NYSTATIN READY MIX

Valsts: Izraēla

Valoda: angļu

Klimata pārmaiņas: Ministry of Health

Aktīvā sastāvdaļa:

NYSTATIN

Pieejams no:

TARO PHARMACEUTICAL INDUSTRIES LTD

ATĶ kods:

A07AA02

Zāļu forma:

SUSPENSION

Kompozīcija:

NYSTATIN 100000 IU/ML

Ievadīšanas:

PER OS

Receptes veids:

Required

Ražojis:

TARO PHARMACEUTICAL INDUSTRIES LTD

Ārstniecības grupa:

NYSTATIN

Ārstniecības joma:

NYSTATIN

Ārstēšanas norādes:

For the treatment of oral fungal infections.

Autorizācija datums:

2021-10-31

Lietošanas instrukcija

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PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed with a doctor’s prescription only
NYSTATIN READY MIX
SUSPENSION
ACTIVE INGREDIENT
Each ml of suspension contains 100,000 units nystatin.
Inactive ingredients and allergens: see section 2 under ‘Important
information about some of
this medicine’s ingredients’, and section 6 ‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions, consult
your
doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
For the treatment of oral fungal infections.
THERAPEUTIC GROUP: anti-fungal.
2. BEFORE USING THIS MEDICINE:
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to nystatin or to any of the other
ingredients in this
medicine (see section 6).
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
•
BEFORE USING NYSTATIN READY MIX, TELL YOUR DOCTOR IF:
You suffer from a fungal infection in the lungs or on the skin
(systemic mycoses) - Do
not use Nystatin Ready Mix in this case.
DRUG INTERACTIONS
IF YOU ARE TAKING OR HAVE RECENTLY TAKEN OTHER MEDICINES, INCLUDING
NON-PRESCRIPTION
MEDICATIONS AND DIETARY SUPPLEMENTS, TELL YOUR DOCTOR OR PHARMACIST.
PREGNANCY, BREASTFEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to become
pregnant, consult your doctor or pharmacist before taking this
medicine.
Pregnancy and fertility
It is not known whether Nystatin Ready Mix can cause harm to your
unborn baby when
taken by a pregnant woman or if Nystatin Ready Mix affect your ability
to conceive, however
absorption of Nystatin Ready Mix from the digestive system is small.
Breastfeeding
It is not known whether Nystatin Ready Mix excreted in breas

Produkta apraksts

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NYSTATIN READY MIX
ORAL SUSPENSION
Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
Nystatin Ready Mix
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Nystatin Ready Mix containing 100,000 units nystatin per ml.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral suspension
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of oral fungal infections.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Neonates (from birth to 1 month):
Clinical studies of limited size in neonates, including preterm and
babies of low weight at
birth, indicate that 1 ml (100,000 U) four times daily is an effective
regimen.
Infants (1 month to 5 years):
2 ml (200,000 U) 4 times daily (1 ml for each side of the mouth).
Children (over 5 years) and adults:
4 – 6 ml (400,000 – 600,000 U) 4 times daily (half dose in each
side of the mouth). It is
recommended to keep the medication in contact with the affected areas
as long as possible.
Older people:
No specific dosage recommendations or precautions.
A dropper filled up to the cap contains 1 ml of suspension.
The preparation should be retained in the mouth as long as possible
before swallowing. The
longer the suspension is kept in contact with the affected area in the
mouth, before
swallowing, the greater will be its effect.
In the prevention and treatment of candidiasis, the dosage regimen for
Nystatin should be
continued for at least 48 hours after symptoms have disappeared. If
signs and symptoms
worsen or persist (beyond 14 days of treatment), the patient should be
reevaluated, and
alternate therapy considered.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Nystatin Ready Mix contains less than 1 mmol sodium (23 mg) per dose,
that is to say
essentially ‘sodium-free’.
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Nystatin Ready Mix contains sorbitol and sucrose. Patients with rare
hereditary problems of
fructose intolerance, glucose-galact