PHENOXYMETHYLPENICILLIN-AFT phenoxymethylpenicillin (as potassium salt) 250mg/5ml powder for oral liquid bottle

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

phenoxymethylpenicillin potassium, Quantity: 56.568 mg/mL (Equivalent: phenoxymethylpenicillin, Qty 50 mg/mL)

Dostopno od:

AFT Pharmaceuticals Pty Ltd

INN (mednarodno ime):

Phenoxymethylpenicillin potassium

Farmacevtska oblika:

Oral Liquid, powder for

Sestava:

Excipient Ingredients: sucrose; sodium benzoate; saccharin sodium; Flavour; Colour

Pot uporabe:

Oral

Enote v paketu:

100 mL after reconstitution as directed

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

When oral therapy is required in the treatment of mild to moderately severe infections due to penicillin sensitive organisms such as penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci. Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. For prophylactic use in recurrent streptococcal infections including the prevention of recurrence following rheumatic fever and/or Sydenham's chorea. For the prevention of bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation. Oral penicillin should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy or complications of childbirth.

Povzetek izdelek:

Visual Identification: Pale orange dry granular powder. Reconstituted solution is a clear orange solution with orange odour and flavour; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Licence status A

Datum dovoljenje:

2010-12-21

Navodilo za uporabo

PHENOXYMETHYLPENICILLIN-AFT
Powder for Oral Liquid BP, Phenoxymethylpenicillin potassium
equivalent to
Phenoxymethylpenicillin 125 mg/5 mL and 250 mg/5 mL
WHAT IS IN THIS LEAFLET
This leaflet contains some common questions about
Phenoxymethylpenicillin-
AFT. It does not contain all the available information. It does not
take the
place of talking with your doctor or pharmacist.
KEEP THIS LEAFLET WITH YOUR MEDICINE. YOU MAY NEED TO REFER TO IT
AGAIN.
WHAT THE MEDICINE IS USED FOR
Phenoxymethylpenicillin-AFT is an antibiotic that belongs to the group
of
medicines called penicillins. It is used to treat infections in
different parts of
the body caused by bacteria. It works by killing the bacteria that are
causing
the infection. It will not work against viruses such as colds or the
flu.
Your doctor may have prescribed Phenoxymethylpenicillin-AFT for
another
reason. Ask your doctor or pharmacist if you have any questions about
why
phenoxymethylpenicillin has been prescribed for you.
BEFORE YOU TAKE THIS MEDICINE
_WHEN YOU MUST NOT TAKE IT _
You must not take Phenoxymethylpenicillin-AFT if:
•
You have had an allergic reaction to any penicillin
•
You have had an allergic reaction to a cephalosporin
•
You have an allergy to any of the ingredients listed at the end of
this
leaflet
Do not take if the packaging shows signs of tampering.
Do not take if the expiry date printed on the pack has passed.
If you are uncertain whether you should take
Phenoxymethylpenicillin-AFT,
talk to your doctor first.
_BEFORE YOU START TO TAKE THE MEDICINE _
Tell your doctor if:
•
You have any allergies to any medicines, foods, preservatives, colours
•
You have or have had any other health problems/medical conditions
including asthma and kidney problems.
•
You are pregnant, intend to become pregnant or are breastfeeding
•
You are taking any other medicines including any that you get without
a
prescription from a pharmacy, supermarket or health food shop.
HOW TO USE THE MEDICINE
Take the dose prescribed by your doctor. It may vary d

Lastnosti izdelka

1
AUSTRALIAN PRODUCT INFORMATION –
PHENOXYMETHYLPENICILLIN-AFT (PHENOXYMETHYLPENICILLIN (AS
POTASSIUM)) POWDER FOR ORAL LIQUID
1.
NAME OF THE MEDICINE
Phenoxymethylpenicillin potassium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted, each bottle of Phenoxymethylpenicillin-AFT
contains phenoxymethylpenicillin
(as potassium) 125 mg per 5 mL, or 250 mg per 5 mL.
Excipients with known effect: benzoates, sugars and saccharin
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for oral liquid.
Phenoxymethylpenicillin-AFT, powder for oral liquid is a pale orange
granular powder which when
reconstituted with purified water forms Phenoxymethylpenicillin-AFT
oral solution which is a clear
orange coloured solution with an orange odour and flavour which
contains phenoxymethylpenicillin
potassium equivalent to phenoxymethylpenicillin 125 mg/5 mL or 250
mg/5 mL respectively.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
When oral therapy is required in the treatment of mild to moderately
severe infections due to
penicillin sensitive organisms such as penicillin sensitive
staphylococci, pneumococci, gonococci and
haemolytic streptococci. Therapy should be guided by bacteriological
studies, including sensitivity
tests, and by clinical response. For prophylactic use in recurrent
streptococcal infections including the
prevention of recurrence following rheumatic fever and/or Sydenham’s
chorea.
For the prevention of bacterial endocarditis in patients with
rheumatic fever and/or congenital heart
disease who are about to undergo dental or upper respiratory surgery
or instrumentation.
Oral penicillin should not be used as adjunctive prophylaxis for
genitourinary instrumentation or
surgery, lower intestinal tract surgery, sigmoidoscopy or
complications of childbirth.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dilution Instructions
125 mg/5 mL: Add 63 mL of purified water and shake well.
250 mg/5 mL: Add 60 mL of purified water and shake well.
2
_Adults_
_ _
250-500 mg e