

effects in a few people. All medicines have side effects. Sometimes these may be

serious but most of the time they are not. You may need medical treatment if you get

some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell you doctor or nurse if you notice any of the following and they worry you:

Oral thrush – white, furry, sore tongue and mouth

Vaginal thrush – sore and itchy vagina and/or discharge

A hard lump, swelling, pain or tenderness at the injection site

Diarrhoea, nausea or vomiting

Altered sense of taste

Headache, dizziness

Fast or irregular heartbeat

Tell you doctor immediately or go to the Emergency Department at your

nearest hospital if you notice any of the following:

Severe skin rash, itching or hives

Red, peeling or dry skin

Swelling of the face, lips or tongue which may cause in difficulty swallowing or

breathing, swelling of the hands, feet or ankles

Tiredness, headaches, being short of breath when exercising, dizziness,

looking pale, yellowing of the skin and/or eyes

Severe diarrhoes that may contain blood or mucous, stomach pain and fever

These are serious side effects and you may need urgent medical attention. Serious

side effects are rare.

Tell you doctor immediately if you notice any of the following particularly if

they occur several weeks after stopping treatment with Ceftriaxone-AFT:

Severe abdominal (stomach) cramps

Watery and severe diarrhoea which may also be bloody

Fever in combination with one or both of the above

These are rare but serious side effects. You may have a serious condition affecting

your bowel. You may need urgent medical attention. However this side effect is rare.

Do not take any medicines to stop the diarrhoea without first checking with

your doctor.

This is not a full list of possible side effects. Some patients may experience other

effects. Tell you doctor if you notice anything that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of

them.

Overdose

You will only be given Ceftriaxone-AFT under medical supervision. It is unlikely that

you will be given too much.

If you are given too much Ceftriaxone-AFT you may experience dizziness,

headaches, stomach upset, chills, tingling or skin reactions. Your doctor will know

what actions to take should you experience any signs of having received too much

Ceftriaxone-AFT

Storage

Ceftriaxone-AFT will be stored in the pharmacy or on the hospital ward. It should be

kept in a cool, dry place, protected from light and moisture at a temperature below 25

°C.

Description

Ceftriaxone-AFT is a white to yellowish powder. It is dissolved before injection into a

vein or muscle.

Other ingredients

Ceftriaxone-AFT contains only Ceftriaxone sodium. If you are on a restricted sodium

intake remind your doctor of this, so allowances can be made for the sodium content

in Ceftriaxone-AFT as appropriate.

If you want to know more

If you want to know more about Ceftriaxone-AFT, talk to your doctor or pharmacist.

Distributor

AFT Pharmaceuticals Pty Ltd

113 Wicks Road

North Ryde

NSW 2113

Ceftriaxone-AFT 500 mg: AUST R 185099

Ceftriaxone-AFT 1 g: AUST R 185100

Ceftriaxone-AFT 2 g: AUST R 185101

Date: 2

7 August