Levofloxacin 500mg/100ml solution for infusion vials

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Levofloxacin hemihydrate

متاح من:

Bowmed Ibisqus Ltd

ATC رمز:

J01MA12

INN (الاسم الدولي):

Levofloxacin hemihydrate

جرعة:

5mg/1ml

الشكل الصيدلاني:

Solution for infusion

طريقة التعاطي:

Intravenous

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 05011200; GTIN: 5060130131048

نشرة المعلومات

WHAT IS IN THIS LEAFLET:
1. What Levofloxacin solution for infusion is and
what it is used for
2. What you need to know before you are given
Levofloxacin solution for infusion
3. How Levofloxacin solution for infusion is given
4. Possible side effects
5. How to store Levofloxacin solution for infusion
6. Contents of the pack and other information
1. WHAT LEVOFLOXACIN SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR
The name of your medicine is Levofloxacin solution
for infusion. Levofloxacin solution for infusion
contains a medicine called levofloxacin. This
belongs to a group of medicines called antibiotics.
Levofloxacin is a ’quinolone’ antibiotic. It works by
killing the bacteria that cause infections in your body.
LEVOFLOXACIN SOLUTION FOR INFUSION CAN BE USED TO
TREAT INFECTIONS OF THE:
• Lungs, in people with pneumonia
•
Urinary tract, including your kidneys or bladder
• Prostate gland, where you have a long lasting
infection
• Skin and underneath the skin, including
muscles. This is sometimes called ‘soft tissue’.
In some special situations, Levofloxacin solution for
infusion may be used to lessen the chances of
getting a pulmonary disease named ‘anthrax’ or
worsening of the disease after you are exposed to
the bacteria causing anthrax.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LEVOFLOXACIN SOLUTION FOR INFUSION
DO NOT HAVE THIS MEDICINE AND TELL YOUR DOCTOR IF:
• you are allergic to levofloxacin, any other
quinolone antibiotic such as moxifloxacin,
ciprofloxacin or ofloxacin or any of the other
ingredients of this medicine (listed in section 6).
Signs of an allergic reaction include a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
• you have ever had epilepsy
• you have ever had problems with your
tendons such as tendonitis that was related to
treatment with a ‘quinolone antibiotic’.
A tendon is the cord that joins your muscle to
your skeleton
• you are a child or a growing teenager
• you are pregnant might become pregnant, or
th

خصائص المنتج

OBJECT 1
LEVOFLOXACIN 500MG/100ML SOLUTION FOR INFUSION
VIALS (5MG/ML IN 100ML VIALS)
Summary of Product Characteristics Updated 21-Dec-2017 | Bowmed
Ibisqus Limited
1. Name of the medicinal product
Levofloxacin Ibigen 5 mg/ml solution for infusion
2. Qualitative and quantitative composition
Each 50 ml vial (5 mg/ml solution) contains 250 mg of levofloxacin as
levofloxacin hemihydrate.
Each 100 ml vial (5 mg/ml solution) contains 500 mg of levofloxacin as
levofloxacin hemihydrate.
Excipients with known effect:
50 ml of solution for infusion contain 7.7 mmol (177 mg) sodium.
100 ml of solution for infusion contain 15.4 mmol (354 mg) sodium.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for infusion
Clear greenish-yellow isotonic solution
4. Clinical particulars
4.1 Therapeutic indications
Levofloxacin Ibigen solution for infusion is indicated in adults for
the treatment of the following
infections (see sections 4.4 and 5.1):
• Community-acquired pneumonia
• Complicated skin and soft tissue infections
For the above-mentioned infections Levofloxacin Ibigen should be used
only when it is considered
inappropriate to use antibacterial agents that are commonly
recommended for the initial treatment of these
infections.
• Pyelonephritis and complicated urinary tract infections (see
section 4.4)
• Chronic bacterial prostatitis
• Inhalation Anthrax: post exposure prophylaxis and curative
treatment (see section 4.4)
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
Posology
The dosage depends on the type and severity of the infection and the
susceptibility of the presumed
causative pathogen. Treatment with Levofloxacin Ibigen after initial
use of the intravenous preparation
may be completed with an appropriate oral presentation according to
the SPC of an appropriate oral
presentation and as considered appropriate for the individual patient.
. Given the bioequivalence of the
parenteral and or