Zinnat 125 mg/5 ml granules for oral suspension

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Cefuroxime axetil

Доступна з:

GlaxoSmithKline (Ireland) Limited

Код атс:

J01DC; J01DC02

ІПН (Міжнародна Ім'я):

Cefuroxime axetil

Дозування:

125 mg/5ml

Фармацевтична форма:

Granules for oral suspension

Тип рецепту:

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

Терапевтична области:

Second-generation cephalosporins; cefuroxime

Статус Авторизація:

Marketed

Дата Авторизація:

1991-01-16

інформаційний буклет

62000000047864
cefuroxime
ZINNAT 125 MG/5 ML GRANULES FOR ORAL SUSPENSION
ZINNAT 250 MG/5 ML GRANULES FOR ORAL SUSPENSION
cefuroxime
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your
doctor or pharmacist or nurse.
-
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor
or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Zinnat is and what it is used for
2.
What you need to know before you take Zinnat
3.
How to take Zinnat
4.
Possible side effects
5.
How to store Zinnat
6.
Contents of the pack and other information
1. WHAT ZINNAT IS AND WHAT IT IS USED FOR
Zinnat is an antibiotic used in adults and children. It
works by killing bacteria that cause infections. It
belongs to a group of medicines called _cephalosporins_.
Zinnat is used to treat infections of:
•
the throat
•
sinus
•
middle ear
•
the lungs or chest
•
the urinary tract
•
the skin and soft tissues.
Zinnat can also be used:
•
to treat Lyme disease (an infection spread by
parasites called ticks).
Your doctor may test the type of bacteria causing
your infection and monitor whether the bacteria are
sensitive to Zinnat during your treatment.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZINNAT
DO NOT TAKE ZINNAT:
•
IF YOU ARE ALLERGIC to cefuroxime or ANY
CEPHALOSPORIN ANTIBIOTICS, or any of the other
ingredients of Zinnat (listed in section 6).
•
if you have ever had a severe allergic
(hypersensitive) reaction to any other type of
betalactam antibiotic (penicillins, monobactams
and carbapenems).

If you think this applies to you, DON’T TAKE ZINNAT
until you have checked with your doctor.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmac

Характеристики продукта

Health Products Regulatory Authority
29 October 2019
CRN009F9L
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zinnat 125 mg/5 ml granules for oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
125 mg cefuroxime per 5 ml (as 150 mg cefuroxime axetil)
Excipient(s) with known effect:
Contains 0.021 g aspartame (E951) per 5 ml dose
Contains 3.1 g of sucrose per 5 ml dose
Contains 6 mg of propylene glycol (E1520) per 5 ml dose
Contains 4.5 mg benzyl alcohol (E1519) per 5 ml dose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zinnat is indicated for the treatment of the infections listed below
in adults and children from the age of 3 months (see
sections 4.4 and 5.1).
• Acute streptococcal tonsillitis and pharyngitis.
• Acute bacterial sinusitis.
• Acute otitis media.
• Acute exacerbations of chronic bronchitis.
• Cystitis.
• Pyelonephritis.
• Uncomplicated skin and soft tissue infections.
• Treatment of early Lyme disease.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual course of therapy is seven days (may range from five to ten
days).
_Table 1. Adults and children (≥40 kg)_
INDICATION
DOSAGE
Acute tonsillitis and pharyngitis, acute bacterial sinusitis
250 mg twice daily
Acute otitis media
500 mg twice daily
Acute exacerbations of chronic bronchitis
500 mg twice daily
Cystitis
250 mg twice daily
Pyelonephritis
250 mg twice daily
Uncomplicated skin and soft tissue infections
250 mg twice daily
Health Products Regulatory Authority
29 October 2019
CRN009F9L
Page 2 of 11
Lyme disease
500 mg twice daily for 14 days (range of 10 to 21 days)
_Table 2. Children (<40 kg)_
INDICATION
DOSAGE
Acute tonsillitis and pharyngitis, acute bacterial
sinusitis
10 mg/kg twice daily to a maximum of 125 mg twice daily
Children aged two years or older with otitis media