Covispharma.com

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 : info@covispharma.com
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.

Source: http://www.covispharma.com/pdfs/zinacef-msds.pdf