Vancomycin 1g powder for concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Vancomycin hydrochloride

Available from:

Bowmed Ibisqus Ltd

ATC code:

J01XA01

INN (International Name):

Vancomycin hydrochloride

Dosage:

1gram

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Gastroenteral; Intravenous; Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010700; GTIN: 5060130131338

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
vancomycin. Please tell your doctor.
If you suffer from renal (kidney) impairment or
receive treatment simultaneously wi

Summary of Product characteristics

OBJECT 1
VANCOMYCIN 1G POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION VIALS
Summary of Product Characteristics Updated 12-Dec-2017 | Bowmed
Ibisqus Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Vancomycin 1000 mg, 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 solu