August 2014 August 2014
Safety Related Changes
It is recommended that Kytril (granisetron) film coated tablets are not taken by patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
In the use of Ventolin sugar free syrup and injection (salbutamol sulphate), nonintravenous formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion.
The use of Avapro (irbesartan) with an ACE inhibitor is now contraindicated in patients with diabetic nephropathy.
Elonva (corifollitropin alfa (rch)) is now contraindicated in polycystic ovarian syndrome.
Teveten Plus (eprosartan mesylate and hydrochlorothiazide) is now contraindicated in severe hepatic impairment, cholestasis and biliary obstructive disorders, therapy resistant hypokalaemia or hypercalcaemia, refractory hyponatraemia and in symptomatic hyperuricaemia/ gout.
Ventolin obstetric injection (salbutamol) is now also contraindicated in the following conditions: at a gestational age less than 24 weeks; intrauterine foetal death, known lethal congenital or lethal chromosomal malformation; any condition of the mother or foetus in which prolongation of the pregnancy is hazardous (e.g. maternal cardiac disease, uncontrolled hypertension, severe pre-eclampsia, active uterine bleeding, premature rupture of the membranes with associated chorioamnionitis, compression of the umbilical cord, foetal acidosis (pH 7.2) or hypoxia (PaO2 18 mm Hg), foetal distress); in patients with pulmonary hypertension, pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease; bronchial asthma; diabetes; uncompensated potassium depletion, hypercalcaemia; maternal hyperthyroidism; ileus; unconsciousness; renal insufficiency; glaucoma and paroxysmal tachycardia.
Zumenon (oestradiol hemihydrate) is now contraindicated in untreated endometrial hyperplasia and known thrombophilic disorders (e.g. protein C, protein S or anti-thrombin deficiency).