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Logo FORTFEN INJECTION AMPOULES

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

FORTFEN INJECTION AMPOULES

COMPOSITION:
Each 3 mL contains:
Diclofenac sodium 75 mg
Preservative: 
Benzyl alcohol 4% m/v
Anti-oxidant: 
Sodium metabisulphite 0,3% m/v
PHARMACOLOGICAL CLASSIFICATION:
A 3.1 Antirheumatics (anti-inflammatory agents)

PHARMACOLOGICAL ACTION:
FORTFEN INJECTION is a non-steroidal compound with antirheumatic, anti-inflammatory, analgesic and antipyretic properties. In vitro its active substance inhibits prostaglandin synthetase and also has an inhibitory effect on platelet aggregation.
Phamacokinetics:
Absorption:
Peak plasma concentrations are attained 10 to 22 minutes after a dose of sodium diclofenac i.m.
Protein binding: 99,7%
The mean terminal elimination half-life of the unchanged medicine is 1 to 2 hours.
Excretion:
Approximately 65% of the dose administered is excreted via the kidneys in the form of metabolites and less than 1% in unchanged form. About 35% of the dose is excreted in metabolised form in the faeces.

INDICATIONS:
FORTFEN INJECTION ampoules are suitable as initial therapy for inflammatory and degenerative rheumatic diseases as well as for the treatment of painful conditions due to inflammation of non-rheumatic origin.

CONTRA-INDICATIONS:
Sensitivity to the active substance. FORTFEN INJECTION is also contra-indicated in asthmatic patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or by other medicines with prostaglandin- synthetase inhibiting activity. Strict accuracy of diagnosis and close medical surveillance are imperative in patients with pre-existing dyshaemopoiesis or disorders of blood coagulation. FORTFEN INJECTION should not be used in patients with porphyria. Pregnancy, lactation and children below the age of 14 years.

WARNINGS:
Administer with caution to patients with hepatic or renal failure. Serious interactions have been reported after the concomitant use of methotrexate and diclofenac.

DOSAGE AND DIRECTIONS FOR USE:
Not intended for intravenous route administration. For adults the dosage is generally 1 FORTFEN INJECTION ampoule daily, injected deep intragluteally into the upper outer quadrant. By way of exception, in severe cases two injections, separated by an interval of a few hours, can be given per day (one into each buttock)
FORTFEN INJECTION ampoules should not be given for more than two days. If necessary the treatment can be continued with oral diclofenac.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Patients may complain of nausea and diarrhoea, headache, tinnitus or dizziness. Peripheral oedema and skin reactions, such as medicine related rash and eczema, have also been encountered. Central nervous system side-effects, such as tiredness, insomnia, nervousness, depression or irritability, have occurred. Blurred vision and other ocular reactions.
Sensitivity reactions (e.g. bronchospasm, anaphylactic/anaphylactoid systemic reactions), elevated transaminase levels, jaundice, hepatitis, renal failure and nephrotic syndrome, may occur.
Dyshemopoiesis (leucopenia, thrombocytopenia, aplastic anaemia) and erythema multiforme have been observed. Agranulocytosis and haemotolytic anaemia have been observed. Abscesses and local necrosis have also occurred particularly in elderly diabetics. The administration of the injection may give rise to local pain.
Precautions:
Patients suffering from impairment of hepatic, cardiac, or renal function should be carefully monitored.
Dosage may have to be reduced in the elderly.
In view of the products inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
During prolonged treatment with diclofenac blood counts and monitoring of hepatic and renal function are indicated as precautionary measures.
Interactions:
When given together with preparations containing lithium or digoxin, FORTFEN INJECTION ampoules may raise their plasma concentrations.
Concurrent treatment with two or more non-steroidal anti-inflammatory agents may promote the occurrence of side-effects.
The concomitant use of FORTFEN INJECTION and acetylsalicylic acid leads to reduced bioavailability of both substances.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions". Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear odourless solution free from foreign particles with a faint benzyl alcohol odour.

PRESENTATION:
5 x 3 mL and 50 x 3 mL colourless glass ampoules.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
27/3.1/0544

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Compu Pharmaceutical Products Ltd.
476 Kings Highway
Suite 115
Lynnwood
0081

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
Aug 93

Britepak

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