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Baclofen 10 Mg/5 Ml Solution For Infusion

Baclofen 10 mg/5 ml solution for infusion


Baclofen

The following information is intended for medical or healthcare professionals only: tfow is Baclofen prepared and administered?

The screening, implantation and dose titration phases of the intrathecal treatment are to be carried out in hospital with very careful monitoring by appropriately qualified specialist doctors and in centres with specific experience. In view of possible life-threatening events or severe adverse reactions appropriate resuscitative equipment should be on stand-by. (see also section 3 “Howto Use Baclofen”).

Baclofen is intended for administration in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, in implantable pumps suitable for continuous administration of intrathecal baclofen into the intrathecal space (EU certified pumps). Establishment of the optimum dose schedule requires that each patient undergoes an initial screening phase with intrathecal bolus, followed by a very careful individual dose titration prior to maintenance therapy. Intrathecal administration of baclofen through an implanted delivery system should only be undertaken by physicians with the necessary knowledge and experience. Specific instructions for implantation, programming and/or refilling of the implantable pump are given by the pump manufacturers, and must be strictly adhered to.

This is necessary because of the great variability between patients in the therapeutic dose that is effective. During long-term treatment baclofen can be delivered continuously into the cerebral spinal fluid using an implantable pump and Baclofen 10 mg/20 ml or Baclofen 10 mg/5 ml.

Evidence demonstrating the efficacy of Baclofen was obtained in clinical trials using the SynchroMed Infusion System. This is an implantable drug delivery system with refillable reservoirs, which is implanted in a subcutaneous pocket usually on the abdominal wall. The device is connected to an intrathecal catheter that passes subcutaneously to the subarachnoid space. Reliable experience with other implantable pump systems is so far not available.

Before using Baclofen in patients with posttraumatic spasticity the subarachnoid space should be investigated using myelography. If this reveals signs of an arachnoiditis, treatment with Baclofen must not be initiated.

Before using Baclofen each solution should be tested to make sure it is clear and colourless; if particulate matter of discolorations are present, the solution must not be used and should be discarded.

Each ampoule is for single use only. The solution it contains is stable, isotonic, pyrogen and antioxidant free and has a pH-value of 5.0-7.0.

Baclofen 10 mg/20 ml, solution for Infusion Baclofen 10 mg/5 ml, solution for Infusion

Implantation phase/Dose titration phases (under hospital conditions)

After confirmation that Baclofen has been effective in the screening phase, intrathecal infusion is established using the above-mentioned implantable infusion pump. The onset of the antispastic effect of baclofen is 6-8 hours after continuous infusion is initiated and the maximum effect is achieved within 24^18 hours.

The initial total daily dose of Baclofen is calculated as follows: if efficacy of the test dose is maintained for more than 12 hours this is administered as the initial daily dose. If the efficacy of the test dose is maintained for less than 12 hours the dose should be doubled and given as the initial daily dose. No dose increase should be administered in the first 24 hours.

After the first day of treatment the dose can be adjusted slowly on a daily basis to achieve the desired clinical effect. In patients with spasticity of spinal origin the daily dosage increment should not exceed 10-30 % of the last dose and in patients with spasticity of cerebral origin this should be limited to 5—15 %. With programmable pumps, the dose should be increased only once every 24 hours. For nonprogrammable pumps with a 76 cm catheter delivering 1 ml_ solution per day, intervals of 48 hours are suggested for evaluation of response to the dose increment. If the daily dose has been significantly increased and no clinical effect is achieved, check for proper pump function and catheter patency.

In general in patients with spasticity of spinal origin the dose can be increased to a maintenance dose of 300-800 jug/day, patients with spasticity of cerebral origin usually require lower doses (see below).


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Very common:

affects more than 1 user in 10

Common:

affects 1 to 10 users in 100

Uncommon:

affects 1 to 10 users in 1,000

Rare:

affects 1 to 10 users in 10,000

Very rare:

affects less than 1 user in 10,000

Not known:

frequency cannot be estimated from the available data


Metabolism and nutrition disorders

Common:

Decreased appetite.

Uncommon:

Dehydration.

Psychiatric disorders

Common:

Depression, Confusional state, Disorientation, Agitataion, Anxiety.

Uncommon:

Suicidal thoughts and attempt, Paranoia, Hallucinations, Disturbed mood.

Nervous system disorders

Very common:

Drowsiness

Common:

Respiratory depression, Convulsion, Lethargy, Slurred quiet speech, Headache, Numbness with tingling of the buttocks and feet, Sleeplessness, Sedation, Dizziness.

Convulsion and headache occur more frequently in patients with cerebral spasticity.

Uncommon:

Ataxia, Hypothermia, Dysphagia, Loss of memory / forgetfulness, Nystagmus.

Eye disorders

Common:

Accommodation disorders with vision blurred or double vision.

Cardiac disorders

Uncommon:

Bradycardia.

Vascular disorders

Common:

Orthostatic hypotension.

Uncommon:

Deep vein thrombosis, Hypertension, Reddening of the skin, Pallor.

Respiratory, thoracic and mediastinal disorders

Common:

Aspiration pneumonia, Dyspnoea, Bradypnoea.

Gastrointestinal disorders

Common:

Vomiting, Constipation, Diarrhoea/bowl incontinence, Nausea, Dry mouth, Increased salivation.

Nausea and vomiting occur more frequently in patients with cerebral spasticity.

Uncommon:

Ileus, Reduced taste perception.

Skin and subcutaneous tissue disorders

Common:

Urticaria, Pruritus.

Uncommon:

Alopecia, Excessive sweating.

Musculoskeletal and connective tissue disorders

Very common:

Hypotonia.

Common:

Hypertonia, Muscular weakness.

Renal and urinary disorders

Common:

Urinary retention, Urinary incontinence.

Urinary retention occurs more frequently in patients with cerebral spasticity.

Reproductive system and breast disorders

Common:

Sexual dysfunction.

General disorders and administration site conditions

Common:

Oedema peripheral, Face oedema, Pain, Fever, Shivering.


-    difficulty in breathing (respiratory depression), respiratory arrest (apnoea)

-    convulsions

-    clouding or loss of consciousness (coma)

-    abnormal low body temperature

If you have any signs of an overdose of Baclofen, tell your doctor straight away.

If you stop using Baclofen

If this medicine must be stopped, this may only be done by your doctor who will reduce the dose gradually to avoid side effects. Suddenly stopping Baclofen can cause withdrawal symptoms which in some cases have proven fatal.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Baclofen can cause side effects, although not everybody gets them. These occur more often at the start of treatment during your hospital stay, but they may also occur later. Many of these side effects are also known to be associated with the specific medical condition for which you are being treated.

_ The following categories are used as the frequency convention for side effects:

For a description of the signs of withdrawal, see “If treatment with Baclofen is interrupted".

For a description of the signs of overdose, see “If you receive more Baclofen than you should".

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE BACLOFEN

Keep out of the reach and sight of children.

Do not use Baclofen after the expiry date which is stated on the ampoule and the folding box. The expiry date refers to the last day of that month.

Storage conditions

This medicinal product does not require any special storage conditions.

The product should be used immediately after opening the ampoule and dilution (in the pump).

Chemical and physical in-use stability has been demonstrated for 2 months at 37°C.

The solution must be clear and colourless. If particulate matter or discoloration are present the solution must not be used and should be discarded.

Any unrequired fraction must be destroyed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION What Baclofen contains

The active substance is: baclofen.

Baclofen 10 mg/5 ml solution for infusion:

1 ml solution for infusion contains 2.0 mg baclofen.

1 ampoule with 5 ml solution for infusion contains 10 mg baclofen.

- The other ingredients are: sodium chloride and water for injections.

What Baclofen looks like and contents of the pack

Solution for infusion.

Baclofen is a clear, colourless solution in a clear, colourless ampoule.

Baclofen 10 mg/5 ml, solution for infusion is available in packs containing 1 and 5 ampoules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceuticals Industries Europe B.V.

Polarisavenue 87 2132 JH Hoofddorp The Netherlands

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany:    Baclofen    10 mg/ 5 ml Infusionslosung

Spain:    Baclofen    10 mg/ 5 ml Solucion para perfusion

France:    Baclofene    SUN 10 mg/ 5 ml Solution pour perfusion

IT:    Baclofene    SUN 10 mg/ 5 ml Soluzione per infusione

UK:    Baclofen 10 mg/ 5 ml Solution for Infusion

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This leaflet was last approved in 03/2011.

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