Prescription medicine

Apomorphine PharmSwed 5 mg/ml solution for infusion is available by prescription. 1 ml of Apomorphine PharmSwed contains 5 mg apomorphine hydrochloride hemihydrate. Each vial of 20 ml contains 100 mg apomorphine hydrochloride hemihydrate.

Therapeutic indications: Treatment of motor oscillations (“on-off” phenomena) in patients with Parkinson's disease where oral antiparkinsonian medicinal products do not provide adequate control.

Contraindications: hypersensitivity to the active substance or to excipients, sodium chloride, sodium metabisulfite (E223) and hydrochloric acid, respiratory depression, dementia, psychotic diseases, hepatic insufficiency. Treatment with apomorphine hydrochloride should not be used in patients who develop severe dyskinesia or dystonia in response to levodopa therapy.

Side effects: Very common are: hallucinations, reactions at the injection site (subcutaneous nodules, calluses, erythema, tenderness and panniculitis), also other local reactions such as irritation, itching, bruising and pain. Common side effects include: transient sedation with each dose, somnolence, dizziness/restlessness and yawning. Less common are: hemolytic anemia, thrombocytopenia, postural hypotension, difficulty breathing, local/general skin rashes, necrosis and ulceration at the injection site, during “on” periods dyskinesia can be severe and thus may lead to treatment having to be postponed. Rare side effects are: eosinophilia, as well as allergic reactions due to the content of sodium metabisulfite. Side effects with no known frequency are: disturbed impulse control, aggression, agitation, peripheral edema, and syncope.

For further information see the summary of product characteristics or www.fass.se.

Marketing Authorisation Holder: Evolan Pharma AB, Box 120, 182 12 Danderyd. www.evolan.se

Summary of Product Characteristics Review Date:2023-09-20

Reimbursement Status: F (All packaging subsidised)

Prescription Status: Prescription

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Invicorp is an injectable drug available by prescription. Invicorp 25 micrograms/2 mg:1 dose (ampoule 0.35 ml) contains 25 micrograms of aviptadil (vasoactive intestinal polypeptide) and 2 mg of phentolamine mesilate. Invicorp is available in packs of 5 and 2 ampoules.

Therapeutic indications: symptomatic treatment of erectile dysfunction with neurogenic or vascular, psychogenic or mixed etiology in adult men.

Contraindications: Hypersensitivity to the active substances or to any of the excipients. Men for whom sexual activity is not appropriate or is contraindicated due to organic disease. Men with any of the following conditions should not be treated with Invicorp: Conditions that may predispose to priapism, such as sickle cell anemia or predisposition to sickle cell anemia, multiple myeloma or leukemia, anatomical deformation of the penis such as angulation, cavernous fibrosis or Peyronie's disease, and penile implants.

Side effects: Common side effects include flushing and bruising. Uncommon side effects include dizziness, headache, palpitations, tachycardia and haematoma. Rare side effects include priapism, penile nodules/fibrosis (after multiple injections) and post-injection pain. Very rare side effects are myocardial infarction and angina pectoris.

For further information see the summary of product characteristics or www.fass.se.

‍Marketing Authorisation Holder: Marketing authorisation holder: Evolan Pharma AB, Box 120, 182 12 Danderyd. www.evolan.se

Summary of Product Characteristics Review DateSummary of Product Characteristics review date: 2023-08-02

Reimbursement Status: F (All packaging subsidised)

Prescription Status: Prescription Available

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Adenosine Life Medical: Solution for injection/infusion 5 mg/m, clear and colourless solution. Packaging: 10x2 milliliter ampoule, 10x10 milliliter vial,10x50 milliliter vial. Therapeutic indications: Cessation of paroxysmal supraventricular tachycardia involving the AV node. Provision of short-term AV block for detection and localization of accessory conduction pathway with preexcitation. Pharmacological provocation of ischemia of the heart associated with myocardial scintigraphy (thallium or technetium) in patients who cannot perform adequate labor tests or for whom labor tests are inappropriate. It can also be used in echocardiography, in cases where other pharmacological methods of provocation cannot be used.

Contraindications: Hypersensitivity to adenosine or mannitol, adverse reactions to previous treatment with adenosine, AV block grade II or III, as well as sick sinus syndrome in patients without a functioning pacemaker, severe hypotension, unstable angina pectoris, non-compensated heart failure. Only for infusions - elevated intracranial pressure, hypovolemia, concomitant therapy with dipyridamole. Interactions: Adenosine interacts with dipyridamole, caffeine and theophylline.

Side effects (intravenous injection): Possible side effects are mild and rapidly transient (usually within 30 seconds). About 50% of patients experience no symptomatic effects. Most common: dizziness, headache, nausea, dyspnea, flush, chest pain, paresthesias, as well as reflector tachycardia. Uncommon: sweating, palpitations, hypotension, pressure in the groin, metallic taste, hyperventilation, anxiety and blurred vision. Rare: pronounced hypotension and arrhythmias including ventricular fibrillation, ventricular extrasystole, atrial fibrillation, and worsening of bronchial asthma. Adverse reactions (intravenous infusion): Infusion produces a higher frequency of side effects. However, most are mild and quickly transient (within a couple of minutes). To reduce the frequency of side effects, the infusion can be combined with light physical work. Most common: chest, head and jaw pain, dizziness, flush, AV block I-II, ST lowering, nausea, epigastric pain and dyspnea. Uncommon: palpitations, hypotension, AV block III and hyperventilation. Rare: pronounced hypotension and arrhythmias including ventricular fibrillation, ventricular extrasystole and atrial fibrillation, and bronchospasm.

For further information see the summary of product characteristics or www.fass.se.

Marketing Authorisation Holder: Evolan Pharma AB, Box 120, 182 12 Danderyd. www.evolan.se

Summary of Product Characteristics Review Date: 08-09-2023

Reimbursement Status: EF (All packages are non-subsidised)

Prescription Status: Prescription

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Melatonin Evolan 1 mg/ml is a clear, slightly yellow to yellow strawberry flavoured oral solution containing the active substance melatonin. Each package contains 200 ml of the drug. The drug is available by prescription and is subsidized for the indication insomnia in children and adolescents 6 through 17 years of age with ADHD where sleep hygiene measures have been inadequate.

Therapeutic indications: Short-term treatment of jet lag in adults and insomnia in children and adolescents 6-17 years of age with ADHD where sleep hygiene measures have been inadequate.

Contraindications: Hypersensitivity to the active substance or to any of the excipients listed in section Contents.

Side effects: Common: Headwork and somnolence. Uncommon: Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety, migraine, lethargy, psychomotor hyperactivity, dizziness, abdominal pain, upper abdominal pain, dyspepsia, mouth ulcers, dry mouth, nausea, hypertension, dermatitis, night sweats, itching, rash, dry skin, hyperbilirubinemia, glycosuria, proteinuria, pain in the extremities, asthenia, chest pain, menopausal disorders, abnormal liver function tests and weight gain. Rare are: Herpes zoster, leukopenia, thrombocytopenia, hypertriglyceridemia, hypocalcemia, hyponatremia, altered mood, aggressiveness, agitation, tearfulness, disorientation, early awakening in the morning, increased libido, depressed mood, depression, syncope, memory impairment, attention deficit, restless legs syndrome, poor sleep quality, paresthesia, impaired visual acuity, blurred vision, increased lacrimation, dizziness, dizziness, angina pectoris, palpitations, flushing, gastroesophageal reflux disease, gastrointestinal disease, blisters in the oral mucosa, ulcers on the tongue, anxious gastrointestinal tract, vomiting, abnormal bowel sounds, flatulence, hypersalivation, halitosis, abdominal discomfort, stomach upset, gastritis, eczema, erythema, hand eczema, psoriasis, general rash, itchy rash, nail disorder, joint inflammation, muscle cramps, neck pain, nocturnal cramps, polyuria, hematuria, nocturia, nocturia, nocturia, priapism, prostatitis, fatigue, pain, thirst, elevated liver enzymes, abnormal blood electrolytes, as well as abnormal laboratory values. No known frequency: Galactorrhea, angioedema, swelling of the tongue, swelling of the mouth, hyperglycaemia and hypersensitivity reaction.

For further information see the summary of product characteristics or www.fass.se.

Marketing Authorisation Holder: Evolan Pharma AB, Box 120, 182 12 Danderyd. www.evolan.se

Summary of Product Characteristics Review Date: 24/06/2025

Reimbursement Status: (F) Subsidized only for insomnia in children and adolescents 6 to 17 years of age with ADHD where sleep hygiene measures have been inadequate.

Prescription Status: Prescription

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