Section 4.4:

Sentence updates:
- "Patients should be warned to avoid ingesting water while swimming. and to discontinue DDAVP/Desmopressin Nasal Drops solution during an episode of vomiting and/or diarrhoea until their fluid balance is once again normal. "

- "Treatment with desmopressin should be interrupted or carefully adjusted during acute intercurrent illness characterised by fluid and/or electrolyte imbalance (such as systemic infections, fever, gastroenteritis)."

 

Section 2: text reworded to state "1 ml contains 100 micrograms desmopressin acetate equivalent to 89 microgram desmopressin."

Section 4.2:  text reformatted.

 

New section, 'General' stating:

"The rhinyle tube has a graduated scale corresponding to 2.5 µg, 5 µg, 10 µg, 15 µg and 20 µg desmopressin acetate.

Method of administration: see instruction in sections 6.5 and 6.6.

Fluid restriction should be observed (see indication specific instructions in section 4.4).

In the event of signs or symptoms of water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain, and in severe cases, convulsions) treatment should be interrupted until the patient has fully recovered.  When restarting treatment strict fluid restriction should be enforced (see section 4.4)."

 

New section ‘Special Populations’, see SPC.

 

Section 4.4:

Following sentences added:

 “Treatment without concomitant reduction of fluid intake may lead to water retention and/or hyponatraemia with or without accompanying warning signs and symptoms (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions).”

“Infants, elderly and patients with serum sodium levels in the lower range of normal may have an increased risk of hyponatraemia. “

“Precautions must be taken in patients at risk for increased intracranial pressure.”

“Desmopressin should be used with caution in patients with conditions characterised by fluid and/or electrolyte imbalance.”

 

Section 4.5:

Sentence update: “Substances, which are known to induce SIADH, e.g., tricyclic antidepressants, selective serotonine reuptake inhibitors, chlorpromazine and carbamazepine, as well as some antidiabetics of the sulfonylurea group particularly chlorpropamide, may cause an additive antidiuretic effect leading to an increased risk of fluid retention/hyponatraemia (see section 4.4 Special Warnings and Precautions for Use).”

 

Sentence added: “It is unlikely that desmopressin will interact with drugs affecting hepatic metabolism, since desmopressin has been shown not to undergo significant liver metabolism in in vitro studies with human microsomes. However, formal in vivo interaction studies have not been performed. “

 

Section 4.6:

Sentence updated: “Published data on a limited number of exposed pregnancies in women with diabetes insipidus (n=53) as well as data on exposed pregnancies in women with bleeding complications (n=216) indicate no adverse effects of desmopressin on pregnancy or on the health of the foetus/newborn child.”

Sentences added: “Animal reproduction studies have shown no clinically relevant effects on parents and offspring. In vitro analysis of human cotyledon models have shown that there is no transplacental transport of desmopressin when administered at therapeutic concentration corresponding to recommended dose. “

Section 4.7:

Text updated from “None” to “DDAVP/Desmopressin Nasal drops solution has no or negligible influence on the ability to drive and use machines.”

Section 4.8:

Full section update – see SPC

Section 5.1:

Full section update – see SPC


Section 5.2:

Full section update – see SPC


Section 5.3:

Full section update – see SPC