Noxafil 40mgml oral suspension

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Posaconazole

Fáanlegur frá:

Merck Sharp & Dohme Ltd

ATC númer:

J02AC04

INN (Alþjóðlegt nafn):

Posaconazole

Skammtar:

40mg/1ml

Lyfjaform:

Oral suspension

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 05020100; GTIN: 5012376031095

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
NOXAFIL® 40 MG/ML ORAL SUSPENSION
posaconazole
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, 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Noxafil is and what it is used for
2.
What you need to know before you take Noxafil
3.
How to take Noxafil
4.
Possible side effects
5.
How to store Noxafil
6.
Contents of the pack and other information
1.
WHAT NOXAFIL IS AND WHAT IT IS USED FOR
Noxafil contains a medicine called posaconazole. This belongs to a
group of medicines called
“antifungals”. It is used to prevent and treat many different
fungal infections.
This medicine works by killing or stopping the growth of some types of
fungi that can cause
infections.
Noxafil can be used in adults to treat the following types of fungal
infections when other antifungal
medicines have not worked or you have had to stop taking them:

infections caused by fungi of the
_Aspergillus_
family that have not improved during treatment
with the anti-fungal medicines amphotericin B or itraconazole or when
these medicines have
had to be stopped;

infections caused by fungi of the
_Fusarium_
family that have not improved during treatment with
amphotericin B or when amphotericin B has had to be stopped;

infections caused by fungi that cause the conditions known as
“chromoblastomycosis” and
“mycetoma” that have not improved during treatment with
itraconazole or when itraconazole
has had to be stopped;

infections caused by a fungus called
_Coccidioides_
that have not improved during treat

Vara einkenni

OBJECT 1
NOXAFIL 40MG/ML ORAL SUSPENSION
Summary of Product Characteristics Updated 26-May-2017 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
Noxafil® 40 mg/mL oral suspension
2. Qualitative and quantitative composition
Each mL of oral suspension contains 40 mg of posaconazole.
Excipient with known effect:
This medicinal product contains approximately 1.75 g of glucose per 5
mL of suspension.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral suspension
White suspension
4. Clinical particulars
4.1 Therapeutic indications
Noxafil oral suspension is indicated for use in the treatment of the
following fungal infections in adults
(see section 5.1):
- Invasive aspergillosis in patients with disease that is refractory
to amphotericin B or itraconazole or in
patients who are intolerant of these medicinal products;
- Fusariosis in patients with disease that is refractory to
amphotericin B or in patients who are intolerant
of amphotericin B;
- Chromoblastomycosis and mycetoma in patients with disease that is
refractory to itraconazole or in
patients who are intolerant of itraconazole;
- Coccidioidomycosis in patients with disease that is refractory to
amphotericin B, itraconazole or
fluconazole or in patients who are intolerant of these medicinal
products;
- Oropharyngeal candidiasis: as first-line therapy in patients who
have severe disease or are
immunocompromised, in whom response to topical therapy is expected to
be poor.
Refractoriness is defined as progression of infection or failure to
improve after a minimum of 7 days of
prior therapeutic doses of effective antifungal therapy_._
Noxafil oral suspension is also indicated for prophylaxis of invasive
fungal infections in the following
patients:
- Patients receiving remission-induction chemotherapy for acute
myelogenous leukemia (AML) or
myelodysplastic syndromes (MDS) expected to result in prolonged
neutropenia and who are at high risk
of developing invasive fungal infections;
- Hematopoietic stem cell transplant (HSCT) re