Noxafil 300mg16.7ml concentrate for solution for infusion vials

国: イギリス

言語: 英語

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

有効成分:

Posaconazole

から入手可能:

Merck Sharp & Dohme Ltd

ATCコード:

J02AC04

INN（国際名）:

Posaconazole

投薬量:

18mg/1ml

医薬品形態:

Solution for infusion

投与経路:

Intravenous

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: ; GTIN: 5013945301212

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
NOXAFIL® 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION
posaconazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 use Noxafil
3.
How to use 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”. Noxafil is used to prevent and treat many different
fungal infections.
Noxafil 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

製品の特徴

OBJECT 1
NOXAFIL 300 MG CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 26-May-2017 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
Noxafil® 300 mg concentrate for solution for infusion
2. Qualitative and quantitative composition
Each vial contains 300 mg of posaconazole.
Each mL contains 18 mg of posaconazole.
Excipient with known effect:
Each vial contains 462 mg (20 mmol) sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion.
Clear, colourless to yellow liquid.
4. Clinical particulars
4.1 Therapeutic indications
Noxafil concentrate for solution for infusion 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.
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 concentrate for solution for infusion 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) recipients who are
undergoing high-dose
immunosuppressive therapy fo