Warfarin 1mg/ml oral suspension sugar free

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Warfarin sodium

Disponibil de la:

Rosemont Pharmaceuticals Ltd

Codul ATC:

B01AA03

INN (nume internaţional):

Warfarin sodium

Dozare:

1mg/1ml

Forma farmaceutică:

Oral suspension

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 02080200; GTIN: 5016119208898

Prospect

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JOB SPECIFICATION
MAIN BODY TEXT
Univers Roman
UNIVERS BOLD
1mg/1ml
BLACK
7474
PANTONE
PANTONE
265
CUTTER
BRAILLE
UKL412
405
210 x 300mm
N/A
30 x 150mm
1
7.5pt
(Horizontally
condensed to 90%)
No
150ml
150ml
N/A
J1BD1RBJ2
J1BD1RBJ1
N/A
1 of 2
Warfarin Sodium 1mg/1ml Oral Suspension
27/02/18
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DH
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1
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APPROVALS
THIRD PARTY APPROVAL REQUIRED
Name:
Name:
Signature:
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Date:
Date:
AUTHORITY APPROVAL SUPPLIED
REGULATORY SIGN-OFF
YES
YES
NO
N/A
TICK APPLICABLE BOX
TICK APPLICABLE BOX
4. POSSIBLE SIDE EFFECTS
Like all medicines, warfarin can cause side effects although not
everybody gets them.
STOP TAKING WARFARIN AND SEE A DOCTOR OR GO TO A HOSPITAL STRAIGHT
AWAY IF YOU NOTICE THE FOLLOWING SERIOUS SIDE EFFECT
- YOU MAY NEED URGENT MEDICAL TREATMENT:
n
ALLERGIC REACTION - the signs may include swelling of your face, lips,
tongue or throat, difficulty breathing or swallowing,
severe itching of your skin with raised lumps.
If you get any of the above, stop taking warfarin and see a doctor or
go to a hospital straight away.
TELL YOUR DOCTOR OR GO TO A HOSPITAL STRAIGHT AWAY IF YOU GET ANY OF
THE
FOLLOWING SIDE EFFECTS. Your doctor may decide to stop your warfarin
treatment:
n
Any bleeding at all as this is a sign that your clotting levels are
low:
Examples of bleeding that have been noted with the use of
warfarin are:
-
nose bleeds without any obvious reason
-
loss of consciousness, fits, numbness, headache, dizziness,
feeling or being sick, slurred speech, blurred vision. These could be
signs that there is a
bleed in your brain
-
change in the colour of your urine - a dark red or brown urine might
be due to bleeding in
your kidneys

Caracteristicilor produsului

OBJECT 1
WARFARIN SODIUM 1MG/1ML ORAL SUSPENSION
Summary of Product Characteristics Updated 16-May-2018 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Warfarin Sodium 1mg/1ml Oral Suspension
2. Qualitative and quantitative composition
Each 1ml of suspension contains Warfarin Sodium 1mg.
Excipients with known effect:
Liquid Maltitol
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Oral Suspension
A white to off white suspension.
4. Clinical particulars
4.1 Therapeutic indications
This medicine is indicated in adults for:
• Prophylaxis of systemic embolism in patients with rheumatic heart
disease and atrial fibrillation.
• Prophylaxis after insertion of prosthetic heart valves.
• Prophylaxis of venous thrombosis and pulmonary embolism and for
use in the treatment of these
conditions to prevent their extension.
4.2 Posology and method of administration
Posology:
A baseline coagulation screen and liver function tests should be
performed before initiating warfarin
therapy.
Adults: The typical induction dose is 10 mg daily for 2 days but this
should be tailored to individual
requirements.
The daily maintenance dose is usually 3 to 9 mg taken at the same time
each day. The exact maintenance
dose depends on the prothrombin time, usually reported as the INR
(international normalised ratio), or
other appropriate coagulation tests.
Control tests should be made at regular intervals and the maintenance
dose should be adjusted according
to the results obtained. Once the maintenance dose is established, it
is rarely necessary to alter it (see
Section 4.4 Commencement of Therapy).
In emergencies, anticoagulant therapy should be initiated with heparin
and warfarin together.
Elderly: As for adults, but dosage may need to be lowered. The elderly
are generally more sensitive to the
effects of warfarin and often require a smaller dose.
Paediatric population:
Dosage for children has not been established. Warfarin 1mg/ml Oral
Suspension is not recommended for
use in children.
Method of