Zinacef (Cefuroxime for Injection) SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1. Product identifier Product name.
: ZINACEF 750 MG * ZINACEF 1.5G * ZINACEF 7.5G * CEFUROXIME SODIUM,
1.2. Relevant identified uses of the substance or mixture and uses advised against Use of the substance/preparation
1.3. Details of the supplier of the safety data sheet Covis Pharma S.à.r.l.
CH General Information: Office : 0041 (0) 41 748 04 04 / Fax : 0041 (0) 41 748 04 09
Note : Zug Area code is 041. In Switzerland this area code must be used before the 7 digit tel. number Medical Emergency : see U.S. information below Information and Advice: US number, available 24 hours Multi-language response
1.4. Emergency telephone number Covis Pharmaceuticals, Inc 1513 Walnut Street Suite 270 Cary, NC 27511 P : 919-535-3049 / Fax : 866-869-9215 e : [email protected] Transport Emergency: For Chemical Emergency, Spill, Leak, Fire, Exposure, or Accident Call CHEMTREC Day or Night Within USA and Canada: 1-800-424-9300 Outside USA and Canada: +1 703-527-3887 (col ect cal s accepted) Medical Emergency +1-866-488-4423 US number, available 24 hours Multi-language response SECTION 2: Hazards identification
2.1. Classification of the substance or mixture GHS-US classification Skin Sens. 1B H317 Zinacef (Cefuroxime for Injection)
2.2. Label elements GHS-US label ing Hazard pictograms (GHS-US)
: H317 - May cause an allergic skin reaction
: P261 - Avoid breathing dust/fume/gas/mist/vapours/spray
P271 - Use only outdoors or in a well-ventilated area
P272 - Contaminated work clothing should not be al owed out of the
P280 - Wear protective gloves/protective clothing/eye protection/face
P302+P352 - IF ON SKIN: Wash with plenty of water/…
P304+P340 - IF INHALED: Remove person to fresh air and keep comfortable
P312 - Call a POISON CENTER/doctor/…/if you feel unwell
P321 - Specific treatment (see . on this label)
P333+P313 - If skin irritation or rash occurs: Get medical advice/attention
P362+P364 - Take off contaminated clothing and wash it before reuse
P403+P233 - Store in a well-ventilated place. Keep container tightly closed
P501 - Dispose of contents/container to .
2.3. Other hazards No additional information available SECTION 3: Composition/information on ingredients
3.1. Substances Not applicable
3.2. Mixtures Product identifier GHS-US classification SECTION 4: First aid measures
4.1. Description of first aid measures First-aid measures after inhalation
: Using appropriate personal protective equipment, move exposed subject to
fresh air. If breathing is difficult or ceases, ensure and maintain ventilation.
Give oxygen as appropriate. The exposed subject should be kept warm and
at rest. Obtain medical attention in cases of known or possible over
exposure, or with symptoms including chest pain, difficulty breathing, loss of
consciousness or other adverse effects, which may be delayed.
Zinacef (Cefuroxime for Injection)
First-aid measures after skin contact : Using appropriate personal protective equipment, remove contaminated
clothing and flush exposed area with large amounts of water. Obtain
medical attention if skin reaction occurs, which may be immediate or
: Wash immediately with clean and gently flowing water. Continue for at least
: Never attempt to induce vomiting. Do not attempt to give any solid or liquid
by mouth if the exposed subject is unconscious or semi-conscious. Wash out
the mouth with water. If the exposed subject is ful y conscious, give plenty
of water to drink. Obtain medical attention.
4.2. Most important symptoms and effects, both acute and delayed No additional information available
4.3. Indication of any immediate medical attention and special treatment needed Treat according to locally accepted protocols. For additional guidance, refer to the current prescribing information or
to the local poison control information centre. Medical treatment in cases of overexposure should be treated as an
overdose of a cephalosporin antibiotic. In allergic individuals, exposure to this material may require treatment for
initial or delayed allergic symptoms and signs. This may include immediate and/or delayed treatment of anaphylactic
reactions. SECTION 5: Firefighting measures
5.1. Extinguishing media Suitable extinguishing media
: Use extinguishing media appropriate for surrounding fire.
5.2. Special hazards arising from the substance or mixture Fire hazard
5.3. Advice for firefighters Protection during firefighting
: Do not enter fire area without proper protective equipment, including
SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures General measures 6.1.1. For non-emergency personnel No additional information available 6.1.2. For emergency responders No additional information available
6.2. Environmental precautions None.
6.3. Methods and material for containment and cleaning up For containment
: Recover the product by vacuuming, shovel ing or sweeping.
6.4. Reference to other sections No additional information available Zinacef (Cefuroxime for Injection) SECTION 7: Handling and storage
7.1. Precautions for safe handling Precautions for safe handling
: No special control measures required for the normal handling of this
product. Normal room ventilation is expected to be adequate for routine
7.2. Conditions for safe storage, including any incompatibilities Storage conditions
: No storage requirements necessary for occupational hazards. Follow
product information storage instructions to maintain efficacy.
7.3. Specific end use(s) No additional information available SECTION 8: Exposure controls/personal protection
8.1. Control parameters No additional information available
8.2. Exposure controls Appropriate engineering controls
: Local exhaust and general ventilation must be adequate to meet exposure
: In case of dust production: protective goggles.
: Wear NIOSH approved respirator when handling.
SECTION 9: Physical and chemical properties
9.1. Information on basic physical and chemical properties Physical state Zinacef (Cefuroxime for Injection)
9.2. Other information No additional information available SECTION 10: Stability and reactivity
10.1. Reactivity No additional information available
10.2. Chemical stability No additional information available
10.3. Possibility of hazardous reactions No additional information available
10.4. Conditions to avoid No additional information available
10.5. Incompatible materials No additional information available
10.6. Hazardous decomposition products No additional information available SECTION 11: Toxicological information
11.1. Information on toxicological effects
Acute toxicity Zinacef (Cefuroxime for Injection) Sodium [6R-[6.alpha.,7.beta.(Z)]]-3-[[(aminocarbonyl)oxy]methyl]-7-[2-furyl(methoxyimino)acetamido]-8-oxo-5- thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate (56238-63-2) LD50 oral rat SECTION 12: Ecological information
12.1. Toxicity Ecology - water
This material contains an active pharmaceutical ingredient that is not toxic
IC50: > 87.6 mg/l, 3 Hours, Activated sludge
This material contains an active pharmaceutical ingredient that is toxic to
> 0.88 mg/l, , Pseudomonas aeruginosa
This material contains an active pharmaceutical ingredient that is not toxic
IC50: > 91 mg/l, 72 Hours, Selenastrum capricornutum, green algae, Static
This material contains an active pharmaceutical ingredient that is not toxic
EC50: > 876 mg/l, 48 Hours, Daphnia magna, Static test
NOEC: > 876 mg/l, 48 Hours, Daphnia magna, Static test
This material contains an active pharmaceutical ingredient that is not toxic
Juvenile Oncorhyncus mykiss, rainbow trout
Zinacef (Cefuroxime for Injection)
EC50: > 105 mg/l, 96 Hours, Static test
12.2. Persistence and degradability No additional information available
12.3. Bioaccumulative potential No additional information available
12.4. Mobility in soil No additional information available
12.5. Other adverse effects No additional information available SECTION 13: Disposal considerations
13.1. Waste treatment methods Waste disposal recommendations
: Dispose of contents/container in accordance with
local/regional/national/international regulations.
SECTION 14: Transport information
In accordance with DOT / ADR / RID / ADNR / IMDG / ICAO / IATA 14.1. UN number Not a dangerous good in sense of transport regulations. 14.2. UN proper shipping name Not applicable SECTION 15: Regulatory information
15.1. US Federal regulations No additional information available
15.2. US State regulations No additional information available SECTION 16: Other information This information is based on our current knowledge and is intended to describe the product for the purposes of health, safety and environmental requirements only. It should not therefore be construed as guaranteeing any specific property of the product.
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