দেশ: নিউ জিলণ্ড
ভাষা: ইংরেজি
সূত্র: Medsafe (Medicines Safety Authority)
Linezolid 20 mg/mL
Pfizer New Zealand Limited
Linezolid 20 mg/mL
20 mg/mL
Granules for oral suspension
Active: Linezolid 20 mg/mL Excipient: Ammonium glycyrrhizinate Aspartame Citric acid monohydrate Colloidal silicon dioxide Dispersible cellulose Sweet-am powder #918.005 Nor-Cap Natural & Artificial Orange Cream Mannitol Orange flavour (cream) 884.010 Orange flavour 884.114 Peppermint flavour SD F93125 Sodium benzoate Sodium chloride Sodium citrate dihydrate Sucrose Sweet flavour (AM) 918.005 Vanilla flavour 712729 (MC008927) Xanthan gum
Bottle, glass, amber, 150 mL
Prescription
Prescription
Pfizer Asia Pacific Pte Ltd
Zyvox is indicated for the treatment of infections when known or suspected to be caused by susceptible organisms including those associated with concurrent bacteraemia such as: · Pneumonia - community acquired and nosocomial pneumonia · Skin and soft tissue infections · Enterococcal infections. Linezolid is active against Gram-positive bacteria only. Linezolid has no clinical activity against Gram-negative pathogens. Specific Gram-negative therapy is required if a concomitant Gram-negative pathogen is documented or suspected. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Package - Contents - Shelf Life: Bottle, glass, amber - 150 mL - 36 months from date of manufacture stored at or below 25°C 3 weeks reconstituted stored at or below 25°C
2000-01-06
ZYVOX ® 1 ZYVOX ® _linezolid_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Zyvox. It does not contain all the available information. It does not take the place of talking to your or your child's doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you or your child taking Zyvox against the expected benefits it will have. IF YOU HAVE ANY CONCERNS ABOUT YOU OR YOUR CHILD TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ZYVOX IS USED FOR Zyvox contains the active ingredient linezolid. Linezolid is an antibiotic (an agent used to destroy certain types of bacteria). It is used in the treatment of bacterial infections such as pneumonia, skin infections or blood infections. Depending on the type of bacteria, you may be given additional medicines. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ZYVOX HAS BEEN PRESCRIBED FOR YOU OR YOUR CHILD. Your doctor may have prescribed it for another reason. This medicine is not addictive. BEFORE TREATMENT WITH ZYVOX _WHEN ZYVOX MUST NOT BE _ _USED_ ZYVOX MUST NOT BE GIVEN IF YOU OR YOUR CHILD: are allergic to linezolid or any of the other ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin. have uncontrolled high blood pressure have pheochromocytoma (a type of tumour of the adrenal gland) have thyrotoxicosis (an overactive thyroid gland) have flushing or other symptoms caused by a carcinoid tumour are taking or have taken in the last two weeks any medicine that is a monoamine oxidase inhibitor (e.g. moclobemide, phenelzine or tranylcypromine to treat depression or selegiline to treat Parkinson's disease) are taking any medicine that is an SSRI or serotonin re-uptake inh সম্পূর্ণ নথি পড়ুন
Version: pfdzyvoa10923 Supersedes: pfdzyvoa10422 Page 1 of 26 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Zyvox ® 600 mg Film coated tablets (Tablets) Zyvox ® 20 mg/mL Granules for oral suspension (Granules) Zyvox ® 2 mg/mL Solution for infusion (Injection) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TABLETS Each Zyvox 600 mg tablet contains 600 mg linezolid. GRANULES Following reconstitution with 123 mL of water, each mL contains 20 mg of linezolid. INJECTION Each 1 mL of Zyvox injection contains 2 mg of linezolid. The 300 mL infusion bag contains 600 mg of linezolid. The 200 mL infusion bag contains 400 mg linezolid. The 100 mL infusion bag contains 200 mg of linezolid. EXCIPIENTS WITH KNOWN EFFECT _Granules_ Each mL also contains 7 mg aspartame, 100 mg mannitol, 210.6 mg sucrose, 1.7 mg sodium as well as 2.4 mg fructose, 7.2 mg sorbitol (E420), ethanol (alcohol), less than 20 mg available in sweeteners and flavouring. _Injection_ Each mL injection contains 45.6 mg glucose and less than 0.5 mg sodium. For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM TABLETS Off-white coated tablet with “ZYV” debossed on one side and “600” debossed on the other. GRANULES White to yellow-orange granules and may contain white to yellow-orange-brown lumps. The constituted suspension is white to yellow-orange and orange flavoured. INJECTION Isotonic, clear, colourless to yellow solution with pH range of 4.4-5.2. Version: pfdzyvoa10923 Supersedes: pfdzyvoa10422 Page 2 of 26 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zyvox is indicated for the treatment of infections when known or suspected to be caused by susceptible organisms including those associated with concurrent bacteraemia such as: Pneumonia - community-acquired and nosocomial pneumonia Skin and soft tissue infections Enterococcal infections. Linezolid is active against Gram-positive bacteria only. Linezolid has no clinical activity against Gram-negative pathogens. Specific Gram-negative therapy is required if a concomitant G সম্পূর্ণ নথি পড়ুন