Vancomycin 1g powder for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Vancomycin hydrochloride

Available from:

Sandoz Ltd

ATC code:

J01XA01

INN (International Name):

Vancomycin hydrochloride

Dosage:

1gram

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010700

Summary of Product characteristics

VANCOMYCIN, 1000 MG, POWDER FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 19-May-2015 | Sandoz
Limited
1. Name of the medicinal product
Vancomycin, 1000 mg, powder for solution for infusion
2. Qualitative and quantitative composition
Each vial contains 1000 mg vancomycin (hydrochloride) equivalent to
1,000,000 IU.
3. Pharmaceutical form
Powder for solution for infusion.
White or almost white powder.
After reconstitution a solution is obtained with a pH of approximately
3.
4. Clinical particulars
4.1 Therapeutic indications
Vancomycin solution, used intravenously is indicated in the therapy of
severe, potentially life-threatening
infections due to susceptible gram-positive microorganisms which
cannot be treated with or failed to
respond to other effective, less toxic antimicrobial medicinal
products, such as penicillins and
cephalosporins.
Vancomycin should be reserved for those cases where there is a
specific indication, to minimize the
chance of resistance emerging.
Vancomycin is useful in the treatment of the following severe
infections caused by susceptible
microorganisms (see section 5.1):
- endocarditis,
- infections of bones (osteomyelitis),
- pneumonia,
- soft-tissue infections.
Endocarditis caused by enterococci, _Streptococcus viridans_ or _S.
bovis_ should be treated with a
combination of vancomycin and an aminoglycoside.
Vancomycin may be used for the perioperative prophylaxis against
bacterial endocarditis, in patients at
high risk of developing bacterial endocarditis when they undergo major
surgical procedures (e.g., cardiac
and vascular procedures, etc) and are unable to receive a suitable
beta-lactam antibacterial agent.
_CONSIDERATION SHOULD BE GIVEN TO OFFICIAL GUIDANCE ON THE APPROPRIATE
USE OF ANTIBACTERIAL AGENTS._
4.2 Posology and method of administration
_Vancomycin powder for solution for infusion must be administered
intravenously. Each dose should be _
_administered at a rate not exceeding 10 mg/min or over a period of
time of at least 60 minutes (whichever_
_is lon