SPC Adverse Drug Reaction Reporting Form

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1. Patient Details:* This field is required.
Name
Please Select
Please Select
Male
Female
Gender
Age
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Are you Pregnant ?* This field is required.
YES
NO
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2. Adverse Drug Reaction* This field is required.What happened?
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Seriousness of the Adverse Drug Reaction?* This field is required.
Non-serious
Serious
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Type Seriousness of the Adverse Drug Reaction?* This field is required.
Patient died
Life threatening
Admitted to hospital or prolong hospitalization
Congenital anomaly
Other
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3. Suspected Medication:
Please Select
Please Select
Abiraterone SPC 250mg F.C. Tablets
Apixaban 2.5mg F.C. Tablets
Apixaban 5mg F.C. Tablets
Azacitidine SPC 100mg Injection
Bortezomib SPC 3.5 mg
Cabazitaxel SPC 60 mg Concentrate and Solvent For Solution For Infusion
Capecitabine SPC 150 mg
Capecitabine SPC 500 mg
Capidair SPC 150mg
Capidair SPC 500mg
Carfilzomib SPC 60 mg Injection
Colistimethate SPC powder for solution for injection or infusion
Dasatinib SPC 100mg film-coated tablets
Dasatinib SPC 140mg film-coated tablets
Dasatinib SPC 20mg film-coated tablets
Dasatinib SPC 50mg film-coated tablets
Dasatinib SPC 70mg film-coated tablets
Dasatinib SPC 80mg film-coated tablets
Dimethyl Fumarate SPC Delayed Release Capsules 120mg (10 caps)
Dimethyl Fumarate SPC Delayed Release Capsules 120mg (30 caps)
Dimethyl Fumarate SPC Delayed Release Capsules 240mg (10 caps)
Dimethyl Fumarate SPC Delayed Release Capsules 240mg (30 caps)
Docetaxel SPC 20mg/1ml
Docetaxel SPC 80mg/4ml
Erlotinib SPC 100mg
Erlotinib SPC 150mg
Fingolimod SPC 0.5 mg Capsule
FONDAPARINUX SPC 2.5MG/0.5ML INJECTION
Fosaprepitant SPC 150mg Injection
Fulvestrant SPC 50mg/ml
Imadair SPC 100mg
Imadair SPC 400mg
Imatinib SPC 100 mg
Imatinib SPC 400 mg
Lacosamide SPC 100mg Tablets
Lacosamide SPC 150mg Tablets
Lacosamide SPC 200mg Tablets
Lacosamide SPC 50mg Tablets
Lenadair SPC 10mg
Lenadair SPC 25mg
Lenadair SPC 5mg
Lenalidomide SPC 10 mg
Lenalidomide SPC 15 mg Capsules
Lenalidomide SPC 2.5 mg Capsules
Lenalidomide SPC 20 mg Capsules
Lenalidomide SPC 25 mg
Lenalidomide SPC 5 mg
Methotrexate SPC 2.5mg Tablets
NOSCO (Momentasone Furoate Monohydrate) 5Ƞg
Pemetrexed SPC 500mg
Pomalidomide SPC 1mg capsules (Blister) & (Bottle)
Pomalidomide SPC 2mg capsules (Blister) & (Bottle)
Pomalidomide SPC 3mg capsules (Blister) & (Bottle)
Pomalidomide SPC 4mg capsules (Blister) & (Bottle)
Pulmirema 0.25 mg/2ml
Pulmirema 0.50 mg/2ml
Pulmirema 1 mg/2ml
Rivaroxaban SPC 10mg F.C. Tablets
Rivaroxaban SPC 15 mg F.C. Tablets
Rivaroxaban SPC 20 mg F.C. Tablets
Sevelamer SPC 800 mg tablets
Zoledronic Acid SPC 0.04 mg/ml
Zoledronic Acid SPC 0.05 mg/ml
SPC Medication Name
Dose, Frequency
Route of administration (e.g. Oral, IV or SC)
Indications
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Did medication stop because of side effect?
Please Select
Please Select
Yes
NO
If above is "YES", please specify the date?
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Action Taken for the medication
Drug Withdrawn
Dose Increased
Dose Reduced
Dose not changed
Unknown
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The Patient outcome:
Recovered
No Improvement
Fatal
Unknown
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Event subsided after stopping (dechallenge):
NO
YES
Unknown
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Event reappear after reintroducing (rechallenge):
NO
YES
Not Applicable
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Your Above answer is YES, please specify:
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4. Concomitant Medications and Medical History:Concomitant Medications (any other Medication that the patient is taking) and Medical History (any chronic diseases that the patient has. For example: Diabetes, Hypertension, etc
Concomitant Medications
Medical History
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5. Reporter’s Information:
Name
Please enter your email
Please enter your phone
Hospitals' Name
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Dear Healthcare Professional,

Adverse Drug Reaction (ADR) is a response to a medicinal product which is noxious and unintended. This includes side effects arising from use of a medicine within the terms of the marketing authorization (e.g. the authorized indications), as well as from use outside the terms of the marketing authorization, including overdose, misuse, abuse and medication errors, and suspected adverse reactions associated with occupational exposure.

Confidentiality: Reporter's and patient's identity are held in strict confidence by Sudair Pharma and protected to the fullest extent of the law, information provided by the reporter will be strictly protected and will not be used in any way against him / her.

Please fill out the reporting form providing the most complete information. Use a separate form for each ADR. Attachment of additional documents (e.g. doctor's records, laboratory results, etc.) are highly appreciated as they would support Sudair Pharma assessment of the event. Kindly submit the completed form to:

Pharmacovigilance and Drug Safety Department

Tell phone: 920001432 (ex. 107)

Fax: + (966) 11 466 8195

Email: Pharmacovigilance@SudairPharma.com

Website: www.sudairpharma.com
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