Cefuroxime 250mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

即購入

ダウンロード 製品の特徴 (SPC)
07-07-2016
ダウンロード 公開評価報告書 (PAR)
30-11--0001

有効成分:

Cefuroxime axetil

から入手可能:

DE Pharmaceuticals

ATCコード:

J01DC02

INN(国際名):

Cefuroxime axetil

投薬量:

250mg

医薬品形態:

Oral tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 05010201

情報リーフレット

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
ZINNAT
® 250 MG TABLETS
(CEFUROXIME AXETIL)
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 side effects, talk to your doctor or pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet.
See section 4.
•
The name of this medicine is Zinnat
®
250 mg Tablets but will be
referred to as Zinnat throughout the remainder of this leaflet.
•
Zinnat
®
250 mg Tablets are also available in other strengths.
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 axetil 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
ca
                                
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製品の特徴

                                OBJECT 1
CEFUROXIME 250MG TABLETS
Summary of Product Characteristics Updated 02-Aug-2016 | Sandoz
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
Cefuroxime 250 mg Tablets
2. Qualitative and quantitative composition
Cefuroxime 250 mg coated tablets contain 300.72 mg cefuroxime axetil
which is equivalent to 250 mg
cefuroxime per tablet.
Excipients with known effect:
1 tablet contains 0.3 mg aspartame (E951)
For the full list of excipients: see section 6.1.
3. Pharmaceutical form
Coated tablets
White to slightly yellowish, biconvex, oblong tablets scored on both
sides.
The tablet can be divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Cefuroxime axetil 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.
- Cy
                                
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