Amantadine sulphate (INNM)

Guidance on Safe Use

First-aid measures

If inhaled: If dust is inhaled, remove from contaminated area. Encourage patient to blow nose to ensure clear passage of breathing. If irritation or discomfort persists seek medical attention. If conscious, give water to drink.

In case of skin contact: immediately flush with plenty of water for at least 15 minutes. Remove contaminated clothes and shoes. Seek medical attention in event of irritation.

In case of eye contact: Immediately flush eyes with plenty of water for at least 15 minutes, occasionally lifting the upper and lower eyelids. Ensure complete irrigation of the eye by keeping eyelids apart and away from eye and moving the eyelids by occasionally lifting the upper and lower lids. If pain persists or recurs seek medical attention. Removal of contact lenses after an eye injury should only be undertaken by skilled personnel. Get medical aid immediately.

If swallowed: If swallowed, refer for medical attention, where possible, without delay. Rinse mouth with water. Never give anything by mouth to an unconscious person. Do NOT induce vomiting. If conscious and alert, rinse mouth and drink 2-4 cupfuls of milk or water. Where Medical attention is not immediately available or where the patient is more than 15 minutes from a hospital.

4.2. Most important symptoms and effects, both acute and delayed –

Amantadine and its salts have been associated with central nervous system side effects, likely due to amantadine's dopaminergic and adrenergic activity, and to a lesser extent, its activity as an anticholinergic. Common side-effects include ankle oedema, nervous excitement, confusion, difficulty in concentration, dizziness, light-headedness, orthostatic hypotension, urinary retention, slurred speech, ataxia, depression, insomnia, lethargy, nausea, anorexia, vomiting, dry mouth, constipation, skin rash, discoloured spots or skin patches (livedo reticularis) and visual disturbances. More serious side-effects may include congestive heart-failure, psychosis and leucopenia. Dose-related responses include hallucination, feelings of detachment and convulsions. Cardiac dysfunction includes arrhythmia, tachycardia and hypertension. Suicide attempts, some of which have been fatal, have been reported in patients treated with amantadine many of whom received short courses for influenza treatment or prophylaxis. Suicide attempts and suicidal ideation have been reported in patients with and without prior history of psychiatric illness.

Direct contact with the eye may cause transient discomfort characterized by tearing or conjunctival redness (as with windburn). Slight abrasive damage may also result. Change in motor activity.

Chronic: Long-term exposure to respiratory irritants may result in disease of the airways involving difficult breathing and related systemic problems. May cause reproductive and fetal effects. Ample evidence from experiments exists that there is a suspicion this material directly reduces fertility. Results in experiments suggest that amantadine may cause disorders in the development of the embryo or fetus, even when no signs of poisoning show in the mother. Limited evidence suggests that repeated or long-term occupational exposure may produce cumulative health effects involving organs or biochemical systems.

Fire-fighting measures

Extinguishing media:

Suitable extinguishing media: Use water spray, dry chemical powder, carbon dioxide or alcohol-resistant foam.

Unsuitable extinguishing media:       

None

Special hazards arising from the substance or mixture:Emits toxic fumes under fire conditions: carbon monoxide (CO), carbon dioxide (CO2), nitrogen oxides (NOx), sulphuric oxides and other pyrolysis products typical of burning organic material. May emit corrosive fumes.

Advice for firefighters: Wear breathing apparatus plus protective gloves. Use water delivered as a fine spray to control fire and cool adjacent area. DO NOT approach containers suspected to be hot. Cool fire exposed containers with water spray from a protected location. If safe to do so, remove containers from path of fire. Equipment should be thoroughly decontaminated after use.

Accidental release measures

Personal precautions, protective equipment and emergency procedures

Use personal protective equipment: wear self - contained breathing apparatus, rubber boots and heavy rubber gloves. Avoid dust formation. Avoid breathing dust. Ensure adequate ventilation.

For non-emergency personnel

Use personal protective equipment. Avoid dust formation. Avoid breathing dust. Ensure adequate ventilation.

For emergency responders

Wear self - contained breathing apparatus and protective clothing to prevent contact with skin and eyes.

Environmental precautions - do not let product enter drains, sewage system, reach ground water or water bodies.

Methods and material for containment and cleaning up

MINOR SPILLS: Remove all ignition sources. Clean up all spills immediately. Avoid contact with skin and eyes. Control personal contact by using protective equipment. Use dry clean up procedures and avoid generating dust. Place in a suitable, labeled container for waste disposal.

MAJOR SPILLS: Advise personnel in area. Alert Emergency Responders and tell them location and nature of hazard. Control personal contact by wearing protective clothing. Prevent, by any means available, spillage from entering drains or water courses. Recover product wherever possible.

Use dry clean up procedures and avoid generating dust. Collect residues and place in sealed plastic bags or other containers for disposal. Wash area down with large amounts of water. If contamination of drains or waterways occurs, advise emergency services.

Handling and storage

Precautions for safe handling

Avoid all personal contact, including inhalation. Wear protective clothing when risk of exposure occurs. Use in a well-ventilated area. Prevent concentration in hollows and sumps. DO NOT enter confined spaces until atmosphere has been checked. DO NOT allow material to contact humans, exposed food. Avoid contact with incompatible materials such as oxidizing agents, moisture. Always wash hands with soap and water after handling. Launder contaminated clothing before re-use. Use good occupational work practice.

Conditions for safe storage, including any incompatibilities

Store in a cool, dry place, well-ventilated area away from incompatible substances. Keep container tightly closed when not in use. Check all containers are clearly labeled. Store in original containers (better in polyethylene or polypropylene container). Keep containers securely sealed. Protect containers against physical damage and check regularly for leaks. Keep away from sources of ignition. Avoid excessive heat and light.

Transport information

Land transport (UN RTDG/ADR/RID)

UN number:

Not dangerous goods

Shipping

Labels:

Not dangerous goods

SpecialProvisions

Inland waterway transport (UN RTDG/ADN(R))

UN number:

Not dangerous goods

Shipping

Labels:

Not dangerous goods

Remarks

Marine transport (UN RTDG/IMDG)

UN number:

Not dangerous goods

Shipping information

Proper shipping name and description:

Not dangerous goods

Chemical name:

Not dangerous goods

Labels:

Not dangerous goods

Remarks

Air transport (UN RTDG/ICAO/IATA)

UN number:

Not dangerous goods

Shipping information

Proper shipping name and description:

Not dangerous goods

Chemical name:

Not dangerous goods

Labels:

Not dangerous goods

Remarks

SpecialProvisions

Exposure controls / personal protection

Appropriate engineering controls - Local exhaust ventilation is required where solids are handled as powders or crystals. Exhaust ventilation should be designed to prevent accumulation and recirculation of particulates in the workplace.

Individual protection measures, such as personal protective equipment

Eye / face protection - For laboratory, larger scale or bulk handling or where regular exposure in an occupational setting occurs: chemical goggles.

Full face shield may be required for supplementary but never for primary protection of eyes.

Contact lenses may pose a special hazard; soft contact lenses may absorb and concentrate irritants. This should include a review of lens absorption and adsorption for the class of chemicals in use and an account of injury experience.

Skin and body protection - Choose body protection according to the amount and concentration of the dangerous substance at the work place.

Hand protection - The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 and US F739. Suitability and durability of glove type is dependent on usage. Important factors in the selection of gloves include such as: frequency and duration of contact, chemical resistance of glove material, glove thickness and dexterity. When prolonged or frequently repeated contact may occur, a glove with a protection class of 5 or higher (breakthrough time greater than 240 minutes according to EN 374) is recommended.

Other - barrier cream, skin cleansing cream, eye wash unit.

Respiratory protection - where risk assessment shows air-purifying respirators are appropriate use a dust mask type N95 (US) or type P1 (EN 143) respirator. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Respirators may be necessary when engineering and administrative controls do not adequately prevent exposures. The decision to use respiratory protection should be based on professional judgment that takes into account toxicity information, exposure measurement data, and frequency and likelihood of the worker's exposure - ensure users are not subject to high thermal loads which may result in heat stress or distress due to personal protective equipment (powered, positive flow, full face apparatus may be an option). Certified respirators will be useful for protecting workers from inhalation of particulates when properly selected and fit tested as part of a complete respiratory protection program. Use approved positive flow mask if significant quantities of dust becomes airborne.

Thermal hazards – none.

Appropriate engineering controls - Local exhaust ventilation is required where solids are handled as powders or crystals. Exhaust ventilation should be designed to prevent accumulation and recirculation of particulates in the workplace.

Individual protection measures, such as personal protective equipment

Eye / face protection - For laboratory, larger scale or bulk handling or where regular exposure in an occupational setting occurs: chemical goggles.

Full face shield may be required for supplementary but never for primary protection of eyes.

Contact lenses may pose a special hazard; soft contact lenses may absorb and concentrate irritants. This should include a review of lens absorption and adsorption for the class of chemicals in use and an account of injury experience.

Skin and body protection - Choose body protection according to the amount and concentration of the dangerous substance at the work place.

Hand protection - The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 and US F739. Suitability and durability of glove type is dependent on usage. Important factors in the selection of gloves include such as: frequency and duration of contact, chemical resistance of glove material, glove thickness and dexterity. When prolonged or frequently repeated contact may occur, a glove with a protection class of 5 or higher (breakthrough time greater than 240 minutes according to EN 374) is recommended.

Other - barrier cream, skin cleansing cream, eye wash unit.

Respiratory protection - where risk assessment shows air-purifying respirators are appropriate use a dust mask type N95 (US) or type P1 (EN 143) respirator. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Respirators may be necessary when engineering and administrative controls do not adequately prevent exposures. The decision to use respiratory protection should be based on professional judgment that takes into account toxicity information, exposure measurement data, and frequency and likelihood of the worker's exposure - ensure users are not subject to high thermal loads which may result in heat stress or distress due to personal protective equipment (powered, positive flow, full face apparatus may be an option). Certified respirators will be useful for protecting workers from inhalation of particulates when properly selected and fit tested as part of a complete respiratory protection program. Use approved positive flow mask if significant quantities of dust becomes airborne.

Thermal hazards – none.

Stability and reactivity

Reactivity - No dangerous reactions known.

Chemical stability - Stable under recommended storage conditions.  

Possibility of hazardous reactions - Avoid contamination with oxidizing agents i.e. nitrates, oxidizing acids, chlorine bleaches, pool chlorine etc.

Conditions to avoid - sources of ignition, moisture, light.

Incompatible materials - strong oxidizing agents.

Hazardous decomposition products - hazardous decomposition products formed under fire conditions - carbon monoxide (CO), carbon dioxide (CO2), nitrogen oxides (NOx), sulphuric oxides and other pyrolysis products typical of burning organic material.

Disposal considerations

Waste treatment methods - Contact a licensed professional waste disposal service to dispose of this material. All waste must be handled in accordance with local, state and federal regulations. Legislation addressing waste disposal requirements may differ by country, state and/or territory. Each user must refer to laws operating in their area. Note that properties of a material may change in use, and recycling or reuse may not always be appropriate. Recycle wherever possible. Consult Waste Management Authority for disposal if no suitable treatment or disposal facility can be identified. Dispose in Incineration in a licensed apparatus (after admixture with suitable combustible material). Decontaminate empty containers.