OSPAMOX 250MG5ML GRANULES FOR ORAL SUSPENSION

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Δραστική ουσία:

AMOXYCILLIN TRIHYDRATE

Διαθέσιμο από:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

INN (Διεθνής Όνομα):

AMOXYCILLIN TRIHYDRATE

Μονάδες σε πακέτο:

60 mL; 100 mL

Κατασκευάζεται από:

SANDOZ GMBH

Φύλλο οδηγιών χρήσης

OSPAMOX
® GRANULES FOR ORAL
SUSPENSION
Amoxicillin Trihydrate (250mg/5ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET:
1.
What is Ospamox used for
2.
How Ospamox works
3.
Before you use Ospamox
4.
How to use Ospamox
5.
While you are using Ospamox
6.
Side effects
7.
Storage and disposal of Ospamox
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT IS OSPAMOX USED FOR
Ospamox is used to treat infections
caused by bacteria in different parts
of the body such as:
•
Infections of the ear, throat, nose
and sinuses
•
Chest infections such as
bronchitis and pneumonia
•
Infections affecting urinary and
genital tract
•
Prevention of heart infections
during mouth or throat surgery
•
Gastrointestinal infections
_ _
•
Skin and soft tissues infections
_ _
Your doctor may have prescribed
Ospamox for another reason.
_ _
HOW OSPAMOX WORKS
Ospamox is an antibiotic. It belongs
to a group of antibiotics called
penicillins which is amoxicillin. It is
used to treat infections caused by
bacteria which are sensitive to
amoxicillin.
BEFORE YOU USE OSPAMOX
-
_When you must not use it _
•
If you are allergic
(hypersensitive) to amoxicillin,
penicillins, cephalosporins or to
any of the other ingredients of
this medicine.
_Pregnancy _
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice
before using this medicine.
As a precautionary measure,
amoxicillin should only be used
during pregnancy if in the judgement
of the physician the potential benefits
outweigh the possible hazards.
_ _
_Breast-feeding _
This medicine passes into breast
milk in small quantities, therefore
in some cases it may be necessary
to stop breastfeeding.
-
_Before you start use it _
Talk to your doctor or pharmacist
before taking Ospamox if you have:
•
any allergic conditions
•
fits/ convulsions
•
kidney disease
•
severe and persistent diarrhea
•
an inherited disorder that
increases the

Αρχείο Π.Χ.Π.

1.
NAME OF THE MEDICINAL PRODUCT
Ospamox
®
250 mg/5 mL Granules for Oral Suspension.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL reconstituted oral suspension contains Amoxicillin 250 mg;
Sodium Benzoate 7.1 mg;
Aspartame 8.5 mg.
3.
PHARMACEUTICAL FORM
Powder for oral suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ospamox is useful in the treatment of infections caused by
amoxicillin-susceptible organisms:
•
Acute bacterial sinusitis
•
Acute otitis media
•
Acute streptococcal tonsillitis and pharyngitis
•
Acute exacerbations of chronic bronchitis
•
Community acquired pneumonia
•
Acute cystitis
•
Asymptomatic bacteriuria in pregnancy
•
Acute pyelonephritis
•
Typhoid and paratyphoid fever
•
Dental abscess with spreading cellulitis
•
Prosthetic joint infections
•
_Helicobacter pylori_ eradication
•
Lyme disease
Amoxicillin is also indicated for the prophylaxis of endocarditis.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of amoxicillin that is selected to treat an individual
infection should take into account:
•
The expected pathogens and their likely susceptibility to
antibacterial agents (see section 4.4)
•
The severity and the site of the infection
•
The age, weight and renal function of the patient; as shown below
The duration of therapy should be determined by the type of infection
and the response of the patient, and
should generally be as short as possible. Some infections require
longer periods of treatment (see section
4.4 regarding prolonged therapy).
ADULTS AND CHILDREN ≥40 KG
INDICATION*
DOSE*
Acute bacterial sinusitis
250 mg to 500 mg every 8 hours or
750 mg to 1 g every 12 hours
Asymptomatic bacteriuria in pregnancy
Acute pyelonephritis
For severe infections 750 mg to 1 g every 8 hours
Acute cystitis may be treated with 3 g twice daily
for one day
Dental abscess with spreading cellulitis
Acute cystitis
Acute otitis media
500 mg e