Sulfasalazine 250mg/5ml oral suspension sugar free

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Sulfasalazine

Saadav alates:

Rosemont Pharmaceuticals Ltd

ATC kood:

A07EC01

INN (Rahvusvaheline Nimetus):

Sulfasalazine

Annus:

50mg/1ml

Ravimvorm:

Oral suspension

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 01050100; GTIN: 5016119220593

Infovoldik

SUGAR FREE
Each 5ml contains 250mg Sulfasalazine.
The product also includes sodium
benzoate (E211) and ethanol.
See leaflet for further information.
ADMINISTRATION: For oral use.
Shake the bottle well before use.
Read the package leaflet before use.
STORAGE: Do not store above 25°C.
Discard 1 month after first opening.
Keep out of the sight and reach of children.
Manufactured by the MA Holder:
ROSEMONT PHARMACEUTICALS LTD.,
LEEDS LS11 9XE, UK.
PL 00427/0196 L1472
Each 5ml contains 250mg Sulfasalazine.
The product also includes sodium
benzoate (E211) and ethanol.
See leaflet for further information.
ADMINISTRATION: For oral use.
Shake the bottle well before use.
Read the package leaflet before use.
STORAGE: Do not store above 25°C.
Discard 1 month after first opening.
Keep out of the sight and reach of children.
Manufactured by the MA Holder:
ROSEMONT PHARMACEUTICALS LTD.,
LEEDS LS11 9XE, UK.
PL 00427/0196
SULFASALAZINE 250MG/5ML ORAL SUSPENSION
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 your pharmacist.
●
This medicine has been prescribed only for you. 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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Sulfasalazine Suspension is and what it is used for
2. What you need to know before you take Sulfasalazine Suspension
3. How to take Sulfasalazine Suspension
4. Possible side effects
5. How to store Sulfasalazine Suspension
6. Contents of the pack and other information
1. WHAT SULFASALAZINE SUSPENSION IS AND WHAT IT IS USED FOR
The active ingredient in Sulfasalazine Suspension is sulfasalazine
which is an anti-inflammatory drug
and belongs to a group of medicines called aminosalicylates.
Your

Toote omadused

OBJECT 1
SULFASALAZINE 250MG/5ML ORAL SUSPENSION
Summary of Product Characteristics Updated 23-Sep-2014 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Sulfasalazine 250mg/5ml Oral Suspension
2. Qualitative and quantitative composition
Sulfasalazine 250mg/5ml
3. Pharmaceutical form
Oral Suspension
4. Clinical particulars
4.1 Therapeutic indications
Induction and maintenance of remission of ulcerative colitis and
treatment of active Crohn's disease.
4.2 Posology and method of administration
The dose is adjusted according to the severity of the disease and the
patient's tolerance of the drug, as
detailed below.
A) Ulcerative Colitis
Adults and the Elderly
_Severe attacks_: 20 to 40 ml four times a day may be given in
conjunction with steroids as part of an
intensive management regime. Rapid passage of the suspension may
reduce the effect of the drug.
The night time interval between doses should not exceed 8 hours.
_Moderate attacks_: 20 ml four times a day may be taken with or
without steroids.
_Maintenance therapy_: With induction of remission, reduce the dose
gradually to 40 ml per day. This
dosage should be continued indefinitely, since discontinuance even
several years after an acute attack is
associated with a four-fold increase in relapse.
Children
The dose is reduced in proportion to body weight.
_Acute attack or relapse_: 0.8 - 1.2 ml/kg/day.
_Maintenance dosage_: 0.4 - 0.6 ml/kg/day.
B) Crohn's Disease
In active Crohn's Disease, sulfasalazine should be administered as in
attacks of ulcerative colitis (see
above).
4.3 Contraindications
Sulfasalazine is contraindicated in:
• Infants under the age of two years.
• Patients with a known hypersensitivity to sulfasalazine, its
metabolites or any of the excipients as well
as sulfonamides, salicylates or the sodium benzoate preservative.
• Patients with porphyria.
4.4 Special warnings and precautions for use
Complete blood counts, including differential white cell count and
liver function tests, should be
performed before starting sulfasal