HOSPIRA

Main information

  • Trade name:
  • HOSPIRA CEFALOTIN SODIUM POWDER FOR INJECTION cefalotin (as sodium) 1g powder for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • HOSPIRA CEFALOTIN SODIUM POWDER FOR INJECTION cefalotin (as sodium) 1g powder for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220982
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220982

HOSPIRA CEFALOTIN SODIUM POWDER FOR INJECTION cefalotin (as sodium) 1g powder for injection

vial

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

38-42 Wharf Road,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

5/03/2015

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. HOSPIRA CEFALOTIN SODIUM POWDER FOR INJECTION cefalotin (as sodium) 1g powder for injection

vial

Product Type

Single Medicine Product

Effective date

12/08/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Culture and susceptibility

studies should be performed. However, therapy may be instituted before results of susceptibility studies are obtained (see PHARMACOLOGY,

Microbiology).,Respiratory tract

Infections caused by S. pneumoniae, Staphylococci (penicillinase and nonpenicillinase

producing), group A beta-haemolytic Streptococci, Klebsiella and H. influenzae.,Skin and soft tissue

Infections, including peritonitis, caused by Staphylococci (penicillinase and nonpenicillinase producing), group A beta-haemolytic Streptococci, E. coli, P.

mirabilis and Klebsiella.,Genitourinary tract

Infections caused by E. coli, P. mirabilis and Klebsiella.,Septicaemia, including endocarditis

Infections caused by S. pneumoniae, Staphylococci (penicillinase and nonpenicillinase producing), group A beta-haemolytic Streptococci, S. viridans, E.

coli, P. mirabilis and

Klebsiella.,Bone and joint

Infections caused by Staphylococci (penicillinase and nonpenicillinase producing).,Other

Prophylactically in vaginal hysterectomy, head and neck surgery, insertion of prosthetic heart valves, and prosthetic arthroplasty. Cefalotin is not

recommended for gastrointestinal procedures or other sites where anaerobic organisms such as Bacteroides tend to prevail. Dosage is required

preoperatively, intraoperatively and postoperatively (i.e. perioperatively, see DOSAGE AND ADMINISTRATION).,If signs of postoperative infection

develop, specimens should be cultured to identify the causative organism so that appropriate therapy can be instituted.,Note: If the susceptibility tests

show that the causative organism is resistant to Hospira™ Cefalotin Sodium Powder for Injection, other appropriate antibiotic therapy should be

instituted.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

2 Years

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Reconstituted Solution

see label for shelf life

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

10 vials per pack

(S4) Prescription Only Medicine

Components

1. Hospira Cefalotin Sodium Powder for Injection 1g/vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Intramuscular

Visual Identification

White to off-white crystalline powder filled in 10 mL clear, Type I glass vial

and sealed with bromobutyl rubber stopper and flip off seal.

Active Ingredients

Public Summary

Page 1 of

Produced at 26.11.2017 at 01:45:44 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

cefalotin

1 g

© 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 26.11.2017 at 01:45:44 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

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

4-6-2018

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

FDA - U.S. Food and Drug Administration

4-6-2018

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System   by Hospira: Recall - Due to the Potential Presence of Particulate Matter

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter

The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

FDA - U.S. Food and Drug Administration

16-11-2018

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Active substance: daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7678 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004310/T/0008

Europe -DG Health and Food Safety

1-11-2018

Taxespira (Hospira UK Limited)

Taxespira (Hospira UK Limited)

Taxespira (Active substance: docetaxel) - Centralised - Withdrawal - Commission Decision (2018)7368 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

22-10-2018

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6971 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3970/T/14

Europe -DG Health and Food Safety

8-10-2018

Palonosetron Hospira (Pfizer Europe MA EEIG)

Palonosetron Hospira (Pfizer Europe MA EEIG)

Palonosetron Hospira (Active substance: palonosetron) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6606 of Mon, 08 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4069/T/04

Europe -DG Health and Food Safety

24-9-2018

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Active substance: topotecan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6238 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1192/T/33

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

16-5-2018

Inflectra (Hospira UK Limited)

Inflectra (Hospira UK Limited)

Inflectra (Active substance: Infliximab) - Centralised - Yearly update - Commission Decision (2018)3054 of Wed, 16 May 2018

Europe -DG Health and Food Safety

15-5-2018

Pemetrexed Hospira (Hospira UK Limited)

Pemetrexed Hospira (Hospira UK Limited)

Pemetrexed Hospira (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3059 of Tue, 15 May 2018

Europe -DG Health and Food Safety