FLOXSAFE IV

Main information

  • Trade name:
  • FLOXSAFE IV 100ML
  • Dosage:
  • 400MG
  • Composition:
  • 100ML
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLOXSAFE IV 100ML
    India
  • Language:
  • English

Other information

Status

  • Source:
  • Central Drugs Standard Control Organization
  • Last update:
  • 09-08-2016

20-3-2018

FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy

FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy

FDA approves Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy

FDA - U.S. Food and Drug Administration

22-2-2018

February 21, 2018: Pharmacy Tech Sentenced to Five Years in Prison for Tampering with Opioids for IV Fluid

February 21, 2018: Pharmacy Tech Sentenced to Five Years in Prison for Tampering with Opioids for IV Fluid

February 21, 2018: Pharmacy Tech Sentenced to Five Years in Prison for Tampering with Opioids for IV Fluid

FDA - U.S. Food and Drug Administration

16-1-2018

FDA Commissioner Scott Gottlieb, M.D., updates on some ongoing shortages related to IV fluids

FDA Commissioner Scott Gottlieb, M.D., updates on some ongoing shortages related to IV fluids

FDA updates on some ongoing shortages related to IV fluids

FDA - U.S. Food and Drug Administration

4-1-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages

Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages

Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages

FDA - U.S. Food and Drug Administration

11-12-2017

FDA Drug Safety Communication: FDA warns of increased risk of death with IV antibacterial Tygacil (tigecycline) and approves new Boxed Warning

FDA Drug Safety Communication: FDA warns of increased risk of death with IV antibacterial Tygacil (tigecycline) and approves new Boxed Warning

This update is in follow-up to the FDA Drug Safety Communication: Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections issued on September 1, 2010.

FDA - U.S. Food and Drug Administration

30-11-2017

Statement by FDA Commissioner Scott Gottlieb, M.D., updating on Puerto Rico related medical product shortages

Statement by FDA Commissioner Scott Gottlieb, M.D., updating on Puerto Rico related medical product shortages

Statement by FDA Commissioner Scott Gottlieb, M.D. on efforts by the agency to address the impact of IV saline products and amino acids for injection shortages following the hurricane and update on FDA’s work in Puerto Rico

FDA - U.S. Food and Drug Administration

17-11-2017

Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls

Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls

Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts by the agency to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls

FDA - U.S. Food and Drug Administration

6-10-2017

Intralipid 20 Percent IV Fat Emulsion by Baxter: Recall - One Shipment of Product Exposed to Subfreezing Temperatures

Intralipid 20 Percent IV Fat Emulsion by Baxter: Recall - One Shipment of Product Exposed to Subfreezing Temperatures

When subjected to freezing, emulsion droplets will increase in size, forming aggregates that can block pulmonary circulation/lead to serious adverse health consequences that can be life-threatening.

FDA - U.S. Food and Drug Administration

5-10-2017

Baxter Initiates Voluntary Nationwide Recall of One Shipment of Intralipid 20% IV Fat Emulsion Due to Product Being Exposed to Subfreezing Temperatures

Baxter Initiates Voluntary Nationwide Recall of One Shipment of Intralipid 20% IV Fat Emulsion Due to Product Being Exposed to Subfreezing Temperatures

Baxter International Inc. announced today it is voluntarily recalling one shipment from a single lot of INTRALIPID 20% IV Fat Emulsion, 100 mL, distributed between 8/11/17 and 8/31/17 to hospitals and healthcare providers in the United States, to the user level. The product has been exposed to subfreezing temperatures during transit to a distribution facility. The subfreezing temperature is outside of the acceptable storage range listed on the product labeling. Other shipments of this lot are not affecte...

FDA - U.S. Food and Drug Administration

3-10-2017

Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin (TMV) Formulation: FDA Statement - Case of Hemorrhagic Occlusive Retinal Vasculitis

Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin (TMV) Formulation: FDA Statement - Case of Hemorrhagic Occlusive Retinal Vasculitis

Prophylactic use of intraocular vancomycin, alone or in a compounded drug, during cataract surgery is generally not recommended because of the risk of HORV.

FDA - U.S. Food and Drug Administration

4-8-2017

FDA Drug Safety Communication: Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone

FDA Drug Safety Communication: Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone

[05-06-2011] The U.S. Food and Drug Administration (FDA) is alerting the healthcare community about syringe connection problems when certain needleless glass syringes containing the cardiac drugs adenosine and amiodarone are used with particular types of intravenous (IV) access systems.

FDA - U.S. Food and Drug Administration

28-7-2017

Compounded Triamicinolone and Moxifloxacin Product for Intravitreal Injection by Guardian Pharmacy Services: Alert to Health Professionals - Serious Adverse Events Reported

Compounded Triamicinolone and Moxifloxacin Product for Intravitreal Injection by Guardian Pharmacy Services: Alert to Health Professionals - Serious Adverse Events Reported

Patients had diminished visual function and adverse reactions after injection into the vitreous of the eye at the end of the cataract surgery procedure.

FDA - U.S. Food and Drug Administration

10-7-2017

Medical Devices Safety Update Volume 5, Number 4, July 2017

Medical Devices Safety Update Volume 5, Number 4, July 2017

Warning on IV solution bags; Zoll upgrade counters clock drift; Hysteroscope cleaning advice updated; Mitroflow valves; Recent safety alerts

Therapeutic Goods Administration - Australia

11-4-2018

MOXIFLOXACIN HYDROCHLORIDE Tablet, Film Coated [Rising Health, LLC]

MOXIFLOXACIN HYDROCHLORIDE Tablet, Film Coated [Rising Health, LLC]

Updated Date: Apr 11, 2018 EST

US - DailyMed

28-3-2018

CARDENE IV (Nicardipine Hydrochloride) Injection, Solution [Chiesi USA, Inc.]

CARDENE IV (Nicardipine Hydrochloride) Injection, Solution [Chiesi USA, Inc.]

Updated Date: Mar 28, 2018 EST

US - DailyMed

8-3-2018

Potentially Unsafe Prescribing Common in Patients With CKD

Potentially Unsafe Prescribing Common in Patients With CKD

Almost half of patients with stage III/IV chronic kidney disease (CKD) were prescribed one or more relatively contraindicated medications, and more than a third were prescribed nonsteroidal anti-inflammatory drugs (NSAIDs), a study found.

US - RxList

7-3-2018

Levaquin vs. Avelox

Levaquin vs. Avelox

Levaquin (levofloxacin) and Avelox (moxifloxacin) are fluoroquinolone antibiotics used to treat several types of bacterial infections.

US - RxList

1-3-2018

There May Be a Better IV Fluid Than Saline, Studies Find

There May Be a Better IV Fluid Than Saline, Studies Find

Title: There May Be a Better IV Fluid Than Saline, Studies FindCategory: Health NewsCreated: 2/28/2018 12:00:00 AMLast Editorial Review: 2/28/2018 12:00:00 AM

US - MedicineNet

27-2-2018

TRIAMCINOLONE-MOXIFLOXACIN PF Suspension [ImprimisRx NJ]

TRIAMCINOLONE-MOXIFLOXACIN PF Suspension [ImprimisRx NJ]

Updated Date: Feb 27, 2018 EST

US - DailyMed

26-2-2018

EU/3/18/1973 (ProQR Therapeutics IV BV)

EU/3/18/1973 (ProQR Therapeutics IV BV)

EU/3/18/1973 (Active substance: 2'-O-(2-methoxyethyl)-modified antisense oligonucleotide targeting exon 13 in the USH2A gene) - Orphan designation - Commission Decision (2018)1241 of Mon, 26 Feb 2018 European Medicines Agency (EMA) procedure number: EMA/OD/197/17

Europe -DG Health and Food Safety

16-2-2018

Stage IV Colon Cancer That Has Spread to the Liver

Stage IV Colon Cancer That Has Spread to the Liver

Title: Stage IV Colon Cancer That Has Spread to the LiverCategory: Doctor's & Expert's views on SymptomsCreated: 7/5/2016 12:00:00 AMLast Editorial Review: 2/16/2018 12:00:00 AM

US - MedicineNet

1-2-2018

'IV Lounges' Are the Latest Health Fad, But Are They Safe?

'IV Lounges' Are the Latest Health Fad, But Are They Safe?

Title: 'IV Lounges' Are the Latest Health Fad, But Are They Safe?Category: Health NewsCreated: 1/31/2018 12:00:00 AMLast Editorial Review: 1/31/2018 12:00:00 AM

US - MedicineNet

31-1-2018

MERREM IV (Meropenem) Injection [AstraZeneca Pharmaceuticals LP]

MERREM IV (Meropenem) Injection [AstraZeneca Pharmaceuticals LP]

Updated Date: Jan 31, 2018 EST

US - DailyMed

19-1-2018

TRIAMCINOLONE-MOXIFLOXACIN PF Injection, Suspension [Imprimis NJOF, LLC]

TRIAMCINOLONE-MOXIFLOXACIN PF Injection, Suspension [Imprimis NJOF, LLC]

Updated Date: Jan 19, 2018 EST

US - DailyMed

19-1-2018

MOXIFLOXACIN PF Injection, Solution [Imprimis NJOF, LLC]

MOXIFLOXACIN PF Injection, Solution [Imprimis NJOF, LLC]

Updated Date: Jan 19, 2018 EST

US - DailyMed

19-1-2018

MOXIFLOXACIN Tablet, Film Coated [Major Pharmaceuticals]

MOXIFLOXACIN Tablet, Film Coated [Major Pharmaceuticals]

Updated Date: Jan 19, 2018 EST

US - DailyMed

18-1-2018

Flu Intensity, IV Bag Shortage Have Hospitals Scrambling

Flu Intensity, IV Bag Shortage Have Hospitals Scrambling

The combination of a severe flu season and reduced supplies of intravenous (IV) fluid bags after Hurricane Maria devastated manufacturing plants in Puerto Rico has hospital teams strategizing on alternatives.

US - RxList

18-1-2018

Flu Intensity, IV Bag Shortage

Flu Intensity, IV Bag Shortage

Flu Intensity, IV Bag Shortage Have Hospitals Scrambling

US - eMedicineHealth

10-1-2018

Succinylcholine

Succinylcholine

Succinylcholine is a skeletal muscle relaxant for intravenous (IV) administration indicated as an adjunct to general anesthesia.

US - RxList

2-1-2018

MOXIFLOXACIN HYDROCHLORIDE Tablet [Novel Laboratories, Inc.]

MOXIFLOXACIN HYDROCHLORIDE Tablet [Novel Laboratories, Inc.]

Updated Date: Jan 2, 2018 EST

US - DailyMed

27-12-2017

Norvasc vs. Tenormin

Norvasc vs. Tenormin

Norvasc (amlodipine) and Tenormin (atenolol) (and Tenormin IV) are used for the prevention and treatment of heart pain or chest pain from angina, and for the treatment of high blood pressure (hypertension).

US - RxList

8-12-2017

CATEGORY IV (Immune System Booster) Liquid [Vitality Works, Inc.]

CATEGORY IV (Immune System Booster) Liquid [Vitality Works, Inc.]

Updated Date: Dec 8, 2017 EST

US - DailyMed

4-12-2017

MOXIFLOXACIN HYDROCHLORIDE Tablet, Film Coated [American Health Packaging]

MOXIFLOXACIN HYDROCHLORIDE Tablet, Film Coated [American Health Packaging]

Updated Date: Dec 4, 2017 EST

US - DailyMed

22-11-2017

AVELOX (Moxifloxacin Hydrochloride) Tablet, Film Coated [PD-Rx Pharmaceuticals, Inc.]

AVELOX (Moxifloxacin Hydrochloride) Tablet, Film Coated [PD-Rx Pharmaceuticals, Inc.]

Updated Date: Nov 22, 2017 EST

US - DailyMed

21-11-2017

MOXIFLOXACIN Solution/ Drops [Akorn, Inc.]

MOXIFLOXACIN Solution/ Drops [Akorn, Inc.]

Updated Date: Nov 21, 2017 EST

US - DailyMed

31-10-2017

VIGAMOX (Moxifloxacin Hydrochloride) Solution/ Drops [A-S Medication Solutions]

VIGAMOX (Moxifloxacin Hydrochloride) Solution/ Drops [A-S Medication Solutions]

Updated Date: Oct 31, 2017 EST

US - DailyMed

27-10-2017

MOXIFLOXACIN HYDROCHLORIDE Tablet, Film Coated [Aurobindo Pharma Limited]

MOXIFLOXACIN HYDROCHLORIDE Tablet, Film Coated [Aurobindo Pharma Limited]

Updated Date: Oct 27, 2017 EST

US - DailyMed

17-10-2017

MOXIFLOXACIN Solution/ Drops [Aurobindo Pharma Limited]

MOXIFLOXACIN Solution/ Drops [Aurobindo Pharma Limited]

Updated Date: Oct 17, 2017 EST

US - DailyMed

13-10-2017

MOXIFLOXACIN HYDROCHLORIDE Tablet, Film Coated [PD-Rx Pharmaceuticals, Inc.]

MOXIFLOXACIN HYDROCHLORIDE Tablet, Film Coated [PD-Rx Pharmaceuticals, Inc.]

Updated Date: Oct 13, 2017 EST

US - DailyMed

12-10-2017

MOXIFLOXACIN HYDROCHLORIDE Tablet [Golden State Medical Supply, Inc.]

MOXIFLOXACIN HYDROCHLORIDE Tablet [Golden State Medical Supply, Inc.]

Updated Date: Oct 12, 2017 EST

US - DailyMed

3-10-2017

MOXIFLOXACIN HYDROCHLORIDE Injection, Solution [Mylan Institutional LLC]

MOXIFLOXACIN HYDROCHLORIDE Injection, Solution [Mylan Institutional LLC]

Updated Date: Oct 3, 2017 EST

US - DailyMed

19-9-2017

VIGAMOX (Moxifloxacin Hydrochloride) Solution/ Drops [REMEDYREPACK INC.]

VIGAMOX (Moxifloxacin Hydrochloride) Solution/ Drops [REMEDYREPACK INC.]

Updated Date: Sep 19, 2017 EST

US - DailyMed

25-8-2017

EU/3/17/1899 (ProQR Therapeutics IV BV)

EU/3/17/1899 (ProQR Therapeutics IV BV)

EU/3/17/1899 (Active substance: Antisense oligonucleotide targeting exon 13 in the USH2A gene) - Orphan designation - Commission Decision (2017)5908 of Fri, 25 Aug 2017 European Medicines Agency (EMA) procedure number: EMA/OD/094/17

Europe -DG Health and Food Safety

2-8-2017

Regulatory and procedural guideline:  Guideline on good pharmacovigilance practices (GVP) - Product- or population-specific considerations IV: paediatric population, draft: consultation open

Regulatory and procedural guideline: Guideline on good pharmacovigilance practices (GVP) - Product- or population-specific considerations IV: paediatric population, draft: consultation open

The paediatric population is defined in the European Union (EU) as that part of the population aged between birth and 18 years. The paediatric population encompasses several subsets.

Europe - EMA - European Medicines Agency

2-8-2017

Regulatory and procedural guideline:  Guidelines on good pharmacovigilance practices (GVP) - Introductory cover note, last updated with revision 2 of module VI on ICSRs finalised post-public consultation, its new addendum on duplicate management and the c

Regulatory and procedural guideline: Guidelines on good pharmacovigilance practices (GVP) - Introductory cover note, last updated with revision 2 of module VI on ICSRs finalised post-public consultation, its new addendum on duplicate management and the c

Introductory cover note, last updated with revision 2 of module VI on ICSRs finalised post-public consultation, its new addendum on duplicate management and the considerations chapter IV on the paediatric population for public consultation

Europe - EMA - European Medicines Agency

5-7-2017

MOXIFLOXACIN Solution/ Drops [Apotex Corp.]

MOXIFLOXACIN Solution/ Drops [Apotex Corp.]

Updated Date: Jul 5, 2017 EST

US - DailyMed