VANCOMYCIN 1000 Milligram Pdr/Conc/Soln for Infus

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VANCOMYCIN HYDROCHLORIDE

Available from:

Quimedical - Produtos Farmaceuticos, Lda.

ATC code:

J01XA01

INN (International Name):

VANCOMYCIN HYDROCHLORIDE

Dosage:

1000 Milligram

Pharmaceutical form:

Pdr/Conc/Soln for Infus

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Glycopeptide antibacterials

Authorization status:

Authorised

Authorization date:

2016-04-29

Patient Information leaflet

  1. WHAT VANCOMYCIN IS AND WHAT IT IS USED FOR
Vancomycin is an antibiotic which helps your 
body fight infections by eliminating certain 
bacteria that cause infections. Vancomycin is 
used for the treatment of the following serious 
infections:
Infections of the bones, lung infections, skin and 
muscle (soft tissue) infection and infection of the 
valves or lining of the heart.
Vancomycin can also be used before some types 
of surgery to prevent possible infections of the 
lining of the heart.
Vancomycin may also be administered orally in 
the treatment of:
•  inflammation of the lining of the small and 
  large intestine with damage to the mucosa 
  (pseudomembranous colitis) caused by a 
  certain type of bacteria (Clostridium difficile), as 
  a result of treatment with antibiotics; 
•  inflammation of the lining of the small and 
  large intestine (enterocolitis) as a result of a 
  certain type of bacteria (Staphylococci).
  2. WHAT YOU NEED TO KNOW BEFORE YOU USE
    VANCOMYCIN
DO NOT USE VANCOMYCIN
•  If you are allergic (hypersensitive) to 
  vancomycin or any other ingredients of this 
  medicine (listed in Section 6).
Tell your doctor if you have had some problems 
with this product or with others in the past.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before 
using Vancomycin.
Before treatment with vancomycin, make sure 
your doctor knows your medical history, 
especially:
•  If you have kidney problems
•  If you have difficulty hearing
•  If you are over 65 years old
The rapid injection of Vancomycin can cause low 
blood pressure, shock, and rarely, cardiac arrest. 
Stopping the infusion usually results in immediate 
cessation of these reactions.
Injection site pain, inflammation of the vein wall 
and blood coagulation may occasionally occur in 
severe form; slow administration can also reduce 
these side effects.
If you are allergic to another antibiotic called 
teicoplanin, you may also be allergic to

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vancomycin 1000mg powder for concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Vancomycin 1000 mg powder for concentrate for solution for infusion
Each vial contains 1000 mg of vancomycin (as vancomycin hydrochloride), equivalent to not less than 1,050,000 IU.
One ml of reconstituted solution contains 50 mg of vancomycin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Homogeneous solid, white to slightly brown.
After reconstitution a solution is obtained with a pH between 2.5 – 4.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vancomycin is indicated in adults, infants, children aged one month to 12 years and adolescents over 12 years.
Vancomycin solution, administered 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 or are resistant to
other antibiotics 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 the bones (osteomyelitis),
Pneumonia,
Soft tissue infections.
Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the
infections listed above.
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 prophyl